Alinity Ci-Series Operation Manual - FSE 80000256-101
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tuấn anhAlinity Ci-Series Operation Manual - FSE 80000256-101
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tuấn anhAlinity ci-series Operations
Manual
For use with the Alinity c processing module and the Alinity i processing module
80000256-101
Table of contents
Read me first........................................................................................ 11
General safety information...................................................................................................... 12
System security........................................................................................................................ 13
Customer service..................................................................................................................... 14
Intended use............................................................................................................................. 15
Proprietary statement...............................................................................................................16
Disclaimers............................................................................................................................... 17
Alinity ci-series warranty statement for USA customers only................................................19
Alinity ci-series agency approvals...........................................................................................20
Intellectual Property statement................................................................................................21
Key to symbols......................................................................................................................... 22
System documentation...........................................................................25
Organization of the operations manual...................................................................................26
Conventions for the operations manual..................................................................................28
Operations manual description................................................................................................29
Toolbar.......................................................................................................................... 30
Navigation pane............................................................................................................ 30
Topic pane.................................................................................................................... 35
Operations manual use............................................................................................................37
Access the operations manual.....................................................................................37
Display and use the procedure map............................................................................38
Use the table of contents............................................................................................. 38
Scroll through a topic or the table of contents...........................................................38
Play an animation......................................................................................................... 39
Access the related information.................................................................................... 40
Use breadcrumbs to access a topic............................................................................40
Redisplay a topic...........................................................................................................41
Page through the content.............................................................................................41
Use the Toggle TOC button......................................................................................... 41
Use the index................................................................................................................ 41
Use the glossary........................................................................................................... 42
Search for a term......................................................................................................... 42
Move and close the operations manual...................................................................... 42
Print a topic from the operations manual....................................................................43
Procedure map description..................................................................................................... 44
Procedure map task lists..............................................................................................45
Use or function..................................................................................... 47
Alinity ci-series hardware overview......................................................................................... 48
Primary components of an Alinity ci-series.................................................................48
Alinity system software overview...........................................................................................126
Descriptions of screen elements............................................................................... 127
Menu bar..................................................................................................................... 130
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Table of contents
Required consumables.......................................................................................................... 133
Reagent kits and components....................................................................................133
Controls....................................................................................................................... 135
Calibrators................................................................................................................... 136
Bulk solutions (c-series).............................................................................................137
Bulk solutions (i-series).............................................................................................. 138
Onboard solutions (c-series)......................................................................................139
Maintenance solutions (c-series)...............................................................................139
ICT module (c-series).................................................................................................140
Probe conditioning solution (i-series)........................................................................ 141
Reaction vessels (i-series)......................................................................................... 142
Sample cups............................................................................................................... 142
Required accessories............................................................................................................ 144
Racks...........................................................................................................................144
Trays............................................................................................................................145
Reagent cartridge with empty bottles (c-series).......................................................145
Automatic processing module activities................................................................................147
System flush (c-series).............................................................................................. 147
System flush (i-series)................................................................................................147
System prime (i-series).............................................................................................. 148
Processing module wash (c-series).......................................................................... 148
Automatic rotation of the reagent carousel (c-series)............................................. 149
Installation procedures and special requirements.....................................151
System installation and relocation........................................................................................ 152
System installation...................................................................................................... 152
System checkout........................................................................................................ 152
System relocation....................................................................................................... 153
System configuration............................................................................................................. 154
Configure screen, General tab.................................................................................. 154
Configure screen, Computer tab............................................................................... 201
Configure screen, Assay tab......................................................................................227
Configure screen, Maintenance & Diagnostics tab.................................................. 310
Utilities screen........................................................................................................................323
Backup/Restore screen..............................................................................................323
System Updates screen............................................................................................. 328
Troubleshooting screen.............................................................................................. 342
Current Firmware screen............................................................................................346
CLI Diagnostics screen (FSE Logon)........................................................................ 347
Principles of operation......................................................................... 349
Principles of operation (c-series)..........................................................................................350
Photometric method (c-series).................................................................................. 350
Potentiometric method (c-series).............................................................................. 355
Assay processing (c-series).......................................................................................361
Indirect assay processing method (c-series)............................................................ 370
SmartWash feature (c-series)....................................................................................370
Optimum sampling sequence feature (c-series)...................................................... 371
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Table of contents
Sample interference indices (c-series)..................................................................... 372
Principles of operation (i-series)...........................................................................................375
CMIA method (i-series)...............................................................................................375
Assay processing (i-series)........................................................................................380
Performance characteristics and specifications....................................... 391
System characteristics...........................................................................................................392
Processing module characteristics (c-series)...........................................................392
Processing module characteristics (i-series)............................................................393
Specifications and requirements...........................................................................................394
Operational specifications..........................................................................................394
System capacities.......................................................................................................397
Physical specifications............................................................................................... 400
Typical floor loading................................................................................................... 401
System clearances..................................................................................................... 403
Electrical specifications and requirements............................................................... 403
Optical specifications (c-series)................................................................................ 406
Water and liquid waste specifications and requirements ........................................406
Environmental specifications and requirements....................................................... 408
Computer and interface specifications......................................................................409
External waste pump specifications and requirements............................................ 410
Bar code label requirements......................................................................................412
Sample specifications and requirements.................................................................. 420
Operating instructions..........................................................................427
System cycle power, start, pause, and stop........................................................................ 428
Cycle power to the system.........................................................................................428
Cycle power to the processing module and the reagent and sample manager
(RSM)..................................................................................................................... 432
Power on the processing module.............................................................................. 436
Power off the processing module..............................................................................440
Power on the reagent and sample manager (RSM).................................................444
Power off the reagent and sample manager (RSM)................................................ 446
Start the processing module and the reagent and sample manager (RSM).......... 447
Pause the processing module....................................................................................447
Pause the reagent and sample manager (RSM)...................................................... 448
Stop the processing module and the reagent and sample manager (RSM).......... 449
Perform an emergency shutdown..............................................................................449
Long-term shutdown (i-series)................................................................................... 452
Log On screen........................................................................................................................454
Log On screen element descriptions.........................................................................454
Log on..........................................................................................................................457
Lock the user interface.............................................................................................. 457
Notepad flyout........................................................................................................................ 458
View a note................................................................................................................. 458
Create a note.............................................................................................................. 459
Pin or unpin a note..................................................................................................... 459
Edit a note................................................................................................................... 460
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Table of contents
Add a comment to a note...........................................................................................461
Delete a note...............................................................................................................461
Delete all unpinned notes...........................................................................................462
Home screen.......................................................................................................................... 463
Home screen element descriptions........................................................................... 464
Host Connection Status flyout....................................................................................472
Printer Status/Queue flyout........................................................................................475
Alinity PRO Connection Status flyout........................................................................ 477
AbbottLink Connection Status flyout..........................................................................478
Abbott Mail Inbox screen............................................................................................479
Instrument statuses.....................................................................................................496
Consumable inventory management.....................................................................................500
Supplies screen.......................................................................................................... 500
Cal/QC Inventory screen............................................................................................ 518
Reagent and sample management....................................................................................... 523
Load racks and cartridges into trays......................................................................... 523
Load trays on the reagent and sample manager (RSM)..........................................524
Load racks on the reagent and sample manager (RSM).........................................526
Load cartridges on the reagent and sample manager (RSM)................................. 527
Load onboard solutions and sample diluents on the reagent and sample
manager (RSM) (c-series).................................................................................... 530
Load racks and reagent cartridges into temporary priority positions...................... 531
Unload trays from the reagent and sample manager (RSM)...................................533
Reagent carousel inventory management.................................................................533
Sample management..................................................................................................562
Specimen, calibration, and control orders............................................................................578
Automated ordering.................................................................................................... 578
Orders screen............................................................................................................. 584
Sample Status screen................................................................................................ 603
Results screen........................................................................................................................616
Results screen, Unreleased tab element descriptions............................................. 617
Results screen, Specimen tab element descriptions................................................618
Results screen, Control tab element descriptions.................................................... 620
Results screen, Exception tab element descriptions................................................621
Results screen, Search flyout element descriptions................................................ 622
Result Details screen..................................................................................................624
Rerun Options flyout, specimen order element descriptions................................... 628
Rerun Options flyout, control order element descriptions........................................629
Descriptions of specimen result flags....................................................................... 630
Descriptions of quality control result flags................................................................632
Descriptions of transmission statuses....................................................................... 634
View the reaction graph and absorbance data for a result (c-series).................... 634
Delete a sample result or an exception.................................................................... 635
Transmit a result or an exception to the host...........................................................635
Quality control analysis..........................................................................................................637
Westgard rule application...........................................................................................637
Levey-Jennings (Graph) screen.................................................................................641
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Table of contents
Quality Control Summary screen...............................................................................648
Print flyout.............................................................................................................................. 658
Print flyout element descriptions................................................................................659
Report File Location window element descriptions.................................................. 661
Print a report............................................................................................................... 662
Print a screen image.................................................................................................. 663
Search flyout.......................................................................................................................... 664
Search for or filter data..............................................................................................664
Archive flyout..........................................................................................................................666
Archive flyout element descriptions...........................................................................666
Archive File Location window element descriptions................................................. 667
Archive the results...................................................................................................... 668
Archive the calibrations.............................................................................................. 669
Insert and remove a USB flash drive....................................................................................671
Calibration procedures......................................................................... 673
Calibration guidelines.............................................................................................................674
Calibration types and methods..............................................................................................675
Calibration method (c-series potentiometric)............................................................675
Calibration types and methods (c-series photometric)............................................ 680
Calibration types and methods (i-series).................................................................. 690
Calibration storage.................................................................................................................699
Active calibration storage...........................................................................................699
Inactive calibration storage........................................................................................ 700
Failed calibration storage...........................................................................................700
Calibration review...................................................................................................................701
System calibration verification................................................................................... 701
Calibration Status screen........................................................................................... 702
Descriptions of calibration statuses...........................................................................708
View the assay calibration status.............................................................................. 709
Fail a calibration......................................................................................................... 710
Operational precautions and limitations..................................................711
General requirements............................................................................................................ 712
Precautions and requirements for system operation........................................................... 713
Precautions and requirements before operation...................................................... 713
Precautions during operation..................................................................................... 713
Requirements for handling the consumables.......................................................................714
Requirements for storage...........................................................................................714
Requirements for use................................................................................................. 714
Requirements for handling the specimens........................................................................... 716
Limitations of result interpretation.........................................................................................718
Hazards.............................................................................................. 719
Operator responsibility........................................................................................................... 720
Safety icons............................................................................................................................721
Biological hazards..................................................................................................................723
Precautions................................................................................................................. 723
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Table of contents
Chemical hazards.................................................................................................................. 725
General precautions................................................................................................... 725
Sodium azide...............................................................................................................726
Sensitizers................................................................................................................... 727
Waste handling and disposal................................................................................................ 728
Liquid wastes that contain (potentially) infectious materials................................... 728
Batteries...................................................................................................................... 729
Spill cleanup...........................................................................................................................730
Requirements for decontamination....................................................................................... 731
Preparation of sodium hypochlorite solutions........................................................... 731
Sodium hypochlorite stability......................................................................................732
Electrical hazards.................................................................................................................. 734
Mechanical hazards...............................................................................................................735
Physical hazards.................................................................................................................... 737
Probes and other sharps............................................................................................737
Heavy objects..............................................................................................................737
Hot objects.................................................................................................................. 738
Tripping hazards......................................................................................................... 738
Service, maintenance, and diagnostics................................................... 739
Maintenance and diagnostics................................................................................................740
Procedures screen..................................................................................................... 740
Procedures Log screen.............................................................................................. 752
Maintenance and diagnostic procedure statuses..................................................... 757
Maintenance procedure descriptions........................................................................ 758
Unscheduled cleaning................................................................................................ 772
Diagnostic procedure descriptions............................................................................ 775
Component replacement....................................................................................................... 827
Processing center component replacement (c-series)............................................ 827
Supply and pump center component replacement (c-series)................................. 864
Processing center component replacement (i-series)............................................. 892
Supply center component replacement (i-series).................................................... 904
Optional component replacement..............................................................................912
Troubleshooting.................................................................................. 917
Approach to troubleshooting................................................................................................. 918
System troubleshooting variables (c-series)............................................................. 919
System troubleshooting variables (i-series).............................................................. 921
Reagent troubleshooting variables (c-series)........................................................... 923
Reagent troubleshooting variables (i-series)............................................................ 924
Operator troubleshooting variables............................................................................925
Environmental troubleshooting variables...................................................................926
Alert Center flyout.................................................................................................................. 927
Alert Center flyout element descriptions................................................................... 927
View the probable cause and corrective action for a message.............................. 928
View additional messages that are associated with a message............................. 928
Delete a message from the Alert Center.................................................................. 929
System Logs screen.............................................................................................................. 930
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Table of contents
System Logs screen, All Messages tab element descriptions.................................930
System Logs screen, Notifications/Alerts tab element descriptions........................932
System Logs screen, Informational tab element descriptions................................. 933
System Logs screen, Inventory tab element descriptions........................................ 934
System Logs screen, User Access tab element descriptions..................................935
System Logs screen, Configuration tab element descriptions.................................936
System Logs screen, Host tab element descriptions............................................... 937
System Logs screen, Abbott Mail tab element descriptions.................................... 938
Message Details For flyout element descriptions.....................................................939
Descriptions of message types..................................................................................940
Message codes...................................................................................................................... 941
General message codes (0001-0999).......................................................................941
Assay-specific message codes (1000-1999)............................................................988
Maintenance and diagnostic message codes (2000-2999)...................................1047
Level sense and fluidics message codes (3000-3999)......................................... 1068
Optics and bar code reader message codes (4000-4999)................................... 1123
Robotics and sensor message codes (5000-5999)................................................1132
Support system message codes (6000-6999)........................................................1201
Temperature message codes (7000-7999)............................................................ 1202
Computer hardware peripheral message codes (8000-8999)...............................1208
Software message codes (9000-9999)...................................................................1224
Observed problems..............................................................................................................1263
Processing module observed problems ................................................................. 1263
Processing module observed problems (c-series)................................................. 1264
Processing module observed problems (i-series).................................................. 1268
Sample results observed problems (c-series)........................................................ 1270
Sample results observed problems (i-series)......................................................... 1276
User interface (UI) computer observed problems.................................................. 1287
Printer observed problems....................................................................................... 1288
Miscellaneous corrective action procedures......................................................................1290
Processing module corrective action procedures.................................................. 1290
Reagent and sample manager (RSM) corrective action procedure......................1304
User interface (UI) computer corrective action procedures.................................. 1306
Verification of assay claims................................................................. 1311
Limit of blank, limit of detection, and limit of quantitation.................................................1312
Verify a limit of blank (LoB) claim........................................................................... 1312
Verify a limit of detection (LoD) claim.....................................................................1315
Limit of quantitation (LoQ)....................................................................................... 1318
Precision............................................................................................................................... 1329
Verify the precision...................................................................................................1329
Evaluate the precision data......................................................................................1330
Calculate a precision verification value.................................................................. 1332
Precision worksheet (c-series)................................................................................ 1333
Precision worksheet (i-series)..................................................................................1335
Perform a calibration verification........................................................................................1337
Calibration verification worksheet (c-series)...........................................................1338
Calibration verification worksheet (i-series)............................................................1339
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Verify the linearity................................................................................................................ 1341
Linearity worksheet (c-series)..................................................................................1342
Linearity worksheet (i-series)...................................................................................1343
Measuring interval................................................................................................................1345
Verify an automated dilution................................................................................................1346
Automated dilution verification worksheet (c-series)..............................................1347
Automated dilution verification worksheet (i-series)...............................................1348
Method comparison............................................................................................................. 1351
Perform a quantitative method comparison............................................................ 1351
Perform a qualitative method comparison.............................................................. 1358
Verify the reference range (expected values)................................................................... 1365
Reference range (expected values) worksheet (c-series).....................................1366
Reference range (expected values) worksheet (i-series)......................................1367
List numbers..................................................................................... 1369
Consumable list numbers.................................................................................................... 1370
Consumable list numbers (c-series)................................................................................... 1371
Consumable list numbers (i-series).................................................................................... 1372
Accessory list numbers........................................................................................................1373
Accessory list numbers (c-series)...................................................................................... 1374
Accessory list numbers (i-series)........................................................................................1377
Glossary.................................................................................................... 1379
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Read me first
Foreword
Congratulations on becoming an operator of the Alinity ci-series. The Alinity ci-series has a
small, compact, and scalable design to help you adapt to day-to-day and long-term needs within
your laboratory. The system is supported by resourceful advocates consisting of dedicated
professionals who excel in engineering, medical technology, training, and service. As part of a
dedicated customer-training program, Abbott Laboratories will teach you how to operate,
maintain, and troubleshoot the system. We are dedicated to helping you achieve measurably
better health care with our resourceful advocates, harmonized systems, and intelligent insights
by providing you with the highest quality and most reliable instrumentation. We look forward to
serving your needs in any way possible.
Related information...
General safety information, page 12
System security, page 13
Customer service, page 14
Intended use, page 15
Proprietary statement, page 16
Disclaimers, page 17
Alinity ci-series warranty statement for USA customers only, page 19
Alinity ci-series agency approvals, page 20
Intellectual Property statement, page 21
Key to symbols, page 22
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General safety information Read me first
General safety information
Before operating the Alinity ci-series, you should read and understand the safety information in
this manual.
For information about actions or conditions that can affect system and assay performance,
carefully review Operational precautions and limitations, page 711.
To become familiar with safety icons on the instrument and in this manual that indicate
potentially hazardous situations, review Hazards, page 719. Comply with the hazard and safety
information to minimize the potential for harm to personnel and damage to the laboratory
environment.
These two sections of the manual contain supplemental information. Do not use the
supplemental information to supersede workplace safety requirements. Review any significant
differences between the supplemental information and the workplace safety requirements with
management or a workplace safety representative.
Related information...
Read me first, page 11
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Read me first System security
System security
Abbott Laboratories is committed to the security of the Alinity systems and reducing
cybersecurity risks associated with our medical devices.
Abbott Laboratories recognizes the importance of incorporating cybersecurity considerations
early and throughout our product design and development process. Our cybersecurity controls
were designed, developed, and implemented based on leading practices, regulatory guidance,
and government agencies.
Although we have designed the Alinity systems with cybersecurity controls, our customers also
play a vital role in protecting information security:
• Use of good laboratory practices and adherence to applicable regulations is recommended
at all times.
• The system should be installed in a secure location.
• Only authorized users should have access to the system because the system may contain
protected health information (PHI) or sensitive data.
• Although Alinity systems incorporate cybersecurity risk mitigation controls relating to network
connectivity, each system should be installed on a secure network that adheres to best
practices from a network security perspective to prevent unauthorized access to data
transmission between the Alinity system and external systems, such as a printer or host.
• Alinity systems also incorporate cybersecurity risk mitigation controls relating to connecting
USB storage devices. Reports or other data exported to USB storage devices should be
controlled with appropriate laboratory practices.
Related information...
Read me first, page 11
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Customer service Read me first
Customer service
For questions about the Alinity ci-series, contact the local representative or find country-specific
contact information at abbottdiagnostics.com.
Related information...
Read me first, page 11
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Read me first Intended use
Intended use
The Alinity ci-series is intended for In Vitro diagnostic use only.
The Alinity ci-series has a scalable design to provide full integration of clinical chemistry and
immunoassay analysis. The Alinity ci-series includes a clinical chemistry module and an
immunoassay module, each performing all sample processing activities, and a system control
module to provide a single user-friendly interface. Each system can be customized by combining
one or more sample processing modules, in multiple configurations, with a system control
module to form a single workstation.
The Alinity c processing module is a fully automated chemistry analyzer allowing random and
continuous access, as well as priority and automated retest processing using photometric and
potentiometric detection technology. The Alinity c processing module uses photometric detection
technology to measure sample absorbance for the quantification of analyte concentration and
uses potentiometric detection technology to measure the electrical potential in a sample. In
addition, the Alinity c processing module uses an integrated chip technology (ICT) module to
measure potentiometric assays (electrolytes).
The Alinity i processing module is a fully automated immunoassay analyzer allowing random and
continuous access, as well as priority and automated retest processing using chemiluminescent
microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the
presence of antigens, antibodies, and analytes in samples.
Related information...
Read me first, page 11
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Proprietary statement Read me first
Proprietary statement
The Alinity ci-series software programs and system documentation are protected by copyright
(©2016 Abbott Laboratories, Abbott Park, Illinois). All rights are reserved.
The software and manual were developed solely for use with the Alinity ci-series as specified in
the operating instructions.
The information, documents, and related graphics published herein (the "Information") are the
sole property of Abbott Laboratories. Permission to use the Information is granted, provided that:
• the copyright notice appears on all copies;
• use of the Information is for operation of ABBOTT products by Abbott trained personnel or
informational use only;
• the Information is not modified in any way; and
• no graphics are used separate from accompanying text.
Each person assumes full responsibility and all risks arising from use of the Information herein.
The Information is presented "AS IS" without warranties, either express or implied, and may
include technical inaccuracies or typographical errors. Abbott Laboratories reserves the right to
make additions, deletions, or modifications to the Information at any time without any prior
notification.
Portions of the Alinity ci-series software may include open source or third party software as
further explained in the Software License Attributions document, which can be accessed on the
Utilities screen.
7-Zip copyright ©1999-2016 Igor Pavlov
Related information...
Read me first, page 11
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Read me first Disclaimers
Disclaimers
All samples (printouts, graphics, displays or screens, etc.) are for information and illustration
purposes only and shall not be used for clinical or maintenance evaluations. Data shown in
sample printouts and screens do not reflect actual patient names or test results.
The Information was developed to be used by Abbott Laboratories trained personnel, by other
persons knowledgeable or experienced with the operation and service of the product identified,
under the direct supervision and with cooperation from Abbott Laboratories technical support or
service representatives.
In no event shall Abbott Laboratories or its affiliates be liable for any damages or losses incurred
in connection with or arising from the use of the information by persons not fully trained by
Abbott Laboratories.
No confidential relationship shall be established in the event that any user of the Information
should make any oral, written or electronic response to Abbott Laboratories (such as feedback,
questions, comments, suggestions, ideas, etc.). Such response and any information submitted
therewith shall be considered non-confidential, and Abbott shall be free to reproduce, publish or
otherwise use such information for any purposes whatsoever including, without limitation, the
research, development, manufacture, service, use, or sale of products incorporating such
information. The sender of any information to Abbott is fully responsible for its content, including
its truthfulness and accuracy and its non-infringement of any other person's proprietary rights.
Abbott Laboratories is not engaged in rendering medical advice or services.
Updates to the Information may be provided in either paper or electronic format. Always refer to
the latest documents for the most current information.
Incremental manual updates may cause the Master Table of Contents or Master Index page
numbering to change.
No part of this media may be reproduced, stored, retrieved, or transmitted in any form or by any
means without the prior written permission of Abbott Laboratories.
Data Usage Statement for AbbottLink
Data collection:
Abbott's AbbottLink software only collects operational and instrument data. It does not gather or
access patient, sensitive health or other identifiable personal information ("Personal Data").
Use of data:
AbbottLink is intended to transmit connected systems operational data, which may be used by
Abbott, and third parties providing related services and products, for troubleshooting, complaint
investigation, performance monitoring, product improvement, research, development, inventory
management, usage analytics, billing and other related purposes. In addition, AbbottLink may be
used to send system updates, to provide remote service and to facilitate Abbott's delivery of third
party services and products to Customer. The terms and conditions for Customer's use of such
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Disclaimers Read me first
third party services and products are to be provided to Customer separately by the applicable
third parties.
No Personal Data is transferred or accessed for company use.
Data privacy assurance:
All Personal Data is removed from operational data prior to AbbottLink retrieval. It is important
that our customers avoid entering Personal Data in any SID (Sample Identification) or comments
fields.
During Remote Support Instrument Screen Sharing, data is accessed and transferred on the
basis of consent provided by the user at the point of each individual screen-sharing event.
Please refer to the form of consent, displayed on your analyzer screen, when taking advantage
of this service.
Related information...
Read me first, page 11
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Read me first Alinity ci-series warranty statement for USA
customers only
Alinity ci-series warranty statement for USA
customers only
Abbott Laboratories warrants new instruments sold by Abbott Diagnostics Division to be free from
defects in workmanship and materials during normal use by the original purchaser. This warranty
shall continue for a period of one year from the date of shipment to the original purchaser, or
until title is transferred from the original purchaser, whichever occurs first (the "Warranty
Period").
If any defects occur during the Warranty period, contact your Abbott Customer Service
Representative immediately, and be prepared to furnish information including the serial number,
the model number, and pertinent details concerning the defect.
This Warranty does not cover defects or malfunctions which: (1) are not reported to Abbott
during the Warranty Period and within one week of occurrence; (2) result from chemical
decomposition or corrosion; (3) are caused primarily by misuse, alteration, damage or failure to
comply with any requirements or instruction contained in the applicable Abbott Operations
Manual (including the substitution of any reagent not authorized by Abbott); or (4) result from
maintenance, repair, or modification, performed or attempted by personnel not authorized by
Abbott without Abbott's authorization.
Abbott's liability for all matters arising from the supply, installation, use, repair, and maintenance
of the instrument, whether arising under this Warranty or otherwise, shall be limited solely to the
repair or (at Abbott's sole discretion) replacement of the instrument or of components thereof.
Replaced parts shall become the property of Abbott Laboratories. In no event shall Abbott be
liable for injuries sustained by third parties.
The ICT module Warranty is 20,000 samples or three months post-installation, whichever occurs
first.
The cuvette warranty is one year post-installation.
EXCEPT AS EXPRESSLY PROVIDED ABOVE, ABBOTT LABORATORIES HEREBY DISCLAIMS
ALL REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS OR IMPLIED, CREATED BY
LAW, CONTRACT OR OTHERWISE, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE OR NON-INFRINGEMENT.
IN NO EVENT SHALL ABBOTT LABORATORIES BE LIABLE FOR ANY INDIRECT, SPECIAL,
PUNITIVE, CONSEQUENTIAL OR INCIDENTAL DAMAGES (INCLUDING WITHOUT LIMITATION
LOST REVENUES, PROFITS, OR DATA) ARISING FROM OR IN CONNECTION WITH THE USE
OF THE INSTRUMENT, REGARDLESS OF WHETHER ABBOTT LABORATORIES HAS BEEN
ADVISED AS TO THE POSSIBILITY OF SUCH DAMAGES.
Related information...
Read me first, page 11
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Alinity ci-series agency approvals Read me first
Alinity ci-series agency approvals
The Alinity c processing module and the Alinity i processing module have been tested and found
to comply with the following agency standards and European Union (EU) directives:
• UL61010-1 Safety Requirements for Electrical Equipment for Measurement, Control, and
Laboratory Use - Part 1: General Requirements
• IEC/EN 61010-1 Safety Requirements for Electrical Equipment for Measurement, Control,
and Laboratory Use - Part 1: General Requirements
• CAN/CSA-C22.2 No. 61010-1 Safety Requirements for Electrical Equipment for
Measurement, Control, and Laboratory Use - Part 1: General Requirements
• IEC/EN 61010-2-101 Safety requirements for electrical equipment for measurement, control
and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical
equipment
• IEC/EN 61010-2-081 Safety requirements for electrical equipment for measurement, control
and laboratory use - Part 2-081: Particular requirements for automatic and semi-automatic
laboratory equipment for analysis and other purposes
• IEC/EN 61010-2-010 Safety requirements for electrical equipment for measurement, control
and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the
heating of materials
• Directive 2012/19/EU: Waste Electrical and Electronic Equipment (WEEE)
• Directive 2011/65/EU: Restriction of the Use of Certain Hazardous Substances in Electrical
and Electronic Equipment (RoHS 2)
• Directive 98/79/EC: In Vitro Diagnostic Medical Devices (IVD)
• IEC/BS EN 61326-1 Electrical equipment for measurement, control and laboratory use -
EMC requirements - Part 1: General requirements
• IEC/BS EN 61326-2-6 Electrical equipment for measurement, control and laboratory use -
EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical
equipment
Legal Manufacturer Abbott GmbH & Co. KG
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580
Related information...
Read me first, page 11
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Read me first Intellectual Property statement
Intellectual Property statement
The green and blue striping, ALINITY, and related brand marks are trademarks of Abbott
Laboratories in various jurisdictions.
Other trademarks are the property of their respective owners. No use of any Abbott trademark,
trade name, or trade dress may be made without the prior written authorization of Abbott
Laboratories, except to identify the product or services of Abbott Laboratories.
For U.S. patent information, see abbott.us/patents.
Related information...
Read me first, page 11
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Key to symbols Read me first
Key to symbols
The following symbols are used on Alinity ci-series labels and labeling.
Symbol Description
Authorized Representative in the European
Community
Caution: Biological RISKS
Caution: Consult accompanying documents
Caution: Hot surface
Caution: Possibility of electric shock
Caution: Probe stick hazard
Consult operating instructions
Date of manufacture
Disconnect Mains Plug
Electrical and electronic equipment waste
NOTE: Indicates that the item needs to be disposed
of in a separate waste collection for electrical and
electronic equipment and must not be disposed of
in the general waste or trash.
Manufacturer
Temperature limitation
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Read me first Key to symbols
Symbol Description
UL Recognized Component Mark
Use by/Expiration date
Acid Wash
Alkaline Wash
Concentrated Wash Buffer
Detergent A
Detergent B
Distributed by
Distributed in the USA by
For use with
ICT Reference Solution
In Vitro Diagnostic Medical Device
Kit
Batch code/Lot number
Manufactured by
Manufactured for
Pre-Trigger Solution
Produced by
Produced for Abbott by
Product of Japan
Product of Singapore
Product of USA
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Key to symbols Read me first
Symbol Description
Quantity
Reaction vessels
Catalog number/List number
Revision
Sample cups
Sequence number
Serial number
Trigger Solution
Unit
Wash buffer
Water Bath Additive
Related information...
Read me first, page 11
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System documentation
Introduction
The Alinity ci-series Operations Manual provides complete instructions for the use and
maintenance of the Alinity ci-series and its modules and components.
Learning to use the operations manual helps to save time, avert trouble, and confidently operate
the system.
Related information...
Organization of the operations manual, page 26
Conventions for the operations manual, page 28
Operations manual description, page 29
Operations manual use, page 37
Procedure map description, page 44
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Organization of the operations manual System documentation
Organization of the operations manual
Section Description
Read me first • General safety information
• Customer service contact information
• Intended use of the system
System documentation • Content organization and conventions
• Use of the operations manual
Section 1: Use or function • Hardware overview
• Software overview
• Required consumables
• Required accessories
Section 2: Installation procedures and special • System installation and relocation
requirements • System configuration
Section 3: Principles of operation • Detection technology
• How the system translates measurements into
results
Section 4: Performance characteristics and System specifications and requirements
specifications
Section 5: Operating instructions Procedures for routine system operation
Section 6: Calibration procedures Procedures for calibration
Section 7: Operational precautions and limitations Operational requirements, precautions, and
limitations to ensure optimal operator safety and
accurate test results
Section 8: Hazards Hazard and safety information
Section 9: Service, maintenance, and diagnostics • Procedures for maintenance and diagnostics
• Description of maintenance and diagnostic
procedures
• Procedures for component replacement
Section 10: Troubleshooting • Troubleshooting basics
• Probable causes and corrective actions for
message codes and observed problems
Appendices Refer to the appendices for the following
information:
• Verification of assay claims
• List numbers
Revision history History of revisions to the operations manual
Glossary Alphabetical listing of terms that are used in the
operations manual
Index Alphabetical listing of subject matter with
references to the location of information
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System documentation Organization of the operations manual
Related information...
System documentation, page 25
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Conventions for the operations manual System documentation
Conventions for the operations manual
Conventions are a set of defined standards that are used to communicate meaning in an
expected manner.
Table 1: Text conventions
Description Use
Italic font style Indicates a reference to related information.
Bold font style Emphasizes key words in procedures. For example,
in the numbered steps, bold font style is applied to
the following elements:
• Toolbar, icon, and menu items
• Buttons
• Commands
• Lists and tabs
• Dialog box titles and options
Numbers in brackets (for example, [1] and [2]) Reference specific areas of a graphic.
Table 2: Content conventions
Description Use
Safety symbols and the CAUTION signal word Identify activities that expose the operator to
potentially dangerous conditions.
IMPORTANT signal word Advises the operator to comply with precautions to
prevent a negative impact on system operations or
results.
NOTE signal word Provides information that is relevant to the topic
content.
Related information list Provides references at the end of a topic that are
related to the topic.
Table 3: Graphic conventions
Description Use
Numerical references on graphics Indicate items in a graphic that are described in the
legend.
Related information...
System documentation, page 25
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System documentation Operations manual description
Operations manual description
The operations manual is designed to be the quickest and most accurate resource for
informational needs. It is accessed from the system software.
Figure 1: Operations manual
Legend:
1. Title bar: Displays the title of the topic
2. Toolbar: Provides elements for navigation
3. Navigation pane: Provides an area to browse the operations manual content
4. Topic pane: Displays the topic content
5. Close button: Closes the operations manual
Related information...
System documentation, page 25
Toolbar, page 30
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Operations manual description System documentation
Navigation pane, page 30
Topic pane, page 35
Toolbar
The toolbar contains navigation elements and a Print button.
Figure 2: Toolbar
Legend:
1. Home link
2. Search box
3. Procedure Map button
4. Toggle TOC button
5. Back and Forward buttons
6. Previous Topic and Next Topic buttons
7. Print button
Related information...
Operations manual description, page 29
Navigation pane
The navigation pane provides the primary navigation functionality. It provides an area to browse
the topic content by using the Content, Index, Glossary, or Search tab.
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System documentation Operations manual description
Figure 3: Navigation pane
Related information...
Operations manual description, page 29
Contents tab, page 31
Index tab, page 33
Glossary tab, page 33
Search tab, page 34
Contents tab
The Contents tab is an element in the navigation pane that displays the table of contents, which
shows how information in the operations manual is organized. Topics are identified by a Book
icon or a Page icon.
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Operations manual description System documentation
Figure 4: Contents tab
Legend:
1. Book icon (closed): Indicates that a list of subtopics is collapsed
2. Book icon (open): Indicates that a list of subtopics is expanded
3. Page icon: Indicates that no subtopics are available
Related information...
Navigation pane, page 30
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System documentation Operations manual description
Index tab
The Index tab is an element in the navigation pane that displays an alphabetical list of all index
entries in the operations manual. Entries are sorted by subject and relevance and include terms
for all experience levels and informational types that range from general to specific.
Figure 5: Index tab
Related information...
Navigation pane, page 30
Glossary tab
The Glossary tab is an element in the navigation pane that displays an alphabetical list of terms
with definitions for those terms.
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Operations manual description System documentation
Figure 6: Glossary tab
Related information...
Navigation pane, page 30
Search tab
The Search tab is an element in the navigation pane that displays a list of search results. The
search results are topic titles in the operations manual that are associated with a search term in
the Search box.
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Figure 7: Search tab
Legend:
1. Search tab
2. Search box
Related information...
Navigation pane, page 30
Topic pane
The topic pane is the area under the toolbar that displays topic content. The topic content may
contain navigation elements (for example, hypertext and image maps) and multimedia.
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Figure 8: Topic pane
Legend:
1. Breadcrumbs: Provide a trail of topic links to show the hierarchy of topics that were previously
accessed
2. Topic content: Provides information about the system
3. Related information: Provides links to related topics
Related information...
Operations manual description, page 29
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System documentation Operations manual use
Operations manual use
The operations manual is designed for quick access to information needed to:
• Understand the concepts behind system operation and performance.
• Accomplish a task.
• Recover from a mistake.
• Troubleshoot a problem.
Related information...
System documentation, page 25
Access the operations manual, page 37
Display and use the procedure map, page 38
Use the table of contents, page 38
Scroll through a topic or the table of contents, page 38
Play an animation, page 39
Access the related information, page 40
Use breadcrumbs to access a topic, page 40
Redisplay a topic, page 41
Page through the content, page 41
Use the Toggle TOC button, page 41
Use the index, page 41
Use the glossary, page 42
Search for a term, page 42
Move and close the operations manual, page 42
Print a topic from the operations manual, page 43
Access the operations manual
Perform this procedure to display the home page of the operations manual or the content
specific to an active screen, a flyout, or a message code.
• On the menu bar, tap System, and then tap Operations Manual (Help).
As an alternative step, tap the Help button at the top of the active screen.
Related information...
Operations manual use, page 37
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Operations manual use System documentation
Display and use the procedure map
Perform this procedure to view a list of procedures that are related to the performance of a
specific task and to display the instructions associated with each procedure.
1. On the toolbar, tap the Procedure Map button .
2. To display a list of related tasks, tap a category on the procedure map that is displayed in
the topic pane.
3. In the expandable list of related tasks for the category, tap a task with a Right Arrow button
.
The Right Arrow button changes to a Down Arrow button and displays a list of subtasks
or procedures.
4. To display a procedure, tap the procedure.
5. To return to the procedure map, tap the Procedure Map button.
Related information...
Operations manual use, page 37
Use the table of contents
Perform this procedure to view a list of topic titles in the operations manual and to display
associated topic content.
1. In the navigation pane, tap the Contents tab.
2. To expand or collapse the list of topic titles, tap a Book icon .
3. At the right side of the navigation pane, slide the scroll bar to view the topic titles.
4. To display the topic content in the topic pane, tap a topic title.
Related information...
Operations manual use, page 37
Scroll through a topic or the table of contents
Perform this procedure to move through content in a topic or to move through the table of
contents.
• In the topic pane or in the navigation pane, drag the scroll box up or down.
The scroll box indicates the position in the topic or in the table of contents.
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System documentation Operations manual use
Figure 9: Scroll bars
Legend:
1. Navigation pane scroll bar
2. Topic pane scroll bar
Related information...
Operations manual use, page 37
Play an animation
The animation toolbar plays, pauses, and stops animations. It also can be used to seek a
specific location in an animation and to switch to a full-screen display.
Figure 10: Animation toolbar
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Operations manual use System documentation
Legend:
1. Play button
2. Seek button
3. Full Screen toggle button
Perform this procedure to play an animation.
1. At the bottom of the image, tap the Play button.
The animation plays and the Play button changes to a Pause button .
NOTE: When a mouse is used to start an animation and the cursor is moved away from the
toolbar, the toolbar is not displayed. Move the cursor below the animation to display the
toolbar again.
2. To specify the playback position of the animation, tap a point on the timeline to move the
Seek button to that position.
3. To display the animation in full-screen mode, tap the Full Screen toggle button.
4. To restore the animation to its original size, tap the Full Screen toggle button again.
Related information...
Operations manual use, page 37
Access the related information
Perform this procedure to access the related information in a topic.
1. In the topic pane, tap a related information hypertext link.
2. To return to the last topic that was viewed, tap the related information hypertext link for the
topic (or tap the Back button ).
Related information...
Operations manual use, page 37
Use breadcrumbs to access a topic
Perform this procedure to access a topic in a breadcrumb trail. As topics are selected in the
navigation pane, a trail of the selected topics, or breadcrumbs, is displayed at the top of the
topic pane.
• At the top of the topic pane, tap a topic breadcrumb.
NOTE: Topic breadcrumbs display associated topic content. The Home link displays the home
page of the operations manual.
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Related information...
Operations manual use, page 37
Redisplay a topic
Perform this procedure to display a topic that is viewed in the active Help session.
1. To display the last topic that was viewed, tap the Back button .
2. To display the next topic in a previously displayed sequence of topics, tap the Forward
button .
Related information...
Operations manual use, page 37
Page through the content
Perform this procedure to move through a sequence of topics similar to the turning of pages of a
book.
1. On the Contents tab, tap a topic to display its content in the topic pane.
2. On the toolbar, tap the Previous Topic button or the Next Topic button .
NOTE: The Previous Topic button is unavailable for the first topic in the manual. The Next
Topic button is unavailable for the last topic in the manual.
Related information...
Operations manual use, page 37
Use the Toggle TOC button
Perform this procedure to hide the navigation pane of the operations manual. The navigation
pane contains the table of contents (TOC).
1. To hide the navigation pane, tap the Toggle TOC button .
2. To display the navigation pane, tap the Toggle TOC button again.
Related information...
Operations manual use, page 37
Use the index
Perform this procedure to view index entries and to display associated topic content.
1. In the navigation pane, tap the Index tab.
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2. At the right side of the navigation pane, slide the scroll bar to view index headings (italic
font style) and index entries (plain font style).
3. To display the topic content in the topic pane, tap an index entry.
Related information...
Operations manual use, page 37
Use the glossary
Perform this procedure to view glossary terms and to display associated definitions.
1. In the navigation pane, tap the Glossary tab.
2. At the right side of the navigation pane, slide the scroll bar to view the glossary terms.
3. To display a definition in the topic pane, tap a glossary term.
Related information...
Operations manual use, page 37
Search for a term
Perform this procedure to search the operations manual.
1. On the toolbar, tap the Search box.
2. With the virtual keyboard, type a search term.
3. Tap the Search icon .
4. In the list of search results on the Search tab, tap a topic title.
In the topic pane, each word of the search term is highlighted in the topic because each
word of the search term is treated individually. If only one word of a search term is in a
topic, the topic is included in the search results.
Related information...
Operations manual use, page 37
Move and close the operations manual
Perform this procedure to change the position of the operations manual and to close the manual.
1. To resize the navigation and topic panes of the manual, drag the divider handle between
the panes toward the left edge or the right edge.
2. To move the manual, drag the title bar.
3. To close the manual, tap the Close button .
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System documentation Operations manual use
Related information...
Operations manual use, page 37
Print a topic from the operations manual
Perform this procedure to print a topic that is displayed in the topic pane.
1. On the toolbar, tap the Print button .
2. In the Print window, tap Print.
Related information...
Operations manual use, page 37
Clean and decontaminate the monitor, page 774
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Procedure map description System documentation
Procedure map description
The procedure map is an image map that displays categories of laboratory-related activities and
provides links to lists of tasks and procedures. The procedure map is used to quickly access
step-by-step instructions to help perform primary laboratory procedures.
Figure 11: Procedure map
Legend:
1. Procedure Map button: Provides access to tasks and procedures that are grouped by categories
2. Sample processing: Provides access to procedures used to prepare for system operation, to order
tests, to load and process samples, to review results, and to print reports
3. Quality control: Provides access to procedures used to review quality control data and to print quality
control reports
4. Manage data: Provides access to procedures used to manage system data
5. Help on Help: Provides access to procedures that describe how to use the operations manual
6. Maintenance: Provides access to procedures used to perform maintenance, to approve maintenance
logs, and to print reports
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System documentation Procedure map description
7. Troubleshooting: Provides access to procedures used to review system logs, to perform diagnostics,
to replace components, and to print diagnostic reports
8. Setup: Provides access to procedures used to configure and view settings for the system, assays,
quality control, and calibration, and to print reports
9. Calibration: Provides access to procedures used to calibrate assays
Related information...
System documentation, page 25
Procedure map task lists, page 45
Procedure map task lists
Task lists are topics that are accessed from the procedure map. Each topic contains an
expandable list of tasks that are related to a procedure map category or a laboratory-related
activity. Each task has a list of links to related procedures.
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Procedure map description System documentation
Figure 12: Procedure map task list
Legend:
1. Task list item that is collapsed
2. Task list item that is expanded
Related information...
Procedure map description, page 44
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Section 1 Use or function
Introduction
The Alinity ci-series of analyzers has a scalable design to provide full integration of multiple
clinical chemistry and immunoassay systems, all of which are controlled by one user-friendly
interface. This intuitive user interface provides a real-time display of each system’s status and a
to-do list of scheduled maintenance activities, which minimizes system interaction and optimizes
productivity. The Alinity ci-series analyzers have also incorporated numerous features to prevent
and reduce errors and to increase walkaway time.
Related information...
Alinity ci-series hardware overview, page 48
Alinity system software overview, page 126
Required consumables, page 133
Required accessories, page 144
Automatic processing module activities, page 147
Operating instructions, page 427
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Use or function
Alinity ci-series hardware overview Section 1
Alinity ci-series hardware overview
With the scalable design of the Alinity ci-series family of analyzers, multiple processing modules
can perform all sample-processing activities and can be physically joined to form one
workstation or system. The processing modules determine the system configuration.
An Alinity ci-series can be configured as:
• One stand-alone chemistry system.
• One stand-alone immunoassay system.
• A multimodule system that is a fully automated clinical chemistry assay and immunoassay
system.
A multimodule system includes one Alinity c processing module and one Alinity i processing
module. Alinity chemistry systems can be configured to process samples by using photometric
and potentiometric methods. Alinity immunoassay systems use the chemiluminescent
microparticle immunoassay (CMIA) method.
Related information...
Use or function, page 47
Primary components of an Alinity ci-series, page 48
Primary components of an Alinity ci-series
An Alinity ci-series, regardless of type, has three primary components:
System control Provides a common user interface among all Alinity products.
module (SCM)
Reagent and sample Transports reagents, samples, calibrators, and controls
manager (RSM) through the Alinity ci-series. Each system has one primary
RSM regardless of the type and number of processing
modules.
Processing module Performs all sample-processing activities from sample
aspiration to final result reporting. The type and number of
processing modules determine the system configuration.
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Use or function
Section 1 Alinity ci-series hardware overview
Figure 13: Primary components of an Alinity ci-series
Legend:
1. Processing module
2. RSM
3. SCM
Related information...
Alinity ci-series hardware overview, page 48
Procedure key, page 50
System control module (SCM), page 52
Reagent and sample manager (RSM), page 62
Processing modules, page 66
Optional components, page 123
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Use or function
Alinity ci-series hardware overview Section 1
Procedure key
The procedure key provides access to the front and rear processing center covers of the Alinity
ci-series processing modules and the reagent and sample manager by overriding the interlocks
for the processing module and system control module covers. The procedure key can be used to
perform maintenance procedures, diagnostic procedures, and component replacement
procedures.
Figure 14: Procedure key for the Alinity c
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Section 1 Alinity ci-series hardware overview
Figure 15: Procedure key for the Alinity i
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Use or function
Alinity ci-series hardware overview Section 1
Figure 16: Procedure key for the system control module
Related information...
Primary components of an Alinity ci-series, page 48
Descriptions of procedure key settings, page 746
Use a procedure key to perform a procedure, page 747
System control module (SCM)
The system control module (SCM) contains the following items:
• A user interface computer provides the software interface to the Alinity ci-series and
provides an interface to a host or middleware computer.
• Hardware and software operate the reagent and sample manager (RSM).
• The power supply operates the user interface computer and the RSM.
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Section 1 Alinity ci-series hardware overview
Figure 17: Front view of the SCM
Legend:
1. Adjustable monitor: Displays the user interface of the Alinity ci-series and accepts on-screen
selections from the operator
2. Front SCM cover: Provides access to the RSM transport
NOTE: The front SCM cover is monitored by a sensor. If the cover is opened when the instrument
status of the RSM is Initializing or Running, the status transitions to Stopped.
3. SCM shelf: Provides a small shelf for the operator and provides access to remove the bar code
scanner
4. Bar code scanner: Provides a means to scan sample bar codes and supply bar codes
5. SCM front door: Provides access to the user interface computer and the procedure lock
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Use or function
Alinity ci-series hardware overview Section 1
Figure 18: Rear view of the SCM
Legend:
1. Rear SCM cover: Provides access to the user interface computer power strip
2. Rear SCM upper access panel: Provides access to the Ethernet switch
3. Rear SCM lower access panel: Provides access to the power supply and RSM electronics
4. SCM main power breaker: Powers on and powers off the SCM power supply
Related information...
Primary components of an Alinity ci-series, page 48
System control module (SCM) hardware components, page 55
Network connectors, page 56
Adjust the monitor position, page 57
Distance alert, page 60
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Use or function
Section 1 Alinity ci-series hardware overview
System control module (SCM) hardware components
Hardware components of the system control module (SCM) include the user interface hardware
and the reagent and sample manager (RSM) hardware.
Figure 19: SCM hardware components
Legend:
1. Bar code scanner: Scans SID bar codes and supply bar codes. When the SCM shelf is accessed, the
bar code scanner can be removed from the holder and can be used as a hand-held scanner.
2. Uninterrupted power supply (UPS): Provides a temporary, continuous flow of power to the user
interface (UI) computer during a power failure, which helps the operator to save data as necessary
and to perform a controlled shutdown procedure. (Optional component)
3. RSM X motor: Moves the RSM transport from position to position and from module to module.
4. Firewall: Provides data protection between the UI computer and the supporting communications
network.
5. UI power strip: Distributes AC power to the UI computer, the adjustable monitor, and the Ethernet
switch.
6. RSM embedded computer: Provides the software control for the RSM.
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Use or function
Alinity ci-series hardware overview Section 1
7. Ethernet switch: Joins communication lines and facilitates the electronic transfer of information
among the UI computer and the processing module embedded computer and the RSM embedded
computer.
8. Network connectors: Provides connections for external devices, such as host interface and
AbbottLink.
9. SCM power supply: Provides AC power to the UI power strip and DC power to the RSM hardware.
10. UI computer: Provides the software interface to the Alinity ci-series and provides an interface to a
host or middleware computer.
11. Water inlet: Provides a common area for the entrance and distribution of water for all processing
modules in a system.
12. Waste manifold: Provides a common waste outlet area for all processing modules in a system.
Related information...
System control module (SCM), page 52
Network connectors
Network connectors provide connections from the user interface computer, through the firewall,
to the wide area network (WAN) and to other external devices, such as the host interface, a
middleware computer, and Alinity PRO.
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Section 1 Alinity ci-series hardware overview
Figure 20: Network connectors
Legend:
1. WAN connector
2. Network connectors
Related information...
System control module (SCM), page 52
Adjust the monitor position
Perform this procedure to adjust the height and angle of the monitor. The monitor support arm
has pivot points to adjust the monitor.
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Use or function
Alinity ci-series hardware overview Section 1
Figure 21: Monitor pivot points
1. Position the monitor at a comfortable level to view.
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Section 1 Alinity ci-series hardware overview
2. Adjust the monitor so that it is an arm's length from the face (38 cm to 76 cm or 15 in. to
30 in.).
3. Tilt the monitor slightly downward to eliminate any glare or reflection.
4. Tilt the monitor slightly backward to use the virtual keyboard.
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5. Move the monitor to the right side or the left side of the instrument as needed. The ideal
position depends on the instrument configuration and the location of the operator.
6. Use the attached handles to rotate the monitor to the rear of the instrument when required.
Related information...
System control module (SCM), page 52
Distance alert
The distance alert is an optional component on the workstation that is used to identify instrument
conditions that require an operator response to maintain the optimal workflow.
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Figure 22: Distance alert
The distance alert illuminates one of three colors (red, amber, or green) based on the status of
the workstation.
The following list provides descriptions of each color. If multiple conditions are present, the
colors are illuminated in the following order:
Red (blinking) • The instrument status of one or more processing modules
in the workstation transitions from Running or Processing
to Stopped or Offline without an operator request to
transition the status.
• A critical alert message is generated and is displayed on
the user interface.
Red The instrument status of one or more processing modules in
the workstation is Running, Processing, or Pausing, and one
of the following conditions is present:
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• A red badge is displayed on any icon on the menu bar.
• An alert message that has not been cleared is present in
the Alert Center.
Amber The instrument status of one or more processing modules in
the workstation is Running, Processing, or Pausing, and one
of the following conditions is present:
• An amber badge is displayed on any icon on the menu
bar except the Results icon.
• An amber badge is displayed on the Results icon if the
distance alert is configured for exception notifications.
• A notification message that has not been cleared is
present in the Alert Center.
Green (blinking) The instrument status of one or more processing modules, but
not all modules, in the workstation is Running or Processing.
Green The instrument status of all processing modules in the
workstation is Running or Processing.
Distance alert off When one of the multiple conditions is present, the following
situations occur:
• The distance alert is disabled.
• The user interface computer is shut down.
Related information...
System control module (SCM), page 52
Reagent and sample manager (RSM)
The reagent and sample manager (RSM) is a transport system used to load calibrators, controls,
specimens, reagents, and onboard solutions. The design of the RSM provides random and
continuous access to load and unload sample racks, calibration and control racks, and reagent
cartridges.
One primary RSM transports samples and reagents through an Alinity ci-series regardless of the
type and number of processing modules.
The RSM performs the following functions:
• Lifts racks and cartridges from the loading area and moves them past the bar code reader
• Positions racks and cartridges for the bar code reader to identify samples, reagents, and
solutions
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• Moves racks and cartridges to the appropriate processing module or returns them to the
loading area
Figure 23: RSM components
Legend:
1. Sample positioner: Positions racks at the sample aspiration position. Each module has two sample
positioners. A rack exchange occurs between the loading area and one sample positioner while the
other sample positioner positions samples for aspiration.
2. RSM bar code reader: An imaging camera that reads bar code labels on samples, racks, and
cartridges.
3. RSM transport: Transports racks and cartridges from the loading area to be read by the bar code
reader and to be placed on the module-specific sample positioner or reagent positioner.
4. Loading area: Positions racks and cartridges for loading and unloading.
Related information...
Primary components of an Alinity ci-series, page 48
Loading area, page 64
Status indicators, page 65
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Reagent supply center (Alinity c) , page 91
Reagent supply center (Alinity i), page 120
Loading area
The loading area holds racks and cartridges for routine and priority processing. Each processing
module includes one loading area.
Figure 24: Loading area
Legend:
1. Priority button: Temporarily assigns an RSM position as a priority position.
2. Priority position: Designated with a blue status indicator. Racks or cartridges inserted in this position
are processed before other positions.
3. Status indicators: Indicate the status of sample processing and when samples and reagents can be
accessed.
4. Tray: Holds racks and cartridges to load on the reagent and sample manager (RSM). Each tray holds
a maximum of five racks or cartridges. Empty trays may remain on the loading area to create five
positions to load racks or cartridges one at a time.
5. Position: Holds one rack or cartridge. Each processing module has 25 positions.
6. Bay: Holds trays that are used to position racks and cartridges for assay processing. Each processing
module contains five bays.
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Related information...
Reagent and sample manager (RSM), page 62
Racks, page 144
Trays, page 145
Reagent kits and components, page 133
Status indicators, page 65
Status indicators
Three status indicators (blue, green, and amber) are located above each reagent and sample
manager (RSM) position to indicate the status of sample processing and when racks and
cartridges can be accessed.
Figure 25: Status indicators
The following list shows the position status:
Indicators off No rack or cartridge is inserted in the position. [1]
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Green (steady) The rack or cartridge is inserted but is not in process. The
rack or cartridge can be accessed. [2]
Amber (steady) The rack or cartridge is in process. The rack or cartridge
cannot be accessed. [4]
Green (blinking) Processing is completed. The rack or cartridge can be
accessed.
If a test is added or a rerun is scheduled before the rack is
removed from the loading area, the status indicator for the
position changes to amber and the rack cannot be accessed.
Amber (blinking) Unloading of a cartridge or vial rack is in process. The
position is reserved and is unavailable to load a rack or
cartridge.
Amber and green A bar code scan error or other error occurred. The rack or
(alternating) cartridge can be accessed.
Blue The RSM position is designated as a priority position. [3]
Related information...
Reagent and sample manager (RSM), page 62
Loading area, page 64
Unload trays from the reagent and sample manager (RSM), page 533
Processing modules
Processing modules perform all sample-processing activities from sample aspiration to final
result reporting.
Unless otherwise indicated, "processing module" is used generically throughout this manual to
refer to both types of modules.
Related information...
Primary components of an Alinity ci-series, page 48
Processing module (Alinity c), page 66
Processing module (Alinity i), page 93
Processing module (Alinity c)
The Alinity c processing module is a chemistry analyzer that performs sample processing. The
processing module processes a maximum of 1350 photometric and potentiometric tests per hour
and has 70 positions in the reagent carousel at a controlled temperature.
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Figure 26: Front view of the Alinity c processing module
Legend:
1. Front processing center cover: Provides access to the components that perform assay-processing
activities.
NOTE: The front processing center cover is monitored by two sensors. If the cover is opened during
Initializing status, Running status, or Processing status, the reagent and sample manager and the
processing module transition to Stopped status.
2. Bulk solution door: Provides access to the bulk solution storage area and the pump center.
3. Front electronics door: Provides access to the processing module electronics and the procedure lock.
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Figure 27: Rear view of the Alinity c processing module
Legend:
1. Rear processing center cover: Provides access to the components that perform assay-processing
activities.
NOTE: The rear processing center cover is monitored by a sensor. If the cover is opened when the
instrument status of the processing module is Initializing, Running, or Processing, the status
transitions to Stopped.
2. Rear access panel: Provides additional access to processing center components.
3. Rear lower access panel: Provides access to the water management unit.
4. Power supply panel: Provides access to the processing module power supply.
5. Processing module main power breaker: Powers on and powers off the power supply.
Related information...
Processing modules, page 66
Processing center (Alinity c), page 69
Supply and pump center (Alinity c), page 85
Reagent supply center (Alinity c) , page 91
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Processing center (Alinity c)
The processing center is the main activity area of the processing module. Samples and reagents
are dispensed and mixed in a reaction carousel where assay processing is performed.
Figure 28: Processing center (Alinity c)
Legend:
1. Pipetting hardware: Aspirates and dispenses sample and reagents
2. Reaction carousel hardware: Positions the cuvettes for sample and reagent dispense, mixing,
photometric or potentiometric analysis, and cuvette washing
Related information...
Processing module (Alinity c), page 66
Pipetting hardware (Alinity c), page 69
Reaction carousel hardware (Alinity c), page 73
Pipetting hardware (Alinity c)
Pipetting hardware aspirates and dispenses samples, reagents, and onboard solutions.
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Figure 29: Pipetting hardware components (Alinity c)
Legend:
1. Sample pipettor (S): Aspirates and dispenses samples into cuvettes and transfers diluted samples
from one cuvette to another.
2. Wash cups (SW, WB, R1W, and R2W): Wash any fluid that remains from the interior and exterior
surfaces of probes.
3. Reagent pipettors (R1 and R2): Aspirate and dispense reagents and onboard solutions into cuvettes.
The R1 pipettor also aspirates and dispenses diluents.
Related information...
Processing center (Alinity c), page 69
Pipettors (Alinity c), page 70
Wash cups (Alinity c), page 72
Sample wash solution area (Alinity c) , page 73
Pipettors (Alinity c)
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Pipettors detect, aspirate, transfer, and dispense samples and reagents into cuvettes. These
pipettor assemblies include a fluid sense system to help identify aspiration errors. The sample
pipettor includes the addition of a pressure-monitoring system to identify aspiration errors. Three
pipettors that have the following functions are located on the system:
• The sample pipettor (S) detects, aspirates, transfers, and dispenses samples into cuvettes.
It also transfers diluted samples from the cuvette that is used to make the dilution into the
cuvette that is used for the reaction.
• The reagent 1 pipettor (R1) detects, aspirates, transfers, and dispenses diluents, reagents,
and onboard solutions into cuvettes.
• The reagent 2 pipettor (R2) detects, aspirates, transfers, and dispenses reagents and
onboard solutions into cuvettes.
Figure 30: Pipettors (Alinity c)
Legend:
1. Sample pipettor
2. Reagent 1 pipettor
3. Reagent 2 pipettor
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Related information...
Pipetting hardware (Alinity c), page 69
Wash cups (Alinity c)
The Alinity c wash cups are active wash stations that use system water to clean the pipettors.
The system has four pipettor wash cups.
Figure 31: Wash cups (Alinity c)
Legend:
1. Sample probe wash cup (SW): Washes the fluid that remains from the probe exterior and interior
between samples to eliminate carryover
2. Whole blood wash cup (WB): Washes the exterior of the sample probe before a whole blood sample
is dispensed into the cuvette
3. Reagent 1 pipettor wash cup (R1W): Washes any fluid that remains from the probe exterior and
interior
4. Reagent 2 pipettor wash cup (R2W): Washes any fluid that remains from the probe exterior and
interior
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Related information...
Pipetting hardware (Alinity c), page 69
Sample wash solution area (Alinity c)
The sample wash solution area stores sample onboard wash solutions that are used for the
SmartWash function and maintenance procedures. The area provides space for two sample
tubes in a removable sample wash solution holder.
Figure 32: Sample wash solution area (Alinity c)
Legend:
1. Sample wash solution holder
2. Detergent A
3. Acid Probe Wash
Related information...
Pipetting hardware (Alinity c), page 69
Reaction carousel hardware (Alinity c)
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The reaction carousel hardware components position the cuvettes for sample and reagent
dispense, mixing, photometric or potentiometric analysis, and cuvette washing.
Figure 33: Reaction carousel hardware (Alinity c)
Legend:
1. Mixers: Mix sample with reagent
2. ICT unit: Measures potentiometric assays (sodium, potassium, and chloride) by using integrated chip
technology (ICT)
3. Lamp: Provides the light source for photometric measurement
4. ICT high-concentration waste area: Receives liquid waste from the ICT unit
5. Cuvette washer: Washes and dries the cuvettes
6. Water bath overflow and waste area: Receives overflow from the water bath, excess water from the
sample pipettor, and liquid waste from the ICT Reference Solution cup
7. Cuvette segments: Hold the cuvettes in the reaction carousel
8. Reaction carousel: Positions the cuvettes for sample processing
9. High-concentration waste pump: Works with the cuvette washer to aspirate waste from the cuvettes to
the optional high-concentration waste bottle or the drain
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Related information...
Processing center (Alinity c), page 69
Reaction carousel (Alinity c), page 75
Cuvette segments (Alinity c), page 76
Lamp (Alinity c), page 77
Mixers (Alinity c), page 78
Cuvette washer (Alinity c), page 79
ICT unit (Alinity c), page 81
ICT high-concentration waste area (Alinity c), page 82
Water bath overflow and waste area (Alinity c), page 83
High-concentration waste pump (Alinity c), page 84
Reaction carousel (Alinity c)
The reaction carousel supports a variety of assay protocols and has 17 cuvette segments
surrounded by a 37°C water bath. The carousel rotates counterclockwise to position the cuvettes
at the following locations:
• Sample dispense
• Reagent 1 dispense
• Reagent 2 dispense
• ICT sample aspiration
• Mixing
• Photometric read position
• Diluted sample aspiration
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Figure 34: Reaction carousel (Alinity c)
Related information...
Reaction carousel hardware (Alinity c), page 73
Cuvette segments (Alinity c)
Cuvette segments suspend cuvettes in the reaction carousel. Each cuvette segment contains 11
cuvettes. The Alinity c processing module contains 17 segments for a total of 187 cuvettes in the
reaction carousel.
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Figure 35: Cuvette segment (Alinity c)
Related information...
Reaction carousel hardware (Alinity c), page 73
Lamp (Alinity c)
The lamp is an optical device that provides the light source for photometric assay measurement.
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Figure 36: Lamp (Alinity c)
Related information...
Reaction carousel hardware (Alinity c), page 73
Mixers (Alinity c)
The Alinity c processing module has two mixers that mix sample with reagent in the cuvette.
After each mixing operation, the exterior of the mixer is washed in the wash cup located beneath
the mixer.
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Figure 37: Mixers (Alinity c)
Legend:
1. Mixer 1: Mixes the sample with reagent 1 or a diluent
2. Mixer 2: Mixes the sample and reagent 1 mixture with reagent 2
Related information...
Reaction carousel hardware (Alinity c), page 73
Cuvette washer (Alinity c)
The cuvette washer is a device with eight nozzles that perform the following functions before
and after each cuvette is used. The nozzles are listed in order from right to left on the cuvette
washer:
Nozzle 1 Dispenses water and aspirates the sample and reagent
mixture to waste
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Nozzle 2 Dispenses Alkaline Wash to clean the cuvette and aspirates
the Alkaline Wash to waste
Nozzle 3 Dispenses Acid Wash to clean the cuvette and aspirates the
Acid Wash to waste
Nozzles 4 and 5 Dispense water to rinse the cuvette and aspirate the water to
waste
Nozzle 6 Dispenses water into the cuvette for the water blank
measurement, which ensures cuvette integrity
Nozzle 7 Aspirates the water that remains in the cuvette to waste
Nozzle 8 Dries the cuvette
Figure 38: Cuvette washer (Alinity c)
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Related information...
Reaction carousel hardware (Alinity c), page 73
ICT unit (Alinity c)
The integrated chip technology (ICT) unit has an ICT probe and an ICT module. It is used to
perform the indirect potentiometric analysis of sodium (Na+), potassium (K+), and chloride (Cl-).
Figure 39: ICT unit (Alinity c)
Legend:
1. ICT module: Measures electrolytes (Na+, K+, and Cl-) at a temperature of 37°C by using integrated
chip technology.
2. ICT probe: Connects to the ICT module in the ICT unit. The ICT probe aspirates the diluted sample
from the cuvettes or ICT Reference Solution from the ICT Reference Solution cup into the ICT
module for processing.
3. ICT Reference Solution cup: Located beneath the ICT probe when the ICT unit is in the home
position. It contains preheated ICT Reference Solution that is aspirated by the ICT probe and
measured by the ICT module. Sensors in the cup confirm that the cup fills completely and that
sufficient solution aspirates during measurement.
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Figure 40: ICT Reference Solution warming ring (Alinity c)
Legend:
1. ICT Reference Solution warming ring: A narrow metal tube located in the water bath. The warming
ring heats the reference solution to 37°C before the ICT Reference Solution cup is filled.
Related information...
Reaction carousel hardware (Alinity c), page 73
ICT high-concentration waste area (Alinity c)
Liquid waste from the ICT unit collects in a high-concentration waste compartment, and then the
waste is removed through the high-concentration waste tubing.
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Figure 41: ICT high-concentration waste area (Alinity c)
Legend:
1. ICT high-concentration waste area
Related information...
Reaction carousel hardware (Alinity c), page 73
Water bath overflow and waste area (Alinity c)
The water bath overflow and waste area is a waste collection compartment that receives
overflow from the water bath, excess water from the sample pipettor, and liquid waste from the
ICT Reference Solution cup.
Water from the sample pipettor and waste from the ICT Reference Solution cup collect in a low-
concentration waste compartment, and then the water and waste are removed through the low-
concentration waste tubing.
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Figure 42: Water bath overflow and waste area (Alinity c)
Legend:
1. Sample tubing: Delivers excess purified water from the sample pipettor into the low-concentration
waste compartment
2. ICT Reference Solution cup low-concentration waste tubing: Delivers liquid waste from the ICT
Reference Solution cup into the low-concentration waste compartment
Related information...
Reaction carousel hardware (Alinity c), page 73
High-concentration waste pump (Alinity c)
The high-concentration waste pump works with the cuvette washer to aspirate waste from the
cuvettes to the optional high-concentration waste bottle or the drain.
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Figure 43: High-concentration waste pump (Alinity c)
Related information...
Reaction carousel hardware (Alinity c), page 73
Supply and pump center (Alinity c)
The supply and pump center stores the processing module pumps, bulk solutions, sample and
reagent syringes, and drives.
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Figure 44: Supply and pump center (Alinity c)
Legend:
1. Bulk solution storage area: Provides the onboard storage for replacement bulk solution bottles
2. Sample and reagent syringes area: Houses the sample and reagent syringes and drives
3. Bulk solution reservoir area: Provides the onboard storage for the ICT Reference Solution, Alkaline
Wash, and Acid Wash that are in use
4. Pump center: Houses the processing module pumps
Related information...
Processing module (Alinity c), page 66
Pump center (Alinity c), page 86
Bulk solution storage area (Alinity c), page 88
Bulk solution reservoir area (Alinity c), page 89
Sample and reagent syringe area (Alinity c), page 90
Pump center (Alinity c)
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The pump center houses the processing module pumps. These pumps provide the pressure that
is needed to aspirate and dispense liquids into the appropriate components in the processing
center.
Figure 45: Pump center (Alinity c)
Legend:
1. Wash solution pump: Delivers diluted Alkaline Wash and Acid Wash solutions to the cuvettes during
daily operation and maintenance procedures.
2. ICT Reference Solution pump: Uses the syringe on the left side of the pump to deliver ICT Reference
Solution into the ICT Reference Solution cup. After the ICT Reference Solution is measured, the ICT
Reference Solution pump uses the syringe on the right side of the pump to drain the cup.
3. ICT aspiration pump: Uses the syringe on the right side of the pump to deliver samples or ICT
Reference Solution into the ICT module for measurement. After measurement is completed, the ICT
aspiration pump uses the syringe on the left side of the pump to aspirate waste from the ICT high-
concentration waste area to the high-concentration waste tubing.
4. ICT aspiration valve: Controls the direction of liquid flow while the ICT aspiration pump operates.
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Related information...
Supply and pump center (Alinity c), page 85
Bulk solution storage area (Alinity c)
The bulk solution storage area, which is located on the bulk solution door, provides the onboard
storage for replacement bulk solution bottles. Bulk solutions from the replacement bottles fill
onboard bulk solution reservoirs. Each bottle has a unique keyed cap that locks into its
appropriate key slot in a bottle holder.
Figure 46: Bulk solution storage area (Alinity c)
Legend:
1. Alkaline Wash: Used by the cuvette washer to clean the cuvettes after sample analysis.
2. Acid Wash: Used by the cuvette washer to clean the cuvettes after sample analysis.
3. ICT Reference Solution: Aspirated and analyzed by the ICT module before and after each sample to
provide a reference potential that is used in result calculation.
4. Bottle release button: Releases a bulk solution cap from a bottle holder to remove and replace a bulk
solution bottle.
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5. Bottle holder: Stores a replacement bulk solution bottle. Contains a mechanism that pierces the bulk
solution septum.
Related information...
Supply and pump center (Alinity c), page 85
Bulk solutions (c-series), page 137
Bulk solution reservoir area (Alinity c)
The bulk solution reservoir area, which is located in the supply center, provides the onboard
storage for bulk solutions in use during assay processing. When onboard bulk solution reservoirs
are empty, bulk solutions from replacement bottles on the bulk solution door fill the reservoirs
without an interruption in system operation.
Figure 47: Bulk solution reservoir area (Alinity c)
Legend:
1. Alkaline Wash reservoir: Holds in-use Alkaline Wash solution.
2. Acid Wash reservoir: Holds in-use Acid Wash solution.
3. ICT Reference Solution reservoir: Holds in-use ICT Reference Solution.
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4. Reservoir bottle tray: Holds the bulk solution reservoirs. Slides out to access the bulk solution
reservoirs.
Related information...
Supply and pump center (Alinity c), page 85
Bulk solutions (c-series), page 137
Sample and reagent syringe area (Alinity c)
The sample and reagent syringe area holds the sample and reagent syringes and drives. Each
drive supports a syringe that aspirates and dispenses samples, reagents, and onboard solutions.
Figure 48: Sample and reagent syringe area (Alinity c)
Legend:
1. Sample syringe: Aspirates and dispenses the sample
2. Reagent syringes 1 and 2: Aspirates and dispenses the reagent and onboard solutions
Related information...
Supply and pump center (Alinity c), page 85
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Reagent supply center (Alinity c)
The reagent supply center provides cooled storage at a controlled temperature for reagent
cartridges, onboard solutions, sample diluents, and frequently used calibrators and controls.
Cartridges and vial racks are loaded on the reagent and sample manager (RSM) and are
transferred to the reagent positioner by the RSM transport.
Figure 49: Reagent supply center (Alinity c)
Legend:
1. Reagent carousel: Holds reagent cartridges and frequently used calibrators and controls. The
carousel rotates to provide reagent access to reagent 1 and reagent 2 pipettors.
2. Reagent positioner: Positions cartridges and onboard vial racks to load in the reagent carousel or
onto the loading area. When the reagent positioner is in the open position, the cartridge or rack can
be transferred to the loading area. When the reagent positioner is in the closed position, the cartridge
or rack can be transferred to the reagent carousel.
3. Reagent transport: Places cartridges and onboard vial racks in the reagent carousel or onto the
reagent positioner.
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Related information...
Processing module (Alinity c), page 66
Reagent carousel (Alinity c), page 92
Reagent and sample manager (RSM), page 62
Reagent carousel (Alinity c)
The reagent carousel is a rotating, circular device that performs the following functions:
• Holds a maximum of 70 bar-coded reagent cartridges, onboard solutions, sample diluents,
and vial racks in a cooled environment at a controlled temperature
• Rotates to position reagent cartridges and onboard solutions so that reagents or solutions
can be aspirated and dispensed
• Rotates to position vial racks for transfer to the sample positioner so that calibrators and
controls can be aspirated and dispensed
Figure 50: Reagent carousel (Alinity c)
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Legend:
1. Reagent segment: A section of the reagent carousel. The reagent carousel has two types of
segments and 12 total segments:
– Eleven segments can hold a maximum of six cartridges. Vial racks cannot be stored in these
segments.
– The twelfth segment contains the reagent carousel calibration target. This segment can hold a
maximum of four cartridges or vial racks.
The total capacity of the 12 segments is 70 cartridges.
2. Reagent position: A section of a reagent segment that holds one cartridge or vial rack.
3. Reagent carousel calibration target: A calibration target that is used to align the reagent pipettor and
the reagent transport to cartridges and vials.
Related information...
Reagent supply center (Alinity c) , page 91
Processing module (Alinity i)
The Alinity i processing module is an immunoassay analyzer that performs sample processing.
The processing module processes a maximum of 200 chemiluminescent microparticle
immunoassay (CMIA) tests per hour and has 47 positions in the reagent carousel at a controlled
temperature.
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Figure 51: Front view of the Alinity i processing module
Legend:
1. Front processing center cover: Provides access to the components that perform assay-processing
activities.
NOTE: The front processing center cover is monitored by two sensors. If the cover is opened during
Initializing status, Running status, or Processing status, the reagent and sample manager and the
processing module transition to Stopped status.
2. RV hopper cover: Provides access to the RV hopper to replenish reaction vessels.
3. Bulk solution door: Provides access to the bulk solution storage area and the RV waste storage area.
4. Front electronics door: Provides access to the processing module electronics and embedded
computer, and the procedure lock.
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Figure 52: Rear view of the Alinity i processing module
Legend:
1. Rear processing center cover: Provides access to the components that perform assay-processing
activities.
NOTE: The rear processing center cover is monitored by one sensor. If the cover is opened when the
instrument status of the processing module is Initializing, Running, or Processing, the status
transitions to Stopped.
2. Rear access panel: Provides additional access to processing center components.
3. Rear electronics panel: Provides access to instrument electronics.
4. Processing module main power breaker: Powers on and powers off the power supply.
5. Rear fluidics panel: Provides access to pumps and syringes.
Related information...
Processing modules, page 66
Processing center (Alinity i), page 96
Supply center (Alinity i), page 115
Reagent supply center (Alinity i), page 120
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Processing center (Alinity i)
The processing center is the main activity area of the processing module. Samples and reagents
are dispensed and mixed in reaction vessels (RVs) in the process and pretreatment paths where
assay processing is performed.
Figure 53: Processing center (Alinity i)
Legend:
1. Process path: Provides incubation at a controlled temperature, liquid aspiration, and wash points as
necessary for assay processing
2. Pretreatment path: Provides incubation at a controlled temperature for pretreatment assay protocols
3. Pipetting hardware: Aspirates and dispenses samples and reagents
4. RV loader: Provides the onboard storage for RVs and transports RVs to the process and pretreatment
paths
Related information...
Processing module (Alinity i), page 93
Process path (Alinity i), page 97
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Pretreatment path (Alinity i), page 107
Pipetting hardware (Alinity i), page 111
RV loader (Alinity i), page 114
CMIA technology and reaction sequence (i-series), page 375
Assay processing (i-series), page 380
Assay processing for One Step 25 (i-series), page 381
Assay processing for Two Step 18-4 (i-series), page 382
Assay processing for pretreatment (i-series), page 384
STAT assay processing for One Step 11 (i-series), page 386
STAT assay processing for Two Step 4-4 (i-series), page 387
Process path (Alinity i)
The process path is a covered, circular path that provides incubation at a controlled
temperature, liquid aspiration, and wash points as necessary for assay processing. The process
path advances reaction vessels (RVs) every 18 seconds and positions them at the designated
locations to process the CMIA reaction.
Figure 54: Process path (Alinity i)
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Legend:
1. Vortexers (VTXR1, VTXR2, and VTXPT): Mix the reaction mixture to suspend microparticles.
2. Diverters (LD, STD, and WZD): Move RVs in the processing module from one lane of the process
path to a different lane during assay processing.
3. Liquid waste arm: Removes the liquid from RVs.
4. Wash zone assemblies (WZ1 and WZ2): Dispense the wash buffer into RVs, and remove and discard
the unbound material from the RV reaction mixture.
5. RV access door (RVA): Provides access to one position on the reaction lane. Use this door only for
diagnostic purposes.
6. Process path motor (PPM): Rotates the process path disk, which holds the RVs, and advances the
RVs from position to position.
7. Pre-Trigger and Trigger manifold (PTTM): First dispenses Pre-Trigger Solution into RVs and then
dispenses Trigger Solution into RVs.
8. Optics: Measures the chemiluminescent emission from RVs and outputs the data that corresponds to
the quantity of emission detected.
9. RV unloader (RVU): Removes used RVs from the process path and discards them into the solid waste
container after assay processing is completed.
Related information...
Processing center (Alinity i), page 96
Vortexers (Alinity i), page 98
Diverters (Alinity i) , page 99
Liquid waste arm (Alinity i), page 100
Wash zone assemblies (Alinity i) , page 101
RV access door (Alinity i) , page 102
Process path motor (Alinity i) , page 103
Pre-Trigger and Trigger manifold (Alinity i) , page 104
Optics (Alinity i), page 105
RV unloader (Alinity i) , page 106
Pretreatment path (Alinity i), page 107
Vortexers (Alinity i)
Three vortexers are located on the process path:
• R1 pipettor vortexer (VTXR1)
• R2 pipettor vortexer (VTXR2)
• Pre-Trigger vortexer (VTXPT)
The vortexers mix the reaction mixture to suspend microparticles.
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Figure 55: Vortexer (Alinity i)
Related information...
Process path (Alinity i), page 97
Diverters (Alinity i)
Diverters move reaction vessels (RVs) in the processing module from one lane of the process
path to a different lane during assay processing. The following three diverters are located on the
process path:
• The load diverter (LD) directs RVs from the load lane to the incubation lane.
• The STAT diverter (STD) directs RVs from the incubation lane to the reaction lane for STAT
assay processing.
• The wash zone diverter (WZD) directs RVs to one of two lanes. One lane moves RVs
through the wash zone where a wash occurs. The other lane moves RVs to the wash zone
bypass lane where a wash does not occur.
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Figure 56: Diverter (Alinity i)
Related information...
Process path (Alinity i), page 97
Liquid waste arm (Alinity i)
The liquid waste arm removes the liquid from reaction vessels before the RV unloader discards
them into the solid waste container.
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Figure 57: Liquid waste arm (Alinity i)
Related information...
Process path (Alinity i), page 97
Wash zone assemblies (Alinity i)
The wash zone assemblies (WZ1 and WZ2) dispense the wash buffer into reaction vessels
(RVs), and remove and discard the unbound analyte from the reaction mixture in RVs. Each
wash zone has four positions where the following actions occur:
• At each position, a magnet attracts paramagnetic microparticles to the wall of the RV.
• At position 1, a dispense nozzle dispenses the wash buffer into the RV.
• At position 2 and position 3, a vacuum is applied to the wash zone probes as they move to
the bottom of RVs and aspirate the liquid from RVs. In addition, nozzles dispense the wash
buffer into RVs. Additional wash and aspiration cycles occur at these positions.
• At position 4, a wash zone probe aspirates liquid waste from the RV.
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Figure 58: Wash zone assembly (Alinity i)
Related information...
Process path (Alinity i), page 97
RV access door (Alinity i)
The RV access door (RVA) is an opening that provides access to one position on the reaction
lane on the process path. Use this door only for diagnostic purposes and confirm that it is closed
during system operation.
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Figure 59: RV access door (Alinity i)
Related information...
Process path (Alinity i), page 97
Process path motor (Alinity i)
The process path motor (PPM) rotates the process path disk, which holds the reaction vessels
(RVs), and advances the RVs from position to position.
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Figure 60: Process path motor (Alinity i)
Related information...
Process path (Alinity i), page 97
Pre-Trigger and Trigger manifold (Alinity i)
The Pre-Trigger and Trigger manifold (PTTM) first dispenses Pre-Trigger Solution into reaction
vessels (RVs) and then dispenses Trigger Solution into RVs.
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Figure 61: Pre-Trigger and Trigger manifold (Alinity i)
Related information...
Process path (Alinity i), page 97
Optics (Alinity i)
The optics measures the chemiluminescent emission from reaction vessels and outputs the data
that corresponds to the quantity of emission detected.
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Figure 62: Optics (Alinity i)
Related information...
Process path (Alinity i), page 97
Optical system and measurement sequence (i-series), page 378
RV unloader (Alinity i)
The RV unloader (RVU) removes used reaction vessels from the process path and discards
them into the solid waste container after assay processing is completed.
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Figure 63: RV unloader (Alinity i)
Related information...
Process path (Alinity i), page 97
Pretreatment path (Alinity i)
The pretreatment path is a covered, circular path that provides incubation at a controlled
temperature for pretreatment assay protocols. The pretreatment path advances reaction vessels
(RVs) in two lockstep durations. It advances RVs at 3 seconds, followed by a 15-second lockstep
for a total of two positions every 18 seconds. RVs are positioned at the designated locations to
process a pretreatment assay protocol. After the pretreatment assay protocol is completed, the
sample is transferred to the process path.
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Figure 64: Pretreatment path (Alinity i)
Legend:
1. Pretreatment path motor (pPM): Rotates the pretreatment path disk, which holds the RVs, and
advances the RVs from position to position
2. Pretreatment vortexer (pVTX): Mixes the reaction mixture to suspend microparticles
3. Pretreatment unload diverter (pUD): Unloads RVs used for sample pretreatments and sample dilutions
from the pretreatment path into the solid waste container
Related information...
Processing center (Alinity i), page 96
Pretreatment unload diverter (Alinity i), page 108
Pretreatment path motor (Alinity i), page 109
Pretreatment vortexer (Alinity i), page 110
Assay processing for pretreatment (i-series), page 384
Process path (Alinity i), page 97
Pretreatment unload diverter (Alinity i)
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The pretreatment unload diverter (pUD) unloads reaction vessels used for sample pretreatments
and sample dilutions from the pretreatment path into the solid waste container.
Figure 65: Pretreatment unload diverter (Alinity i)
Related information...
Pretreatment path (Alinity i), page 107
Pretreatment path motor (Alinity i)
The pretreatment path motor (pPM) rotates the pretreatment path disk, which holds the reaction
vessels (RVs), and advances the RVs from position to position.
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Figure 66: Pretreatment path motor (Alinity i)
Related information...
Pretreatment path (Alinity i), page 107
Pretreatment vortexer (Alinity i)
The pretreatment vortexer (pVTX) is located on the pretreatment path. The pretreatment vortexer
mixes the reaction mixture to suspend microparticles.
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Figure 67: Pretreatment vortexer (Alinity i)
Related information...
Pretreatment path (Alinity i), page 107
Pipetting hardware (Alinity i)
Pipetting hardware aspirates and dispenses samples and reagents.
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Figure 68: Pipetting hardware components (Alinity i)
Legend:
1. Sample pipettor (S): Aspirates and dispenses samples into reaction vessels (RVs)
2. Reagent pipettors (R1 and R2): Aspirate and dispense reagents into RVs
3. Wash cups (SW, R1W, and R2W): Wash any fluid that remains from the interior and exterior surfaces
of probes
Related information...
Processing center (Alinity i), page 96
Pipettors (Alinity i), page 112
Wash cups (Alinity i), page 113
Pipettors (Alinity i)
Pipettors detect, aspirate, transfer, and dispense samples and reagents into reaction vessels
(RVs). These pipettor assemblies include a pressure-monitoring system that helps to identify
aspiration errors. Three pipettors that have the following functions are located on the system:
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• The sample pipettor (S) detects, aspirates, transfers, and dispenses samples into RVs in the
process path and the pretreatment path. It also transfers pretreated samples from the
pretreatment path to the process path after the appropriate incubation period.
• The reagent 1 pipettor (R1) detects, aspirates, transfers, and dispenses reagents into RVs in
the process path and the pretreatment path. It also transfers diluted samples from the
pretreatment path to the process path as required.
• The reagent 2 pipettor (R2) detects, aspirates, transfers, and dispenses reagents into RVs in
the process path.
Figure 69: Pipettor (Alinity i)
Related information...
Pipetting hardware (Alinity i), page 111
Wash cups (Alinity i)
Active wash cups (SW, R1W, and R2W) wash any fluid that remains from the interior and
exterior surfaces of probes. In addition, a vacuum source dries the exterior surfaces of probes.
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Figure 70: Wash cup (Alinity i)
Related information...
Pipetting hardware (Alinity i), page 111
RV loader (Alinity i)
The RV loader system (RVL) provides the onboard storage for reaction vessels (RVs) and
transports RVs to the process path and the pretreatment path.
The RV loader performs the following functions:
• Feeds RVs from the upper hopper to the lower hopper as needed
• Lifts RVs one at a time and places them in an upright position in the linear queue
• Lifts RVs from the linear queue and places them on the process path and the pretreatment
path
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Figure 71: RV loader assembly (Alinity i)
Legend:
1. Upper hopper: Stores bulk RVs loaded by the operator.
2. Lower hopper and RV orienter: The lower hopper stores a limited amount of RVs. The RV orienter lifts
one RV at a time and places the RV in the linear queue.
3. Linear queue: Stages upright RVs in preparation for loading.
4. RV pick and place assembly: Moves RVs one at a time to the process path and the pretreatment
path.
Related information...
Processing center (Alinity i), page 96
Supply center (Alinity i)
The supply center is the onboard storage area for bulk solutions and reaction vessel (RV) solid
waste.
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Figure 72: Supply center (Alinity i)
Legend:
1. Bulk solution storage area: Provides the onboard storage for replacement bulk solution bottles
2. Bulk solution reservoir area: Provides the onboard storage for in-use bulk solutions
3. RV waste storage area: Provides the storage for used RVs
Related information...
Processing module (Alinity i), page 93
Bulk solution storage area (Alinity i), page 116
Reservoir areas (Alinity i), page 117
RV waste storage area (Alinity i) , page 119
Bulk solution storage area (Alinity i)
The bulk solution storage area, which is located on the bulk solution door, provides the onboard
storage for replacement bulk solution bottles. Bulk solutions from the replacement bottles fill
onboard bulk solution reservoirs. Each bottle has a unique keyed cap that locks into its
appropriate key slot in a bottle holder.
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Figure 73: Bulk solution storage area (Alinity i)
Legend:
1. Concentrated Wash Buffer: Mixed with purified water and then pumped to sample and reagent
pipettor assemblies and to wash zones during assay processing.
2. Trigger Solution: Produces the chemiluminescent reaction that provides the final read.
3. Pre-Trigger Solution: Separates the acridinium dye from the conjugate that is bound to the
microparticle complex. This action prepares the acridinium dye for the addition of Trigger Solution.
4. Bottle release button: Releases a bulk solution cap from a bottle holder to remove and replace a bulk
solution bottle.
5. Bottle holder: Stores a replacement bulk solution bottle. Contains a mechanism that pierces the bulk
solution septum.
Related information...
Supply center (Alinity i), page 115
Bulk solutions (i-series), page 138
Reservoir areas (Alinity i)
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The bulk solution reservoir area, which is located in the supply center, provides the onboard
storage for bulk solutions in use during assay processing. When onboard bulk solution reservoirs
are empty, bulk solutions from replacement bottles on the bulk solution door fill the reservoirs
without an interruption in system operation. Concentrated Wash Buffer from its onboard bulk
solution reservoir is diluted tenfold by the system and is stored in a 4 L diluted wash buffer
reservoir for use during assay processing.
Figure 74: Bulk solution reservoir area (Alinity i)
Legend:
1. Reservoir bottle tray: Holds transfer pumps, bulk solution reservoirs, and the vacuum and waste
accumulator. Slides out to access the bulk solution reservoirs.
2. Transfer pump rack: Holds transfer pumps for the Pre-Trigger Solution, the Trigger Solution, and the
Concentrated Wash Buffer. The pumps transfer bulk solutions from replacement bottles to bulk
solution reservoirs.
3. Concentrated Wash Buffer reservoir: Holds in-use Concentrated Wash Buffer.
4. Trigger Solution reservoir: Holds in-use Trigger Solution.
5. Pre-Trigger Solution reservoir: Holds in-use Pre-Trigger Solution.
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Figure 75: Pump drawer (Alinity i)
Legend:
1. Diluted wash buffer reservoir: Holds diluted wash buffer for use during assay processing
Related information...
Supply center (Alinity i), page 115
Bulk solutions (i-series), page 138
RV waste storage area (Alinity i)
The RV waste storage area, which is located in the supply center, provides storage for the RV
waste container and holds used reaction vessels (RVs).
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Figure 76: RV waste storage area (Alinity i)
Legend:
1. RV waste chute: Directs the used RVs into the RV waste container. The RV waste container can be
removed during assay processing. When the container is removed, the RV waste chute closes and
holds 50 RVs before the processing module pauses.
2. RV waste container: Holds the used RVs.
3. RV waste storage tray: Holds the RV waste container.
Related information...
Supply center (Alinity i), page 115
Reagent supply center (Alinity i)
The reagent supply center provides cooled storage at a controlled temperature for reagent
cartridges, maintenance solutions, and frequently used calibrators and controls. Cartridges and
vial racks are loaded on the reagent and sample manager (RSM) and are transferred to the
reagent positioner by the RSM transport.
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Figure 77: Reagent supply center (Alinity i)
Legend:
1. Reagent carousel: Holds reagent cartridges, maintenance solutions, and frequently used calibrators
and controls. The carousel rotates to provide reagent access to reagent 1 and reagent 2 pipettors.
2. Reagent positioner: Positions cartridges and onboard vial racks to load in the reagent carousel or
onto the loading area. When the reagent positioner is in the open position, the cartridge or rack can
be transferred to the loading area. When the reagent positioner is in the closed position, the cartridge
or rack can be transferred to the reagent carousel.
3. Reagent transport: Places cartridges and onboard vial racks in the reagent carousel or onto the
reagent positioner.
Related information...
Processing module (Alinity i), page 93
Reagent carousel (Alinity i), page 121
Reagent and sample manager (RSM), page 62
Reagent carousel (Alinity i)
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The reagent carousel is a rotating, circular device that performs the following functions:
• Holds a maximum of 47 bar-coded reagent cartridges, onboard solutions, and vial racks in a
cooled environment at a controlled temperature
• Provides microparticle dispersion by continuous rotation of microparticle reagent bottles
• Rotates to position reagent cartridges and onboard solutions so that reagents or solutions
can be aspirated and dispensed
• Rotates to position vial racks for transfer to the sample positioner so that calibrators and
controls can be aspirated and dispensed
Figure 78: Reagent carousel (Alinity i)
Legend:
1. Reagent segment: A section of the reagent carousel that holds a maximum of six cartridges or vial
racks. The reagent carousel has a total of eight reagent segments. One segment contains the
reagent carousel calibration target. This segment holds a maximum of five cartridges or vial racks.
2. Reagent position: A section of a reagent segment that holds one cartridge or vial rack.
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3. Reagent carousel calibration target: A calibration target that is used to align the reagent pipettor to
cartridges and vials.
Related information...
Reagent supply center (Alinity i), page 120
Optional components
The following components are optional for processing modules:
Uninterrupted power Provides a temporary, continuous flow of power to the
supply (UPS) processing module during a power failure.
External waste pump Moves waste from the waste outlet to an elevated drain.
High-concentration Collects the high-concentration liquid waste from the cuvettes
waste bottle (c-series) and the ICT unit.
Related information...
Primary components of an Alinity ci-series, page 48
External waste pump, page 123
Empty the high-concentration waste bottle and update the inventory (c-series), page 514
External waste pump
The external waste pump is an optional component that moves waste from the waste manifold to
an elevated drain when a floor drain is not available.
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Figure 79: Front view of the external waste pump
Legend:
1. Power outlet: Provides power to the external waste pump.
2. Power switch: Turns on and turns off the power to the pump. When the power switch is turned on, the
pump automatically activates to move the waste.
3. Voltage select switch: Shifts the allowable voltage from 110 V to 220 V.
4. Manual operating switch: Turns on the power to the pump and activates the pump.
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Figure 80: Rear view of the external waste pump
Legend:
1. Waste outlet quick disconnect: Provides a connection for tubing to an elevated drain
2. Inlet quick disconnect: Provides a connection for tubing from the waste manifold
Related information...
Optional components, page 123
External waste pump electrical specifications and requirements, page 411
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Alinity system software overview
The Alinity system software has a user interface that is designed to provide access to system
information, software functions, and Help for an active screen. The user interface is a display
format where the operator can select icons, buttons, menu commands, and other screen
elements.
The user interface is common among all Alinity systems.
Figure 81: User interface layout
Legend:
1. Menu bar: Provides navigation elements and status indicators. Each icon on this bar represents a
screen category. When an icon is selected, an associated screen is displayed. The Alert Center at
the top of this bar indicates when alerts and notifications occur on the system and provides access to
details about alerts and notifications.
2. Screen header: Provides the screen title, the system name, the Help button, the Notepad button, the
name of the logged-on operator, the Lock button, the date and time, and the software version.
3. Information area: Provides access to all system information and functions associated with the
selected screen element.
4. Function buttons: Provide access to functions associated with the active screen. Buttons with blue
text are available for use. Buttons with purple text are unavailable for use until a screen element is
selected.
5. Flyout: Provides additional details or additional functions associated with the active screen.
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6. Critical message: Provides information about conditions or errors of system operation.
7. Help button: Provides access to the Help for the active screen, a flyout, or a message code.
Related information...
Use or function, page 47
Descriptions of screen elements, page 127
Menu bar, page 130
Descriptions of screen elements
Screen elements are items on each screen that are used to interact with the system software.
The following list provides descriptions of screen elements:
Icons Display a screen.
Menus Display a screen.
Tabs Used to group the same type of information or to filter
information.
Buttons Initiate a command such as the following examples:
• Display another screen or flyout.
• Add items to a list.
• Refresh the information on the screen.
• Confirm that entered edits are saved.
• Delete items from the system.
• Display the Help for the active screen, flyout, or message
code.
Flyouts Display additional information or menus, or are used for
specific tasks such as search, print, and update.
Badges Used on menu buttons and icons to display status notifications
such as alerts and warnings, and informational notifications
such as a number on the Notepad button indicating unread
notes.
Data entry boxes • Text boxes: Used to type text. An asterisk is displayed
when the information is required.
• Spin boxes: Used to type text or to enter text by tapping
the Up Arrow and Down Arrow buttons. An asterisk is
displayed when the information is required.
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Drop-down lists Display a list from which to select one item.
Options Display a list of choices from which to select one item.
Check boxes Display a list of choices from which to select one or more
items.
Sliders Used to select a value from a range of values.
Specific screen element descriptions that explain the kind of information to enter, select, or view
are available for each screen and can be accessed by the links provided in the following
Related information... section.
Related information...
Alinity system software overview, page 126
Home screen element descriptions, page 464
Supplies screen element descriptions (c-series), page 501
Supplies screen element descriptions (i-series), page 505
Orders screen element descriptions, page 584
Sample Status screen element descriptions, page 604
Results screen, Unreleased tab element descriptions, page 617
Results screen, Specimen tab element descriptions, page 618
Results screen, Control tab element descriptions, page 620
Results screen, Exception tab element descriptions, page 621
Calibration Status screen element descriptions, page 702
Procedures Log screen, Maintenance tab element descriptions, page 753
System Logs screen, All Messages tab element descriptions, page 930
System Logs screen, Notifications/Alerts tab element descriptions, page 932
System Logs screen, Informational tab element descriptions, page 933
System Logs screen, Inventory tab element descriptions, page 934
System Logs screen, User Access tab element descriptions, page 935
System Logs screen, Configuration tab element descriptions, page 936
System Logs screen, Host tab element descriptions, page 937
System Logs screen, Abbott Mail tab element descriptions, page 938
Cal/QC Inventory screen element descriptions, page 519
Reagents screen, Current tab element descriptions, page 534
Reagents screen, Historical tab element descriptions, page 538
Create Order screen, Specimen tab element descriptions, page 591
Create Order screen, Control tab element descriptions, page 593
Create Order screen, Calibration tab element descriptions, page 594
Procedures screen element descriptions, page 741
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Procedures Log screen, Diagnostics tab element descriptions, page 754
Users Import screen, Users Export screen element descriptions, page 157
Calibrator Set screen element descriptions, page 255
Calibrator Set View/Edit screen element descriptions, page 256
Import Calibrators screen element descriptions (c-series), page 258
Install/Uninstall Assays screen, Available Files tab element descriptions, page 268
Install/Uninstall Assays screen, Installed Files tab element descriptions, page 270
Import/Export Assays screen, Export Files tab element descriptions (c-series), page 275
Import/Export Assays screen, Import Files tab element descriptions (c-series), page 276
Quality Control screen element descriptions, page 290
Control Create/Edit screen element descriptions, page 291
Import screen element descriptions, page 294
Westgard screen element descriptions, page 308
Install/Uninstall Procedures screen, Available Files tab element descriptions, page 311
Install/Uninstall Procedures screen, Installed Files tab element descriptions, page 312
User-Defined Maintenance screen, Create/Edit tab element descriptions, page 315
User-Defined Maintenance screen, Export tab element descriptions, page 317
Backup/Restore screen element descriptions, page 324
System Updates screen element descriptions, page 329
System Update Import screen element descriptions, page 334
Control Summary Details screen element descriptions, page 650
Assay Parameters screen element descriptions, page 229
Assay Display Order screen element descriptions, page 281
Panel Definition screen element descriptions, page 283
Current Firmware screen element descriptions, page 346
Users screen element descriptions, page 156
Create New User screen element descriptions, page 159
Edit User screen element descriptions, page 161
User Profile screen element descriptions, page 166
Modules screen, reagent and sample manager (RSM) element descriptions, page 168
Modules screen, c-series element descriptions, page 170
Modules screen, i-series element descriptions, page 172
Printers screen element descriptions, page 177
Bar Codes screen element descriptions, page 184
Reagents and Supplies screen, Reagents/Diluents tab element descriptions, page 187
Reagents and Supplies screen, Supplies tab element descriptions , page 189
Reports screen element descriptions, page 196
Abbott Mail screen element descriptions, page 199
Audio Settings screen element descriptions, page 207
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Host Setup screen element descriptions, page 209
HL7 Communication screen element descriptions, page 213
ASTM Communication screen element descriptions, page 216
Shortcuts screen element descriptions, page 218
Automatic Backup screen element descriptions, page 219
AbbottLink screen element descriptions, page 222
Cal/QC Ordering screen element descriptions, page 287
Troubleshooting screen element descriptions, page 342
Calibration Status Details screen element descriptions, page 704
Perform Procedure screen element descriptions, page 745
Log On screen element descriptions, page 454
Abbott Mail Inbox screen, All tab element descriptions, page 480
Abbott Mail Inbox screen, Assay Files tab element descriptions, page 481
Abbott Mail Inbox screen, Assay Inserts tab element descriptions, page 482
Abbott Mail Inbox screen, System Updates tab element descriptions , page 483
Abbott Mail Inbox screen, Calibrator Data tab element descriptions (c-series), page 484
Manual File Request screen, Assay Files tab element descriptions, page 486
Manual File Request screen, Calibrator Data tab element descriptions (c-series), page 487
Reagent Cartridge Details screen element descriptions, page 541
Order Details (Specimen, Control, and Calibrator) screen element descriptions, page 588
Sample Details (Specimen, Control, and Calibrator) screen element descriptions, page 608
Result Details (Specimen and Control) screen element descriptions, page 624
Quality Control Summary screen element descriptions, page 648
General Settings screen element descriptions, page 203
Levey-Jennings (Graph) screen element descriptions, page 641
Point Details screen element descriptions, page 644
Menu bar
The menu bar provides navigation elements that are used to display screens, flyouts, and
menus. The following figure shows examples of the Alert Center flyout, status indicators, buttons,
icons, and the System menu.
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Figure 82: Menu bar
Legend:
1. Alert Center: Provides the Alert Center button, which displays a flyout of status information, and
provides two types of status indicators for system problems that require attention. Status indicators
called badges are displayed on icons to notify the operator when a specific system problem requires
attention:
– A red triangle (alert) badge indicates system problems that require immediate attention.
– An amber circle (notification) badge indicates system problems that require attention that is not
immediate.
2. Icons: Navigation elements that provide access to specific screens and functions. The menu bar
provides these icons:
– Home
– Sample Status
– Orders
– Results
– QC
– CAL
– Reagents
– Supplies
System button: Displays a menu of commands. System menu commands that are configured as
icons are not displayed on the menu.
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3. Configurable icons: Navigation elements that can be configured to provide navigation for common
functions. Some of the System menu commands can be configured for these icons.
Related information...
Alinity system software overview, page 126
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Required consumables
Required consumables are replenishable items that are needed for sample processing on the
Alinity ci-series. Be sure to maintain an adequate inventory of required consumables.
CAUTION: Many of the consumables used with the Alinity ci-series are mixtures of
chemical substances or biological substances. Some of the mixtures may be hazardous
to the operator under certain conditions. See warnings or instructions provided on
product-specific labels, in the product documentation, and in product-specific Safety
Data Sheets.
Related information...
Use or function, page 47
Reagent kits and components, page 133
Controls, page 135
Calibrators, page 136
Bulk solutions (c-series), page 137
Bulk solutions (i-series), page 138
Onboard solutions (c-series), page 139
Maintenance solutions (c-series), page 139
ICT module (c-series), page 140
Probe conditioning solution (i-series), page 141
Reaction vessels (i-series), page 142
Sample cups, page 142
Biological hazards, page 723
Chemical hazards, page 725
Reagent kits and components
Reagent kits are one or more cartridges that contain all the necessary reagent components for
an Alinity ci-series assay.
Reagent cartridges can be stored on the system according to the assay-specific instructions. For
more information about onboard storage, see the assay documentation.
Abbott prepackaged reagent cartridges contain a two-dimensional bar code. Each bar code
includes the following information:
• Reagent identifier
• Reagent serial number
• Test size (number of tests for each cartridge)
• Expiration date
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• Onboard stability time
• Master calibration information for assays that use the 2-point adjustment calibration method
(only for Alinity i-series)
Figure 83: Reagent cartridges and components
Legend:
1. Alinity i reagent cartridge: Provides the necessary components for an Alinity ci-series
chemiluminescent microparticle immunoassay assay. Each reagent bottle in the cartridge contains an
integrated septum unless otherwise indicated in the assay documentation.
2. Alinity c reagent cartridge: Provides the necessary components for an Alinity ci-series photometric or
potentiometric assay.
3. Alinity Reagent Replacement Cap: Seals a reagent cartridge to prevent reagent leakage when the
cartridge is removed from the system and is stored in an external refrigerator.
Related information...
Required consumables, page 133
Loading area, page 64
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Controls
Controls are samples that contain known concentrations of analyte. Controls are available as
single-constituent and multiconstituent controls. Some controls can be stored for use in the
reagent carousel. To identify the controls that are required for an assay, see the assay
documentation.
Figure 84: Alinity ci-series controls
Legend:
1. Single-constituent control: An assay-specific sample that contains known concentrations of an
analyte.
2. Multiconstituent control: A sample that contains multiple analytes.
3. Alinity ci-series Calibrator/Control Replacement Caps: Replace the original caps on calibrator and
control vials that are loaded on the reagent and sample manager for calibration and control testing.
The replacement cap seals the vial to prevent leakage when the vial is removed from the system and
is stored in an external refrigerator. The original cap is not used to prevent analyte cross
contamination.
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Related information...
Required consumables, page 133
Calibrators
Calibrators are samples that contain known concentrations of analyte. A variety of single-
constituent and multiconstituent calibrators are used on the Alinity c-series. Single-constituent
calibrators are used on the Alinity i-series. Some calibrators can be stored in the reagent
carousel. To identify the required calibrators for an assay, see the assay documentation.
Figure 85: Alinity ci-series calibrators
Legend:
1. Alinity i calibrators: Include single-constituent calibrators that are used in the calibration of i-series
assays.
2. Alinity c calibrators: Include single-constituent and multiconstituent calibrators that are used in the
calibration of c-series photometric assays.
3. Alinity c ICT calibrators: Used in the calibration of c-series potentiometric assays.
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4. Alinity ci-series Calibrator/Control Replacement Caps: Replace the original caps on calibrator and
control vials that are loaded on the reagent and sample manager for calibration and control testing.
The replacement cap seals the vial to prevent leakage when the vial is removed from the system and
is stored in an external refrigerator. The original cap is not used to prevent analyte cross
contamination.
Related information...
Required consumables, page 133
Bulk solutions (c-series)
Bulk solutions are liquid solutions that are provided in large quantities for use during sample
processing. The Alinity c-series uses three bulk solutions. Each bulk solution bottle is loaded on
the bulk solution door.
Figure 86: Bulk solutions (c-series)
Legend:
1. Alkaline Wash (0.5 L bottle): An alkaline wash solution that is used by the cuvette washer to clean the
cuvettes after sample analysis.
2. ICT Reference Solution: (975 mL in a 1 L bottle): A midconcentration standard solution that is
aspirated and analyzed by the ICT module before and after each sample. The solution provides a
reference potential that is used in result calculation.
3. Acid Wash (0.5 L bottle): An acidic wash solution that is used by the cuvette washer to clean the
cuvettes after sample analysis.
Related information...
Required consumables, page 133
Bulk solution storage area (Alinity c), page 88
Bulk solution reservoir area (Alinity c), page 89
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Bulk solutions (i-series)
Bulk solutions are liquid solutions that are provided in large quantities for use during assay
processing. The Alinity i-series uses three bulk solutions. Each bulk solution bottle is loaded on
the bulk solution door.
Figure 87: Bulk solutions (i-series)
Legend:
1. Pre-Trigger Solution (1 L bottle): A solution that contains 1.32% (W/V) hydrogen peroxide solution that
separates the acridinium dye from the conjugate that is bound to the microparticle complex. This
action prepares the acridinium dye for the addition of Trigger Solution. Pre-Trigger Solution is
sensitive to light, is stored at a temperature of 2°C to 8°C, and is stable on the system for 28 days.
2. Trigger Solution (1 L bottle): A solution that contains 0.35N sodium hydroxide solution that produces
the chemiluminescent reaction that provides the final read. This solution is stored at a temperature of
2°C to 30°C and is stable on the system for a maximum of 28 days. Some assays require a shorter
onboard stability period. For more information, see the assay documentation.
3. Concentrated Wash Buffer (2 L bottle): A solution that contains phosphate-buffered saline and
antimicrobial agents. This solution is diluted tenfold by the system and then is pumped to sample and
reagent pipettor assemblies and to wash zones during assay processing. This solution is stored at a
temperature of 15°C to 30°C and is stable on the system for 30 days.
Related information...
Required consumables, page 133
Bulk solution storage area (Alinity i), page 116
Reservoir areas (Alinity i), page 117
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Onboard solutions (c-series)
Onboard solutions are detergents that are used to wash sample probes, reagent probes, mixers,
and reaction cuvettes. The solutions are used by the SmartWash feature during system
operation. They may also be used during some maintenance and diagnostic procedures.
Onboard solutions include Acid Probe Wash, Detergent A, and Detergent B. For specific
information about each solution, see the product documentation.
Figure 88: Onboard solutions (c-series)
Related information...
Required consumables, page 133
SmartWash feature (c-series), page 370
Maintenance solutions (c-series)
The c-series maintenance solutions are liquid solutions that are supplied as a three-component
kit and are used during the automated daily maintenance procedure. The large bottle of the
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maintenance cartridge is filled with Water Bath Additive, an antimicrobial solution that is used to
prevent and control microbial contamination in the water bath. During maintenance, the solution
is dispensed into the water bath. The small bottle of the maintenance cartridge is empty and is
reserved for the reconstituted Cleaning Solution. Cleaning Solution is supplied as a lyophilized
material with a diluent. The reconstituted cleaning solution is added to the small bottle. During
daily maintenance, the reconstituted cleaning solution is used to clean sample and reagent
probes, mixers, the ICT probe, and the ICT module.
Figure 89: Maintenance solutions (c-series)
Related information...
Required consumables, page 133
5501 Daily Maintenance (c-series), page 759
ICT module (c-series)
The ICT module is an integrated chip that is a component of the ICT unit and contains the
sodium (Na+), potassium (K+), chloride (Cl-), and reference electrodes. The warranty for the ICT
module is 20,000 samples or 3 months after installation, whichever occurs first.
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Figure 90: ICT module (c-series)
Related information...
Required consumables, page 133
Probe conditioning solution (i-series)
Probe conditioning solution is a solution that contains recalcified human plasma. Some
maintenance procedures require this solution after the sample pipettor probe is cleaned to
condition the probe to prevent the nonspecific binding of analytes in the probe. This solution is
stored at a temperature of 2°C to 8°C and is stable on the system for 52 days.
Figure 91: Probe conditioning solution (i-series)
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Related information...
Required consumables, page 133
Reaction vessels (i-series)
Reaction vessels (RVs) are disposable containers in which the CMIA reaction occurs. The
operator can add RVs at any time.
Figure 92: Reaction vessel (i-series)
Related information...
Required consumables, page 133
Sample cups
Sample cups are 1400 μL disposable containers that hold samples. Volume graduation marks at
125 μL, 500 μL, and 1400 μL eliminate the need to pipette with precision.
Sample cups can be placed in sample tubes with bar code labels to facilitate positive
identification.
Figure 93: Sample cup
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Related information...
Required consumables, page 133
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Required accessories
Required accessories are parts that are needed for sample processing on the Alinity ci-series.
Be sure to maintain an adequate inventory of required accessories.
Related information...
Use or function, page 47
Racks, page 144
Trays, page 145
Reagent cartridge with empty bottles (c-series), page 145
Racks
Racks are accessories that are used on the reagent and sample manager to transport
specimens, calibrators, and controls to the sample pipettor. The Alinity ci-series uses three types
of racks.
Figure 94: Racks
Legend:
1. Vial rack: Bar-coded for identification with the letter V. Holds six open vials of calibrators or controls
for immediate use. The rack cannot be stored in the reagent carousel.
2. Onboard vial rack: Bar-coded for identification with the letter U. Holds six vials of calibrators or
controls. The rack is stored in the reagent carousel.
3. Sample rack: Bar-coded for identification. Holds six primary tubes, aliquot tubes, or sample cups. Any
combination of tubes and cups can be used in the rack.
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4. Sample gauge: Used to verify that the amount of sample in an aliquot tube exceeds 8 mm.
Related information...
Required accessories, page 144
Loading area, page 64
Reagent and sample manager (RSM) sample processing for onboard calibrators and controls,
page 567
Onboard storage criteria for calibrator and control vials, page 568
Trays
Trays are accessories that are used to hold multiple racks of samples, calibrators, and controls
and to hold reagent cartridges. Trays of racks and cartridges are loaded on the reagent and
sample manager. Each tray holds a maximum of five racks or cartridges. Empty trays may
remain on the loading area to create five positions to load racks or cartridges one at a time.
Figure 95: Tray
Related information...
Required accessories, page 144
Loading area, page 64
Reagent cartridge with empty bottles (c-series)
The c-series Reagent Cartridge, Black (Large), is a single-use cartridge that contains two empty,
black reagent bottles that can be filled with saline, user-defined sample diluents, and user-
defined reagents. When the bottles are filled and labeled with a one-dimensional (1D) reagent
bar code, the cartridge can be loaded in the reagent carousel. The R1 bottle is the larger bottle
and has a maximum fill volume of 74 mL. The R2 bottle is the smaller bottle and has a maximum
fill volume of 47 mL.
IMPORTANT: Do not exceed the maximum fill volumes for the reagent bottles to prevent
damage to the reagent carousel.
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Figure 96: c-series Reagent Cartridge, Black (Large)
Related information...
Required accessories, page 144
Prepare sample diluents and user-defined reagents (c-series), page 552
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Automatic processing module activities
Periodically, system operations occur automatically to maintain the optimal performance and
condition of the system.
Related information...
Use or function, page 47
System flush (c-series), page 147
System flush (i-series), page 147
System prime (i-series), page 148
Processing module wash (c-series), page 148
Automatic rotation of the reagent carousel (c-series), page 149
System flush (c-series)
A system flush is an automated process that removes bubbles that may be present. The system
performs periodic flushes at the beginning of a run on all pipettors by pumping purified water
through the pipettor probes into the wash cups.
ICT Reference Solution, Alkaline Wash, and Acid Wash are flushed automatically when the
following situations occur:
• The first time that the instrument status of the processing module transitions to Running
after the module is powered on
• After a bulk solution is replaced on the bulk solution door and the bulk solution reservoir is
at or below the lowest detectable level
Related information...
Automatic processing module activities, page 147
System flush (i-series)
A system flush is an automated process that removes bubbles that may be present. The system
performs periodic flushes on all pipettors by pumping wash buffer through the pipettor probes
into the wash cups. To flush the wash zone assemblies and the Pre-Trigger and Trigger
manifold, the system pumps fluid through a bypass valve and into the waste line.
Wash buffer, Pre-Trigger Solution, and Trigger Solution are flushed automatically when one of
the following situations occurs:
• After 8 hours of inactivity when the instrument status of the processing module is Running
• The first time that the instrument status of the processing module transitions to Running
after the module is powered on
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• After a bulk solution is replaced on the bulk solution door and the bulk solution reservoir is
at or below the lowest detectable level
Related information...
Automatic processing module activities, page 147
System prime (i-series)
A system prime is an automated process that removes air from wash zone delivery nozzles, Pre-
Trigger delivery nozzles, and Trigger delivery nozzles. To perform a prime, the system pushes
fluid through the delivery nozzles and into a reaction vessel (RV). Then, the RV is discarded
automatically.
The wash zone delivery nozzles, the Pre-Trigger delivery nozzles, and Trigger delivery nozzles
are primed when the instrument status of the system transitions from Running to Processing.
Related information...
Automatic processing module activities, page 147
Processing module wash (c-series)
Processing module wash is the process that cleans hardware components that have come in
contact with reagents and samples.
The following table describes the wash solutions used for each hardware component.
Component Wash
Sample probes and • A wash with purified water is performed during assay processing.
reagent probes • Additional washes with purified water, Acid Probe Wash, Detergent A, or
Detergent B (only for reagent probes) may be performed if a SmartWash is
configured in the assay parameters.
• Automatic washes with Detergent A and Acid Probe Wash are performed
during assay processing every 1500 tests.
Cuvette segments • Washes with purified water, Alkaline Wash, and Acid Wash are performed
before and after each use.
• Additional washes with Acid Probe Wash, Detergent A, or Detergent B may be
performed if a SmartWash is configured in the assay parameters.
Mixers • A wash with purified water is performed during assay processing.
• Additional washes with purified water, Acid Probe Wash, Detergent A, or
Detergent B may be performed if a SmartWash is configured in the assay
parameters for the corresponding reagent probe.
• Automatic washes with Detergent A and Acid Probe Wash are performed
during assay processing every 1500 tests.
Related information...
Automatic processing module activities, page 147
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Automatic rotation of the reagent carousel (c-series)
Automatic rotation of the reagent carousel is a programmed rotation that stabilizes the carousel
temperature. The reagent carousel automatically rotates 18 positions every 20 minutes when the
instrument status of the processing module is Running or Idle.
Related information...
Automatic processing module activities, page 147
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NOTES
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Section 2 Installation procedures and special requirements
Introduction
For accurate test results and optimal system performance, the Alinity ci-series must be correctly
installed. After the system has been installed, configure it to meet individual laboratory
requirements.
Related information...
System installation and relocation, page 152
System configuration, page 154
Utilities screen, page 323
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System installation and relocation
An Abbott Laboratories representative performs the installation and the relocation of the Alinity
ci-series.
Related information...
Installation procedures and special requirements, page 151
System installation, page 152
System checkout, page 152
System relocation, page 153
System installation
Before the installation of the Alinity ci-series, an Abbott Laboratories representative confirms that
the site is prepared. The system location must meet environmental specifications and electrical
requirements before the representative can install the system.
The representative unpacks, positions, and installs the system. During the installation, the
representative performs the system setup and confirms that the system operates within the
manufacturer's specifications.
After the installation, the customization or configuration of the system may be performed before
any testing is initiated.
Related information...
System installation and relocation, page 152
Specifications and requirements, page 394
System checkout
After the Alinity ci-series is installed, the following procedures may be performed to ensure that
the system operates appropriately:
• Install assay files.
• Configure system settings.
• Configure Abbott assays.
• Configure user-defined assays.
• Configure calibrator sets.
• Configure quality controls.
• Order and calibrate assays.
• Order and run controls.
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• Perform testing that is specific to the site requirements.
Related information...
System installation and relocation, page 152
Install assay files, page 272
Configure screen, General tab, page 154
Configure screen, Computer tab, page 201
Configure screen, Assay tab, page 227
Orders screen, page 584
System relocation
For information about the relocation of the Alinity ci-series, contact an Abbott Laboratories
representative.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
Before the system can be moved or can be shipped, decontamination is required.
Related information...
System installation and relocation, page 152
Requirements for decontamination, page 731
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System configuration
Configuration settings define the information that the Alinity ci-series needs to meet laboratory-
specific requirements. System configuration is performed after system installation. The system
can be reconfigured at any time if necessary.
Related information...
Installation procedures and special requirements, page 151
Configure screen, General tab, page 154
Configure screen, Computer tab, page 201
Configure screen, Assay tab, page 227
Configure screen, Maintenance & Diagnostics tab, page 310
Configure screen, General tab
The operator can perform the following tasks from the General tab of the Configure screen:
Users • Create new users.
• Edit existing users.
• Manage user PINs.
• Export and import users from one Alinity ci-series to a
different Alinity ci-series.
User Profile • Configure a personal display theme.
• Change a personal user PIN.
Modules • Edit the quality control shift start time.
• Edit parameters that are specific to a processing module.
• Add a module, delete a module, or configure a module.
This task requires an FSE logon.
Printers • Add a printer.
• Delete a printer.
• Edit printer settings.
Bar Codes • Enable and disable bar code types.
• Configure bar code parameters.
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Reagents and Configure reagent and supply low alerts.
Supplies
Reports Configure automatic printing of reports.
Abbott Mail • Enable and disable download options for Abbott Mail
items.
• Configure the download language for the Abbott Mail
documentation.
Related information...
System configuration, page 154
Users screen, page 155
User Profile screen, page 165
Modules screen, page 168
Printers screen, page 176
Bar Codes screen, page 183
Reagents and Supplies screen, page 186
Reports screen, page 196
Abbott Mail screen, page 199
System checkout, page 152
Users screen
On the Users screen, the operator can view the following information for users that have been
created on the system:
• Operator ID
• First and last names
• Access level
• Status
• Date on which a user was created
The system administrator can perform the following functions:
• Create new users.
• Edit a user name, the access level, and the status.
• Reset a user PIN.
• Import and export user data.
The operator can search for a specific user.
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Related information...
Configure screen, General tab, page 154
Users screen element descriptions, page 156
Users Import screen, Users Export screen element descriptions, page 157
Descriptions of access levels, page 158
Create New User screen element descriptions, page 159
Create a new user, page 160
Edit User screen element descriptions, page 161
Edit a user, page 162
Inactivate or activate a user, page 163
Import users, page 163
Export users, page 164
Manage user PINs, page 165
Users screen element descriptions
On the Users screen, the user can filter and display user profile information.
Elements
Operator ID Displays the operator ID of the user.
Last Name Displays the last name of the user.
First Name Displays the first name of the user.
Level Displays one the following access levels for the user:
• General
• Supervisor
• Administrator
Status Displays one the following statuses for the user:
Active The user can log on to the system if
the status of the user profile is Active.
Inactive The user cannot log on to the system if
the status of the user profile is Inactive.
Created On Displays the date and time that the user profile was created.
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Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Search Displays the Search flyout.
Import Navigates to the Users Import screen.
Export Navigates to the Users Export screen.
Create New User Navigates to the Create New User screen.
Edit User Navigates to the Edit User screen.
Set Pin Navigates to the Set Pin screen.
Text Size Increases or decreases the size of text displayed.
Related information...
Users screen, page 155
Descriptions of screen elements, page 127
Users Import screen, Users Export screen element descriptions
On the Users Import screen, the operator can import users on a USB flash drive. On the Users
Export screen, the operator can export users to a USB flash drive.
Elements
button The Previous Folder button navigates to the previously
selected folder.
button The Selected Folders button displays all previously selected
folders.
Folder Name Displays the currently selected folder.
button The Home button navigates to the C drive folder.
File Name Displays the name of the exported user database file.
Created On Displays the date and time that the exported user database
file was created.
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Import File Displays the file location and file name of the selected
exported user database file. The element is displayed only on
the Users Import screen.
Export Location Displays the drive and folder location to which the exported
user database file is exported. The element is displayed only
on the Users Export screen.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Import Imports the selected file. This function button is displayed only
on the Users Import screen.
Export Exports the users database. This function button is displayed
only on the Users Export screen.
Text Size Increases or decreases the size of text displayed.
Related information...
Users screen, page 155
Descriptions of screen elements, page 127
Descriptions of access levels
An access level is the identifier that controls the access to certain user interface functionality.
The system software has three types of operator access levels:
General operator Used to display the current operator ID on various screens
and to print the operator ID of the current user on printouts
and reports.
Supervisor Used to perform supervisor functions such as the following
examples:
• Configure automatically generated reports.
• Configure quality control settings.
• Configure user-defined maintenance.
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• Configure audio settings.
• Configure calibrator settings.
System administrator Used to perform administrator functions such as the following
examples:
• Configure system settings.
• Approve maintenance logs.
• Install and uninstall assays.
• Accept Abbott Mail items.
Additionally, Abbott Customer Service may provide a user name and a temporary password to
operators who call for troubleshooting assistance. This logon authorizes selected functions in
addition to those functions allowed by the system administrator logon.
Related information...
Users screen, page 155
Log On screen, page 454
Create New User screen element descriptions
On the Create New User screen, the system administrator can create a new user profile.
Elements
Operator ID Displays a box to enter the operator ID of the new user.
First Name Displays a box to enter the first name of the new user.
Last Name Displays a box to enter the last name of the new user.
Level Displays the following access level options for the new user:
• General
• Supervisor
• Administrator
Status Displays the following status options for the new user:
Active The new user can log on to the system
if this option is enabled.
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Inactive The new user cannot log on to the
system if this option is enabled.
PIN Displays a box to enter the four-digit personal identification
number of the new user.
Re-enter PIN Displays a box to reenter the four-digit personal identification
number of the new user.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Save Saves changes.
Text Size Increases or decreases the size of text displayed.
Related information...
Users screen, page 155
Descriptions of screen elements, page 127
Create a new user
Operator access level System administrator
Perform this procedure to create a new user. An operator ID and a PIN must be created for an
operator to log on to the system software and use the system.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap Users.
3. On the Users screen, tap Create New User.
4. On the Create New User screen, enter the operator ID.
The operator ID can contain a maximum of 12 alphanumeric characters.
5. Type the first and last names.
6. In the Level area, tap an option for the operator access level.
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7. In the Status area, tap a status option.
8. Enter a unique four-digit PIN.
9. To confirm the PIN, reenter it.
10. To save the new user settings, tap Save.
To delete the new user settings, tap Cancel.
11. To create another new user, repeat steps 4, page 160 through 9, page 161.
12. To return to the Users screen, tap Done.
Related information...
Users screen, page 155
Edit User screen element descriptions
On the Edit User screen, the system administrator can edit an existing user profile.
Elements
Operator ID Displays the operator ID of the user.
First Name Displays the first name of the user.
Last Name Displays the last name of the user.
Level Displays the access level of the user. One of the following
options is enabled:
• General
• Supervisor
• Administrator
Status Displays the status of the user. One of the following options is
enabled:
Active The user can log on to the system if
this option is enabled.
Inactive The user cannot log on to the system if
this option is enabled.
Created On Displays the date and time that the user profile was created.
Created By Displays the operator ID of the system administrator who
created the user profile.
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Last Updated On Displays the date and time that the user profile was most
recently edited.
Last Updated By Displays the operator ID of the system administrator who most
recently edited the user profile.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Save Saves changes.
Text Size Increases or decreases the size of text displayed.
Related information...
Users screen, page 155
Descriptions of screen elements, page 127
Edit a user
Operator access level System administrator
Perform this procedure to edit the first name, the last name, and the access level of a user.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap Users.
3. On the Users screen, tap an operator ID to edit.
NOTE: To filter the operator IDs, tap Search.
4. Tap Edit User.
5. On the Edit User screen, edit any of the following information:
– First Name
– Last Name
– Level
– Status
NOTE: A user cannot edit the level and status of the user's own profile.
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6. To save the edits to the user settings, tap Save.
To delete the edits to the user settings, tap Cancel.
7. To return to the Users screen, tap Done.
Related information...
Users screen, page 155
Search for or filter data, page 664
Inactivate or activate a user
Operator access level System administrator
Perform this procedure to inactivate or activate a user.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap Users.
3. On the Users screen, tap an operator ID to inactivate or activate.
NOTE: To filter the operator IDs, tap Search.
4. Tap Edit User.
5. In the Status area of the Edit User screen, tap one of the following options:
– Tap Inactive to inactivate a user.
– Tap Active to activate a user.
6. To save the edit to the user settings, tap Save.
To delete the edit to the user settings, tap Cancel.
7. To return to the Users screen, tap Done.
Related information...
Users screen, page 155
Search for or filter data, page 664
Import users
Required materials USB flash drive with user file to import
Operator access level System administrator
Perform this procedure to import users on a USB flash drive.
1. Insert the USB flash drive.
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2. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
3. On the General tab of the Configure screen, tap Users.
4. On the Users screen, tap Import.
5. On the Users Import screen, tap the USB flash drive, the folder, and the file to import.
6. Tap Import.
7. When a confirmation message is displayed, tap Yes, and then tap OK.
8. Remove the USB flash drive.
9. To return to the Users screen, tap Done.
Related information...
Users screen, page 155
Insert and remove a USB flash drive, page 671
Export users
Required materials USB flash drive
Operator access level System administrator
Perform this procedure to export users to a USB flash drive. After the users are exported, the
users can be installed on a different system.
1. Insert the USB flash drive.
2. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
3. On the General tab of the Configure screen, tap Users.
4. On the Users screen, tap Export.
5. On the Users Export screen, tap the USB drive and folder to which to export the user files.
6. Tap Export.
7. When a confirmation message is displayed, tap Yes, and then tap OK.
8. Remove the USB flash drive.
9. To return to the Users screen, tap Done.
Related information...
Users screen, page 155
Insert and remove a USB flash drive, page 671
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Manage user PINs
Operator access level System administrator
Perform this procedure to change one or more user PINs. System administrators can change
their personal user PINs and the user PINs of other users.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap Users.
3. On the Users screen, tap an operator ID to edit.
NOTE: To filter the operator IDs, tap Search.
4. Tap Set PIN.
5. In the Set PIN flyout, enter the following information:
a. Your PIN (the current four-digit PIN of the logged-on system administrator or user)
b. New PIN (a new four-digit PIN for the selected operator ID)
c. Re-enter New PIN (the confirmation of the new PIN for the selected operator ID)
6. To save the edits to the user settings and return to the Users screen, tap Done.
7. When a confirmation message is displayed, tap Yes.
8. To delete the edits to the user settings and return to the Users screen, tap Cancel.
Related information...
Users screen, page 155
Search for or filter data, page 664
User Profile screen
On the User Profile screen, the operator can perform the following functions:
• Configure a personal display theme.
• Change a personal user PIN.
Related information...
Configure screen, General tab, page 154
User Profile screen element descriptions, page 166
Configure a personal display theme, page 167
Change a personal user PIN, page 167
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User Profile screen element descriptions
On the User Profile screen, the operator can change the user pin and display theme.
Elements
General
Username Displays the configured operator ID.
First Name Displays the first name of the user.
Last Name Displays the last name of the user.
Level Displays one of the following access levels:
• General
• Supervisor
• Administrator
Created On Displays the date and time that a user was created.
Display
Theme Displays the current theme options:
Light Bar Changes the theme bar to a light color.
Dark Bar Changes the theme bar to a dark color.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Set Pin Navigates to the Set Pin screen.
NOTE: This function button is available after a user is
selected.
Cancel Navigates to the User Profile message box where previous
edits can be deleted by tapping the Continue button.
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Related information...
User Profile screen, page 165
Descriptions of screen elements, page 127
Configure a personal display theme
Perform this procedure to configure a display theme. General operators can configure their
personal display themes but cannot configure the display themes of other users.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap User Profile.
3. Under Display on the User Profile screen, tap an option in the Theme area.
4. To save the edits to the user profile settings, tap Done.
To delete the edits to the user profile settings, tap Cancel.
Related information...
User Profile screen, page 165
Change a personal user PIN
Perform this procedure to change a user PIN. General operators can change their personal user
PINs but cannot change the user PINs of other users.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap User Profile.
3. On the User Profile screen, tap Set PIN.
4. In the Set PIN flyout, enter the following information:
a. Your PIN (the current four-digit PIN of the logged-on user)
b. New PIN (a new four-digit PIN for the selected operator ID)
c. Re-enter New PIN (the confirmation of the new PIN for the selected operator ID)
5. To save the edits to the user profile settings and return to the User Profile screen, tap
Done.
6. To delete the edits to the user profile settings and return to the User Profile screen, tap
Cancel.
Related information...
User Profile screen, page 165
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Modules screen
On the Modules screen, the operator can view the following information:
• Serial numbers for each processing module and the reagent and sample manager (RSM)
• The number of assigned reagent carousel positions for onboard calibrators and controls
• The quality control shift start time
• The location and number of priority sections
• Specific parameters for each processing module and the RSM
• Instrument test cycle counts
The supervisor can edit the quality control shift start time.
The system administrator can perform the following functions:
• Configure the module name.
• Configure the number of assigned reagent carousel positions for onboard calibrators and
controls.
• Configure the location and number of priority sections.
• Configure specific parameters for each processing module and the RSM.
Related information...
Configure screen, General tab, page 154
Modules screen, reagent and sample manager (RSM) element descriptions, page 168
Modules screen, c-series element descriptions, page 170
Modules screen, i-series element descriptions, page 172
Configure reagent and sample manager module settings, page 174
Configure c-series module settings , page 174
Configure i-series module settings, page 175
Modules screen, reagent and sample manager (RSM) element descriptions
On the Modules screen, the operator can configure module settings for the reagent and sample
manager (RSM).
Module Information area
Module Displays a drop-down list that is used to select a module to
display module-specific information.
Module Type Displays the module type.
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Module Name Displays a box that is used to enter a maximum of 12
alphanumeric characters. The box is an optional element.
Module Details area
Cover Interlocks (FSE Displays the Override Interlocks options:
Logon)
• On
• Off (default)
When this option is enabled, the system control module
(SCM) cover can be open while the instrument status of the
RSM is Running. All tests become exceptions.
Retest Options Displays the Automatically Reposition Samples for Retest
options:
• Yes
• No (default)
When this option is enabled, the RSM is configured to
reposition sample racks for automatic retesting.
Priority Positions Displays the following settings:
Location of Priority Displays the following options:
Positions
• Leftmost: The priority position
location can start at position 1.
• Rightmost: The priority position
location can start at position 25.
Number of Priority Displays a slider that is used to
Positions configure priority positions from 0
through 25 in increments of 5.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Add Module (FSE Displays the Add Module screen.
Logon)
NOTE: This function button is not used for the RSM.
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Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Save Saves changes.
Related information...
Modules screen, page 168
Descriptions of screen elements, page 127
Modules screen, c-series element descriptions
On the Modules screen, the operator can configure Alinity c-series module settings.
Module Information area
Module Displays a drop-down list that is used to select a module to
display module-specific information.
Module Type Displays the module type.
SN Displays the serial number of the selected module.
Module Name Displays a box that is used to enter a maximum of 12
alphanumeric characters. The box is an optional element.
Module Details area
Onboard Cal/QC Displays the Onboard Cal/QC Positions drop-down list, which
is used to configure the number of reagent carousel positions
that are available for onboard vial racks. When a reagent
carousel position is configured, the position is unavailable for
cartridge storage. A position from 1 through 4 can be
selected. The default position is 1.
Quality Control Displays the Shift Start Time spin box, which is used to
configure a shift start time and to define quality control runs
with respect to Westgard rules that relate to within-run and
between-run data points. Use the HH:MM format to enter a
shift start time by typing the time in the box or by tapping the
Up Arrow and Down Arrow buttons. Use the AM or PM
button to configure the time of day.
ICT Module Displays the Installed options:
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• Yes (default)
• No
Liquid Waste Displays the Installed options:
Container
• Yes
• No (default)
Instrument Test Cycle Displays the following settings:
Counts
Tests Initiated Count Displays the total number of tests that
are scheduled and either have
completed successfully with results or
have become exceptions.
NOTE: This number excludes derived
results and HIL tests. Integrated chip
technology (ICT) tests count only as
one.
Tests Completed Displays the total number of tests that
Count have completed data reduction and a
valid absorbance (c-series photometric)
or voltage (c-series potentiometric) is
generated.
NOTE: This number excludes derived
results and HIL tests. ICT tests count
only as one.
Cover Interlocks (FSE Displays the Override Interlocks options:
Logon)
• On
• Off (default)
When this option is enabled, the processing module covers
can be open while the instrument status of the module is
Running. All tests become exceptions.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
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Add Module (FSE Displays the Add Module screen. This function button is used
Logon) to add a module to the system software.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Save Saves changes.
Related information...
Modules screen, page 168
Descriptions of screen elements, page 127
Modules screen, i-series element descriptions
On the Modules screen, the operator can configure Alinity i-series module settings.
Module Information area
Module Displays a drop-down list that is used to select a module to
display module-specific information.
Module Type Displays the module type.
SN Displays the serial number of the selected module.
Module Name Displays a box that is used to enter a maximum of 12
alphanumeric characters. The box is an optional element.
Module Details area
Onboard Cal/QC Displays the Onboard Cal/QC Positions drop-down list, which
is used to configure the number of reagent carousel positions
that are available for onboard vial racks. When a reagent
carousel position is configured, the position is unavailable for
cartridge storage. A position from 1 through 4 can be
selected. The default position is 1.
Quality Control Displays the Shift Start Time spin box, which is used to
configure a shift start time and to define quality control runs
with respect to Westgard rules that relate to within-run and
between-run data points. Use the HH:MM format to enter a
shift start time by typing the time in the box or by tapping the
Up Arrow and Down Arrow buttons. Use the AM or PM
button to configure the time of day.
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Optics Values Displays the following settings:
Normalization Displays a box that is used to enter an
optics normalization value.
Linearity Displays a box that is used to enter an
optics linearity value.
STAT Protocol Displays the STAT Protocol Percentage slider, which is used
to configure the number of reaction vessel positions that are
allocated for STAT assay protocols. If this percentage does
not reflect the actual number of STAT protocols that were
run, throughput may be decreased.
Instrument Test Cycle Displays the following settings:
Counts
Tests Initiated Count Displays the total number of tests that
are scheduled and either have
completed successfully with results or
have become exceptions.
Tests Completed Displays the total number of tests that
Count have completed data reduction and a
valid relative light unit (RLU) reading is
generated.
Cover Interlocks (FSE Displays the Override Interlocks options:
Logon)
• On
• Off (default)
When this option is enabled, the processing module covers
can be open while the instrument status of the module is
Running. All tests become exceptions.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Add Module (FSE Displays the Add Module screen. This function button is used
Logon) to add a module to the system software.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
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Save Saves changes.
Related information...
Modules screen, page 168
Descriptions of screen elements, page 127
Configure reagent and sample manager module settings
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to configure reagent and sample manager module settings.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap Modules.
3. In the Module Name box on the Modules screen, if a name other than the name that is
displayed is needed, type a new module name.
4. Under Retest Options, tap an option to reposition samples for retesting automatically.
5. Under Priority Sections, enter the following information:
– Location of Priority Sections
– Number of Priority Sections
6. To save the edits to the module settings, tap Save.
To delete the edits to the module settings, tap Cancel.
7. To return to the Configure screen, tap Done.
Related information...
Modules screen, page 168
Automated retest of specimens, page 583
Configure c-series module settings
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator, except where noted
Perform this procedure to configure c-series module settings.
1. On the menu bar, tap System, and then tap Configure.
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NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap Modules.
3. Under Module Information on the Modules screen, tap a c-series module in the drop-down
list.
4. In the Module Name box, if a name other than the name that is displayed is needed, type a
new module name.
5. In the Onboard Cal/QC Position drop-down list under Onboard Cal/QC, tap the number of
reagent carousel positions that are assigned to onboard calibrators and controls.
6. In the Shift Start Time box under Quality Control, enter the time for quality controls to be
performed automatically.
NOTE: A supervisor can configure the shift start time.
7. In the Installed area under ICT Module, tap an option.
8. In the Installed area under Liquid Waste Container, tap an option.
9. To save the edits to the module settings, tap Save.
To delete the edits to the module settings, tap Cancel.
10. To return to the Configure screen, tap Done.
Related information...
Modules screen, page 168
Westgard rule run descriptions, page 640
Configure i-series module settings
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator, except where noted
Perform this procedure to configure i-series module settings.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap Modules.
3. Under Module Information on the Modules screen, tap an i-series module in the drop-down
list.
4. In the Module Name box, if a name other than the name that is displayed is needed, type a
new module name.
5. In the Onboard Cal/QC Position drop-down list under Onboard Cal/QC, tap the number of
reagent carousel positions that are assigned to onboard calibrators and controls.
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6. In the Shift Start Time box under Quality Control, enter the time for quality controls to be
performed automatically.
NOTE: A supervisor can configure shift start time.
7. Under STAT Protocol, slide the STAT Protocol Percentage button to the right or left to
increase or decrease the STAT percentage.
8. Under Optics Values, enter the values for Normalization and Linearity that are located on
the optics assembly.
NOTE: Normalization and linearity values need to be updated only when an optics assembly
is replaced.
9. To save the edits to the module settings, tap Save.
To delete the edits to the module settings, tap Cancel.
10. To return to the Configure screen, tap Done.
Related information...
Modules screen, page 168
Westgard rule run descriptions, page 640
Printers screen
On the Printers screen, the operator can view information for a configured printer.
The system administrator can perform the following functions:
• Add a new printer.
• Verify a new printer.
• Change the configuration of an existing printer.
• Configure a printer as the default.
• Access the printer queue.
• Remove a configured printer from the software.
Related information...
Configure screen, General tab, page 154
Printers screen element descriptions, page 177
Add Printer flyout/Edit Printer flyout element descriptions, page 178
Printer Verification flyout element descriptions, page 179
Printer Queue flyout element descriptions, page 180
Add a printer, page 180
Edit a printer, page 181
Verify a printer, page 182
Change the default printer, page 183
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Remove a printer, page 183
Printers screen element descriptions
On the Printers screen, the system administrator can configure or edit new or existing printers.
Elements
Name Displays the name of each configured printer.
IP Address Displays the Internet protocol address for the printer.
Verified User Displays the identification of the operator who verified the
printer operation.
Verified Date Displays the date and time of the last successful verification
of the printer operation.
Paper Size Displays the paper size configured for the printer: A4 or
Letter.
Duplex Displays a check mark if the printer is configured to print on
both sides (duplex). If the printer is configured to print on one
side (simplex), no check mark is displayed.
Default Displays a check mark if the printer is configured as the
default printer.
Status Displays one of the following statuses for the printer: OK or
Error.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Add Printer Displays the Add Printer flyout.
Edit Printer Displays the Edit Printer flyout.
Verify Printer Displays the Printer Verification flyout.
Make Default Used to select a default printer if more than one printer is
configured. A check mark is displayed in the Default column
in the row of the default printer. Only one printer can be
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configured as the default. If only one printer is configured, the
system designates the printer as the default printer.
Printer Queue Displays the Printer Queue flyout.
Remove Printer Displays a message requesting confirmation to delete a
configured printer. Any print jobs in the printer queue will also
be deleted. If the currently configured default printer is
deleted, the system designates the most recently configured
printer as the new default printer. Printer drivers are not
deleted.
Text Size Increases or decreases the size of text displayed.
Related information...
Printers screen, page 176
Descriptions of screen elements, page 127
Add Printer flyout/Edit Printer flyout element descriptions
The operator can configure a new printer or edit printer information for an existing printer. A
maximum of 5 printers can be configured.
Elements
Name Used to configure a unique printer name. The printer name
can contain 1 to 20 characters.
IP Address Used to enter the internet protocol (IP) address for a new
printer.
Paper Size Used to select the paper size configured for the printer: A4 or
Letter
Print on Both Sides Used to select to print documents on both sides of the paper
(duplex) or to print on a single side (simplex).
Driver Displays the printer drivers installed on the system. The
operator can select a printer driver when adding a new
printer.
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Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Printers screen, page 176
Printer Verification flyout element descriptions
The Printer Verification flyout displays a verification report that can be printed. The printed
verification report can be compared to a report that is displayed to verify a printer.
Elements
Print Options Displays the print options for the Printer Verification flyout.
Report Selection Displays a list of the reports that are available to print. A
preview of the selected report is displayed before the report is
printed.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Print Prints the selected report.
Text Size Increases or decreases the size of text displayed.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Printers screen, page 176
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Printer Queue flyout element descriptions
The Printer Queue flyout provides information about individual jobs in the printer queue for the
selected printer. A printer queue is displayed for each configured printer.
Elements
Printer Displays the name of the selected printer.
Status Displays one of the following statuses for the print request:
Queued, Printing, Error, Deleting, or Out of Paper.
Operator ID Displays the identification of the operator who submitted the
print request.
Date Displays the date and time that the print request was
submitted to the printer queue.
Document Displays the name of the document in the printer queue.
Pages Displays the number of pages for the document in the printer
queue.
Size Displays the size of the document in the printer queue.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Delete All Deletes all print requests from the printer queue.
Delete Selected Deletes selected print requests from the printer queue.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Printers screen, page 176
Add a printer
Operator access level System administrator
Perform this procedure to add a printer.
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1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap Printers.
3. On the Printers screen, tap Add Printer.
4. In the Add Printer flyout, enter the following information:
– Name
– IP Address
NOTE: Use the following format for the IP address: xxx.xxx.xxx.xxx
– Paper Size
– Print on Both Sides
– Driver
NOTE: Choose a universal or generic driver for the type of printer.
5. To add the printer, tap Done.
To return to the Printers screen without adding the printer, tap Cancel.
6. To return to the Configure screen, tap Done.
After the new printer is added, the printer must be verified before it is available to print a report
or document.
Related information...
Printers screen, page 176
Verify a printer, page 182
Edit a printer
Operator access level System administrator
Perform this procedure to edit the printer settings for a configured printer.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap Printers.
3. In the list on the Printers screen, tap a printer.
4. Tap Edit Printer.
5. In the Edit Printer flyout, edit any of the following information:
– Name
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– IP Address
– Paper Size
– Print on Both Sides
6. To save the edits to the printer settings, tap Done.
To delete the edits to the printer settings, tap Cancel
7. To return to the Configure screen, tap Done.
Related information...
Printers screen, page 176
Verify a printer
Operator access level System administrator
Perform this procedure when a new printer is added. After the new printer is added, the printer
must be verified before it is available to print a report or document.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap Printers.
3. In the list on the Printers screen, tap a printer.
4. Tap Verify Printer.
5. Under Report Selection in the Printer Verification flyout, tap Printer Verification Report.
6. Tap Print.
7. Compare the printed report to the report that is displayed in the Printer Verification flyout.
The printed report and the displayed report must be identical. If the two reports are not
identical, the printer is not verified.
NOTE: To adjust the size of the text in the displayed report, tap the Text Size button.
8. Tap Done.
9. When a confirmation message is displayed, tap one of the following buttons:
– Tap Yes if the printed report and the displayed report are identical.
– Tap No if the printed report and the displayed report are not identical.
Related information...
Printers screen, page 176
Add a printer, page 180
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Change the default printer
Operator access level System administrator
Perform this procedure to change the default printer.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap Printers.
3. In the list on the Printers screen, tap a printer.
4. Tap Make Default.
5. To return to the Configure screen, tap Done.
Related information...
Printers screen, page 176
Remove a printer
Operator access level System administrator
Perform this procedure to remove a printer.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap Printers.
3. In the list on the Printers screen, tap a printer.
4. Tap Remove Printer.
5. When a confirmation message is displayed, tap Yes.
NOTE: If the printer that was removed is the default printer, the first remaining printer in the
list becomes the default printer.
6. To return to the Configure screen, tap Done.
Related information...
Printers screen, page 176
Bar Codes screen
On the Bar Codes screen, the operator can view the following information:
• Sample bar code types that are enabled or are disabled
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• Configuration settings for each bar code type
The system administrator can perform the following functions:
• Enable or disable sample bar code types.
• Configure checksums.
• Configure the transmission of checksum digits to the user interface (UI) computer.
• Configure the transmission of start and stop characters to the UI computer.
• Configure primary and secondary code lengths.
Related information...
Configure screen, General tab, page 154
Bar Codes screen element descriptions, page 184
Change sample bar code settings , page 185
Bar Codes screen element descriptions
On the Bar Codes screen, the operator can configure bar code symbology settings.
Elements
Bar Codes Displays the following bar code options:
• Code 128
• Code 39
• Interleaved 2 of 5
• Codabar
Bar Code Type Displays the following options for bar code types:
• Enabled
• Disabled
NOTE: Code 128 cannot be disabled.
Checksums Displays the following options for checksums if the selected
bar code type supports checksums:
• Enabled
• Disabled
Send Checksums to Used to specify whether the checksums are sent to the user
UI Computer interface (UI) computer if the selected bar code type supports
it.
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Send Start/Stop Used to specify whether the start and stop characters are
Characters to UI sent to the UI computer if the selected bar code type supports
Computer it.
Primary Code Length Used to specify the length for the primary bar code. The
range is from 2 through 20 with an incremental value of 2.
The default is 10.
Secondary Code Used to specify the length for the secondary bar code if a
Length second code length is necessary. The range is from 2 through
20 with an incremental value of 2. The default is 8.
Function buttons
Done Saves changes and displays the previously viewed screen.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Save Saves changes.
Related information...
Bar Codes screen, page 183
Descriptions of screen elements, page 127
Change sample bar code settings
Required instrument Reagent and sample manager: Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to change the sample bar code settings.
NOTE: For Code 128 symbology, the option is enabled and does not require additional
configuration.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap Bar Codes.
3. On the Bar Codes screen, for Code 39, Codabar, and Interleaved 2 of 5 symbologies, tap
the Bar Code Type option to enable or disable the bar code type.
4. For Code 39, Codabar, and Interleaved 2 of 5 symbologies, tap the Checksums option to
enable or disable checksums.
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5. For Codabar symbology, if the checksums are enabled, tap the Send Checksums to UI
Computer check box to send the checksums to the user interface (UI) computer.
6. For Codabar symbology, if the checksums are enabled, tap the Send Start/Stop Characters
to UI Computer check box to send start and stop characters to the UI computer.
7. For Interleaved 2 of 5 symbology, edit the following settings:
– Primary Code Length
– Secondary Code Length
8. To save the edits to the bar code settings, tap Save.
To delete the edits to the bar code settings, tap Cancel.
9. To return to the Configure screen, tap Done.
Related information...
Bar Codes screen, page 183
Sample bar code label guidelines, page 417
Reagents and Supplies screen
On the Reagents and Supplies screen, the operator can view reagent and supply settings.
The system administrator can perform the following functions:
• Configure the ability to run controls for each reagent lot or reagent cartridge.
• Configure the default reagent low alert for all immunoassay reagents and clinical chemistry
reagents.
• Configure the ability to run reagents that are beyond the reagent onboard stability expiration
and the reagent lot expiration.
• Configure reagent low alert settings for individual reagents.
• Configure low alert settings for bulk solutions.
• Configure the ability to use supplies that are beyond the supply stability expiration and the
supply lot expiration.
The system administrator can also perform the following functions only for c-series modules:
• Configure the ability to run calibrations for each reagent lot or reagent cartridge.
• Configure low alert settings for onboard diluents and onboard solutions.
• Configure which module in a multimodule system uses Detergent B.
Related information...
Configure screen, General tab, page 154
Reagents and Supplies screen, Reagents/Diluents tab element descriptions, page 187
Reagents and Supplies screen, Supplies tab element descriptions , page 189
Configure system level reagent settings, page 192
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Configure diluent low alert settings (c-series), page 193
Configure individual c-series reagent settings, page 193
Configure individual i-series reagent settings, page 194
Configure supply settings, page 195
Reagents and Supplies screen, Reagents/Diluents tab element descriptions
The Reagents/Diluents tab is used to configure reagent options, diluent options, and supply low
alerts.
System Level Options area
Override Reagent Used to override a reagent's onboard stability.
Stability
The following options are available:
• On
• Off (default)
Override Reagent Lot Used to override a reagent's expiration.
Expiration
The following options are available:
• On
• Off (default)
Run Controls for Displays the options that are used to specify which reagent
Onboard Reagents by kits to run for quality control:
Lot Runs the controls only on one cartridge
for each lot (default)
Cartridge Runs the controls for all cartridges in a
lot
NOTE: If the control option is changed, the control option
does not change in the assay parameters for individual assays
that are currently installed. This change affects only the new
assay files that are installed or are imported.
Default Assay Displays a box that is used to enter the amount of time in
Calibration Interval hours that the calibration is valid.
Default i-series Displays a box that is used to enter the reagent low alert for
Reagent Low Alert all i-series reagents. The notification is displayed when the
number of remaining tests falls below the defined value.
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Default c-series Displays a box that is used to enter the reagent low alert for
Reagent Low Alert all c-series reagents. The notification is displayed when the
number of remaining tests falls below the defined value.
Diluent Low Alert area
Diluent Displays the name of the diluent.
Low Alert (Percent) Displays a box that is used to enter the diluent low alert
percentage. The notification is displayed when the percent
volume level falls below the defined value:
• Range: 1% to 50%
• Default: 20%
NOTE: If the diluent low alert percentage is changed, the
status of all onboard diluents is reevaluated.
c-series Reagents tab
Reagent Displays a list of assay names that are configured on the
system.
Calibrate Reagent By Displays the options that are used to calibrate an assay:
Lot Calibrates according to the lot number
of the reagent
Cartridge Calibrates each reagent cartridge
according to the assay
Reagent Low Alert Displays the boxes that are used to enter the reagent low
(Test Count) alert for individual assays. The notification is displayed when
the number of remaining tests for all onboard kits for a
specific reagent falls below the defined value. The default for
c-series tests is 100.
Alert Low Value Displays the low alert that is used by an assay:
System Uses the system low alert value
Reagent Uses the individual reagent low alert
value
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i-series Reagents tab
Reagent Displays a list of assay names that are configured on the
system.
Reagent Low Alert Displays the boxes that are used to enter the reagent low
(Test Count) alert for individual assays. The notification is displayed when
the number of remaining tests for all onboard kits for a
specific reagent falls below the defined value. The default for
i-series tests is 50.
Alert Low Value Displays the low alert that is used by an assay:
System Uses the system low alert value
Reagent Uses the individual reagent low alert
value
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Save Saves changes.
Print 1D Barcode Displays the Print 1D flyout. This function button is available
only for user-defined assays and diluents.
Text Size This function button is unavailable on this screen.
Related information...
Reagents and Supplies screen, page 186
Descriptions of screen elements, page 127
Reagents and Supplies screen, Supplies tab element descriptions
The Supplies tab is used to configure supply options and low alerts.
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Elements
Supply Options
i-series Supply
Options Override Stability Used to override the i-series bulk
solutions stability dates.
Options are:
• On
• Off (Default)
Override Lot Used to override the bulk solutions lot
Expiration expiration date.
Options are:
• On
• Off (Default)
c-series Supply
Options Override Stability Used to override the c-series bulk
solutions stability dates.
Options are:
• On
• Off (Default)
Override Lot Used to override the bulk solutions lot
Expiration expiration date.
Options are:
• On
• Off (Default)
Override ICT Module Used to override the ICT module
Expiration expiration.
Options are:
• On
• Off (Default)
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c-series Onboard Displays the c-series onboard solutions by module.
Solutions
Supply Low Alerts
i-series Bulk Solutions Used to enter low alert level percentages of the i-series bulk
solutions: Wash Buffer, Trigger, and Pre-Trigger. The
notification displays when the volume falls below the defined
value.
• Range: 1-50%
• Default: 20%
c-series Bulk Used to enter low alert level percentages of the c-series bulk
Solutions solutions: ICT Reference Solution, Alkaline Wash, and Acid
Wash. The notification displays when the volume falls below
the defined value.
• Range: 1-50%
• Default: 20%
c-series Onboard Used to enter low alert level percentages of the c-series
Solutions onboard solutions: Sample-Acid Probe Wash, Sample-
Detergent A, Reagent-Acid Probe Wash, Reagent-Detergent A,
and Reagent-Detergent B. The notification displays when the
volume falls below the defined value.
• Range: 1-50%
• Default: 20%
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Save Saves changes.
Related information...
Reagents and Supplies screen, page 186
Descriptions of screen elements, page 127
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Configure system level reagent settings
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to configure the following system level reagent settings:
• The option to run controls for each reagent lot or each reagent cartridge
• The option to run reagents that are beyond the reagent onboard stability expiration and the
reagent lot expiration
• Reagent low alert settings for all immunoassay reagents and clinical chemistry reagents
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap Reagents and Supplies.
3. Under System Level Options on the Reagents and Supplies screen, configure the following
override options:
– Override Reagent Stability
– Override Reagent Lot Expiration
NOTE: Running the system with overridden reagents is not recommended except when
troubleshooting is required. All results that are generated from overridden reagents are
flagged with an EXP result flag.
4. Tap one of the following Run Controls for Onboard Reagents by options:
– Lot: Run controls only on one cartridge for each lot.
– Cartridge: Run controls for all cartridges in a lot.
NOTE: Changing the control option does not change the control option in the assay
parameters for individual assays that are currently installed. This change only affects new
assay files that are installed or are imported.
5. In the Default i-series Reagent Low Alert box, type the number of remaining tests that
trigger the low alert status for all i-series reagents.
6. In the Default c-series Reagent Low Alert box, type the number of remaining tests that
trigger the low alert status for all c-series reagents.
7. To save the edits to the reagent settings, tap Save.
To delete the edits to the reagent settings, tap Cancel.
8. To return to the Configure screen, tap Done.
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Related information...
Reagents and Supplies screen, page 186
Configure diluent low alert settings (c-series), page 193
Configure individual c-series reagent settings, page 193
Configure individual i-series reagent settings, page 194
Configure diluent low alert settings (c-series)
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to configure low alert settings for c-series onboard diluents.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap Reagents and Supplies.
3. Under Diluent Low Alert on the Reagents and Supplies screen, for the appropriate diluent,
edit the remaining low alert percentage that triggers the low alert status.
4. To save the edits to the reagent settings, tap Save.
To delete the edits to the reagent settings, tap Cancel.
5. To return to the Configure screen, tap Done.
Related information...
Reagents and Supplies screen, page 186
Configure system level reagent settings, page 192
Configure individual c-series reagent settings
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to configure the following individual c-series reagent settings:
• The option to run calibrations for each reagent lot or each reagent cartridge
• Reagent low alert settings for individual c-series reagents
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
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2. On the General tab of the Configure screen, tap Reagents and Supplies.
3. On the Reagents and Supplies screen, tap the c-series Reagents tab.
4. For each appropriate reagent under Calibrate Reagent By on the c-series Reagents tab,
tap one of the following options:
– Lot: Run calibrations only on one cartridge for each lot.
– Cartridge: Run calibrations for all cartridges in a lot.
5. For each appropriate reagent under Reagent Low Alert (Test Count), edit the number of
remaining tests that trigger the low alert status.
6. To save the edits to the reagent settings, tap Save.
To delete the edits to the reagent settings, tap Cancel.
7. To return to the Configure screen, tap Done.
Related information...
Reagents and Supplies screen, page 186
Configure system level reagent settings, page 192
Configure individual i-series reagent settings
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure configure reagent low alert settings for individual i-series reagents.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap Reagents and Supplies.
3. On the Reagents and Supplies screen, tap the i-series Reagents tab.
4. For each appropriate reagent under Reagent Low Alert (Test Count) on the i-series
Reagents tab, edit the number of remaining tests that trigger the low alert status.
5. To save the edits to the reagent settings, tap Save.
To delete the edits to the reagent settings, tap Cancel.
6. To return to the Configure screen, tap Done.
Related information...
Reagents and Supplies screen, page 186
Configure system level reagent settings, page 192
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Configure supply settings
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to configure the following supply settings:
• Low alert settings for bulk solutions and onboard solutions
• The option to run supplies that are beyond the supply onboard stability expiration and the
supply lot expiration
• The c-series modules that use Detergent B
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap Reagents and Supplies.
3. On the Reagents and Supplies screen, tap the Supplies tab.
4. Under Supply Options on the Supplies tab, configure the following override options:
– i-series Supply Options:
• Override i-series Stability
NOTE: The system tracks onboard stability for Pre-Trigger Solution and Trigger
Solution.
• Override i-series Lot Expiration
– c-series Supply Options
• Override c-series Stability
NOTE: The system tracks onboard stability for sample onboard wash solutions,
Detergent B, and Acid Probe Wash.
• Override c-series Lot Expiration
• Override ICT Module Expiration
5. Under c-series Onboard Solutions, tap the check box for each module that uses Detergent
B.
6. For each appropriate supply under Supply Low Alerts, edit the remaining percentage that
triggers the low alert status.
7. To save the edits to the supply settings, tap Save.
To delete the edits to the supply settings, tap Cancel.
8. To return to the Configure screen, tap Done.
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Related information...
Reagents and Supplies screen, page 186
Reports screen
On the Reports screen, the operator can view settings for automatically generated reports.
The operator can configure print screen output options.
The supervisor can configure settings for automatically generated reports.
The system administrator can configure a facility name to display on each report.
Related information...
Configure screen, General tab, page 154
Reports screen element descriptions, page 196
Configure report settings, page 197
Configure the print screen file output destination, page 198
Reports screen element descriptions
On the Reports screen, the operator can generate reports automatically and can identify the
print screen output.
Elements
Automatic Report Generation area
Used to enable automatic printing of the Sample Laboratory Report, the Result List Report
(Released), the Calibration Details Report, and the Procedure Report (Maintenance). This area
provides three automatic printing options:
• Off (default)
• Default Printer
• Save to File
If the Save to File option is selected, the Sample Laboratory File Location box is displayed to
enter the drive and folder where the file is saved. The Browse button is used to select the drive
and folder location.
Sample Laboratory Automatically prints the Sample Laboratory Report after all
results for a sample are released.
Results List Automatically prints the Result List Report for released results
based on one of the following criteria:
• 15 results
• 15 minutes
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Calibration Details Automatically prints the Calibration Details Report after a
calibration is generated and becomes active.
Maintenance Automatically prints the Procedure Report when a
Procedure maintenance procedure is completed.
Site Name Used to enter the facility's name to be displayed on each
report.
Print Screen area
Send Print Screen Used to select the destination of a generated print screen.
Output To This area provides two destination options:
• Default Printer
• Save to File (default)
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Save Saves changes.
Related information...
Reports screen, page 196
Descriptions of screen elements, page 127
Configure report settings
Operator access level Supervisor, except where noted
Perform this procedure to configure report settings.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap Reports.
3. Under Automatic Report Generation on the Reports screen, enter the following information:
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– Sample Laboratory Report
– Result List Report
– Calibration Details Report
– Maintenance Procedure Report
– Site Name
NOTE: The site name must be configured by a system administrator.
4. Under Print Screen, tap one of the following Send Print Screen Output To options:
– Default Printer
– Save to File
NOTE: The print screen output can be configured by a general operator.
5. To save the edits to the report settings, tap Save.
To delete the edits to the reports settings, tap Cancel.
6. To return to the Configure screen, tap Done.
Related information...
Reports screen, page 196
Configure the print screen file output destination
Perform this procedure to configure when a print screen file is generated, to print the file to
default printer, or to save a copy of the file to a USB flash drive.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap Reports.
3. Under Print Screen on the Reports screen, tap one of the following Send Print Screen
Output To options:
– Default Printer
– Save to File
4. To save the edit to the print screen file output destination, tap Save.
To delete the edit to the print screen file output destination, tap Cancel.
5. To return to the Configure screen, tap Done.
Related information...
Reports screen, page 196
Print a screen image, page 663
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Abbott Mail screen
On the Abbott Mail screen, the operator can view the Abbott Mail download options.
The system administrator can perform the following functions:
• Enable or disable Abbott Mail items that can be downloaded automatically.
• Configure the download language for the Abbott Mail documentation.
Related information...
Configure screen, General tab, page 154
Abbott Mail screen element descriptions, page 199
Configure Abbott Mail settings, page 200
Abbott Mail screen element descriptions
On the Abbott Mail screen, the operator can configure download and language options.
Elements
Download Options
Automatically Used to configure download options for the following items:
Download
Assay Files • Enable: Requests for assay file
updates are sent automatically.
(Default)
• Disable: Requests for assay file
updates are not sent automatically.
Assay Inserts • Enable: Requests for assay inserts
are sent automatically when a
reagent is scanned. (Default)
• Disable: Requests for assay
inserts are not sent automatically
when a reagent is scanned.
Assay Insert • Enable: Requests for a new assay
Notifications insert are sent automatically.
(Default)
• Disable: Requests for a new assay
insert are not sent automatically.
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Calibrator Data • Enable: Requests for calibrator
value assignment updates are sent
automatically. (Default)
• Disable: Requests for calibrator
value assignment updates are not
sent automatically.
Download Language Displays a drop-down list that is used to specify a language
for Abbott Mail from a set of available languages.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Save Saves changes.
Text Size Increases or decreases the size of text displayed.
Related information...
Abbott Mail screen, page 199
Descriptions of screen elements, page 127
Configure Abbott Mail settings
Operator access level System Administrator
Perform this procedure to configure Abbott Mail settings.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap Abbott Mail.
3. Under Download Options on the Abbott Mail screen, enable or disable automatic
downloads for the following Abbott Mail items:
– Assay Files
– Assay Inserts
– Assay Insert Notifications
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NOTE: If the assay insert notifications are disabled, assay inserts are assigned
automatically to the new reagent lot without being displayed on the Abbott Mail screen.
The assay insert status is Current.
– Calibrator Data
4. In the Download Language drop-down list, tap the language for the Abbott Mail
documentation.
5. To save the edits to the Abbott Mail settings, tap Save.
To delete the edits to the Abbott Mail settings, tap Cancel.
6. To return to the Configure screen, tap Done.
Related information...
Abbott Mail screen, page 199
Configure screen, Computer tab
The operator can perform the following tasks from the Computer tab of the Configure screen:
General Settings Configure the following settings:
• Date and time
• Number format
• Speaker volume
• System name
• System language
• Screen time-out
• The disabling of sample processing when a maintenance
procedure is overdue
• Authentication requirement for a general user logon
Audio Settings Configure the sound for various alerts.
Host Setup Configure the following settings:
• Host interface options
• Host transmission options
• Specimen and control release modes
HL7 Communication Configure the following settings:
• Message headers
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• Sender channel
• Receiver channel
• Test HL7 communication
ASTM Communication Configure the following settings:
• ASTM channel settings
• Test ASTM communication
Shortcuts Configure user-defined System menu commands as icons on
the menu bar.
Automatic Backup Configure automatic backup options.
Alinity PRO • Enable or disable inventory sharing.
• Enable or disable status update messages.
• Configure status update message settings.
AbbottLink View AbbottLink settings.
Distance Alert Enable or disable the following options:
• Distance alert
• Exception notifications
Related information...
System configuration, page 154
General Settings screen, page 202
Audio Settings screen, page 206
Host Setup screen, page 209
HL7 Communication screen, page 212
ASTM Communication screen, page 215
Shortcuts screen, page 217
Automatic Backup screen, page 219
Alinity PRO screen, page 221
AbbottLink screen, page 222
Distance Alert screen, page 225
System checkout, page 152
General Settings screen
On the General Settings screen, the operator can view the following information:
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• Date and time zone
• Number format
• System information
The operator can configure the speaker volume.
The system administrator can perform the following functions:
• Configure system date and time settings.
• Configure the number format.
• Adjust the speaker volume.
• Configure the system name and the system language.
• Configure the Log On screen time-out setting.
• Enable or disable instrument processing when maintenance is overdue.
• Configure the system to require authentication for the general operator logon.
Related information...
Configure screen, Computer tab, page 201
General Settings screen element descriptions, page 203
Configure general settings, page 205
General Settings screen element descriptions
The General Settings screen displays the date and time zone, the number format, the speaker
volume, and the system information.
Elements
Date/Time Zone
System Date Used to edit the system date.
Date Format Used to edit the system date format.
The following options are available:
• MM.DD.YYYY (default)
• DD.MM.YYYY
• YYYY.MM.DD
Time Zone Displays a drop-down list that is used to select the area-
specific time zone.
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System Time Used to edit the system time.
Time Format Displays the following options:
• 12-hour clock
• 24-hour clock
Automatically Adjust Displays a check box that is used to adjust the clock
Clock for Daylight automatically for Daylight Saving Time.
Saving Time
Number Format
Thousand/Decimal Used to select the number format for the thousands and
Separator decimal separator.
The following options are available:
• Comma and Period (1,000,000.00) (default)
• Period and Comma (1.000.000,00)
• None and Period (1000000.00)
• None and Comma (1000000,00)
Speaker Volume
Speaker Volume Used to adjust the speaker volume from 0 through 10.
NOTE: This setting is available only if the system is
configured with speakers.
System Information
System Name Displays the system name.
SCM Serial Number Displays the serial number of the system control module.
System Language Displays a drop-down list that is used to select the system
language.
Log On Screen Time- Used to edit the setting for the screen time-out:
out
• Range is from 0 minutes through 60 minutes.
• Default is 15 minutes.
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NOTE: If the time-out is configured as zero, the system does
not track inactivity.
Disable Sample Displays a check box that is used to disable sample
Processing When processing if maintenance is overdue. For the default setting,
Maintenance Is the check box is selected.
Overdue
Require Displays a check box that is used to require a user PIN for a
Authentication For general operator logon. For the default setting, the check box
General Operator is selected.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Save Saves changes.
Text Size Increases or decreases the size of text displayed.
Related information...
General Settings screen, page 202
Descriptions of screen elements, page 127
Configure general settings
Required instrument Stopped, Warming, or Idle, except where noted
status
Operator access level System administrator, except where noted
Perform this procedure to configure the general settings for the system.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Computer tab.
3. On the Computer tab of the Configure screen, tap General Settings.
4. Under Date/Time Zone on the General Settings screen, enter the following information:
– System Date
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– Date Format
– Time Zone
– System Time
– Time Format
– Automatically Adjust Clock for Daylight Saving Time
NOTE: When any of the Date/Time Zone settings are changed, the user interface (UI)
computer shuts down and restarts.
5. Under Number Format, tap an option in the Thousand/Decimal Separator area.
NOTE: When the number format is changed, the UI computer shuts down and restarts.
6. Under Speaker Volume, slide the Speaker Volume button to the right or left to increase or
decrease the speaker volume.
NOTE: The speaker volume can be configured at any operator level and in any instrument
status.
7. Under System Information, enter the following information:
– System Name
– System Language
NOTE: The system language can be configured at any operator level.
When the system language is changed, the UI computer shuts down and restarts.
– Disable Sample Processing When Maintenance Is Overdue
– Log On Screen Time-Out
NOTE: The Log On screen time-out can be configured in any instrument status.
– Require Authentication for General Operator
NOTE: Required authentication can be configured in any instrument status.
8. To save the edits to the general settings, tap Save.
To delete the edits to the general settings, tap Cancel.
9. To return to the Configure screen, tap Done.
Related information...
General Settings screen, page 202
Audio Settings screen
On the Audio Settings screen, the operator can view the following information:
• Audio alert global settings
• Message alert settings
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The supervisor can perform the following functions:
• Enable or disable global settings for audible alerts.
• Configure the alert volume.
• Configure a unique audible alert for critical messages.
• Configure a unique audible alert for alert messages.
• Configure a unique audible alert for notification messages.
Related information...
Configure screen, Computer tab, page 201
Audio Settings screen element descriptions, page 207
Configure audio settings, page 208
Audio Settings screen element descriptions
The Audio Settings screen displays the audio and message alert settings.
Elements
Global Settings area
Turn Off All Audio Displays a check box that is used to disable all audio alerts
Alerts on the system. For the default setting, the check box is
selected.
Alert Volume Used to adjust the volume of all audio alerts from 0 through
10. The default setting is 5.
Message Alert Settings area
Used to select a sound for the following message types:
• Critical
• Alert
• Notification
Critical, Alert, Displays a drop-down list for each message type that is used
Notification to select an available sound.
Repeat Displays a drop-down list that is used to select the number of
times for an alert to repeat. The alert can repeat from 0 times
through 20 times or continuously for the selected message
type.
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Play Displays a button that is used to preview the audio alert
before the setting is saved.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Save Saves changes.
Text Size Increases or decreases the size of text displayed.
Related information...
Audio Settings screen, page 206
Descriptions of screen elements, page 127
Configure audio settings
Operator access level Supervisor
Perform this procedure to configure the audio settings for the system.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Computer tab.
3. On the Computer tab of the Configure screen, tap Audio Settings.
4. Under Global Settings on the Audio Settings screen, enter the following information:
– Tap the Turn Off All Audio Alerts check box to enable or disable audio alerts.
– Slide the Alert Volume button to the right or left to increase or decrease the alert
volume.
5. Under Message Alert Settings, enter the following information for each message category:
– Tap the audio sound in the message category drop-down list.
– Tap the number of times to repeat the audio sound in the Repeat drop-down list.
NOTE: To hear a sample of the selected sound, tap the Play button next to the drop-down
list.
6. To save the edits to the audio settings, tap Save.
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To delete the edits to the audio settings, tap Cancel.
7. To return to the Configure screen, tap Done.
Related information...
Audio Settings screen, page 206
Host Setup screen
On the Host Setup screen, the operator can view the following information:
• Interface options
• Transmission options
• Result release mode options
The system administrator can perform the following functions:
• Configure interface and query mode options.
• Configure transmission options for specimen, control, calibrator, sample status, and test
status.
• Configure result release mode options for specimen and control.
Related information...
Configure screen, Computer tab, page 201
Host Setup screen element descriptions, page 209
Configure host settings, page 211
Host Setup screen element descriptions
The Host Setup screen displays the interface, transmission, and result release settings.
Elements
Interface Options area
Used to configure host interface communication.
Host Interface Used to configure the system to receive orders from and
transmit results to a host computer.
The following options are available:
• HL7
• ASTM
• Off (default)
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Query Mode Used to configure the system to send queries for orders to the
host computer.
The following options are available:
• On
• Off (default)
Query Time-Out Used to enter the maximum time period that the system waits
Seconds for the host computer to respond to a query.
The range is from 5 seconds through 60 seconds.
The default setting is 10 seconds.
Transmission Options area
Used to define the method for transmitting the released results to the host computer.
Specimens • Single
• Collated (default)
• Collated by Module (This option is available only for a
multimodule system.)
Control • Single
• Collated (default)
• Collated by Module (This option is available only for a
multimodule system.)
• Off
Calibration • On
• Off (default)
Sample Status • On
• Off (default)
Test Status • On
• Off (default)
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Result Release Mode Options area
Used to configure the release mode for specimens, controls, and exceptions. The following
options are available for each result type:
• Manual (default)
• Automatic
• Automatic with Exceptions
• Hold
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Save Saves changes.
Text Size Increases or decreases the size of text displayed.
Related information...
Host Setup screen, page 209
Descriptions of screen elements, page 127
Configure host settings
Prerequisite HL7 communication or ASTM communication must be
configured before the host interface type is selected.
Required instrument Any instrument status, except where noted
status
Operator access level System administrator
Perform this procedure to configure the host settings for the system.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Computer tab.
3. On the Computer tab of the Configure screen, tap Host Setup.
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4. Under Interface Options on the Host Setup screen, enter the following information:
– Host Interface
NOTE: To configure Host Interface, the required instrument status is Stopped,
Warming, or Idle.
– Query Mode
– Query Time-Out Seconds
5. Under Transmission Options, enter the following information:
– Specimen
NOTE: To configure Specimen, the required instrument status is Stopped, Warming, or
Idle.
– Control
– Calibrator
– Sample Status
– Test Status
NOTE: The transmission options Calibrator, Sample Status, and Test Status are only
available if Host Interface is configured for HL7.
6. Under Result Release Mode Options, enter the following information:
NOTE: To configure Result Release Mode Options, the required instrument status is
Stopped, Warming, or Idle.
– Specimen
– Control
7. To save the edits to the host settings, tap Save.
To delete the edits to the host settings, tap Cancel.
8. To return to the Configure screen, tap Done.
Related information...
Host Setup screen, page 209
Edit result settings of assay parameters , page 239
Host orders, page 578
Verify the HL7 communication, page 1307
Verify the ASTM communication, page 1308
HL7 Communication screen
On the HL7 Communication screen, the operator can view the following information:
• Message headers
• Sender channel options
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• Receiver channel options
The system administrator can perform the following functions:
• Configure message headers.
• Configure sender channels.
• Configure receiver channels.
• Test HL7 communication settings.
Related information...
Configure screen, Computer tab, page 201
HL7 Communication screen element descriptions, page 213
Configure HL7 communication settings, page 214
HL7 Communication screen element descriptions
On the HL7 Communication screen, the operator can configure the host communications settings
for the system.
Elements
Message Headers
Used to configure the sending and receiving message headers.
MSH-3 Sending Used to configure the MSH-3 Sending Application for HL7
Application host messaging for a maximum of 20 alphanumeric
characters.
MSH-4 Sending Used to configure the MSH-4 Sending Facility for HL7 host
Facility messaging for a maximum of 20 alphanumeric characters.
MSH-5 Receiving Used to configure the MSH-5 Receiving Application for HL7
Application host messaging for a maximum of 20 alphanumeric
characters.
MSH-6 Receiving Used to configure the MSH-6 Receiving Facility for HL7 LIS
Facility messaging for a maximum of 20 alphanumeric characters.
Sender Channel, Receiver Channel
Connection Type Displays the following options:
• Active Transient (default)
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• Passive
• Active Persistent (only for Sender Channel)
IP Address Used to configure the IP address. The IP address is
configured as four decimal numbers. The range for each
number is from 0 through 255 and is separated by periods
(supports the IPv4 address).
Port Number Used to enter the port number. The port number range is from
0 through 65535.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Save/Test Tests previously defined settings and saves changes.
Related information...
HL7 Communication screen, page 212
Descriptions of screen elements, page 127
Configure HL7 communication settings
Required instrument Stopped, Warming, or Idle, except where noted
status
Operator access level System administrator
Perform this procedure to configure the HL7 communication settings for the system.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Computer tab.
3. On the Computer tab of the Configure screen, tap HL7 Communication.
4. Under Message Headers on the HL7 Communication screen, enter the following
information:
– MSH-3 Sending Application
– MSH-4 Sending Facility
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– MSH-5 Receiving Application
– MSH-6 Receiving Facility
NOTE: Message headers can be configured in any instrument status.
5. Under Sender Channel, enter the following information:
– Connection Type
NOTE: If the Passive option in the Connection Type area is selected, the IP Address
and Port Number options are configured automatically.
– IP Address
– Port Number
6. Under Receiver Channel, enter the following information:
– Connection Type
NOTE: If the Passive option in the Connection Type area is selected, the IP Address
and Port Number options are configured automatically.
– IP Address
– Port Number
7. To save the edits to the HL7 communication settings, tap Save/Test.
To delete the edits to the HL7 communication settings, tap Cancel.
8. To return to the Configure screen, tap Done.
Related information...
HL7 Communication screen, page 212
Verify the HL7 communication, page 1307
Host orders, page 578
ASTM Communication screen
On the ASTM Communication screen, the operator can view ASTM channel settings.
The system administrator can perform the following functions:
• Configure the IP address and the port number.
• Configure the character encoding setting.
• Test the ASTM channel settings.
Related information...
Configure screen, Computer tab, page 201
ASTM Communication screen element descriptions, page 216
Configure ASTM communication settings, page 217
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ASTM Communication screen element descriptions
The ASTM Communication screen displays a single TCP/IP communication channel to send and
receive messages to and from an ASTM host. The screen is used to open a connection to the
configured port and IP address for the ASTM host channel when the following conditions are
met:
• The host interface is configured for ASTM.
• The host connection status is enabled.
Elements
ASTM Channel Settings
IP Address Used to enter the IP address. The IP address is configured as
four decimal numbers. The range for each number is from 0
through 255 and is separated by periods (supports the IPv4
address).
Port Number Used to enter the port number. The port number range is from
0 through 65535.
Character Encoding Displays a drop-down list that provides the following items:
• Windows-1252
• UTF-8 (default)
• Shift-JIS
• ASCII
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Save/Test Tests previously defined settings and saves changes.
Related information...
ASTM Communication screen, page 215
Descriptions of screen elements, page 127
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Configure ASTM communication settings
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to configure the ASTM communication settings for the system.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Computer tab.
3. On the Computer tab of the Configure screen, tap ASTM Communication.
4. Under the ASTM Channel Settings on the ASTM Communication screen, enter the following
information:
– IP Address
– Port Number
– Character Encoding
5. To save the edits to the ASTM communication settings, tap Save/Test.
To delete the edits to the ASTM communication settings, tap Cancel.
6. To return to the Configure screen tap Done.
Related information...
ASTM Communication screen, page 215
Verify the ASTM communication, page 1308
Host orders, page 578
Shortcuts screen
On the Shortcuts screen, the operator can view the following information:
• Configured menu bar shortcut icons
• Available shortcut icon options
The system administrator can configure two shortcuts as icons on the menu bar.
Related information...
Configure screen, Computer tab, page 201
Shortcuts screen element descriptions, page 218
Configure shortcut icons, page 218
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Shortcuts screen element descriptions
On the Shortcuts screen, the operator can configure user-defined System menu commands as
icons at the bottom of the menu bar.
Elements
Available Shortcuts Displays a list of available icons that can be configured on the
menu bar.
The following icons are available:
• Cal/QC inventory
• Procedures (default)
• Configure
• Create Order (default)
• Help (Operations Manual)
NOTE: Only two icons can be configured at one time as
shortcuts. The remaining available System menu commands
can be found in the System menu on the menu bar.
First Shortcut Displays the configured icon.
Second Shortcut Displays the configured icon.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Save Saves changes.
Related information...
Shortcuts screen, page 217
Descriptions of screen elements, page 127
Configure shortcut icons
Operator access level System administrator
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Perform this procedure to change configurable menu bar shortcut icons.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Computer tab.
3. On the Computer tab of the Configure screen, tap Shortcuts.
4. In the First Shortcut drop-down list, tap an icon name.
5. In the Second Shortcut drop-down list, tap an icon name.
6. To save the edits to the shortcuts settings, tap Save.
To delete the edits to the shortcuts settings, tap Cancel.
7. To return to the Configure screen, tap Done.
Related information...
Shortcuts screen, page 217
Automatic Backup screen
On the Automatic Backup screen, the operator can view the automatic backup options.
The system administrator can enable or disable the automatic backup and can configure the
automatic backup options.
Related information...
Configure screen, Computer tab, page 201
Automatic Backup screen element descriptions, page 219
Configure an automatic backup, page 220
Automatic Backup screen element descriptions
On the Automatic Backup screen, the operator can enable system automatic backups.
Automatic Backup Options area
Automatically Perform Displays a check box that is used to select if an automatic
Backup backup is performed daily.
Time of Daily Backup Displays a spin box that is used to enter the time of day for
daily automatic backups to be performed. The default is 01:00
A.M.
Weekly Backup on Displays a drop-down list that is used to select the day of the
week for daily automatic backups to be saved as the weekly
backup. The default is Sunday.
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Automatic Backup Displays a text box that is used to enter the location for
Location system automatic backups to be copied to removable storage.
Browse Displays a button that is used to select the drive and folder
location for the automatic backup.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Save Saves changes.
Text Size This function button is unavailable on this screen.
Related information...
Automatic Backup screen, page 219
Descriptions of screen elements, page 127
Configure an automatic backup
Operator access level System administrator
Perform this procedure to configure an automatic backup. Seven daily automatic backups and
four weekly automatic backups are saved on the hard drive and a USB flash drive.
NOTE: A USB flash drive must be inserted to create automatic backups.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Computer tab.
3. On the Computer tab of the Configure screen, tap Automatic Backup.
4. Under Automatic Backup Options on the Automatic Backup screen, tap the Automatically
Perform Backup check box to enable the automatic backup.
5. Enter the following information:
– Time of Daily Backup
– Weekly Backup On
– Automatic Backup Location
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6. To save the edits to the automatic backup settings, tap Save.
To delete the edits to the automatic backup settings, tap Cancel.
7. To return to the Configure screen, tap Done.
Related information...
Automatic Backup screen, page 219
Insert and remove a USB flash drive, page 671
Alinity PRO screen
Alinity PRO is a data-sharing software application between Alinity systems and the Alinity PRO
computer. Alinity PRO provides the following options:
• Inventory sharing allows the laboratory to share reagents, calibrators, and controls between
different instruments that are controlled by a different user interface computer.
• The operational dashboard allows the operator to view a live representation of the current
status of all Alinity systems from one computer. With this information, the operator can
schedule activities that are needed on the instrument.
On the Alinity PRO screen, the operator can view the Alinity PRO settings.
The system administrator can perform the following functions:
• Enable or disable the inventory-sharing feature.
• Enable or disable status update message transmissions.
• Configure the IP address and the port number.
Related information...
Configure screen, Computer tab, page 201
Configure Alinity PRO settings, page 221
Configure Alinity PRO settings
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to configure the Alinity PRO settings for the system.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Computer tab.
3. On the Computer tab of the Configure screen, tap Alinity PRO.
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4. Under Alinity PRO Settings on the Alinity PRO screen, tap Enable or Disable for the
following options:
– Inventory Sharing
– Status Update Messages
5. If Status Update Messages is enabled, enter the following information:
– Status Update Interval
– IP Address
– Port Number
6. To save the edits to the Alinity PRO settings, tap Save.
To delete the edits to the Alinity PRO settings, tap Cancel.
7. To return to the Configure screen, tap Done.
Related information...
Alinity PRO screen, page 221
AbbottLink screen
AbbottLink is a data-sharing software application between the laboratory instrumentation and the
Abbott internal systems for the transfer of instrument data, Abbott Mail documentation, and
system updates.
On the AbbottLink screen, the operator can view the AbbottLink settings.
If the logon for CSC or FSE is used, the following functions can be performed:
• Enable or disable the AbbottLink service.
• Enable or disable proxy settings.
• Configure proxy server settings.
Related information...
Configure screen, Computer tab, page 201
AbbottLink screen element descriptions, page 222
Configure AbbottLink settings (CSC Logon), page 224
AbbottLink screen element descriptions
The AbbottLink screen displays the AbbottLink settings.
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Elements
AbbottLink Service area
Enable Used to enable AbbottLink service. This option is the default.
Disable Used to disable AbbottLink service.
Connection Status Displays the connection status of AbbottLink service.
Instrument Information area
Model Displays the model name of the instrument.
Serial Number Displays the serial number of the instrument.
AbbottLink Host Displays the host name of the instrument.
IP Address Displays the IP address of the instrument.
Proxy Settings area
Enable Used to enable the proxy settings.
Disable Used to disable the proxy settings. This option is the default.
Auto-Configuration Used to configure the host URL address. When this option is
selected, the URL box is displayed and is blank. The URL box
can contain a maximum of 50 characters.
HTTP and SOCKS
Host Used to enter the host address. When
the HTTP option or the SOCKS option
is selected, the Host box is displayed
and is blank. The Host box can contain
a maximum of 50 characters.
Port Used to enter the port number. When
the HTTP option or the SOCKS option
is selected, the Port box is displayed
and is blank. The integer value of the
port number can be from 0 through
65535.
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Authenticate using the Used to designate that the proxy server
following information requires authentication. When this
check box is selected, the Username
and Password boxes are displayed and
are blank. Each box can contain a
maximum of 50 characters.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Save Saves changes.
Related information...
AbbottLink screen, page 222
Descriptions of screen elements, page 127
Configure AbbottLink settings (CSC Logon)
Required instrument Stopped, Warming, or Idle
status
Operator access level CSC
Perform this procedure to configure AbbottLink settings.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Computer tab.
3. On the Computer tab of the Configure screen, tap AbbottLink.
4. Under AbbottLink Service on the AbbottLink screen, tap Enable or Disable.
5. If the AbbottLink service is enabled, under Proxy Settings, tap Enable or Disable.
6. If the proxy settings are enabled, tap one of the following proxy server options:
– Auto-Configuration
– HTTP
– SOCKS
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7. If the Auto-Configuration option is selected, type the URL address in the URL box.
8. If the HTTP option or the SOCKS option is selected, perform the following steps:
a. In the Host box, type the host information.
b. In the Port box, type the port information.
c. If the proxy server requires authentication, tap the Authenticate using the following
information check box.
d. If the Authenticate using the following information check box is selected, type the
user name and password in the Username and Password boxes.
9. To save the edits to the AbbottLink settings, tap Save.
To delete the edits to the AbbottLink settings, tap Cancel.
10. To return to the Configure screen, tap Done.
Related information...
AbbottLink screen, page 222
Distance Alert screen
On the Distance Alert screen, the operator can view the distance alert settings and can verify
the distance alert function.
The system administrator can perform the following functions:
• Enable or disable the distance alert.
• Enable or disable distance alert functionality for exception notifications.
Related information...
Configure screen, Computer tab, page 201
Configure distance alert settings, page 225
Verify the distance alert function, page 226
Configure distance alert settings
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to configure the distance alert settings.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Computer tab.
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3. On the Computer tab of the Configure screen, tap Distance Alert.
4. Under Distance Alert Options on the Distance Alert screen, tap Enable or Disable for the
following options:
– Distance Alert
– Exception Notification
5. To save the edits to the distance alert settings, tap Save.
To delete the edits to the distance alert settings, tap Cancel.
6. To return to the Configure screen, tap Done.
Related information...
Distance Alert screen, page 225
Verify the distance alert function
Prerequisite The distance alert must be enabled.
Operator access level System administrator
Perform this procedure to verify the functionality of the distance alert lights.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Computer tab.
3. On the Computer tab of the Configure screen, tap Distance Alert.
4. On the Distance Alert screen, tap Test.
The distance alert lights are turned off if any of them are illuminated. The lights blink three
times in the following order:
a. Red
b. Yellow
c. Green
When the test is completed, all the lights remain off.
5. To return to the Configure screen, tap Done.
Related information...
Distance Alert screen, page 225
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Configure screen, Assay tab
The operator can perform the following tasks from the Assay tab of the Configure screen:
Assay Parameters • Configure assay settings.
• Configure calibrator settings.
• Add, delete, or edit SmartWash settings.
• Configure result settings.
• Configure retest rules.
Calibrator Set • Create, edit, or delete a calibrator set.
• Import calibrator data.
Install/Uninstall • Install new or revised assay files.
Assays
• Uninstall assay files.
Import/Export Assays • Import assay files from a USB flash drive.
• Export assay files from a USB flash drive.
Assay Display Order Configure the order in which assays are displayed on screens
and in reports.
Panel Definition Configure assay panels for specimens, controls, or
calibrations.
Cal/QC Ordering • Configure general calibration settings.
• Configure general quality control settings.
Quality Control • Configure multiconstituent and single-constituent controls.
• Import control data.
Westgard Enable or disable Westgard rules for each assay.
Related information...
System configuration, page 154
Assay Parameters screen, page 228
Calibrator Set screen, page 255
Install/Uninstall Assays screen, page 268
Import/Export Assays screen (c-series), page 275
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Assay Display Order screen, page 280
Panel Definition screen, page 283
Cal/QC Ordering screen, page 286
Quality Control screen, page 289
Westgard screen, page 308
System checkout, page 152
Assay Parameters screen
On the Assay Parameters screen, the operator can view the following information:
• General settings
• Calibration settings
• Results settings
• Retest rules
• SmartWash (c-series)
The system administrator can perform the following functions:
• Edit general assay settings.
• Edit calibration settings.
• Edit result and interpretation information.
• Configure assay retest rules.
• Configure SmartWash settings.
Related information...
Configure screen, Assay tab, page 227
Assay Parameters screen element descriptions, page 229
Edit general settings of assay parameters (c-series photometric), page 230
Edit general settings of assay parameters (c-series potentiometric), page 231
Edit general settings of assay parameters (i-series), page 232
Edit general settings of assay parameters (calculated), page 234
Edit calibration settings of assay parameters (c-series photometric), page 235
Edit calibration settings of assay parameters (c-series potentiometric), page 237
Edit calibration settings of assay parameters (i-series), page 238
Edit result settings of assay parameters , page 239
Configure retest rules, page 241
Configure SmartWash settings (c-series), page 243
Edit SmartWash settings (c-series), page 245
Create a user-defined assay (c-series photometric), page 247
Create a calculated assay, page 251
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Assay Parameters screen element descriptions
The Assay Parameters screen displays the assays that are installed on the system.
Elements
Installed Assays Identifies the total number of assay parameter files that are
configured on the system.
All option Displays all assays that are available on the system.
i-series option Displays all assays that are available on one or more Alinity i
processing modules.
c-series option Displays all assays that are available on one or more Alinity c
processing modules.
Calculated option Displays all calculated assays.
Function buttons
Configure Navigates to the previous configuration screen.
Select All Selects or deselects all items in a list. The button switches
between Select All and Deselect All.
Print Displays the Print flyout.
Create Navigates to the Create Assay flyout where the operator can
tap one of the following options:
• Calculated
• Photometric
View/Edit Navigates to the General tab of the Assay Parameters screen
for the selected assay or the first assay that is selected when
multiple assays are chosen.
Text Size Increases or decreases the size of text displayed.
Related information...
Assay Parameters screen, page 228
Descriptions of screen elements, page 127
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Edit general settings of assay parameters (c-series photometric)
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to edit the following general settings of assay parameters for a c-series
photometric assay:
• Assay name
• Assay availability
• Module allocation
• The option to run controls by lot or cartridge
• Default dilution
• The option to add a dilution protocol
NOTE: A user-defined dilution protocol can be created only for assays with fewer than three
configured dilution protocols.
The user-defined dilution protocol is retained except when an additional dilution protocol is
included with an assay file revision in the same position as the user-defined dilution
protocol.
NOTE: All assay parameters of a user-defined photometric assay can be edited.
The assay parameters of an assay with a pending order cannot be edited.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Assay Parameters.
4. On the Assay Parameters screen, tap one or more assays to edit.
NOTE: To filter the list of assays, tap the c-series tab.
5. Tap View/Edit.
6. In the Assay Name box on the General tab of the Assay Parameters screen, edit the default
name of the assay if necessary.
NOTE: The assay name can contain a maximum of 10 alphanumeric characters.
7. In the Assay Availability drop-down list, tap an item.
8. In the Module area, tap the module number check boxes for the modules that are allocated
to load the reagent of the assay.
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NOTE: This option is available only if the Alinity ci-series is configured with more than one
processing module of the same type.
9. In the Run Controls for Onboard Reagents by drop-down list, tap an item.
10. Under Sample, tap an option in the Default Dilution area if more than one option is
available.
11. Under Sample, enter the following information as necessary to create a new dilution
protocol.
– Dilution name
NOTE: The dilution name can contain a maximum of 10 alphanumeric characters.
– Sample (volume)
– Diluted Sample (volume)
– Diluent (volume)
– Water (volume)
NOTE: The operator has a responsibility to confirm the performance of the configured
dilution protocol.
12. To save the edits to the assay parameter settings, tap Save.
To delete the edits to the assay parameter settings, tap Cancel.
13. If more than one assay was selected, at the right side of the Assay Parameters screen, tap
the next assay to configure, and then repeat steps 6, page 230 through 12, page 231.
14. To return to the Assay Parameters screen, tap Done.
15. To return to the Configure screen, tap Configure.
Related information...
Assay Parameters screen, page 228
Edit general settings of assay parameters (c-series potentiometric)
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to edit the following general settings of assay parameters for a c-series
potentiometric assay:
• Assay name
• Assay availability
• Module allocation
• The option to run controls by lot or cartridge
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NOTE: The assay parameters of an assay with a pending order cannot be edited.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Assay Parameters.
4. On the Assay Parameters screen, tap one or more assays to edit.
NOTE: To filter the list of assays, tap the c-series tab.
5. Tap View/Edit.
6. In the Assay Name box on the General tab of the Assay Parameters screen, edit the default
name of the assay if necessary.
NOTE: The assay name can contain a maximum of 10 alphanumeric characters.
7. In the Assay Availability drop-down list, tap an item.
8. In the Module area, tap the module number check boxes for the modules that are allocated
to load the reagent of the assay.
NOTE: This option is available only if the Alinity ci-series is configured with more than one
processing module of the same type.
9. In the Run Controls for Onboard Reagents by drop-down list, tap an item.
10. To save the edits to the assay parameter settings, tap Save.
To delete the edits to the assay parameter settings, tap Cancel.
11. If more than one assay was selected, at the right side of the Assay Parameters screen, tap
the next assay to configure, and then repeat steps 6, page 232 through 10, page 232.
12. To return to the Assay Parameters screen, tap Done.
13. To return to the Configure screen, tap Configure.
Related information...
Assay Parameters screen, page 228
Edit general settings of assay parameters (i-series)
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to edit the following general settings of assay parameters for an i-series
assay:
• Assay name
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• Assay availability
• Module allocation
• The option to run controls by lot or cartridge
• Default dilution
NOTE: The assay parameters of assays with pending orders cannot be edited.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Assay Parameters.
4. On the Assay Parameters screen, tap one or more assays to edit.
NOTE: To filter the list of assays, tap the i-series tab.
5. Tap View/Edit.
6. In the Assay Name box on the General tab of the Assay Parameters screen, edit the default
name of the assay if necessary.
NOTE: The assay name can contain a maximum of 10 alphanumeric characters.
7. In the Assay Availability drop-down list, tap an item.
8. In the Module area, tap the module number check boxes for the modules that are allocated
to load the reagent of the assay.
NOTE: This option is available only if the Alinity ci-series is configured with more than one
processing module of the same type.
9. In the Run Controls for Onboard Reagents by drop-down list, tap an item.
10. Under Dilution, tap an option in the Default Dilution area if more than one option is
available.
11. To save the edits to the assay parameter settings, tap Save.
To delete the edits to the assay parameter settings, tap Cancel.
12. If more than one assay was selected, at the right side of the Assay Parameters screen, tap
the next assay to configure, and then repeat steps 6, page 233 through 11, page 233.
13. To return to the Assay Parameters screen, tap Done.
14. To return to the Configure screen, tap Configure.
Related information...
Assay Parameters screen, page 228
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Edit general settings of assay parameters (calculated)
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to edit an assay that uses a mathematical formula to derive a calculated
result.
NOTE: The assay parameters of assays with pending orders cannot be edited.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Assay Parameters.
4. On the Assay Parameters screen, tap one or more assays to edit.
NOTE: To filter the list of assays, tap the Calculated tab.
5. Tap View/Edit.
6. In the Assay Name box on the General tab of the Assay Parameters screen, edit the default
name of the calculated assay.
7. In the Assay Availability drop-down list, tap an item.
8. Tap Select Assays.
NOTE: The Select Assays button is unavailable for Abbott calculated assays that have
assay numbers from 3000 through 3999.
9. In the Select Assays flyout, tap the constituent assays that are used in the new calculated
formula.
For example, to create an LDL calculation, tap Chol, tap Ultra HDL, and then tap Trig.
NOTE: Assays are assigned to the calculator buttons in the order in which the assays are
selected.
10. To save the assay selection, tap Done.
To delete the assay selection, tap Cancel.
11. For each assay under Selected Assay, perform one of the following steps to enter a result
range:
– To define a specific result range, type a value in the Minimum box and type a value in
the Maximum box.
– To define a range where the results are less than or equal to a specific value, leave the
Minimum box blank and type a value in the Maximum box.
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– To define a range where the results are greater than or equal to a specific value, type a
value in the Minimum box and leave the Maximum box blank.
NOTE: If the selected assay test result falls outside the defined result range, the calculated
test result becomes an exception and the result is not reported.
12. To delete the existing calculated formula, tap the Backspace key.
NOTE: The formulas cannot be edited for Abbott calculated assays that have assay
numbers from 3000 through 3999.
13. To enter a new calculated formula, tap one or more constituent assays, which are indicated
by the ASSAY1, ASSAY2, ASSAY3, and ASSAY4 buttons on the calculator, and then tap
the appropriate calculator function buttons.
The formula is displayed as it is entered in the Calculated Formula box.
For example, to enter the formula for an LDL calculation [Cholesterol - HDL - (Triglyceride ÷
5)], perform the following steps:
a. On the calculator, tap ASSAY1 (Cholesterol), and then tap the Minus Sign button.
b. Tap ASSAY2 (HDL), and then tap the Minus Sign button.
c. Tap the Opening Parenthesis button, and then tap ASSAY3 (Triglyceride).
d. Tap the Slash Mark (divide) button, tap 5, and then tap the Closing Parenthesis
button.
14. To save the edits to the assay parameter settings, tap Save.
To delete the edits to the assay parameter settings, tap Cancel.
15. To return to the Assay Parameters screen, tap Done.
16. To return to the Configure screen, tap Configure.
Related information...
Assay Parameters screen, page 228
Edit calibration settings of assay parameters (c-series photometric)
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to edit the following calibration settings of assay parameters for a c-
series photometric assay:
• Full calibration interval
• Adjust calibration type
• Adjust calibration interval
• Replicates
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• Validity checks
NOTE: The assay parameters of assays with pending orders cannot be edited.
All calibration settings of a user-defined photometric assay can be edited.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Assay Parameters.
4. On the Assay Parameters screen, tap one or more assays to edit.
NOTE: To filter the list of assays, tap the c-series tab.
5. Tap View/Edit.
6. On the Assay Parameters screen, tap the Calibration tab.
7. Under Calibration on the Calibration tab of the Assay Parameters screen, enter the
following information:
– Full Calibration Interval (Hours)
NOTE: If an assay file contains a default calibration interval other than zero, the
calibration interval can be decreased but cannot be increased. This setting is
unavailable for assays when the absorbance data reduction method and the use factor
and blank data reduction method are used.
– Adjust Type
NOTE: This setting is unavailable for assays when the factor data reduction method and
the use factor and blank data reduction method are used.
– Adjust Interval
– Default Ordering Type
NOTE: This setting is available only if Adjust Type is configured with an option other
than None.
8. Under Calibrators, type the number of replicates in the Replicates box.
9. Under Validity Checks, enter the following information:
– Blank Absorbance Range
– Span
– Span Absorbance Range
– Expected Cal Factor
– Expected Cal Factor Tolerance %
10. To save the edits to the assay parameter settings, tap Save.
To delete the edits to the assay parameter settings, tap Cancel.
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11. If more than one assay was selected, at the right side of the Assay Parameters screen, tap
the next assay to configure, and then repeat steps 7, page 236 through 10, page 236.
12. To return to the Assay Parameters screen, tap Done.
13. To return to the Configure screen, tap Configure.
Related information...
Assay Parameters screen, page 228
Edit calibration settings of assay parameters (c-series potentiometric)
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to edit the following calibration settings of assay parameters for a
potentiometric assay:
• Full calibration interval
• Replicates
• Slope limit (%)
• Index options
NOTE: The assay parameters of assays with pending orders cannot be edited.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Assay Parameters.
4. On the Assay Parameters screen, tap one or more assays to edit.
NOTE: To filter the list of assays, tap the c-series tab.
5. Tap View/Edit.
6. On the Assay Parameters screen, tap the Calibration tab.
7. Under Calibration on the Calibration tab of the Assay Parameters screen, enter the
following information:
– Full Calibration Interval (Hours)
NOTE: If an assay file contains a default calibration interval other than zero, the
calibration interval can be decreased but cannot be increased.
– Replicates
– Slope Limit (%)
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8. Under Index Options, enter the following information:
– Index Used
– Index Concentration
– Index Range
9. To save the edits to the assay parameter settings, tap Save.
To delete the edits to the assay parameter settings, tap Cancel.
10. If more than one assay was selected, at the right side of the Assay Parameters screen, tap
the next assay to configure, and then repeat steps 7, page 237 through 9, page 238.
11. To return to the Assay Parameters screen, tap Done.
12. To return to the Configure screen, tap Configure.
Related information...
Assay Parameters screen, page 228
Edit calibration settings of assay parameters (i-series)
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to configure the calibrator replicates and the calibration interval.
NOTE: The assay parameters of assays with pending orders cannot be edited.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Assay Parameters.
4. On the Assay Parameters screen, tap one or more assays to edit.
NOTE: To filter the list of assays, tap the i-series tab.
5. Tap View/Edit.
6. On the Assay Parameters screen, tap the Calibration tab.
7. Under Calibration on the Calibration tab of the Assay Parameters screen, enter the
following information:
– Calibration Interval (Hours)
NOTE: If an assay file contains a default calibration interval other than zero, the
calibration interval can be decreased but cannot be increased.
– Replicates
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8. To save the edits to the assay parameter settings, tap Save.
To delete the edits to the assay parameter settings, tap Cancel.
9. If more than one assay was selected, at the right side of the Assay Parameters screen, tap
the next assay to configure, and then repeat steps 6, page 238 through 8, page 239.
10. To return to the Assay Parameters screen, tap Done.
11. To return to the Configure screen, tap Configure.
Related information...
Assay Parameters screen, page 228
Edit result settings of assay parameters
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to configure the results settings of assay parameters for an assay.
NOTE: The assay parameters of assays with pending orders cannot be edited.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Assay Parameters.
4. On the Assay Parameters screen, tap one or more assays to edit.
NOTE: To filter the list of assays, tap the tab for i-series, c-series, or Calculated.
5. Tap View/Edit.
6. On the Assay Parameters screen, tap the Results tab.
7. Under Result Units on the Results tab of the Assay Parameters screen, enter the following
information:
– Result Units
NOTE: For Abbott assays, tap a units option in the drop-down list if more than one
option is available.
For non-Abbott assays or calculated assays, type the unit name.
– Decimal Places
– Result Unit UCUM
NOTE: This setting can be edited only for non-Abbott assays or calculated assays.
– Correlation Factor
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NOTE: This setting is available only for c-series.
– Intercept
NOTE: This setting is available only for c-series.
8. If Result Units is edited, tap Save to update the displayed result values to the new unit.
9. Under Results, enter the following information:
– Low Linearity
NOTE: For i-series assays, this setting can be edited only when the default dilution is
the first dilution.
– High Linearity
NOTE: For i-series assays, this setting can be edited only when the default dilution is
the first dilution. This value cannot be edited to exceed the high-linearity default of the
assay.
10. To add a new result range, perform the following steps:
a. Tap Add Result.
b. In the Add Result flyout, enter the following information:
• Gender
• Age Unit
• Age Range
• Normal Range
• Extreme Range
NOTE: An extreme range is not required.
c. To save the edits to the result settings, tap Done.
To delete the edits to the result settings, tap Cancel.
11. To edit a result range, perform the following steps:
a. In the Results list, tap a result range.
b. Tap Edit Result.
c. In the Edit Result flyout, edit any of the following information:
• Gender
• Age Unit
• Age Range
• Normal Range
• Extreme Range
d. To save the edits to the result settings, tap Done.
To delete the edits to the result settings, tap Cancel.
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12. To delete a result range, perform the following steps:
a. In the Results list, tap a result range.
b. Tap Delete Result.
c. When a confirmation message is displayed, tap Yes.
13. Under Interpretation, tap an interpretation in the Name drop-down list.
NOTE: If User-Defined is selected, type the name of the interpretation in the Name box.
14. In the Range box, type an interpretation range value.
NOTE: Not all interpretation names and ranges are editable.
15. For the appropriate interpretation, tap Review Required.
NOTE: If Review Required is selected, the results are held for manual release when the
Hold option is configured for the Result Release Mode and the results are within the
specific interpretation range.
16. For each available interpretation, repeat steps 13, page 241 through 15, page 241.
17. Tap Save.
18. If more than one assay was selected, at the right side of the Assay Parameters screen, tap
the next assay to configure, and then repeat steps 7, page 239 through 17, page 241.
19. To return to the assay list on the Assay Parameters screen, tap Done.
20. To return to the Configure screen, tap Configure.
Related information...
Assay Parameters screen, page 228
Configure host settings, page 211
Configure retest rules
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to configure one or more retest rules with criteria based on result
concentration ranges, interpretations, or exceptions.
NOTE: The retest rules must be defined in order since the system runs the first rule that meets
the defined criteria.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Assay Parameters.
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4. On the Assay Parameters screen, tap one or more assays to configure.
NOTE: To filter the list of assays, tap the tab for i-series, c-series, or Calculated.
5. Tap View/Edit.
6. On the Assay Parameters screen, tap the Retest Rules tab.
7. Under Assay Retest Rules on the Retest Rules tab of the Assay Parameter screen, type
the name in the Retest Rule Name box.
NOTE: Under Assay Retest Rules, if a retest rule is selected, tap the selected rule to
cancel the selection.
8. If the criteria is based on result ranges, perform the following steps:
a. In the Result Indicator area, tap the Result Range option.
b. To enter a result range, perform one of the following steps:
• To retest all samples automatically when the original results are within a specific
range, type values in both result range boxes.
• To retest all samples automatically when the original results are less than or equal
to a specific value, leave the first result range box blank and type a value in the
second result range box.
• To retest all samples automatically when the original results are greater than or
equal to a specific value, type a value in the first result range box and leave the
second result range box blank.
9. If the criteria is based on interpretations, perform the following steps:
a. In the Result Indicator area, tap the Interpretation option.
b. In the Interpretation drop-down list, tap an interpretation.
10. If the criteria is based on exceptions, tap the Exception option in the Result Indicator area.
NOTE: The assay is retested if one of the following message codes is generated:
– 1037 Unable to calculate result. Rate reaction linearity failure.
– 1038 Unable to calculate result. Insufficient absorbance reads within absorbance range.
– 1039 Unable to calculate result. Absorbance exceeded optical limits.
– 1040 Unable to calculate result. No absorbance reads within absorbance range.
– 1041 Unable to calculate result. Reaction check failure.
– 1042 Unable to calculate result. ICT Reference Solution voltage drift error.
– 1043 Unable to calculate result. Final RLU read falls outside the specification of the
highest calibrator.
– 1044 Unable to calculate result. Final RLU read falls outside the specification of the
lowest calibrator.
– 1402 Unable to process test. Activated read failure.
– 1403 Unable to process test. Final read failure.
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11. In the Original Dilution drop-down list, tap an original dilution.
12. Tap Retest Assays.
13. In the Retest Assays flyout, tap one or more retest assays.
14. To save the retest assay selection, tap Done.
To delete the retest assay selection, tap Cancel.
15. Under Retest Dilution, tap a retest dilution in the Retest Dilution drop-down list for each
assay.
16. Under Replicates, tap the number of replicates in the Replicates drop-down list for each
assay.
17. To add the retest rule, tap Add Rule.
18. To add additional retest assays, repeat steps 12, page 243 through 17, page 243.
19. To save the edits to the rule settings, tap Save.
To delete the edits to the rule settings, tap Cancel.
20. If more than one assay was selected, at the right side of the Assay Parameters screen, tap
the next assay to configure, and then repeat steps 7, page 242 through 19, page 243.
21. To return to the Assay Parameters screen, tap Done.
22. To return to the Configure screen, tap Configure.
Related information...
Assay Parameters screen, page 228
Configure SmartWash settings (c-series)
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
The SmartWash feature provides an additional wash for the reagent probes, sample probe, and
cuvette to prevent assay-to-assay interference.
Perform this procedure to configure the following settings:
• SmartWash settings for user-defined assays
• Additional SmartWash settings for a c-series photometric or potentiometric assay
NOTE: Consider the following information when SmartWash settings are configured:
• The assay parameters of an assay with a pending order cannot be edited.
• Only one wash solution needs to be configured for each component. The system uses only
one configured wash solution for each component.
• SmartWash settings are performed in the order in which they are configured.
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• Reagent probe settings that use the All option need to be configured last.
• User-defined SmartWash parameters are retained unless additional SmartWash parameters
are included with an assay file revision.
• The effectivity of the new settings to reduce assay-to-assay interference needs to be
evaluated.
Based on the testing performed with Abbott reagents, the following guidelines can be used to
select a wash solution to use for SmartWash settings:
• Water may be adequate for removing any soluble salts.
• Alkaline wash solutions, such as Detergent A and Detergent B, are more effective than
water or Acid Probe Wash for removing any proteins, latex particles, and contaminants that
enhance viscosity.
• Acid Probe Wash is more effective than alkaline wash solutions or water for removing any
metal contaminants or their salts.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Assay Parameters.
4. On the Assay Parameters screen, tap one or more assays to edit.
NOTE: To filter the list of assays, tap the c-series tab.
5. Tap View/Edit.
6. Tap the SmartWash tab.
7. In the Virtual Line drop-down list, tap one of the following items:
– Both: The assay does not require separation from another assay and can use Line A or
Line B cuvettes.
– Line A: The assay uses only the odd-numbered cuvettes.
– Line B: The assay uses only the even-numbered cuvettes.
8. Under Define SmartWash, tap one of the following options in the Component area:
– Reagent Probe R1
– Reagent Probe R2
– Cuvette
– Sample Probe
9. In the Interfering Reagent list, tap the name of the reagent that interferes with the selected
assay.
NOTE: This list is unavailable if the Sample Probe component option was selected.
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10. In the Wash Solution drop-down list, tap an item.
11. In the Wash Volume box, type a wash volume value.
NOTE: This box is unavailable if the Sample Probe component option was selected.
12. In the Replicates drop-down list, tap a number.
NOTE: This list is unavailable if the Cuvette component option was selected.
13. Tap Add SmartWash to add the SmartWash to the SmartWash Information area.
14. If a SmartWash is needed for another component, repeat steps 8, page 244 through 13,
page 245.
15. To save the edits to the assay parameter settings, tap Save.
To delete the edits to the assay parameter settings, tap Cancel.
16. If more than one assay was selected, at the right side of the Assay Parameters screen, tap
the next assay to configure, and then repeat steps 6, page 244 through 15, page 245.
17. To return to the Assay Parameters screen, tap Done.
18. To return to the Configure screen, tap Configure.
Related information...
Assay Parameters screen, page 228
SmartWash feature (c-series), page 370
Edit SmartWash settings (c-series)
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
The SmartWash feature provides an additional wash for the reagent probes, sample probe, and
cuvette to prevent assay-to-assay interference.
Perform this procedure to edit the following settings:
• SmartWash settings for user-defined assays
• Additional SmartWash settings that were configured for a c-series photometric or
potentiometric assay
NOTE: Consider the following information when SmartWash settings are edited:
• The assay parameters of an assay with a pending order cannot be edited.
• Abbott-provided SmartWash settings cannot be edited.
• Only one wash solution needs to be configured for each component. The system uses only
one configured wash solution for each component.
• SmartWash settings are performed in the order in which they are configured.
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• Reagent probe settings that use the All option need to be configured last.
• User-defined SmartWash parameters are retained unless additional SmartWash parameters
are included with an assay file revision.
• The effectivity of the new settings to reduce assay-to-assay interference needs to be
evaluated.
Based on the testing performed with Abbott reagents, the following guidelines can be used to
select a wash solution to use for SmartWash settings:
• Water may be adequate for removing any soluble salts.
• Alkaline wash solutions, such as Detergent A and Detergent B, are more effective than
water or Acid Probe Wash for removing any proteins, latex particles, and contaminants that
enhance viscosity.
• Acid Probe Wash is more effective than alkaline wash solutions or water for removing any
metal contaminants or their salts.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Assay Parameters.
4. On the Assay Parameters screen, tap one or more assays to edit.
NOTE: To filter the list of assays, tap the c-series tab.
5. Tap View/Edit.
6. Tap the SmartWash tab.
7. In the Virtual Line drop-down list, tap an item to change the virtual line setting.
NOTE: This step is performed only for user-defined assays.
8. Under SmartWash Information, tap a SmartWash to edit.
9. Tap Delete SmartWash to delete a configured SmartWash or to edit the option in the
Component area.
10. In the Interfering Reagent list, tap the name of the reagent that interferes with the selected
assay.
NOTE: This list is unavailable if the Sample Probe component option was selected.
11. In the Wash Solution drop-down list, tap an item.
12. In the Wash Volume box, type a wash volume value.
NOTE: This box is unavailable if the Sample Probe component option was selected.
13. In the Replicates drop-down list, tap a number.
NOTE: This list is unavailable if the Cuvette component option was selected.
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14. Tap Add SmartWash to add the SmartWash to the SmartWash Information area.
15. If a SmartWash is needed for another component, repeat steps 8, page 246 through 14,
page 247.
16. To save the edits to the assay parameter settings, tap Save.
To delete the edits to the assay parameter settings, tap Cancel.
17. If more than one assay was selected, at the right side of the Assay Parameters screen, tap
the next assay to configure, and then repeat steps 6, page 246 through 16, page 247.
18. To return to the Assay Parameters screen, tap Done.
19. To return to the Configure screen, tap Configure.
Related information...
Assay Parameters screen, page 228
Create a user-defined assay (c-series photometric)
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to create a c-series photometric user-defined assay. A user-defined
assay has an assay number from 2000 through 2999.
NOTE: The system count for user-defined assays is determined by the number of configured
user-defined reagents.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Assay Parameters.
4. On the Assay Parameters screen, tap Create.
5. In the Create Assay flyout, tap Photometric, and then tap Done.
6. On the General tab of the Assay Parameters screen, configure the following settings:
a. In the Assay Name box, type the name of the assay.
The next available assay number is displayed in the Assay Number box.
b. If an alternate assay number is needed, type a number from 2000 through 2999 in the
Assay Number box.
c. In the Assay Availability drop-down list, tap an item.
d. In the Module area, tap the module number check boxes for the modules that are
allocated to load the reagent of the assay.
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NOTE: This option is available only if the Alinity ci-series is configured with more than
one processing module of the same type.
e. In the Run Controls for Onboard Reagents by drop-down list, tap an item.
f. In the Reaction Definition area, enter the information.
g. In the Validity Checks area, enter the information.
h. In the Sample area, enter the information.
i. To configure a new reagent, tap New Reagent.
j. In the New Reagent flyout, enter the information, and then tap Done.
The new reagent name is displayed in the Reagent drop-down list in the Reagent area.
k. If a new sample diluent needs to be configured, repeat steps 6.i, page 248 and 6.j,
page 248.
The new sample diluent name is displayed in the Diluent drop-down list in the Reagent
area.
l. In the Reagent area, configure the remaining settings.
7. Tap the Calibration tab, and then configure the following settings:
a. In the Calibration area, enter the information.
b. To configure a new calibrator set, tap New Cal Set, enter the information in the New
Cal Set flyout, and then tap Done.
c. In the Calibrators area, enter the information.
d. In the Validity Checks area, enter the information.
e. To save the general and calibration assay parameter settings, tap Save.
8. Tap the Results tab, and then configure the following settings:
a. In the Result Units area, enter the information.
b. If Result Units is edited, tap Save to update the displayed result values to the new unit.
c. Under Results, type a value in the Low Linearity box.
d. In the High Linearity box, type a value.
e. To configure a result range, tap Add Result.
f. In the Add Result flyout, enter the information.
NOTE: An extreme range is not required.
g. Tap Done.
h. To complete the result range configuration, repeat steps 8.f, page 248 through 8.h,
page 248.
i. To configure an interpretation range, under Interpretation, tap an interpretation in the
Name drop-down list.
NOTE: If User-Defined is selected, type the name of the interpretation in the Name box.
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j. In the Range box, type an interpretation range value.
k. For the appropriate interpretation, tap the Review Required check box.
NOTE: If the Review Required check box is selected, the results are held for manual
release when the Hold option is configured for the Result Release Mode and the results
are within the specific interpretation range.
l. To configure additional interpretation range settings, repeat steps 8.j, page 249 through
8.l, page 249.
9. Tap the Retest Rules tab, and then configure the following settings:
a. In the Retest Rule Name box, type a name.
NOTE: Under Assay Retest Rules, if a retest rule is selected, tap the selected rule to
cancel the selection.
b. If the criteria is based on result ranges, tap Result Range in the Result Indicator area,
and then perform one of the following steps to enter a range:
• To retest all samples automatically when the original results are within a specific
range, type values in both result range boxes.
• To retest all samples automatically when the original results are less than or equal
to a specific value, leave the first result range box blank and type a value in the
second result range box.
• To retest all samples automatically when the original results are greater than or
equal to a specific value, type a value in the first result range box and leave the
second result range box blank.
c. If the criteria is based on interpretations, tap Interpretation in the Result Indicator
area.
d. In the Interpretation drop-down list, tap an interpretation.
e. If the criteria is based on exceptions, tap Exception in the Result Indicator area.
NOTE: The assay is retested if one of the following message codes is generated:
• 1037 Unable to calculate result. Rate reaction linearity failure.
• 1038 Unable to calculate result. Insufficient absorbance reads within absorbance
range.
• 1039 Unable to calculate result. Absorbance exceeded optical limits.
• 1040 Unable to calculate result. No absorbance reads within absorbance range.
• 1041 Unable to calculate result. Reaction check failure.
• 1042 Unable to calculate result. ICT Reference Solution voltage drift error.
• 1043 Unable to calculate result. Final RLU read falls outside the specification of
the highest calibrator.
• 1044 Unable to calculate result. Final RLU read falls outside the specification of
the lowest calibrator.
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• 1402 Unable to process test. Activated read failure.
• 1403 Unable to process test. Final read failure.
f. In the Original Dilution drop-down list, tap an original dilution.
g. Tap Retest Assays.
h. In the Retest Assays flyout, tap one or more retest assays.
i. To save the retest assay selection, tap Done.
To delete the retest assay selection, tap Cancel.
j. Under Retest Dilution, tap a retest dilution in the Retest Dilution drop-down list for
each assay.
k. Under Replicates, tap the number of replicates in the Replicates drop-down list for
each assay.
l. To add additional retest assays, repeat steps 9.g, page 250 through 9.k, page 250.
m. Tap Add Rule to add the retest rule.
n. To configure additional retest rules, repeat steps 9.a, page 249 through 9.m, page 250.
10. Tap the SmartWash tab, and then configure the following settings:
a. In the Virtual Line drop-down list, tap one of the following items:
• Both: The assay does not require separation from another assay and can use Line
A or Line B cuvettes.
• Line A: The assay uses only the odd-numbered cuvettes.
• Line B: The assay uses only the even-numbered cuvettes.
b. Under Define SmartWash, tap an option in the Component area.
c. In the Interfering Reagent list, tap the name of the reagent that interferes with the
assay.
NOTE: This list is unavailable if the Sample Probe component option was selected.
d. In the Wash Solution drop-down list, tap an item.
e. In the Wash Volume box, type a wash volume value.
NOTE: This box is unavailable if the Sample Probe component option was selected.
f. In the Replicates drop-down list, tap a number.
NOTE: This list is unavailable if the Cuvette component option was selected.
g. Tap Add SmartWash to add the SmartWash to the SmartWash Information area.
h. To complete the SmartWash settings, repeat steps 10.a, page 250 through 10.g, page
250.
11. To save the edits to the assay parameter settings, tap Save.
To delete the edits to the assay parameter settings, tap Cancel.
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12. To return to the Assay Parameters screen, tap Done.
13. To return to the Configure screen, tap Configure.
Related information...
Assay Parameters screen, page 228
End-point assay reactions (c-series), page 351
Rate assay reactions (c-series), page 352
Create a calculated assay
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to create an assay that uses a mathematical formula to derive a
calculated result.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Assay Parameters.
4. On the Assay Parameters screen, tap Create.
5. In the Create Assay flyout where the Calculated option is selected, tap Done.
6. On the General tab of the Assay Parameters screen, type the name of the calculated assay
in the Assay Name box.
7. In the Assay Number box, if an assay number other than the number that is displayed is
needed, type a number from 2000 through 2999.
NOTE: An Abbott calculated assay has an assay number from 3000 through 3999 that
cannot be edited.
8. In the Assay Availability drop-down list, tap an assay availability item.
9. Tap Select Assays.
10. In the Select Assays flyout, tap the constituent assays that are used in the calculated
formula.
For example, to create an LDL calculation, tap Chol, tap Ultra HDL, and then tap Trig.
NOTE: Assays are assigned to the calculator buttons in the order in which the assays are
selected.
11. To save the assay selection, tap Done.
To delete the assay selection, tap Cancel.
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12. To enter a calculated formula, tap one or more constituent assays, which are indicated by
the ASSAY1, ASSAY2, ASSAY3, and ASSAY4 buttons on the calculator, and then tap the
appropriate calculator function buttons.
The formula is displayed as it is entered in the Calculated Formula box.
For example, to enter the formula for an LDL calculation [Cholesterol - HDL - (Triglyceride ÷
5)], perform the following steps:
a. On the calculator, tap ASSAY1 (Cholesterol), and then tap the Minus Sign button.
b. Tap ASSAY2 (HDL), and then tap the Minus Sign button.
c. Tap the Opening Parenthesis button, and then tap ASSAY3 (Triglyceride).
d. Tap the Slash Mark (divide) button, tap 5, and then tap the Closing Parenthesis
button.
13. For each assay under Selected Assay, perform one of the following steps to enter a result
range:
– To define a specific result range, type a value in the Minimum box and type a value in
the Maximum box.
– To define a range where the results are less than or equal to a specific value, leave the
Minimum box blank and type a value in the Maximum box.
– To define a range where the results are greater than or equal to a specific value, type a
value in the Minimum box and leave the Maximum box blank.
NOTE: If the selected assay test result falls outside the defined result range, the calculated
test result becomes an exception and the result is not reported.
14. To save the edits to the calculated assay settings, tap Save.
To delete the edits to the calculated assay settings, tap Cancel.
15. Tap the Results tab.
16. Under Result Units on the Results tab of the Assay Parameters screen, enter the following
information:
– Result Units
– Decimal Places
– Result Unit UCUM
17. If Result Units is edited, tap Save to update the displayed result values to the new unit.
18. Under Results, enter the following information:
– Low Linearity
NOTE: For i-series assays, this setting can be edited only when the default dilution is
the first dilution.
– High Linearity
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NOTE: For i-series assays, this setting can be edited only when the default dilution is
the first dilution. This value cannot be edited to exceed the high-linearity default of the
assay.
19. To add a new result range, perform the following steps:
a. Tap Add Result.
b. In the Add Result flyout, enter the following information:
• Gender
• Age Unit
• Age Range
• Normal Range
• Extreme Range
NOTE: An extreme range is not required.
c. To save the edits to the result settings, tap Done.
To delete the edits to the result settings, tap Cancel.
20. Under Interpretation, tap an interpretation in the Name drop-down list.
NOTE: If User-Defined is selected, type the name of the interpretation in the Name box.
21. In the Range box, type an interpretation range value.
22. For the appropriate interpretation, tap the Review Required check box.
NOTE: If Review Required is selected, the results are held for manual release when the
Hold option is configured for the Result Release Mode and the results are within the
specific interpretation range.
23. For each available interpretation, repeat steps 20, page 253 through 22, page 253.
24. To save the edits to the review result settings, tap Save.
To delete the edits to the review result settings, tap Cancel.
25. Tap the Retest Rules tab.
26. Under Assay Retest Rules on the Retest Rules tab of the Assay Parameter screen, type
the name in the Retest Rule Name box.
NOTE: Under Assay Retest Rules, if a retest rule is selected, tap the selected rule to
cancel the selection.
27. If the criteria is based on result ranges, perform the following steps:
a. In the Result Indicator area, tap the Result Range option.
b. To enter a result range, perform one of the following steps:
• To retest all samples automatically when the original results are within a specific
range, type values in both result range boxes.
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• To retest all samples automatically when the original results are less than or equal
to a specific value, leave the first result range box blank and type a value in the
second result range box.
• To retest all samples automatically when the original results are greater than or
equal to a specific value, type a value in the first result range box and leave the
second result range box blank.
28. If the criteria is based on interpretations, perform the following steps:
a. In the Result Indicator area, tap the Interpretation option.
b. In the Interpretation drop-down list, tap an interpretation.
29. If the criteria is based on exceptions, tap the Exception option in the Result Indicator area.
NOTE: The assay is retested if one of the following message codes is generated:
– 1037 Unable to calculate result. Rate reaction linearity failure.
– 1038 Unable to calculate result. Insufficient absorbance reads within absorbance range.
– 1039 Unable to calculate result. Absorbance exceeded optical limits.
– 1040 Unable to calculate result. No absorbance reads within absorbance range.
– 1041 Unable to calculate result. Reaction check failure.
– 1042 Unable to calculate result. ICT Reference Solution voltage drift error.
– 1043 Unable to calculate result. Final RLU read falls outside the specification of the
highest calibrator.
– 1044 Unable to calculate result. Final RLU read falls outside the specification of the
lowest calibrator.
– 1402 Unable to process test. Activated read failure.
– 1403 Unable to process test. Final read failure.
30. In the Original Dilution drop-down list, tap an original dilution.
31. Tap Retest Assays.
32. In the Select Retest Assays flyout, tap the retest assays.
33. To save the retest assay selection, tap Done.
To delete the retest assay selection, tap Cancel.
34. Under Retest Dilution, tap a retest dilution in the Retest Dilution drop-down list for each
assay.
35. Under Replicates, tap the number of replicates in the Replicates drop-down list for each
assay.
36. To add additional retest assays, repeat steps 31, page 254 through 35, page 254.
37. To save the edits to the retest rule settings, tap Add Rule.
To delete the edits to the retest rule settings, tap Cancel.
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38. To save the edits to the assay file and return to the Assay Parameters screen, tap Done.
39. To return to the Configure screen, tap Configure.
Related information...
Assay Parameters screen, page 228
Calibrator Set screen
On the Calibrator Set screen, the operator can perform the following functions:
• View calibrator data.
• View or print calibrator value sheets.
• Create new calibrator lots by scanning the bar codes on the calibrator cartons.
The supervisor and the system administrator can perform the following functions:
• Manually create new calibrator lots or import calibrator data to create new calibrator lots.
• Edit calibrator data.
• Delete calibrator lots.
The system administrator can delete imported calibrator data.
Related information...
Configure screen, Assay tab, page 227
Calibrator Set screen element descriptions, page 255
Calibrator Set View/Edit screen element descriptions, page 256
Import Calibrators screen element descriptions (c-series), page 258
View calibrator lot data, page 259
Create a new calibrator lot from a bar code, page 259
Manually create a new calibrator lot, page 260
Import calibrator data (c-series), page 261
Delete imported calibrator data (c-series), page 263
Delete a calibrator lot, page 263
Descriptions of calibrator import statuses (c-series), page 264
Edit calibrator data (c-series), page 264
Edit calibrator data (i-series), page 266
View or print a calibrator value sheet (c-series), page 267
Calibrator Set screen element descriptions
The Calibrator Set screen displays the calibrator sets that are configured on the system.
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Elements
Calibrator Sets Displays the total number of calibrator sets that are
configured on the system.
All option Displays all calibrator sets that are available on the system.
i-series option Displays all calibrator sets that are available on one or more
Alinity i processing modules.
c-series option Displays all calibrator sets that are available on one or more
Alinity c processing modules.
Function buttons
Configure Navigates to the previous configuration screen.
View/Edit Navigates to the Calibrator Set View/Edit screen for the
selected calibrator set.
Delete Displays a message requesting confirmation to delete the
selected items.
Import Navigates to the Import Calibrators screen.
Text Size Increases or decreases the size of text displayed.
Related information...
Calibrator Set screen, page 255
Descriptions of screen elements, page 127
Calibrator Set View/Edit screen element descriptions
The Calibrator Set View/Edit screen displays the data for the selected calibrator set.
Elements
Calibrator Set Name Displays the name of the selected calibrator set.
Lot Displays the lot number of the selected calibrator set.
Default Displays a check box that is used to identify the lot number
that is displayed as the default lot number for the calibrator
set.
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NOTE: The first configured lot number is identified as the
default lot number. The default lot number can be changed
when two or more lot numbers are configured.
Expiration Date Displays the expiration date of the selected calibrator set.
Level Displays the number of levels defined for the calibrator set.
Concentration values must be defined for all levels of the
default lot number.
Assay Identifies the name of the assays in the calibrator set.
Cal 1 Displays the concentration of the level 1 calibrator.
Cal 2 Displays the concentration of the level 2 calibrator.
Cal 3 Displays the concentration of the level 3 calibrator.
Cal 4 Displays the concentration of the level 4 calibrator.
Cal 5 Displays the concentration of the level 5 calibrator.
Cal 6 Displays the concentration of the level 6 calibrator.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Print Displays the Print flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Save Saves changes.
Delete Displays a message requesting confirmation to delete the
selected items.
Text Size Increases or decreases the size of text displayed.
Related information...
Calibrator Set screen, page 255
Descriptions of screen elements, page 127
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Import Calibrators screen element descriptions (c-series)
The Import Calibrators screen displays the calibrator files that are available for import to the
selected calibrator set. The calibrator files are used to configure a new lot number for an
existing calibrator set and can be located on the system or on a USB flash drive.
Elements
Calibration Set Displays the calibrator set name of the calibrator data file
selected for import.
Lot Number Displays the lot number of the calibrator data file selected for
import.
Number of Levels Displays the number of calibrator levels defined for the
calibrator data file selected for import.
Expiration Date Displays the expiration date of the calibrator data file selected
for import.
button The Previous Folder button navigates to the previously
selected folder.
Folder Name Displays the currently selected folder.
button The Home button navigates to the C drive folder.
Calibrator Files Displays the calibrator data files in the specified folder that
are available for import for the selected calibrator set.
File Assay/Number Displays the assay name and assay number for each assay in
the calibrator data file selected for import.
System Assay/Number Displays the assay name and assay number for each assay
on the system that corresponds to the assay number in the
calibrator data file selected for import.
Status Displays the import status of the assay. Data for an assay that
has a status of OK is imported. Data is not imported for
assays that have the following statuses:
• No Assay
• Previously Defined
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Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Delete Deletes the selected calibrator file on the hard drive. Files on
a USB flash drive cannot be deleted.
Import Imports the selected calibrator file.
Text Size Increases or decreases the size of text displayed.
Related information...
Calibrator Set screen, page 255
Descriptions of screen elements, page 127
View calibrator lot data
Perform this procedure to view calibrator lot data for configured calibrator sets.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Calibrator Set.
4. In the list on the Calibrator Set screen, tap a calibrator set.
5. Tap View/Edit to display the calibrator data for the default lot number.
6. In the Lot drop-down list under Calibrator Set Configuration, tap other calibrator lot
numbers to display.
7. To return to the list of calibrator sets on the Calibrator Set screen, tap Done.
Related information...
Calibrator Set screen, page 255
Create a new calibrator lot from a bar code
Perform this procedure to create a new calibrator lot for an existing calibrator set by scanning
the bar code on the calibrator carton.
NOTE: This capability is specific to some single-constituent and multiconstituent calibrators. To
identify calibrators that have this capability, see the product documentation.
For c-series assays with this capability, values for the initial calibrator lot number must be
configured manually. Subsequent calibrator lots can be configured by scanning the bar code on
the calibrator carton.
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1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Calibrator Set.
4. In the list on the Calibrator Set screen, tap a calibrator set.
5. Tap View/Edit to display the calibrator data for the default lot number.
NOTE: The first configured lot number is designated automatically as the default lot number.
6. In the Lot drop-down list under Calibrator Set Configuration, tap New Lot.
7. Use the bar code scanner to scan the bar code on the calibrator carton.
The system automatically creates a new calibrator lot with the lot number and expiration
date from the calibrator carton.
8. To configure the new calibrator lot as the default, tap the Default check box.
NOTE: The default lot can be changed when the instrument status is Running or Processing
if no orders are present for the calibrator set and, for c-series assays, if the calibrator set is
not loaded in the reagent carousel. The data must be defined for all assays and all levels of
the default lot.
9. To save the calibrator lot settings, tap Save.
To delete the calibrator lot settings, tap Cancel.
10. To return to the list of calibrator sets on the Calibrator Set screen, tap Done.
Related information...
Calibrator Set screen, page 255
Manually create a new calibrator lot
Operator access level Supervisor
Perform this procedure to create a new calibrator lot manually for an existing calibrator set.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Calibrator Set.
4. In the list on the Calibrator Set screen, tap a calibrator set.
5. Tap View/Edit to display the calibrator data for the default lot number.
6. In the Lot drop-down list under Calibrator Set Configuration, tap New Lot.
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7. In the Lot box, enter the calibrator lot number.
NOTE: If the lot is not the initial calibrator lot, the existing calibrator data is copied to the
new lot.
8. In the Expiration Date box, enter the calibrator expiration date.
9. To configure the new calibrator lot as the default, tap the Default check box.
NOTE: The first configured lot number is designated automatically as the default lot number.
The default lot can be changed when the instrument status is Running or Processing if no
orders are present for the calibrator set and, for c-series assays, if the calibrator set is not
loaded in the reagent carousel. The data must be defined for all assays and all levels of the
default lot.
10. For c-series assays, in the Store Onboard area, tap Yes or No to indicate whether the
calibrator set is stored in the reagent carousel:
– If Yes is selected, type the number of hours in the Onboard Stability (Hours) box.
NOTE: Onboard storage capability is available for some calibrators. To identify
calibrators that have this capability and the onboard stability time for each calibrator,
see the product documentation.
– If No is selected, proceed to step 11.
11. For c-series photometric assays, enter a calibrator value for each assay and each level in
the calibrator set.
12. To save the edits to the calibrator lot settings, tap Save.
To delete the edits to the calibrator lot settings, tap Cancel.
13. To return to the list of calibrator sets on the Calibrator Set screen, tap Done.
Related information...
Calibrator Set screen, page 255
Import calibrator data (c-series)
Operator access level Supervisor
Required materials A calibrator data file on a USB flash drive or on the hard drive
Perform this procedure to import calibrator data files to create a new calibrator lot for a
configured calibrator set.
Calibrator data files may be accessed at abbottdiagnostics.com or may be requested through
Abbott Mail.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
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2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Calibrator Set.
4. In the list on the Calibrator Set screen, tap a calibrator set.
5. Tap Import.
On the Import Calibrators screen, the Hard Drive button is selected.
6. Tap the calibrator data file to import.
If the calibrator data file is located on a USB flash drive, perform the following steps:
a. Insert the USB flash drive.
b. Tap the USB Flash Drive button.
c. Tap the appropriate folder.
d. Tap the calibrator data file to import.
NOTE: The assay names and assay numbers for the data in the file and for the
corresponding system assays are displayed with an import status. Data for all calibrator
levels is imported for assays that have a status of OK. No data is imported for assays that
have a status of No Assay or Previously Defined. These statuses are displayed in red text.
7. For the selected calibrator data file, perform one of the following steps:
– If no data is available to import because the assays have a status of No Assay or
Previously Defined, tap Done to return to the Calibrator Set screen and end the
procedure.
– To import the data for assays that have a status of OK, tap Import.
8. Under Calibrator Set Configuration on the Calibrator Set screen, tap the Default check box
to configure the calibrator lot as the default.
NOTE: The first configured lot number is designated automatically as the default lot number.
The default lot number can be changed when the instrument status is Running or
Processing if no orders are pending for the calibrator set and the calibrator set is not loaded
in the reagent carousel. For all assays and all levels of the default lot number, the data
must be defined.
9. To save the calibrator data file settings, tap Save.
To delete the calibrator data file settings, tap Cancel.
10. To return to the list of calibrator sets on the Calibrator Set screen, tap Done.
11. If a USB flash drive was inserted, remove the USB flash drive.
Calibrator data files that are imported from a USB flash drive are saved to an internal storage
location on the system. To reinstall the calibrator data files on a future date, tap the Hard Drive
button.
Related information...
Calibrator Set screen, page 255
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Insert and remove a USB flash drive, page 671
Delete imported calibrator data (c-series)
Operator access level System administrator
Perform this procedure to delete calibrator data files from the user interface computer. After a
calibrator data file is deleted, the file is unavailable to be reinstalled.
NOTE: This procedure cannot be used to delete calibrator data files from a USB flash drive.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Calibrator Set.
4. In the list on the Calibrator Set screen, tap a calibrator set.
5. Tap Import.
On the Import Calibrators screen, the Hard Drive button is selected.
6. In the Calibrator Files list, tap the calibrator data file to delete.
7. Tap Delete.
8. To delete the calibrator data file, tap Continue.
To cancel the delete function, tap Cancel.
9. To return to the list of calibrator sets on the Calibrator Set screen, tap Done.
Related information...
Calibrator Set screen, page 255
Delete a calibrator lot
Required instrument Stopped, Warming, or Idle
status
Operator access level Supervisor
Perform this procedure to delete a calibrator lot number.
NOTE: The default lot number cannot be deleted. To delete a lot number that is configured as
the default, first change the default lot number.
The calibrator lot number is deleted automatically from the system 6 months after the calibrator
lot has reached the configured expiration date.
1. On the menu bar, tap System and then tap Configure.
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NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Calibrator Set.
4. In the list on the Calibrator Set screen, tap a calibrator set.
5. Tap View/Edit to display the calibrator data for the default lot number.
6. In the Lot drop-down list under Calibrator Set Configuration, tap a calibrator lot number
that is not the default.
7. Tap Delete.
8. When a confirmation message is displayed, tap Continue.
9. To return to the list of calibrator sets on the Calibrator Set screen, tap Done.
Related information...
Calibrator Set screen, page 255
Descriptions of calibrator import statuses (c-series)
Calibrator import status information is used to resolve issues that occur when calibrator data is
imported. The system displays one calibrator import status for each assay on the Import
Calibrators screen.
The following list provides descriptions of the calibrator import statuses:
OK The imported assay has the same assay number and result
units as the assay that was configured on the system. The
data is imported.
No Assay No assay on the system has the same assay number in the
imported file. The data is not imported.
Previously Defined The data has been manually entered or imported. The data is
not imported.
Related information...
Calibrator Set screen, page 255
Edit calibrator data (c-series)
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to edit calibrator data settings.
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1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Calibrator Set.
4. In the list on the Calibrator Set screen, tap a calibrator set.
5. Tap View/Edit to display the calibrator data for the default lot number.
6. In the Lot drop-down list under Calibrator Set Configuration, tap a calibrator lot number
that is not the default.
7. To configure the calibrator lot number as the default, tap the Default check box.
NOTE: The default lot number can be changed when the instrument status is Running or
Processing if no orders are pending for the calibrator set and the calibrator set is not loaded
in the reagent carousel. The default lot number must include all assays that are assigned to
the calibrator set.
8. In the Expiration Date box, enter the calibrator expiration date.
NOTE: The expiration date cannot be edited if one of the following situations occurred:
– The calibrator lot number has expired.
– The calibrator lot number was created by scanning the bar code on the calibrator
carton.
– The calibrator lot number was created by importing calibrator data.
9. In the Store Onboard area, tap Yes or No to indicate whether the calibrator set is stored in
the reagent carousel:
– If Yes is selected, type the number of hours in the Onboard Stability (hours) box.
NOTE: Onboard storage capability is available for some calibrators. To identify
calibrators that have this capability and the onboard stability time for each calibrator,
see the product documentation.
– If No is selected, proceed to step 11.
10. For photometric assay calibrator sets, tap Level, and then enter a calibrator value to
increase the number of levels in the calibrator.
NOTE: The number of calibrator levels cannot be decreased for a previously configured
calibrator. For all enabled assays and all levels of the default lot number, the data must be
defined.
11. Enter calibrator values for all levels of each enabled assay if the values are not present.
NOTE: Calibrator values cannot be edited for a calibrator lot number that is created by
scanning the bar code on the calibrator carton label.
12. To delete the selected calibrator lot number, perform the following steps:
a. Tap Delete.
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b. When a confirmation message is displayed, tap Continue.
NOTE: A calibrator lot number cannot be deleted if the lot number is the default or if the
calibrator is loaded in the reagent carousel.
13. To save the edits to the calibrator lot settings, tap Save.
To delete the edits to the calibrator lot settings, tap Cancel.
14. To edit another calibrator lot number, tap a lot number in the Lot drop-down list, and then
repeat steps 7, page 265 through 13, page 266.
15. To return to the list of calibrator sets on the Calibrator Set screen, tap Done.
Related information...
Calibrator Set screen, page 255
Edit calibrator data (i-series)
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to change the default calibrator lot number and to delete a calibrator lot
number.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Calibrator Set.
4. In the list on the Calibrator Set screen, tap a calibrator set.
5. Tap View/Edit to display the calibrator data for the default lot number.
6. In the Lot drop-down list under Calibrator Set Configuration, tap a calibrator lot number
that is not the default.
7. To configure the calibrator lot number as the default, tap the Default check box.
NOTE: The default lot number can be changed when the instrument status is Running or
Processing if no orders are pending for the calibrator set. The default lot number must
include all assays that are assigned to the calibrator set.
8. To delete the selected calibrator lot number, perform the following steps:
a. Tap Delete.
b. When a confirmation message is displayed, tap Yes.
NOTE: A calibrator lot number cannot be deleted if the lot number is the default.
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9. To save the edits to the calibrator lot settings, tap Save.
To delete the edits to the calibrator lot settings, tap Cancel.
10. To edit another calibrator lot number, tap a lot number in the Lot drop-down list, and then
repeat steps 7, page 266 through 9, page 267.
11. To return to the list of calibrator sets on the Calibrator Set screen, tap Done.
Related information...
Calibrator Set screen, page 255
View or print a calibrator value sheet (c-series)
Required materials USB flash drive (Print to File option only)
Perform this procedure to view or print a calibrator value sheet or to save the calibrator value
sheet as a portable document format (PDF) file.
NOTE: A calibrator value sheet is available only for a calibrator lot that was created from an
imported file that has not previously been deleted on the hard drive.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Calibrator Set.
4. In the list on the Calibrator Set screen, tap a calibrator set.
5. Tap View/Edit to display the calibrator data for the default lot number.
6. In the Lot drop-down list under Calibrator Set Configuration, tap a calibrator lot number
that is not the default.
7. Tap Print.
8. Under Report Selection in the Print flyout, tap Calibrator Insert.
9. To rotate the document, use the Rotate toolbar.
10. To browse the document, use the Page toolbar.
11. To increase or decrease the font size in the document, use the Zoom toolbar.
12. To fit the document to the window width ( ) or to resize the document to fit one full page in
the window ( ), use the Fit toolbar.
13. To find a word or phrase in the document, use the Find toolbar.
14. In the Print flyout, choose a printer or tap Print to File in the Print Location drop-down list.
15. To print the document, enter the number of copies to print, and then tap Print.
16. If Print to File was selected in the Print Location drop-down list, perform the following
steps to indicate the file destination:
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a. Insert a USB flash drive.
b. Tap the appropriate USB flash drive.
c. Tap the destination folder.
d. Tap OK.
e. Remove the USB flash drive.
17. To return to Calibrator Set Configuration on the Calibrator Set screen, tap Done.
Related information...
Calibrator Set screen, page 255
Insert and remove a USB flash drive, page 671
Install/Uninstall Assays screen
On the Install/Uninstall Assays screen, the operator can view or print assay installation reports.
The system administrator can perform the following functions:
• Install assays.
• Uninstall assays.
• Delete assays on the hard drive.
Related information...
Configure screen, Assay tab, page 227
Install/Uninstall Assays screen, Available Files tab element descriptions, page 268
Install/Uninstall Assays screen, Installed Files tab element descriptions, page 270
Descriptions of file update statuses, page 271
Descriptions of assay file reagent statuses, page 272
Install assay files, page 272
Uninstall assay files, page 274
Delete assay files, page 274
Install/Uninstall Assays screen, Available Files tab element descriptions
The Available Files tab displays all assay files that are available for installation on the system or
on a USB flash drive.
Elements
Available Assays Displays the number of assays that are available for
installation for the currently selected option.
All option Displays all assay files that are available for installation.
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i-series option Displays all assay files that are available for installation on
one or more Alinity i processing modules.
c-series option Displays all assay files that are available for installation on
one or more Alinity c processing modules.
Calculated option Displays all calculated assay files that are available for
installation.
Status Displays the status of the file installation. The status includes
file integrity and file installation success or failure.
button The Previous Folder button navigates to the previously
selected folder.
Folder Name Displays the currently selected folder.
button The Home button navigates to the C drive folder.
Assay Name Displays the name of the assay file.
Assay Number Displays the number of the assay file.
Version Displays the version of the assay file.
Update Status Displays the file update status of all assay files that are
available on the system.
The Available Files tab has five file update statuses:
• Current
• New
• Update
• Installed
• Previous
Reagent Status Displays the assay file reagent status to determine if a new
reagent lot is necessary to support a new assay file.
The Available Files tab has three assay file reagent statuses:
• OK
• New reagent needed
• Unknown
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Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Select All Selects or deselects all items in a list. The button switches
between Select All and Deselect All.
Print Displays the Print flyout.
Install Installs the selected files on the current screen.
Delete Displays a message requesting confirmation to delete the
selected items.
Text Size Increases or decreases the size of text displayed.
Related information...
Install/Uninstall Assays screen, page 268
Descriptions of screen elements, page 127
Descriptions of assay file reagent statuses, page 272
Descriptions of file update statuses, page 271
Install/Uninstall Assays screen, Installed Files tab element descriptions
The Installed Files tab displays all assay files that are installed on the system.
Elements
Installed Assays Displays the number of assays installed for the currently
selected option.
All option Displays all assay files that are available for installation.
i-series option Displays all assay files that are available for installation on
one or more Alinity i processing modules.
c-series option Displays all assay files that are available for installation on
one or more Alinity c processing modules.
Calculated option Displays all calculated assay files that are available for
installation.
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Status Displays the status of the file installation. The status includes
file integrity and file installation success or failure.
Assay Name Displays the name of the assay file.
Assay Number Displays the number of the assay file.
Version Displays the version of the assay file
Release Status Displays the status of the assay file. The Installed Files tab
has one file status: Released.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Select All Selects or deselects all items in a list. The button switches
between Select All and Deselect All.
Print Displays the Print flyout.
Uninstall Displays a message requesting confirmation to uninstall files
from the user interface.
Text Size Increases or decreases the size of text displayed.
Related information...
Install/Uninstall Assays screen, page 268
Descriptions of screen elements, page 127
Descriptions of file update statuses
File update status information is used to determine if an assay file or a procedure file is new, is
updated, or is installed on the system.
The following list provides descriptions of the file update statuses. The statuses are described in
the order in which they are sorted:
Current The file is the same version as the file that is installed on the
system.
New The file is not installed on the system.
Update The file is a newer version than the file that is installed on the
system.
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Installed The file was installed successfully.
NOTE: Installed is a temporary status that is updated after the
screen is refreshed.
Previous The file is an older version than the file that is installed on the
system.
Related information...
Install/Uninstall Assays screen, page 268
Install/Uninstall Assays screen, Available Files tab element descriptions, page 268
Import/Export Assays screen, Export Files tab element descriptions (c-series), page 275
Import/Export Assays screen, Import Files tab element descriptions (c-series), page 276
Install/Uninstall Procedures screen, page 310
Install/Uninstall Procedures screen, Available Files tab element descriptions, page 311
Install/Uninstall Procedures screen, Installed Files tab element descriptions, page 312
Descriptions of assay file reagent statuses
Assay file reagent status information is used to determine if a new reagent lot is necessary to
support a new assay file.
The following list provides descriptions of the assay file reagent statuses. The statuses are
described in the order in which they are sorted:
OK A new reagent lot is not necessary to support the new assay
file.
New reagent needed A new reagent lot is necessary to support the new assay file.
Unknown The assay file is new and has not been installed previously on
the system. The reagent lot information is unknown.
Related information...
Install/Uninstall Assays screen, page 268
Install/Uninstall Assays screen, Available Files tab element descriptions, page 268
Install assay files
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Required materials An assay file on the hard drive or on a USB flash drive
Perform this procedure to install assay files on the system.
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NOTE: When an assay is installed that uses the data from a reference assay, the reference
assay must be installed first.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Install/Uninstall Assays.
On the Available Files tab of the Install/Uninstall Assays screen, the Hard Drive button is
selected.
NOTE: If the assay is located on a USB flash drive, insert the USB flash drive, and then tap
the USB Flash Drive button.
4. Under Assays on the Available Files tab, tap one or more assay files to install (or tap
Select All).
NOTE: To filter the list of installed assay files, tap the option for i-series, c-series, or
Calculated.
5. To print the assay-specific installation information, tap Print.
6. Review the specific information for each assay before installation.
Assays may have specific installation requirements.
7. Tap Install.
8. When a confirmation message is displayed because an updated assay file requires a new
version of the reagent, refer to the assay-specific installation information to verify the
reagent requirements.
Do not install the new assay file until the correct reagent has been received.
Tap one of the following options:
– Tap Yes to install the new assay file.
– Tap No to cancel the specific assay installation.
– Tap Cancel to cancel all assay file installations if more than one assay file was
selected.
9. Refer to the assay-specific installation information for specific calibration and quality control
requirements.
Calibration and all levels of controls may need to be run before results are reported.
10. To return to the Configure screen, tap Done.
Assay files that are installed from a USB flash drive are saved to an internal storage location on
the system.
Related information...
Install/Uninstall Assays screen, page 268
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Uninstall assay files, page 274
Create a control order, page 597
Create a calibration order, page 599
System checkout, page 152
Insert and remove a USB flash drive, page 671
Uninstall assay files
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to uninstall assay files from the system software. Assay files remain
available to be reinstalled from the Available Files tab of the Install/Uninstall Assays screen.
NOTE: An assay file cannot be uninstalled if the assay file is referenced by another assay, has
pending orders, or is a constituent of a calculated assay.
When an assay file is uninstalled, calibrations for the assay file and any assay configuration
including controls are deleted.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Install/Uninstall Assays.
4. On the Install/Uninstall Assays screen, tap the Installed Files tab.
5. On the Installed Files tab, tap one or more assay files to uninstall (or tap Select All).
NOTE: To filter the list of installed assay files, tap the option for i-series, c-series, or
Calculated.
6. Tap Uninstall.
7. When a confirmation message is displayed, tap Yes.
8. To return to the Configure screen, tap Done.
Related information...
Install/Uninstall Assays screen, page 268
Install assay files, page 272
Delete assay files
Required instrument Stopped, Warming, or Idle
status
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Operator access level System administrator
Perform this procedure to delete assay files from the user interface computer. After an assay
file is deleted, the assay file is unavailable to be reinstalled.
NOTE: An assay file cannot be deleted if the assay file is referenced by another assay, has
pending orders, or is a constituent of a calculated assay.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Install/Uninstall Assays.
4. On the Available Files tab of the Install/Uninstall Assays screen, tap one or more assay
files to delete (or tap Select All).
NOTE: To filter the list of installed assay files, tap the option for i-series, c-series, or
Calculated.
5. Tap Delete.
6. When a confirmation message is displayed, tap Yes.
7. To return to the Configure screen, tap Done.
Related information...
Install/Uninstall Assays screen, page 268
Import/Export Assays screen (c-series)
On the Import/Export Assays screen, the operator can export assay files for import on an Alinity
ci-series by using a c-series processing module.
The system administrator can import assay files to an Alinity ci-series by using a c-series
processing module.
Related information...
Configure screen, Assay tab, page 227
Import/Export Assays screen, Export Files tab element descriptions (c-series), page 275
Import/Export Assays screen, Import Files tab element descriptions (c-series), page 276
Select Items window element descriptions (c-series), page 277
Export assay files (c-series), page 278
Import assay files (c-series), page 279
Import/Export Assays screen, Export Files tab element descriptions (c-series)
The Export Files tab displays all c-series photometric assay files that are available to export.
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Elements
Status Displays the status of the assay to be exported or when an
attempt has been made to export an assay.
Assay Name Displays the name of the assay file.
Assay Number Displays the number of the assay file.
Version Displays the version of the assay file
Release Status Displays the status of the assay file. The Installed Files tab
has one file status: Released.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Select All Selects or deselects all items in a list. The button switches
between Select All and Deselect All.
Export Initiates the process to export an assay file.
Text Size Increases or decreases the size of text displayed.
Related information...
Import/Export Assays screen (c-series), page 275
Descriptions of screen elements, page 127
Descriptions of file update statuses, page 271
Import/Export Assays screen, Import Files tab element descriptions (c-series)
The Import Files tab displays all assay files that are available to import from a USB flash drive.
Elements
Status Displays the status of the file import. The status includes file
integrity and file import success or failure.
button The Previous Folder button navigates to the previously
selected folder.
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Folder Name Displays the currently selected folder.
button The Home button navigates to the C drive folder.
Assay Name Displays the name of the assay file.
Assay Number Displays the number of the assay file.
Version Displays the version of the assay file
Update Status Displays the status of the assay file. The Import Files tab has
five file update statuses:
• Current
• New
• Update
• Installed
• Previous
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Select All Selects or deselects all items in a list. The button switches
between Select All and Deselect All.
Import Imports the selected files.
Text Size Increases or decreases the size of text displayed.
Related information...
Import/Export Assays screen (c-series), page 275
Descriptions of screen elements, page 127
Descriptions of file update statuses, page 271
Select Items window element descriptions (c-series)
The Select Items window displays the drive and folders that are used to export an assay file.
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Elements
button The Previous Folder button navigates to the previously
selected folder.
button The Selected Folders button displays all previously selected
folders.
Folder Name Displays the currently selected folder.
button The Home button navigates to the C drive folder.
Name Displays the name of the drive or folder.
Last Update Displays the date and time that the files in the folder were last
updated.
Function buttons
OK Saves the file and closes the window.
Cancel Cancels the operation and closes the window.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Import/Export Assays screen (c-series), page 275
Export assay files (c-series)
Required materials USB flash drive
Perform this procedure to export c-series photometric assay files.
NOTE: Multiple versions of the same assay file can be exported to the same location on a USB
flash drive.
If an assay file is exported to a location occupied by the same assay file and version number,
the data in the existing file is overwritten.
1. Insert the USB flash drive.
2. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
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3. On the Configure screen, tap the Assay tab.
4. On the Assay tab of the Configure screen, tap Import/Export Assays.
5. On the Export Files tab of the Import/Export Assays screen, tap one or more of the installed
assay files (or tap Select All).
6. Tap Export.
7. On the Export screen, select the file location for the exported assay files:
a. Tap the appropriate USB flash drive.
b. Tap the appropriate folder.
8. To complete the export of the assay files, tap OK.
NOTE: In the Status area, a message is displayed that contains the name, number, and
version of each exported assay file and is displayed for any error conditions that occur.
If the USB flash drive has insufficient space for all the assay files that are exported, only
the assay files that can fit on the USB flash drive are exported.
9. To return to the Configure screen, tap Done.
10. Remove the USB flash drive.
Exported assay files can only be imported. They cannot be installed on the Install/Uninstall
Assays screen.
Related information...
Import/Export Assays screen (c-series), page 275
Insert and remove a USB flash drive, page 671
Import assay files (c-series)
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Required materials One or more exported c-series photometric assay files on a
USB flash drive
Perform this procedure to import c-series photometric assay files.
NOTE: Exported assay files can only be imported. They cannot be installed on the Install/
Uninstall Assays screen.
1. Insert the USB flash drive.
2. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
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3. On the Configure screen, tap the Assay tab.
4. On the Assay tab of the Configure screen, tap Import/Export Assays.
5. On the Import/Export Assays screen, tap the Import Files tab.
6. On the Import Files tab, tap the appropriate USB flash drive and folder that contain the
exported assay files.
NOTE: Exported assay files that have an invalid checksum cannot be imported and are not
displayed in the folder.
7. Tap one or more of the exported assay files (or tap Select All).
8. Tap Import.
NOTE: In the Status area, a message is displayed that contains the name, number, and
version of each imported assay file and is displayed for any error conditions that occur. The
assay status of an imported assay file is Installed.
The parameter for Run Controls for Onboard Reagents by is configured as the default for
assay files that do not have the parameter configured. The assay-specific setting is retained
for the imported assay files if the setting is configured.
The import is not completed in the following instances:
– An exported assay with the same version number is present on the system.
– An exported assay requires a reference assay and the reference assay is not installed.
9. To return to the Configure screen, tap Done.
10. Remove the USB flash drive.
Assay files that have the parameter for Calibrator Set configured as None are enabled when
they are imported.
If an assay file has a setting other than None configured as the parameter for Calibrator Set,
the assay file is disabled and the calibrator concentration values are deleted when the assay file
is imported.
Related information...
Import/Export Assays screen (c-series), page 275
Insert and remove a USB flash drive, page 671
Assay Display Order screen
On the Assay Display Order screen, the operator can view assay display order settings.
The system administrator can configure the assay display order on the user interface and for
reports.
Related information...
Configure screen, Assay tab, page 227
Assay Display Order screen element descriptions, page 281
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Configure the assay display order, page 282
Assay Display Order screen element descriptions
On the Assay Display Order screen, the system administrator can configure the order in which
assays are displayed on screens and flyouts that have an assay list and in the following reports:
• Sample Laboratory Report
• Sample Status Report
• QC Summary Report
Elements
Display Order Applies Displays the following options to indicate the areas to which
to the configured display order is applied:
Reports Only The configured assay display order is
displayed only on printed reports.
Reports and Displays The configured assay display order is
applied to user interface computer
screens that have an assay list and to
the previously listed reports.
Assay Displays a list of the assays that are installed on the system.
Display Order Displays the assay display order list.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Add> Moves the selected assays from the Assay list to the Display
Order list in the order in which the assays were selected.
<Reset Moves the selected assay from the Display Order list to the
Assay list.
Insert Before Inserts an assay, or a group of assays in the order in which
the assays were selected, before the selected assay in the
Display Order list.
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Insert After Inserts an assay, or a group of assays in the order in which
the assays were selected, after the selected assay in the
Display Order list.
<<Reset All Moves all assays from the Display Order list to the Assay list.
Text Size Increases or decreases the size of text displayed.
Related information...
Assay Display Order screen, page 280
Descriptions of screen elements, page 127
Configure the assay display order
Operator access level System administrator
Perform this procedure to configure the assay display order on the following user interface
elements:
• Screens and flyouts that have an assay list
• The sample laboratory report, the sample status report, and the quality control summary
report
NOTE: When the assay display order is defined, assays are displayed in the defined order on
screens and in reports as configured. Any new assays and assays that are not defined in the
display order are displayed in alphanumeric order on screens and in reports after the assays in
the display order.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Assay Display Order.
4. In the Display Order Applies to area of the Assay Display Order screen, tap Reports Only
or Reports and Displays.
5. To edit the assay display order, perform one of the following steps:
– To add assays to the end of the Display Order list, in the Assay list, tap each assay in
the order to display, and then tap ADD>.
– To insert assays in the Display Order list, in the Assay list, tap each assay in the order
to display. Tap the assay in the Display Order list where the assays need to be
inserted, and then tap Insert Before or Insert After. The assays are inserted in the
selected location.
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– To change the order of the assays in the Display Order list, tap the assays that need to
be moved, and then tap Reset. The assays are moved to the Assay list. Perform one of
the previous two steps to move the assays to the Display Order list in the correct order.
– To move all assays from the Display Order list to the Assay list, tap <<Reset All.
6. To save the edits to the display order settings and return to the Configure screen, tap Done.
To delete the edits to the display order settings and return to the Configure screen, tap
Cancel.
Related information...
Assay Display Order screen, page 280
Panel Definition screen
On the Panel Definition screen, the operator can view panel definitions for specimens, quality
control (QC), and calibrations.
The system administrator can perform the following functions:
• Configure new panels for specimens, QC, and calibrations.
• Edit an existing panel.
• Delete a panel.
Related information...
Configure screen, Assay tab, page 227
Panel Definition screen element descriptions, page 283
Configure a panel, page 285
Edit a panel definition, page 285
Delete a panel, page 286
Panel Definition screen element descriptions
The Panel Definition screen displays the panel names and the constituent assays for panels that
are configured on the system.
Elements
Panel Configuration area
Panel Name Displays the name of the selected panel. The operator can
type a new panel name that can contain a maximum of 10
characters.
Panel Type Determines the screens on which the panel is displayed:
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• If the Specimen check box is selected, the panel is
displayed on the Specimen tab of the Create Order
screen.
• If the Control check box is selected, the panel is
displayed on the Control tab of the Create Order screen.
• If the Calibration check box is selected, the panel is
displayed on the Calibration tab of the Create Order
screen.
Panels Displays a list of configured panels.
Assays Displays the configured assays on the system.
All option Displays all assays that are available on the system.
i-series option Displays all assays that are available on one or more Alinity i
processing modules.
c-series option Displays all assays that are available on one or more Alinity c
processing modules.
Calculated option Displays all calculated assays.
Number of Selected Displays the total number of assays in the panel.
Assays
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Save Saves changes.
Delete Displays a message requesting confirmation to delete the
selected items.
Text Size Increases or decreases the size of text displayed.
Related information...
Panel Definition screen, page 283
Descriptions of screen elements, page 127
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Configure a panel
Operator access level System administrator
Perform this procedure to configure a panel that can be used when ordering specimens, quality
control (QC), and calibrations. Twenty-five unique panels can be configured. A panel can be
configured with any combination of panel types, specimen, QC, and calibration.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Panel Definition.
4. In the Panel Name box on the Panel Definition screen, type a panel name.
NOTE: A panel name can have a maximum of 10 characters.
5. In the Panel Type area, tap the one or more check boxes.
6. In the Assays list, tap one or more individual assays to include in the panel.
NOTE: To filter the list of assays, tap the option for i-series, c-series, or Calculated.
7. To save the edits to the panel settings, tap Save.
To delete the edits to the panel settings, tap Cancel.
8. To return to the Configure screen, tap Done.
Related information...
Panel Definition screen, page 283
Edit a panel definition
Operator access level System administrator
Perform this procedure to edit a panel definition. When a defined panel is edited, existing orders
are not affected.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Panel Definition.
4. In the Panels list on the Panel Definition screen, tap a panel to edit.
5. Edit any of the following information:
– Panel Name
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NOTE: When a panel name is edited, a new panel is created. If the original panel is not
needed, it must be deleted.
– Panel Type
– Assays
6. To save the edits to the panel settings, tap Save.
To delete the edits to the panel settings, tap Cancel.
7. To return to the Configure screen, tap Done.
Related information...
Panel Definition screen, page 283
Delete a panel, page 286
Delete a panel
Operator access level System administrator
Perform this procedure to delete a panel. When a defined panel is deleted, existing orders are
not affected.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Panel Definition.
4. In the Panels list on the Panel Definition screen, tap a panel to delete.
5. Tap Delete.
6. When a confirmation message is displayed, tap Yes.
7. To return to the Configure screen, tap Done.
Related information...
Panel Definition screen, page 283
Edit a panel definition, page 285
Cal/QC Ordering screen
On the Cal/QC Ordering screen, the operator can view calibration and quality control settings.
The system administrator can perform the following functions:
• Configure the ability to use calibrations that are beyond the calibration expiration.
• Configure the ability to use calibrators that are beyond the calibrator lot expiration.
• Configure the ability to use controls that are beyond the control lot expiration.
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• Configure the ability to disable a reagent when a control fails.
• Configure the ability to require quality control to run after a calibration is generated.
• Configure whether the control expiration date must be entered before an order is created.
Related information...
Configure screen, Assay tab, page 227
Cal/QC Ordering screen element descriptions, page 287
Configure calibration and control ordering settings, page 288
Cal/QC Ordering screen element descriptions
The Cal/QC Ordering screen displays the calibration and quality control settings.
Elements
Calibration Configuration area
Displays calibration configuration settings.
Calibration Expiration Used to override a calibration status of Expired. One of the
Override following options is enabled:
• On
• Off (default)
Calibration Lot Used to configure if an expired calibrator lot expiration can be
Expiration Override overridden. One of the following options is enabled:
• On
• Off (default)
Control Configuration area
Displays control configuration settings.
Control Lot Expiration Used to override a control status of Expired. One of the
Override following options is enabled:
• On
• Off (default)
Disable Reagent on Used to configure if a reagent needs to be disabled for a
Control Failure quality control failure. One of the following options is enabled:
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• On
• Off (default)
Control Required After Used to configure if quality control must be run after a
Calibration calibration is generated. One of the following options is
enabled:
• On
• Off (default)
Entry of Expiration Used to configure if an expiration date must be entered for all
Date Required control material before a control order can be created. One of
the following options is enabled:
• On
• Off (default)
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Save Saves changes.
Related information...
Cal/QC Ordering screen, page 286
Descriptions of screen elements, page 127
Configure calibration and control ordering settings
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to configure calibration and control ordering settings.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
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3. On the Assay tab of the Configure screen, tap Cal/QC Ordering.
4. Under Calibration Configuration on the Cal/QC Ordering screen, enter the following
information:
– Calibration Expiration Override
– Calibrator Lot Expiration Override
5. Under Control Configuration, enter the following information:
– Control Lot Expiration Override
– Disable Reagent on Control Failure
– Control Required after Calibration
– Entry of Expiration Date Required
6. To save the edits to the ordering settings, tap Save.
To delete the edits to the ordering settings, tap Cancel.
7. To return to the Configure screen, tap Done.
Related information...
Cal/QC Ordering screen, page 286
Quality Control screen
On the Quality Control screen, the operator can view quality control settings.
The supervisor can perform the following functions:
• Configure multiconstituent and single-constituent controls.
• Edit multiconstituent and single-constituent controls.
• Import control data.
• Delete a quality control.
Related information...
Configure screen, Assay tab, page 227
Quality Control screen element descriptions, page 290
Control Create/Edit screen element descriptions, page 291
Import screen element descriptions, page 294
Manually create a new quality control lot, page 295
Edit a quality control, page 298
Delete a quality control, page 302
Delete a quality control lot, page 303
Import quality control data, page 304
Delete imported quality control data, page 305
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View or print a quality control insert, page 306
Descriptions of quality control import statuses, page 307
Quality Control screen element descriptions
The Quality Control screen displays the quality controls that are configured.
Elements
Control Count Displays the total number of quality controls that are
configured.
Selected Assays Displays the number of assays selected for control
configuration.
All option Displays all assays that are available on the system.
i-series option Displays all assays that are available on one or more Alinity i
processing modules.
c-series option Displays all assays that are available on one or more Alinity c
processing modules.
Calculated option Displays all calculated assays.
Function buttons
Configure Navigates to the previous configuration screen.
Create Navigates to the Control Create/Edit screen where a new
quality control can be created.
View/Edit Displays the Control Create/Edit screen for the selected
quality control.
Delete Displays a message requesting confirmation to delete the
selected items.
Import Navigates to the Import screen where the selected quality
control can be imported.
Related information...
Quality Control screen, page 289
Descriptions of screen elements, page 127
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Control Create/Edit screen element descriptions
On the Control Create/Edit screen, the operator can create a new quality control configuration or
can edit an existing quality control configuration.
Control Configuration area
Control Name Displays the name of quality control.
Lot Displays the lot number of the selected quality control.
Default Displays a check box that is used to identify the lot number
that is displayed as the default lot number for control orders.
NOTE: The first configured lot number is designated
automatically as the default lot number. To change the default
lot number, two or more control lot numbers must be
configured.
Expiration Date Displays the expiration date of the selected quality control.
Level Displays the level number that corresponds to the listed
control data.
Level Name Displays the level name that corresponds to the level number.
Automated Identifies the control as one that is periodically evaluated for
automated control ordering when the Yes option is selected.
Stored Onboard Indicates that the quality control is stored on the reagent
carousel. This area is available only if Yes was selected in
the Automated area.
Low Alert Volume (%) Indicates the percent remaining volume at which low alert
flags are generated. This area is available only if Yes was
selected in the Automated area.
Start Time Identifies the shift start time for the control if the Use Module
Shift Time check box is not selected. This area is available
only if Yes was selected in the Automated area.
Use Module Shift Displays a check box that is used to identify the control as
Time one that uses the system-configured module shift time to
define control run intervals. The check box is available only if
Yes was selected in the Automated area.
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Time Interval Displays the time interval in minutes, after the shift start time,
(Minutes) that is used to create automated orders for the control. This
area is available only if Yes was selected in the Automated
area.
Onboard Stability Displays the maximum time in hours that the control can
(Hours) remain on the reagent carousel. This area is available only if
Yes was selected in the Stored Onboard area.
NOTE: Onboard stability tracking occurs after the vial is
scanned by the RSM bar code reader and is scheduled to be
loaded in the reagent carousel. The onboard stability tracking
continues when the vial is unloaded from the system.
In-Use Stability Displays the maximum time in hours that the control can be
(Hours) used on the processing module without refrigerated storage. A
value of zero indicates that in-use stability is not tracked.
Assay check box Enables all assays in the control level for testing when the
Assay check box is selected. Individual assays can be
enabled or disabled for the control level by selecting or
clearing the check box for the corresponding assay name.
Assay Identifies the name of each assay in the control.
Expected 1 SD Displays the value that represents the expected one standard
deviation (SD) for the control level if configured.
Expected Mean Displays the expected mean value for the control level if
configured.
NOTE: Quality control reports, Levey-Jennings graphs, and
quality control summary data are not generated if the values
for Expected 1 SD and Expected Mean are not defined.
Manufacturer 1 SD Displays the manufacturer value that represents one SD for
the control level if configured.
Manufacturer Mean Displays the manufacturer mean value for the control level if
configured.
Expected Range Low Displays the lower limit of the control range for the control
level if configured.
Expected Range High Displays the upper limit of the control range for the control
level if configured.
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Default Dilution Displays the selected dilution for the assay for quality control
testing.
Test Interval Displays the test count interval used to create automated
orders for the control.
Time Interval Displays the time interval in minutes that is used to create
(Minutes) automated orders for the assay. The configured assay time
interval supersedes the configured control level time interval if
both intervals are defined for the same lot number.
Calculate Mean/SD Automatically calculates the Expected 1 SD and Expected
Mean values when the Expected Range Low and Expected
Range High values are entered and the check box is selected.
NOTE: To calculate the Expected 1 SD value, the Expected
Range Low value is subtracted from the Expected Range High
value and the difference is divided by four. To calculate the
Expected Mean value, the Expected Range Low value and the
Expected Range High value are added and the sum is divided
by two.
The automatic calculation cannot be performed if a value has
been entered in the Expected 1 SD box or the Expected
Mean box.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Print Displays the Print flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Delete Displays a message requesting confirmation to delete the
selected items.
Save Saves changes.
Set Stability Navigates to the Set Stability flyout where onboard stability
values for individual analytes are displayed.
Related information...
Quality Control screen, page 289
Descriptions of screen elements, page 127
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Manually create a new quality control lot, page 295
Import screen element descriptions
The Import screen displays the quality control files that are available for import. The quality
control files are used to configure a new control or to configure a new lot number for an existing
control. Quality control files can be located on the system or on a USB flash drive.
Elements
Control Name Displays the control name of the quality control file selected
for import.
Lot Displays the lot number of the quality control file selected for
import.
Number of Levels Displays the number of levels defined for the quality control
file selected for import.
Expiration Date Displays the expiration date of the quality control file selected
for import.
button The Previous Folder button navigates to the previously
selected folder.
Folder Name Displays the currently selected folder.
button The Home button navigates to the C drive folder.
Quality Control Files Displays the quality control files in the specified folder that
are available for import for the selected control. If New
Control was selected on the Quality Control screen, all quality
control files in the specified folder are displayed.
File Assay/Number Displays the assay name and assay number for each assay in
the quality control file selected for import.
System Assay/Number Displays the assay name and assay number for each assay
on the system that corresponds to the assay number in the
quality control file selected for import.
Status Displays the import status of the assay. Data for an assay that
has a status of OK is imported. Data is not imported for
assays that have the following statuses:
• No Assay
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• Previously Defined
• Units Mismatch
• Version Mismatch (only for Technopath control products)
File Units Displays the result units that are available for the quality
control file.
System Units Displays the result units that are available for the assay
installed on the system.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Delete Deletes the selected quality control file on the hard drive.
Files on a USB flash drive cannot be deleted.
Import Imports the selected quality control file.
Text Size Increases or decreases the size of text displayed.
Related information...
Quality Control screen, page 289
Descriptions of screen elements, page 127
Manually create a new quality control lot
Operator access level Supervisor
Perform this procedure to create manually a new single-constituent control lot or multiconstituent
control lot.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Quality Control.
4. On the Quality Control screen, tap New Control.
5. In the Selected Assays list, tap one or more individual assays to include in the control.
6. Tap Create.
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7. Under Control Configuration on the Control Create/Edit screen, type a control name in the
Control Name box.
NOTE: A control name can have from 1 through 10 characters.
8. To enter a control lot number, perform one of the following steps:
– Tap the Lot box, and then enter the control lot number.
– Tap the Lot box, tap New Lot, and then enter the control lot number.
NOTE: A control lot number can have from 3 through 9 characters. The first configured lot
number is designated automatically as the default lot number for control orders. To change
the default lot number, two or more control lot numbers must be configured.
A maximum of 20 lot numbers can be configured for a control name.
9. In the Expiration Date box, enter the control expiration date.
NOTE: If the Alinity ci-series is configured to require a control expiration date, the expiration
date must be entered to create orders for the control.
10. In the Level drop-down list, confirm that the level identifier is correct.
If the level identifier is incorrect, tap a level in the drop-down list.
11. In the Level Name box, type a level name.
NOTE: A level name can have from 1 through 10 characters.
12. In the Automated area, tap Yes or No to indicate whether the system software needs to
periodically evaluate the control and to create orders according to configured time intervals
or test intervals.
13. In the Time Interval (Minutes) box, type the number of minutes to define the frequency to
create an automated order for the control.
NOTE: The Time Interval (Minutes) box is available only if Yes was selected in the
Automated area.
14. To specify a shift start time for automated control orders to be created that differs from the
configured module shift start time, perform the following steps:
a. Tap to clear the Use Module Shift Time check box.
b. Use the HH:MM format to type a time in the Start Time box, and then tap AM or PM.
NOTE: The Use Module Shift Time check box and the Start Time box are available only if
Yes was selected in the Automated area.
15. In the Stored Onboard area, tap Yes or No to indicate whether the control can be stored in
the reagent carousel.
NOTE: The Stored Onboard area is available only if Yes was selected in the Automated
area.
Onboard storage capability is available for some controls. To identify controls that have this
capability and the onboard stability time for each control, see the product documentation.
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16. In the Onboard Stability (Hours) box, type the number of hours.
NOTE: Onboard storage capability is available for some controls. To identify controls that
have this capability and the onboard stability time for each control, see the product
documentation.
17. In the Low Alert Volume (%) box, type the percentage value.
NOTE: The Low Alert Volume (%) box is available only if Yes was selected in the
Automated area.
18. If the in-use stability time is provided, type the number of hours in the In-Use Stability
(Hours) box.
NOTE: In-use stability reflects the maximum time that the control can be used on the
processing module without refrigerated storage. A value of zero indicates that in-use stability
is not tracked.
19. To disable one or more of the individual assays that were selected in step 5, tap to clear the
check box next to the assay name.
20. Enter the following information for each assay:
– Expected 1 SD
– Expected Mean
NOTE: To calculate automatically the values for Expected 1 SD and Expected Mean
from an entered range, type a value in the Expected Range Low box, type a value in
the Expected Range High box, and then tap the Calculate Mean/SD check box for the
assay.
To calculate the Expected 1 SD value, the Expected Range Low value is subtracted
from the Expected Range High value and the difference is divided by four. To calculate
the Expected Mean value, the Expected Range Low value and the Expected Range
High value are added and the sum is divided by two.
The automatic calculation cannot be performed if a value has been entered in the
Expected 1 SD box or the Expected Mean box.
NOTE: Quality control reports, Levey-Jennings graphs, and quality control summary
data are not generated if the values for Expected 1 SD and Expected Mean are not
defined.
– Manufacturer 1 SD
– Manufacturer Mean
– Expected Range Low
– Expected Range High
NOTE: To flag the controls automatically when the control results fall outside a specific
range, type a value in the Expected Range Low box and type a value in the Expected
Range High box.
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To flag the controls automatically when the control results are less than a specific
value, type a value in the Expected Range Low box and leave the Expected Range
High box blank.
To flag the controls automatically when the control results are greater than a specific
value, leave the Expected Range Low box blank and type a value in the Expected
Range High box.
If neither the Expected Range Low value nor the Expected Range High value is
defined, control results are not evaluated for the application of the CNTL flag.
– Default Dilution
– Test Interval
– Time Interval (Minutes)
NOTE: The test interval and the time interval determine the automatic control order
frequency. The configured assay time interval supersedes the configured control level
time interval if both intervals are defined for the same lot number.
21. To enter the onboard stability times for the individual analytes, tap Set Stability.
NOTE: If the onboard stability time of an individual analyte is less than the onboard stability
time of the control that was entered in step 16, the analyte is disabled for onboard use from
the control.
22. To save the edits to the control level settings, tap Save.
To delete the edits to the control level settings, tap Cancel.
23. To add another level, tap a level in the Level drop-down list, type a level name in the Level
Name box, and then repeat steps 20, page 297 through 22, page 298.
NOTE: A maximum of six levels can be configured.
24. To return to the Quality Control screen, tap Done.
Related information...
Quality Control screen, page 289
Control Create/Edit screen element descriptions, page 291
Automated control ordering, page 579
Edit a quality control
Required instrument Stopped, Warming, or Idle
status
Operator access level Supervisor
Perform this procedure to edit the settings for a single-constituent control or a multiconstituent
control.
1. On the menu bar, tap System, and then tap Configure.
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NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Quality Control.
4. In the Control Count list on the Quality Control screen, tap a control name.
5. For a multiconstituent control, in the Selected Assays list, tap one or more individual assays
to include in the control or to remove from the control.
6. Tap View/Edit to display the control data for the default lot number.
NOTE: If an assay was removed from the multiconstituent control, in the confirmation
message that is displayed, tap Yes to confirm the removal. Tap No to retain the assay in the
control.
7. In the Lot drop-down list under Control Configuration on the Control Create/Edit screen,
tap other control lot numbers to display.
8. To configure the selected control lot number as the default, tap the Default check box.
9. To enter the control expiration date, tap the Expiration Date box.
NOTE: The expiration date cannot be edited if one of the following situations occurred:
– The control lot number has expired.
– The control lot number was created by importing control data.
10. In the Level Name box, type a level name.
NOTE: A level name can have from 1 through 10 characters.
11. In the Automated area, tap Yes or No to indicate whether the system software needs to
evaluate the control periodically and to create orders according to configured time intervals
or test intervals.
12. In the Time Interval (Minutes) box, type the number of minutes to define the frequency to
create an automated order for the control.
NOTE: The Time Interval (Minutes) box is available only if Yes was selected in the
Automated area.
The time interval increases incrementally based on the configured module or control shift
start time.
13. To edit the shift start time for the control, perform one of the following steps:
– Tap the Use Module Shift Time check box.
– Tap to clear the Use Module Shift Time check box. Use the HH:MM format to type a
time in the Start Time box, and then tap AM or PM.
NOTE: The Use Module Shift Time check box and the Start Time box can be edited only if
Yes was selected in the Automated area.
14. In the Stored Onboard area, tap Yes or No to indicate whether the control can be stored in
the reagent carousel.
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NOTE: The Stored Onboard area is available only if Yes was selected in the Automated
area.
This parameter cannot be edited for controls that are currently stored on the system.
Onboard storage capability is available for some multiconstituent controls. To identify
controls that have this capability and the onboard stability time for the control, see the
product documentation.
15. In the Onboard Stability (Hours) box, type the number of hours.
NOTE: This parameter cannot be edited for controls that are currently stored on the system.
16. In the Low Alert Volume (%) box, type the percentage value.
NOTE: The Low Alert Volume (%) box is available only if Yes was selected in the
Automated area.
17. If the in-use stability time is provided, type the number of hours in the In-Use Stability
(Hours) box.
In-use stability reflects the maximum time that the control can be used on the processing
module without refrigerated storage. A value of zero indicates that in-use stability is not
tracked.
18. To enable or disable one or more assays for the current control level, tap the check box
next to the assay name.
NOTE: Assays that are disabled for a control level are not run when the control level is
ordered.
To disable all the assays for a specific control level, tap the Assay check box. When all the
assays for the control level are disabled, the level is not run when the control is ordered.
19. Edit the following information for a control assay as necessary:
– Expected 1 SD
– Expected Mean
NOTE: To edit the expected standard deviation and expected mean values, first tap to
clear the Calculate Mean/SD check box for the assay if the check box is selected.
Quality control reports, Levey-Jennings graphs, and quality control summary data are
not generated if the values for Expected 1 SD and Expected Mean are not defined.
– Manufacturer 1 SD
– Manufacturer Mean
– Expected Range Low
– Expected Range High
NOTE: To flag the controls automatically when the control results fall outside a specific
range, type a value in the Expected Range Low box and type a value in the Expected
Range High box.
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To flag the controls automatically when the control results are less than a specific
value, type a value in the Expected Range Low box and leave the Expected Range
High box blank.
To flag the controls automatically when the control results are greater than a specific
value, leave the Expected Range Low box blank and type a value in the Expected
Range High box.
Edits to the previously entered control ranges are applied to the Expected Mean and
Expected 1 SD values if the Calculate Mean/SD check box is selected.
To calculate the Expected Mean value, the Expected Range Low value and the
Expected Range High value are added and the sum is divided by two. To calculate the
Expected 1 SD value, the Expected Range Low value is subtracted from the Expected
Range High value and the difference is divided by four.
The update to the Expected Mean and Expected 1 SD values occurs when the Save
button is selected in step 21, page 301.
– Default Dilution
– Test Interval
– Time Interval (Minutes)
NOTE: The test interval and the time interval determine the automatic control order
frequency. The configured assay time interval supersedes the configured control level
time interval if both intervals are defined for the same lot number.
20. To edit or enter the onboard stability times for the individual assays, perform the following
steps:
a. Tap Set Stability.
b. In the Set Stability flyout, type the number of stability hours.
c. To save the onboard stability setting, tap Done.
To delete the onboard stability setting, tap Cancel.
NOTE: If the onboard stability time of an individual assay is less than the onboard stability
time of the control that was entered in step 15, page 300, the assay is disabled for onboard
use from the control:
– To disable the assay, tap Continue.
– To edit the onboard stability value of the analyte, tap Cancel.
21. To save the edits to the control level settings, tap Save.
To delete the edits to the control level settings, tap Cancel.
NOTE: If the previously configured value for Expected Mean or Expected 1 SD was edited, a
message is displayed with the option to perform a reevaluation of the control data against
the Westgard rules:
– To reevaluate the control results, tap Continue.
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All control results, up to the maximum of 5000 points, for the control lot and level are
recalculated.
– To cancel the reevaluation of the control results, tap Cancel.
22. To edit the assays for another control level, tap a level in the Level drop-down list, and then
repeat steps 18, page 300 through 21, page 301.
23. To return to the Quality Control screen, tap Done.
Related information...
Quality Control screen, page 289
Automated control ordering, page 579
Delete a quality control
Prerequisite Release, archive, and delete the control results that are
associated with the control to be deleted.
Required instrument Stopped, Warming, or Idle
status
Operator access level Supervisor
Perform this procedure to delete a configured single-constituent control or a configured
multiconstituent control.
NOTE: Controls with pending orders or controls that have vials loaded on the system cannot be
deleted.
All the configured lot numbers and the control name are also deleted with the associated quality
control data.
Individual control lot numbers are deleted automatically when the following situations occur:
• No pending orders are present for the control lot number.
• The last control data point for the control lot is deleted.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Quality Control.
4. In the Control Count list on the Quality Control screen, tap a control name.
5. Tap Delete.
6. When a confirmation message is displayed, tap Yes.
To cancel the delete function and return to the Quality Control screen, tap No.
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Related information...
Quality Control screen, page 289
Release a specimen result or a control result, page 614
Archive the results, page 668
Delete a quality control lot
Prerequisite Release, archive, and delete the control results that are
associated with the control to be deleted.
Required instrument Stopped, Warming, or Idle
status
Operator access level Supervisor
Perform this procedure to delete a lot number for a configured single-constituent control or a
configured multiconstituent control.
NOTE: Control lot numbers with pending orders or control lot numbers that have vials loaded on
the system cannot be deleted.
Individual control lot numbers are deleted automatically when the following situations occur:
• No pending orders are present for the control lot number.
• The last control data point for the control lot is deleted.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Quality Control.
4. In the Control Count list on the Quality Control screen, tap a control name.
5. Tap View/Edit to display the control data for the default lot number.
6. In the Lot drop-down list under Control Configuration on the Control Create/Edit screen,
tap other control lot numbers to display.
7. Tap Delete.
8. When a confirmation message is displayed, tap Yes.
To cancel the delete function and return to the Control Create/Edit screen, tap No.
9. To return to the Quality Control screen, tap Done.
Related information...
Quality Control screen, page 289
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Import quality control data
Required materials One or more quality control data files on a USB flash drive or
on the hard drive
Operator access level Supervisor
Perform this procedure to import quality control data files to create a new control or to create a
new control lot for a configured multiconstituent control.
NOTE: If a control product has separate c-series and i-series data files, both data files must be
imported on the Alinity ci-series.
If the expected mean and expected standard deviation (1 SD) values are not provided in the
quality control data file, the import process converts manufacturer-provided ranges for these
values.
To calculate the Expected Mean value, the Expected Range Low value and the Expected Range
High value are added and the sum is divided by two. To calculate the Expected 1 SD value, the
Expected Range Low value is subtracted from the Expected Range High value and the
difference is divided by four.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Quality Control.
4. In the Control Count list on the Quality Control screen, tap a control name or tap New
Control.
5. Tap Import.
On the Import screen, the Hard Drive button is selected.
6. In the Quality Control Files list, tap the quality control data file to import.
If the quality control data file is located on a USB flash drive, perform the following steps:
a. Insert the USB flash drive.
b. Tap the USB Flash Drive button.
c. Tap the appropriate folder.
d. Tap the quality control data file to import.
NOTE: The assay names and assay numbers for the data in the file and for the
corresponding system assays are displayed with an import status. Data for all quality control
levels is imported for assays that have a status of OK. No data is imported for assays with
the following statuses:
– No Assay
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– Previously Defined
– Units Mismatch
– Version Mismatch
These statuses are displayed in red text.
7. For the selected quality control data file, perform one of the following steps:
– If no data is available to import because of the import status, tap Done to return to the
Quality Control screen and end the procedure.
– To import the data for assays that have a status of OK, tap Import.
8. Under Control Configuration on the Control Create/Edit screen, tap the Default check box
to configure the control lot as the default.
NOTE: The first configured lot number is designated automatically as the default lot number
for control orders.
9. To disable an assay for the control level, tap to clear the check box next to the assay name.
NOTE: Assays that are disabled for a control level are not run when the control level is
ordered. All assays for each control level are enabled when a new control is imported.
Disabled and enabled assay statuses are retained when a new control lot number is created
for the control.
10. To save the quality control data file settings, tap Save.
To delete the quality control data file settings, tap Cancel.
11. To edit the assays for another level, tap a level in the Level drop-down list, and then repeat
steps 9, page 305 and 10, page 305.
12. To return to the Quality Control screen, tap Done.
13. If a USB flash drive was inserted, remove the USB flash drive.
Quality control data files that are imported from a USB flash drive are saved to an internal
storage location on the system. To reinstall the quality control data files on a future date, tap the
Hard Drive button.
Related information...
Quality Control screen, page 289
Delete imported quality control data
Operator access level System administrator
Perform this procedure to delete quality control data files from the user interface computer. After
a quality control data file is deleted, the file is unavailable to be reinstalled.
NOTE: This procedure cannot be used to delete quality control data files from a USB flash drive.
1. On the menu bar, tap System, and then tap Configure.
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NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Quality Control.
4. In the Control Count list on the Quality Control screen, tap a control name.
5. Tap Import.
On the Import screen, the Hard Drive button is selected.
6. In the Quality Control Files list, tap the quality control data file to delete.
7. Tap Delete.
8. To delete the quality control data file, tap Continue.
To cancel the delete function, tap Cancel.
9. To return to the list of control names on the Quality Control screen, tap Done.
Related information...
Quality Control screen, page 289
View or print a quality control insert
Required materials USB flash drive (Print to File option only)
Perform this procedure to view or print a quality control (QC) insert or to save the insert as a
portable document format (PDF) file.
NOTE: A QC insert is available only for selected quality control products and only for control lot
numbers that were created from an imported file and have not been deleted previously on the
hard drive.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Quality Control.
4. In the Control Count list on the Quality Control screen, tap a control name.
5. Tap View/Edit to display the quality control data for the default lot number.
6. In the Lot drop-down list under Control Configuration, tap a control lot number that is not
the default.
7. Tap Print.
8. Under Report Selection in the Print flyout, tap Control Insert.
9. To rotate the document, use the Rotate toolbar.
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10. To browse the document, use the Page toolbar.
11. To increase or decrease the font size in the document, use the Zoom toolbar.
12. To fit the document to the window width ( ) or to resize the document to fit one full page in
the window ( ), use the Fit toolbar.
13. To find a word or phrase in the document, use the Find toolbar.
14. In the Print flyout, choose a printer or tap Print to File in the Print Location drop-down list.
15. To print the document, enter the number of copies to print, and then tap Print.
16. If Print to File was selected in the Print Location drop-down list, perform the following
steps to indicate the file destination:
a. Insert a USB flash drive.
b. Tap the appropriate USB flash drive.
c. Tap the destination folder.
d. Tap OK.
e. Remove the USB flash drive.
17. To return to Control Configuration on the Control Create/Edit screen, tap Done.
Related information...
Quality Control screen, page 289
Descriptions of quality control import statuses
Quality control import status information is used to resolve issues that occur when quality control
data is imported. The system displays one quality control import status for each assay on the
Import Controls screen.
The following list provides descriptions of the quality control import statuses:
OK The imported assay has the same assay number and result
units as the assay that was configured on the system. The
data is imported.
No Assay No assay on the system has the same assay number in the
imported file. The data is not imported.
Previously Defined The data has been manually entered or imported. The data is
not imported.
Unit Mismatch The imported assay has a different value in the Unified Code
for Units of Measure (UCUM) area than the system assay
with the same assay number. The data is not imported.
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Version Mismatch The imported assay has the same assay number as the assay
that was configured on the system, but the imported assay
does not have the same assay version as the configured
assay. The data is not imported.
Related information...
Quality Control screen, page 289
Westgard screen
On the Westgard screen, the operator can view the Westgard rule settings for each assay
installed on the system.
The supervisor or system administrator can configure Westgard rule settings for each assay
installed on the system.
Related information...
Configure screen, Assay tab, page 227
Westgard screen element descriptions, page 308
Configure Westgard rules, page 309
Westgard screen element descriptions
The Westgard screen displays the Westgard rule configuration settings for the assays installed
on the system.
Elements
Rule Configuration area
All option Displays all assays that are available on the system.
i-series option Displays all assays that are available on one or more Alinity i
processing modules.
c-series option Displays all assays that are available on one or more Alinity c
processing modules.
Calculated option Displays all calculated assays.
Rule Name Displays a list of the Westgard rules that are available for
each assay.
Enable check box Used to enable the corresponding rule for Westgard analysis
for the assay.
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Rule Settings Used to configure the corresponding rule for Westgard
analysis by selecting one of the following options:
Warning Assay results generated after a control
result meets the criteria of a rule that is
configured as a warning are not
flagged with the CNTL flag.
Failure Assay results generated after a control
result meets the criteria of a rule that is
configured as a failure are flagged with
the CNTL flag.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Save Saves changes.
Text Size Increases or decreases the size of text displayed.
Related information...
Westgard screen, page 308
Descriptions of screen elements, page 127
Westgard rule descriptions, page 638
Configure Westgard rules
Required instrument Stopped, Warming, or Idle
status
Operator access level Supervisor
Perform this procedure to configure Westgard rules, which are used to assess quality control
results.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Assay tab.
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3. On the Assay tab of the Configure screen, tap Westgard.
4. Under Assays on the Westgard screen, tap an assay to configure.
5. Under Rule Name, tap one or more rules to enable.
6. Under Rule Settings, tap Warning or Failure for each rule that is enabled.
7. To save the edits to the rule settings, tap Save.
To delete the edits to the rule settings, tap Cancel.
8. To return to the Configure screen, tap Done.
Related information...
Westgard screen, page 308
Westgard rule application, page 637
Configure screen, Maintenance & Diagnostics tab
The operator can perform the following tasks from the Maintenance & Diagnostics tab of the
Configure screen:
Install/Uninstall M&Ds • Install new or revised maintenance and diagnostic
procedure files.
• Uninstall maintenance and diagnostic procedures files.
User-Defined • Create or edit a user-defined maintenance procedure file.
Maintenance
• Import or export a user-defined maintenance procedure
file.
• Print a list of the user-defined maintenance procedures
with a description of each procedure.
Related information...
System configuration, page 154
Install/Uninstall Procedures screen, page 310
User-Defined Maintenance screen, page 315
Install/Uninstall Procedures screen
On the Install/Uninstall Procedures screen, the system administrator can perform the following
functions:
• Install maintenance and diagnostic procedures.
• Uninstall maintenance and diagnostic procedures.
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Related information...
Configure screen, Maintenance & Diagnostics tab, page 310
Install/Uninstall Procedures screen, Available Files tab element descriptions, page 311
Install/Uninstall Procedures screen, Installed Files tab element descriptions, page 312
Install procedure files, page 314
Uninstall procedure files, page 314
Descriptions of file update statuses, page 271
Install/Uninstall Procedures screen, Available Files tab element descriptions
The Available Files tab displays all procedure files that are available for installation on the
system or on a USB flash drive.
Elements
Displaying Procedure Displays the file folder hierarchy that contains the procedure
Files In files displayed in the Procedure list.
Status Displays the status of the file installation. The status includes
file integrity and file installation success or failure.
button The Previous Folder button navigates to the previously
selected folder.
Folder Name Displays the currently selected folder.
button The Home button navigates to the C drive folder.
Procedure Displays the number and name of the selected procedure.
Type Displays the type of the selected procedure. The Available
Files tab has two procedure types:
• Maintenance
• Diagnostics
Update Status Displays the status of all procedure files that are available.
The Available Files tab has five file statuses:
• Current
• New
• Update
• Installed
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• Previous
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Select All Selects or deselects all items in a list. The button switches
between Select All and Deselect All.
Install Installs the selected files on the current screen.
Text Size Increases or decreases the size of text displayed.
Related information...
Install/Uninstall Procedures screen, page 310
Descriptions of screen elements, page 127
Descriptions of file update statuses, page 271
Install/Uninstall Procedures screen, Installed Files tab element descriptions
The Installed Files tab displays all procedure files that are installed on the system.
Elements
Status Displays the status of the file installation. The status includes
file integrity and file installation success or failure.
Procedure Displays the number and name of the installed procedure.
Version Displays the version of the procedure.
Type Displays the type of the selected procedure. The Installed
Files tab has two procedure types:
• Maintenance
• Diagnostics
Category Displays the category for the procedure. The Installed Files
tab has the following categories.
The following categories are displayed for maintenance
procedures:
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• Daily
• Weekly
• Monthly
• Quarterly
• Semiyearly
• Yearly
• As Needed
The following categories are displayed for diagnostic
procedures:
• Optics
• Pipettors
• Fluidics-Wash
• Temperature
• RV Loader (i-series only)
• Process Path (i-series only)
• Sample Manager
• Reagent Manager
• Modules
• Utilities
• Reaction Mechanisms (c-series only)
• ICT (c-series only)
Function buttons
Select All Selects or deselects all items in a list. The button switches
between Select All and Deselect All.
Uninstall Displays a message requesting confirmation to uninstall files
from the user interface.
Text Size Increases or decreases the size of text displayed.
Related information...
Install/Uninstall Procedures screen, page 310
Descriptions of screen elements, page 127
Descriptions of file update statuses, page 271
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Install procedure files
Required materials A procedure file is located on the hard drive or on a USB
flash drive.
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to install maintenance and diagnostics procedure files.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Maintenance & Diagnostics tab.
3. On the Maintenance & Diagnostics tab of the Configure screen, tap Install/Uninstall
M&Ds.
On the Available Files tab of the Install/Uninstall Procedures screen, the Hard Drive button
is selected.
NOTE: If the procedure is located on a USB flash drive, insert the USB flash drive, and then
tap the USB Flash Drive button.
4. Under Procedure on the Available Files tab, tap one or more procedure files to install (or
tap Select All).
5. Tap Install.
6. To return to the Configure screen, tap Done.
Procedure files that are installed from a USB flash drive are saved to an internal storage
location on the system.
Related information...
Install/Uninstall Procedures screen, page 310
Export a user-defined maintenance procedure, page 321
Insert and remove a USB flash drive, page 671
Uninstall procedure files
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to uninstall maintenance and diagnostic procedure files. Uninstalled
procedure files are listed in the procedure log with a history of previous actions. Procedure files
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remain available to be reinstalled from the Available Files tab of the Install/Uninstall Procedures
screen.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Maintenance & Diagnostics tab.
3. On the Maintenance & Diagnostics tab of the Configure screen, tap Install/Uninstall
Procedures.
4. On the Install/Uninstall Procedures screen, tap the Installed Files tab.
5. On the Installed Files tab, tap one or more procedure files to uninstall (or tap Select All).
6. Tap Uninstall.
7. When a confirmation message is displayed, tap Yes.
8. To return to the Configure screen, tap Done.
Related information...
Install/Uninstall Procedures screen, page 310
User-Defined Maintenance screen
On the User-Defined Maintenance screen, the supervisor or the system administrator can
perform the following functions:
• Create a text-based maintenance procedure.
• Print a procedure.
• Uninstall a procedure.
• Export a procedure.
Related information...
Configure screen, Maintenance & Diagnostics tab, page 310
User-Defined Maintenance screen, Create/Edit tab element descriptions, page 315
User-Defined Maintenance screen, Export tab element descriptions, page 317
Create a user-defined maintenance procedure, page 319
Edit a user-defined maintenance procedure , page 319
Uninstall a user-defined maintenance procedure, page 320
Export a user-defined maintenance procedure, page 321
User-Defined Maintenance screen, Create/Edit tab element descriptions
The Create/Edit tab displays the user-defined procedures that can be edited and allows the
operator to create new user-defined procedures.
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Elements
Installed User-Defined Displays the procedure number and name of installed
Maintenance procedures.
Procedures
Operator ID Displays the ID of the operator logged onto the system when
the procedure was created or edited. When creating a new
procedure the operator ID is blank.
Date/Time Displays the date and time the procedure was created or
edited. When creating a new procedure the operator ID is
blank.
Number Displays the number of the procedure. When creating a new
procedure the next available procedure number is displayed.
Once the procedure is created and saved the number can not
be edited.
The user-defined procedure number can be any number from
3950 through 3999.
Version Displays the version of the procedure. When creating a new
procedure the version is defined as 1. When the procedure is
edited and saved the version will increment.
Name Displays the name of the procedure. Once the procedure is
created and saved the name can not be edited.
The name can be 1 through 65 characters.
Frequency Displays the frequency of the procedure.
Frequency options are:
• Daily
• Weekly
• Monthly
• Quarterly
• Semiyearly
• Yearly
• As Needed
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Module Displays the module for which the procedure is intended.
Once the procedure is created and saved the module can not
be edited.
The following module options are available:
• Reagent and sample manager (RSM)
• i-series
• c-series
Description Displays a brief procedure description. When creating a new
procedure the field is blank.
The description can be 1 through 125 characters.
Instructions Displays the procedure instructions. When creating a new
procedure the field is blank.
The procedure instructions can contain from 1 through 5500
characters.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Print Displays the Print flyout.
Cancel Displays a message requesting confirmation to cancel
selections or entries.
Save Saves selections or entries.
Uninstall Displays a message requesting confirmation to uninstall files
from the user interface.
Text Size Increases or decreases the size of text displayed.
Related information...
User-Defined Maintenance screen, page 315
Descriptions of screen elements, page 127
Print a report, page 662
User-Defined Maintenance screen, Export tab element descriptions
The Export tab displays all user-defined maintenance procedures that are available for export.
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Elements
Status Displays the status of the file export.
button The Previous Folder button navigates to the previously
selected folder.
Folder Name Displays the currently selected folder.
button The Home button navigates to the C drive folder.
Procedure Displays the number and name of the procedure.
Version Displays the version of the procedure.
Category Displays the category for the procedure. The Export tab has
the following categories.
• Daily
• Weekly
• Monthly
• Quarterly
• Semiyearly
• Yearly
• As Needed
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Select All Selects or deselects all items in a list. The button switches
between Select All and Deselect All.
Export Exports the select files from the user interface computer to
the USB flash drive.
Text Size Increases or decreases the size of text displayed.
Related information...
User-Defined Maintenance screen, page 315
Descriptions of screen elements, page 127
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Create a user-defined maintenance procedure
Required instrument Stopped, Warming, or Idle
status
Operator access level Supervisor and system administrator
Perform this procedure to create a user-defined, text-based maintenance procedure.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Maintenance & Diagnostics tab.
3. On the Maintenance & Diagnostics tab of the Configure screen, tap User-Defined
Maintenance.
4. On the Create/Edit tab of the User-Defined Maintenance screen, if a procedure number
other than the number that is displayed is needed, type a number from 3950 through 3999.
5. Type the name of the procedure.
6. Tap the time interval in the Frequency drop-down list.
7. Tap the Module button for which the procedure is intended.
8. Type a brief procedure description that is displayed on the Procedures screen with the
procedure number and name.
9. Type the procedure instructions.
10. To save the procedure, tap Save.
To delete the procedure, tap Cancel.
11. To create another procedure, repeat steps 4, page 319 through 10, page 319.
12. To return to the Configure screen, tap Done.
Related information...
User-Defined Maintenance screen, page 315
Edit a user-defined maintenance procedure , page 319
Edit a user-defined maintenance procedure
Required instrument Stopped, Warming, or Idle
status
Operator access level Supervisor and system administrator
Perform this procedure to edit a user-defined maintenance procedure.
1. On the menu bar, tap System, and then tap Configure.
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NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Maintenance & Diagnostics tab.
3. On the Maintenance & Diagnostics tab of the Configure screen, tap User-Defined
Maintenance.
4. On the Create/Edit tab of the User-Defined Maintenance screen, under Installed User-
Defined Maintenance Procedures, tap the procedure to edit.
5. Edit any or all of the following information:
– Frequency
– Description
– Instructions
6. To save the edits to the procedure, tap Save.
To delete the edits to the procedure, tap Cancel.
7. To edit another procedure, repeat steps 4, page 320 through 6, page 320.
8. To return to the Configure screen, tap Done.
Related information...
User-Defined Maintenance screen, page 315
Create a user-defined maintenance procedure, page 319
Uninstall a user-defined maintenance procedure
Required instrument Stopped, Warming, or Idle
status
Operator access level Supervisor and system administrator
Perform this procedure to uninstall user-defined maintenance procedure files. Uninstalled
procedure files are listed in the procedure log with a history of previous actions. Procedure files
remain available to be reinstalled from the Available Files tab of the Install/Uninstall Procedures
screen.
NOTE: If a user-defined maintenance procedure file is uninstalled, the procedure number can be
reused and the new information overwrites the previous information. If a new procedure name is
assigned to a reused procedure number, the previous procedure name remains in the procedure
log for the previous months. However, the new procedure name is displayed for the current
month.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Maintenance & Diagnostics tab.
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3. On the Maintenance & Diagnostics tab of the Configure screen, tap User-Defined
Maintenance.
4. On the Create/Edit tab of the User-Defined Maintenance screen, under Installed User-
Defined Maintenance Procedures, tap one or more procedure files to uninstall.
5. Tap Uninstall.
6. When a confirmation message is displayed, tap Yes.
7. To return to the Configure screen, tap Done.
Related information...
User-Defined Maintenance screen, page 315
Export a user-defined maintenance procedure
Required instrument Stopped, Warming, or Idle
status
Required materials USB flash drive
Operator access level Supervisor
Perform this procedure to export user-defined maintenance procedure files to a USB flash drive.
After the procedure files are exported, the files can be installed from the USB flash drive to a
different system.
1. Insert the USB flash drive.
2. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
3. On the Configure screen, tap the Maintenance & Diagnostics tab.
4. On the Maintenance & Diagnostics tab of the Configure screen, tap User-Defined
Maintenance.
5. On the User-Defined Maintenance screen, tap the Export tab.
6. On the Export tab, tap the USB flash drive to which to export the procedure files.
7. Tap one or more procedure files to export (or tap Select All).
8. Tap Export.
9. Remove the USB flash drive.
10. To return to the Configure screen, tap Done.
Related information...
User-Defined Maintenance screen, page 315
Install procedure files, page 314
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Insert and remove a USB flash drive, page 671
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Section 2 Utilities screen
Utilities screen
The operator can perform the following tasks from the Utilities screen:
Backup/Restore • Perform a backup.
• Copy a backup to a USB flash drive.
• Restore a backup (CSC Logon).
System Updates • Download system updates.
• Install and verify system updates.
• Decline nonmandatory system updates.
Troubleshooting Retrieve system log packages.
Current Firmware View the current firmware.
CLI Diagnostics (FSE Run CLI commands.
Logon)
Licenses View or print the Licenses Report.
Related information...
Installation procedures and special requirements, page 151
Backup/Restore screen, page 323
System Updates screen, page 328
Troubleshooting screen, page 342
Current Firmware screen, page 346
CLI Diagnostics screen (FSE Logon), page 347
Backup/Restore screen
On the Backup/Restore screen, the operator can view a list of previously created backups.
The operator can perform the following functions:
• Perform a backup.
• Copy a backup to a USB flash drive.
If the logon for CSC or FSE is used, an option to restore a backup is available.
Related information...
Utilities screen, page 323
Backup/Restore screen element descriptions, page 324
Copy Backup flyout element descriptions, page 325
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Backup flyout element descriptions, page 325
Perform a manual backup, page 326
Copy a backup to a USB flash drive, page 327
Restore a backup (CSC Logon), page 327
Backup/Restore screen element descriptions
On the Backup/Restore screen, the operator can create a manual backup.
If the logon for CSC or FSE is used, an option to restore a backup is available.
Elements
Displaying Backup Displays the currently selected drive and folder.
Files In
button The Previous Folder button navigates to the previously
selected folder.
Folder Name Displays the currently selected folder.
button The Home button navigates to the C drive folder.
Date/Time Displays the date and time that the backup was generated.
Type Displays the type of backup. Two backup types are available
on the Backup/Restore screen:
• Automatic
• Manual
Version Displays the system software version at the time that the
backup was generated.
Comment Displays the comment entered when the backup was
generated. A comment is displayed only for manual backups.
Function buttons
Utilities Displays the Utilities screen.
Create Backup Displays the Backup flyout.
Copy Displays the Copy Backup flyout.
Restore Initiates the process to restore a system backup.
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Related information...
Backup/Restore screen, page 323
Descriptions of screen elements, page 127
Copy Backup flyout element descriptions
The Copy Backup flyout displays the drive and folders that are used to save a backup copy.
Elements
button The Previous Folder button navigates to the previously
selected folder.
Folder Name Displays the currently selected folder.
button The Home button navigates to the C drive folder.
Name Displays the name of the drive or folder.
Last Update Displays the date and time that the files in the folder were
most recently updated.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Backup/Restore screen, page 323
Backup flyout element descriptions
In the Backup flyout, the operator can enter a comment.
Elements
Comment Used to enter a comment for a backup. The comment can
contain a maximum of 100 characters.
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Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Backup/Restore screen, page 323
Perform a manual backup
Required materials A USB flash drive is required only if a copy of a backup is
saved to the USB flash drive.
Required instrument Any status except Processing and Pausing
status
Perform this procedure after a software update is downloaded, a new assay file is downloaded,
or the system configuration is changed. The last three manual backups are saved on the hard
drive.
1. On the menu bar, tap System, and then tap Utilities.
2. On the Utilities screen, tap Backup/Restore.
3. On the Backup/Restore screen, tap Create Backup to save a backup on the hard drive.
To save a backup on the hard drive and a copy of the backup on a USB flash drive, perform
the following steps:
– Insert the USB flash drive.
– Tap the appropriate USB flash drive and folder.
– Tap Create Backup.
4. In the Comment box in the Backup flyout, type the reason that the manual backup was
performed, and then tap Done.
5. If the USB flash drive was inserted, remove the USB flash drive.
Related information...
Backup/Restore screen, page 323
Insert and remove a USB flash drive, page 671
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Copy a backup to a USB flash drive
Required materials USB flash drive
Perform this procedure to copy a backup from the system to a USB flash drive.
1. Insert the USB flash drive.
2. On the menu bar, tap System, and then tap Utilities.
3. On the Utilities screen, tap Backup/Restore.
4. On the Backup/Restore screen, tap a backup to copy.
5. Tap Copy.
6. In the Copy Backup flyout, tap the USB flash drive and folder to which to copy the backup.
7. To copy the backup, tap Done.
To cancel the copy function, tap Cancel.
8. Remove the USB flash drive.
9. To return to the Utilities screen, tap Utilities.
Related information...
Backup/Restore screen, page 323
Insert and remove a USB flash drive, page 671
Restore a backup (CSC Logon)
Required instrument Stopped, Warming, or Idle
status
Operator access level CSC
Perform this procedure as indicated during troubleshooting to restore files from a previously
created backup.
To restore a backup, the following items must match the currently installed software:
• System control module (SCM) serial number
• Software version
• Processing module type
If the logon for FSE is used and the SCM serial number does not match the current SCM serial
number, available backups are displayed with the configuration for the backup file that includes
the processing module types and respective module serial numbers. This functionality allows the
FSE to restore a backup when the user interface (UI) computer is replaced.
NOTE: When a backup is restored, the UI computer shuts down and restarts.
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1. On the menu bar, tap System, and then tap Utilities.
2. On the Utilities screen, tap Backup/Restore.
3. On the Backup/Restore screen, tap a backup to restore.
4. Tap Restore.
5. When a confirmation message is displayed, tap Yes, and then tap OK.
NOTE: When a backup is restored, the UI computer shuts down and restarts. To reestablish
communication among the UI computer, each processing module, and the reagent and
sample manager (RSM), cycle power to each processing module and the RSM.
Related information...
Backup/Restore screen, page 323
Cycle power to the processing module and the reagent and sample manager (RSM), page 432
System Updates screen
An Abbott Laboratories representative installs the Alinity ci-series and the system software. After
the system is running, occasional software and hardware updates may be received that need to
be installed manually. System updates are distributed as technical service bulletins (TSBs) and
can be downloaded from the Abbott Mail screen. The system administrator can install simple
TSBs. The Abbott Laboratories representative needs to install more difficult TSBs. All TSBs are
tracked on the System Updates screen.
On the System Updates screen, the operator can view system updates and system update
documentation.
The operator can print system update documentation.
The system administrator can perform the following functions:
• Download software updates.
• Install and verify system updates.
• Decline nonmandatory system updates.
If the logon for CSC or FSE is used, the option to import system updates from a USB flash drive
is available.
If the logon for FSE is used, the option to decline a mandatory system update is available.
Related information...
Utilities screen, page 323
System Updates screen element descriptions, page 329
Comments flyout element descriptions, page 332
Status Change flyout element descriptions (FSE Logon), page 333
System Update Import screen element descriptions, page 334
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Descriptions of system update statuses, page 335
View or print system update documentation, page 335
Download the system update software, page 336
Install a system update, page 336
Decline a system update, page 337
Manually verify a system update, page 338
Add a comment to a system update, page 338
Set a declined system update as available for installation, page 339
Import a system update, page 339
Manually apply a system update (FSE Logon), page 340
Set an applied system update as available for installation (FSE Logon), page 340
Change the status of an installed TSB to a status of Install Failed (FSE Logon), page 341
Change the status of a TSB that failed to install to a status of Pending Verification (FSE Logon),
page 342
System Updates screen element descriptions
The System Updates screen displays system updates that are available for installation, system
updates that are installed, and system updates that have been declined by the operator.
Elements
TSB Number Displays the technical service bulletin (TSB) number. System
updates are distributed as a TSB.
Module SN Displays the serial number of the module associated with the
TSB.
Status Displays the status of each system update. The System
Updates screen has 11 system update statuses:
• Available
• Download Requested
• Download Failed
• Ready to Install
• Install in Progress
• Install Failed
• Pending Verification
• Applied
• Manually Applied
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• Superseded
• Ignored
Date Displays the date of the current status for the TSB.
Include data for Displays a check box that is used to include past module
historic modules (if configurations in the TSB list.
any)
Details area
TSB Number Displays the TSB number. System updates are distributed as
a TSB.
Product Code Displays a list of product codes that apply to the TSB that is
displayed. The following product codes are available:
• 205 (Alinity i)
• 210 (Alinity c)
• 214 (system control module)
Mandatory Displays if the system update is mandatory and must be
installed.
Requires System Displays if the software needs to be restarted after the TSB is
Restart installed.
Install Access Level Displays the minimum access level that is necessary to install
the TSB. The System Update screen has five access levels:
• General
• Supervisor
• Administrator
• CSC
NOTE: This access level requires Abbott Customer
Service authorization.
• FSE
NOTE: This access level requires field service
installation.
Requires Verification Displays if the TSB requires a manual verification after the
installation is completed. If the TSB requires a manual
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verification, the System Update Letter for the TSB provides
instructions and can be printed.
If the access level is CSC or FSE, the instructions may be
included in the TSB that is located on the TSB database.
Prerequisite Update Displays a list of TSB numbers that must be installed before
the TSB that is displayed is installed.
Superseded Updates Displays a list of TSB numbers that are outdated by the
installation of the TSB that is displayed.
Description Displays a short description of the TSB. For more information,
the System Update Letter can be printed.
Activity Log area
Timestamp Displays the date and time of the current status for the TSB.
Status Displays the current status of the TSB. The System Updates
screen has 11 system update statuses:
• Available
• Download Requested
• Download Failed
• Ready to Install
• Install in Progress
• Install Failed
• Pending Verification
• Applied
• Manually Applied
• Superseded
• Declined
Operator ID Displays the operator ID of the operator logged on when the
status was updated for the TSB.
Function buttons
Utilities Displays the Utilities screen.
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Import Imports the selected file.
Print Displays the Print flyout.
Set as Available Sets the system update status of the TSB to Available. This
function button is located on the Installed Updates tab and
the Declined Updates tab.
Install Failed Sets the system update status of the TSB to Install Failed.
This function button is located on the Installed Updates tab.
Download Requests a system software installer to be downloaded. This
function button is located on the Available Files tab.
Install Installs the selected TSB. This function button is located on
the Available Files tab.
Decline Sets the system update status of the TSB to Ignored and
moves the TSB to the Declined Updates tab. This function
button is located on the Available Files tab.
Verify Sets the system update status of the TSB to Manually
Applied. This function button is located on the Available Files
tab.
Change Status Displays the Status Change flyout. The Status drop-down list
has two change statuses:
• Manually Applied
• Pending Verification
Comments Displays the Comments flyout.
Text Size Increases or decreases the size of text displayed.
Related information...
System Updates screen, page 328
Descriptions of system update statuses, page 335
Descriptions of screen elements, page 127
Comments flyout element descriptions
In the Comments flyout, the operator can enter a comment.
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Elements
Comments Used to enter a comment for the system update.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Clear Removes text from the comment box without closing the
flyout.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
System Updates screen, page 328
Status Change flyout element descriptions (FSE Logon)
If the logon for FSE is used, in the Status Change flyout, the operator can adjust the status of a
technical service bulletin (TSB).
Elements
Status Displays a drop-down list that has a maximum of two statuses
based on the current TSB status:
• Manually Applied
• Pending Verification
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
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? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
System Updates screen, page 328
System Update Import screen element descriptions
On the System Update Import screen, the operator can import a translated version of the
operations manual.
If the logon for CSC or FSE is used, the operator can import system updates on the System
Update Import screen.
Elements
button The Previous Folder button navigates to the previously
selected folder.
Folder Name Displays the currently selected folder.
button The Home button navigates to the C drive folder.
File Name Displays the name of the system update file.
File Date And Time Displays the date and time of the system update file.
Import File Displays the file location and file name of the selected system
update file.
Function buttons
Utilities Displays the Utilities screen.
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Import Imports the selected file.
Text Size Increases or decreases the size of text displayed.
Related information...
System Updates screen, page 328
Descriptions of screen elements, page 127
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Descriptions of system update statuses
System update status information is used to determine the status of each system update.
The following list provides descriptions of the system update statuses. When the Status column
header is selected, the system update statuses sort alphabetically in ascending order:
Available The software installer for a system update is available to
download.
Download Requested A request to download the system software installer is in
process.
Download Failed An error occurred and the request was not completed.
Ready to Install The system software installer is present and is ready to
install.
Install in Progress The installation is in process.
Install Failed An error occurred and the installation was not completed.
Pending Verification The installation of the system update was successful, but a
manual verification by the operator is required.
Applied The installation of the system update is completed.
Manually Applied The system update was completed after a manual verification
or by an Abbott Laboratories representative.
Superseded The system update was superseded by a different system
update.
Ignored The system update was declined and was not installed.
Related information...
System Updates screen, page 328
System Updates screen element descriptions, page 329
View or print system update documentation
Perform this procedure to view or print system update documentation.
1. On the menu bar, tap System, and then tap Utilities.
2. On the Utilities screen, tap System Updates.
3. On the Available Files tab of the System Updates screen, tap a technical service bulletin
(TSB) number in the TSB list.
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4. Tap Print.
5. Under Report Selection in the Print flyout, tap System Update Letter.
6. To rotate the document, use the Rotate toolbar.
7. To browse the document, use the Page toolbar.
8. To increase or decrease the font size in the document, use the Zoom toolbar.
9. To resize the document to fit the window width ( ) or to resize the document to fit one full
page in the window ( ), use the Fit toolbar.
10. To find a word or phrase in the document, use the Find toolbar.
11. To print the document, tap Print.
To return to the System Updates screen, tap Done.
Related information...
System Updates screen, page 328
Download the system update software
System update status Available or Download Failed
Operator access level The access level depends on the system update.
Perform this procedure to download the software installer for a new system update or a previous
software installer download that failed. After the software installer is downloaded, the system
update is ready for installation.
1. On the menu bar, tap System, and then tap Utilities.
2. On the Utilities screen, tap System Updates.
3. On the Available Files tab of the System Updates screen, tap a technical service bulletin
(TSB) number in the TSB list.
4. Tap Download.
5. To return to the Utilities screen, tap Utilities.
Related information...
System Updates screen, page 328
Install a system update, page 336
Install a system update
System update status Ready to Install
Required instrument Stopped, Warming, or Idle
status
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Operator access level The access level depends on the system update.
Perform this procedure to install a system update.
1. On the menu bar, tap System, and then tap Utilities.
2. On the Utilities screen, tap System Updates.
3. On the Available Files tab of the System Updates screen, tap a technical service bulletin
(TSB) number in the TSB list.
4. Tap Install.
5. When a confirmation message is displayed, tap Yes.
6. To return to the Utilities screen, tap Utilities.
Related information...
System Updates screen, page 328
Download the system update software, page 336
Decline a system update
System update status Ready to Install or Available
Operator access level The access level depends on the system update. Mandatory
system updates can be declined only by an Abbott
Laboratories representative.
Perform this procedure to decline a system update. After the system update is declined, the
update is moved to the Declined Updates tab. System updates that have been declined can be
set as available for installation if necessary.
1. On the menu bar, tap System, and then tap Utilities.
2. On the Utilities screen, tap System Updates.
3. On the Available Files tab of the System Updates screen, tap a technical service bulletin
(TSB) number in the TSB list.
4. Tap Decline.
5. In the Comment box, type the reason that the TSB needs to be declined.
NOTE: Additional comments can be added to a TSB record. To maintain the traceability of
the comments, include a date and an operator ID with each comment.
6. To decline the TSB, tap Done.
To return to the TSB list without declining the TSB, tap Cancel.
7. To return to the Utilities screen, tap Utilities.
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Related information...
System Updates screen, page 328
Set a declined system update as available for installation, page 339
Manually verify a system update
System update status Pending Verification
Operator access level The access level depends on the system update.
Perform this procedure when a software system update requires a manual verification.
1. On the menu bar, tap System, and then tap Utilities.
2. On the Utilities screen, tap System Updates.
3. On the Available Files tab of the System Updates screen, tap a technical service bulletin
(TSB) number in the TSB list.
4. Tap Verify.
5. When a confirmation message is displayed, tap Yes.
6. To return to the Utilities screen, tap Utilities.
Related information...
System Updates screen, page 328
Add a comment to a system update
Perform this procedure to add a comment to a system update.
1. On the menu bar, tap System, and then tap Utilities.
2. On the Utilities screen, tap System Updates.
3. To add a comment to an available update, a declined update, or an installed update, tap the
appropriate tab on the System Updates screen.
4. On the appropriate tab of the System Updates screen, tap a technical service bulletin (TSB)
number in the TSB list.
5. Tap Comments.
6. In the Comments flyout, type the information that is associated with the update.
NOTE: Additional comments can be added to a TSB record. To maintain the traceability of
the comments, include a date and an operator ID with each comment.
7. To save the comment, tap Done.
To delete the comment, tap Cancel.
To clear the entered comments, tap Clear.
8. To return to the Utilities screen, tap Utilities.
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Related information...
System Updates screen, page 328
Set a declined system update as available for installation
System update status Declined
Operator access level The access level depends on the system update.
Perform this procedure to change the status of a system update from Declined to Available and
to allow a declined update to be set as available for installation.
1. On the menu bar, tap System, and then tap Utilities.
2. On the Utilities screen, tap System Updates.
3. On the System Updates screen, tap the Declined Updates tab.
4. On the Declined Updates tab of the System Updates screen, tap a technical service bulletin
(TSB) number in the TSB list.
5. Tap Set As Available.
6. In the Comment box, type the reason that the TSB needs to be set as available for
installation.
NOTE: Additional comments can be added to a TSB record. To maintain the traceability of
the comments, include a date and an operator ID with each comment.
7. To save the change to the TSB status, tap Done.
To return to the TSB list without changing the TSB status, tap Cancel.
8. To return to the Utilities screen, tap Utilities.
Related information...
System Updates screen, page 328
Decline a system update, page 337
Import a system update
Required materials USB flash drive
Operator access level System administrator
Perform this procedure to import a translated version of the operations manual.
If the logon for CSC or FSE is used, this procedure can also be performed to import a system
update that was not available through Abbott Mail or to import a system update when Abbott Mail
is not available.
1. Insert a USB flash drive that contains the system update.
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2. On the menu bar, tap System, and then tap Utilities.
3. On the Utilities screen, tap System Updates.
4. On the Available Files tab of the System Updates screen, tap Import.
5. Tap the appropriate USB flash drive and folder that contain the system update.
6. Under File Name, tap the system update in the list of updates.
7. Tap Import.
8. When a confirmation message is displayed, tap Yes.
9. To return to the Utilities screen, tap Utilities.
Related information...
System Updates screen, page 328
Insert and remove a USB flash drive, page 671
Manually apply a system update (FSE Logon)
System update status Available, Ready to Install, or Pending Verification
Operator access level FSE
Perform this procedure after the following tasks are completed:
• A hardware system update is installed and is verified.
• A software restore procedure is performed to reconcile system updates that have been
installed and that do not need to be installed again.
1. On the menu bar, tap System, and then tap Utilities.
2. On the Utilities screen, tap System Updates.
3. On the Available Files tab of the System Updates screen, tap a technical service bulletin
(TSB) number in the TSB list.
4. Tap Change Status.
5. In the Status drop-down list, tap Manually Applied.
6. When a confirmation message is displayed, tap Yes.
7. To return to the Utilities screen, tap Utilities.
Related information...
System Updates screen, page 328
Set an applied system update as available for installation (FSE Logon)
System update status Applied or Manually Applied
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Operator access level FSE
Perform this procedure when a system update that was installed previously needs to be
reinstalled.
1. On the menu bar, tap System, and then tap Utilities.
2. On the Utilities screen, tap System Updates.
3. On the System Updates screen, tap the Installed Updates tab.
4. On the Installed Updates tab of the System Updates screen, tap a technical service bulletin
(TSB) number in the TSB list.
5. Tap Set As Available.
6. When a confirmation message is displayed, tap Yes.
7. To return to the Utilities screen, tap Utilities.
Related information...
System Updates screen, page 328
Change the status of an installed TSB to a status of Install Failed (FSE Logon)
System update status Pending Verification, Applied, or Manually Applied
Operator access level FSE
Perform this procedure when a manual verification procedure fails for a system update that has
a status of Pending Verification, Applied, or Manually Applied.
1. On the menu bar, tap System, and then tap Utilities.
2. On the Utilities screen, tap System Updates.
3. On the System Updates screen, tap the Installed Updates tab.
4. On the Installed Updates tab of the System Updates screen, tap a technical service bulletin
(TSB) number in the TSB list.
5. Tap Install Failed.
6. When a confirmation message is displayed, tap Yes.
7. To return to the Utilities screen, tap Utilities.
Related information...
System Updates screen, page 328
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Change the status of a TSB that failed to install to a status of Pending Verification (FSE
Logon)
System update status Install Failed
Operator access level FSE
Perform this procedure when a system update that has a status of Install Failed requires a
manual verification procedure to be performed.
1. On the menu bar, tap System, and then tap Utilities.
2. On the Utilities screen, tap System Updates.
3. On the Available Files tab of the System Updates screen, tap a technical service bulletin
(TSB) number in the TSB list.
4. Tap Change Status.
5. In the Status Change flyout, tap the Status drop-down list, and then tap Pending
Verification.
6. To save the status change, tap Done.
To cancel the status change and return to the TSB list, tap Cancel.
7. When a confirmation message is displayed, tap Yes.
8. To return to the Utilities screen, tap Utilities.
Related information...
System Updates screen, page 328
Troubleshooting screen
On the Troubleshooting screen, the operator can retrieve system log packages that can be used
for troubleshooting by an Abbott Laboratories representative.
Related information...
Utilities screen, page 323
Troubleshooting screen element descriptions, page 342
Descriptions of troubleshooting packages, page 343
Retrieve a troubleshooting package, page 345
Troubleshooting screen element descriptions
System logs are used primarily to troubleshoot instrument problems and to gather data about an
instrument operation. All troubleshooting packages can be retrieved when the instrument status
is Idle.
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Elements
Troubleshooting Data
Troubleshooting Displays a list of the troubleshooting packages that are
Packages available.
Function buttons
Utilities Navigates to the Utilities screen.
Retrieve AbbottLink Used to send the troubleshooting package to AbbottLink.
Retrieve Removable Used to save the troubleshooting package to a USB flash
Media drive.
Related information...
Troubleshooting screen, page 342
Descriptions of troubleshooting packages, page 343
Descriptions of screen elements, page 127
Descriptions of troubleshooting packages
Troubleshooting package information contains system logs and data that is used by an Abbott
Laboratories representative to troubleshoot instrument and assay issues.
The following list provides descriptions of the troubleshooting packages:
Core Operational Data Includes core operational data (for example, result data,
calibration data, and instrument operational data) that is
located in the operational data recorder (ODR) of the
instrument.
The following files are collected:
• Result data
• Calibration data
• Message history data
• Maintenance and diagnostic (MnD) data
• Assay activity data
• Reagent data
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• Vortexer (ITV) data
• Liquid level detection (LLD) data
• Pipettor pressure monitoring (PM) data
• Wash buffer dilution assembly (IARM) data
• Wash monitoring (WAM) data
• Temperature data
• Vacuum pressure data
• Optics data
• Event data
• Motor data
Instrument Logs Includes instrument logs.
The following logs are collected:
• System control module logs (InstClient and InstServer)
• Processing module logs (c-series and i-series)
• Reagent and sample manager logs
• Communication logs with external systems (for example,
HL7 and ASTM host communication logs)
• Result data
• Assay activity data
• Liquid level detection (LLD) data
• Pipettor pressure monitoring (PM) data
External Includes all communication logs with external systems (for
Communication Logs example, HL7 and ASTM host communication logs).
Maintenance and Includes data that is captured when a maintenance procedure
Diagnostics Data or a diagnostic procedure is performed.
(CSC Logon)
PM And LLD Data Includes PM and LLD data for both c-series and i-series
(CSC Logon) processing modules.
Motor Move Data Includes integrated circuit board motor movement data for
(CSC Logon) both c-series and i-series processing modules.
CC Pipettor PM Raw Includes the c-series pipettor PM raw data.
Data (CSC Logon)
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CC PHM Data (CSC Includes the c-series prognostic health monitoring data.
Logon)
IA Heater Duty Cycle Includes the i-series heater duty cycle data.
Data (CSC Logon)
Related information...
Troubleshooting screen, page 342
Troubleshooting screen element descriptions, page 342
Retrieve a troubleshooting package
Required instrument Stopped, Warming, or Idle
status
Required materials A USB flash drive is required only if a troubleshooting
package is saved to the USB flash drive.
Perform this procedure to retrieve a troubleshooting package that can be used for
troubleshooting by an Abbott Laboratories representative.
1. On the menu bar, tap System, and then tap Utilities.
2. On the Utilities screen, tap Troubleshooting.
3. Under Troubleshooting Packages on the Troubleshooting screen, tap a package to
retrieve.
4. To send the troubleshooting package to AbbottLink, tap Retrieve AbbottLink.
To save the troubleshooting package on a USB flash drive, tap Retrieve Removable Media,
and then perform the following steps:
a. Insert the USB flash drive.
b. In the Retrieve to Removable Media flyout, tap the appropriate USB flash drive and
folder.
c. To save the troubleshooting package, tap Done.
To cancel the save function, tap Cancel.
d. Remove the USB flash drive.
5. To return to the Utilities screen, tap Utilities.
Related information...
Troubleshooting screen, page 342
Insert and remove a USB flash drive, page 671
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Current Firmware screen
On the Current Firmware screen, the operator can view the i-series processing module firmware
and the reagent and sample manager firmware when requested by an Abbott Laboratories
representative.
Related information...
Utilities screen, page 323
Current Firmware screen element descriptions, page 346
Current Firmware screen element descriptions
The Current Firmware screen displays the firmware for the i-series processing module and the
reagent and sample manager (RSM).
Elements
Module ID Displays the number of the processing module or the RSM.
Device Name Displays the name of the device.
Version Number Displays the version number of the firmware.
Build Date / Time Displays the date and time that the firmware was created. If
the firmware version information is unavailable because of a
device communication failure, dashes are displayed.
NOTE: The build date and time are not applicable to the bar
code reader, servo controller boards, and the PHM data
board.
Refresh Date / Time Displays the date and time that the version information was
obtained. If the firmware version information is unavailable
because of a device communication failure, dashes are
displayed.
Function buttons
Utilities Displays the Utilities screen.
Text Size Increases or decreases the size of text displayed.
Related information...
Current Firmware screen, page 346
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Descriptions of screen elements, page 127
CLI Diagnostics screen (FSE Logon)
If the logon for FSE is used, an option to run CLI commands is available. For more information
about CLI commands and how to run these commands, see the service documentation.
Related information...
Utilities screen, page 323
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NOTES
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Section 3 Principles of operation
Introduction
The Alinity ci-series uses photometric, potentiometric, and chemiluminescent microparticle
immunoassay (CMIA) detection technologies to measure analyte concentrations in samples.
Related information...
Principles of operation (c-series), page 350
Principles of operation (i-series), page 375
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Principles of operation (c-series) Section 3
Principles of operation (c-series)
Principles of operation for the c-series provide an overview of photometric and potentiometric
detection technologies, the assay processing, and the SmartWash feature used for analyte
measurement. The principles also include an overview of sample interference indices for lipemic,
hemolyzed, and icteric samples.
Related information...
Principles of operation, page 349
Photometric method (c-series), page 350
Potentiometric method (c-series), page 355
Assay processing (c-series), page 361
Indirect assay processing method (c-series), page 370
SmartWash feature (c-series), page 370
Optimum sampling sequence feature (c-series), page 371
Sample interference indices (c-series), page 372
Photometric method (c-series)
The c-series uses the photometric detection technology to measure sample absorbance for the
quantitation of analyte concentration.
Related information...
Principles of operation (c-series), page 350
Photometric technology (c-series), page 350
Optical measurement (c-series), page 353
Photometric technology (c-series)
Photometric technology is the measurement of the amount of light that a sample absorbs. A
beam of light is passed through a sample and the intensity of light that reaches a detector is
measured. Beer's Law establishes the mathematical relationship between the absorbance of the
solution and the concentration of the analyte. The absorbance of the solution changes as the
reaction progresses. Measurements occur either when all the reactant is depleted and the
reaction is stable (end-point assays) or when the reactant reaches a stable rate (rate assays).
Related information...
Photometric method (c-series), page 350
End-point assay reactions (c-series), page 351
Rate assay reactions (c-series), page 352
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Section 3 Principles of operation (c-series)
End-point assay reactions (c-series)
End-point assay reactions proceed until all reactant is depleted and the absorbance is stable.
When the reaction is completed, the system measures the absorbance readings used for
calibration and to calculate results.
For end-point assays, the system calculates the concentration by using the absorbance data
obtained during the main read time specified on the General tab of the Assay Parameters
screen.
The following illustration shows a typical end-point assay reaction curve.
Figure 97: Example of an end-point assay reaction curve (c-series)
Where:
Abs Absorbance
T Time measured in photometric read points
SD Sample dispense
FRD First reagent dispense and mixing
SRD Second reagent dispense and mixing
M Main read time
Related information...
Photometric technology (c-series), page 350
Create a user-defined assay (c-series photometric), page 247
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Principles of operation (c-series) Section 3
Rate assay reactions (c-series)
Rate assay reactions reach a stable rate in which the change in absorbance between readings is
constant. The system performs several readings during this time, calculates the change of
absorbance per minute (rate), and then uses the rate to calculate results.
For rate assays, the system uses the linear least squares method to calculate the change of
absorbance per minute (Δ Abs/min) during the main read time specified on the General tab of
the Assay Parameters screen. The calculation must include a minimum of three photometric
points to receive a result without a flag. The maximum number of photometric points is 38.
The following illustration shows a typical rate assay reaction curve.
Figure 98: Example of a rate down assay reaction curve (c-series)
Where:
Abs Absorbance
T Time measured in photometric read points
SD Sample dispense
FRD First reagent dispense and mixing
SRD Second reagent dispense and mixing
M Main read time
ABL Lower limit of the absorbance range
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Related information...
Photometric technology (c-series), page 350
Create a user-defined assay (c-series photometric), page 247
Optical measurement (c-series)
The c-series uses an optical measurement to obtain absorbance readings and then converts
them to assay-specific analyte concentration units or assay-specific qualitative interpretations.
Related information...
Photometric method (c-series), page 350
Optical system and measurement sequence (c-series), page 353
Data reduction calculation (c-series photometric), page 355
Optical system and measurement sequence (c-series)
The optical system on the processing module is a direct photometry system that directs and
aligns the light from the source lamp, through the water bath and the cuvette, to the optics unit.
The optical system directs and aligns only the light that originates from the source lamp and
simultaneously measures the intensity of 16 different wavelengths.
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Figure 99: Optical system (c-series)
Legend:
1. Preamp board
2. Linear photodiode array
3. Diffraction grating
4. Entrance slit
5. Convex lens
6. Water bath lens
7. Cuvette
8. Heat glass
9. Lamp
10. Data acquisition (DAQ) board
11. Central processing unit (CPU) board
The measurement sequence occurs as the optical system performs the following actions:
1. A convex lens focuses the light from a tungsten halogen lamp and passes the light through
the cuvette to measure absorbance changes as the reaction progresses.
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2. A second convex lens focuses the light through the entrance slit onto the diffraction grating.
3. The diffraction grating separates the focused light beam into 16 component wavelengths
(340 nm to 804 nm) and reflects the light spectrum onto the photodiode array.
4. The photodiode array measures the light intensity at the different wavelengths.
5. The preamp board, the DAQ board, and the CPU board convert and amplify the signal from
the photodiode array and then communicate transmittance values to the user interface
computer where data reduction and result calculation occur.
Related information...
Optical measurement (c-series), page 353
Data reduction calculation (c-series photometric)
The data reduction calculation is used to calculate final absorbance values and the result
concentration.
The system control module (SCM) receives transmittance readings from the processing module
for each cuvette, determines the readings that are necessary to calculate the result, and then
converts these readings to absorbance values. The system uses readings from one wavelength
(monochromatic) or two wavelengths (bichromatic) to calculate assay results. Most assays are
bichromatic.
Number of wavelengths measured at each read How the absorbance values are calculated
point
1 - Monochromatic Uses the reading from one wavelength
2 - Bichromatic Subtracts the readings that occur at the secondary
wavelength from the readings that occur at the primary
wavelength and uses the difference as the absorbance
value
NOTE: The system adjusts the absorbance data readings to light path length values of 10 mm.
The absorbance data readings are blank corrected, as specified for each test, and then are
converted to concentration units.
Related information...
Optical measurement (c-series), page 353
Potentiometric method (c-series)
The c-series uses the potentiometric detection technology to measure the electrical potential in
a sample. In addition, the c-series uses an integrated chip technology (ICT) module to measure
potentiometric assays (electrolytes).
Related information...
Principles of operation (c-series), page 350
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Integrated chip technology (c-series), page 356
ICT measurement (c-series), page 356
Integrated chip technology (c-series)
Integrated chip technology (ICT) is the method that the c-series uses to simultaneously measure
sodium, potassium, and chloride. ICT methodology uses solid-state, ion-selective electrodes that
are contained in one chip (ICT module), which reduces the maintenance that is necessary to
perform electrolyte measurements.
The ICT module contains the following electrodes:
Sodium (Na+) A crown ether ionophore that is incorporated into an ion-
selective plastic membrane. (Because the electrode does not
use a glass membrane, it is less affected by sample pH
changes.)
Potassium (K+) Valinomycin that is incorporated into an ion-selective plastic
membrane.
Chloride (Cl-) A solid silver chloride (AgCl) disk.
Reference A silver-silver chloride electrode in a potassium chloride (KCl)
gel inner solution that is separated from the sample by a
porous ceramic tube.
Related information...
Potentiometric method (c-series), page 355
ICT measurement (c-series)
The c-series uses ICT measurement to obtain millivolt readings and then converts them to
assay-specific analyte conversion units. The measurements of ICT Reference Solution and ICT
samples are used to calculate assay results.
Related information...
Potentiometric method (c-series), page 355
ICT Reference Solution and sample delivery and processing (c-series), page 356
Measurement by the ICT module (c-series), page 359
Data reduction calculation (c-series potentiometric), page 360
ICT Reference Solution and sample delivery and processing (c-series)
ICT Reference Solution and ICT samples are delivered to the ICT module where measurements
occur.
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Figure 100: ICT Reference Solution delivery (c-series)
During ICT Reference Solution delivery and processing, the ICT Reference Solution cup is filled
with the ICT Reference Solution, which is analyzed, and then the waste is removed:
1. The syringe on the left side of the ICT Reference Solution pump moves the ICT Reference
Solution from the bottle, through the warming ring, and into the ICT Reference Solution cup.
2. The ICT unit moves down to position the ICT probe in the ICT Reference Solution cup.
3. The syringe on the right side of the ICT aspiration pump aspirates the ICT Reference
Solution from the cup into the ICT module.
4. The ICT module measures the ICT Reference Solution. The system converts the
measurements into millivolt readings that are used for reference when sample result
concentrations are calculated.
5. High-concentration waste processing begins:
The syringe on the right side of the ICT aspiration pump moves the ICT Reference Solution
from the ICT module to the high-concentration waste compartment.
6. The syringe on the left side of the ICT aspiration pump moves the liquid waste from the
high-concentration waste compartment.
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7. The syringe on the left side of the ICT aspiration pump moves the liquid waste to the high-
concentration waste tubing.
8. Low-concentration waste processing begins:
The syringe on the right side of the ICT Reference Solution pump moves the remaining ICT
Reference Solution from the ICT Reference Solution cup.
9. The syringe on the right side of the ICT Reference Solution pump moves the solution to the
low-concentration waste compartment in the water bath overflow and waste area.
10. Gravity causes the liquid waste to drain from the low-concentration waste compartment in
the water bath overflow and waste area to the low-concentration waste tubing.
Figure 101: ICT sample delivery (c-series)
During ICT sample delivery and processing, the sample and the ICT Sample Diluent are
dispensed, the sample is analyzed, and then the waste is removed:
1. The sample pipettor dispenses 15 μL of sample into a cuvette.
2. Reagent pipettor 1 dispenses 69 μL of ICT Sample Diluent (ICTD5) and 276 μL of water into
the cuvette.
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3. Mixer 1 mixes the sample, the diluent, and the water.
4. The reaction carousel continues to rotate until the cuvette aligns with the ICT unit. The
cuvette alignment occurs after 37 reaction carousel movements.
5. The ICT unit moves out and down to position the ICT probe in the cuvette.
6. The syringe on the right side of the ICT aspiration pump aspirates the sample from the
cuvette into the ICT module.
7. The ICT module measures the sample. The system converts the measurements into millivolt
readings that are used to calculate sample result concentrations.
8. The syringe on the right side of the ICT aspiration pump moves the sample from the ICT
module to the high-concentration waste compartment.
9. The syringe on the left side of the ICT aspiration pump aspirates the liquid waste from the
high-concentration waste compartment.
10. The syringe on the left side of the ICT aspiration pump moves the liquid waste to the high-
concentration waste tubing.
Related information...
ICT measurement (c-series), page 356
Measurement by the ICT module (c-series)
The ICT module measures:
• ICT Reference Solution (once before and after each serum sample and twice before and
after each urine sample) to provide a reference potential that is used to calculate results.
• Samples (patient, quality control, and calibrator) to obtain readings that are used to
calculate results.
The following measurements are captured:
• The potential difference between the sample and the ICT Reference Solution for each
electrode
• The potential of each electrode in contact with the ICT Reference Solution
• The potential of each electrode in contact with the sample
The following figure shows internal components of the ICT module on the right side of the
module. The direction of the sample flow is indicated by the arrow.
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Figure 102: ICT module and internal components (c-series)
Legend:
1. O-ring
2. Reference electrode
3. Cl- electrode
4. K+ electrode
5. Na+ electrode
Related information...
ICT measurement (c-series), page 356
Data reduction calculation (c-series potentiometric)
The data reduction calculation is used to calculate the final result concentration. For each
sample, the system compares millivolt readings from the sample to millivolt readings from the
ICT Reference Solution that is analyzed immediately after the sample. The difference in the
millivolt readings is used to calculate assay results.
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Related information...
ICT measurement (c-series), page 356
Assay processing (c-series)
Many kinds of assay-processing activities occur between sample aspiration and final result
reporting. Components that are located around the reaction carousel perform these activities.
Figure 103: Assay-processing components (c-series)
Legend:
1. Sample pipettor
2. Sample probe and whole blood wash cups
3. Mixers
4. Mixer wash cups
5. ICT unit
6. Lamp
7. Reagent 2 pipettor and wash cup
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8. Cuvette washer
9. Cuvette segments
10. Reagent 1 pipettor and wash cup
The movement of the reaction carousel, the timing of these movements, and the position of the
components cause each reaction activity to occur at a specified time and location.
During assay processing, the reaction carousel rotates counterclockwise one-fourth turn every 4
seconds to position the cuvettes at each location. Each rotation moves incrementally to 47
cuvette positions in the reaction carousel. As each rotation occurs, the cuvettes pass the
photometric position where the lamp is located, and the photometer measures the absorbance of
each cuvette.
The following illustration shows key positions in the reaction carousel where activities occur.
Figure 104: Reaction carousel positions
The following table describes the movement and timing for all assay protocol types.
Position Description
1 The sample pipettor dispenses the sample into the cuvette at the starting position
[1].
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Position Description
2 The reaction carousel rotates one-fourth turn (47 cuvette positions). The cuvette
that contains the sample is located at the first reagent dispense position [2].
Reagent 1 pipettor dispenses reagent 1 into the cuvette.
3 The reaction carousel rotates one-fourth turn to the first mixing position [3] where
mixer 1 mixes the sample and reagent 1.
Rotation from 3 to 4 As the reaction carousel rotates from position 3 to position 4, the cuvette passes
the photometric position [6] where the lamp is located, and the photometer
measures the absorbance.
4 No activity occurs in this position [4].
5 The reaction carousel completes a full rotation of four cycles. Each cycle rotates
the reaction carousel 47 cuvette positions (one-fourth turn). After four cycles are
completed, the cuvette has moved 188 positions (4 x 47 = 188). Since the reaction
carousel has 187 cuvettes, the cuvette is now one position beyond the original
starting position [5].
6 through 153 The reaction carousel continues to rotate and the reaction mixture incubates. The
photometer measures the absorbance each time that the cuvette passes the
photometric position [6] for a total of 38 readings.
154 through 182 The cuvette washer [7] aspirates the reaction mixture to waste and cleans the
cuvette with Alkaline Wash, Acid Wash, and purified water. Then, the cuvette
washer dispenses purified water into the cuvette for the water blank measurement,
which ensures cuvette integrity. Finally, the cuvette washer aspirates the water and
dries the cuvette.
183 through 188 The clean cuvette rotates to the starting position [1].
Some assay protocols can also use the following positions.
Position Description
5 If onboard dilution is required, the sample pipettor aspirates the diluted sample [5]
and dispenses the sample into the new cuvette that is located at position 1.
40 For an ICT sample, the ICT probe aspirates the diluted sample into the ICT unit [8].
75 If the reaction requires a second reagent, the reagent 2 pipettor dispenses reagent
2 into the cuvette [9].
76 Mixer 2 [10] mixes the second reagent with the sample and reagent mixture.
The following illustration shows the relationship between the timing of photometric readings and
the dispense of samples and reagents. The maximum reaction time is 10 minutes.
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Figure 105: Photometric timing (c-series)
Where:
Abs Absorbance
T Time measured in photometric read points
SD Sample dispense
FRD First reagent dispense and mixing
SRD Second reagent dispense and mixing
Related information...
Principles of operation (c-series), page 350
Assay processing for a one-reagent protocol (c-series), page 364
Assay processing for a two-reagent protocol (c-series), page 366
Assay processing for a dilution protocol (c-series), page 367
Assay processing for a pretreatment protocol (c-series), page 368
Assay processing for an ICT protocol (c-series), page 369
Assay processing for a one-reagent protocol (c-series)
The following steps describe the assay processing and the photometric reaction that occurs
during a one-reagent assay protocol.
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Figure 106: One-reagent assay protocol (c-series)
Legend:
1. At position 1, the sample pipettor aspirates sample and then dispenses the sample into a cuvette.
2. At position 2, the reagent 1 pipettor aspirates reagent and then dispenses the reagent into the
cuvette.
3. At position 3, mixer 1 mixes the sample and the reagent.
4. At positions 4 through 153, the reaction mixture incubates, and the photometer measures the
absorbance each time that the cuvette passes the photometric position [6].
5. At positions 154 through 182, the cuvette washer aspirates the reaction mixture to waste and cleans
the cuvette with Alkaline Wash, Acid Wash, and purified water. Then, the cuvette washer dispenses
purified water into the cuvette for the water blank measurement, which ensures cuvette integrity.
Finally, the cuvette washer aspirates the water and dries the cuvette.
Related information...
Assay processing (c-series), page 361
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Assay processing for a two-reagent protocol (c-series)
The following steps describe the assay processing and the photometric reaction that occurs
during a two-reagent assay protocol.
Figure 107: Two-reagent assay protocol (c-series)
Legend:
1. At position 1, the sample pipettor aspirates sample and then dispenses the sample into a cuvette.
2. At position 2, the reagent 1 pipettor aspirates reagent and then dispenses the reagent into the
cuvette.
3. At position 3, mixer 1 mixes the sample and the reagent.
4. At positions 4 through 74, the reaction mixture incubates and the photometer measures the
absorbance each time that the cuvette passes the photometric position [7].
5. At position 75, the reagent 2 pipettor aspirates the reagent and then dispenses the second reagent
into the cuvette.
6. At position 76, mixer 2 mixes the second reagent with the sample and reagent mixture.
7. At positions 77 through 153, the reaction mixture incubates, and the photometer measures the
absorbance each time that the cuvette passes the photometric position.
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8. At positions 154 through 182, the cuvette washer aspirates the reaction mixture to waste and cleans
the cuvette with Alkaline Wash, Acid Wash, and purified water. Then, the cuvette washer dispenses
purified water into the cuvette for the water blank measurement, which ensures cuvette integrity.
Finally, the cuvette washer aspirates the water and dries the cuvette.
Related information...
Assay processing (c-series), page 361
Assay processing for a dilution protocol (c-series)
The following steps describe the assay processing that occurs when a sample is diluted before a
one-reagent or two-reagent assay protocol is performed.
Figure 108: Assay processing for a dilution protocol (c-series)
Legend:
1. At position 1, the sample pipettor aspirates the sample and then dispenses the sample into a cuvette.
2. At position 2, the reagent 1 pipettor aspirates the diluent and then dispenses the diluent into the
cuvette.
3. At position 3, mixer 1 mixes the sample and the diluent.
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4. At position 5, the sample pipettor aspirates the diluted sample and then dispenses the diluted sample
into a new cuvette. Then, the system processes the diluted sample according to the one-reagent or
two-reagent assay protocol as appropriate.
Related information...
Assay processing (c-series), page 361
Assay processing for a pretreatment protocol (c-series)
The following steps describe the assay processing that occurs when a sample is pretreated
before a one-reagent or two-reagent assay protocol is performed.
Figure 109: Assay processing for a pretreatment protocol (c-series)
Legend:
1. At position 1, the sample pipettor aspirates the sample and then dispenses the sample into a cuvette.
2. At position 2, the reagent 1 pipettor aspirates the pretreatment reagent and then dispenses the
pretreatment reagent into the cuvette.
3. At position 3, mixer 1 mixes the sample and the pretreatment reagent.
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4. At position 5, the sample pipettor aspirates the pretreated sample and then dispenses the pretreated
sample into a new cuvette. Then, the system processes the pretreated sample according to the one-
reagent or two-reagent assay protocol as appropriate.
Related information...
Assay processing (c-series), page 361
Assay processing for an ICT protocol (c-series)
The following steps describe the assay processing and the potentiometric reaction that occurs
for integrated chip technology (ICT) assays.
Figure 110: ICT assay protocol (c-series)
Legend:
1. At position 1, the sample pipettor aspirates sample and then dispenses the sample into a cuvette.
2. At position 2, the reagent 1 pipettor aspirates ICT sample diluent and then dispenses the ICT sample
diluent into the cuvette.
3. At position 3, mixer 1 mixes the sample and the ICT sample diluent.
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4. At position 40, the ICT probe aspirates the diluted sample, and then the ICT module analyzes the
diluted sample.
NOTE: The ICT module analyzes the ICT Reference Solution once before and after each serum
sample and twice before and after each urine sample to provide a reference potential that is used to
calculate results.
5. At positions 154 through 182, the cuvette washer aspirates the reaction mixture to waste and cleans
the cuvette with Alkaline Wash, Acid Wash, and purified water. Then, the cuvette washer dispenses
purified water into the cuvette for the water blank measurement, which ensures cuvette integrity.
Finally, the cuvette washer aspirates the purified water and dries the cuvette.
Related information...
Assay processing (c-series), page 361
Indirect assay processing method (c-series)
The indirect assay processing method for photometric assays provides for two results to be
generated from one cuvette during a single assay processing cycle. The assay pair has primary
and secondary assays. The two assays are used as constituent assays for the calculated assay
result. This option is available only when the assay parameters are installed from an assay file
that is provided by Abbott Laboratories.
The two assays must be ordered at the same time when calibrations, specimens, and controls
are processed. Each assay generates its own calibration, control results, and specimen results.
The information on the General tab of the Assay Parameters screen can be used to determine if
an assay is a primary or a secondary assay. The reagent volumes of the secondary assay are
configured as zero.
Related information...
Principles of operation (c-series), page 350
SmartWash feature (c-series)
SmartWash is a c-series feature that provides an additional wash process (when needed) for
reagent probes, sample probes, and cuvettes. The SmartWash feature is used during assay
processing to reduce interference (carryover) between specific assay combinations.
To reduce reagent carryover between assays known to demonstrate it, configure the assay
combination as a SmartWash pair. This configuration option provides for an additional wash
process between the measurement of the assays.
NOTE: The configuration of SmartWash parameters for Abbott reagents is determined by
reagent carryover studies that identify assay pairs that do not meet the reagent carryover
criteria.
Reagent carryover specifications of the c-series meet or exceed the bias or total allowable error
requirements for each assay. The specifications are developed by using internationally
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recognized assay performance criteria. The following list provides examples of recognized assay
performance criteria:
• The U.S. Clinical Laboratory Improvement Act (CLIA)
• Guidelines for Quality Assurance of Medical Laboratory Examinations of the German
Medical Association
• National Academy of Clinical Biochemistry (NACB)
• National Kidney Disease Education Program (NKDEP) Guidelines
• Desirable Biological Variation Database Specifications (C. Ricos et al.)
When possible, reagent carryover testing is performed by using serum-based control samples
that contain analyte concentrations near medical decision levels. Assay pairs that meet the
reagent carryover criteria are not configured with SmartWash parameters. In some instances,
because of system-specific conditions, customers may choose to configure SmartWash
parameters for Abbott assay pairs.
To minimize the consecutive measurement of assays configured as SmartWash pairs, the c-
series uses the optimum sampling sequence feature, which automatically changes the sampling
sequence.
Related information...
Principles of operation (c-series), page 350
Onboard solutions (c-series), page 139
Configure SmartWash settings (c-series), page 243
Optimum sampling sequence feature (c-series)
The optimum sampling sequence (OSS) feature is an automatic process in which the c-series
rearranges the sampling sequence to maximize processing speed and system throughput. This
rearrangement prevents the consecutive aspiration of interfering reagents and therefore reduces
the number of required washes and unused cuvettes. If this rearrangement is not possible, the
system automatically activates the SmartWash feature.
In the following example, assays A, B, and C are ordered and a SmartWash parameter is
configured for A and B. The elimination of the wash cycle shows how throughput is improved
when the OSS feature is used.
OSS feature not used OSS feature used
Cycle System operations Cycle System operations
1 Sampling for assay A 1 Sampling for assay B
2 Wash (empty cuvettes) 2 Sampling for assay A
3 Sampling for assay B 3 Sampling for assay C
4 Sampling for assay C
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Related information...
Principles of operation (c-series), page 350
Sample interference indices (c-series)
The sample interference indices are sample measurements that estimate the presence of lipids,
hemoglobin, and bilirubin in lipemic, hemolyzed, and icteric samples, respectively. The estimation
is based on the absorbance measurement of:
• Turbidity for lipids (lipemia).
• Red color for hemoglobin (hemolysis).
• Yellow color for bilirubin (icterus).
Related information...
Principles of operation (c-series), page 350
Sample interference indices protocol (c-series), page 372
Sample interference indices measurement (c-series), page 372
Sample interference indices protocol (c-series)
The sample interference indices protocol measures lipemia, hemolysis, and icterus in a sample.
Saline is configured as a reference photometric assay that the system uses to estimate the
indices for a sample. Analysis of the three indices requires one additional cuvette for each
sample.
Related information...
Sample interference indices (c-series), page 372
Sample interference indices measurement (c-series)
Sample interference indices measurement is the process that the c-series uses to measure
lipemia, hemolysis, and icterus in a sample after the sample has been mixed with saline.
Specimens that contain interfering substances such as lipemia, hemolysis, and icterus absorb at
different wavelengths as shown in the following figure.
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Figure 111: Absorption spectra of NADH and hemolyzed, icteric, and lipemic samples (c-
series)
Where:
Abs Absorbance
λ (𝗇𝗆) Wavelength (nm)
N NADH, the reference absorbance peak
H Hemolysis
I Icterus
L Lipemia
To measure the three interfering substances, first the system measures absorbance values of
four wavelength pairs. Then by using the appropriate photometric reads, the system applies a
mathematical calculation to determine the relative interferent concentration:
• Lipemia = M (a01 x A1 + a02 x A2 + a03 x A3 + a04 x A4)
• Hemolysis = M (a05 x A1 + a06 x A2 + a07 x A3 + a08 x A4)
• Icterus = M (a09 x A1 + a10 x A2 + a11 x A3 + a12 x A4)
Where:
M The correction for the sample dilution is (Reagent
volume + Sample volume) ÷ Sample volume.
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Constants that are specific to each interferent: Constants are used by the system to calculate the
• a01, a02, a03, a04 (lipemia) sample interference indices. Constants are not
• a05, a06, a07, a08 (hemolysis) definable by the operator.
• a09, a10, a11, a12 (icterus)
Absorbance level that is measured at wavelength Absorbance primary wavelength - Absorbance
pairs: secondary wavelength
• A1 (500 nm/524 nm)
• A2 (572 nm/604 nm)
• A3 (628 nm/660 nm)
• A4 (524 nm/804 nm)
Related information...
Sample interference indices (c-series), page 372
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Principles of operation (i-series)
Principles of operation for the i-series provide an overview of chemiluminescent microparticle
immunoassay (CMIA) detection technology, assay processing, and the optical system used for
analyte measurement.
Related information...
Principles of operation, page 349
CMIA method (i-series), page 375
Assay processing (i-series), page 380
CMIA method (i-series)
Chemiluminescent microparticle immunoassay (CMIA) is a detection technology used to measure
analyte concentration.
Related information...
Principles of operation (i-series), page 375
CMIA technology and reaction sequence (i-series), page 375
Optical system and measurement sequence (i-series), page 378
Data reduction calculation (i-series), page 380
CMIA technology and reaction sequence (i-series)
Chemiluminescent microparticle immunoassay (CMIA) detection technology is used to determine
the presence of antigens, antibodies, and analytes in samples.
The following reactants and analyte are necessary for CMIA detection technology:
Paramagnetic microparticles coated with capture molecules (antigens,
antibodies, or viral particles) that are specific for the analyte being
measured
Sample analyte that is measured
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Acridinium-labeled conjugate
Pre-Trigger Solution
Trigger Solution
A CMIA reaction sequence is the order of interactions between the analyte in the sample and the
reactants. The sequence is specific to the assay protocol.
The following two-step sequence illustrates the basic principles of a reaction.
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Figure 112: CMIA reaction sequence
1. The sample and the paramagnetic microparticles coated with capture molecules are
dispensed into the reaction vessel (RV). The vortexer mixes the reaction mixture.
2. The reaction mixture incubates. The analyte in the sample binds to the capture molecules
on the paramagnetic microparticles and forms an immune complex.
3. A magnet attracts the paramagnetic microparticles (which are bound to the specific analyte)
to a wall of the RV. The wash zone assembly washes the reaction mixture to remove
unbound materials. Additional assay processing can now occur.
4. The pipettor dispenses a chemiluminescent, acridinium-labeled conjugate into the RV. The
conjugate binds to the immune complex to complete the reaction mixture. The vortexer
mixes the reaction mixture.
The reaction mixture incubates.
5. The wash zone assembly washes the reaction mixture to remove unbound materials.
6. The Pre-Trigger Solution nozzle dispenses the Pre-Trigger Solution (hydrogen peroxide) into
the reaction mixture. The vortexer mixes the reaction mixture. The Pre-Trigger Solution:
– Creates an acidic environment to prevent the early release of energy (light emission).
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– Helps to prevent any clumping in microparticles.
– Separates the acridinium dye from the conjugate that is bound to the microparticle
complex. This action prepares the acridinium dye for the next step.
The CMIA optical system performs a background read.
7. The Trigger Solution nozzle dispenses the Trigger Solution (sodium hydroxide) into the
reaction mixture. The Trigger Solution creates an alkaline environment that, with the
exposure to peroxide in the Pre-Trigger Solution, causes the acridinium dye to undergo an
oxidative reaction. The oxidative reaction causes a chemiluminescent reaction to occur. N-
methylacridone forms and releases energy (light emission) as N-methylacridone returns to
its ground state.
The CMIA optical system measures the chemiluminescent emission (activated read) over a
predefined time period to determine a result.
Related information...
CMIA method (i-series), page 375
Processing center (Alinity i), page 96
Optical system and measurement sequence (i-series)
The optical system on the processing module directs the chemiluminescent emission from the
reaction vessel (RV) to the optics. The i-series module uses an optical measurement to obtain
relative light unit (RLU) readings and then converts them to assay-specific analyte concentration
units or qualitative interpretations for index (cutoff) assays.
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Figure 113: Optical system (i-series)
Legend:
1. Photomultiplier tube (PMT)
2. Optics
3. Light pipe
4. Trigger Solution delivery nozzle
5. RV
6. Shutter assembly
7. Magnet
The measurement sequence occurs as the optical system performs the following actions:
1. Closes the shutter around the RV to seal off ambient light.
2. Turns on the high voltage to the PMT, performs a background read (the Pre-Trigger Solution
has been dispensed), and transfers the data to the computer.
3. Dispenses the Trigger Solution into the RV. This solution initiates the chemiluminescent
reaction that results in the emission of photons of light.
4. Uses the light pipe to collect the emitted photons of light and directs them to the PMT,
which is located in the CMIA reader.
5. Performs an activated read with the collected photons of light.
6. Transfers the count data to the computer. Based on the assay type, the chemiluminescent
light produced during this reaction is directly proportional or indirectly proportional to the
amount of analyte in the sample.
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7. Sums the signal over a defined time period to yield the RLU.
8. Turns off the high voltage to the PMT.
9. Opens the shutter.
Related information...
CMIA method (i-series), page 375
Optics (Alinity i), page 105
Data reduction calculation (i-series)
The data reduction calculation is used to calculate the final read in relative light units (RLUs):
Final read (RLUs) = Activated read - Background
When the calculation is performed:
1. The system sums the signal measured by the CMIA optical system.
2. The system verifies the following information:
– Background counts fall within an acceptable range.
– The activated read profile falls within an acceptable set of ranges.
3. The system subtracts background counts from activated read counts to calculate the final
read.
Related information...
CMIA method (i-series), page 375
Assay processing (i-series)
Many kinds of assay-processing activities occur between sample aspiration and final result
reporting. Movements of the process path, the timing of these movements, and positions of
components cause each reaction activity to occur at a specified time and location.
The technology of the i-series provides a variety of assay protocols or assay-processing
methods. Based on the protocol type, assay-processing steps occur at different positions on the
process path.
Related information...
Principles of operation (i-series), page 375
Assay processing for One Step 25 (i-series), page 381
Assay processing for Two Step 18-4 (i-series), page 382
Assay processing for pretreatment (i-series), page 384
STAT assay processing for One Step 11 (i-series), page 386
STAT assay processing for Two Step 4-4 (i-series), page 387
Processing center (Alinity i), page 96
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Assay processing for One Step 25 (i-series)
A One Step 25 assay protocol is a method of assay processing in which the sample and all
required reagents are added to the reaction vessel (RV) before the microparticles are washed.
The total processing time for a One Step 25 assay protocol is 29 minutes, which includes a 25-
minute incubation time.
The following steps describe the assay processing and the CMIA reaction that occurs during a
One Step 25 assay protocol.
Figure 114: One Step 25 assay protocol (i-series)
1. At position 1, the sample pipettor dispenses the sample into the RV.
2. At position 2, the reagent 1 pipettor dispenses microparticles and the acridinium-labeled
conjugate.
NOTE: For a delayed one-step assay, the reagent 2 pipettor adds the acridinium-labeled
conjugate at position 71 and the vortexer mixes the reaction mixture at position 72.
3. At position 3, the vortexer mixes the sample, microparticles, and the conjugate.
4. At positions 4 through 86, the reaction mixture incubates for 25 minutes.
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5. At positions 87 through 90, wash zone 2 washes the reaction mixture in the RV and then
removes unbound materials.
6. At position 94, the Pre-Trigger Solution nozzle dispenses the Pre-Trigger Solution into the
reaction mixture, and then the vortexer mixes the reaction mixture.
7. At position 98, the CMIA optical system performs a background read, the Trigger Solution
nozzle dispenses the Trigger Solution into the reaction mixture, and then the CMIA optical
system performs an activated read.
8. At position 100, the liquid waste arm aspirates the liquid waste from the RV.
9. At position 101, the RV unloader removes the RV and discards it into the solid waste
container.
Related information...
Assay processing (i-series), page 380
Processing center (Alinity i), page 96
Assay processing for Two Step 18-4 (i-series)
A Two Step 18-4 assay protocol is a method of assay processing in which the sample and some
reagents are added to the reaction vessel (RV) before the microparticles are washed. The
conjugate reagent is added to the RV after the microparticles are washed. The total processing
time for a Two Step 18-4 assay protocol is 29 minutes, which includes a 22-minute incubation
time.
The following steps describe the assay processing and the CMIA reaction that occurs during a
Two Step 18-4 assay protocol.
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Figure 115: Two Step 18-4 assay protocol (i-series)
1. At position 1, the sample pipettor dispenses the sample into the RV.
2. At position 2, the reagent 1 pipettor dispenses microparticles.
3. At position 3, the vortexer mixes the sample and microparticles.
4. At positions 4 through 63, the reaction mixture incubates for 18 minutes.
5. At positions 64 through 67, wash zone 1 washes the reaction mixture in the RV and then
removes unbound materials.
6. At position 71, the reagent 2 pipettor dispenses the acridinium-labeled conjugate.
7. At position 72, the vortexer mixes the reaction mixture.
8. At positions 73 through 86, the reaction mixture incubates for 4 minutes.
9. At positions 87 through 90, wash zone 2 washes the reaction mixture in the RV and then
removes unbound materials.
10. At position 94, the Pre-Trigger Solution nozzle dispenses the Pre-Trigger Solution into the
reaction mixture, and then the vortexer mixes the reaction mixture.
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11. At position 98, the CMIA optical system performs a background read, the Trigger Solution
nozzle dispenses the Trigger Solution into the reaction mixture, and then the CMIA optical
system performs an activated read.
12. At position 100, the liquid waste arm aspirates the liquid waste from the RV.
13. At position 101, the RV unloader removes the RV and discards it into the solid waste
container.
Related information...
Assay processing (i-series), page 380
Processing center (Alinity i), page 96
Assay processing for pretreatment (i-series)
A pretreatment assay protocol has additional steps that are performed before a one-step or two-
step assay protocol is performed. The i-series module automatically performs these steps when
pretreatment is required.
Based on the pretreatment type, incubation times and the number of pretreatment reagents vary.
Two pretreatment assay protocols are available for use:
• Pretreatment 7 performs the pretreatment assay protocol once and requires an additional 7
minutes.
• Pretreatment 7-7 performs the pretreatment assay protocol twice and requires an additional
14 minutes.
The following steps describe the assay processing and the CMIA reaction that occurs during a
pretreatment assay protocol.
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Figure 116: Pretreatment assay protocol (i-series)
1. At pretreatment position 1, the sample pipettor dispenses the sample into the reaction vessel
(RV).
2. At pretreatment position 2, the reagent 1 pipettor dispenses the first pretreatment reagents
into the sample in the RV.
3. At pretreatment position 6, the vortexer mixes the sample and pretreatment reagents.
4. At pretreatment positions 7 through 48, the reaction mixture incubates for 7 minutes.
5. At pretreatment position 48, the sample pipettor performs one of the following actions to
complete the pretreatment assay protocol:
– Transfers the pretreated sample to a new RV in pretreatment position 1 to process a
second 7-minute pretreatment assay protocol (Pretreatment 7-7)
– Transfers the pretreated sample to a new RV in process path position 1 (Pretreatment
7)
After the pretreatment assay protocol is completed, the one-step or two-step assay protocol
begins.
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Related information...
Assay processing (i-series), page 380
Pretreatment path (Alinity i), page 107
Processing center (Alinity i), page 96
STAT assay processing for One Step 11 (i-series)
A One Step 11 assay protocol is a method of assay processing in which the sample and all
required reagents are added to the reaction vessel (RV) before the microparticles are washed. A
One Step 11 assay protocol has a shorter incubation time than a One Step 25 assay protocol.
The total processing time for a One Step 11 assay protocol is 15 minutes, which includes an 11-
minute incubation time.
The following steps describe the assay processing and the CMIA reaction that occurs during a
One Step 11 assay protocol.
Figure 117: One Step 11 assay protocol (i-series)
1. At position 1, the sample pipettor dispenses the sample into the RV.
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2. At position 2, the reagent 1 pipettor dispenses microparticles and the acridinium-labeled
conjugate.
3. At position 3, the vortexer mixes the sample, microparticles, and the conjugate.
4. At positions 4 through 40, the reaction mixture incubates for 11 minutes.
5. At positions 41 through 44, wash zone 2 washes the reaction mixture in the RV and then
removes unbound materials.
6. At position 48, the Pre-Trigger Solution nozzle dispenses the Pre-Trigger Solution into the
reaction mixture, and then the vortexer mixes the reaction mixture.
7. At position 52, the CMIA optical system performs a background read, the Trigger Solution
nozzle dispenses the Trigger Solution into the reaction mixture, and then the CMIA optical
system performs an activated read.
8. At position 54, the liquid waste arm aspirates the liquid waste from the RV.
9. At position 55, the RV unloader removes the RV and discards it into the solid waste
container.
Related information...
Assay processing (i-series), page 380
Processing center (Alinity i), page 96
STAT assay processing for Two Step 4-4 (i-series)
A Two Step 4-4 assay protocol is a method of assay processing in which the sample and some
reagents are added to the reaction vessel (RV) before the microparticles are washed. The
conjugate reagent is added to the RV after the microparticles are washed. A Two Step 4-4 assay
protocol has a shorter incubation time than a Two Step 18-4 assay protocol. The total
processing time for a Two Step 4-4 assay protocol is 18 minutes, which includes an 8-minute
incubation time.
The following steps describe the assay processing and the CMIA reaction that occurs during a
Two Step 4-4 assay protocol.
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Figure 118: Two Step 4-4 assay protocol (i-series)
1. At position 1, the sample pipettor dispenses the sample into the RV.
2. At position 2, the reagent 1 pipettor dispenses microparticles.
3. At position 3, the vortexer mixes the sample and microparticles.
4. At positions 4 through 17, the reaction mixture incubates for 4 minutes.
5. At positions 18 through 21, wash zone 1 washes the reaction mixture in the RV and then
removes unbound materials.
6. At position 25, the reagent 2 pipettor dispenses the acridinium-labeled conjugate.
7. At position 26, the vortexer mixes the reaction mixture.
8. At positions 27 through 40, the reaction mixture incubates for 4 minutes.
9. At positions 41 through 44, wash zone 2 washes the reaction mixture in the RV and then
removes unbound materials.
10. At position 48, the Pre-Trigger Solution nozzle dispenses the Pre-Trigger Solution into the
reaction mixture, and then the vortexer mixes the reaction mixture.
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11. At position 52, the CMIA optical system performs a background read, the Trigger Solution
nozzle dispenses the Trigger Solution into the reaction mixture, and then the CMIA optical
system performs an activated read.
12. At position 54, the liquid waste arm aspirates the liquid waste from the RV.
13. At position 55, the RV unloader removes the RV and discards it into the solid waste
container.
Related information...
Assay processing (i-series), page 380
Processing center (Alinity i), page 96
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NOTES
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Section 4 Performance characteristics and specifications
Introduction
Before operating the Alinity ci-series, become familiar with system performance characteristics,
throughput capabilities and capacities, specifications, and requirements for samples,
temperature, waste, and clearance.
Related information...
System characteristics, page 392
Specifications and requirements, page 394
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System characteristics
System characteristics provide a basic overview of the Alinity ci-series.
For additional characteristics that are specific to a processing module, see the appropriate
module type.
Table 4: System characteristics
Primary components • System control module
• Reagent and sample manager
• Processing module
Bar code reader Located on the RSM transport
Onboard data storage 2 solid-state hard drives
Operator interface • Touchscreen monitor
• Bar code scanner
Priority scheduling • 0 to 25 configurable priority positions per processing module
• Unlimited temporary priority positions
Quality control • Levey-Jennings and Westgard rules
• Control range tracking
Stored data protection Uninterrupted power supply (UPS) (optional)
Related information...
Performance characteristics and specifications, page 391
Processing module characteristics (c-series), page 392
Processing module characteristics (i-series), page 393
Processing module characteristics (c-series)
Table 5: Processing module characteristics (c-series)
Detection technology:
• Photometric End-point and rate
• Potentiometric Integrated chip technology (ICT) ion-selective electrodes
Pipetting capability Robotic precision with clot detection
Related information...
System characteristics, page 392
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Processing module characteristics (i-series)
Table 6: Processing module characteristics (i-series)
Detection technology Chemiluminescent microparticle immunoassay (CMIA)
Emission measurement The optics measures the chemiluminescent emission from reaction
vessels and outputs the data that corresponds to the quantity of emission
detected.
Pipetting capability Robotic precision with clot detection
Related information...
System characteristics, page 392
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Specifications and requirements
Specifications and requirements for the Alinity ci-series pertain to the appropriate installation and
operation of the system.
Related information...
Performance characteristics and specifications, page 391
Operational specifications, page 394
System capacities, page 397
Physical specifications, page 400
Typical floor loading, page 401
System clearances, page 403
Electrical specifications and requirements, page 403
Optical specifications (c-series), page 406
Water and liquid waste specifications and requirements , page 406
Environmental specifications and requirements, page 408
Computer and interface specifications, page 409
External waste pump specifications and requirements, page 410
Bar code label requirements, page 412
Sample specifications and requirements, page 420
System installation, page 152
Operational specifications
Operational specifications for processing modules include the following information:
• Dispensing volumes
• Sample probe carryover specifications
• Processing temperatures
• Module throughput and time to first result
• System status transition times
Related information...
Specifications and requirements, page 394
Processing module operational specifications (c-series), page 395
Processing module operational specifications (i-series), page 396
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Processing module operational specifications (c-series)
Table 7: Processing module operational specifications (c-series)
Dispensing volumes:
• Sample pipettor 1.5 µL to 35 µL in 0.1 µL increments
• Sample pipettor (ICT) 15 µL per sample
• Reagent 1 pipettor • Reagent 1
45 µL to 250 µL in 1 µL increments
• Onboard solutions
45 µL to 345 µL in 1 µL increments
• Reagent 2 pipettor • Reagent 2
20 µL to 160 µL in 1 µL increments
• Onboard solutions
20 µL to 345 µL in 1 µL increments
• ICT Reference Solution 550 µL per sample
Sample probe carryover performance:
• Serum, plasma, urine, cerebrospinal fluid, and < 0.1 ppm
hemolysate
• Whole blood < 1000 ppm
Temperature:
• Onboard reagent refrigerator 2°C to 10°C
• Reaction mixture 36.7°C to 37.3°C
Throughput:
• Photometric assays Maximum of 900 tests per hour (serum, plasma,
urine, cerebrospinal fluid, and hemolysate
applications)
• Potentiometric assays Maximum of 675 tests per hour
• Whole blood assays Maximum of 225 tests per hour
• Photometric and potentiometric assay mix: Maximum of 1350 tests per hour
– 25% potentiometric (3 tests per sample)
• Mixed load list: Maximum of 900 tests per hour
– 1% to 3% whole blood tests
– 10% to 20% potentiometric tests
• Time to first result • 10 min or less (photometric)
NOTE: The time to first result starts at • 4 min or less (potentiometric)
aspiration and does not include sample
handling.
System status transition times:
NOTE: The Stopped to Processing and Idle to
Processing time intervals were generated with a
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sample loaded on the reagent and sample manager
(RSM). If a sample is not loaded, the cuvettes are
filled with water and the system status transitions to
Running.
Processing module (c-series):
• Offline to Stopped 1 min
• Stopped to Idle 2 min
• Stopped to Processing 6 min
• Idle to Processing (with a sample loaded on 4 min
the RSM)
• Idle to Processing (with no sample loaded on 21 min
the RSM)
RSM:
• Offline to Stopped 1 min
• Stopped to Idle 15 s
• Stopped to Running 30 s
• Idle to Running 30 s
Related information...
Operational specifications, page 394
Processing module operational specifications (i-series)
Table 8: Processing module operational specifications (i-series)
Dispensing volumes:
• Sample 2 µL to 200 µL in 1 µL increments
• Reagent 5 µL to 150 µL in 1 µL increments
• Pre-Trigger Solution 100 µL per test
• Trigger Solution 300 µL per test
Sample probe carryover performance < 0.1 ppm (serum, plasma, urine, or cerebrospinal
fluid)
Temperature:
• Onboard reagent refrigerator 2°C to 12°C
• Reaction mixture 36.4°C to 37.6°C
Throughput:
• Routine assays Maximum of 200 tests per hour
• STAT assays Maximum of 200 tests per hour
• Pretreatment 7 assays Maximum of 200 tests per hour
• Pretreatment 7-7 assays Maximum of 100 tests per hour
• Mixed load list: Maximum of 170 tests per hour
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– 10 % pretreatment
– 25 % STAT
– 65 % routine
• Time to first result • 29 min (routine)
NOTE: The time to first result starts at • 36 min to 43 min (pretreatment)
aspiration and does not include sample • 15 min (STAT)*
handling. * The estimated processing time including
sample handling is 18 min.
System status transition times:
Processing module (i-series):
• Offline to Stopped 3 min
• Stopped to Idle 3 min
• Stopped to Running 7 min
• Idle to Running 4 min to 7 min*
* If the pretreatment path is repopulated with
reaction vessels, the duration of initialization is
7 min.
Reagent and sample manager:
• Offline to Stopped 1 min
• Stopped to Idle 15 s
• Stopped to Running 30 s
• Idle to Running 30 s
Related information...
Operational specifications, page 394
System capacities
System capacities include storage information for the software data, processing modules, and
the reagent and sample manager.
Related information...
Specifications and requirements, page 394
Software data storage capacities, page 397
Processing module capacities (c-series), page 398
Processing module capacities (i-series), page 399
Reagent and sample manager capacities, page 400
Software data storage capacities
Table 9: Software data storage capacities
Assay files 200 assay files
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Calibrations:
• Active • 1 active calibration for a maximum of 4
different reagent lots for each assay on a
processing module
• Inactive • Maximum of 3 months
Levey-Jennings graph data Maximum of 4 months
Messages history 120,000 messages
Print spooler 10 print requests
Reagent cartridges 1000 cartridges per processing module
Released control results* 20,000 results per processing module
Released specimen results* 200,000 results
Unreleased results:* 20,000 results
• Specimens
• Controls
• Calibrations
Unreleased results include test orders, tests in
process, and exceptions.
* Results include system-ordered constituents for calculated assays. The constituent results
cannot be displayed on the Results screen.
Related information...
System capacities, page 397
Processing module capacities (c-series)
Table 10: Processing module capacities (c-series)
Bulk solutions:
• ICT Reference Solution 975 mL
• Alkaline Wash 500 mL
• Acid Wash 500 mL
Bulk solution reservoirs:
• ICT Reference Solution reservoir 1L
• Alkaline Wash reservoir 0.5 L
• Acid Wash reservoir 0.5 L
Reagent carousel positions 70
NOTE: Four of the 70 positions are available for the
storage of onboard vial racks.
Reaction carousel 187 cuvettes
Reaction cuvettes:
• Minimum volume 80 µL
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• Maximum volume 360 µL
High-concentration waste bottle:
• Volume 10 L
• Weight 10 kg (22 lb)
Related information...
System capacities, page 397
Processing module capacities (i-series)
Table 11: Processing module capacities (i-series)
Bulk solutions:
• Pre-Trigger Solution 975 mL
• Trigger Solution 975 mL
• Concentrated Wash Buffer 2L
Bulk solution reservoirs:
• Pre-Trigger Solution reservoir 1L
• Trigger Solution reservoir 1L
• Concentrated Wash Buffer reservoir 2L
• Diluted wash buffer reservoir 4L
Biohazard bag size 5 gal
39.37 cm (15.5 in.) x 57.15 cm (22.5 in.)
Process path positions 46
Pretreatment path positions 61
Reagent carousel positions 47
Reaction vessel (RV):
• Total volume 1000 µL
• Maximum reaction mixture volume 400 µL
RV hopper 1200 RVs
Solid waste:
• Container capacity 1000 RVs
5 h of run time at 200 RVs/h
• Waste chute capacity • 50 RVs before system operation is paused
• 208 RVs total capacity
30 min of run time when the waste container is
removed during assay processing
Related information...
System capacities, page 397
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Reagent and sample manager capacities
Table 12: Reagent and sample manager capacities
Bays 5 per processing module
Priority sections Configurable
0 to 25
Racks: 6 positions per rack
• Sample rack
• Vial rack
• Vial rack with a septum retainer
Trays • 5 sample racks or 30 positions
• 5 reagent cartridges
Related information...
System capacities, page 397
Physical specifications
The approximate physical specifications for the Alinity ci-series are described in the table for the
following configurations:
Stand-alone Includes the specifications for the processing module (Alinity
processing module c or Alinity i), the reagent and sample manager (RSM), and
the system control module (SCM)
Each additional Includes the specifications for one processing module (Alinity
processing module c or Alinity i)
Table 13: Physical specifications
Module Depth Width Height Weight
Stand-alone 117 cm (46 in.) 118 cm (46.5 in.) 135 cm (53 in.) • Alinity c
processing module 711.6 kg
(1568.9 lb)
• Alinity i
623.2 kg
(1373.9 lb)
Each additional 117 cm (46 in.) 80.8 cm (31.8 in.) 135 cm (53 in.) • Alinity c
processing module 536.6 kg
(1183.0 lb)
• Alinity i
448.2 kg
(988.1 lb)
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Related information...
Specifications and requirements, page 394
Typical floor loading
Typical floor loads at each pad are provided in the following tables.
NOTE: Floor loading is the distribution of force at the pads on a leveled system. Distributed
loads vary with the mechanical linking of modules and pad adjustment.
Figure 119: Alinity c single-module system
Table 14: Alinity c weight specifications
Load at each foot 1. 118.8 kg (262 lb)
2. 186.9 kg (412 lb)
3. 140.1 kg (309 lb)
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4. 83.5 kg (184 lb)
5. 22.7 kg (50 lb)
6. 27.2 kg (60 lb)
7. 29 kg (64 lb)
8. 32.2 kg (71 lb)
Figure 120: Alinity i single-module system
Table 15: Alinity i weight specifications
Load at each foot 1. 189.6 kg (418 lb)
2. 125.6 kg (277 lb)
3. 37.2 kg (82 lb)
4. 141.1 kg (311 lb)
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5. 11.3 kg (25 lb)
6. 17.2 kg (38 lb)
7. 52.6 kg (116 lb)
8. 10 kg (22 lb)
Related information...
Specifications and requirements, page 394
System clearances
Table 16: System clearances
Left and right clearances 60 cm (24 in.)
(to allow the positioning of the processing module
so that the power connector can be disconnected
from the module without difficultly)
Rear clearance 109 cm (43 in.)
(for safety access to main circuit breakers, cooling,
airflow, cable and tubing routing, maintenance, and
traffic)
Above clearance 195.6 cm (77 in.)
(to open the processing center covers and to allow
for the height of the distance alert)
Front clearance 122 cm (48 in.)
(to open the front doors and to access, remove, and
replace bulk solutions)
Related information...
Specifications and requirements, page 394
General requirements, page 712
Electrical specifications and requirements
Electrical specifications and requirements include information about circuits, outlet types, and
outlet requirements.
Related information...
Specifications and requirements, page 394
System control module (SCM) electrical specifications and requirements, page 404
Processing module electrical specifications and requirements (c-series), page 404
Processing module electrical specifications and requirements (i-series), page 405
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Electrical hazards, page 734
System control module (SCM) electrical specifications and requirements
Table 17: System control module (SCM) electrical specifications and requirements
AC power:*
• Voltage 90 VAC to 264 VAC
• Frequency 47 Hz to 63 Hz
Circuit breaker that can be reset 20 A
NOTE: If an uninterrupted power supply (UPS) is
used with the system, see the UPS manufacturer
specifications.
Outlet (1):
• North America (twistlock) NEMA L6-20R (240 VAC, 20 A)
• North America (twistlock) NEMA L5-20R (120 VAC, 20 A)
• North America NEMA 5-20R (120 VAC, 20 A)
• Universal IEC 60309 (IP44 Blue) 2P 3W (250 VAC, 16/20 A)
NOTE: If an UPS is used with the system, see the
UPS manufacturer specifications.
Power cord length 3.7 m (12 ft)
Rated power consumption* Maximum of 1600 VA (1.6 kVA)
* If an UPS is used, the UPS must meet the voltage, frequency, and power consumption
requirements of the SCM. It is recommended that the UPS be approved for safety by a
Nationally Recognized Testing Laboratory (NRTL) such as UL or TUV. In addition, it is
recommended that the UPS meets the electromagnetic compatibility (EMC) requirements in IEC
62040-2.
Related information...
Electrical specifications and requirements, page 403
Environmental specifications and requirements, page 408
Processing module electrical specifications and requirements (c-series)
Table 18: Processing module electrical specifications and requirements (c-series)
AC power:*
• Voltage 180 VAC to 264 VAC
• Frequency 50 Hz or 60 Hz
Circuit breaker that can be reset 20 A
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NOTE: If an uninterrupted power supply (UPS) is
used with the system, see the UPS manufacturer
specifications.
Heat dissipation Average of 3481 Btu
Outlet (1):
• North America (twistlock) NEMA L6-20R (240 VAC, 20 A)
NOTE: If an UPS is used with the system, see the
UPS manufacturer specifications.
• Universal IEC 60309 (IP44 Blue) 2P 3W (250 VAC, 16 A)
NOTE: If an UPS is used with the system, see the
UPS manufacturer specifications.
Power cord length 3.7 m (12 ft)
Rated power consumption* Maximum of 3000 VA (3 kVA)
* If an UPS is used, the UPS must meet the voltage, frequency, and power consumption
requirements of the c-series. It is recommended that the UPS be approved for safety by a
Nationally Recognized Testing Laboratory (NRTL) such as UL or TUV. In addition, it is
recommended that the UPS meets the electromagnetic compatibility (EMC) requirements in IEC
62040-2.
Related information...
Electrical specifications and requirements, page 403
Environmental specifications and requirements, page 408
Processing module electrical specifications and requirements (i-series)
Table 19: Processing module electrical specifications and requirements (i-series)
AC power:*
• Voltage 180 VAC to 264 VAC
• Frequency 47 Hz to 63 Hz
Circuit breaker that can be reset 30 A
NOTE: If an uninterrupted power supply (UPS) is
used with the system, see the UPS manufacturer
specifications.
Heat dissipation • Idle status: 1054 Btu
• Typical running mode: 1634 Btu
NOTE: The system includes one processing module
and one system control module.
Outlet (1):
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• North America (twistlock) NEMA L6-30R (240 VAC, 30 A)
• Universal IEC 60309 (IP44 Blue) 2P 3W (250 VAC, 30/32 A)
NOTE: If an UPS is used with the system, see the
UPS manufacturer specifications.
Power cord length 3.7 m (12 ft)
Rated power consumption* Maximum of 4000 VA (4 kVA)
* If an UPS is used, the UPS must meet the voltage, frequency, and power consumption
requirements of the i-series. It is recommended that the UPS be approved for safety by a
Nationally Recognized Testing Laboratory (NRTL) such as UL or TUV. In addition, it is
recommended that the UPS meets the electromagnetic compatibility (EMC) requirements in IEC
62040-2.
Related information...
Electrical specifications and requirements, page 403
Environmental specifications and requirements, page 408
Optical specifications (c-series)
Table 20: Optical specifications (c-series)
Light source Tungsten-halogen lamp
Detector Silicon photodiode array
Light path length 5 mm ± 0.02 mm
Photometric method Diffraction grating
Reaction cuvette Rectangular glass cuvette
Wavelengths 16 wavelengths (nm): 340, 380, 404, 416, 450, 476,
500, 524, 548, 572, 604, 628, 660, 700, 748, and
804
Photometric range -0.1 Abs to 3.2 Abs (converted to a 10 mm light path
length)
Linearity ≤ ± 2% at 2.0 Abs
Related information...
Specifications and requirements, page 394
Water and liquid waste specifications and requirements
Water and liquid waste specifications and requirements provide a basic overview of the Alinity ci-
series.
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For additional characteristics that are specific to a processing module, see the appropriate
module type.
Table 21: Water and liquid waste specifications and requirements
Water quality:
• Maximum microbial contamination ≤ 1000 colony-forming units per mL
• Minimum resistivity 1 MΩ/cm at 25°C (77°F)
• Pressure (at the system control module) 10 psi to 90 psi
IMPORTANT: Do not process samples when
maintenance is performed on the purified
water system. After maintenance is
completed, ensure that the pressure is within
specifications.
• Temperature 15°C (59°F) to 37°C (98.6°F)
Liquid waste configuration (system control Maximum of 2 gravity-fed waste tubes and
module) 2 pressure waste tubes
Drainage port:
• Location Within 3 m (9.5 ft) from the rear of the system
• Height • c-series ≤ 10 cm (4 in.) above floor level
• i-series ≤ 50.8 cm (20 in.) above floor level
NOTE: If the drainage port specifications are not NOTE: In a multimodule system, use the
met or if the drain is located in a sink or is specifications for the most restrictive processing
otherwise elevated, the external waste pump module type.
(optional accessory) must be used.
Related information...
Specifications and requirements, page 394
Processing module water and liquid waste specifications and requirements (c-series), page 407
Processing module water and liquid waste specifications and requirements (i-series), page 408
Processing module water and liquid waste specifications and requirements (c-series)
Table 22: Processing module water and liquid waste specifications and requirements (c-
series)
Purified water consumption per processing
module:
• Average 27 L/h
• Maximum (during cuvette wash) ≤ 30 L/h
Liquid waste configuration 2 gravity-fed waste tubes and 1 pressure waste tube
Each waste tube drains to the system control
module waste manifold.
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Liquid waste output per processing module:
• Average 30 L/h
• Maximum (during water bath exchange) ≤ 200 L/h
• High-concentration waste ≤ 2.5 L/h
Drainage capacity per processing module ≥ 300 L/h
Related information...
Water and liquid waste specifications and requirements , page 406
Processing module water and liquid waste specifications and requirements (i-series)
Table 23: Processing module water and liquid waste specifications and requirements (i-
series)
Purified water consumption:
• Average ≤ 10 L/h
• Peak flow rates • ≤ 20 L/h (maximum of 15 min)
• ≤ 30 L/h (maximum of 2 min during the prime
of the wash buffer dilution assembly)
Liquid waste configuration 1 gravity-fed waste tube and 1 pressure waste tube
Each waste tube drains to the system control
module waste manifold.
Liquid waste output per processing module:
• Average 8 L/h
• Maximum (during the prime of the wash buffer 30 L/h
dilution assembly)
Drainage capacity per processing module 0.5 L/min or 30 L/h for a maximum of 2 min
Related information...
Water and liquid waste specifications and requirements , page 406
Environmental specifications and requirements
Table 24: Environmental specifications and requirements
Altitude 30.8 m (100 ft) below sea level to 2590.8 m
(8500 ft) above sea level
Electrical safety parameters:
• Installation category II (overvoltage category)
• Pollution degree 2
Heat dissipation while in a typical running mode See electrical specifications and requirements that
are specific to a module.
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Humidity • Relative humidity from 20% through 85%
• Maximum dew point of 22.3°C (72.14°F) at
standard atmospheric pressure
Noise level Does not exceed 80 dBA during normal operation
above a reference sound pressure of 20 µPa
Placement • For indoor use only. Do not install the system
near direct sunlight.
• Do not install the system near drafts from
heating and cooling vents.
Storage and transport • Keep dry.
• Fragile: Handle with care.
Temperature during operation 15°C to 30°C (59°F to 86°F)
Related information...
Specifications and requirements, page 394
System control module (SCM) electrical specifications and requirements, page 404
Processing module electrical specifications and requirements (c-series), page 404
Processing module electrical specifications and requirements (i-series), page 405
Computer and interface specifications
Table 25: Computer and interface specifications
Processor Minimum: Intel Core i7-2600 Class Processor;
3.4 GHz, 8 GB RAM
Hard drive:
• C drive Minimum: 100 GB solid-state hard drive
• D drive Minimum: 100 GB solid-state hard drive
USB flash drive Minimum: 2 GB
NOTE: Do not use a USB flash drive that is
software encrypted with password protection.
Operator interface:
• Monitor LCD (minimum 21 in.)
Speakers are included in the monitor.
• Touchscreen Standard DVI or higher connection including a USB
connector
• Keyboard Not provided. If a keyboard is provided by the user,
the keyboard needs to have a USB connection.
• Mouse Not provided. If a mouse is provided by the user, the
mouse needs to use optical movement technology
with a USB connection.
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• Bar code scanner USB connection
Symbologies (bar code types) that can be read:
• Code 128
• Standard Code 39
• Codabar
• Interleaved 2 of 5
• Data Matrix ECC 200 (reagents and supplies)
Printer drivers • Brother Mono Universal
• Cannon Generic PCL6
• Epson Standard Business
• HP Universal Printing PCL6
• Lexmark Universal v2 XL
• Samsung Universal 2
Ports • USB
• 9-PIN serial
• 2 LAN connections capable of a minimum of 1
Gbps
Host interface:
• Communications mode Bidirectional
• Connections • ASTM - Single TCP/IP
• HL7 - Dual TCP/IP
• Interface reference documents ASTM:
• CLSI LIS01-A2: Specification for Low-Level
Protocol to Transfer Messages Between
Clinical Laboratory Instruments and Computer
Systems
• CLSI LIS2-A2: Specification for Transferring
Information Between Clinical Laboratory
Instruments and Information Systems
HL7:
• HL7 version 2.5.1 Messaging Standard
• HL7 version 2.3.1 Implementation Support
Guide, Appendix C
• IHE Laboratory Technical Framework,
Laboratory Analytical Workflow (LAW) profile
Processing module interface Ethernet
Related information...
Specifications and requirements, page 394
External waste pump specifications and requirements
The external waste pump is an optional component for use with the Alinity ci-series when a floor
drain is unavailable. The pump moves waste from the waste outlet to an elevated drain.
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Related information...
Specifications and requirements, page 394
External waste pump general specifications, page 411
External waste pump electrical specifications and requirements, page 411
External waste pump clearances, page 412
External waste pump general specifications
Table 26: External waste pump general specifications
Depth 33 cm (13 in.)
Width 33 cm (13 in.)
Height 33 cm (13 in.)
Weight 8 kg (18 lb)
Related information...
External waste pump specifications and requirements, page 410
External waste pump electrical specifications and requirements
Table 27: External waste pump electrical specifications and requirements
AC power:
• North America • Voltage: 104 VAC to 126 VAC
• Frequency: 47 Hz to 63 Hz
• International • Voltage: 207 VAC to 253 VAC
• Frequency: 47 Hz to 63 Hz
NOTE: The voltage selector must be set manually.
Circuit breaker that can be reset:
• North America 1.6 A
• Universal 0.8 A
Outlet (1):
• North America NEMA 5-15 three prong (120 VAC, 15 A)
• Universal IEC 320 M grounded (220 VAC to 240 VAC)
Related information...
External waste pump specifications and requirements, page 410
External waste pump, page 123
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External waste pump clearances
Table 28: External waste pump clearances
Clearance on either side 12.7 cm (5 in.)
(for access)
Clearance in front 22.9 cm (9 in.)
(for access)
Clearance in rear 22.9 cm (9 in.)
(for access)
Related information...
External waste pump specifications and requirements, page 410
Bar code label requirements
Bar code label requirements include information about bar code guidelines and the format, label
length, and placement of bar codes.
Related information...
Specifications and requirements, page 394
1D reagent bar code label requirements (c-series), page 412
Sample bar code label requirements, page 416
1D reagent bar code label requirements (c-series)
One-dimensional (1D) reagent bar code label requirements are provided to ensure that 1D
reagent bar code labels meet the recommended guidelines and are correctly affixed to reagent
cartridges.
Related information...
Bar code label requirements, page 412
1D reagent bar code label guidelines (c-series), page 412
1D reagent bar code label data format (c-series), page 414
1D reagent bar code label placement (c-series), page 415
1D reagent bar code label guidelines (c-series)
Table 29: 1D reagent bar code label guidelines (c-series)
Component Description
Printer type Use a printer with a minimum resolution of 300 dots per inch (DPI). The
appropriate maintenance of a bar code printer is essential.
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Component Description
NOTE: Laser and ink-jet printers with resolutions that are less than
300 DPI and dot-matrix printers are not recommended to produce
acceptable labels.
Label stock Use a good-quality, white label stock. The black ink used for bar codes
must be compatible with the label stock used for bar codes.
Printed labels must be clean and dry when they are presented to a bar
code reader.
NOTE: The contrast between the bars and the background label must be
the maximum contrast that is possible. For help with increasing the
contrast, contact the bar code label supplier. If the use of color on the
label is needed, a color band may be used outside the bar code portion
of the label. For optimal performance, use only black bars on a white
background for the bar code portion of the label.
When labels are printed, the system software provides the following
Avery label templates:
• 5520
• L4773
• L7060
Bar code print quality Use labels with an American National Standards Institute (ANSI) grade of
A, B, or C.
Label print quality is an important factor that affects the functionality of
the bar code reader to correctly decode label information. The
performance of the bar code reader can be enhanced by using labels
with an ANSI grade of A, B, or C. Although bar code labels with ANSI
grades lower than C can provide valid reads, the number of no reads is
higher and the possibility of misreads is increased.
NOTE: ANSI document X3.182-1990, Guideline for Bar Code Print Quality,
provides a standardized methodology to measure and grade bar code
print quality. As a usual practice, evaluate all bar code labels according
to this methodology. For help with grading the labels, contact the bar
code label supplier or the print supplier. In addition, commercially
available verifier systems can perform these evaluations.
Symbology The symbology to use on the c-series is Code 128.
Length Maximum length of the printed bar code is 50 mm (1.97 in.).
Height Minimum height of the printed bar code is 10 mm (0.39 in.).
Quiet zone Minimum quiet zone distance is 5 mm (0.2 in.).
The quiet zone is the distance from the left edge of the label to the first
black bar and from the last black bar to the right edge of the label.
Density Minimum density (narrow bar width) is 7.5 mil (0.19 mm or 0.0075 in.).
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Related information...
1D reagent bar code label requirements (c-series), page 412
1D reagent bar code label data format (c-series)
Table 30: 1D reagent bar code label data format (c-series)
Digit Description
1 to 6 Reagent name: A unique six-digit alphanumeric entry is assigned to the reagent.
NOTE: The reagent name (digits 1 to 6) of the 1D reagent bar code label must be
identical to the name of the corresponding user-defined reagent.
7 to 10 Serial number: A four-digit numeric entry identifies the unique serial number of the
reagent cartridge.
Range: 0000-9999
NOTE: Each cartridge in one lot of reagent must have a unique numeric identifier.
11 to 15 Lot number: A five-digit alphanumeric entry identifies the unique lot number of the
reagent cartridge.
NOTE: The system software creates lot and serial number data for the reagent
cartridge from digits 1 through 6 of the reagent name, digits 11 through 13 of the
reagent lot number, and digits 7 through 10 of the reagent serial number. In the
system software, alpha characters that are used in lot numbers are not case
sensitive.
16 Expiration year: The one-digit numeric entry identifies the year that the reagent
expires.
Range: 0-9
The selection represents the last digit of the year. The range is then interpreted as
1 year before the selection and 8 years in the future. For example, if the current
year is 2003, the following information is applicable:
• A bar code entry of 3 represents an expiration year of 2003.
• A bar code entry of 2 represents an expiration year of 2002.
• A bar code entry of 1 represents an expiration year of 2011.
• A bar code entry of 0 represents an expiration year of 2010.
17 to 18 Expiration week: The two-digit numeric entry identifies the day of the year that the
reagent expires.
Range: 00-52
Examples:
• 00 = Expires at the end of the 7th day of the year
• 01 = Expires at the end of the 14th day of the year
• 51 = Expires at the end of the 364th day of the year
• 52 = Expires at the end of the last day of the year
NOTE: If a value greater than 52 is entered, the reagent expiration is not tracked.
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Related information...
1D reagent bar code label requirements (c-series), page 412
1D reagent bar code label placement (c-series)
Table 31: 1D reagent bar code label placement (c-series)
Orientation With the handle of the reagent cartridge facing to the right side of the
cartridge, the label can be affixed to the R1 reagent bottle. The R1
reagent bottle is the larger bottle and is positioned leftmost in the
cartridge. The printed bars of the label must be vertically oriented.
Placement The top edge of the label must be aligned with the cartridge transport
tab. The left edge of the label must be aligned with the left edge of the
R1 reagent bottle.
Vertical angle The vertical angle of the label must be ±5 degrees.
When the label is not as vertically straight as possible, the bar code
reader may not locate the required quiet zones and the start and stop
characters.
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Figure 121: Correct placement of the 1D reagent bar code label (c-series)
Related information...
1D reagent bar code label requirements (c-series), page 412
Print a 1D reagent bar code report (c-series), page 555
Sample bar code label requirements
Sample bar code label requirements are provided to ensure that sample bar code labels meet
the recommended guidelines and are correctly affixed to sample tubes.
Related information...
Bar code label requirements, page 412
Sample bar code label guidelines, page 417
SID length, page 418
Sample bar code label placement, page 418
Sample management, page 562
Load samples into sample racks, page 569
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Sample bar code label guidelines
Table 32: Bar code label guidelines
Component Description
Printer type Use a printer with a minimum resolution of 300 dots per inch (DPI). The
appropriate maintenance of a bar code printer is essential.
NOTE: Laser and ink-jet printers with resolutions that are less than
300 DPI and dot-matrix printers are not recommended to produce
acceptable labels.
Printers with resolutions that are less than 600 DPI are not recommended
to produce labels that have a 5.0 mil density (narrow bar width).
Label stock Use a good-quality, white label stock. The black ink used for bar codes
must be compatible with the label stock used for bar codes.
Printed labels must be clean and dry when they are presented to a bar
code reader.
NOTE: The contrast between the bars and the background label must be
the maximum contrast that is possible. For help with increasing the
contrast, contact the bar code label supplier. If the use of color on the
label is needed, a color band may be used outside the bar code portion
of the label. For optimal performance, use only black bars on a white
background for the bar code portion of the label.
Bar code print quality Use labels with an American National Standards Institute (ANSI) grade of
A, B, or C.
Label print quality is an important factor that affects the functionality of
the bar code reader to correctly decode label information. The
performance of the bar code reader can be enhanced by using labels
with an ANSI grade of A, B, or C. Although bar code labels with ANSI
grades lower than C can provide valid reads, the number of no reads is
higher and the possibility of misreads is increased.
NOTE: ANSI document X3.182-1990, Guideline for Bar Code Print Quality,
provides a standardized methodology to measure and grade bar code
print quality. As a usual practice, evaluate all bar code labels according
to this methodology. For help with grading the labels, contact the bar
code label supplier or the printer supplier. In addition, commercially
available verifier systems can perform these evaluations.
Symbology The following symbologies can be used on the Alinity ci-series:
• Standard Code 39
• Codabar
• Interleaved 2 of 5
• Code 128 (Subsets A, B, and C)
Quiet zone Minimum quiet zone distance is 6.35 mm (0.25 in.).
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Component Description
The quiet zone is the distance from the top edge of the label to the first
black bar and from the last black bar to the bottom edge of the label.
Density Minimum density (narrow bar width) is 5.0 mil (0.127 mm or 0.005 in.).
Ratio (wide to narrow bar) Minimum ratio: 2:1
Maximum ratio: 3:1
Sample bar code label length Generally, a 51 mm label fits a 75 mm sample tube and a 76 mm label
fits a 100 mm sample tube.
Related information...
Sample bar code label requirements, page 416
Change sample bar code settings , page 185
SID length
The following factors affect the number of characters that can fit on a sample bar code label:
• Sample bar code label length
• Sample bar code label placement
• Symbology
• Density
• Ratio
• Quiet zone
A maximum of 20 characters are permitted on the sample bar code label. However, the
maximum number of readable characters may be less than 20 for some symbologies because of
the overall label length, the narrow bar width, and the ratio.
If a checksum function is enabled when a bar code label (Code 39, Codabar, or Interleaved 2 of
5) is printed, a checksum character is added to the label. The checksum character is usually
added after the last character on the right side of the label and on the left side of the stop
character. The operator-readable portion of the label may or may not display the checksum
character. When a checksum function is used on an Interleaved 2 of 5 bar code label, use a
minimum of four characters.
Related information...
Sample bar code label requirements, page 416
Sample bar code label placement
Table 33: Sample bar code label placement
Orientation The label must be perpendicular to the axis of the tube and must be
affixed to the tube in a ladder orientation where the printed bars are
horizontal.
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Placement:
• Top • The label must not exceed the top of the tube.
• Bottom • The label must be a minimum of 8 mm from the bottom of the tube.
This placement ensures that the entire label is visible to the bar code
reader when the tube is placed into a sample rack.
Vertical angle The vertical angle of the label must be ±5 degrees.
When the label is not as vertically straight as possible, the bar code
reader may not locate the required quiet zones and the start and stop
characters.
Figure 122: Correct placement of the sample bar code label
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Figure 123: Incorrect placement of the sample bar code label
Legend:
1. Placement is too low
2. Placement exceeds vertical angle
3. Edges that are peeled loose
4. Clear tape over the label
5. Flap that extends from the label
Related information...
Sample bar code label requirements, page 416
Sample specifications and requirements
Sample specifications and requirements include criteria for onboard sample storage, sample cup
and tube specifications, and sample volume requirements. Sample type and sample volume are
assay dependent. For more information about specimen collection, preparation, and storage, see
the assay documentation.
Related information...
Specifications and requirements, page 394
Sample cup and tube specifications and requirements, page 421
Sample volume requirements, page 423
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Onboard sample storage, page 425
Sample management, page 562
Load samples into sample racks, page 569
Rerun a test or an exception for a specimen or control, page 612
Sample cup and tube specifications and requirements
The following sample cups and tubes are acceptable for use on the Alinity ci-series.
Figure 124: Alinity ci-series sample cups
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Figure 125: Alinity ci-series sample cups used with sample tubes
Measurement Maximum limit
Height 108 mm
Figure 126: Aliquot and primary sample tubes
IMPORTANT: Conical tubes can be used only for c-series whole blood applications. For sample
cup and tube requirements that are specific to assays, see the assay documentation.
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Measurement Limits
1. Height • Nominal: 75 mm to 100 mm
• Extreme: 72 mm to 102 mm
2. Outside diameter • Nominal: 10 mm to 13 mm
• Extreme: Maximum of 13.2 mm
3. Inside diameter • Nominal: NA
• Extreme: Minimum of 7.75 mm
NOTE: The use of serum filters in sample tubes is acceptable if the filter opening (inside
diameter) and the filter height meet the sample tube specifications.
Related information...
Sample specifications and requirements, page 420
Sample volume requirements
Sample volume requirements depend on the sample vessel type, the onboard sample storage
conditions, and the ordered assays. For sample volume information, see the assay
documentation.
The Alinity ci-series calculates the minimum sample cup volume that is necessary to test a
sample. The sample cup volume is printed on the order list report.
NOTE:
• The minimum sample cup volume for controls and calibrators is valid for the current
inventory on all processing modules in a workstation at the time of the sample order.
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• If the minimum sample cup volume is less than 150 μL, the sample must be priority loaded
to avoid concentration effects because of sample evaporation. If the sample is not priority
loaded, a minimum volume of 150 μL is necessary to test the sample.
• To ensure accurate liquid level detection, do not fill the sample cups above the 1400 μL
graduation mark.
• The reliability of assay results cannot be guaranteed if an adequate sample volume is not
used.
• Ensure that the sample volume is adequate so that retesting can be performed if the
samples are loaded on the reagent and sample manager (RSM) and the RSM is configured
to reposition the samples automatically for retesting.
Table 34: Minimum sample volume requirements
Sample cup:
IMPORTANT: Sample cups cannot be used with
whole blood samples on a c-series because of the
potential for sample probe damage.
• c-series 50 μL (sample cup dead volume) + 8 μL
(overaspiration volume) + Combined sample volume
of the ordered assays and replicates
NOTE: The overaspiration volume in the sample
probe is dispensed into the wash cup after the
sample is pipetted for an assay that requires an
onboard dilution or has a sample volume that is
greater than 15 μL. Therefore, each time this action
occurs, an additional 8 μL overaspiration volume is
aspirated from the sample for the next assay.
• i-series 50 μL (sample cup dead volume) + Combined
sample volume of the ordered assays and replicates
Aliquot tube volumes The minimum sample volume must not be less than
8 mm from the bottom of the tube.
Primary tube volumes The minimum sample volume must not be less than
8 mm above the separation point (clot, gel
separator, or plasma or red cell interface) to
prevent contamination of the sample during
aspiration.
Primary tube volumes (whole blood) The maximum sample volume must not be more
than 78 mm above the bottom of the sample tube.
Related information...
Sample specifications and requirements, page 420
Requirements for handling the specimens, page 716
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Onboard sample storage
The Alinity ci-series requires a minimum of 150 µL for routine testing of controls and specimens.
This recommendation supports onboard sample storage for 3 hours under average laboratory
conditions without observable concentration effects because of sample evaporation. The
reliability of assay results cannot be guaranteed if the recommendation is not followed.
The following table describes the approximate amount of time required to decrease the weight of
various starting sample volumes by 5% when the weight is measured in sample cups under
different environmental conditions.
The high and low temperatures (30°C and 15°C) were tested with low humidity. An environment
of 25°C and 45% relative humidity (RH) is considered to be representative of average laboratory
conditions.
Table 35: Onboard sample storage
Onboard time 15°C 25°C 30°C
(h) 15% RH 45% RH 15% RH
1 60 µL 60 µL 100 µL
2 70 µL 80 µL 180 µL
3 100 µL 120 µL 280 µL
4 130 µL 160 µL 365 µL
5 160 µL 200 µL 450 µL
Related information...
Sample specifications and requirements, page 420
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Performance characteristics and specifications
Specifications and requirements Section 4
NOTES
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Section 5 Operating instructions
Introduction
This section provides instructions on how to perform normal operating procedures on the Alinity
ci-series.
Before operating the system, become familiar with hardware components of the system and with
fundamental principles of the user interface.
Related information...
System cycle power, start, pause, and stop, page 428
Log On screen, page 454
Notepad flyout, page 458
Home screen, page 463
Consumable inventory management, page 500
Reagent and sample management, page 523
Specimen, calibration, and control orders, page 578
Results screen, page 616
Quality control analysis, page 637
Print flyout, page 658
Search flyout, page 664
Archive flyout, page 666
Insert and remove a USB flash drive, page 671
Use or function, page 47
Calibration procedures, page 673
Mechanical hazards, page 735
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System cycle power, start, pause, and stop Section 5
System cycle power, start, pause, and stop
To perform certain tasks, the operator may need to cycle power to the entire Alinity ci-series, to
the reagent and sample manager (RSM), or to one or more processing modules.
To cycle power, the specific component must be powered off and then must be powered on
after a certain time period has elapsed. After the power is on, a start must be performed to
transition the instrument status to Idle.
Based on the instrument status of the RSM and the processing module, a pause may be
required so that the following tasks can be performed:
• Maintenance and diagnostics
• Component replacement
• Loading of c-series sample onboard wash solutions
Related information...
Operating instructions, page 427
Cycle power to the system, page 428
Cycle power to the processing module and the reagent and sample manager (RSM), page 432
Power on the processing module, page 436
Power off the processing module, page 440
Power on the reagent and sample manager (RSM), page 444
Power off the reagent and sample manager (RSM), page 446
Start the processing module and the reagent and sample manager (RSM), page 447
Pause the processing module, page 447
Pause the reagent and sample manager (RSM), page 448
Stop the processing module and the reagent and sample manager (RSM), page 449
Perform an emergency shutdown, page 449
Long-term shutdown (i-series), page 452
Cycle power to the system
Required instrument • Processing module: Offline, Stopped, Warming, or Idle
status
• Reagent and sample manager (RSM): Offline, Stopped,
or Idle
NOTE: The instrument status for each processing module and the RSM must be one of the
required statuses to ensure that sample processing is not interrupted.
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Perform this procedure to cycle power to the system control module (SCM), the RSM, and one
or more processing modules to reestablish communication among the system components, to
store configuration information, or to troubleshoot the system.
1. On the menu bar, tap the Home icon.
2. On the Home screen, tap Shutdown.
3. When a confirmation message is displayed, tap Yes.
The user interface (UI) computer powers off when the system software completes the
shutdown.
4. Open the SCM front door.
5. Move the SCM power switch downward.
NOTE: When the SCM power switch is turned off, the power is turned off to the RSM for all
processing modules in a multimodule system.
6. Open the front electronics door of each Alinity c processing module in the system.
7. Locate the power switch for each Alinity c processing module.
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Figure 127: Alinity c processing module power switch
8. Locate the main power breaker for each Alinity i processing module.
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Section 5 System cycle power, start, pause, and stop
Figure 128: Alinity i processing module main power breaker
9. Move the power switch downward to power off each Alinity c processing module.
Power off the main power breaker of each Alinity i processing module.
10. Ensure that each processing module remains powered off for 1 minute.
11. Power on the UI computer.
12. Wait for the Log On screen to display on the UI computer.
13. Move the SCM power switch upward to power on the RSM and the SCM bar code scanner.
14. Move the power switch upward to power on each Alinity c processing module.
Power on the main power breaker of each Alinity i processing module.
NOTE: After the power is turned on, the RSM and the processing modules initialize and the
instrument statuses transition to Stopped.
15. Log on to the system software.
16. To transition the instrument statuses to Idle, start the RSM and each processing module.
17. Close the front electronics door of each Alinity c processing module.
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18. Close the SCM front door.
Related information...
System cycle power, start, pause, and stop, page 428
Log on, page 457
Cycle power to the processing module and the reagent and sample
manager (RSM)
Required instrument • Processing module: Offline, Stopped, Warming, or Idle
status
• Reagent and sample manager (RSM): Offline, Stopped,
or Idle
NOTE: The instrument status for each processing module and the RSM must be one of the
required statuses to ensure that sample processing is not interrupted.
Perform this procedure to cycle power to the RSM and one or more processing modules to
reestablish communication with the system control module (SCM), to store configuration
information, or to troubleshoot the system.
1. Open the SCM front door.
2. Move the SCM power switch downward.
NOTE: When the SCM power switch is turned off, the power is turned off to the RSM for
each processing module in a multimodule system and for the SCM bar code scanner.
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3. Open the front electronics door of one or more of the processing modules.
4. Locate the processing module power switch for one or more of the processing modules.
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Figure 129: Alinity c processing module power switch
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Section 5 System cycle power, start, pause, and stop
Figure 130: Alinity i processing module power switch
5. Move the processing module power switch downward to power off one or more of the
processing modules.
6. Ensure that each processing module remains powered off for 1 minute.
7. Move the SCM power switch upward to power on the RSM and the SCM bar code scanner.
8. Move the processing module power switch upward to power on one or more of the
processing modules.
NOTE: After the power is turned on, the RSM and one or more of the processing modules
initialize and the instrument statuses transition to Stopped.
9. To transition the instrument statuses to Idle, start the RSM and one or more of the
processing modules.
10. Close the front electronics door of one or more of the processing modules.
11. Close the SCM front door.
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Related information...
System cycle power, start, pause, and stop, page 428
Restore a backup (CSC Logon), page 327
Start the processing module and the reagent and sample manager (RSM), page 447
Power on the processing module
Prerequisite Confirm that the following criteria are met to ensure the
appropriate initialization of communication between the
system components:
• The system control module is powered on and the user
interface is displayed.
• One or more processing modules have been powered off
for a minimum of 1 minute.
Perform this procedure to power on one or more of the processing modules.
NOTE: If only the front power switch of a processing module is off, the reagent carousel power
is maintained.
1. Locate the main power breaker of the processing module.
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Figure 131: Alinity c processing module main power breaker
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Figure 132: Alinity i processing module main power breaker
2. If the main power breaker of the processing module is off, move the breaker to the ON/I
position.
3. Open the front electronics door of the processing module.
4. Locate the power switch of the processing module.
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Figure 133: Alinity c processing module power switch
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System cycle power, start, pause, and stop Section 5
Figure 134: Alinity i processing module power switch
5. If the power switch of the processing module is off, move the switch upward to power on the
processing module.
NOTE: After the power is turned on, the processing module initializes and the instrument
status transitions to Stopped.
6. To transition the instrument status to Idle, start the processing module.
7. Close the front electronics door of the processing module.
Related information...
System cycle power, start, pause, and stop, page 428
Start the processing module and the reagent and sample manager (RSM), page 447
Power off the processing module
Required instrument Offline, Stopped, Warming, or Idle
status
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Section 5 System cycle power, start, pause, and stop
NOTE: The instrument status for each processing module must be one of the required statuses
to ensure that sample processing is not interrupted.
Perform this procedure to power off one or more processing modules during component
replacement or troubleshooting.
NOTE: If only the front power switch of a processing module is off, the reagent carousel power
is maintained. To turn off all power to the processing module, move the main power breaker of
the module to the off position.
1. Open the front electronics door of the processing module.
2. Locate the power switch of the processing module.
Figure 135: Alinity c processing module power switch
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Figure 136: Alinity i processing module power switch
3. Move the processing module power switch downward to power off the processing module.
NOTE: To power off all processing modules in a multimodule system, the power must be
turned off separately for each module.
4. To turn off all power to the processing module, perform steps 5 and 6.
If the reagent carousel power does not need to be turned off, proceed to step 7.
5. Locate the main power breaker of the processing module.
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Figure 137: Alinity c processing module main power breaker
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Figure 138: Alinity i processing module main power breaker
6. Move the main power breaker of the processing module to the OFF/O position to turn off all
power to the processing module.
7. Let the processing module power remain off for a minimum of 1 minute before the power is
turned on again.
8. Close the front electronics door of the processing module.
To power off the Alinity i processing module for more than 7 days, perform a long-term
shutdown.
Related information...
System cycle power, start, pause, and stop, page 428
Power on the reagent and sample manager (RSM)
Prerequisite Confirm that the user interface computer is powered on and
the user interface is displayed to ensure the appropriate
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initialization of communication between the system
components.
Perform this procedure to power on the reagent and sample manager (RSM).
NOTE: The SCM power switch provides power to the RSM.
1. Open the SCM front door.
2. Move the SCM power switch upward.
NOTE: When the SCM power switch is turned on, the power is turned on for the RSM of
each processing module in a multimodule system. After the power is turned on, the RSM
initializes and the instrument status transitions to Stopped.
3. To transition the instrument status to Idle, start the RSM.
4. Close the SCM front door.
Related information...
System cycle power, start, pause, and stop, page 428
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System cycle power, start, pause, and stop Section 5
Start the processing module and the reagent and sample manager (RSM), page 447
Power off the reagent and sample manager (RSM)
Required instrument Offline, Stopped, Warming, or Idle
status
NOTE: The instrument status for the RSM must be one of the required statuses to ensure that
sample processing is not interrupted.
Perform this procedure to power off the RSM to perform maintenance or troubleshooting
procedures.
1. Open the system control module (SCM) front door.
2. Move the SCM power switch downward.
NOTE: When the SCM power switch is turned off, the power is turned off for the RSM of
each processing module in a multimodule system and for the SCM bar code scanner.
3. Close the SCM front door.
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Related information...
System cycle power, start, pause, and stop, page 428
Start the processing module and the reagent and sample manager
(RSM)
Required instrument Stopped or Idle
status
Perform this procedure to complete the following tasks:
• Initialize a processing module or the reagent and sample manager (RSM) and transition the
instrument status from Stopped to Idle.
• Reinitialize a processing module or the RSM when the instrument status is Idle.
• Prepare for sample processing.
1. On the menu bar, tap the Home icon.
2. On the Home screen, perform one of the following steps:
– Tap one or more of the processing modules or the RSM.
– Tap one or more of the processing modules and the RSM.
3. Tap Start.
Related information...
System cycle power, start, pause, and stop, page 428
Cycle power to the processing module and the reagent and sample manager (RSM), page 432
Power on the processing module, page 436
Power on the reagent and sample manager (RSM), page 444
Replace the level sensor for Pre-Trigger Solution, Trigger Solution, or Concentrated Wash Buffer
(i-series), page 906
Replace the diluted wash buffer level sensor (i-series), page 909
Empty the bulk solution reservoirs (i-series), page 1297
Empty the diluted wash buffer reservoir (i-series), page 1301
Remove racks from the sample positioners, page 1305
Pause the processing module
Required instrument Running or Processing
status
Perform this procedure to transition the instrument status of the processing module from Running
or Processing to Idle. The instrument status must be Idle to perform the following tasks:
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• Maintenance and diagnostics
• Component replacement
• Loading of c-series sample onboard wash solutions
1. On the menu bar, tap the Home icon.
2. On the Home screen, tap one or more of the processing modules.
3. Tap Pause.
4. When a confirmation message is displayed, tap Yes.
NOTE: When the processing module is paused, the instrument status of the module transitions to
Pausing. Then, the processing module performs the following steps:
• Completes the aspiration for the test in process (i-series).
• Completes the aspiration for each test for the sample in process (c-series).
• Returns the sample rack to the reagent and sample manager.
• Transitions to Idle status. All scheduled tests remain as scheduled until the instrument status
of the processing module transitions to Idle. After the processing module transitions to Idle
status, all scheduled tests become exceptions.
The instrument status of the processing module transitions to Idle unless the Run button is
selected to initiate a run before the status transitions.
NOTE: Do not lift a front or rear processing center cover before the instrument status of the
processing module transitions to Idle.
Related information...
System cycle power, start, pause, and stop, page 428
Pause the reagent and sample manager (RSM)
Required instrument Running
status
Perform this procedure to transition the instrument status of the reagent and sample manager
(RSM) from Running to Idle. The instrument status must be Idle to perform the following tasks:
• Perform maintenance procedures or diagnostic procedures.
• Remove a rack or cartridge when the status indicator is amber.
• Stop the transportation of samples to one or more of the processing modules.
1. On the menu bar, tap the Home icon.
2. On the Home screen, tap the RSM.
3. Tap Pause.
4. When a confirmation message is displayed, tap Yes.
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NOTE: When the RSM is paused, the instrument status of the RSM transitions to Pausing.
The processing module completes sample aspiration for all scheduled tests and the RSM
returns the racks to their original locations. Scheduled loading and unloading of reagent
cartridges are completed. The instrument status of the RSM transitions to Idle unless the
Run button is selected to initiate a run before the status transitions.
NOTE: Do not lift a front processing center cover before the instrument status of the processing
module transitions to Idle.
Related information...
System cycle power, start, pause, and stop, page 428
Stop the processing module and the reagent and sample manager
(RSM)
Required instrument Running, Processing, or Idle
status
Perform this procedure to transition the instrument status of the system from Running,
Processing, or Idle to Stopped.
1. On the menu bar, tap the Home icon.
2. On the Home screen, perform one of the following steps:
– Tap one or more of the processing modules or the RSM.
– Tap one or more of the processing modules and the RSM.
3. Tap Stop.
4. When a confirmation message is displayed, tap Yes.
Related information...
System cycle power, start, pause, and stop, page 428
Perform an emergency shutdown
Perform this procedure to shut down the system when an emergency situation occurs.
1. Locate the main power breaker for the system control module (SCM) and all processing
modules.
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Figure 139: SCM main power breaker
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Section 5 System cycle power, start, pause, and stop
Figure 140: Alinity c processing module main power breaker
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Figure 141: Alinity i processing module main power breaker
2. Move each main power breaker to the OFF/O position.
3. Unplug the power connector from the power supply.
IMPORTANT: To remove all power to all processing modules and the reagent and sample
manager, unplug the power connector from the power supply for each processing module
and the SCM.
Related information...
System cycle power, start, pause, and stop, page 428
Long-term shutdown (i-series)
If the Alinity i-series needs to be shut down for more than 7 days, a long-term shutdown
procedure must be performed. The procedure flushes the system with water and air to remove
bulk solutions from pumps and tubing. The procedure prevents salt buildup, which may cause
damage to the system. Contact an Abbott Laboratories representative to perform the long-term
shutdown procedure.
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Related information...
System cycle power, start, pause, and stop, page 428
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Log On screen Section 5
Log On screen
On the Log On screen, the operator can view the following information:
• System information
• Status information
The operator can log on to the computer.
Related information...
Operating instructions, page 427
Log On screen element descriptions, page 454
Log on, page 457
Lock the user interface, page 457
Descriptions of access levels, page 158
Log On screen element descriptions
On the Log On screen, the operator can log on to the system and can view system and status
information for all modules.
Elements
Log On area
Used to enter an operator ID and a four-digit numeric pin to log on to the system. The system
has three types of access levels: General, Supervisor, and Administrator.
Log On Used to enter an operator ID or to display the identification of
the previous operator. The default logon is Admin (system
administrator). The following elements are available:
, + Done The Plus button displays a box that is
used to enter the operator ID. The
operator ID can contain a maximum of
12 alphanumeric characters. The +
Done button displays the operator ID
that was entered. The button switches
between and + Done.
Four operator logon Displays the identification of the last
buttons four operators who logged on to the
system.
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Four circles Used to indicate the entry of the four-
digit PIN. As each digit of the PIN is
entered, each circle is shaded.
Numeric keypad Used to enter the four-digit PIN for the
operator ID. The Clear All button is
used to clear all digits that were
entered. The Backspace button is used
clear the last digit that was entered.
If the system is configured for a
password-controlled logon, the
challenge ID and password must be
configured before the password-
controlled logon is used.
System Information area
Displays the current statuses of tests in process on the system.
Time of Completion Displays the completion time for the last test in process on
the system.
Total Samples Displays the total number of samples that have a status of
Scheduled, Running, or In Process.
Orders Pending Displays the number of test orders that have a status of
Pending, Scheduled, Running, or In Process.
Exceptions Displays the number of exceptions that have not been rerun
or released. The number is displayed in red text.
System Status area
Displays badges to indicate the statuses of instruments, reagents, and supplies for all system
modules.
Instrument Status Displays the overall instrument status for all system modules.
icon The instrument status is indicated by the following badges:
Green check mark The instrument status for all modules is
Running or Processing.
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Amber circle The instrument status for one or more
modules is Idle, Initializing, Warming,
Pausing, or Maintenance.
Red triangle The instrument status for all modules is
Offline or Stopped.
Reagent Status icon Displays the overall reagent status for all system modules.
The status of reagents loaded on the system is indicated by
the following badges:
Green check mark The reagent status for all modules is
OK, Mixing, Overridden, or Disabled.
Amber circle One or more reagent carousel inventory
items have reached or exceeded the
configured low alert setting.
Red triangle One or more cartridges or racks have a
status of Expired, LLS Error, Empty, No
Assay, Incomplete, BC Fail, or
Undefined.
Supply Status icon Displays the overall status of supplies for all system
processing modules. The status of the supplies is indicated by
the following badges:
Green check mark The status of supply items and waste
containers for all processing modules is
OK.
Amber circle One or more supply items have
reached or exceeded the configured
low alert setting.
Red triangle One or more supply items are empty or
expired, or the waste container is full.
Function buttons
? Displays Help from the operations manual for the active
screen, flyout, or message code.
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Related information...
Log On screen, page 454
Descriptions of screen elements, page 127
Log on
Perform this procedure to log on to the Alinity ci-series.
1. If the Log On screen is displayed, proceed to step 2.
If any other screen is displayed, tap the Lock button .
2. Tap an operator logon button.
If the appropriate operator logon button is not displayed, perform the following steps:
a. Tap the Plus button .
b. Type the operator ID.
c. Tap the + Done button.
3. To display the Home screen, tap the four-digit PIN for the operator ID.
Related information...
Log On screen, page 454
Cycle power to the system, page 428
Lock the user interface
Perform this procedure to lock the user interface.
NOTE: When the user interface is locked, the operator is not logged off. Any samples that are in
process generate results with the last logged-on operator ID until a new operator logs on.
• On the screen header, tap the Lock button .
Related information...
Log On screen, page 454
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Notepad flyout Section 5
Notepad flyout
The Notepad feature allows operators to document information that is posted to each user
account. For example, notes can be created to provide the instrument status, the status of
sample processing, or laboratory procedures and guidelines. Pinned notes cannot be deleted
from the personal view of an operator. The maximum number of notes displayed for all operators
is 99.
In the Notepad flyout, the operator can view all notes.
The operator can perform the following functions:
• Create a note.
• Add a comment to a note.
• Delete notes from the personal view of the operator.
• Pin or unpin notes that the operator created.
The system administrator can pin or unpin any operator notes.
Related information...
Operating instructions, page 427
View a note, page 458
Create a note, page 459
Pin or unpin a note, page 459
Edit a note, page 460
Add a comment to a note, page 461
Delete a note, page 461
Delete all unpinned notes, page 462
View a note
Perform this procedure to view a note. A blue dot indicates a note or comment that has not been
read.
1. On the screen header, tap Notepad.
2. In the list of notes in the Notepad flyout, tap a note to view.
Notes are displayed in the following order:
a. Pinned notes and comments that have not been read
b. Unpinned notes and comments that have not been read
c. Pinned notes and comments that have been read
d. Unpinned notes and comments that have been read
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NOTE: To filter the list by the author of the original note, tap an author in the Author drop-
down list.
Related information...
Notepad flyout, page 458
Create a note
Perform this procedure to create a note that is displayed to all operators when they are logged
on the system. For example, notes can be created to provide the instrument status, the status of
sample processing, or laboratory procedures and guidelines.
1. On the screen header, tap Notepad.
2. In the Notepad flyout, tap Add Note.
3. In the Add Note flyout, tap the Title box and type the title of the note.
4. Tap the Note box and type the note.
NOTE: The author of a note can edit the note until a comment is added to the note. After a
comment has been added, the note cannot be edited.
5. To save the note, tap Done.
To delete the note, tap Cancel. When the confirmation message is displayed, tap Yes.
6. To create a new note, repeat steps 2, page 459 through 5, page 459.
7. To close the Notepad flyout, tap Done.
Related information...
Notepad flyout, page 458
Pin or unpin a note
Operator access level • System administrator: Pins or unpins all operator notes
• Operator: Pins or unpins the notes that were created by
the operator
Perform this procedure to pin a note so that the note cannot be deleted by other operators from
their personal views or to unpin a note so that the note can be deleted.
1. On the screen header, tap Notepad.
2. In the list of notes in the Notepad flyout, tap a note to pin.
Notes are displayed in the following order:
a. Pinned notes and comments that have not been read
b. Unpinned notes and comments that have not been read
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Notepad flyout Section 5
c. Pinned notes and comments that have been read
d. Unpinned notes and comments that have been read
NOTE: To filter the list by the author of the original note, tap an author in the Author drop-
down list.
3. To pin a note, tap Pin.
To unpin a note, tap Unpin.
4. To pin or unpin additional notes, repeat steps 2, page 459 and 3, page 460.
5. To close the Notepad flyout, tap Done.
Related information...
Notepad flyout, page 458
Edit a note
Perform this procedure to edit a note. The author of a note can edit the note until a comment is
added to the note. After a comment has been added, the note cannot be edited.
1. On the screen header, tap Notepad.
2. In the list of notes in the Notepad flyout, tap a note to edit.
Notes are displayed in the following order:
a. Pinned notes and comments that have not been read
b. Unpinned notes and comments that have not been read
c. Pinned notes and comments that have been read
d. Unpinned notes and comments that have been read
NOTE: To filter the list by the author of the original note, tap an author in the Author drop-
down list.
3. In the note box, tap Tap to Edit.
4. Edit the note.
5. To save the edits to the note, tap Save.
To delete the edits to the note, tap Cancel.
6. To edit a different note, repeat steps 2, page 460 through 5, page 460.
7. To close the Notepad flyout, tap Done.
Related information...
Notepad flyout, page 458
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Add a comment to a note
Perform this procedure to add a comment to a note. If the original note is still available in the
view of the operator, a badge is displayed on the Notepad button to notify the operator that a
new comment was added.
NOTE: A maximum of 20 comments can be added to each note.
1. On the screen header, tap Notepad.
2. In the list of notes in the Notepad flyout, tap a note.
Notes are displayed in the following order:
a. Pinned notes and comments that have not been read
b. Unpinned notes and comments that have not been read
c. Pinned notes and comments that have been read
d. Unpinned notes and comments that have been read
NOTE: To filter the list by the author of the original note, tap an author in the Author drop-
down list.
3. Tap Add Comment.
4. In the Comment box in the Add Comment flyout, type a comment.
5. To save the comment, tap Done.
To delete the comment, tap Cancel. When the confirmation message is displayed, tap Yes.
6. To add a comment to a different note, repeat steps 2, page 461 through 5, page 461.
7. To close the Notepad flyout, tap Done.
Related information...
Notepad flyout, page 458
Delete a note
Operator access level • System administrator: Deletes pinned notes from the
views of all operators
• Operator: Deletes pinned notes, which were created by
the operator, from the views of all operators and deletes
unpinned notes from the view of the operator
Perform this procedure to delete pinned and unpinned notes. Unpinned notes are deleted from
the view of the operator. Pinned notes are deleted from the views of all operators.
1. On the screen header, tap Notepad.
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2. In the list of notes in the Notepad flyout, tap a note to delete.
Notes are displayed in the following order:
a. Pinned notes and comments that have not been read
b. Unpinned notes and comments that have not been read
c. Pinned notes and comments that have been read
d. Unpinned notes and comments that have been read
NOTE: To filter the list by the author of the original note, tap an author in the Author drop-
down list.
3. Tap Delete.
4. To delete an additional note, repeat steps 2, page 462 and 3, page 462.
5. To close the Notepad flyout, tap Done.
Related information...
Notepad flyout, page 458
Delete all unpinned notes
Perform this procedure to delete all unpinned notes from the view of the operator permanently.
1. On the screen header, tap Notepad.
2. In the Notepad flyout, tap Delete All.
3. When a confirmation message is displayed, tap Yes.
4. To close the Notepad flyout, tap Done.
Related information...
Notepad flyout, page 458
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Section 5 Home screen
Home screen
On the Home screen, the operator can view the following information:
• System information and module status information
• System conditions and module conditions that require an operator response
The operator can perform the following functions:
• Start, run, pause, and stop modules.
• Shut down the computer.
Figure 142: Home screen
Related information...
Operating instructions, page 427
Home screen element descriptions, page 464
Host Connection Status flyout, page 472
Printer Status/Queue flyout, page 475
Alinity PRO Connection Status flyout, page 477
AbbottLink Connection Status flyout, page 478
Abbott Mail Inbox screen, page 479
Instrument statuses, page 496
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Home screen element descriptions
Menu bar
Alert Center - Alert The red triangle (alert badge) navigates to the Alerts tab in
badge the Alert Center flyout. The number of alert messages in the
Alert Center is displayed next to the alert badge. Alerts are
generated for system problems that require immediate
attention.
Alert Center - The amber circle (notification badge) navigates to the
Notification badge Notifications tab in the Alert Center flyout. The number of
notification messages in the Alert Center is displayed next to
the notification badge. Notifications are generated for system
problems that do not require immediate attention.
Alert Center button Displays the Alert Center flyout.
Home icon Navigates to the Home screen.
Sample Status icon Navigates to the All Samples tab on the Sample Status
screen.
Orders icon Navigates to the All Orders tab on the Orders screen.
Results icon Navigates to one of the following tabs on the Results screen:
• Unreleased tab when no badge is present and the system
is configured for manual or hold release of specimen
results.
• Specimen tab when no badge is present and the system
is configured for automatic release of specimen results.
• Exception tab when an amber badge is present,
indicating that one or more test exceptions have been
generated.
QC icon Navigates to one of the following views:
• The All view on the Quality Control screen when no
badges are present.
• The module-specific view for the lowest numbered
module with a module-specific badge.
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An amber badge is displayed on the QC icon when one or
more quality control (QC) tests completed processing and
generated a Westgard warning.
A red badge is displayed on the QC icon when one or more
QC tests completed processing and are out of range or
generated a Westgard failure.
CAL icon Navigates to one of the following views:
• The All view of the Current tab on the Calibration Status
screen when no badges are present.
• The module-specific view for the lowest numbered
module with a module-specific badge.
An amber badge is displayed on the CAL icon when a
calibration is within 1 hour of expiration.
A red badge is displayed on the CAL icon when a calibration
has expired or failed.
Reagents icon Navigates to one of the following views:
• The All view of the Current tab on the Reagents screen
when no badges are present.
• The module-specific view for the lowest numbered
module with a module-specific badge.
NOTE: A badge can be generated for a reagent on the
reagent and sample manager (RSM). These badges are
not module specific.
An amber badge is displayed on the Reagents icon when a
low alert status is applied to one or more items in the reagent
carousel or when an item in the reagent carousel or on the
RSM is within 1 hour of lot or onboard stability expiration.
A red badge is displayed on the Reagents icon when a
cartridge or rack has a load status error or when a cartridge
or rack with a status other than OK, Mixing, Low Alert, or
Disabled is displayed on the Current tab.
Supplies icon Navigates to the Supplies screen.
If no badges are present, the module 1 view is displayed. If
badges are present, the module-specific view for the lowest
numbered module with a module-specific badge is displayed.
An amber badge is displayed on the Supplies icon when one
or more inventory items have exceeded the configured low
alert setting.
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A red badge is displayed on the Supplies icon when an
inventory item has a status other than OK, Overridden, or Low.
System button Displays a menu of commands. The following list describes
the default menu commands:
Cal/QC Inventory Navigates to the Cal/QC Inventory
screen. The Cal/QC Inventory icon can
be configured to display on the menu
bar.
Procedures Log Navigates to the Procedures Log
screen.
Abbott Mail Navigates to the Abbott Mail screen.
Configure Navigates to the Configure screen. The
Configure icon can be configured to
display on the menu bar.
System Logs Navigates to the System Logs screen.
Utilities Navigates to the Utilities screen.
Operations Manual Displays the online Alinity ci-series
(Help) Operations Manual. The Operations
Manual (Help) icon can be configured
to display on the menu bar.
File Explorer (FSE Navigates to the File Explorer window.
Logon)
Commands configured as icons are not displayed in the
menu.
Procedures icon Navigates to the Maintenance tab, the Diagnostics tab, or
the In Process tab on the Procedures screen.
An amber badge is displayed on the Procedures icon when a
maintenance procedure or a diagnostic procedure that is in
process has a status of "Waiting user response."
A red badge is displayed when a maintenance procedure is
overdue.
Create Order icon Navigates to the Specimen tab on the Create Order screen.
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Screen header
Home/System name Displays the screen title and the configured system name.
? Help button Displays Help from the operations manual for the active
screen.
Notepad button Displays the Notepad flyout. A notification badge showing the
number of unread notes is displayed on the Notepad button
when a note for the logged-on operator has not been viewed.
The badge is removed after all unread notes have been
viewed.
Lock button Locks the screen and displays the Log On screen. The
operator must enter a user name and password to unlock the
screen.
Logged on Displays the user name of the operator logged on the system.
Time Displays the current system time.
Date Displays the current system date.
Software version Displays the current version of software installed on the
system.
Abbott A symbol Displays the Print to File dialog box. The operator can print
the screen to a file or a configured printer.
System Status bar
The System Status bar provides system-monitoring information and status information for
devices connected to the system. The following statuses may be displayed on the System
Status bar: Host, Printer, Alinity PRO, AbbottLink, and Abbott Mail.
Host button Displays the Host Connection Status flyout. The button is
displayed only when the system is configured for the host
system. The status of the host communication is indicated by
the following button colors:
Green The system is communicating with the
host and detects no errors.
Red Communication is unavailable.
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Printer button Displays the Printer Status/Queue flyout. The button is
displayed only when the system is configured for a printer.
The status of the printer connection is indicated by the
following button colors:
Green The printer interface detects no errors.
Yellow The printer is low on ink or is out of
paper.
Red Communication is unavailable.
Alinity PRO button Displays the Alinity PRO Connection Status flyout. The button
is displayed only when the system is configured for an Alinity
PRO interface. The status of the Alinity PRO connection is
indicated by the following button colors:
Green The system is communicating with
Alinity PRO and detects no errors.
Red Communication with Alinity PRO has an
error condition.
AbbottLink button Displays the AbbottLink Connection Status flyout. The button
is displayed only when the system is configured for
AbbottLink. The status of the AbbottLink communication is
indicated by the following button colors:
Green The system is communicating with
AbbottLink.
Red Communication is unavailable.
Mail button Navigates to the All tab on the Abbott Mail Inbox screen. The
button is displayed only when the system is configured for
AbbottLink. A badge displays the number of new mail items
received since the last time the Abbott Mail Inbox was viewed.
Information area
RSM image Displays the RSM, the RSM name (if configured), and the
current status for the RSM.
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Processing module Displays the module type, the module name (if configured),
image the module number, and the current status of the processing
module. A separate image is displayed for each processing
module on the system. The following status updates are
displayed on the processing module image:
• Instrument Status
• Reagent Status
• Supply Status
• QC Status
• Calibration Status
• Maintenance
• Tests In Progress
Instrument Status Displays the current status of the RSM and individual
button processing modules. The instrument status is indicated by the
following colors:
Green The instrument status of the module is
Running or Processing.
Yellow The instrument status of the module is
Idle, Initializing, Warming, Pausing, or
Maintenance.
Red The instrument status of the module is
Offline or Stopped.
NOTE: The Processing status and the Warming status are not
displayed for the RSM.
Reagent Status button Navigates to the Current tab on the Reagent Status screen
for the module selected. The status of reagents loaded in the
reagent carousel and loading area of the RSM is indicated by
the following colors:
Green The cartridge status is OK, Mixing,
Overridden, or Disabled.
Yellow The volume of one or more reagent
carousel items is below the configured
low alert setting.
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Red One or more reagent carousel items
have a cartridge status of Expired, LLS
Error, Empty, No Assay, Incomplete, BC
Fail, Load Error, or Undefined. A
reagent status of Empty triggers a red
status only if no additional tests for the
reagent are present on the module.
Supply Status button Navigates to the Supplies screen for the module selected.
The status of supplies loaded on the system is indicated by
the following colors:
Green The status of all supply items and the
waste container is OK.
Yellow The volume of a supply item is at or
below the configured low alert setting,
the waste container is near capacity, or
the ICT module has exceeded the
warranty period (number of days on the
system or number of samples
processed).
Red A supply item is empty or the waste
container is full.
QC Status button Navigates to the Quality Control Summary screen. The status
of the quality control is indicated by the following colors:
Green All control results are within the
acceptable range. No Westgard failures
or warnings for the module are present.
Yellow A Westgard warning has occurred on
the module or an onboard control has
exceeded the lot or stability expiration.
Red A control result, lot, or level for the
module is out of range or has a
Westgard failure status.
Calibration Status Navigates to the Current tab on the Calibration Status screen
button for the module selected. The status of current assay
calibrations is indicated by the following colors:
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Green All calibrations for onboard reagents
are Active, Pending QC, or In Process.
Yellow One or more calibrations for onboard
reagents are within 1 hour of expiration.
Red One or more calibrations for onboard
reagents have expired or failed, or are
not active.
Maintenance button Navigates to the Maintenance tab or the In Process tab on
the Procedures screen for the module selected. The status of
the system maintenance is indicated by the following colors:
Green All required maintenance procedures
have been performed. Navigates to the
Maintenance tab.
Yellow A maintenance procedure or a
diagnostic procedure is in process and
requires an operator response.
Navigates to the In Process tab.
Red One or more maintenance procedures
are overdue. Navigates to the
Maintenance tab.
Tests In Progress Displays the total number of tests in progress (Scheduled, In
button Process, and Running). If no tests are in progress on the
module, three dashes are displayed. Navigates to the All
Orders tab on the Orders screen.
Total Samples Displays the total number of samples with a status of
Scheduled, Running, or In Process. Navigates to the Sample
Status screen.
Sample Status button Navigates to the Sample Status screen.
Exceptions Displays the number of exceptions in the Exception tab on
the Results screen that have not been rerun or released.
Navigates to the Exception tab on the Results screen.
Exceptions button Navigates to the Exception tab on the Results screen.
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Orders Pending Displays the number of test orders with a status of Pending,
Scheduled, Running, or In Process. Navigates to the All
Orders tab on the Orders screen.
Orders button Navigates to the All Orders tab on the Orders screen.
Function buttons
Shutdown Displays a message requesting confirmation to shut down the
system.
Start Initializes and homes the RSM or one or more selected
processing modules, and transitions the instrument status
from Stopped to Idle.
Stop Displays a message requesting confirmation to transition the
instrument status of the RSM or the selected processing
module from Running, Processing, or Idle to Stopped.
Pause Displays a message requesting confirmation to transition the
instrument status of the RSM from Running to Idle or to
transition the instrument status of the selected processing
module from Running or Processing to Idle.
Run Transitions the instrument status of the RSM or the selected
processing module from Stopped, Idle, or Pausing to Running
or Processing (only for c-series).
Related information...
Home screen, page 463
Descriptions of screen elements, page 127
Instrument statuses, page 496
Host Connection Status flyout
In the Host Connection Status flyout, the operator can view the status of the host connection.
The operator can perform the following functions:
• Cancel pending transmissions.
• Enable or disable the host connection.
Related information...
Home screen, page 463
Host Connection Status flyout element descriptions, page 473
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Descriptions of host connection statuses, page 473
Cancel pending transmissions, page 474
Enable or disable the host connection, page 474
Host Connection Status flyout element descriptions
The Host Connection Status flyout provides host communication information.
Elements
Host Type Displays the type of host communication interface: HL7 or
ASTM.
Connection Status Displays the current connection status for the host
communication interface: Enabled, Disabled, Disabled and
Query Suspended.
Queued Messages Displays the number of messages pending transmission to the
host interface connection.
Message Displays a message code to explain the disabled host
communication status.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Enable Resets the host communication interface.
Disable Disconnects the host communication interface.
Clear Queue Removes all messages pending transmission to the host. The
button is unavailable until messages are waiting to be
transmitted.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Host Connection Status flyout, page 472
Descriptions of host connection statuses
Host connection status information is used to determine if the host connection is enabled or is
disabled.
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The following list provides descriptions of the host connection statuses:
Enabled The connection is available for host communication.
Disabled The connection is unavailable for host communication
because of a communication error, or the operator has
manually disabled the connection.
Disabled and Query The connection is unavailable for host communication
Suspended because of a communication error that is associated with a
host query. The configuration setting for query mode is on, but
the system has suspended the query mode operation until the
host connection is enabled.
Related information...
Host Connection Status flyout, page 472
Cancel pending transmissions
Prerequisite The host connection status must be Disabled or Disabled and
Query Suspended.
Perform this procedure to clear all queued messages (including results) that are pending
transmission to the host.
1. On the menu bar, tap the Home icon.
2. On the System Status bar of the Home screen, tap Host.
3. In the Host Connection Status flyout, tap Clear Queue.
4. To close the Host Connection Status flyout, tap Done.
Related information...
Host Connection Status flyout, page 472
User interface (UI) computer corrective action procedures, page 1306
Enable or disable the host connection
Perform this procedure to enable or disable the host connection.
1. On the menu bar, tap the Home icon.
2. On the System Status bar of the Home screen, tap Host.
3. In the Host Connection Status flyout, tap one of the following options:
– Tap Enable to enable the host connection.
– Tap Disable to disable the host connection.
4. To close the Host Connection Status flyout, tap Done.
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Related information...
Host Connection Status flyout, page 472
User interface (UI) computer corrective action procedures, page 1306
Printer Status/Queue flyout
In the Printer Status/Queue flyout, the operator can view a print job in the printer queue and can
delete a print job.
Related information...
Home screen, page 463
Printer Status/Queue flyout element descriptions, page 475
View a print job in the printer queue, page 476
Delete a print job, page 476
Printer Status/Queue flyout element descriptions
The Printer Status/Queue flyout provides information about the printer status and jobs in the
printer queue for the configured default printer.
Elements
Printer Displays the name of the configured default printer.
Printer Status Displays one of the following statuses for the printer: OK or
Error.
Number of Printer Displays the number of print requests in the printer queue. A
Jobs maximum of 10 printer jobs are allowed in the queue. Print
requests are performed in the order in which they are
received.
Print Queue Displays information about individual jobs in the printer queue.
Status Displays one of the following statuses for the print request:
Queued, Printing, Error, Deleting, or Out of Paper.
Operator ID Displays the identification of the operator who submitted the
print request.
Date Displays the date and time that the print request was
submitted to the printer queue.
Document Displays the name of the document in the printer queue.
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Pages Displays the number of pages for the document in the printer
queue.
Size Displays the size of the document in the printer queue.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Delete All Deletes all print requests from the printer queue.
Delete Selected Deletes selected print requests from the printer queue.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Printer Status/Queue flyout, page 475
View a print job in the printer queue
Perform this procedure to view a print job in the printer queue.
1. On the menu bar, tap the Home icon.
2. On the System Status bar of the Home screen, tap Printer.
NOTE: If a printer is not configured, the Printer button is not displayed.
3. In the Printer Status/Queue flyout, view the print job.
4. To close the Printer Status/Queue flyout, tap Done.
Related information...
Printer Status/Queue flyout, page 475
Delete a print job
Perform this procedure to delete a print job that is printing, is waiting to be printed, or has
generated a print error.
1. On the menu bar, tap the Home icon.
2. On the System Status bar of the Home screen, tap Printer.
3. In the Printer Status/Queue flyout, perform one of the following options:
– To delete one print job in the printer queue, tap the print job, and then tap Delete
Selected.
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– To delete all print jobs in the printer queue, tap Delete All.
4. To close the Printer Status/Queue flyout, tap Done.
Related information...
Printer Status/Queue flyout, page 475
Alinity PRO Connection Status flyout
In the Alinity PRO Connection Status flyout, the operator can view the status of the Alinity PRO
connection.
Related information...
Home screen, page 463
Alinity PRO Connection Status flyout element descriptions, page 477
Alinity PRO Connection Status flyout element descriptions
The Alinity PRO Connection Status flyout provides Alinity PRO connection information.
Elements
Status Displays one of the following connection statuses for Alinity
PRO: OK or Error.
Last Update Displays the date and time of the last connection status
update.
Message Displays a message code to explain a connection status of
Error.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Alinity PRO Connection Status flyout, page 477
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AbbottLink Connection Status flyout
In the AbbottLink Connection Status flyout, the operator can view the status of the AbbottLink
connection and can restart AbbottLink.
Related information...
Home screen, page 463
AbbottLink Connection Status flyout element descriptions, page 478
Restart AbbottLink, page 478
AbbottLink Connection Status flyout element descriptions
The AbbottLink Connection Status flyout provides AbbottLink connection information.
Elements
Status Displays the connection status for AbbottLink: Connected or
Disconnected.
Last Updated Displays the date and time of the last connection status
update.
Function buttons
Restart Restarts the AbbottLink program on the user interface
computer.
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
AbbottLink Connection Status flyout, page 478
Restart AbbottLink
Perform this procedure to restart the AbbottLink software on the user interface computer.
1. On the menu bar, tap the Home icon.
2. On the System Status bar of the Home screen, tap AbbottLink.
3. In the AbbottLink Connection Status flyout, tap Restart.
The AbbottLink software stops and restarts.
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4. To close the AbbottLink Connection Status flyout, tap Done.
Related information...
AbbottLink Connection Status flyout, page 478
Abbott Mail Inbox screen
On the Abbott Mail Inbox screen, the operator can view Abbott Mail items and Abbott Mail
documentation.
The system administrator can perform the following functions:
• Accept Abbott Mail items.
• Delete Abbott Mail items.
• Request assay files.
• Request calibration data files.
• Decline system updates.
Related information...
Home screen, page 463
Abbott Mail Inbox screen, All tab element descriptions, page 480
Abbott Mail Inbox screen, Assay Files tab element descriptions, page 481
Abbott Mail Inbox screen, Assay Inserts tab element descriptions, page 482
Abbott Mail Inbox screen, System Updates tab element descriptions , page 483
Abbott Mail Inbox screen, Calibrator Data tab element descriptions (c-series), page 484
Manual File Request screen, page 486
Assay file mail description, page 489
Assay insert mail description, page 489
System update mail description, page 490
Calibrator data mail description (c-series), page 490
Descriptions of mail statuses, page 491
Descriptions of view statuses, page 491
View Abbott Mail items, page 491
View or print Abbott Mail documentation, page 492
Accept Abbott Mail items, page 492
Delete Abbott Mail items, page 493
Manually request assay files, page 493
Manually request calibrator data files, page 494
Decline Abbott Mail system updates, page 495
Print a report, page 662
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Abbott Mail Inbox screen, All tab element descriptions
The All tab displays the new and viewed mail for all categories of mail items received in the
Abbott Mail Inbox. Mail items can be filtered into four categories (Assay Files, Assay Inserts,
System Updates, and Calibrator Data) by selecting the appropriate tab.
Elements
View Status Displays a status to show whether the mail is new or has been
viewed. The mail item displays one of the following statuses:
New or Viewed.
Mail Status Displays the status of each item in the Abbott Mail Inbox. The
mail item displays one of the following statues:
• New
• Update
• Error
Category Displays the type of mail item in the Abbott Mail Inbox. The
mail item is associated with one of the following four
categories:
• Assay Files
• Assay Inserts
• System Updates
• Calibrator Data
Date/Time Displays the date and time that the mail item was received.
Subject Displays a description of the mail item.
Number Displays a number identifier for the mail item if applicable.
Revision Displays the version of the document for mail items with
revisions.
Function buttons
Install Assay Navigates to the Install/Uninstall Assays screen.
Import Cal Lot Navigates to the Calibrator Set screen.
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Select All Selects or deselects all items in a list. The button switches
between Select All and Deselect All.
Search Displays the Search flyout.
Print Displays the Print flyout.
Request Navigates to the Manual File Request screen.
Accept Used to remove assay inserts from the Abbott Mail Inbox or to
make selected mail items available for installation or import.
Delete Deletes the selected mail item.
Text Size Increases or decreases the size of text displayed.
Related information...
Abbott Mail Inbox screen, page 479
Descriptions of screen elements, page 127
Abbott Mail Inbox screen, Assay Files tab element descriptions
The Assay Files tab displays the new and viewed assay file mail items received in the Abbott
Mail Inbox.
Elements
View Status Displays a status to show whether the mail is new or has been
viewed. The mail item displays one of the following statuses:
New or Viewed.
Mail Status Displays the status of each item in the Abbott Mail Inbox. The
mail item displays one of the following statues:
• New
• Update
• Error
Date/Time Displays the date and time that the mail item was received.
Subject Displays a description of the mail item.
List Number Displays the list number associated with the assay file.
Revision Displays the assay file version.
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Function buttons
Install Assay Navigates to the Install/Uninstall Assays screen.
Select All Selects or deselects all items in a list. The button switches
between Select All and Deselect All.
Search Displays the Search flyout.
Print Displays the Print flyout.
Request Assay Navigates to the Manual File Request screen.
Accept Used to make the selected mail item available for installation.
Assay files with a version number less than or equal to the
installed assay file or a version currently available to install
are not available for installation.
Delete Deletes the selected mail item.
Text Size Increases or decreases the size of text displayed.
Related information...
Abbott Mail Inbox screen, page 479
Descriptions of screen elements, page 127
Abbott Mail Inbox screen, Assay Inserts tab element descriptions
The Assay Inserts tab displays the new and viewed assay file mail items received in the Abbott
Mail Inbox.
Elements
View Status Displays a status to show whether the mail is new or has been
viewed. The mail item displays one of the following statuses:
New or Viewed.
Mail Status Displays the status of each item in the Abbott Mail Inbox. The
mail item displays one of the following statuses:
• New
• Update
• Error
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Date/Time Displays the date and time that the mail item was received.
Subject Displays a description of the mail item.
Commodity Number Displays the commodity number assigned to the assay insert.
Revision Displays the assay insert version.
Function buttons
Select All Selects or deselects all items in a list. The button switches
between Select All and Deselect All.
Search Displays the Search flyout.
Print Displays the Print flyout.
Accept Used to set the assay insert status to Current on the Reagent
Cartridge Details screen and removes the mail item from the
Abbott Mail Inbox.
Delete Deletes the selected mail item.
Text Size Increases or decreases the size of text displayed.
Related information...
Abbott Mail Inbox screen, page 479
Descriptions of screen elements, page 127
Abbott Mail Inbox screen, System Updates tab element descriptions
The System Updates tab displays the new and viewed system update notifications and system
software updates received in the Abbott Mail Inbox.
Elements
View Status Displays a status to show whether the mail is new or has been
viewed. The mail item displays one of the following statuses:
New or Viewed.
Mail Status Displays the status of each item in the Abbott Mail Inbox. The
mail item displays one of the following statues:
• New
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• Update
• Error
Date/Time Displays the date and time that the mail item was received.
Subject Displays a description of the mail item.
TSB Number Displays the technical service bulletin (TSB) number for the
mail item.
Priority Displays the priority level of the TSB. The mail item displays
one of the following statuses: Mandatory or Optional.
Function buttons
System Updates Navigates to the System Updates screen.
Select All Selects or deselects all items in a list. The button switches
between Select All and Deselect All.
Search Displays the Search flyout.
Print Displays the Print flyout.
Accept Used to make hardware and software system updates
available for installation and removes the items from the
Abbott Mail Inbox.
Decline Used to decline the download of system update mail items.
Delete Deletes the selected mail item.
Text Size Increases or decreases the size of text displayed.
Related information...
Abbott Mail Inbox screen, page 479
Descriptions of screen elements, page 127
Abbott Mail Inbox screen, Calibrator Data tab element descriptions (c-series)
The Calibrator Data tab displays the new and viewed calibrator data mail items received in the
Abbott Mail Inbox.
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Elements
View Status Displays a status to show whether the mail is new or has been
viewed. The mail item displays one of the following statuses:
New or Viewed.
Mail Status Displays the status of each item in the Abbott Mail Inbox. The
mail item displays one of the following statues:
• New
• Update
• Error
Date/Time Displays the date and time that the mail item was received.
Subject Displays a description of the mail item.
Lot number Displays the calibrator lot number.
List number Displays the calibrator list number.
Expiration Date Displays the calibrator expiration date.
Function buttons
Import Cal Lot Navigates to the Calibrator Set screen.
Select All Selects or deselects all items in a list. The button switches
between Select All and Deselect All.
Search Displays the Search flyout.
Print Displays the Print flyout.
Request Calibrator Navigates to the Manual File Request screen.
Accept Used to make the selected mail calibrator data item available
for import.
Delete Deletes the selected mail item.
Text Size Increases or decreases the size of text displayed.
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Related information...
Abbott Mail Inbox screen, page 479
Descriptions of screen elements, page 127
Manual File Request screen
On the Manual File Request screen, the operator can view manual requests for assay files and
clinical chemistry assay calibrator data. The screen displays one pending request and the last
five completed requests.
The system administrator can use an AbbottLink connection to request manually the assay files
to send to the system software.
Related information...
Abbott Mail Inbox screen, page 479
Manual File Request screen, Assay Files tab element descriptions, page 486
Manual File Request screen, Calibrator Data tab element descriptions (c-series), page 487
Requested Categories flyout element descriptions, page 488
Descriptions of assay file request statuses, page 489
Manually request assay files, page 493
Manual File Request screen, Assay Files tab element descriptions
On the Assay Files tab, the operator can manually request the immunoassay and clinical
chemistry assay files to be downloaded.
Elements
i-series Displays the immunoassay assay categories.
c-series Displays the clinical chemistry assay categories.
Request Status Displays information about the status of the manual file
request. A maximum of five manual file requests are
displayed.
Date/Time Displays the date and time that the assay file was requested,
timed out, or was completed.
Operator ID Displays the operator ID of the operator who requested the
file.
Items Requested Displays the list of assay categories that was requested. If
one category is selected, the name of the category is
displayed. If multiple assay categories are selected, the
number of categories selected is displayed.
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Status Displays the status of the manual file request.
One of the following statues is displayed:
• Pending
• Complete
• Expired
• Failed
Message Displays more information about the status of the manual file
request.
Function buttons
Done Saves changes and displays the previously viewed screen or
closes the flyout.
Request Assay Used to request assay file downloads for the selected assay
categories.
Details Displays the Requested Categories flyout.
Text Size Increases or decreases the size of text displayed.
Related information...
Manual File Request screen, page 486
Descriptions of screen elements, page 127
Manual File Request screen, Calibrator Data tab element descriptions (c-series)
On the Calibrator Data tab, the operator can manually request the clinical chemistry calibrator
value assignment data to be downloaded.
Elements
Request Status Displays information about the status of the manual file
request. A maximum of five manual file requests are
displayed.
Date/Time Displays the date and time that the file was requested, timed
out, or was completed.
Operator ID Displays the operator ID of the operator who requested the
file.
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Items Requested Displays the list of clinical chemistry calibrator value
assignment data that was requested.
Status Displays the status of the manual file request.
One of the following statues is displayed:
• Pending
• Complete
• Expired
• Failed
Message Displays more information about the status of the manual file
request. Displays the number of calibrator data files that were
downloaded or the number of file errors if applicable.
Function buttons
Done Saves changes and displays the previously viewed screen or
closes the flyout.
Request Calibrator Used to request downloads of the clinical chemistry calibrator
value assignment data.
Text Size Increases or decreases the size of text displayed.
Related information...
Manual File Request screen, page 486
Descriptions of screen elements, page 127
Requested Categories flyout element descriptions
In the Requested Categories flyout, the operator can view requested assay categories when
multiple categories are selected.
Elements
Categories Displays a list of the requested assay categories.
Function buttons
Done Saves changes and displays the previously viewed screen or
closes the flyout.
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? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Manual File Request screen, page 486
Descriptions of assay file request statuses
Assay file request status information is used to monitor the status of the requested download.
The following list provides descriptions of the assay file request statuses. The statuses are
described in the order in which they are sorted:
Pending The request is in process.
The download speed capability of the laboratory affects the
amount of time needed to process a request. The status of a
request for an Abbott Mail item can remain as Pending for a
maximum of 24 hours.
Completed The request is completed.
Expired The request was not received within the 24-hour time-out.
Failed An error occurred and the request was not completed.
Related information...
Manual File Request screen, page 486
Assay file mail description
Abbott Mail allows assay files to be sent automatically or manually to the system software. When
a new assay file is needed on the system, the system administrator can use an AbbottLink
connection to request the new assay file to send to the system software. After the new assay file
is installed, the system software checks weekly for any updates to the assay file. If an updated
assay file is available, the updated assay file is sent automatically to the Abbott Mail Inbox
screen. The system administrator needs to review the assay file documentation before the
updated assay file is installed. If the assay file update requires specific reagents, the system
administrator needs to wait until the appropriate reagents are available before the updated assay
file is installed.
Related information...
Abbott Mail Inbox screen, page 479
Manually request assay files, page 493
Assay insert mail description
Abbott Mail allows assay inserts to be sent automatically to the system software. When a new
reagent lot is loaded on the system, the system software uses the new reagent lot number to
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request a new assay insert through an AbbottLink connection. AbbottLink determines if the new
reagent lot requires a new assay insert.
If a new assay insert is required, the new assay insert is downloaded to Abbott Mail and is
assigned to the new reagent lot in the reagent cartridge details. The status of the assay insert
remains as New until the system administrator reviews and accepts the assay insert in Abbott
Mail.
If the reagent lot uses the current assay insert, the current assay insert is assigned to the new
reagent lot.
Related information...
Abbott Mail Inbox screen, page 479
System update mail description
Abbott Mail allows system update notifications and system software updates to be sent to the
system software when new updates are available for installation. System updates are tracked as
technical service bulletins.
The following list provides the categories of Abbott Mail system updates:
Hardware notifications A hardware update is available to install on the system. An
Abbott Laboratories representative schedules and installs the
hardware update.
Software notifications A software update is available to install on the system, but the
software installer has not been downloaded. When the
software notification is accepted, the software installer is
downloaded to the system and is available for installation.
Software notifications The software notification and the software installer are
and installer downloaded to the system. When the software notification is
accepted, the software is available for installation.
Related information...
Abbott Mail Inbox screen, page 479
Calibrator data mail description (c-series)
Abbott Mail allows c-series calibrator data to be sent automatically or manually to the system
software. When new calibrator sets require calibrator data to be imported to the system, the
system administrator can use an AbbottLink connection to request the calibrator data files to
send to the system software. After the calibrator data is imported, the system software checks
weekly for any calibrator data that is associated with new lot numbers for each calibrator set.
When calibrator data is requested for a new calibrator set that has not been configured with a
calibrator lot number, all available calibrator lot number data is downloaded to the system.
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When calibrator data is requested for an existing calibrator set that has been configured with
one or more calibrator lot numbers, only the calibrator lot number data that is newer than the
configured data is sent to the system software.
Related information...
Abbott Mail Inbox screen, page 479
Manually request calibrator data files, page 494
Descriptions of mail statuses
Mail status information is used to determine if an Abbott Mail item is new, is updated, or has
produced an error.
The following list provides descriptions of the mail statuses. When the Mail Status column
header is selected, the statuses are sorted in the following order:
Error An error occurred when the mail item was downloaded from
AbbottLink.
New The mail item is not installed on the system
Update The mail item is a newer version than the mail item that is
installed on the system.
Related information...
Abbott Mail Inbox screen, page 479
Descriptions of view statuses
View status information is used to determine if an Abbott Mail item has been previously viewed.
The following list provides descriptions of the view statuses. The statuses are described in the
order in which they are sorted:
New The mail item has not been viewed by an operator.
Viewed The mail item has been viewed by an operator.
Related information...
Abbott Mail Inbox screen, page 479
View Abbott Mail items
Perform this procedure to view new and unaccepted Abbott Mail items.
1. On the menu bar, tap the Home icon.
2. On the System Status bar of the Home screen, tap Mail.
The All tab of the Abbott Mail Inbox screen displays new and unaccepted mail items.
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3. To filter the list of mail items on the Abbott Mail Inbox screen, tap a tab (or tap Search).
Related information...
Abbott Mail Inbox screen, page 479
View or print Abbott Mail documentation
Perform this procedure to view or print Abbott Mail documentation. The documentation includes
assay inserts, system update information, assay file information, and calibrator value assignment
information.
1. On the menu bar, tap the Home icon.
2. On the System Status bar of the Home screen, tap Mail.
3. In the list of mail items on the All tab of the Abbott Mail Inbox screen, tap one or more items
(or tap Select All).
4. Tap Print.
5. Under Report Selection in the Print flyout, tap the documentation type that is associated
with the mail item to print.
6. To rotate the document, use the Rotate toolbar.
7. To browse through the document, use the Page toolbar.
8. To increase or decrease the font size in the document, use the Zoom toolbar.
9. To resize the document to fit the window width ( ) or to resize the document to fit one full
page in the window ( ), use the Fit toolbar.
10. To find a word or phrase in the document, use the Find toolbar.
11. If more than one document was selected, tap Previous or Next to view the previous or next
document.
12. To print the document, tap Print.
To return to the Abbott Mail Inbox screen, tap Done.
Related information...
Abbott Mail Inbox screen, page 479
Reagents screen, page 533
Accept Abbott Mail items
Operator access level System administrator
Perform this procedure to accept Abbott Mail items. When Abbott Mail items are accepted, files
are available for installation or assay inserts are designated as reviewed by the system
administrator, and the items are removed from the Abbott Mail Inbox screen.
NOTE: Thoroughly review the Abbott Mail documentation of the item before accepting the item.
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1. On the menu bar, tap the Home icon.
2. On the System Status bar of the Home screen, tap Mail.
The All tab of the Abbott Mail Inbox screen displays new and unaccepted mail items.
3. In the list of mail items on the All tab of the Abbott Mail Inbox screen, tap one or more items
(or tap Select All).
NOTE: To filter the list of mail items, tap Search.
4. Tap Accept.
Related information...
Abbott Mail Inbox screen, page 479
Delete Abbott Mail items
Operator access level System administrator
Perform this procedure to delete the following Abbott Mail items:
• Assay files that are not wanted for installation
• Calibrator value data files that are not wanted for installation
• Assay inserts that have a mail status of Error
• System update files that have a mail status of Error
1. On the menu bar, tap the Home icon.
2. On the System Status bar of the Home screen, tap Mail.
The All tab of the Abbott Mail Inbox screen displays new and unaccepted mail items.
3. In the list of mail items on the All tab of the Abbott Mail Inbox screen, tap one or more items
(or tap Select All).
NOTE: To filter the list of mail items, tap Search.
4. Tap Delete.
Related information...
Abbott Mail Inbox screen, page 479
Manually request assay files, page 493
Manually request calibrator data files, page 494
Manually request assay files
Operator access level System administrator
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Perform this procedure to request new assay files manually. When new assay files are
requested, all assays files that are not installed or are not available to be installed are
downloaded for each assay category that is selected.
NOTE: Only one active request can be performed at a time. If an automatic request or a manual
request for a file is pending, a new request cannot be initiated.
1. On the menu bar, tap the Home icon.
2. On the System Status bar of the Home screen, tap Mail.
3. On the Abbott Mail Inbox screen, tap Request.
4. On the Assay Files tab of the Manual File Request screen, tap each assay category that
contains the assay files to download.
NOTE: An individual assay file cannot be requested to download. When new assay files are
requested, all assays files that are not installed or are not available to be installed are
downloaded for each assay category that is selected. After the assay files are downloaded,
any file that is not needed can be deleted from the Abbott Mail Inbox screen.
5. Tap Request Assay.
NOTE: The download speed capability of the laboratory affects the amount of time needed
to process a request. The status of an assay file request can remain as Pending for a
maximum of 24 hours.
6. To return to the Abbott Mail Inbox screen, tap Done.
Related information...
Abbott Mail Inbox screen, page 479
Manual File Request screen, page 486
Assay file mail description, page 489
Delete Abbott Mail items, page 493
Manually request calibrator data files
Operator access level System administrator
Perform this procedure to request new calibrator data files manually. When new calibrator data
files are requested, all calibrator data files that are not installed or are not available to be
installed are downloaded.
NOTE: Only one active request can be performed at a time. If an automatic request or a manual
request for a file is pending, a new request cannot be initiated.
1. On the menu bar, tap the Home icon.
2. On the System Status bar of the Home screen, tap Mail.
3. On the Abbott Mail Inbox screen, tap Request.
4. On the Manual File Request screen, tap the Calibrator Data tab.
5. On the Calibrator Data tab of the Manual File Request screen, tap Request Calibrator.
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NOTE: When new calibrator data files are requested, all calibrator data files that are not
installed or are not available to be installed are downloaded. After the calibrator data files
are downloaded, any file that is not needed can be deleted from the Abbott Mail Inbox
screen.
The download speed capability of the laboratory affects the amount of time needed to
process a request. The status of a file request can remain as Pending for a maximum of 24
hours.
6. To return to the Abbott Mail Inbox screen, tap Done.
Related information...
Abbott Mail Inbox screen, page 479
Calibrator data mail description (c-series), page 490
Delete Abbott Mail items, page 493
Decline Abbott Mail system updates
Operator access level System administrator
NOTE: The system administrator cannot decline mandatory
updates.
Perform this procedure to decline a system update that is not wanted. A system update that has
been downloaded successfully cannot be deleted. A system update that is declined is removed
from the Abbott Mail Inbox screen.
NOTE: Thoroughly review the system update documentation before declining the system update.
1. On the menu bar, tap the Home icon.
2. On the System Status bar of the Home screen, tap Mail.
3. On the Abbott Mail Inbox screen, tap the System Updates tab.
4. In the list of system updates on the System Updates tab, tap one or more updates (or tap
Select All).
NOTE: To filter the list of system updates, tap Search.
5. Tap Decline.
NOTE: The system administrator cannot decline mandatory updates.
6. In the Comment box in the Reason to Decline System Update flyout, type a reason to
decline for each system update.
NOTE: To decline a system update, a comment must be entered.
7. To confirm the decline of the system update, tap Done.
To cancel the decline of the system update and return to the Abbott Mail Inbox screen, tap
Cancel.
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Related information...
Abbott Mail Inbox screen, page 479
Instrument statuses
Instrument status refers to the operational modes of the Alinity ci-series. The processing
modules and the reagent and sample manager (RSM) have the following instrument statuses:
Table 36: Instrument statuses
Status Description
Offline Indicates when the processing module is not communicating with the
system control module (SCM).
This status is displayed for the following conditions:
• Power to the processing module is off.
• Power to the processing module has been turned on, but
communication between the module and the SCM has not been
reestablished.
• Communication failure between the processing module and the SCM
has occurred because of a software error or a system error.
Stopped Indicates when the processing module is turned on and is communicating
with the SCM.
This status is displayed for the following conditions:
• Power to the processing module is on, but Start on the Home screen
has not been selected.
• Stop on the Home screen was selected.
• A diagnostic procedure has completed.
• A procedure has completed with an error.
• A fatal error was detected during assay processing.
Start on the Home screen must be selected to initialize the processing
module and to transition the status to Idle.
Initializing Indicates a temporary status that occurs when Start or Run on the Home
screen is selected.
After initialization is completed, the status transitions to Running,
Processing, or Idle based on whether Start or Run on the Home screen
was selected. Initialization is specific to a module. Based on the module,
the following functions are performed:
• c-series • Initialization after Start is selected:
– Confirms that the volume of water dispensed from the cuvette
washer is adequate
• Initialization after Start or Run is selected:
– Homes the motors
– Confirms that processing center covers are closed
– Verifies that the reagent carousel inventory is adequate
– Confirms that racks and cartridges are not located on the
reagent positioner
– Confirms that the volume of the bulk solutions is adequate
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Status Description
– Confirms that the volume of the sample onboard wash solutions
is adequate
• Initialization after Run is selected:
– Washes the probes
– Washes the cuvettes
– Verifies that the supply inventory is adequate
– Sets the optics gain
• i-series • Initialization after Start or Run is selected:
– Homes the motors
– Confirms that processing center covers are closed
– Confirms that the RV unloader is in the correct position
– Performs a vacuum check
– Verifies that the reagent carousel inventory is adequate
– Confirms that racks and cartridges are not located on the
reagent positioner
• Initialization after Run is selected:
– Washes the pipettor probes
– Starts the mixing of the microparticles
– Verifies that the supply inventory is adequate
– Performs a background check
– Fills the process path load lane with clean reaction vessels
(RVs)
– Clears RVs from the pretreatment path and adds clean RVs
• RSM • Initialization after Start or Run is selected:
– Homes all moving parts
– Confirms that front processing center covers are closed for
each processing module
– Confirms that the bar code reader is functioning correctly
– Homes the sample positioner for each processing module
– Confirms that racks and cartridges are not located on the
sample positioners or the RSM transport
Warming Indicates when the processing module has completed initialization but
has not reached the required temperature.
NOTE: This status is not displayed for the RSM.
Idle Indicates when the processing module has successfully completed
initialization and is ready to accept a run request.
This status is displayed for the following conditions:
• Start is initiated and is completed (including temperature
initialization).
• Pausing status is completed.
Running Indicates when the processing module has successfully completed
initialization and is ready to process tests.
This status is displayed for the following conditions:
• Run on the Home screen was selected.
• Tests have completed processing, but Pause or Stop on the Home
screen has not been selected.
Processing Indicates when the processing module is actively processing tests.
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Status Description
For c-series, this status is displayed after Run on the Home screen is
selected and initialization is completed. During this time, cuvettes are
washed and filled with water. If a sample is not loaded on the RSM, the
module status transitions to Running after these activities are completed.
NOTE: This status is not displayed for the RSM.
Pausing Indicates when the processing module is not aspirating samples and is
completing assay processing before the module status transitions to Idle
or Stopped.
The module status transitions to Idle for the following conditions:
• Pause on the Home screen was selected.
• Supply inventory is insufficient.
When an error is detected during assay processing, the module status
transitions to Stopped.
Maintenance Indicates when a maintenance procedure or a diagnostic procedure is in
process on the processing module.
Related information...
Home screen, page 463
Instrument status transition, page 498
Home screen element descriptions, page 464
Instrument status transition
The processing module has several types of instrument statuses. The following tables describe
the progression of instrument statuses from Offline to Running and the approximate duration of
each transition.
Table 37: Alinity c-series
Starting status Function Transitional status Duration of Ending status
transition
(minutes)
Offline Power on the None 1 Stopped
module.
Stopped Tap Start. Initializing 3 Idle
Stopped Tap Run after Initializing 6 Processing
loading a sample.
Idle Tap Run after Initializing 4 Processing
loading a sample.
Idle Tap Run without Initializing 21* Processing
loading a sample.
Running Load a sample. None Immediate Processing
Processing Tap Pause. Pausing 0 to 15 Idle
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Starting status Function Transitional status Duration of Ending status
transition
(minutes)
(Sample processing
is completed.)
Running Tap Pause. Pausing Immediate Idle
* The number of cuvettes that are washed and filled with water is 187.
Table 38: Alinity i-series
Starting status Function Transitional status Duration of Ending status
transition
(minutes)
Offline Power on the None 3 Stopped
module.
Stopped Tap Start. Initializing 4 Idle
Stopped Tap Run. Initializing 7 Running
Idle Tap Run. Initializing 4 to 7* Running
Running Load a sample. None Immediate Processing
Processing Tap Pause. Pausing 0 to 45 Idle
(Sample processing
is completed.)
Running Tap Pause. Pausing Immediate Idle
* If the pretreatment path is repopulated with reaction vessels, the duration of initialization is
7 minutes.
Related information...
Instrument statuses, page 496
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Consumable inventory management
Consumable inventory management includes procedures to prepare and replenish supplies and
to empty waste. Use the Supplies screen to view and manage in-use supply inventory.
Before performing sample processing, verify that onboard consumable inventory is adequate.
Related information...
Operating instructions, page 427
Supplies screen, page 500
Cal/QC Inventory screen, page 518
Supplies screen
On the Supplies screen, the operator can view the following information:
• c-series
– Percentage of bulk solutions
– Percentage of onboard solutions in the sample wash solution area
– Status of the liquid waste in the high-concentration waste bottle
– Status of the ICT module
• i-series
– Percentage of bulk solutions
– Status of the reaction vessel (RV) waste
– Status of RVs
The operator can perform the following functions:
• c-series: Update the inventory for bulk solutions, onboard solutions, the liquid waste, and the
ICT module.
• i-series: Update the inventory for bulk solutions, RVs, and the RV waste.
NOTE: The c-series and the i-series calculate the supply volume and the percent-remaining
information on required tests for samples that have been scheduled on the reagent and sample
manager.
Related information...
Consumable inventory management, page 500
Supplies screen element descriptions (c-series), page 501
Supplies screen element descriptions (i-series), page 505
Verify the supply and waste inventory, page 508
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Replace bulk solutions and update the inventory, page 508
Replace sample onboard wash solutions and update the inventory (c-series), page 511
Solutions used in daily operations (c-series), page 513
Empty the high-concentration waste bottle and update the inventory (c-series), page 514
Remove the RV waste and update the inventory (i-series), page 515
Replenish reaction vessels (RVs) and update the inventory (i-series), page 517
Supplies screen element descriptions (c-series)
Elements
Module bar Used to select an individual module to view supply status
information.
Alkaline Wash area, Acid Wash area, ICT Reference area
Bottle Empty Displays when the bulk solution bottle on the bulk solution
door is empty.
Status bar The Alkaline Wash area and the Acid Wash area display a
graphical representation of the status and total remaining
supply. The ICT Reference area displays a graphical
representation of the status and total remaining supply only if
the c-series is configured to use the ICT module. Statuses are
indicated by the following colors:
1. Green = OK
2. Yellow = Low Level or Overridden
3. Red = Empty, Lot Expired
When an item meets the criteria for more than one status, the
higher number status is applied to the item. For example, an
item that is both Low Level and Lot Expired is displayed as Lot
Expired.
Total Remaining Estimated percent of bulk solution available in both the
reservoir and bulk solution storage area. The total remaining
volume includes the reservoir bottle and the bulk solution
bottle volumes minus the solution volume needed for tests
that have been scheduled but not yet processed. The color-
coded indicator changes colors as follows:
Green The supply item percent remaining is
above the low alert setting.
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Yellow The supply item percent remaining is at
or below the low alert setting.
Red The supply item percent remaining is
zero.
Replaced button Used to confirm bottle replacement when the bar code
scanner is not used.
Update button Displays the Supply Details flyout.
Currently in Use Displays information about the solution contained in the
reservoir.
Expiration Displays the expiration date for the bulk solution currently in
use. The color-coded indicator changes colors as follows:
Green The supply item has not yet exceeded
the lot expiration.
Yellow The supply item is within 8 hours of
exceeding the lot expiration.
Red The supply item has exceeded the lot
expiration.
Lot Displays the lot number for the solution currently in use.
Stability Days Displays the number of days that the bulk solution has been
on the system. The color-coded indicator changes colors as
follows:
Green The supply item has not yet exceeded
the onboard stability.
Yellow The supply item is within 8 hours of
exceeding the onboard stability.
Red The supply item has exceeded the
onboard stability.
The indicator is yellow when the supply item status has been
overridden.
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ICT Module area
Status bar Displays a graphical representation of the ICT module status
and the warranty period (number of days on the system and
number of samples processed) only if the c-series is
configured to use the ICT module. Statuses are indicated by
the following colors:
1. Green = OK
2. Yellow = Overridden, Exceeded
3. Red = Lot Expired, Update Required
When an item meets the criteria for more than one status, the
higher number item status is applied. For example, an item
that is both Exceeded and Lot Expired is displayed as Lot
Expired.
Expiration Displays the expiration date for the ICT module currently in
use. The color-coded indicator changes colors as follows:
Green The supply item has not yet exceeded
the serial number expiration.
Yellow The supply item is within 8 hours of
exceeding the serial number expiration.
Red The supply item has exceeded the
serial number expiration.
SN Displays the serial number of the ICT module.
Days On Board Displays the number of days that the ICT module has been
installed. The color-coded indicator changes to yellow when
the number of days on the system exceeds 90 days.
Samples Processed Displays the number of ICT samples processed. The color-
coded indicator changes to yellow when the number of
samples processed exceeds 20,000 samples.
Update button Displays the Supply Details flyout.
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Acid Probe Wash area, Detergent A area
Status bar Displays a graphical representation of the status and total
remaining supply. Statuses are indicated by the following
colors:
1. Green = OK
2. Yellow = Low Level or Overridden
3. Red = Empty, Lot Expired
When an item meets the criteria for more than one status, the
higher number item status is applied. For example, an item
that is both Low Level and Lot Expired is displayed as Lot
Expired.
Expiration Displays the expiration date for the sample onboard wash
solution. The color-coded indicator changes colors as follows:
Green The supply item has not yet exceeded
the lot expiration.
Yellow The supply item is within 8 hours of
exceeding the lot expiration.
Red The supply item has exceeded the lot
expiration.
Lot Displays the lot number for the solution currently in use.
Stability Hours Displays the number of hours of onboard stability for the
sample onboard wash solution. The color-coded indicator
changes colors as follows:
Green The supply item has not yet exceeded
the onboard stability.
Yellow The supply item is within 8 hours of
exceeding the onboard stability.
Red The supply item has exceeded the
onboard stability.
The sample onboard wash solution is stable for 24 hours.
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Position The Acid Probe Wash area displays position 1, the location of
the sample onboard wash solution in the sample wash
solution area. The Detergent A area displays position 2, the
location of the sample onboard wash solution in the sample
wash solution area.
Update button Displays the Supply Details flyout.
Liquid Waste area
NOTE: The Liquid Waste area is displayed only if the area is configured for Liquid Waste
Container.
Status bar Displays a graphical representation of the status and available
capacity. Statuses are indicated by the following colors:
1. Green = OK
2. Yellow = Near Capacity
3. Red = Full
The liquid waste status on each module is indicated as the
percent of capacity remaining.
Update button Displays the Supply Details flyout.
Related information...
Supplies screen, page 500
Descriptions of screen elements, page 127
Replace the ICT module or the ICT probe (c-series), page 859
Supplies screen element descriptions (i-series)
Elements
Module bar Used to select an individual module to view supply status
information.
Pre-Trigger area, Trigger area, Wash Buffer area
Bottle Empty Displays when the bulk solution bottle on the bulk solution
door is empty.
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Status bar Displays a graphical representation of the status and total
remaining supply. Statuses are indicated by the following
colors:
1. Green = OK
2. Yellow = Low Level or Overridden
3. Red = Empty, Lot Expired, Stability Expired
When an item meets the criteria for more than one status, the
higher number item status is applied. For example, an item
that is both Low Level and Stability Expired is displayed as
Stability Expired.
Total Remaining Estimated percent of bulk solution available in both the
reservoir and bulk solution storage area. The total remaining
volume includes the reservoir bottle and the bulk solution
bottle volumes minus the solution volume needed for tests
that have been scheduled but not yet processed. The color-
coded indicator changes colors as follows:
Green The supply item percent remaining is
above the low alert setting.
Yellow The supply item percent remaining is at
or below the low alert setting.
Red The supply item percent remaining is
zero.
Replaced button Used to confirm bottle replacement when the bar code
scanner is not used. This action resets the onboard stability
time when the operator indicates that the item is replaced.
Update button Displays the Supply Details flyout.
Currently in Use Displays information about the solution contained in the
reservoir.
Expiration Displays the expiration date for the bulk solution currently in
use. The color-coded indicator changes colors as follows:
Green The supply item has not yet exceeded
the lot expiration.
Yellow The supply item is within 8 hours of
exceeding the lot expiration.
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Red The supply item has exceeded the lot
expiration.
Lot Displays the lot number for the solution currently in use.
Stability Days Displays the number of days that the bulk solution has been
onboard the system. The color-coded indicator changes
colors as follows:
Green The supply item has not yet exceeded
the onboard stability.
Yellow The supply item is within 8 hours of
exceeding the onboard stability.
Red The supply item has exceeded the
onboard stability.
The indicator is yellow when the supply item status has been
overridden.
RVs area
Status bar Displays a graphical representation of the status and total
remaining supply. Statuses are indicated by the following
colors:
1. Green = OK
2. Yellow = Low Level
3. Red = Empty
Lot Displays the lot number for the RVs currently in use.
Update button Displays the Supply Details flyout.
RV Waste area
Status bar Displays a graphical representation of the status and total
remaining supply. Statuses are indicated by the following
colors:
1. Green = OK
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2. Yellow = Near Capacity
3. Red = Full
The solid waste status on each module is indicated as
percent of capacity remaining and is displayed as a numeric
value between 0 and 100.
Update button Displays the Supply Details flyout.
Related information...
Supplies screen, page 500
Descriptions of screen elements, page 127
Verify the supply and waste inventory
Perform this procedure to verify the supply and waste inventory before sample processing is
initiated or when a status indicator is displayed.
NOTE: The status that is displayed reflects the inventory that remains after the system
processes samples that are scanned by the RSM bar code reader.
Orders can be created when inventory levels are insufficient. However, when sample processing
is initiated while the levels are insufficient, tests become exceptions and are not processed.
1. On the menu bar, tap Supplies.
2. On the Supplies screen, tap a Module button.
3. Verify the supply and waste inventory.
Related information...
Supplies screen, page 500
Initiate or resume sample processing, page 574
Replace bulk solutions and update the inventory
Perform this procedure to replace and update the bulk solution inventory when a bottle is empty,
has reached the onboard stability expiration date, or is expired.
NOTE: For bulk solutions that have an onboard stability claim, onboard stability tracking occurs
when the bottle is replaced and is updated. To achieve the maximum usage of the bulk solution,
do not replace the solution until the total percent of the remaining solution is below the low alert
setting.
NOTE: To replace a new lot number of ICT Reference Solution, the instrument status of the c-
series processing module must be Stopped, Warming, or Idle and the bulk solution status must
be Empty. Perform quality control testing before assay processing.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
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1. Verify that a new bulk solution is within the expiration date on the bulk solution bottle label.
Do not use solutions that are expired.
NOTE: When bulk solution bottles are installed, the Alinity ci-series tracks and maintains a
record of the bulk solution lot number, the expiration date and, when applicable, the onboard
stability.
2. On the menu bar, tap Supplies.
3. On the Supplies screen, tap a Module button.
4. Use the bar code scanner to scan the bar code on the new bulk solution bottle.
Under Supply Details in the flyout, the system automatically updates the bulk solution with
the lot number and expiration date of the new bottle.
To enter manually the lot number and the expiration date, perform the following steps:
a. Tap Update for the new bulk solution.
b. Under Supply Details in the flyout, enter the expiration date and the lot number.
c. To save the information, tap Done.
5. Repeat step 4, page 509 for each bulk solution that is replaced.
6. Open the bulk solution door.
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7. Press the bottle release button to disengage the empty bulk solution bottle from the bottle
holder.
NOTE: The color of the bulk solution cap matches the color of the bottle release button.
8. Remove and discard the empty bulk solution bottle according to the laboratory waste
disposal procedures of the facility.
9. Remove the protective cover from the cap of the new bulk solution bottle.
10. Invert the new bulk solution bottle and place it in the bottle holder.
11. Push down the bottle until it locks.
12. Close the bulk solution door.
NOTE: When the bulk solution door is closed, the door sensor confirms that the bottle was
replaced.
To confirm manually that the bottle was replaced, tap Replaced on the Supplies screen.
Related information...
Supplies screen, page 500
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Waste handling and disposal, page 728
Empty the bulk solution reservoirs (i-series), page 1297
Replace sample onboard wash solutions and update the inventory (c-series)
Required instrument Idle
status
Required materials • 16 mm x 100 mm sample tubes
• Cartridge of Acid Probe Wash, LN 01R6070
• Cartridge of Detergent A, LN 08P9670
• Measuring device that can deliver 10 mL
Perform this procedure to replace the sample onboard wash solutions, Acid Probe Wash and
Detergent A, and to update the inventory when the sample tubes are empty or the wash solutions
are expired.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
1. To replace Acid Probe Wash, use a measuring device to dispense up to 10 mL of the wash
solution from the cartridge into a 16 mm x 100 mm sample tube.
2. To replace Detergent A, use a measuring device to dispense up to 10 mL of the wash
solution from the cartridge into a 16 mm x 100 mm sample tube.
3. Lift the rear processing center cover.
4. Locate the sample wash solution holder.
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5. Remove each empty or expired tube of wash solution and place each new tube in the
appropriate position:
– Acid Probe Wash [1]
– Detergent A [2]
IMPORTANT: The operator has a responsibility to load the correct wash solution in the
correct position.
6. Discard the used sample tubes according to the laboratory waste disposal procedures of the
facility.
7. Close the rear processing center cover.
8. On the menu bar, tap Supplies.
9. On the Supplies screen, tap a Module button.
10. Use the bar code scanner to scan the bar code on the Acid Probe Wash cartridge.
Under Supply Details in the flyout, the system automatically updates the sample onboard
wash solution with the lot number and expiration date of the cartridge.
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To enter manually the lot number and the expiration date, perform the following steps:
a. Tap Update for the new sample onboard wash solution.
b. Under Supply Details in the flyout, enter the expiration date and the lot number.
c. To save the information, tap Done.
NOTE: After the new sample onboard wash solution is updated in the system software, the
onboard stability of the solution is 24 hours.
11. Repeat step 10, page 512 for the Detergent A cartridge.
12. Place a new replacement cap on each bottle in each cartridge to store the cartridges for
future use.
13. Store the cartridges in an upright position according to instructions in the product
documentation.
Related information...
Supplies screen, page 500
Solutions used in daily operations (c-series)
The following tables describe the purpose, onboard stability, and placement information for c-
series solutions used in daily operations.
Table 39: Bulk solutions (c-series)
Solution Purpose Onboard stability Placement
ICT Reference Solution • ICT analysis 90 days Bulk solution door
• 5501 Daily
Maintenance
Alkaline Wash Wash the cuvettes 30 days Bulk solution door
Acid Wash Wash the cuvettes 30 days Bulk solution door
Table 40: Onboard sample wash solutions (c-series)
Solution Purpose Onboard stability Placement
Acid Probe Wash • Wash the sample 1 day Sample wash solution
probe area, position 1
• 5501 Daily
Maintenance
Detergent A • Wash the sample 1 day Sample wash solution
probe area, position 2
• 5501 Daily
Maintenance
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Table 41: Onboard wash solutions (c-series)
Solution Purpose Onboard stability Placement
Acid Probe Wash • Wash the reagent See the product Reagent carousel
probes documentation
• 5501 Daily
Maintenance
Detergent A • Wash the reagent See the product Reagent carousel
probes documentation
• 5501 Daily
Maintenance
Detergent B Wash the reagent probes See the product Reagent carousel
documentation
c-series Maintenance 5501 Daily Maintenance 14 days or 12 tests, Reagent carousel
Solutions whichever occurs first
Related information...
Supplies screen, page 500
5501 Daily Maintenance (c-series), page 759
Empty the high-concentration waste bottle and update the inventory (c-series)
Required instrument Offline, Stopped, or Idle
status
Required materials Absorbent towels
Perform this procedure to empty the high-concentration waste bottle when the bottle is full.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
CAUTION: Lifting Hazard. This activity or area exposes you to a lifting hazard.
1. Disconnect the float switch cable from the waste bottle cap.
2. Place an absorbent towel next to the waste bottle to absorb any spills from the cap.
3. Unscrew the waste bottle from the cap. Ensure that the tubing attached to the cap is not
kinked.
4. Place the cap with the attached tubing on the absorbent towel.
5. Dispose of liquid waste according to the laboratory biohazard waste disposal procedures of
the facility.
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CAUTION: Do not move open waste containers that are filled with liquid. Close full
or partially full containers before attempting to move them. Keep the closures in
place while the containers are moved.
6. Screw the cap onto the waste bottle. Ensure that the tubing attached to the cap is not
kinked.
7. Reconnect the float switch cable.
8. On the menu bar, tap Supplies.
9. On the Supplies screen, tap a Module button.
10. Tap Update for the liquid waste.
11. Under Supply Details in the flyout, tap the Emptied Liquid Waste check box.
12. To save the information, tap Done.
Related information...
Supplies screen, page 500
Optional components, page 123
Waste handling and disposal, page 728
Remove the RV waste and update the inventory (i-series)
Required materials Biohazard bag
Perform this procedure to empty the RV waste container and to update the RV waste status.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
1. Open the bulk solution door.
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2. Pull out the RV waste storage tray.
3. Remove and discard the biohazard bag and its contents according to the laboratory
biohazard waste disposal procedures of the facility.
4. Install a new biohazard bag in the RV waste container.
NOTE: The biohazard bag must fit snugly and must be opened fully in the RV waste
container so that reaction vessels can drop freely into the container.
5. Slide the RV waste storage tray into the RV waste storage area until the RV waste chute is
fully open.
6. Close the bulk solution door.
7. On the menu bar, tap Supplies.
8. On the Supplies screen, tap a Module button.
9. Tap Update for the RV waste.
10. Under Supply Details in the flyout, tap the Emptied RV Waste check box.
11. To save the information, tap Done.
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Related information...
Supplies screen, page 500
Waste handling and disposal, page 728
Replenish reaction vessels (RVs) and update the inventory (i-series)
Perform this procedure to replenish and update the reaction vessel (RV) inventory when the
inventory is low or is empty.
1. On the menu bar, tap Supplies.
2. On the Supplies screen, tap a Module button.
3. Tap Update for the RVs.
4. Use the bar code scanner to scan the bar code on the new RV bag (or manually enter the
lot number in the Lot Number box).
Under Supply Details in the flyout, the system automatically updates the RVs with the lot
number of the new RV bag.
NOTE: To ensure that the bar code is read, perform the following steps:
– Verify that RVs are present behind the bar code on the RV bag to provide a contrast for
the bar code.
– Place the RV bar code 10 cm to 13 cm (4 in. to 5 in.) from the bar code scanner.
– Center the bar code scanner beam on the bar code label.
5. If one or more full bags of RVs are added to the RV hopper, tap Add 500 RVs after each
bag is added.
If a partial bag of RVs is added to the RV hopper, enter the estimated number of RVs that
are added.
The maximum capacity of the RV hopper is 1000 RVs.
6. To save the information, tap Done.
7. Open the RV hopper cover.
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8. To add a full bag of RVs, pour all contents of the bag into the RV hopper.
To add a partial bag of RVs, pour some contents of the bag into the RV hopper and
estimate the quantity of RVs that were added.
NOTE: Do not overfill the RV hopper.
9. Close the RV hopper cover.
Related information...
Supplies screen, page 500
Cal/QC Inventory screen
On the Cal/QC Inventory screen, the operator can view the following information:
• Inventory details for quality control vials that are run on the system
• Inventory details for calibrator vials that are used to calibrate assays
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Related information...
Consumable inventory management, page 500
Cal/QC Inventory screen element descriptions, page 519
Cal/QC Inventory screen, Search flyout element descriptions, page 520
Descriptions of vial statuses, page 521
Verify vial inventory data, page 522
Reagent and sample manager (RSM) sample processing for onboard calibrators and controls,
page 567
Onboard storage criteria for calibrator and control vials, page 568
Cal/QC Inventory screen element descriptions
All Vials tab, Calibration tab, Control tab
Display status information for all calibrator and control vials that are scanned by the system.
Calibration and control vial status information can be filtered by selecting the Calibration tab or
the Control tab.
Elements
M/P Displays the module (M) number and position (P) number in
the reagent carousel for vial racks that are stored on the
system. Dashes are displayed for the module and position
when the vial rack is not located in the reagent carousel.
RSM / P Displays the reagent and sample manager (RSM) module
number and position (P) number where the rack that contains
the calibrator or control vial is located. The RSM and position
are blank when the vial rack is not located on the RSM.
Rack/P Displays the rack ID and position (P) of the calibrator or
control vial in the rack.
Name Displays the calibrator or control name, which can be one of
the following items:
• The calibrator assay or calibrator set name, CAL (only for
i-series), and the calibrator level.
• The control name with the control level number and the
control level name if it is configured.
Lot Displays the lot number of the calibrator or control.
SN Displays the serial number of the calibrator or control vial.
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Vial Status Displays the calibrator or control vial status (Empty, LLS Error,
Expired, Low Alert, Overridden, or OK).
Remaining Capacity Displays the percentage of volume that remains in the
calibrator or control vial. The remaining capacity is not
displayed until after the first aspiration.
Onboard Stability Displays the stability of open vials of calibrators or controls
that are stored on the system in the reagent carousel.
Onboard stability tracking occurs after the vial is scanned by
the RSM bar code reader and is scheduled to be loaded in
the reagent carousel. The onboard stability tracking continues
when the vial is unloaded from the system.
In Use Stability Displays the remaining time that the calibrator or control is
known to have been removed from refrigerated storage. In-
use stability tracking occurs after the vial is scanned by the
RSM bar code reader. For calibrators, in-use stability tracking
stops when the vial is unloaded from the RSM (for c-series
and i-series) or is returned to the reagent carousel (only for c-
series). For controls, in-use stability tracking stops when the
vial is unloaded from the RSM or is returned to the reagent
carousel. Quality controls that have the in-use stability
configured as zero are not tracked.
Expiration Displays the expiration date of the calibrator or control.
Load Status Displays the status of vial racks that are loaded or unloaded
between the RSM and the reagent carousel.
Function buttons
Search Displays the Search flyout.
Related information...
Cal/QC Inventory screen, page 518
Descriptions of screen elements, page 127
Cal/QC Inventory screen, Search flyout element descriptions
The Search flyout of the Cal/QC Inventory screen provides calibrator or control information.
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Elements
Name Filters data by the name of the calibrator or control.
Lot Filters data by the lot number of the calibrator or control.
SN Filters data by the serial number of the calibrator or control
vial.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Cal/QC Inventory screen, page 518
Descriptions of vial statuses
Vial status information is used to determine the status of each calibrator (Cal) vial and quality
control (QC) vial and to determine if any problems with onboard vials have occurred.
When all the vials in an onboard vial rack have a status of Empty, LLS Error, or Expired, the
onboard vial rack is unloaded automatically from the reagent carousel.
The following list provides descriptions of the vial statuses. When the Vial Status column header
is selected, the statuses are sorted in the following order:
Empty A Cal or QC vial is empty.
LLS Error One liquid level sense or pressure monitor error occurred
during aspiration of a Cal or QC vial.
Expired A Cal or QC vial is expired or has exceeded the stability time.
Low Alert The remaining volume of a Cal or QC vial is below the
configured volume for the low alert notification.
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Overridden The operator has overridden a Cal or QC vial that is expired
or has exceeded the stability time.
OK A Cal or QC vial is okay.
Related information...
Cal/QC Inventory screen, page 518
Reagents screen, page 533
Verify vial inventory data
Perform this procedure to verify the vial inventory data for calibrator and control vials that were
previously scanned by the RSM bar code reader before performing sample processing.
NOTE: Calibrator and control vials that were previously stored on the system must be loaded into
the same onboard vial rack if the vials are returned to onboard storage.
The data on the Cal/QC Inventory screen does not reflect the usage of the calibrator and control
vials on a processing module that is controlled by a different system control module.
1. On the menu bar, tap System, and then tap Cal/QC Inventory.
NOTE: The Cal/QC Inventory command can be configured as an icon on the menu bar and
thereby is removed from the System menu.
2. On the All Vials tab of the Cal/QC Inventory screen, use the bar code scanner to scan the
bar code on the vial.
NOTE: The vial inventory data is filtered and the scanned vial data is displayed.
3. Verify the vial inventory data for the scanned vial.
4. Repeat steps 2, page 522 and 3, page 522 for each vial to be scanned.
NOTE: Vials that are scanned after the first vial are added to the list that is displayed on the
screen in the order in which they are scanned.
5. To display the inventory data for all vials, tap Clear Filter.
Related information...
Cal/QC Inventory screen, page 518
Search for or filter data, page 664
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Reagent and sample management
Reagent and sample management includes procedures for the following activities:
• Manage reagent carousel inventory.
• Prepare, load, and unload samples.
• Initiate sample processing.
Related information...
Operating instructions, page 427
Load racks and cartridges into trays, page 523
Load trays on the reagent and sample manager (RSM), page 524
Load racks on the reagent and sample manager (RSM), page 526
Load cartridges on the reagent and sample manager (RSM), page 527
Load onboard solutions and sample diluents on the reagent and sample manager (RSM) (c-
series), page 530
Load racks and reagent cartridges into temporary priority positions, page 531
Unload trays from the reagent and sample manager (RSM), page 533
Reagent carousel inventory management, page 533
Sample management, page 562
Load racks and cartridges into trays
Perform this procedure to load prepared racks and cartridges into trays.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
IMPORTANT: When transporting or loading racks, avoid splashing the sample outside the
sample cups and tubes.
1. Position the rack or cartridge so that the rack handle or cartridge handle is located at the
front of the tray, which is indicated by an arrow.
2. Slide the rack or cartridge into the tray until the rack or cartridge stops.
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3. Confirm that the rack or cartridge is flush against the back of the tray.
Related information...
Reagent and sample management, page 523
Load cartridges on the reagent and sample manager (RSM), page 527
Prepare reagent cartridges, page 548
Prepare onboard solutions (c-series), page 551
Prepare sample diluents and user-defined reagents (c-series), page 552
Load samples into sample racks, page 569
Prepare and load vials into vial racks for immediate use, page 572
Prepare and load vials into vial racks for onboard storage, page 549
Load trays on the reagent and sample manager (RSM)
Perform this procedure to load trays in routine positions or priority positions on the reagent and
sample manager (RSM). Empty trays may remain on the loading area to create five positions to
load racks or cartridges one at a time.
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CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
IMPORTANT: When transporting or loading racks, avoid splashing the sample outside the
sample cups and tubes.
1. For routine loading on the RSM, confirm that the status indicators above the bay positions to
load are not illuminated, which indicates that the positions are available.
For priority loading on the RSM, confirm that the status indicators above the bay positions to
load are blue, which indicates that the positions are available.
2. Hold the tray handle, which is indicated with an arrow, and slide the tray into a bay on the
RSM until the tray stops.
If the tray contains racks or cartridges, green status indicators are illuminated.
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Related information...
Reagent and sample management, page 523
Load racks and reagent cartridges into temporary priority positions, page 531
Load cartridges on the reagent and sample manager (RSM), page 527
Load racks on the reagent and sample manager (RSM)
Required instrument • Processing module: Warming, Idle, Running, Processing,
status or Pausing
• Reagent and sample manager (RSM): Running
Perform this procedure to load prepared sample racks or vial racks on the RSM. Racks can be
loaded in routine positions or priority positions.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
IMPORTANT: When transporting or loading racks, avoid splashing the sample outside the
sample cups and tubes.
1. For routine loading on the RSM, confirm that the status indicators above the bay positions to
load are not illuminated, which indicates that the positions are available.
For priority loading on the RSM, confirm that the status indicators above the bay positions to
load are blue, which indicates that the positions are available.
2. Hold the rack handle, and slide the rack into a routine position or a priority position on the
RSM until a green status indicator illuminates.
If the position on the RSM does not contain a tray, load the rack into a tray and slide the
tray into the RSM.
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NOTE: For calibrator and control vials that have an onboard stability claim, onboard stability
tracking occurs after the vial is scanned by the bar code reader.
For calibrators that have an in-use stability claim, in-use stability tracking occurs after the vial is
scanned by the bar code reader. After the vial is unloaded from the RSM, the timer for in-use
stability tracking stops.
Related information...
Reagent and sample management, page 523
Load samples into sample racks, page 569
Automated retest of specimens, page 583
Load cartridges on the reagent and sample manager (RSM)
Required instrument • Processing module: Warming, Idle, Running, Processing,
status or Pausing
• Reagent and sample manager (RSM): Running
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Perform this procedure to load prepared cartridges on the RSM. The RSM automatically loads
cartridges in the reagent carousel. Cartridges can be loaded in routine positions or priority
positions. If one cartridge of a two-cartridge reagent set is loaded in a priority position, both
cartridges will be priority loaded.
NOTE: To ensure correct tracking status, do not move the cartridges to a processing module
that is controlled by a different system control module.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
1. For routine loading on the RSM, confirm that the status indicators above the bay positions to
load are not illuminated, which indicates that the positions are available.
For priority loading on the RSM, confirm that the status indicators above the bay positions to
load are blue, which indicates that the positions are available.
2. Hold the cartridge handle, and slide the cartridge into a routine position or a priority position
on the RSM until a green status indicator illuminates.
If the position on the RSM does not contain a tray, load the cartridge into a tray and slide
the tray into the RSM.
NOTE: Some assays require two reagent cartridges. These reagent cartridges are indicated
with 1/2 and 2/2 on them. Both reagent cartridges must be loaded, but they do not need to
be inserted into adjacent positions. After the reagent cartridges are loaded on the RSM and
the bar code reader scans the bar code label, the system software links the two reagent
cartridges as a set. If a two-cartridge reagent set is removed from the system, the reagent
set must be replaced as a set.
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NOTE: For products that have an onboard stability claim, onboard stability tracking occurs
after the cartridge is scanned by the bar code reader. After the cartridge is unloaded from
the reagent carousel and is removed from the RSM, the timer for onboard stability tracking
stops.
For information about product onboard stability, see the product documentation.
Related information...
Reagent and sample management, page 523
Load racks and cartridges into trays, page 523
Prepare onboard solutions (c-series), page 551
Prepare sample diluents and user-defined reagents (c-series), page 552
Prepare reagent cartridges, page 548
Load trays on the reagent and sample manager (RSM), page 524
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Load onboard solutions and sample diluents on the reagent and
sample manager (RSM) (c-series)
Required instrument • Processing module: Idle, Running, Processing, or Pausing
status
• Reagent and sample manager (RSM): Running
Perform this procedure to load prepared onboard solution and sample diluent cartridges on the
RSM. The RSM automatically loads cartridges in the reagent carousel. Cartridges can be loaded
in routine positions or priority positions.
NOTE: To ensure correct tracking status, do not move the cartridges to a processing module
that is controlled by a different system control module.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
1. For routine loading on the RSM, confirm that the status indicators above the bay positions to
load are not illuminated, which indicates that the positions are available.
For priority loading on the RSM, confirm that the status indicators above the bay positions to
load are blue, which indicates that the positions are available.
2. Hold the cartridge handle, and slide the cartridge into a routine position or a priority position
on the RSM until a green status indicator illuminates.
If the position on the RSM does not contain a tray, load the cartridge into a tray and slide
the tray into the RSM.
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NOTE: For onboard solutions that have an onboard stability claim, onboard stability tracking
occurs after the cartridge is scanned by the bar code reader. After the cartridge is unloaded
from the reagent carousel and is removed from the RSM, the timer for onboard stability
tracking stops.
For information about product onboard stability, see the product documentation.
Related information...
Reagent and sample management, page 523
Load racks and reagent cartridges into temporary priority positions
Perform this procedure to temporarily assign a reagent and sample manager (RSM) position as
a priority position if no priority positions are configured or if additional priority positions are
required. Priority positions are designated with a blue status indicator above the bay position.
1. On the left side of the loading area of a processing module, press the priority button [1].
When the priority button is pressed, the button illuminates.
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2. Insert a rack, cartridge, or tray into any position on the loading area of the specific
processing module.
If a rack is inserted into a position, the system designates the position as a priority position.
If a tray is inserted into a position, all positions of the tray are designated as priority
positions. When the rack is removed, the blue status indicator for the priority position is not
illuminated.
NOTE: After the priority button is pressed, the rack, cartridge, or tray must be inserted into a
position within 10 seconds. To deactivate the RSM priority button before the time-out
expires, press the priority button again.
Related information...
Reagent and sample management, page 523
Load trays on the reagent and sample manager (RSM), page 524
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Unload trays from the reagent and sample manager (RSM)
Prerequisite Confirm that one of the following position indicators is
illuminated on the reagent and sample manager (RSM):
• Blinking green
• Steady green
• Alternating green and amber
Perform this procedure to unload trays from the RSM.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
• Grasp the tray handle, which is indicated with an arrow, and slide the tray out of the RSM.
Related information...
Reagent and sample management, page 523
Status indicators, page 65
Reagent carousel inventory management
Reagent carousel inventory management includes procedures to prepare and unload reagent
carousel inventory items. Use the Reagents screen to view and manage in-use inventory.
Before performing sample processing, verify that onboard reagent inventory is adequate.
Related information...
Reagent and sample management, page 523
Reagents screen, page 533
Reagents screen
On the Reagents screen, the operator can view the following information for cartridges and
racks that are loaded in the reagent carousel:
• The Current tab displays:
– A list of cartridges and racks that are currently loaded on the system for all modules.
– A graphical representation of the reagent carousel for individual modules that indicates
the position and status of the cartridges and racks.
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• The Historical tab displays a list of cartridges and racks that are currently loaded on the
system and were previously loaded on the system.
The operator can perform the following functions:
• Search for a specific cartridge or rack based on specified search criteria.
• Access reagent cartridge details.
• Unload a cartridge.
• Print a reagent report.
Related information...
Reagent carousel inventory management, page 533
Reagents screen, Current tab element descriptions, page 534
Reagents screen, Historical tab element descriptions, page 538
Reagents screen, Search flyout element descriptions, page 539
Reagent Cartridge Details screen, page 540
Descriptions of cartridge statuses, page 543
Descriptions of load statuses, page 545
Descriptions of assay insert statuses, page 546
Verify the reagent carousel inventory, page 547
Prepare reagent cartridges, page 548
Prepare and load vials into vial racks for onboard storage, page 549
Prepare onboard solutions (c-series), page 551
Prepare sample diluents and user-defined reagents (c-series), page 552
Print a 1D reagent bar code report (c-series), page 555
Unload racks and cartridges from a reagent carousel to the RSM, page 557
Cancel a rack unload or a cartridge unload, page 558
Unload reagents from the reagent and sample manager (RSM), page 558
Disable a reagent cartridge, page 559
Enable a reagent cartridge, page 560
View or print assay inserts, page 561
Delete a reagent carousel item (CSC Logon), page 561
Descriptions of vial statuses, page 521
View or print Abbott Mail documentation, page 492
Print a report, page 662
Search for or filter data, page 664
Reagents screen, Current tab element descriptions
The Current tab displays the reagent carousel inventory information for items loaded in the
reagent carousel or on the reagent and sample manager (RSM).
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Elements
Module bar - All button
Module bar Used to select all modules or an individual module to view
reagent status information.
All button Displays the reagent status information in a table format for
all modules.
M/P Displays the module (M) number and the position (P) number
in the reagent carousel where the reagent carousel inventory
item is loaded.
RSM / P Displays the RSM module number and the position (P)
number on the loading area where the reagent carousel
inventory item is loaded or unloaded.
Name Displays the name of the reagent carousel inventory item.
Cartridge Status Displays the status of the reagent carousel inventory item.
For statuses other than OK, Mixing (only for i-series), Low
Alert, and Overridden, the text in the list associated with the
item is displayed in red.
Remaining Displays an estimated amount that remains in the reagent
carousel inventory item. Information is not displayed for vial
racks.
Cal Status Displays the calibration status for the assay that uses the
reagent cartridge. Information is displayed only for reagent
cartridges.
Lot Displays the lot number for the reagent carousel inventory
item. Information is not displayed for vial racks.
SN Displays the serial number for the reagent carousel inventory
item. Information is not displayed for vial racks.
Expiration Displays the expiration date of the reagent carousel inventory
item. If the expiration date is overridden, a cartridge status of
Overridden is displayed. Information is not displayed for vial
racks.
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Load Status Displays the load or unload status of the reagent carousel
inventory item.
Onboard Stability Displays the number of onboard stability days that remain for
reagent carousel inventory items that have an onboard
stability claim. If the remaining time is less than 24 hours, < 1
is displayed. Information is not displayed for vial racks.
Module bar - Module button
Module bar Used to select all modules or an individual module to view
reagent status information.
Module button Displays the reagent carousel graphic for an individual
module. In addition, reagent status information for the
individual module is displayed in the Reagent Carousel List
area.
An amber badge is displayed on the Module button when a
low alert status is triggered for one or more items in the
reagent carousel or when an item in the reagent carousel or
on the RSM is within 1 hour of the lot or onboard stability
expiration.
A red badge is displayed on the Module button when a
reagent carousel inventory item that has a load status error is
present or when a cartridge or rack that has a status other
than OK, Mixing (only for i-series), Low Alert, Overridden, or
Disabled is displayed on the Current tab.
Reagent carousel Displays a graphical representation of the reagent carousel
graphic that displays the reagent carousel positions.
The status of reagents and racks in the reagent carousel
positions is indicated by the following colors:
White No cartridge is loaded in the position.
Green A cartridge that has a status of OK or
Mixing (only for i-series) is loaded in
the position.
Yellow A cartridge that has a status of Low
Alert, Overridden, or Disabled is loaded
in the position. This status also includes
reagents that have a lot or onboard
stability expiration within 1 hour.
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Red A cartridge has an error condition
(such as LLS Error or Load Error) or a
status of Expired, Empty, No Assay,
Undefined, Incomplete, or BC Fail. The
text in the list associated with the item
is displayed in red.
Purple An onboard vial rack is loaded in the
position.
P Displays the reagent carousel position numbers.
Name Displays the name of the reagent carousel inventory item.
Cartridge Status Displays the status of the reagent carousel inventory item.
For statuses other than OK, Mixing (only for i-series), Low
Alert, and Overridden, the text in the list associated with the
item is displayed in red.
Remaining Displays an estimated number of tests that remain in the
reagent cartridge. Information is not displayed for vial racks.
Cal Status Displays the calibration status for the assay that uses the
reagent cartridge. Information is not displayed for vial racks.
Load Status Displays the load or unload status of the reagent carousel
inventory item.
Scheduled Tests Displays the number of scheduled tests for the reagent
carousel inventory item.
Ready to Unload Displays the time that the reagent carousel inventory item is
ready to unload.
Function buttons
Select All Selects or deselects all items in a list. The button switches
between Select All and Deselect All. This function button is
displayed only when the All button is selected.
Search Displays the Search flyout.
Print Displays the Print flyout.
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Details Navigates to the Details screen for the selected items on the
current screen.
Unload Unloads the selected reagent carousel inventory item.
Cancel Unload Cancels the unloading of the selected reagent carousel
inventory item.
Related information...
Reagents screen, page 533
Descriptions of screen elements, page 127
Reagents screen, Historical tab element descriptions
The Historical tab displays the reagent carousel inventory information for reagents that are
currently loaded on the system or for reagents that were previously loaded on the system and
removed.
Elements
M/P Displays the module (M) number and the position (P) number
in the reagent carousel where the reagent carousel inventory
item is loaded.
RSM / P Displays the reagent and sample manager (RSM) module
number and the position (P) number on the loading area
where the reagent carousel inventory item is loaded or
unloaded.
Name Displays the name of the reagent carousel inventory item.
Cartridge Status Displays the status of the reagent carousel inventory item.
For statuses other than OK, Mixing (only for i-series), Low
Alert, and Overridden, the text in the list associated with the
item is displayed in red.
Remaining Displays an estimated number of tests that remain in the
reagent carousel inventory item. Information is not displayed
for vial racks.
Cal Status Displays the calibration status for the assay that uses the
reagent cartridge. Information is displayed only for reagent
cartridges.
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Lot Displays the lot number for the reagent carousel inventory
item. Information is not displayed for vial racks.
SN Displays the serial number for the reagent carousel inventory
item. Information is not displayed for vial racks.
Expiration Displays the expiration date of the reagent carousel inventory
item. If the expiration date is overridden, a cartridge status of
Overridden is displayed. Information is not displayed for vial
racks.
Onboard Stability Displays the number of onboard stability days that remain for
reagent carousel inventory items that have an onboard
stability claim. If the remaining time is less than 24 hours, < 1
is displayed. Information is not displayed for vial racks.
Unload Time Displays the time that the reagent carousel inventory item was
unloaded.
Function buttons
Select All Selects or deselects all items in a list. The button switches
between Select All and Deselect All.
Search Displays the Search flyout.
Print Displays the Print flyout.
Details Navigates to the Details screen for the selected items on the
current screen.
Delete (CSC Logon) Displays a message requesting confirmation to delete the
selected items.
Text Size Increases or decreases the size of text displayed.
Related information...
Reagents screen, page 533
Descriptions of screen elements, page 127
Reagents screen, Search flyout element descriptions
The Search flyout of the Reagents screen can be used to filter the Reagents screen to display
specific reagent carousel inventory items.
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Elements
Module Used to search by the module.
Position Used to search by the reagent carousel position.
Reagent Lot Used to search by the lot number of the reagent carousel
inventory item.
Name Used to search by the name of the reagent carousel inventory
item.
Reagent SN Used to search by the serial number of the reagent carousel
inventory item.
Calibration Status Used to search by the calibration status.
Cartridge status Used to search by the cartridge status.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Reagents screen, page 533
Search flyout, page 664
Descriptions of cartridge statuses, page 543
Descriptions of calibration statuses, page 708
Reagent Cartridge Details screen
On the Reagent Cartridge Details screen, the operator can view the following information:
• Cartridge details for reagents, onboard solutions, diluents, and maintenance solutions
• Calibrator and control vial information
• Assay details
• Assay insert details
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The operator can perform the following functions:
• Disable a reagent cartridge.
• Enable a reagent cartridge.
• View or print an assay insert.
Related information...
Reagents screen, page 533
Reagent Cartridge Details screen element descriptions, page 541
Enable a reagent cartridge, page 560
Reagent Cartridge Details screen element descriptions
The Reagent Cartridge Details screen displays the details of the selected reagent cartridge.
Elements
Reagent Cartridge Information area
Displays details of the selected reagent cartridge.
Status Displays the current status of the reagent cartridge.
Lot Number Displays the lot number of the reagent.
Expiration Displays the date on which the reagent expires. If the
expiration date is overridden, Overridden is displayed.
Expiration Status Displays the expiration status of the reagent cartridge:
• OK: The expiration has not been exceeded.
• Expired: The expiration has been exceeded.
Remaining Displays an estimated number of tests remaining in the
reagent cartridge.
Onboard Stability Displays the number of onboard stability hours that remain for
(Hours) the reagent cartridge.
Stability Status Displays the status of the stability of the reagent cartridge:
• OK: The stability has not been exceeded.
• Expired: The stability has been exceeded.
NOTE: Stability status is not shown for sample diluents.
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Assay Details area
Displays the specific assay details.
Module Displays the number of the module used to process the test.
Assay Name Displays the assay name.
Assay Number Displays the assay number.
Assay Version Displays the assay version.
CAL Status Displays the calibration status for the assay that uses the
reagent cartridge.
Cartridge Details area
Displays the specific reagent cartridge details.
ID Displays the cartridge ID number.
SN Displays the serial number for the reagent cartridge.
Position Displays the position on the reagent carousel in which the
reagent cartridge is placed for processing.
RSM/P Displays the reagent and sample manager (RSM) module and
position number where the reagent cartridge is located.
Load Status Displays the status of reagents that are loaded or unloaded
between the RSM and the reagent carousel.
Assay Insert Details area
Used to view a portable document format (PDF) version of an assay insert if the status of the
assay insert details is New or Current.
Date and Time Displays the date and time that an assay insert download was
requested.
Status Displays the download status when an assay insert is
requested.
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Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Print Displays the Print flyout.
Disable Disables the selected reagent. This function button switches
between Disable and Enable.
Related information...
Reagent Cartridge Details screen, page 540
Descriptions of screen elements, page 127
Descriptions of cartridge statuses
Cartridge status information is used to determine the status of each reagent carousel inventory
item and to determine if any problems with onboard inventory items have occurred. Reagent
carousel inventory can include the following items:
• Reagents
• Onboard solutions
• Calibrators and controls
• Maintenance solutions
• Diluents
When a reagent carousel inventory item has a status of Empty, LLS Error, or Expired, the system
initiates a cartridge unload request.
The following list provides descriptions of the cartridge statuses. When the Cartridge Status
column header is selected, the statuses are sorted in the following order:
BC Fail The bar code on a reagent carousel inventory item is not
readable.
NOTE: This status is also displayed when the reagent
carousel cover is removed. When the instrument status of the
reagent and sample manager (RSM) is Running, reagent
carousel items are removed from the reagent carousel, are
scanned, and are reloaded.
Undefined The reagent configuration for a 1D reagent bar code is not
defined.
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Load Error A hardware error occurred when a reagent cartridge was
loaded and prevented the loading of the cartridge in the
reagent carousel.
Incomplete A hardware error occurred when a two-cartridge reagent set
was loaded or unloaded, which caused the reagent cartridges
to be separated.
NOTE: One of the following conditions can cause this status
to display:
• One reagent cartridge is located on the RSM and the
other cartridge is located in the reagent carousel.
• One reagent cartridge is located on the RSM or the
reagent carousel and the other cartridge is no longer
stored on the system.
No Assay A reagent is not used by any assay file that is installed on the
system.
Empty A reagent carousel inventory item is empty.
LLS Error Three consecutive liquid level sense or pressure monitor
errors occurred during aspiration of a reagent carousel
inventory item.
Expired A reagent inventory item is expired or has exceeded the
onboard stability time.
Disabled The operator or the system has disabled a reagent cartridge
to prevent the processing of patient samples.
Low Alert The remaining volume of a reagent carousel inventory item is
below the configured number of tests for the low alert
notification.
Overridden The operator has overridden a reagent carousel inventory
item that is expired or has exceeded the onboard stability
time.
Mixing A vortexer is mixing a reagent to disperse the microparticles.
NOTE: This status is not displayed for c-series reagents.
OK A reagent carousel inventory item is okay.
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Related information...
Reagents screen, page 533
Reagents screen, Search flyout element descriptions, page 539
Descriptions of load statuses
Load status information is used to determine the status of the loading and unloading of
cartridges and racks and to determine if loading problems or unloading problems have occurred.
The following list provides descriptions of the load statuses. The statuses are described in the
order in which they are sorted:
Unload error A cartridge or rack cannot be unloaded because one of the
following situations occurred:
• A hardware error occurs when the cartridge or rack is
unloaded.
• A hardware condition prevents the unloading of cartridges
or racks.
• The instrument status of the processing module
transitions to Stopped while the cartridge or rack is being
unloaded.
• The instrument status of the reagent and sample
manager (RSM) transitions to Stopped or Idle while the
cartridge or rack is being unloaded.
Load error A hardware error occurred when a cartridge or rack was
loaded, or a hardware condition prevents the loading of
cartridges or racks.
Scheduled unload A cartridge or rack needs to be unloaded from the reagent
carousel, but the cartridge or rack cannot be unloaded
immediately because one of the following situations occurred:
• Tests are in process for the cartridge or rack.
• No positions are available on the RSM for the cartridge or
rack.
• The system is loading or unloading another cartridge or
rack.
Scheduled load A cartridge or rack needs to be loaded in the reagent
carousel, but the cartridge or rack cannot be loaded
immediately because one of the following situations occurred:
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• No positions are available in the reagent carousel for the
cartridge or rack.
• The system is loading another cartridge or rack.
Partially unloaded The first cartridge of a two-cartridge reagent set has been
unloaded into the RSM, but the second cartridge cannot be
unloaded into the RSM because no positions are available.
Scanning The bar code reader has scanned the first cartridge of a two-
cartridge reagent set and is waiting to scan the second
cartridge.
Unloading A cartridge or rack is being unloaded from the reagent
carousel. For a two-cartridge reagent set, the load status
remains as Unloading until both cartridges have been
unloaded.
Loading A cartridge or rack is being loaded in the reagent carousel.
For a two-cartridge reagent set, the load status remains as
Loading until both cartridges have been loaded.
Blank A status is not displayed for any of the following conditions:
• A cartridge or rack is loaded successfully in the reagent
carousel.
• A cartridge or rack is unloaded successfully into the
RSM.
• A cartridge or rack is loaded on the RSM but is not
scanned by the bar code reader.
Processing An onboard vial rack has been removed from the reagent
carousel for control processing or calibration processing.
Related information...
Reagents screen, page 533
Descriptions of assay insert statuses
Assay insert status information is used to determine if an assay insert is available to download, is
new, is current, or is disabled. The following list provides descriptions of the assay insert
statuses:
Requested An automatic request to download an assay insert has been
sent. The system software is waiting for a response from
AbbottLink.
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New A new assay insert has been downloaded to the system
software and has been assigned to a reagent. The system
administrator has not reviewed and has not accepted the
assay insert in Abbott Mail.
Current The system administrator has reviewed and has accepted the
assay insert in Abbott Mail.
Unavailable An assay insert was not provided by AbbottLink, or the assay
insert is missing or is corrupted.
Disabled The system is not configured for Abbott Mail to send
automatic requests for assay inserts.
Related information...
Reagents screen, page 533
View or print assay inserts, page 561
Verify the reagent carousel inventory
Perform this procedure to verify the reagent carousel inventory before sample processing is
initiated or when a status indicator is displayed. Reagent carousel inventory may include the
following items:
• Reagents
• Onboard solutions and diluents
• Calibrators and controls
• Maintenance cartridges
NOTE: The status that is displayed reflects the inventory that remains after the system
processes samples that are scanned by the RSM bar code reader.
Orders can be created when inventory levels are insufficient. However, when sample processing
is initiated while the levels are insufficient, tests become exceptions and are not processed.
1. On the menu bar, tap Reagents.
The Current tab of the Reagents screen displays the reagent carousel inventory for all
modules.
2. To display the reagent carousel inventory for one module, tap a Module button.
3. Verify the reagent carousel inventory.
Related information...
Reagents screen, page 533
Initiate or resume sample processing, page 574
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Prepare reagent cartridges
Prerequisite For instructions for reagent handling and use, see the assay
documentation.
Perform this procedure to prepare reagent cartridges to load on the reagent and sample
manager (RSM).
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
IMPORTANT: For i-series reagent cartridges that have an integrated septum, during assay
processing, the reagent pipettor pierces the reagent cartridge septum. After the septum is
pierced, do not invert the cartridge since this action causes reagent leakage and may
compromise test results. Store pierced cartridges in an upright position.
1. Verify that the reagent cartridges are within the expiration date on the cartridge label. Do not
use cartridges that are expired.
NOTE: When a reagent cartridge is scanned by the RSM bar code reader, the Alinity ci-
series tracks and maintains a record of the cartridge reagent lot number and expiration
date.
2. Verify that the reagent bottles have not leaked.
3. Turn the cap counterclockwise on each reagent bottle until the cap stops.
4. Align the tabs on the cap with the grooves in the reagent cartridge and pull the cap to
remove it.
NOTE: A reagent bottle that has a yellow cap requires special preparation. For specific
instructions for reagent handling, see the assay documentation.
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Related information...
Reagents screen, page 533
Load racks and cartridges into trays, page 523
Load cartridges on the reagent and sample manager (RSM), page 527
Prepare and load vials into vial racks for onboard storage
Prerequisite For instructions for calibrator or control handling and use, see
the assay documentation.
Perform this procedure to prepare and load calibrator or control vials for storage on the Alinity
ci-series.
NOTE: To ensure correct tracking status, do not move the vials to a processing module that is
controlled by a different system control module.
Onboard stability tracking occurs after the vial is scanned by the RSM bar code reader. In-use
stability tracking occurs when the calibrator is not in refrigerated storage while on the system.
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CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
1. Verify that the calibrators or controls are within the expiration dates on the vial labels. Do
not use calibrators or controls that are expired.
NOTE: When a calibrator or control vial is scanned by the RSM bar code reader, the Alinity
ci-series tracks and maintains a record of the calibrator lot number and expiration date or
the control lot number and expiration date.
2. Inspect each vial for bubbles. Remove bubbles with a clean applicator stick before
performing sample processing. Use a new applicator stick for each vial to prevent cross
contamination.
3. Open each vial and discard the caps.
4. Place each vial in the onboard vial rack with standoffs so that the vial bar code is visible in
the rack window and the bar code fills the width of the window.
NOTE: After a vial is scanned by the RSM bar code reader, the vial is assigned to the
onboard vial rack and cannot be moved.
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Related information...
Reagents screen, page 533
Prepare and load vials into vial racks for immediate use, page 572
Load racks and cartridges into trays, page 523
Automated control ordering, page 579
Automated calibration ordering, page 581
Prepare onboard solutions (c-series)
Prerequisite For instructions for onboard solution handling and use, see
the product documentation.
Perform this procedure to prepare cartridges of c-series onboard solutions to load on the
reagent and sample manager (RSM).
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
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1. Verify that the onboard solution cartridges are within the expiration date on the cartridge
label. Do not use cartridges that are expired.
NOTE: When a cartridge is scanned by the RSM bar code reader, the Alinity ci-series tracks
and maintains a record of the cartridge lot number and expiration date.
2. Verify that the onboard solution bottles have not leaked.
3. Turn the cap counterclockwise on each onboard solution bottle until the cap stops.
4. Align the tabs on the cap with the grooves in the cartridge and pull the cap to remove it.
Related information...
Reagents screen, page 533
Load racks and cartridges into trays, page 523
Load cartridges on the reagent and sample manager (RSM), page 527
Prepare sample diluents and user-defined reagents (c-series)
Required materials • c-series Reagent Cartridge, Black (Large), LN 04S1720
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• Measuring device that can deliver 74 mL
• 1D reagent bar code label that corresponds to the diluent
or reagent to be filled
Perform this procedure to fill and label reagent cartridges with the following items to load on the
reagent and sample manager (RSM):
• Saline for use as a diluent
• Saline for use with the Sample Interference Indices Saline Protocol
• User-defined diluents
• User-defined reagents
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
1. Verify that the saline, the diluent, and the reagents are within the expiration dates if dates
are provided. Do not use solutions that are expired.
2. Affix the 1D reagent bar code label to an R1 reagent bottle according to the following
guidelines. The R1 bottle is the larger bottle and is positioned leftmost in the cartridge when
the cartridge handle faces to the right side of the cartridge.
– Vertically orient the printed bars of the label within a vertical angle limit of ±5 degrees.
– Align the top edge of the label with the cartridge transport tab at the left edge of the R1
bottle.
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Figure 143: Correct placement of the 1D reagent bar code label
3. Determine whether the R1 bottle or the R1 and R2 bottles need to be filled:
– Saline diluent: R1 bottle
– Saline for use with the Sample Interference Indices Saline Protocol: R1 bottle
– User-defined diluent: R1 bottle
– User-defined reagent: R1 bottle or R1 and R2 bottles, based on the application
4. Turn the cap counterclockwise on each reagent bottle until the cap stops.
5. Align the tabs on the cap with the grooves in the cartridge and pull the cap to remove it.
NOTE: If only the R1 bottle needs to be filled, both reagent cartridge caps must be removed
to load the cartridge on the RSM.
6. Pour the saline, the other diluent, or the user-defined reagent into the measuring device.
NOTE: Between measurements of different solutions, use a separate measuring device,
dispose of the device, or thoroughly clean the device. Fill each reagent bottle according to
the maximum fill volumes:
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– R1 bottle: 74 mL
– R2 bottle: 47 mL
IMPORTANT: Do not exceed the maximum fill volumes for the reagent bottles to prevent
damage to the reagent carousel.
Figure 144: Prepare sample diluents and user-defined reagents
Related information...
Reagents screen, page 533
Reagent cartridge with empty bottles (c-series), page 145
Load racks and cartridges into trays, page 523
Load cartridges on the reagent and sample manager (RSM), page 527
Print a 1D reagent bar code report (c-series)
Required materials Use one of the following Avery labels:
• 5520
• L4773
• L7060
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Perform this procedure to print a 1D reagent bar code report. The report provides reagent
cartridge labels to use with the following solutions:
• Saline for use as a diluent
• Saline for use with the Sample Interference Indices Saline Protocol
• User-defined diluents
• User-defined reagents
NOTE: The 1D reagent bar code report can be printed only for one diluent or one reagent at a
time. Additional reports can be generated after one report is completed.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap Reagents and Supplies.
3. On the Reagents and Supplies screen, tap the name of the diluent or reagent to print the
report:
– To print a label report for saline or another diluent, tap the diluent name under Diluent
Low Alert on the Reagents/Diluents tab.
– To print a label report for saline for the sample interference indices or a user-defined
reagent, tap the reagent name on the c-series Reagents tab.
4. Tap Print 1D Bar Code.
5. In the Print 1D Bar Code flyout, choose a printer or tap Print to File in the Print Location
drop-down list.
6. In the Label Options area, enter the following information:
– Lot
– Expiration
NOTE: The 1D bar code format encodes expiration dates by the week. If the entered
expiration date does not correspond to the end of a seven-day week, the expiration date
for the printed bar code is the end of the previous week.
– Starting Serial Number
– Number of Labels
NOTE: When the entry for the starting serial number is added to the number of labels to
print, the entry must not exceed 9999.
7. In the Report Selection list, tap one of the following options that correspond to the label
type:
– 1D Bar Code Report - 5520
– 1D Bar Code Report - L4773
– 1D Bar Code Report - L7060
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8. Ensure that the printer contains a sufficient amount of label stock.
9. Tap Print.
10. If Print to File was selected in the Print Location drop-down list, perform the following
steps to indicate the file destination:
a. Insert a USB flash drive.
b. Tap the appropriate USB flash drive.
c. Tap the destination folder.
d. Tap OK.
e. Remove the USB flash drive.
11. To return to the Configure screen, tap Done.
Related information...
Reagents screen, page 533
1D reagent bar code label placement (c-series), page 415
Insert and remove a USB flash drive, page 671
Unload racks and cartridges from a reagent carousel to the RSM
Required instrument • Processing module: Warming, Idle, Running, Processing,
status or Pausing
• Reagent and sample manager (RSM): Running or
Pausing
Perform this procedure to unload an item from a reagent carousel to the RSM. This procedure
provides space for a different item in the reagent carousel. Reagent carousel inventory may
include the following items:
• Reagents
• Onboard solutions and diluents
• Calibrators and controls
• Maintenance items
The Alinity ci-series automatically unloads items that have a cartridge status of Empty, Expired,
or LLS Error.
1. On the menu bar, tap Reagents.
The Current tab of the Reagents screen displays the reagent carousel inventory for all
modules.
2. To display the reagent carousel inventory for one module, tap a Module button.
3. Confirm that the carousel item to unload is not required for tests that are in process.
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If an item is unloaded, all scheduled tests that require the item become exceptions.
NOTE: View the Scheduled Test column to identify whether a reagent has any scheduled
tests.
4. Tap the item to unload.
5. Tap Unload.
The item is unloaded to an available position on the RSM that is nearest to the system
control module.
NOTE: Multiple items can be selected and unloaded from the reagent carousel inventory
that is displayed for all modules on the Current tab. Only one item can be selected and
unloaded from the reagent carousel inventory that is displayed for the selected module.
Related information...
Reagents screen, page 533
Unload reagents from the reagent and sample manager (RSM), page 558
Cancel a rack unload or a cartridge unload
Prerequisite The load status of the rack or cartridge must be Scheduled
Unload.
Perform this procedure to cancel an unload request that was initiated by an operator and to
leave an item in the reagent carousel.
NOTE: If the system initiates an unload request because the carousel item has a cartridge status
of Expired, Empty, or LLS Error, the operator cannot cancel the unload request.
1. On the menu bar, tap Reagents.
The Current tab of the Reagents screen displays the reagent carousel inventory for all
modules.
2. To display the reagent carousel inventory for one module, tap a Module button.
3. Confirm that the carousel item has a load status of Scheduled Unload.
4. Tap the carousel item.
5. Tap Cancel Unload.
Related information...
Reagents screen, page 533
Unload reagents from the reagent and sample manager (RSM)
Prerequisite Confirm that one of the following status indicators is
illuminated on the reagent and sample manager (RSM):
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• Blinking green
• Steady green
• Alternating green and amber
Perform this procedure to unload reagents from the RSM when the reagents are not needed on
the system.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
1. Slide the reagent cartridge, or the tray that contains the cartridge, out of the RSM.
NOTE: Onboard stability tracking occurs after the reagent cartridge is scanned by the bar
code reader and is being loaded in the reagent carousel. After the reagent cartridge is
unloaded from the reagent carousel and is removed from the RSM, the timer for onboard
stability tracking stops.
For information about reagent onboard stability, see the assay documentation.
2. Place a new replacement cap on each reagent bottle in the reagent cartridge to store the
cartridge for future use.
Empty reagent cartridges can be discarded without replacement caps.
3. Store reagent cartridges in an upright position in refrigerated storage according to
instructions in the assay documentation.
Two reagent cartridges that are linked together by the system software must be stored
together as a set.
IMPORTANT: After an immunoassay reagent cartridge septum is pierced, do not invert the
reagent cartridge since this action causes reagent leakage and may compromise test
results.
Related information...
Reagents screen, page 533
Unload racks and cartridges from a reagent carousel to the RSM, page 557
Disable a reagent cartridge
Perform this procedure to disable a reagent cartridge manually. A reagent cartridge is disabled
to prevent the processing of specimens by the system but to permit the manual ordering of
quality controls and calibrations to resolve performance issues with the cartridge. After the
issues are resolved, enable the cartridge so that the system can process the specimens.
1. On the menu bar, tap Reagents.
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The Current tab of the Reagents screen displays the reagent carousel inventory for all
modules.
2. To display the reagent carousel inventory for one module, tap a Module button.
3. Under Reagent Carousel List, tap a reagent cartridge to disable.
4. Tap Details.
5. On the Reagent Cartridge Details screen, tap Disable.
6. When a confirmation message is displayed, tap Yes.
7. To return to the Reagents screen, tap Done.
IMPORTANT: To order a calibration or control for a disabled reagent cartridge, the cartridge
must be selected in the Assay Options flyout. If only one reagent cartridge is loaded on the
system, the disabled reagent cartridge is selected automatically.
Related information...
Reagents screen, page 533
Enable a reagent cartridge, page 560
Processing module corrective action procedures, page 1290
Enable a reagent cartridge
Perform this procedure to enable a reagent cartridge manually. A reagent cartridge is disabled to
prevent the processing of specimens by the system but to permit the manual ordering of quality
controls and calibrations to resolve performance issues with the cartridge. After the issues are
resolved, enable the cartridge so that the system can process the specimens.
1. On the menu bar, tap Reagents.
The Current tab of the Reagents screen displays the reagent carousel inventory for all
modules.
2. To display the reagent carousel inventory for one module, tap a Module button.
3. Under Reagent Carousel List, tap a reagent cartridge to enable.
4. Tap Details.
5. On the Reagent Cartridge Details screen, tap Enable.
6. When a confirmation message is displayed, tap Yes.
7. To return to the Reagents screen, tap Done.
Related information...
Reagents screen, page 533
Disable a reagent cartridge, page 559
Reagent Cartridge Details screen, page 540
Processing module corrective action procedures, page 1290
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View or print assay inserts
Assay insert status New or Current
Perform this procedure to view or print assay inserts from the Reagent Cartridge Details screen.
1. On the menu bar, tap Reagents.
The Current tab of the Reagents screen displays the reagent carousel inventory for all
modules.
2. To display the reagent carousel inventory for one module, tap a Module button.
3. Under Reagent Carousel List, tap a reagent cartridge.
4. Tap Details.
5. On the Reagent Cartridge Details screen, tap Print.
6. Under Report Selection in the Print flyout, tap Assay Insert.
7. To rotate the document, use the Rotate toolbar.
8. To browse the document, use the Page toolbar.
9. To increase or decrease the font size in the document, use the Zoom toolbar.
10. To fit the document to the window width ( ) or to resize the document to fit one full page in
the window ( ), use the Fit toolbar.
11. To find a word or phrase in the document, use the Find toolbar.
12. To print the document, tap Print.
To return to the Reagents screen, tap Done.
Related information...
Reagents screen, page 533
Descriptions of assay insert statuses, page 546
Delete a reagent carousel item (CSC Logon)
Required instrument Stopped, Warming, or Idle
status
Operator access level CSC
Perform this procedure to delete a reagent cartridge, a maintenance cartridge, an onboard
solution, or a diluent from the system.
NOTE: If a reagent carousel item is deleted, the inventory and the onboard stability time will be
incorrect if the cartridge is loaded again.
Deleted reagent cartridges remain associated with patient and quality control results. When all
reagent cartridges associated with a calibration are deleted, the calibration is also deleted.
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1. On the menu bar, tap Reagents.
The Current tab of the Reagent screen displays the reagent carousel inventory for all
modules.
2. Tap the Historical tab.
3. Under Reagent Carousel List, tap a reagent carousel item.
4. Tap Delete.
5. When a confirmation message is displayed, tap Yes.
Related information...
Reagents screen, page 533
Sample management
Sample management includes procedures used to prepare samples, to initiate processing, and
to unload samples. For more information about specimen collection, preparation, and storage,
see requirements for handling the specimens and see the assay documentation.
Before samples are loaded on the Alinity ci-series, the operator must be familiar with sample and
sample bar code label requirements.
Related information...
Reagent and sample management, page 523
Sample processing, page 562
Load samples into sample racks, page 569
Prepare and load vials into vial racks for immediate use, page 572
Initiate or resume sample processing, page 574
Suspend and access a sample that has tests in process, page 575
Unload samples from the reagent and sample manager (RSM), page 575
Unload vials from the reagent and sample manager (RSM), page 576
Sample bar code label requirements, page 416
Sample specifications and requirements, page 420
Sample processing
The progression of samples through the Alinity ci-series differs based on the system
configuration and the available reagent inventory.
Various hardware components are used to process assays. Not all assay types use every
component on the system. The system continues to process assays when the appropriate
hardware component is available.
Related information...
Sample management, page 562
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Control sample processing, page 563
Calibration sample processing, page 564
Reagent and sample manager (RSM) processing priorities, page 565
Reagent and sample manager (RSM) sample processing, page 565
Reagent and sample manager (RSM) sample processing for onboard calibrators and controls,
page 567
Onboard storage criteria for calibrator and control vials, page 568
Reagent inventory processing, page 569
Control sample processing
When multiple reagent cartridges for an assay are loaded on the system and before the
sampling process for a control order begins, the system determines which cartridges to use
based on the following configuration parameter and the Reagent Selection options that are
chosen for the order.
Run Controls for • If the assay is configured to run controls for onboard
Onboard Reagents by reagents by cartridge, the control order runs for each
cartridge of the corresponding reagent for each module.
• If the assay is configured to run controls for onboard
reagents by lot, the control order runs only for one
cartridge of each reagent lot for each module.
NOTE: Control orders for calculated assays are processed independently of the configuration
parameter. The system software automatically runs one replicate of each constituent assay for
one reagent cartridge on one module. The cartridge and module are selected by the system
software.
All Reagent Selection options require the following conditions for the control order to process:
• A calibration for the assay either is available with a status of Active or Pending QC, or is in
process.
• Reagent cartridges with the same lot as the available or in-process calibration are loaded on
the system.
The following list provides descriptions of the Reagent Selection options:
Module For each selected module, the system runs the control order
for each reagent lot or cartridge, based on the Run Controls
for Onboard Reagents by configuration parameter, if the
assay is configured for use on each selected module.
NOTE: The Module option is available only for multimodule
systems that have more that one module of the same type.
Auto The system runs the control order on each module with the
assay that is configured for use and for each reagent lot or
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cartridge, based on the Run Controls for Onboard Reagents
by configuration parameter.
Select cartridge The system runs the control order for the selected reagent
cartridge if the cartridge status is OK, Low Alert, Overridden,
Disabled, or Mixing and the assay is configured for use on the
module where the selected reagent cartridge is located.
Related information...
Sample processing, page 562
Calibration sample processing
When multiple reagent lots for an assay are loaded on the system and before the sampling
process for a calibration order begins, the system determines which lots to calibrate by using the
calibration status of the reagent lot and the selected order options for the reagent and module
according to the following rules.
NOTE: For c-series photometric assays that are configured to perform calibrations by cartridge,
the reagent lot is composed of the reagent lot number and the reagent cartridge serial number.
This combination of the two numbers is evaluated for calibration processing. The calibration-by-
cartridge option is unavailable for user-defined c-series assays or i-series assays.
If the Reagent Selection option is Module, the following conditions are applicable for each
selected module that has an instrument status of Running or Processing when the calibrator
samples are scanned:
• The system calibrates all reagent lots that are loaded on the system when no reagent lots
for the assay have a calibration status of Active or Pending QC.
• The system calibrates all reagent lots that are loaded on the system when all reagent lots
for the assay have a calibration status of Active or Pending QC.
• The system calibrates only the reagent lots that are loaded on the system that do not have
a calibration status of Active or Pending QC when some reagent lots for the assay have a
calibration status of Active or Pending QC and some do not.
NOTE: The Module option is available only for multimodule systems that have more than one
module of the same type.
If the Reagent Selection option is Auto, the following conditions are applicable for all modules
that have an instrument status of Running or Processing when the calibrator samples are
scanned:
• The system calibrates all reagent lots that are loaded on the system when no reagent lots
for the assay have a calibration status of Active or Pending QC.
• The system calibrates all reagent lots that are loaded on the system when all reagent lots
for the assay have a calibration status of Active or Pending QC.
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• The system calibrates only the reagent lots that are loaded on the system that do not have
a calibration status of Active or Pending QC when some reagent lots for the assay have a
calibration status of Active or Pending QC and some do not.
Related information...
Sample processing, page 562
Create a calibration order, page 599
Reagent and sample manager (RSM) processing priorities
After a rack or cartridge is loaded on the reagent and sample manager (RSM), the RSM
transport moves the rack or cartridge to or from a processing module location. The RSM
transport performs the processing priorities in the following order:
1. Unload a completed sample rack from a module-specific sample positioner.
2. Load priority retest sample racks on the designated module-specific sample positioner in the
order in which the racks are presented to the RSM.
NOTE: If both lanes of the module-specific sample positioner are occupied, when a routine
sample rack is available, the rack is removed from the sample positioner and processing for
the routine sample is delayed until the sample positioner is available.
3. Load priority sample racks, vial racks, or onboard vial racks on the designated module-
specific sample positioner in the order in which the racks are presented to the RSM.
NOTE: If both lanes of the module-specific sample positioner are occupied, when a routine
sample rack is available, the rack is removed from the sample positioner and processing for
the routine sample is delayed until the sample positioner is available.
4. Load priority cartridges or onboard vial racks in the reagent storage area in the order in
which the cartridges or racks are presented to the RSM.
5. Load routine retest sample racks on the designated module-specific sample positioner.
6. Load routine sample racks on the designated module-specific sample positioner in the order
in which the racks are presented to the RSM.
7. Load routine cartridges in the reagent storage area in the order in which the cartridges are
presented to the RSM.
8. Unload cartridges or onboard vial racks from the reagent storage area.
Related information...
Sample processing, page 562
Reagent and sample manager (RSM) sample processing
After a sample rack or vial rack for immediate use is loaded on the loading area of the reagent
and sample manager (RSM), the rack is moved to the aspiration location.
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On a multimodule system, samples are routed to the first available processing module. If multiple
processing modules are available, the system first routes the samples to the numbered module
that has the lowest number.
Figure 145: RSM sample processing
After a sample rack or a vial rack for immediate use is loaded on the loading area of the RSM
and a run is initiated, the RSM performs the following functions:
1. The RSM transport moves to the position of the first rack according to the system software
prioritization and picks up the rack. The status indicator on the RSM is amber, which
indicates that the rack is being accessed by the RSM transport.
2. The RSM transport positions the rack for the bar code reader to identify the rack ID and the
SID. Then the RSM transport returns the rack to its original position in the loading area.
3. The system software determines if an order is present in the software for each sample in
the rack. If no orders are present and the system is configured for host order queries, the
user interface computer sends a query to the host.
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4. The RSM transport moves the rack to an available sample positioner lane if an order is
present or a query returns a test order. If a sample positioner lane is not available, the rack
remains on the loading area until a sample positioner lane is available.
5. The sample positioner moves the rack to the aspiration position.
6. The sample pipettor aspirates the sample.
7. The sample positioner moves the rack to the transport position.
8. The RSM transport picks up the rack and, if necessary, moves the rack to a sample
positioner on the next processing module if a sample positioner is available. Then the RSM
transport returns the rack to its original position on the loading area.
NOTE: If a sample positioner is not available on the next processing module, the rack is
returned to its original position on the loading area until a sample positioner on the next
module is available.
9. The status indicator blinks green after all samples in the rack are aspirated.
If the system is configured to reposition samples for reruns automatically, the status
indicator is amber until all reruns are aspirated.
If tests are added to a sample or reruns are requested before the sample is unloaded, the
status indicator changes from blinking green to amber while the sample is reaspirated.
Related information...
Sample processing, page 562
Reagent and sample manager (RSM) sample processing for onboard calibrators and
controls
After an onboard vial rack is loaded on the loading area of the reagent and sample manager
(RSM) and a run is initiated, the required sample processing is completed and the rack is loaded
in the reagent carousel.
On a multimodule system, samples are routed to the first available processing module. If multiple
processing modules are available, the system first routes the samples to the numbered module
that has lowest number.
NOTE: All vials in the onboard vial rack must meet the criteria for onboard storage.
Onboard vial racks are processed as priority racks regardless of the position of the rack on the
loading area of the RSM.
Onboard stability tracking occurs when the software schedules the rack to be loaded on the
system. The onboard stability tracking of calibrators and controls continues when the rack is
unloaded.
After an onboard vial rack is loaded on the loading area of the RSM and a run is initiated, the
RSM performs the following functions:
1. The RSM transport moves to the position of the first onboard vial rack according to the
system software prioritization and picks up the rack. The status indicator on the RSM is
amber, which indicates that the rack is being accessed by the RSM transport.
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2. The RSM transport positions the onboard vial rack for the bar code reader to identify the
rack ID and the SID. Then the RSM transport returns the rack to its original position on the
loading area.
3. The system software determines if an order is present in the software for each calibrator set
and control in the onboard vial rack. If no orders are present, the samples are evaluated to
determine whether automated orders for calibration sets and controls can be created.
4. If no automated orders are created, the onboard vial rack is scheduled to be loaded in the
reagent carousel. The RSM transport loads the onboard vial rack on the reagent positioner
according to the processing priorities of the RSM.
5. The reagent transport moves the onboard vial rack to an available position in the reagent
carousel for storage.
NOTE: If the onboard vial rack cannot be loaded in the reagent carousel, the rack remains
in its original position on the loading area and the status indicator blinks green.
6. If sample processing is required as a result of existing or automated orders, the onboard vial
rack is moved to an available sample positioner lane and sample processing is completed
according to the processing priorities of the RSM.
7. After all sample processing is completed, the onboard vial rack is processed as described in
steps 4 and 5.
Related information...
Sample processing, page 562
Racks, page 144
Cal/QC Inventory screen, page 518
Onboard storage criteria for calibrator and control vials
Onboard vial racks that contain bar-coded calibrator and control vials are loaded in the reagent
carousel for onboard storage if the following criteria are met. Vials that are ineligible for onboard
storage can be processed in a vial rack or can be pipetted into sample cups and processed in a
sample rack.
1. All vials that are needed for a complete calibrator set are loaded in the onboard vial rack.
2. Each vial in a calibrator set has the same lot number and the lot number is configured as
the default.
3. Each calibrator set is configured as stored in the reagent carousel.
4. Each control vial is configured as stored in the reagent carousel.
5. A position in the reagent carousel is configured for the onboard storage of an onboard vial
rack and is available to receive the rack.
6. All vials have at least 48 hours before the lot expiration and onboard stability expiration are
exceeded.
7. All calibrator vials have a vial status of OK.
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8. No control vials have a vial status of Expired, Low Alert, or Empty.
9. None of the vials have been processed previously in a different onboard vial rack.
10. The bar code label of each vial in a rack matches the lot number of a configured calibrator
or control.
Related information...
Sample processing, page 562
Racks, page 144
Cal/QC Inventory screen, page 518
Reagent inventory processing
When multiple reagent cartridges with active calibrations are loaded on the Alinity ci-series, the
following criteria are evaluated in this order to determine which one to use to process a test:
1. The reagent cartridge nearest to its open stability expiration date
2. The reagent cartridge nearest to its reagent lot expiration date
3. The reagent cartridge with the fewest remaining tests
NOTE: Regardless of these criteria, available reagent cartridges are used before cartridges that
have a status of Mixing.
When more than one reagent cartridge is required for an assay, the cartridges are linked
together when loaded on the system and are evaluated as a set.
Constituents of calculated assays that use the same reagent cartridge must be run with the
same reagent lot.
Related information...
Sample processing, page 562
Create a specimen order, page 595
Create a control order, page 597
Load samples into sample racks
Perform this procedure to load aliquot tubes, primary tubes, or sample cups that contain samples
(specimens, calibrators, or controls) into sample racks.
Before loading samples into the sample rack, become familiar with sample specifications and
requirements and sample bar code label requirements.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
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1. If loading calibrators or controls, verify that they are within the expiration date on the bottle
label. Do not use calibrators or controls that are expired.
2. Refer to the assay documentation to determine the minimum sample volume that is required
in the sample cup or tube for the tests to be processed.
NOTE: The minimum sample volume information is printed in the Order List Report.
3. Use the sample gauge to verify that the sample volume in an aliquot tube is adequate:
a. Load the aliquot tube into the sample rack so that the sample volume is visible in the
sample rack window [1].
b. Verify that the amount of sample in the aliquot tube exceeds the 8 mm sample gauge
line [2].
IMPORTANT: Do not use the sample gauge to verify aliquot tube volumes for c-series
whole blood applications.
4. Verify that the sample volume above the separation point (clot, gel separator, or plasma or
red cell interface) in a primary tube is a minimum of 8 mm.
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5. Use the sample cup volume graduation marks to verify that the sample volume in a sample
cup is adequate.
6. If loading non-bar-coded samples, print the Order List Report to ensure that each sample is
loaded in the correct rack and position.
IMPORTANT: The operator has a responsibility to load the correct sample in the correct
rack and position.
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7. Load the sample into the sample rack so that the sample bar code, if used, is visible in the
sample rack window and the bar code fills the width of the window.
IMPORTANT: If loading sample cups or tubes, ensure that they are pushed down
completely in the sample rack and they are not tilted.
Avoid splashing the sample outside the sample cups or tubes.
Related information...
Sample management, page 562
Sample specifications and requirements, page 420
Sample bar code label requirements, page 416
Load racks and cartridges into trays, page 523
Load racks on the reagent and sample manager (RSM), page 526
Automated control ordering, page 579
Create a specimen order, page 595
Create a control order, page 597
Create a calibration order, page 599
Prepare and load vials into vial racks for immediate use
Prerequisite For instructions for calibrator or control handling and use, see
the assay documentation.
Perform this procedure to prepare and load calibrator or control vials for assay processing on
the Alinity ci-series.
NOTE: To ensure correct in-use stability tracking status, do not move the vials to a processing
module that is controlled by a different system control module.
In-use stability tracking occurs after the vial is scanned by the RSM bar code reader. After the
vial is removed from the reagent and sample manager, the timer for in-use stability tracking
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stops. For vials that are stored on the system, the timer for in-use stability tracking stops when
the vials are returned to the reagent carousel.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
1. Verify that the calibrators or controls are within the expiration dates on the vial labels. Do
not use calibrators or controls that are expired.
NOTE: When a calibrator or control vial is scanned by the RSM bar code reader, the Alinity
ci-series tracks and maintains a record of the calibrator lot number and expiration date or
the control lot number and expiration date.
2. Inspect each vial for bubbles. Remove bubbles with a clean applicator stick before
performing sample processing. Use a new applicator stick for each vial to prevent cross
contamination.
3. Open each vial and discard the caps.
4. Place each vial in the white vial rack with standoffs so that the vial bar code is visible in the
rack window and the bar code fills the width of the window.
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Related information...
Sample management, page 562
Load racks and cartridges into trays, page 523
Prepare and load vials into vial racks for onboard storage, page 549
Automated control ordering, page 579
Automated calibration ordering, page 581
Create a calibration order, page 599
Initiate or resume sample processing
Required instrument Stopped, Idle, or Pausing
status
Perform this procedure to process a run after ordering and loading samples or to resume sample
processing after pausing or stopping the processing module or the reagent and sample manager
(RSM).
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NOTE: Verify that each processing module has adequate supplies and reagents before initiating
or resuming sample processing.
1. On the menu bar, tap the Home icon.
2. On the Home screen, perform one of the following steps:
– Tap one or more of the processing modules or the RSM.
– Tap one or more of the processing modules and the RSM.
3. Tap Run.
Related information...
Sample management, page 562
Verify the reagent carousel inventory, page 547
Verify the supply and waste inventory, page 508
Suspend and access a sample that has tests in process
Required instrument Running
status
Perform this procedure to suspend sample processing of a rack to immediately access a
sample.
NOTE: When a rack is suspended, the processing module completes sample aspiration of the
current sample. After sample aspiration is completed, the rack is returned to its original position
on the reagent and sample manager (RSM), and any scheduled tests become exceptions and
are not processed.
1. On the menu bar, tap Sample Status.
2. Under SID Name, tap a sample.
NOTE: To filter the list of results, tap a tab (or tap Search).
3. Tap Suspend.
4. When a confirmation message is displayed, tap Yes.
The rack is returned to its original position on the RSM.
Related information...
Sample management, page 562
Sample Status screen, page 603
Search for or filter data, page 664
Unload samples from the reagent and sample manager (RSM)
Prerequisite Confirm that one of the following status indicators is
illuminated on the reagent and sample manager (RSM):
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• Blinking green
• Steady green
• Alternating green and amber
Perform this procedure to unload samples from the RSM when the samples are not needed on
the system.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
IMPORTANT: When transporting or unloading racks, avoid splashing the samples outside the
sample cups and tubes.
1. Slide the rack, or the tray that contains the rack, out of the RSM.
2. Remove the samples from the rack.
3. Dispose of sample cups in a biohazardous waste container.
4. Store the remaining samples according to laboratory guidelines.
Related information...
Sample management, page 562
Unload vials from the reagent and sample manager (RSM)
Prerequisite Confirm that one of the following status indicators is
illuminated on the reagent and sample manager (RSM):
• Blinking green
• Steady green
• Alternating green and amber
Perform this procedure to unload calibrator or control vials from the RSM when the calibrator or
control is not needed on the system.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
IMPORTANT: When transporting or unloading racks, avoid splashing the calibrators or controls
outside the vials.
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1. Slide the rack, or the tray that contains the rack, out of the RSM.
NOTE: In-use stability tracking occurs after a vial is scanned by the bar code reader. After
the vial is removed from the RSM, the timer for in-use stability tracking stops.
For information about reagent in-use stability, see the assay documentation.
2. Remove the vials from the rack.
NOTE: Racks that contain vials can be placed in refrigerated storage. To maintain reagent
in-use stability for storage, each vial must contain a replacement cap before the vials are
stored.
3. Place a new replacement cap on each vial to store the vials for future use.
NOTE: Empty vials without replacement caps can be discarded in a biohazard waste
container.
4. Store the vials in refrigerated storage according to instructions in the assay documentation.
Related information...
Sample management, page 562
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Specimen, calibration, and control orders
Order requests for specimens, calibrator samples, and quality control samples can be created
automatically or manually by an operator.
Related information...
Operating instructions, page 427
Automated ordering, page 578
Orders screen, page 584
Sample Status screen, page 603
Automated ordering
Order requests for specimens, controls, and calibrations can be created automatically. The
following list describes automated ordering capabilities according to sample type:
Specimen Automated specimen ordering is available by using host
computer downloads, host order queries, or the retest option
of the Alinity ci-series.
Control Automated control ordering is available by configuring the
system parameters of the Alinity ci-series.
Calibration Automated calibration ordering is available by configuring the
system parameters of the Alinity ci-series.
Related information...
Specimen, calibration, and control orders, page 578
Host orders, page 578
Automated control ordering, page 579
Automated calibration ordering, page 581
Automated retest of specimens, page 583
Host orders
Automated specimen ordering is available by using host computer downloads or host order
queries. For automated ordering by a host computer, the system must be configured to
communicate with the host.
Host computer Specimen orders are downloaded from the host computer to
download the user interface (UI) computer. When the bar code reader
scans a bar-coded specimen, and the host computer has
downloaded an order to the UI computer, the system
processes the order.
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Rerun orders that are sent by the host computer are rerun if
the specimen has not been unloaded from the reagent and
sample manager. Orders that are downloaded can be viewed
on the Orders screen.
Host order query A specimen order is downloaded from the host computer to
the UI computer after a request is sent from the UI computer.
When the bar code reader scans a bar-coded specimen, and
an order does not exist on the UI computer, the UI computer
sends a query to the host computer.
If the host computer has an order request for the specimen,
the order is sent to the UI computer. When the order is
received, the order can be viewed on the Orders screen.
If the host computer has no order requests for the specimen
(or no record of the sample), a message is generated and is
displayed on the Host tab of the System Logs screen.
NOTE: If the host computer creates rerun orders, the orders
must be downloaded to the UI computer. The UI computer
does not send queries for rerun orders.
Related information...
Automated ordering, page 578
Configure host settings, page 211
Configure HL7 communication settings, page 214
Configure ASTM communication settings, page 217
Automated control ordering
Automated control ordering is the process that the system uses to order quality control tests
automatically. The control SID is associated with a predefined test list. Automated control orders
are created in the following ways:
• When a control sample bar code label from an onboard vial rack, a vial rack, or a sample
rack is scanned
• When the system software periodically evaluates the control vials that are stored in onboard
vial racks in the reagent carousel
• When the configured time interval or test interval is exceeded
Control vials in vial racks and onboard vial racks and bar-coded samples in sample racks are
evaluated when they are scanned by the RSM bar code reader for each processing module that
has an instrument status of Running or Processing.
The rack ID of a vial rack or an onboard vial rack notifies the system software that calibrators or
controls are loaded in the rack. The SID for controls in a vial rack or an onboard vial rack is
composed of the control lot number, the control level, and the vial serial number. The SID for
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controls in a sample rack is composed of the control lot number and level, and QQQ is added to
the beginning of the SID.
The scanned bar code is compared to the configured single-constituent and multiconstituent
controls. If the bar code corresponds to a configured control lot number and level, and an order
for the control is present in the system software, the order is completed. The order is not
completed for a control vial that has a vial status of Empty, Expired, or LLS Error.
If no control order is present in the system software and the control vial meets the criteria to
create an automated order, the system automatically creates the order and processes the tests
for the SID. The order that is created can be viewed on the Orders screen.
NOTE: Control vials that are stored on the system are evaluated for automated control orders
every 15 minutes on each processing module that has an instrument status of Processing (and
when the instrument status transitions from Idle to Running or Processing).
On multimodule systems, automated control orders are evaluated on all processing modules on
which the analyte can be run.
Automated control orders are created for controls that have the Automated parameter on the
Control Configuration screen configured as Yes if the following criteria are met:
• No order has been created since the configured shift start time.
The order is created for all analytes that use the control lot number and level with an
onboard reagent lot or reagent lot and cartridge combination for assays configured to run
controls by using a cartridge.
• The time interval or test interval has been exceeded.
The order is created for each onboard reagent lot or reagent lot and cartridge combination.
NOTE: The time interval is determined from the configured shift start time and resets daily
at the shift start time. Orders that are created when the time interval is exceeded are
created independently from manual orders and those orders created as the result of a
configured test interval.
Orders are created for a calculated assay only when the Start Time parameter on the
Control Configuration screen is defined for the control level.
The test interval for an assay begins when an order for the control lot number and level is
completed without a Westgard failure or a quality control (QC) range failure. The interval is
based on the number of specimen tests initiated for the assay since the last valid order. The
test interval resets after it is exceeded and a valid control result is generated for the control
level and the analyte.
• The most recent control result for the analyte generated a Westgard failure or a QC range
failure.
Orders are created for the onboard reagent lot or reagent lot and cartridge combination.
NOTE: Orders are not created if the control is in an onboard vial rack that has been
assigned a position in the reagent carousel.
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• A usable calibration is present for the assay that has not been verified by quality control or
a calibration order for the assay has a status of Scheduled or Running.
Automated control orders are created for controls that have the Automated parameter on the
Control Configuration screen configured as No when control samples are scanned by the RSM
bar code reader if no order has been created since the configured shift start time.
NOTE: The order is created for all analytes that use the control lot number and level if an
onboard reagent lot or reagent lot and cartridge combination is present.
Regardless of the configured option for the Automated parameter, automated control orders are
not created in the following instances:
• A control order that has a status of Pending is present.
• The reagent cartridge status is Disabled.
• The control vial status is Empty, Expired, or LLS Error.
Related information...
Automated ordering, page 578
Load samples into sample racks, page 569
Edit a quality control, page 298
Manually create a new quality control lot, page 295
Prepare and load vials into vial racks for immediate use, page 572
Prepare and load vials into vial racks for onboard storage, page 549
Automated calibration ordering
Automated calibration ordering is the process that the system uses to create calibration orders
automatically. Automated calibration orders are created in the following ways:
• When a bar code label from an onboard vial rack or a vial rack is scanned
• When the system software periodically evaluates the calibrator vials that are stored in
onboard vial racks in the reagent carousel
Calibrator vials in vial racks and onboard vial racks are evaluated when they are scanned by the
RSM bar code reader for each processing module that has an instrument status of Running or
Processing.
The rack ID of a vial rack or an onboard vial rack notifies the system software that calibrators or
controls are loaded in the rack. The SID for calibrators in a vial rack or an onboard vial rack is
composed of the calibrator lot number and the vial serial number.
The scanned bar code is compared to the configured calibrator set. If the bar code corresponds
to a configured calibrator lot number and an order for the calibrator set is present in the system
software, the order is completed. No automated orders are created. The order is not completed
for a calibrator vial in the calibrator set that has a vial status of Empty, Expired, or LLS Error.
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If no calibration order is present in the system software and the calibrator vial meets the criteria
to create an automated order, the system automatically creates and processes the order. The
order that is created can be viewed on the Orders screen.
NOTE: For c-series assays that are used for full and adjustment calibrations, calibrator vials are
evaluated first for the full calibration. If orders are not created for the full calibration, the
adjustment calibration is evaluated.
NOTE: Calibrator vials that are stored on the system are evaluated for automated calibration
orders every 15 minutes on each processing module that has an instrument status of Processing
(and when the instrument status transitions from Idle to Running or Processing).
On multimodule systems, automated calibration orders are evaluated on all processing modules
on which the analyte can be run.
Automated calibration orders are created if the following criteria are met:
• No calibration with a status of Active or Overridden is present for the assay.
Orders are created for each uncalibrated onboard reagent lot or reagent lot and cartridge
combination for assays configured to run calibrations by using a cartridge.
• All onboard reagent lots or reagent lot and cartridge combinations have a status of Active or
Overridden, but one or more lots or lot and cartridge combinations will expire within 8 hours.
Orders are created for the onboard reagent lots or reagent lot and cartridge combinations
that will expire if a calibration is not in process.
• The calibrator is a single-constituent calibrator, all onboard reagent lots or reagent lot and
cartridge combinations have a status of Active or Overridden, and no calibrations are in
process.
Orders are created for all onboard reagent lots or reagent lot and cartridge combinations.
NOTE: Order are not created if the calibrator is in an onboard vial rack that has been
assigned a position in the reagent carousel.
• The calibrator is in an onboard vial rack and a calibration that has a status of Active is
present, but the calibration will expire before the onboard vial rack is evaluated again, and
no calibrations are in process.
The order is created for each onboard reagent lot or reagent lot and cartridge combination
that will expire.
• The assay is a c-series assay that uses the factor data reduction method, and the
calibration is expired or will expire before the next evaluation interval.
Orders are created for all onboard reagent lots or reagent lot and cartridge combinations.
Automated calibration orders are not created in the following instances:
• A calibration order for the same assay is present.
• The reagent cartridge status is Disabled.
• The vial status of any calibrator vial in the calibrator set is Empty, Expired, or LLS Error.
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Related information...
Automated ordering, page 578
Prepare and load vials into vial racks for immediate use, page 572
Prepare and load vials into vial racks for onboard storage, page 549
Automated retest of specimens
Automated retest is the process that the system uses to generate rerun orders for specimen
tests automatically. For each test, the system can generate a maximum of four automatic rerun
orders.
Retest rules are not applied to calibrator tests, control tests, and tests that are performed with a
manual dilution.
Automated retest has two steps:
1. The system compares test results to the configured retest rules, starting with the first rule. If
a test result meets the criteria of a retest rule, the system generates a rerun order without
further evaluation of the configured retest rules.
NOTE: If the rerun order that is generated is used for a different assay, the order is
suppressed if a test for the specimen is present that has a status of Pending, Scheduled,
Running, or Complete. The order is not suppressed if the test is a calculated assay or the
system-ordered constituent of a calculated assay.
The rerun order is scheduled and uses the Automatic option of reagent selection. The rerun
order is displayed with the R processing code on the Sample Status screen, the All Orders
tab of the Orders screen, and the Rerun tab of the Orders screen.
The system can be configured to reposition specimens for retest automatically. Specimens
that are loaded on the reagent and sample manager (RSM) are moved to the sample
aspiration point and rerun orders are generated automatically. If the system is not
configured to reposition specimens automatically, the specimens must be loaded manually
on the RSM.
2. The system compares the specimen rerun test results to the configured retest rules. If a
rerun test result meets the criteria of a retest rule, the system generates a second rerun
order. This rerun order is displayed and processed in the same manner as the first order.
NOTE: The system suppresses a second rerun order if the order is based on the same
retest rule criteria as the first rerun order.
Related information...
Automated ordering, page 578
Configure reagent and sample manager module settings, page 174
Load racks on the reagent and sample manager (RSM), page 526
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Orders screen
On the Orders screen, the operator can view specimen, control, calibration, and rerun orders.
The operator can perform the following functions:
• Find information about a specific order based on specified search criteria.
• Access the order information.
• Add a comment to a test order.
• Delete an order.
• Create a new specimen order, control order, or calibration order.
Related information...
Specimen, calibration, and control orders, page 578
Orders screen element descriptions, page 584
Orders screen, Search flyout element descriptions, page 586
Order Details screen, page 588
Create Order screen, page 591
Descriptions of test statuses, page 601
Descriptions of processing codes, page 602
Delete a test from a sample order, page 602
System checkout, page 152
Orders screen element descriptions
All Orders tab, Rerun tab, Specimen tab, Control tab, Calibrator tab
Displays rerun, specimen, control, and calibrator test orders. Order status information can be
filtered by order type by selecting the Rerun tab, Specimen tab, Control tab, or Calibrator tab.
Elements
R/P Displays the rack ID (R) and position (P) number. The rack/
position can be sorted in ascending order, first
alphanumerically by rack, and then numerically by position.
SID Displays the sample identification for the order, which can be
one of the following items:
• The bar code number or identification assigned to the
specimen.
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• The control lot number and level number. Bar-coded
controls include a serial number when quality controls are
run in a vial rack. Bar-coded controls include the prefix
QQQ followed by the control lot number and level when
the controls are run in a sample rack.
• The calibrator lot number and calibrator level number.
The SID can be sorted alphanumerically in ascending order.
Name Displays the name, which can be one of the following items:
• The patient's name.
• The control name with the control level number and the
control level name, if configured, for control orders.
• The calibrator or calibrator set name, CAL (only for i-
series), and the calibrator level for calibration orders.
Assay Displays the name of the test ordered.
Test Type Displays the sample type for the order: Specimen, Control, or
Calibrator. The Test Type column is displayed only on the All
Orders tab and the Rerun tab.
Status Displays the current test status (Pending, Scheduled, Running,
In Process, or Complete) of the assay ordered.
Time Displays the estimated time that the order will be completed
(in a 24-hour format). Time information is displayed for all
samples with a status of Running.
Code Displays the processing codes to indicate processing
conditions.
Function buttons
Create Order Navigates to the Create Order screen.
Select All Selects or deselects all items in a list. The button switches
between Select All and Deselect All.
Search Displays the Search flyout.
Print Displays the Print flyout.
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Details Navigates to the Details screen for the selected items on the
current screen.
Delete Displays a message requesting confirmation to delete the
selected items.
Text Size Increases or decreases the size of text displayed.
Related information...
Orders screen, page 584
Descriptions of screen elements, page 127
Descriptions of test statuses, page 601
Descriptions of processing codes, page 602
Orders screen, Search flyout element descriptions
In the Search flyout of the Orders screen, the operator can enter specific data that is used to
filter the data on the screen.
Elements
Module Used to search by the module. The module number for orders
of calculated assays is 6 (the system control module).
Name Used to search by the name, which can be one of the
following items:
• The patient's name.
• The control name with the control level number and the
control level name, if configured, for control orders.
• The calibrator or calibrator set name, CAL (only for i-
series), and the calibrator level for calibration orders.
SID Used to search by the sample identification for the order,
which can be one of the following items:
• The bar code number or identification assigned to the
specimen.
• The control lot number and level number. Bar-coded
controls include a serial number when quality controls are
run in a vial rack. Bar-coded controls include the prefix
QQQ followed by the control lot number and level when
the controls are run in a sample rack.
• The calibrator lot number and calibrator level number.
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Rack Used to search by the rack identification number.
PID Used to search by the patient identification number.
Position Displays a drop-down list that is used to search by the rack
position.
RSM Position Displays a drop-down list that is used to search by a position
on the reagent and sample manager.
Assay Used to search by the assay name.
Time From Used to enter a search start time.
Time To Used to enter a search end time.
Status Used to search by the test status. The Search flyout has four
test statuses:
• Pending
• In Process
• Scheduled
• Running
Test Type Used to search the results for a specific sample type. The
Search flyout has three options:
• Specimen
• Control
• Calibrator
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Orders screen, page 584
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Search flyout, page 664
Descriptions of test statuses, page 601
Order Details screen
On the Order Details screen, the operator can view the details for a specimen test order, a
control test order, or a calibrator test order.
The operator can add a comment to a specimen test order, a control test order, or an individual
calibrator test order.
Related information...
Orders screen, page 584
Order Details (Specimen, Control, and Calibrator) screen element descriptions, page 588
Add a comment to an order, page 590
Order Details (Specimen, Control, and Calibrator) screen element descriptions
The Order Details screen displays the result details for specimens, controls, and calibrators.
Elements
Test Information area
SID Displays the sample identification.
Rack/Position Displays the rack ID and position number.
Operator ID Displays the ID of the operator logged on when the test was
ordered.
Test Type Displays the sample type for the test: Specimen or Control.
Module/Position Displays the module number and position of the rack on the
loading area.
Time of Completion Displays the date and time that the tests in process were
completed.
Status Displays the current status (Pending, Scheduled, Running, In
Process, or Complete) of the assay ordered.
PID Displays the patient identification. This element is displayed
only for specimens.
Gender Displays the gender of the patient. This element is displayed
only for specimens.
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Control Lot Displays the lot number of the control. This element is
displayed only for controls.
Calibrator Lot Displays the lot number of the calibrator. This element is
displayed only for calibrators.
Time of Completion Displays the date and time that the tests in process were
completed.
Name Displays the name of the patient.
Date of Birth Displays the date of birth for the patient. This element is
displayed only for specimens.
Draw Date and Time Displays the date and time that the sample was drawn. This
element is displayed only for specimens.
Lot Expiration Displays the date and time of the control or calibrator lot
expiration. This element is not displayed for specimens.
Assay Information area
Assay Name Displays the name of the assay file.
Assay Number Displays the number of the assay file.
Assay Version Displays the version number of the assay file.
Dilution Displays the type of dilution used to process the test.
Codes Displays the processing codes associated with the test.
Reference Assay Displays the photometric reference assay.
Reagent Information area
Reagent Lot Displays the master lot number for the reagent.
Reagent SN Displays the serial number of the reagent cartridge.
Reagent Lot Displays the expiration date of the reagent cartridge.
Expiration
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Additional Information area
Doctor Displays the name of the patient's doctor. This element is
displayed only for specimens.
Location Displays the location associated with the patient. This element
is displayed only for specimens.
Comment Used to enter a comment for the test.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Previous Displays the previous item when multiple items are selected.
Next Displays the next item when multiple items are selected.
Related information...
Order Details screen, page 588
Descriptions of screen elements, page 127
Add a comment to an order
Perform this procedure to add a comment to a specimen order, a control order, or a calibration
order.
1. On the menu bar, tap Orders.
2. In the list on the Orders screen, tap one or more tests (or tap Select All).
NOTE: To filter the list, tap a tab (or tap Search).
3. Tap Details.
4. In the Comment box on the Order Details screen, type additional information that is
associated with the test.
NOTE: Comments are displayed and are printed with the test. In addition, comments for
samples are displayed if comments were entered when the order was created.
5. If more than one order was selected, tap Next or Previous to display each order, and then
type a comment for each order.
6. To save the comments, tap Done.
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Related information...
Order Details screen, page 588
Search for or filter data, page 664
Create Order screen
On the Create Order screen, the operator can create an order when the following situations
occur:
• The system is not connected to a host computer.
• The host computer is not functioning.
• An additional test is needed.
The operator can perform the following functions:
• Add information that is specific to a specimen.
• Add assay options that are specific to a test.
Related information...
Orders screen, page 584
Create Order screen, Specimen tab element descriptions, page 591
Create Order screen, Control tab element descriptions, page 593
Create Order screen, Calibration tab element descriptions, page 594
Create a specimen order, page 595
Create a control order, page 597
Create a calibration order, page 599
Add a test to a specimen order, page 600
Create Order screen, Specimen tab element descriptions
On the Specimen tab, the operator can create a specimen order.
Elements
Order Type area
Single Specimen Orders one or more tests as a single sample.
option
Sample Data area
SID Used to enter the bar code number or identification assigned
to the specimen. The SID can have a maximum of 20
alphanumeric characters.
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Rack Used to enter the rack ID in which samples are placed for
processing. This element is optional when bar-coded samples
are used.
Position Used to enter the position for the rack or sample on the
reagent carousel in which the sample is placed for
processing. This element is optional when bar-coded samples
are used.
Manual Dilution: 1 - Used to enter the dilution factor to calculate the sample
concentration automatically and to report the result.
Designate Sample Used to enter the S code on the Orders screen, the Results
STAT check box screen, and the Sample Status screen. The operator must
priority load the samples with the S code to process the
samples first.
Comments Used to enter comments for the sample. Comments are
displayed and can be printed for each test ordered for the
sample. Comments can have a maximum of 50 characters.
Assays area
All option Displays all assays that are available on the system.
i-series option Displays all assays that are available on one or more Alinity i
processing modules.
c-series option Displays all assays that are available on one or more Alinity c
processing modules.
Calculated option Displays all calculated assays.
Panels Displays all assay panels that are available.
Assays Displays all assays that are available for a selected module.
Number of Selected Displays the number of assays that are selected.
Assays
Function buttons
Order Status Navigates to the Orders screen.
Patient Details Displays the Patient Details flyout.
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Assay Options Displays the Assay Options flyout.
Add Order Saves and navigates to the order on the Orders screen.
Related information...
Create Order screen, page 591
Descriptions of screen elements, page 127
Create Order screen, Control tab element descriptions
On the Control tab, the operator can create a control order.
Elements
Orders area
Rack Used to enter the rack ID in which samples are placed for
processing. This element is optional when bar-coded samples
are used.
Position Used to enter the position for the rack or sample on the
reagent carousel in which the sample is placed for
processing. This element is optional when bar-coded samples
are used.
Control Data area
Control Name Displays the control identification name that can be selected
from the drop-down list.
Control Lot Displays the control lot number that can be selected from the
drop-down list.
Control Level Displays the control level that can be selected from the drop-
down list.
Manual Dilution: 1 - Used to enter the dilution factor to calculate the sample
concentration automatically and to report the result.
Designate Sample Used to display the S code on the Orders screen, the Results
STAT check box screen, and the Sample Status screen. The operator must
priority load the samples with the S code to process the
samples first.
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Assays area
All option Displays all assays that are available on the system.
i-series option Displays all assays that are available on one or more Alinity i
processing modules.
c-series option Displays all assays that are available on one or more Alinity c
processing modules.
Calculated option Displays all calculated assays.
Panels Displays all assay panels that are available.
Assays Displays all assays that are available for a selected module.
Number of Selected Displays the number of assays that are selected.
Assays
Function buttons
Order Status Navigates to the Orders screen.
Assay Options Displays the Assay Options flyout.
Add Order Saves and navigates to the order on the Orders screen.
Related information...
Create Order screen, page 591
Descriptions of screen elements, page 127
Create Order screen, Calibration tab element descriptions
On the Calibration tab, the operator can create a calibration order.
Elements
Sample Data area
Rack Used to enter the rack ID in which samples are placed for
processing. This element is optional when bar-coded samples
are used.
Starting Position Used to enter the position of the first calibrator.
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Assays area
All option Displays all assays that are available on the system.
i-series option Displays all assays that are available on one or more Alinity i
processing modules.
c-series option Displays all assays that are available on one or more Alinity c
processing modules.
Panels Displays all assay panels that are available.
Assays Displays all assays that are available for a selected module.
Number of Selected Displays the number of assays that are selected.
Assays
Function buttons
Order Status Navigates to the Orders screen.
Assay Options Displays the Assay Options flyout.
Add Order Saves and navigates to the order on the Orders screen.
Related information...
Create Order screen, page 591
Descriptions of screen elements, page 127
Create a specimen order
Perform this procedure to create a specimen order manually.
1. On the menu bar, tap Orders.
2. On the Orders screen, tap Create Order.
3. Under Sample Data on the Specimen tab of the Create Order screen:
– Enter the SID.
IMPORTANT: To ensure that the processed tests include the correct information,
confirm that the SID is not reused before previously pending orders are completed or
are deleted.
– Enter the rack ID and the position number.
NOTE: If bar-coded samples are used, the rack ID and the position number are not
required. If a rack and a position are entered and the bar code on the sample is not
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read, the system automatically uses the scanned rack ID as the unique rack ID and the
sample is processed as entered.
– If the specimen was diluted manually, type the dilution factor in the Manual Dilution: 1 -
box.
NOTE: Not all assays support manual dilutions. Assays that do not support manual
dilution are displayed as unavailable when a manual dilution is selected. For dilution
information, see the assay documentation.
– To display the STAT processing code for the SID, tap the Designate Sample STAT
check box.
NOTE: Samples that are designated as STAT must be priority loaded to be processed
as STAT samples.
4. In the Comments box, type additional information that is associated with the sample.
Comments are displayed and are printed with each test that is ordered for the sample.
5. Under Assays, tap an assay panel to run (or tap one or more of the individual assays to
run).
The number of selected assays is displayed.
NOTE: To filter the list of available assays, tap the option for i-series, c-series, or
Calculated.
To order a calculated assay, perform one of the following steps:
– Tap only the calculated assay.
The system automatically orders the assays that are necessary to complete the
calculation but does not release or report the results ordered by the system.
Constituent assays for some calculated immunoassays that are installed from an assay
file (assay numbers 3000 through 3999) cannot be ordered automatically by the system
and must be ordered separately. For specific assay requirements, see the assay
documentation.
– Tap the calculated assay and one or more of its constituent assays.
The system automatically orders the additional constituent assays that are necessary to
complete the calculation but does not release or report the constituent results ordered
by the system.
– Tap the calculated assay and all of its constituent assays.
The system releases and reports all results.
6. Tap Assay Options.
7. For each selected assay in the Assay Options flyout, perform the following steps if these
situations occur:
– If more than one processing module of the same type is configured for a system, under
Module Selection, tap Module to specify a processing module, and then tap the
appropriate module check boxes to override the system module scheduler.
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– Under Dilution Protocols/Number of Replicates, if the default number of replicates for
one or more dilutions is incorrect, tap the correct number of replicates for each dilution.
IMPORTANT: For i-series assays, do not order more than 10 tests for each sample that
is loaded in sample cups.
For c-series ICT assays, do not order more than 15 tests for each sample that is loaded
in sample cups or tubes.
The total number of tests for each sample includes all assays, replicates, dilutions, and
available reagent lots for the order.
8. To save the assay option selections, tap Done.
9. Tap Patient Details.
10. In the Patient Details flyout, enter the patient demographic information.
If a draw date or a time is entered, both the draw date and the time must be entered.
11. To save the patient demographic information, tap Done.
12. To save the specimen order, tap Add Order.
13. To view the specimen order, tap Order Status.
Related information...
Create Order screen, page 591
Load samples into sample racks, page 569
Reagent inventory processing, page 569
Create a control order
Perform this procedure to create a control order manually.
1. On the menu bar, tap Orders.
2. On the Orders screen, tap Create Order.
3. On the Create Order screen, tap the Control tab.
4. Under Orders on the Control tab, enter the rack ID and the position number that correspond
to the sample location.
NOTE: If bar-coded samples are used or if the control product is located in the reagent
carousel, the rack ID and the position number are not required.
5. Under Control Data:
– Tap a control name in the Control Name drop-down list.
– Tap a control lot in the Control Lot drop-down list.
– Tap a control level in the Control Level drop-down list.
– If the control was diluted manually, type the dilution factor in the Manual Dilution: 1-
box.
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– To display the STAT processing code for the control, tap the Designate Sample STAT
check box.
NOTE: Controls that are designated as STAT must be priority loaded to be processed
as STAT controls.
6. Under Assays, tap an assay panel to run (or tap one or more of the individual assays to
run).
The number of selected assays is displayed.
NOTE: To filter the list of available assays, tap the option for i-series, c-series, or
Calculated.
7. Tap Assay Options.
8. For each selected assay in the Assay Options flyout, perform the following steps:
– Tap a Reagent Selection option to designate the reagent cartridge or the processing
module to run the control:
• The default is Auto. The system determines which reagent cartridge is used to
perform the test according to reagent inventory processing.
• If more than one reagent cartridge is loaded in the reagent carousel, tap Select
Cartridge, and then tap a reagent cartridge in the list.
• If more than one processing module of the same type is configured for a system,
tap Module to specify a processing module, and then tap the appropriate module
check boxes to override the system module scheduler.
– Under Dilution Protocols/Number of Replicates, if the default number of replicates for
one or more dilutions is incorrect, tap the correct number of replicates for each dilution.
IMPORTANT: For i-series assays, do not order more than 10 tests for each sample that
is loaded in sample cups.
For c-series ICT assays, do not order more than 15 tests for each sample that is loaded
in sample cups or tubes.
The total number of tests for each sample includes all assays, replicates, dilutions, and
available reagent lots for the order.
9. To save the assay option selections, tap Done.
10. To save the control order, tap Add Order.
11. To view the control order, tap Order Status.
Related information...
Create Order screen, page 591
Install assay files, page 272
Load samples into sample racks, page 569
Reagent inventory processing, page 569
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Create a calibration order
Perform this procedure to create a calibration order manually.
1. On the menu bar, tap Orders.
2. On the Orders screen, tap Create Order.
3. On the Create Order screen, tap the Calibration tab.
4. Under Sample Data on the Calibration tab, enter the rack ID and the starting position.
NOTE: The rack ID and the starting position specify the use of samples that are loaded on
the reagent and sample manager. However, the ID and the position are not required if the
calibration uses bar-coded samples, the calibration uses only water, or the calibrator
product is loaded in the reagent carousel.
5. Under Assays, tap an assay panel to calibrate (or tap one or more of the individual assays
to calibrate).
The number of selected assays is displayed.
NOTE: To filter the list of available assays, tap the option for i-series or c-series.
6. Tap Assay Options.
7. For each selected assay in the Assay Options flyout, perform the following steps:
a. In the Calibrator Lot drop-down list, tap a calibrator lot or confirm the default data.
b. If an adjust type is available, tap it to perform an adjust calibration.
c. Tap a Reagent Selection option to designate the reagent cartridge or the processing
module to perform the calibration:
• The default is Auto. The system determines which reagent cartridge is used to
perform the calibration according to calibration sample processing.
• If more than one reagent cartridge is loaded in the reagent carousel, tap Select
Cartridge, and then tap a reagent cartridge in the list.
• If more than one processing module of the same type is configured for a system,
tap Module to specify a processing module, and then tap the appropriate module
check boxes to override the system module scheduler.
8. To save the assay option selections, tap Done.
9. To save the calibration order, tap Add Order.
10. To view the calibration order, tap Order Status.
Related information...
Create Order screen, page 591
Install assay files, page 272
Load samples into sample racks, page 569
Calibration sample processing, page 564
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Calibration procedures, page 673
Adjustment calibration (c-series photometric), page 687
Adjustment calibration (i-series), page 694
Prepare and load vials into vial racks for immediate use, page 572
Add a test to a specimen order
Perform this procedure to add a test to a specimen order.
NOTE: If a calculated assay is added and new constituent results are wanted for the calculation,
add the constituent assays in addition to the calculated assay.
1. On the menu bar, tap Orders.
2. On the Orders screen, tap Create Order.
3. Under Sample Data on the Specimen tab of the Create Order screen:
– Enter the SID of the original specimen.
– If the original specimen was diluted manually, type the dilution factor of the specimen in
the Manual Dilution: 1 - box.
4. Under Assays, tap an assay panel to run (or tap one or more of the individual assays to
run).
The number of selected assays is displayed.
NOTE: To filter the list of available assays, tap the option for i-series, c-series, or
Calculated.
To order a calculated assay, perform one of the following steps:
– Tap only the calculated assay.
The system automatically orders the assays that are necessary to complete the
calculation but does not release or report the results ordered by the system.
Constituent assays for some calculated immunoassays that are installed from an assay
file (assay numbers 3000 through 3999) cannot be ordered automatically by the system
and must be ordered separately. For specific assay requirements, see the assay
documentation.
– Tap the calculated assay and one or more of its constituent assays.
The system automatically orders the additional constituent assays that are necessary to
complete the calculation but does not release or report the constituent results ordered
by the system.
– Tap the calculated assay and all of its constituent assays.
The system releases and reports all results.
5. Tap Assay Options.
6. For each selected assay in the Assay Options flyout, perform the following steps if these
situations occur:
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– If more than one processing module of the same type is configured for a system, under
Module Selection, tap Module to specify a processing module, and then tap the
appropriate module check boxes to override the system module scheduler.
– Under Dilution Protocols/Number of Replicates, if the default number of replicates for
one or more dilutions is incorrect, tap the correct number of replicates for each dilution.
IMPORTANT: For i-series assays, do not order more than 10 tests for each sample
loaded in sample cups.
For c-series ICT assays, do not order more than 15 tests for each sample loaded in
sample cups or tubes.
The total number of tests for each sample includes all assays, replicates, dilutions, and
available reagent lots for the order.
7. To save the assay option selections, tap Done.
8. To save the additional specimen order, tap Add Order.
9. To view the additional specimen order, tap Order Status.
Related information...
Create Order screen, page 591
Search for or filter data, page 664
Descriptions of test statuses
Test status information is used to determine the progress of an ordered test or to manage
specimen and control results. The system tracks the test statuses for each ordered or completed
test.
The following list provides descriptions of the test statuses. The statuses are described in the
order in which they are displayed, are sorted, and are printed:
Pending The test is ordered, but the RSM bar code reader has not
scanned the corresponding sample.
Scheduled The test is ordered and the sample is scanned by the RSM
bar code reader, but the instrument has not aspirated the
sample.
Running The test is ordered, the sample is scanned, and the
instrument is processing the sample.
In Process For a calculated test, the tests that are necessary to calculate
the test result are in process.
Exception The test order failed and a test result was not generated.
Complete The test is completed.
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Related information...
Orders screen, page 584
Orders screen element descriptions, page 584
Sample Status screen element descriptions, page 604
Orders screen, Search flyout element descriptions, page 586
Descriptions of processing codes
Information about processing codes is used to determine how samples are processed. One or
more processing codes are displayed if the codes are applicable to an ordered test or test
results.
The following list provides descriptions of the processing codes. The codes are described in the
order in which they are displayed, are sorted, and are printed:
S The sample is ordered as a STAT sample.
D The test is an automated dilution with a dilution factor that is
greater than 1, or the test is an automated dilution that is not
the first configured dilution.
M The sample is diluted manually.
R The test is a rerun.
* The test is an original result for a rerun.
C The test has a comment.
Related information...
Orders screen, page 584
Results screen, page 616
Orders screen element descriptions, page 584
Sample Status screen element descriptions, page 604
Results screen, Unreleased tab element descriptions, page 617
Results screen, Specimen tab element descriptions, page 618
Delete a test from a sample order
Prerequisite The test status must be Pending or In Process.
Perform this procedure to delete a test that does not need to be processed.
1. On the menu bar, tap Orders.
2. In the list on the Orders screen, tap one or more tests (or tap Select All).
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NOTE: To filter the list, tap a tab (or tap Search).
3. Tap Delete.
4. When a confirmation message is displayed, tap OK.
Related information...
Orders screen, page 584
Search for or filter data, page 664
Sample Status screen
On the Sample Status screen, the operator can view the following information:
• Specimen orders, control orders, and calibration orders
• Unreleased results for specimens and controls
• Tests that are scheduled for reruns
• Test exceptions that have not been rerun, released, or deleted
The operator can perform the following functions:
• Find information about a specific test based on specified search criteria.
• Access test information.
• Add a comment to a test order.
• Transmit a result.
• Suspend the processing of a sample.
• Rerun a test.
• Print a sample status report.
Related information...
Specimen, calibration, and control orders, page 578
Sample Status screen element descriptions, page 604
Sample Status screen, Search flyout element descriptions, page 606
Sample Details screen, page 608
Rerun a test or an exception for a specimen or control, page 612
Release a specimen result or a control result, page 614
Suspend and access a sample that has tests in process, page 575
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Sample Status screen element descriptions
All Samples tab, Specimen tab, Control tab, Calibrator tab
Displays the status of the following items:
• Specimen orders
• Control orders, exceptions, and results
• Calibrator orders and exceptions
Sample status information can be filtered by sample type by selecting the Specimen tab,
Control tab, or Calibrator tab.
Elements
SID Name SID: Displays the sample identification, which can be one of
the following items:
• The bar code number or identification assigned to the
specimen.
• The control name and level.
• The calibrator name and level.
The SID can be sorted alphanumerically in ascending order.
Name: Displays the name, which can be one of the following
items:
• The patient's name for specimen orders.
• The control name and level for control orders.
• The calibrator name and level for calibration orders.
The name is displayed in green text.
R/P M/P R/P: Displays the rack ID (R) and position (P) number. The
rack/position can be sorted in ascending order, first
alphanumerically by rack, and then numerically by position.
M/P: Displays the module number (M) and position (P) of the
rack on the loading area. The M/P is displayed in green text.
Assay/Codes Assay: Displays the name of the test requested for
processing.
Codes: Displays one or more single-character codes to
indicate processing conditions.
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Additional information is indicated by the following colors:
Black The test has a status of Scheduled,
Pending, Running, or In Process.
Green The test has completed but is not
released.
Blue The test has completed and has been
released.
Red The test is an exception or has a flag.
Status/Result Displays the current status (Pending, Scheduled, Running, In
Process, Exceptions, or Complete) of specimen orders,
control orders, and calibration orders or displays specimen
results and control results.
Displays the following test descriptions:
• Date and time (estimated completion time when tests are
processing).
• Result value and result units.
• Date and time (time of completion).
• Message code and description (where applicable).
Additional information is indicated by the following colors:
Black The test has a status of Scheduled,
Pending, Running, or In Process.
Green The test has completed but is not
released.
Blue The test has completed and has been
released.
Red The test is an exception or has a flag.
Interpretation Displays the interpretation of the result value obtained.
Flags Displays the flags associated with specimen results and
quality control results.
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Function buttons
Select All Selects or deselects all items in a list. The button switches
between Select All and Deselect All.
Search Displays the Search flyout.
Print Displays the Print flyout.
Details Navigates to the Details screen for the selected items on the
current screen.
Suspend Displays a message requesting confirmation to suspend
processing on the selected module or section to access a
sample.
Rerun Displays the Rerun Options flyout.
Release Releases the selected test results or exceptions. Test results
remain on the Sample Status screen until all results for the
specimen or control are released. Test exceptions that have
not been rerun or released for transmission remain on the
screen. Rerun or released test exceptions remain on the
Sample Status screen until all results are transmitted.
Text Size Increases or decreases the size of text displayed.
Related information...
Sample Status screen, page 603
Descriptions of screen elements, page 127
Descriptions of test statuses, page 601
Descriptions of processing codes, page 602
Descriptions of specimen result flags, page 630
Descriptions of quality control result flags, page 632
Sample Status screen, Search flyout element descriptions
In the Search flyout of the Sample Status screen, the operator can enter specific data that is
used to filter the data on the screen.
Elements
Find Sample Used to select a location in the database to find the sample.
The Search flyout has two options:
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Sample Status Used to search for the sample on the
Sample Status screen.
System Wide Used to search for the sample on all
data screens.
Module Displays a drop-down list that is used to search for a module
by the module number.
RSM Position Used to search by a position number on the reagent and
sample manager.
SID Used to search by the bar code number or identification
assigned to the sample.
PID Used to search by the patient identification number.
Last Name Used to search by the patient's last name.
First Name Used to search by the patient's first name.
Rack Used to search by the rack ID number.
Position Displays a drop-down list that is used to search by the rack
position.
Start Date Used to enter a search start date.
End Date Used to enter a search end date.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Sample Status screen, page 603
Search flyout, page 664
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Sample Details screen
On the Sample Details screen, the operator can view the following information:
• Details for specimen results, control results, or exceptions
• Details for a specimen test order, a control test order, or a calibrator test order
The operator can add a comment to an order, a result, or an exception.
Related information...
Sample Status screen, page 603
Sample Details (Specimen, Control, and Calibrator) screen element descriptions, page 608
Add a comment to a result or an exception, page 612
Sample Details (Specimen, Control, and Calibrator) screen element descriptions
The Sample Details screen displays the sample details for specimens, controls, and calibrators.
Elements
Test Information area
SID Displays the sample identification.
Rack/Position Displays the rack ID and position number.
Operator ID Displays the ID of the operator logged on when the test was
processed.
Sample Type Displays the sample type for the test:
• Specimen
• Control
• Calibrator
Module/Position Displays the module number and position of the rack on the
loading area.
Time of Completion Displays the date and time that the tests in process were
completed.
PID Displays the patient identification. This element is displayed
only for specimens.
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Gender Displays the gender of the patient. This element is displayed
only for specimens.
Date of Birth Displays the date of birth for the patient. This element is
displayed only for specimens.
Name Displays the name of the patient. This element is displayed
only for specimens.
Transmission Status Displays the status of the test transmission to the host. This
element is not displayed for calibrators.
Released By Displays the ID of the operator logged on when the test was
released. This element is not displayed for calibrators.
Control Information area
This area is displayed only for controls.
Control Name Displays the name of the control.
Control Lot Displays the lot number of the control.
Control Level Displays the name of the control level.
Control Lot Exp. Displays the expiration date of the control lot.
Calibrator Information area
This area is displayed only for calibrators.
Calibrator Name Displays the name of the calibrator.
Calibrator Lot Displays the lot number of the calibrator.
Calibration Method Displays the data reduction method used for the assay.
Calibrator Level Displays the name of the calibrator level.
Calibrator Lot Exp. Displays the expiration date of the calibrator lot.
Calibration Type Displays the type of assay calibration performed.
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Assay Information area
Assay Name Displays the name of the assay file.
Assay Number Displays the number of the assay file.
Assay Version Displays the version number of the assay file.
Result Displays the value, unit, and (where applicable) interpretation
of the result.
Absorbance/mV (c- Displays the response value used to calculate the result:
series)
• Millivolt (only for ICT)
• Absorbance (only for photometric assays)
NOTE: This element is not displayed for sample interference
index assays.
RLU (i-series) Displays the response value in relative light units that is used
to calculate the result.
Flag Displays the flags associated with specimen results and
quality control results.
Interpretation Displays the interpretation of the result value obtained.
Normal Range Displays the normal or therapeutic range for the assay. This
element is displayed only for specimens.
Control Range Displays the control range configured for the assay. If a
control range is not configured, the control range that is
displayed is calculated based on the configured expected
mean and expected standard deviation (1 SD). This element is
displayed only for controls.
Codes Displays the processing codes associated with the test.
Dilution Displays the type of dilution used to process the test.
Cuvette (c-series) Displays the number of the cuvette used to process the test.
This element is not displayed for calibrators.
Module SN Displays the serial number of the module.
Message Displays the message code number and description.
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Reagent Information area
Reagent Lot Displays the master lot number for the reagent.
Reagent SN Displays the serial number of the reagent cartridge.
Reagent Lot Displays the expiration date of the reagent cartridge.
Expiration
Calibration Displays the date and time of the reagent calibration.
Additional Information area
Doctor Displays the name of the patient's doctor. This element is
displayed only for specimens.
Location Displays the location associated with the patient. This element
is displayed only for specimens.
Draw Date and Time Displays the date and time that the sample was drawn. This
element is displayed only for specimens.
Archive Status Displays the archive status of the test: Archived or Not
Archived. This element is not displayed for calibrators.
Archive Date and Time Displays the date and time that the test was archived. This
element is not displayed for calibrators.
Comment Used to enter a comment for the test.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Previous Displays the previous item when multiple items are selected.
Next Displays the next item when multiple items are selected.
Related information...
Sample Details screen, page 608
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Descriptions of screen elements, page 127
Add a comment to a result or an exception
Perform this procedure to add a comment to a result or an exception. This procedure can be
performed from the Sample Status screen or the Results screen.
1. To find test results that require a comment, perform the steps from one of the following
screens:
Sample Status screen:
– On the menu bar, tap Sample Status.
– Under SID Name on the All Samples tab, tap a sample.
NOTE: To filter the list, tap the Specimen tab or the Control tab (or tap Search).
Results screen:
– On the menu bar, tap Results.
The default is the Unreleased tab.
– To add a comment to a released specimen, a released control, or an exception, tap the
appropriate tab.
NOTE: To filter the list, tap Search.
2. In the list, tap one or more results or exceptions (or tap Select All).
3. Tap Details.
4. In the Comment box, type additional information that is associated with the result or
exception.
Comments are displayed and are printed with the result or exception. In addition, comments
for samples and tests are displayed if comments were entered.
5. If more than one result or exception was selected, tap Next or Previous to display each
order, and then type a comment for each order.
6. To save the comments, tap Done.
Related information...
Sample Details screen, page 608
Results screen, page 616
Result Details screen, page 624
Search for or filter data, page 664
Rerun a test or an exception for a specimen or control
Perform this procedure to rerun a specimen test, a control test, or an exception. If additional
tests are required, a new order must be created. This procedure can be performed from the
Sample Status screen or the Results screen.
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NOTE: Only exceptions with a status of Blank can be rerun.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
1. Retrieve the original sample and verify the following conditions:
– The volume is adequate.
– The sample integrity is acceptable.
2. Return the sample to the reagent and sample manager.
3. To find the test result to rerun, perform the steps from one of the following screens:
Sample Status screen:
– On the menu bar, tap Sample Status.
– Under SID Name on the All Samples tab, tap the sample.
NOTE: To filter the list, tap the Specimen tab or the Control tab (or tap Search).
Results screen:
– On the menu bar, tap Results.
The default is the Unreleased tab.
– To rerun an exception, tap the Exception tab.
NOTE: To filter the list, tap Search.
4. In the list, tap one or more tests to rerun (or tap Select All).
NOTE: To rerun a calculated assay, perform one of the following steps:
– Tap only the calculated assay.
The system automatically orders the assays that are necessary to complete the
calculation but does not release or report the results ordered by the system.
Constituent assays for some calculated immunoassays that are installed from an assay
file (assay numbers 3000 through 3999) cannot be ordered automatically by the system
and must be ordered separately. For specific assay requirements, see the assay
documentation.
– Tap the calculated assay and one or more of its constituent assays.
The system automatically orders the additional constituent assays that are necessary to
complete the calculation but does not release or report the constituent results ordered
by the system.
– Tap the calculated assay and all of its constituent assays.
The system releases and reports all results.
5. Tap Rerun.
6. For each selected assay in the Rerun Options flyout, perform the following steps:
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– Enter the rack ID and the position number.
NOTE: When bar-coded samples are used, the rack ID and the position number are not
required.
– If more than one processing module of the same type is configured for a system, under
Module Selection, tap Module to specify a processing module, and then tap the
appropriate module check boxes to override the system module scheduler.
– Under Dilution Protocols/Number of Replicates, if the default number of replicates for
one or more dilutions is incorrect, tap the correct number of replicates for each dilution.
7. To save the rerun option selections, tap Done.
The rerun tests that are scheduled can be viewed on the Sample Status screen or the
Orders screen.
Related information...
Sample Status screen, page 603
Sample specifications and requirements, page 420
Results screen, page 616
Search for or filter data, page 664
Release a specimen result or a control result
Perform this procedure to release manually the specimen results or control results that have
been reviewed. This procedure can be performed from the Sample Status screen or the Results
screen.
1. To find test results to release, perform the steps from one of the following screens:
Sample Status screen:
– On the menu bar, tap Sample Status.
– Under SID Name on the All Samples tab, tap a sample.
NOTE: To filter the list, tap the Specimen tab or the Control tab (or tap Search).
Results screen:
– On the menu bar, tap Results.
The default is the Unreleased tab.
NOTE: To filter the list, tap Search.
2. In the list, tap one or more tests to release (or tap Select All).
3. Tap Release.
Related information...
Sample Status screen, page 603
Delete a quality control, page 302
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Results screen, page 616
Search for or filter data, page 664
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Results screen
On the Results screen, the operator can view the following information:
• Specimen and control results
• Specimen and control exceptions
The operator can perform the following functions:
• Find information about a specific test based on specified search criteria.
• Access result information.
• Release or delete a result.
• Rerun a test.
Related information...
Operating instructions, page 427
Results screen, Unreleased tab element descriptions, page 617
Results screen, Specimen tab element descriptions, page 618
Results screen, Control tab element descriptions, page 620
Results screen, Exception tab element descriptions, page 621
Results screen, Search flyout element descriptions, page 622
Result Details screen, page 624
Rerun Options flyout, specimen order element descriptions, page 628
Rerun Options flyout, control order element descriptions, page 629
Descriptions of specimen result flags, page 630
Descriptions of quality control result flags, page 632
Descriptions of transmission statuses, page 634
View the reaction graph and absorbance data for a result (c-series), page 634
Delete a sample result or an exception, page 635
Transmit a result or an exception to the host, page 635
Rerun a test or an exception for a specimen or control, page 612
Release a specimen result or a control result, page 614
Descriptions of processing codes, page 602
Archive the results, page 668
Add a comment to a result or an exception, page 612
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Results screen, Unreleased tab element descriptions
The Unreleased tab displays completed specimen and control results that have not been
released. The Unreleased tab is not displayed if patient and control release modes are set to
automatic or automatic with exceptions.
Elements
Module ID Displays the number of the module used to process the test.
The module number for results of calculated assays is 6
(system control module).
R/P Displays the rack ID (R) and position (P) number.
SID Displays the sample identification, which can be one of the
following items:
• The bar code number or identification assigned to the
specimen.
• The control lot number and level number. Bar-coded
controls include a serial number when quality controls are
run in a vial rack. Bar-coded controls include the prefix
QQQ followed by the control lot number and level when
the controls are run in a sample rack.
• The calibrator lot number and calibrator level number.
Name Displays the name, which can be one of the following items:
• The name of the specimen.
• The control name with the control level number and the
control level name, if configured, for control orders.
• The calibrator or calibrator set name, CAL (only for i-
series), and the calibrator level for calibration orders.
Assay Displays the name of the test.
Result Displays the value and unit of the test result.
Interpretation Displays the interpretation of the test result.
Flag Displays the flags associated with specimen results and
quality control results. All results with flags are displayed in
red text.
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Code Displays one or more single-character codes to indicate
processing conditions.
Time Displays the date and time that the test completed processing.
Function buttons
Select All Selects or deselects all items in a list. The button switches
between Select All and Deselect All.
Search Displays the Search flyout.
Print Displays the Print flyout.
Details Navigates to the Details screen for the selected items on the
current screen.
Rerun Displays the Rerun Options flyout.
Release Moves the selected test results to the Specimen tab or the
Control tab.
Delete Displays a message requesting confirmation to delete the
selected items.
Text Size Increases or decreases the size of text displayed.
Related information...
Results screen, page 616
Descriptions of screen elements, page 127
Descriptions of specimen result flags, page 630
Descriptions of quality control result flags, page 632
Descriptions of processing codes, page 602
Results screen, Specimen tab element descriptions
The Specimen tab displays released specimen results.
Elements
Module ID Displays the number of the module used to process the test.
The module number for results of calculated assays is 6 (the
system control module).
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R/P Displays the rack ID (R) and position (P) number.
SID Displays the bar code number or identification assigned to the
specimen.
Name Displays the name of the specimen.
Assay Displays the name of the test.
Result Displays the value and unit of the test result.
Interpretation Displays the interpretation of the test result.
Flag Displays the flags associated with the specimen results.
Code Displays one or more single-character codes to indicate
processing conditions.
Time Displays the date and time that the test completed processing.
Function buttons
Select All Selects or deselects all items in a list. The button switches
between Select All and Deselect All.
Search Displays the Search flyout.
Print Displays the Print flyout.
Archive Displays the Archive flyout.
Details Navigates to the Details screen for the selected items on the
current screen.
Transmit Sends selected test results to the host computer.
Delete Displays a message requesting confirmation to delete the
selected items.
Text Size Increases or decreases the size of text displayed.
Related information...
Results screen, page 616
Descriptions of screen elements, page 127
Descriptions of specimen result flags, page 630
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Descriptions of processing codes, page 602
Results screen, Control tab element descriptions
The Control tab displays released control results.
Elements
Module ID Displays the number of the module used to process the test.
The module number for results of calculated assays is 6 (the
system control module).
R/P Displays the rack ID (R) and position (P) number.
SID Displays the bar code number or identification assigned to the
control.
Control Displays the name of the control that was processed.
Lot Displays the lot number of the control that was processed.
Level Displays the level of the control that was processed.
Assay Displays the name of the test.
Result Displays the value and unit of the test result.
Flag Displays the flags associated with the quality control results.
Time Displays the date and time that the test completed processing.
Function buttons
Select All Selects or deselects all items in a list. The button switches
between Select All and Deselect All.
Search Displays the Search flyout.
Print Displays the Print flyout.
Archive Displays the Archive flyout.
Details Navigates to the Details screen for the selected items on the
current screen.
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Transmit Sends selected test results to the host computer.
Delete Displays a message requesting confirmation to delete the
selected items.
Text Size Increases or decreases the size of text displayed.
Related information...
Results screen, page 616
Descriptions of screen elements, page 127
Descriptions of quality control result flags, page 632
Results screen, Exception tab element descriptions
The Exception tab displays rerun and unreleased test exceptions and test exceptions that have
been released manually or automatically for transmission. A test exception remains on the
Exception tab until the exception is deleted by an operator or is deleted automatically after
24 hours based on the completion time of the exception.
Elements
Module ID Displays the number of the module used to process the test.
R/P Displays the rack ID (R) and position (P) number.
SID Displays the bar code number or identification assigned to the
specimen, control, or calibrator test order.
Name Displays the name of the specimen, control, or calibrator.
Test Type Displays the type of sample that was ordered: Specimen,
Control, or Calibrator.
Assay Displays the name of the test.
Status Displays the status of the exception, which can be one of the
following statuses:
Blank Exceptions have not been rerun or
released.
Rerun Exceptions have been rerun, but they
have not been released.
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Released Exceptions have been released
manually or automatically for
transmission to a host computer.
Message Code Displays the numeric message code for the exception and the
message text that describes the error.
Function buttons
Select All Selects or deselects all items in a list. The button switches
between Select All and Deselect All.
Search Displays the Search flyout.
Print Displays the Print flyout.
Details Navigates to the Details screen for the selected items on the
current screen.
Rerun Displays the Rerun Options flyout.
Release Marks the exception with a Released status and releases the
exception for transmission to the host computer.
Transmit Sends selected test results to the host computer.
Delete Displays a message requesting confirmation to delete the
selected items.
Text Size Increases or decreases the size of text displayed.
Related information...
Results screen, page 616
Descriptions of screen elements, page 127
Results screen, Search flyout element descriptions
In the Search flyout of the Results screen, the operator can enter specific data that is used to
filter the data on the screen.
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Elements
Module Used to search by the module. The module number for the
results of calculated assays is 6 (the system control module).
Name Used to search by the name, which can be one of the
following items:
• The name of the specimen.
• The control name with the control level number and the
control level name, if configured, for control orders.
Control Lot Used to search by the control lot.
Control Level Used to search by the control level.
SID Used to search by the bar code number or identification
assigned to the sample.
PID Used to search by the patient identification number.
Rack Used to search by the rack identification number.
Position Displays a drop-down list that is used to search by the rack
position.
RSM Position Displays a drop-down list that is used to search by a position
on the reagent and sample manager.
Assay Used to search by the assay name.
Reagent Lot Used to search by the reagent lot number.
Date From Used to enter a search start date.
To Used to enter a search end date.
Start Time Used to enter a search start time.
End Time Used to enter a search end time.
Operator Used to search by the operator ID.
Results with Used to search the results that have one of the following
associated items:
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• Flags
• Interpretations
Test Type Used to search the results for a specific sample type. The
Search flyout has two test types:
• Specimen
• Control
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Results screen, page 616
Result Details screen
On the Result Details screen, the operator can view the following information:
• Details for specimen results, control results, or exceptions
• Reaction graphs only for c-series
The operator can add a comment to a result or an exception.
Related information...
Results screen, page 616
Result Details (Specimen and Control) screen element descriptions, page 624
Add a comment to a result or an exception, page 612
Result Details (Specimen and Control) screen element descriptions
The Result Details screen displays the result details for specimens and controls.
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Elements
Test Information area
SID Displays the sample identification.
Rack/Position Displays the rack ID and position number.
Operator ID Displays the ID of the operator logged on when the test was
processed.
Sample Type Displays the sample type for the test: Specimen or Control.
Module/Position Displays the module number and position of the rack on the
loading area.
Time of Completion Displays the date and time that the tests in process were
completed.
PID Displays the patient identification. This element is displayed
only for specimens.
Gender Displays the gender of the patient. This element is displayed
only for specimens.
Date of Birth Displays the date of birth for the patient. This element is
displayed only for specimens.
Name Displays the name of the patient. This element is displayed
only for specimens.
Transmission Status Displays the status of the test transmission to the host. This
element is not displayed for calibrators.
Released By Displays the ID of the operator logged on when the test was
released. This element is not displayed for calibrators.
Control Information area
This area is displayed only for controls.
Control Name Displays the name of the control.
Control Lot Displays the lot number of the control.
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Control Level Displays the name of the control level.
Control Lot Exp. Displays the expiration date of the control lot.
Assay Information area
Assay Name Displays the name of the assay file.
Assay Number Displays the number of the assay file.
Assay Version Displays the version number of the assay file.
Result Displays the value, unit, and (where applicable) interpretation
of the result.
Absorbance/mV (c- Displays the response value used to calculate the result:
series)
• Millivolt (only for ICT)
• Absorbance (only for photometric assays)
NOTE: This element is not displayed for sample interference
index assays.
RLU (i-series) Displays the response value in relative light units that is used
to calculate the result.
Flag Displays the flags associated with specimen results and
quality control results.
Interpretation Displays the interpretation of the result value obtained.
Normal Range Displays the normal or therapeutic range for the assay. This
element is displayed only for specimens.
Control Range Displays the control range configured for the assay. If a
control range is not configured, the control range that is
displayed is calculated based on the configured expected
mean and expected standard deviation (1 SD). This element is
displayed only for controls.
Codes Displays the processing codes associated with the test.
Dilution Displays the type of dilution used to process the test.
Cuvette (c-series) Displays the number of the cuvette used to process the test.
This element is not displayed for calibrators.
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Module SN Displays the serial number of the module.
Message Displays the message code number and description.
Reagent Information area
Reagent Lot Displays the master lot number for the reagent.
Reagent SN Displays the serial number of the reagent cartridge.
Reagent Lot Displays the expiration date of the reagent cartridge.
Expiration
Calibration Displays the date and time of the reagent calibration.
Additional Information area
Doctor Displays the name of the patient's doctor. This element is
displayed only for specimens.
Location Displays the location associated with the patient. This element
is displayed only for specimens.
Draw Date and Time Displays the date and time that the sample was drawn. This
element is displayed only for specimens.
Archive Status Displays the archive status of the test: Archived or Not
Archived. This element is not displayed for calibrators.
Archive Date and Time Displays the date and time that the test was archived. This
element is not displayed for calibrators.
Comment Used to enter a comment for the test.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Previous Displays the previous item when multiple items are selected.
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Next Displays the next item when multiple items are selected.
Related information...
Result Details screen, page 624
Descriptions of screen elements, page 127
Rerun Options flyout, specimen order element descriptions
In the Rerun Options flyout, the operator can order a rerun for a specimen test.
Elements
Sample ID Displays the bar code number or identification assigned to the
specimen.
Assay Displays the name of the test ordered.
Rack Displays the rack ID if it was entered in the original order.
Position Displays the rack position if a rack ID was entered in the
original order.
SID Displays the bar code number or identification assigned to the
specimen.
Assay Displays the name of the assay ordered.
Name Displays the specimen name.
Result Displays the value and unit of the test result.
Module Selection
Auto The system scheduler selects the processing module.
Dilution Protocols / Used to select the correct number of replicates for each
Number of Replicates dilution protocol.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
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Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Results screen, page 616
Rerun Options flyout, control order element descriptions
In the Rerun Options flyout, the operator can order a rerun on a control test.
Elements
Sample ID Displays the control lot number and level number. Bar-coded
controls include a serial number when quality controls are run
in a vial rack. Bar-coded controls include the prefix QQQ
followed by the control lot number and level when the controls
are run in a sample rack.
Assay Displays the name of the test ordered.
Rack Displays the rack ID if it was entered in the original order.
Position Displays the rack position if a rack ID was entered in the
original order.
Control Name Displays the control name.
Assay Displays the name of the assay ordered.
Control Level Displays the control level.
Result Displays the value and unit of the test result.
Control Lot Displays the control lot.
Reagent Selection
Select Cartridge Used to designate the reagent cartridge. When Select
Cartridge is selected, the following information is available:
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Module ID Displays the number of the processing
module where the reagent cartridge is
located.
Position Displays the reagent carousel position
where the reagent cartridge is located.
Reagent Lot Displays the reagent cartridge lot
number.
Serial Number Displays the reagent cartridge serial
number.
Cartridge Status Displays the reagent cartridge status.
Dilution Protocols / Used to select the correct number of replicates for each
Number of Replicates dilution protocol.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Results screen, page 616
Descriptions of specimen result flags
Specimen result flag information is used to provide additional information about a result and to
indicate that the result may need to be reviewed. When a specimen result has a flag, the
information is displayed in red text on the Results screen. One or more result flags are displayed
if they are applicable to a specimen result.
The following list provides descriptions of the specimen result flags. The flags are described in
the order in which they are sorted:
EXP* The result was measured by using one of the following
expired items:
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• Reagent
• Supply
• Onboard solution
EXPC* The result was calculated by using an expired calibration or
expired calibrators.
A#1* (c-series) The result was calculated by using the only reading, of all the
readings in the main or flex reading window, that has
measured absorbance within the defined absorbance range.
This condition can occur when the result concentration is high
or the sample is lipemic.
A#2* (c-series) The result was calculated by using the only two readings, of
all the readings in the main or flex reading window, that have
measured absorbance within the defined absorbance range.
This condition can occur when the result concentration is high
or the sample is lipemic.
CNTL* The result was calculated after the quality control failed.
The flag is displayed on subsequent results until the failed
quality control (QC) result is rerun for the same control name
and control level and the result is within acceptable limits.
When out-of-range QC results are deleted, the CNTL flag is
not removed from patient results.
NOTE: Only Westgard rules that are configured as a failure
produce a CNTL flag for a patient result.
< or > The result falls outside the dynamic or linear range.
NOTE: For c-series assays, the displayed value is the result
of an adjustment by the sample dilution factor. Additionally,
the displayed > value reflects an adjustment by the entered
correlation factor and intercept for assays that use nonlinear
calibration methods when the sample absorbance exceeds
the highest calibrator absorbance.
FLEX* (c-series) The result was calculated by using the reading data that was
measured during the flex read time.
LL or HH The result falls outside the defined extreme range.
NOTE: The result is rounded to the reporting number of
decimals for an assay and then is compared against the
range.
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PSHH* (c-series ICT The result may be affected by the ICT sample that was
assays) measured immediately before this sample. The sample must
be rerun to verify that no affects have occurred.
LOW or HIGH The result falls outside the defined normal range.
NOTE: The result is rounded to the reporting number of
decimals for an assay and then is compared against the
range.
* These flags are carried over from a constituent assay result to a calculated assay result.
Related information...
Results screen, page 616
Sample Status screen element descriptions, page 604
Results screen, Unreleased tab element descriptions, page 617
Results screen, Specimen tab element descriptions, page 618
A#1 result flag (c-series), page 1270
A#2 result flag (c-series), page 1271
FLEX result flag (c-series), page 1276
PSHH result flag (c-series), page 1276
Descriptions of quality control result flags
Quality control (QC) result flag information is used to provide additional information about a
result and to indicate that the result may need to be reviewed. When a QC result has a flag, the
information is displayed in red text on the Results screen. One or more result flags are
displayed if they are applicable to a QC result.
The following list provides descriptions of the QC result flags. The flags are described in the
order in which they are sorted:
CNTL The QC result falls outside the minimum and maximum
control level range.
Westgard rule The QC result failed a Westgard rule.
EXP* The result was measured by using one of the following
expired items:
• Reagent
• Supply
• Onboard solution
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• Control material
• ICT module (only for c-series)
EXPC* The result was calculated by using an expired calibration or
expired calibrators.
A#1* (c-series) The result was calculated by using the only reading, of all the
readings in the main or flex reading window, that has
measured absorbance within the defined absorbance range.
This condition can occur when the result concentration is high
or the sample is lipemic.
A#2* (c-series) The result was calculated by using the only two readings, of
all the readings in the main or flex reading window, that have
measured absorbance within the defined absorbance range.
This condition can occur when the result concentration is high
or the sample is lipemic.
< or > The result falls outside the dynamic or linear range.
NOTE: For c-series assays, the displayed value is the result
of an adjustment by the sample dilution factor. Additionally,
the displayed > value reflects an adjustment by the entered
correlation factor and intercept for assays that use nonlinear
calibration methods when the sample absorbance exceeds
the highest calibrator absorbance.
FLEX* (c-series) The result was calculated by using the reading data that was
measured during the flex read time.
PSHH* (c-series ICT The result may be affected by the ICT sample that was
assays) measured immediately before this sample. The sample must
be rerun to verify that no affects have occurred.
* These flags are carried over from a constituent assay result to a calculated assay result.
Related information...
Results screen, page 616
Sample Status screen element descriptions, page 604
Results screen, Unreleased tab element descriptions, page 617
Results screen, Control tab element descriptions, page 620
A#1 result flag (c-series), page 1270
A#2 result flag (c-series), page 1271
FLEX result flag (c-series), page 1276
PSHH result flag (c-series), page 1276
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Results screen Section 5
Descriptions of transmission statuses
Transmission status information is used to determine the progress of a result transmission to the
host. The transmission status is displayed on the Result Details flyout.
The following list provides descriptions of the transmission statuses:
Transmitted The test is completed and has been successfully transmitted
to the host.
Pending transmission The test is completed, but the test is waiting to be transmitted
to the host.
Pending collation The test is completed, but the system is waiting for one of the
following actions to occur before the system transmits to the
host:
• All tests that are associated with the SID are completed.
• All tests that are associated with the SID on a specific
processing module are completed.
Related information...
Results screen, page 616
View the reaction graph and absorbance data for a result (c-series)
Perform this procedure to view the reaction graphs and absorbance data for the released and
unreleased specimen and control results for c-series.
1. On the menu bar, tap Results.
The Unreleased tab on the Results screen is the default.
2. To view the reaction graph or absorbance data for a released specimen or a released
control, tap the appropriate tab.
NOTE: To filter the list of results, tap Search.
3. In the list on the tab, tap one or more results (or tap Select All).
4. Tap Details.
5. On the Result Details screen, tap Graph View to display the reaction graph and absorbance
data for the first result.
6. To edit the absorbance scale of the reaction graph, type the values in the Y Axis Scale
boxes, and then tap Rescale.
NOTE: Although an updated view of the reaction graph is displayed, edits to the Y axis scale
are not saved.
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7. If more than one result was selected, tap Next or Previous to display the reaction graph
and absorbance data for each result.
8. To return to the reagent and additional information on the Result Details screen, tap Details
View.
9. To return to the Results screen, tap Done.
Related information...
Results screen, page 616
Print a report, page 662
Delete a sample result or an exception
Perform this procedure to complete the following tasks:
• Delete a released or an unreleased sample result that is not needed on the system.
• Delete a control result that is not needed on the system.
• Delete an exception that is not needed for troubleshooting.
1. On the menu bar, tap Results.
The Unreleased tab of the Results screen is the default.
2. To delete released specimens, released controls, or exceptions, tap the appropriate tab.
3. In the list on the tab, tap one or more results or exceptions (or tap Select All).
NOTE: To filter the list, tap Search.
4. Tap Delete.
5. When a confirmation message is displayed, tap Yes.
Related information...
Results screen, page 616
Search for or filter data, page 664
Transmit a result or an exception to the host
Perform this procedure to transmit a released specimen result, a released control result, or an
exception to the host.
1. On the menu bar, tap Results.
The Unreleased tab on the Results screen is the default.
2. To transmit released specimens, released controls, or exceptions, tap the appropriate tab.
3. In the list on the tab, tap one or more results or exceptions (or tap Select All).
NOTE: To filter the list, tap Search.
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Results screen Section 5
4. Tap Transmit.
Related information...
Results screen, page 616
User interface (UI) computer corrective action procedures, page 1306
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Section 5 Quality control analysis
Quality control analysis
Quality control analysis is the process by which quality control (QC) data is monitored. QC data
includes both unreleased and released control results. The Alinity ci-series monitors QC data
with Levey-Jennings graphs, Westgard rules, control range tracking, and QC data summaries.
To help ensure quality results and maintain optimal system performance, comply with the
following requirements:
• Carefully follow all directions in the operations manual and the reagent manufacturer's
assay documentation.
• Do not use expired or contaminated consumables.
• Perform maintenance procedures and calibration procedures as recommended.
IMPORTANT: Quality control issues must be evaluated and resolved before specimens are
tested.
The system evaluates quality control (QC) results by assay for each control lot. If reagents are
configured to be disabled when a control failure occurs, and a control failure occurs for one or
more reagent cartridges, the failure prevents the use of one or more of the cartridges.
A system configuration parameter determines whether controls are run for an assay for each
reagent lot or each reagent cartridge. If quality control is run for each reagent cartridge and any
control level fails, the individual reagent cartridge is disabled. If quality control is run for each
reagent lot and the last tested control level fails, all reagent cartridges for that lot are disabled,
including any cartridges that are subsequently loaded on the system. The system enables the
reagent cartridge or the reagent lot after the failed QC result is rerun and the result is within
acceptable limits.
Related information...
Operating instructions, page 427
Westgard rule application, page 637
Levey-Jennings (Graph) screen, page 641
Quality Control Summary screen, page 648
Westgard rule application
When Westgard rules are configured, the Alinity ci-series compares a control result at
completion against the expected mean and standard deviation for the control level. Previous
results, released and unreleased, for the same assay and module are considered in the analysis.
Control results that are marked as excluded are not considered.
Related information...
Quality control analysis, page 637
Westgard rule descriptions, page 638
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Westgard rule run descriptions, page 640
Configure Westgard rules, page 309
Westgard rule descriptions
Control results for an assay are evaluated at completion against all Westgard rules that are
enabled for the assay. Westgard rules that are configured as a failure are evaluated first, and
then the rules that are configured as a warning are evaluated.
NOTE: When one-material (1M) rules are evaluated, previous control results that have the same
control name, control level name, and control lot number are considered.
When across-materials (xM) rules are evaluated, previous control results that have the same
control name, the same control lot number, and different control level names are considered.
If a control result meets the failure criteria for only one Westgard rule, the result is flagged with
the corresponding rule flag. If the failure criteria for more than one Westgard rule is met, only
one rule flag is applied to the control result according to the following order:
1. 1-3s
2. 2-2s 1R 1M
3. 2-2s 1R xM
4. 2-2s xR 1M
5. R-4s
6. 4-1s 1m
7. 4-1s xM
8. 10-x 1M
9. 10-x xM
10. 1-2s
When a failure is identified, no further evaluation occurs. A CNTL flag is applied to each patient
result associated with an assay that has a control failure. The CNTL flag is not applied to patient
results for control failures that are configured as a warning.
The following list provides descriptions of the Westgard rules:
1-2s Control rule to test whether a control measurement exceeds
the control limits of Mean (x) + 2 standard deviation (SD) or x
- 2 SD.
1-3s Control rule to test whether a control measurement exceeds
the control limits of x + 3 SD or x - 3 SD.
2-2s 1R 1M Control rule to test whether two consecutive control
measurements for the same control material within the same
run exceed the same control limit of either x + 2 SD or x -
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2 SD. Both control results must fall on the same side of the
mean.
2-2s 1R xM Control rule to test whether two consecutive control
measurements across control materials within the same run
exceed the same control limit of either x + 2 SD or x - 2 SD.
Both control results must fall on the same side of the mean.
The two control results must have different control level
names.
2-2s xR 1M Control rule to test whether two consecutive control
measurements for the same control material across two
different runs exceed the same control limit of either x + 2 SD
or x - 2 SD. Both control results must fall on the same side of
the mean. The previous consecutive control result can be
obtained during any previous run.
R-4s Control rule to test whether the range, or difference, between
control measurements that are run within 30 minutes of each
other exceeds 4 SD. The two control results must have the
same control name, can have the same or different control
level names, and do not need to be consecutive. The current
control result is compared against each control result, which
is older than the current result by 30 minutes or less. Each
result must be greater than 2 SD, but in opposite directions.
4-1s 1M Control rule to test whether four consecutive control
measurements for the same control material exceed the same
control limit of either x + 1 SD or x - 1 SD. All four control
results must fall on the same side of the mean. The previous
control results can be obtained during any run.
4-1s xM Control rule to test whether four consecutive control
measurements across control materials exceed the same
control limit of either x + 1 SD or x - 1 SD. All four control
results must fall on the same side of the mean. The previous
control results can be obtained during any run. For this rule,
both control results with the same or different control level
names are considered.
10-x 1M Control rule to test whether 10 consecutive control
measurements for the same control material fall on the same
side of the mean. If a control result falls on the mean, the rule
does not fail. The previous control results can be obtained
during any run.
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Quality control analysis Section 5
10-x xM Control rule to test whether 10 consecutive control
measurements across control materials fall on the same side
of the mean. If a control result falls on the mean, the rule
does not fail. The previous control results can be obtained
during any run. For this rule, both control results with the
same or different control level names are considered.
Related information...
Westgard rule application, page 637
Westgard screen element descriptions, page 308
Westgard rule run descriptions
Westgard rule run descriptions identify the options to define quality control run intervals on the
Alinity ci-series. A time-based quality control run is configured by using a start time and a time
interval to define the number of hours in the run. The run period is used to evaluate the following
Westgard rules:
• 2-2s 1R 1M
• 2-2s 1R xM
• 2-2s xR 1M
• 4-1s 1M
• 4-1s xM
The following list provides Westgard rule run descriptions:
Start time for the first The quality control shift start time is defined for each c-series
run processing module and each i-series processing module by
configuring the Shift Start Time parameter on the Modules
screen. The system creates quality control orders at the
configured time for those controls for which the Automated
and Use Module Shift Time options are enabled.
The quality control shift start time is defined for a control by
configuring the Start Time parameter in the Control
Configuration area of the Control Create/Edit screen. The
system creates quality control orders at the configured time
for the control when the Automated option is enabled.
Run period length On a control-level basis, the Time Interval (Minutes)
parameter defines the time interval in minutes after the shift
start time for additional control orders to be created. If the
configured time interval cannot be divided equally into timed
run periods in the 24-hour day, the last run is composed of
the remaining hours.
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If the assay time interval is configured, the configured assay
time interval supersedes the configured control level time
interval if both intervals are defined for the same quality
control lot number.
Related information...
Westgard rule application, page 637
Configure c-series module settings , page 174
Configure i-series module settings, page 175
Levey-Jennings (Graph) screen
On the Levey-Jennings (Graph) screen, the operator can perform the following functions:
• View a maximum of six Levey-Jennings graphs and the statistical data for the same control
name and lot number for a specific processing module.
• View the Levey-Jennings graphs for the same assay, control name, and lot number for a
maximum of four processing modules of the same type in a multimodule system.
• Change the criteria for a Levey-Jennings graph and its data.
• Include or exclude points from a Levey-Jennings graph.
• Print a Levey-Jennings report.
• Recalculate the Westgard analysis for a Levey-Jennings point.
• View the details of a selected Levey-Jennings point.
• Add a comment to a Levey-Jennings point.
Related information...
Quality control analysis, page 637
Levey-Jennings (Graph) screen element descriptions, page 641
Point Details screen element descriptions, page 644
Display the value for a Levey-Jennings point, page 646
Exclude or include a Levey-Jennings point, page 646
View the details for a Levey-Jennings point, page 647
Add a comment to a Levey-Jennings point, page 647
Levey-Jennings (Graph) screen element descriptions
The Levey-Jennings (Graph) screen displays the quality control graphs for the selected assay.
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Quality control analysis Section 5
Elements
Assay Displays the name of the assay selected on the Quality
Control Summary screen.
Control Displays the name of the control.
Lot Number Displays the lot number of the control.
Exp. Date Displays the expiration date of the control lot.
Comparison Type Displays the source of the mean and standard deviation (SD)
used to compare to the expected mean and SD.
The following comparison types are available in the drop-
down list:
• None
• Manufacturer
• Module Cumulative
• System Cumulative
Selected Data Range Displays control data for the date range selected on the
Quality Control Summary screen.
Displayed Data Range Displays the date range of the displayed points. As the graph
is navigated, the displayed data range changes to reflect the
points being viewed.
Level Displays the name of the control level.
Exp. Date Displays the expiration date of the control lot.
Module Displays the number of the module used to process one or
more controls.
Mean Displays the expected mean value as configured.
SD Displays the expected SD value as configured.
Control Range Displays the expected control range as configured.
Comparison Mean Displays the mean used to compare to the expected control
mean. Information that is displayed is determined by the
comparison type selected.
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Comparison SD Displays the SD used to compare to the expected control SD.
Information that is displayed is determined by the comparison
type selected.
N Displays the number of control points covered by the selected
date range.
Graph elements
Mean Represented by the center line of the graph and indicates the
expected control mean.
+1 SD and -1 SD Represented by the first line above and below the mean
(green area).
+2 SD and -2 SD Represented by the second line above and below the mean
(yellow area).
+3 SD and -3 SD Represented by the third line above and below the mean (red
area).
Points Control results that fall within the defined control range and
do not fail configured Westgard rules are represented by a
black dot and are graphed in the order of completion.
Control points that caused a warning condition based on the
Westgard analysis are represented by a yellow dot.
Control points that failed Westgard analysis are represented
by a red dot.
Control points beyond +/- 3 SD are shown as a horizontal line.
Excluded control points are represented by a white circle with
a black dot.
Function buttons
QC Summary Navigates to the Quality Control Summary screen.
Point Details Navigates to the Point Details screen.
Print Displays the Print flyout.
Text Size Increases or decreases the size of text displayed.
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Quality control analysis Section 5
Related information...
Levey-Jennings (Graph) screen, page 641
Descriptions of screen elements, page 127
Point Details screen element descriptions
The Point Details screen displays the details for the selected control value.
Elements
Control Information area
Control Name Displays the name of the control.
Control Lot Displays the lot number of the control.
Operator ID Displays the identification of the operator logged onto the
system when the control result was generated or released.
Control Level Displays the name of the control level.
Control Lot Exp. Displays the expiration date of the control lot.
Time of Completion Displays the date and time that the control result was
generated.
Assay Name Displays the name of the assay file.
Assay Number Displays the number of the assay file.
Point Information area
Point Value Displays the control result.
Flags Displays the flags associated with the quality control result.
Codes Displays the processing codes associated with the control
result.
Point SD Displays the standard deviation of the control result.
Mean Displays the expected mean value as configured.
1 SD Displays the expected standard deviation value as configured.
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2 SD Displays the expected standard deviation value as configured.
3 SD Displays the expected standard deviation value as configured.
Reagent Information area
Reagent Lot Displays the master lot number for the reagent.
Reagent SN Displays the serial number of the reagent cartridge.
Reagent Lot Displays the expiration date of the reagent cartridge.
Expiration
Calibration Displays the date and time of the reagent calibration.
Module/Position Displays the module number and the position number in the
reagent carousel where the cartridge is loaded. Dashes are
displayed for the module and position number when the
cartridge is not loaded on the system.
Additional Information area
Include or Exclude Used to exclude a quality control result or to include a
Point previously excluded result.
Perform Westgard Re- Used to recalculate the Westgard analysis.
evaluation
System Comment Displays the system comments.
Comment Used to enter a reason for the inclusion or exclusion of the
control point.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Related information...
Levey-Jennings (Graph) screen, page 641
Descriptions of screen elements, page 127
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Quality control analysis Section 5
Display the value for a Levey-Jennings point
Perform this procedure to display the result value and the date and time for a specific point on
the Levey-Jennings (Graph) screen.
1. Create a Levey-Jennings graph.
2. Tap a point on the Levey-Jennings graph.
3. Tap Point Details.
4. On the Point Details screen, view the point value and the date and time that the control was
run.
5. To return to the Levey-Jennings (Graph) screen, tap Done.
6. To display the value for another Levey-Jennings point, repeat steps 2, page 646 through 5,
page 646.
7. To return to the Quality Control Summary screen, tap QC Summary.
Related information...
Levey-Jennings (Graph) screen, page 641
Create a Levey-Jennings graph, page 654
Exclude or include a Levey-Jennings point
Perform this procedure to exclude a point, or to include a previously excluded point, from the
quality control statistics.
1. Create a Levey-Jennings graph.
2. Tap a point on the Levey-Jennings graph.
3. Tap Point Details.
4. On the Point Details screen, perform one of the following steps:
– Tap Include to include a previously excluded point.
– Tap Exclude to exclude a point.
NOTE: The system software automatically excludes a control result that exceeds a value
that is six times the expected standard deviation (SD).
5. In the Comment box, type a reason for the inclusion or exclusion of the point.
NOTE: The comment replaces a previously entered comment.
After a point is included or excluded, the system software recalculates the cumulative mean,
SD, and sample size for the quality control (QC) data. Excluded points are not included in
the recalculation.
6. To recalculate the Westgard analysis, tap the Perform Westgard Re-evaluation check box.
NOTE: The system software does not recalculate the Westgard data if more than 5000 QC
data points are pending an adjustment.
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7. To save the edits and return to the Levey-Jennings (Graph) screen, tap Done.
8. To include or exclude another Levey-Jennings point, repeat steps 2, page 646 through 7,
page 647.
9. To return to the Quality Control Summary screen, tap QC Summary.
Related information...
Levey-Jennings (Graph) screen, page 641
Create a Levey-Jennings graph, page 654
View the details for a Levey-Jennings point
Perform this procedure to view the details for a specific point on a Levey-Jennings graph.
1. Create a Levey-Jennings graph.
2. Tap a point on the Levey-Jennings graph to display the point value and the date and time
that the control was run.
3. Tap Point Details to display all data that is available for the selected point.
4. On the Point Details screen, view the details for the selected point.
5. To return to the Levey-Jennings (Graph) screen, tap Done.
6. To view the details for another Levey-Jennings point, repeat steps 2, page 647 through 5,
page 647.
7. To return to the Quality Control Summary screen, tap QC Summary.
Related information...
Levey-Jennings (Graph) screen, page 641
Create a Levey-Jennings graph, page 654
Add a comment to a Levey-Jennings point
Perform this procedure to add a comment to a point on a Levey-Jennings graph.
1. Create a Levey-Jennings graph.
2. Tap a point on the Levey-Jennings graph.
3. Tap Point Details.
4. In the Comment box on the Point Details screen, type a comment.
NOTE: The new comment replaces any existing comment for the point.
5. To save the comment and return to the Levey-Jennings (Graph) screen, tap Done.
6. To add a comment to another Levey-Jennings point, repeat steps 2, page 647 through 5,
page 647.
7. To return to the Quality Control Summary screen, tap QC Summary.
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Related information...
Levey-Jennings (Graph) screen, page 641
Create a Levey-Jennings graph, page 654
Quality Control Summary screen
On the Quality Control Summary screen, the operator can view the statistical data for all assay
control levels.
NOTE: Statistical calculations are performed for all released results, including quality control
results for a specific processing module, assay, control name, lot number, and level
combination.
The quality control summary data is not displayed if the values for expected mean and expected
standard deviation (1 SD) are not defined for the control.
The operator can perform the following functions:
• Find information about a specific control based on specified search criteria.
• Access quality control information.
• Create a Levey-Jennings graph for a selected assay control level.
• Print the QC Analysis Report and the QC Summary Report.
The system administrator can clear a control failure for an assay for a specific control, lot
number, and level.
Related information...
Quality control analysis, page 637
Quality Control Summary screen element descriptions, page 648
Control Summary Details screen, page 650
Clear Control Failure flyout element descriptions, page 653
Create a Levey-Jennings graph, page 654
Clear a control failure, page 656
View the quality control (QC) summary data, page 656
View the control summary details, page 657
Quality Control Summary screen element descriptions
Elements
Module Used to select all modules or individual modules to view
information.
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Date Range Used to enter a date range to search or displays the control
summary information for the selected date range.
Update button Searches and displays data for the entered date range when
a new date is selected.
Module Displays the module number.
Assay Displays the name of the assay.
Control Name Displays the name of the control.
Lot Number Displays the lot number for the control.
Level Displays the level for the control that was processed.
N Displays the number of control points that are available for
the same level, lot, assay, and module used in the calculation.
Flagged Displays the number of flagged control results.
Actual Mean Displays the mean calculated for the level, lot, and assay for
a processing module and the specified date range.
Actual SD Displays the standard deviation calculated for the level, lot,
and assay for a processing module and the specified date
range.
%CV Displays the percent coefficient of variation calculated for the
level, lot, and assay for a processing module and the
specified date range.
Expected Mean Displays the expected mean configured for the control level.
Expected SD Displays the expected standard deviation configured for the
control level.
Expected Range Displays the expected control range configured for the control
level.
Function buttons
Select All Selects or deselects all items in a list. The button switches
between Select All and Deselect All.
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Search Displays the Search flyout.
Print Displays the Print flyout.
Details Navigates to the Details screen for the selected items on the
current screen.
Graph Displays the Levey-Jennings (QC) screen for the selected
assay.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Text Size Increases or decreases the size of text displayed.
Related information...
Quality Control Summary screen, page 648
Descriptions of screen elements, page 127
Control Summary Details screen
On the Control Summary Details screen, the operator can view the following statistical data for a
selected control lot number and level:
• Expected mean and expected standard deviation (SD)
• Manufacturer mean and SD
• Quality control data for the selected processing module and the defined date range
• System control data that represents the data for all processing modules of the same type in
a multimodule system for the defined date range
• Module cumulative data that represents all the data for the selected processing module
• System cumulative data that represents the data for all processing modules of the same
type in a multimodule system
Related information...
Quality Control Summary screen, page 648
Control Summary Details screen element descriptions, page 650
Control Summary Details screen element descriptions
The Control Summary Details screen displays the details for an assay control level.
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Elements
Control Information area
Assay Displays the name of the assay.
Control Lot Displays the lot number of the control.
Control Name Displays the name of the control.
Control Level Displays the name of the control level.
Date Range Displays the default date range or the date range entered on
the Quality Control Summary screen.
Module / Serial No. Displays the module number and the serial number of the
module that processed the control.
NOTE: Module 6 displays the quality control summary data for
calculated assays.
Expected area
Mean Displays the configured mean for the control.
SD Displays the configured standard deviation (SD) for the
control.
Range Displays the configured range for the control.
Manufacturer area
Mean Displays the configured manufacturer's mean for the control.
SD Displays the configured manufacturer's SD for the control.
Module Date Range area
Mean Displays the calculated mean for the selected module and
date range.
NOTE: The statistical calculations in the Module Date Range
area are based on all released results. These calculations
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also include the results in the date range for a specific
combination of module, assay, control name, control lot
number, and control level.
SD Displays the calculated SD for the selected module and date
range.
% CV Displays the calculated percent coefficient of variation (%CV)
for the selected module and date range.
N Displays the number of data points in the control file for the
selected module and date range.
Range Displays the range of values in the control file for the selected
module and date range.
System Date Range area
Mean Displays the calculated mean for the data in the date range
for all modules of the same type in a multimodule system.
SD Displays the calculated SD for the data in the date range for
all modules of the same type in a multimodule system.
% CV Displays the calculated %CV for the data in the date range for
all modules of the same type in a multimodule system.
N Displays the number of data points in the control file in the
date range for all modules of the same type in a multimodule
system.
Range Displays the range of values in the control file in the date
range for all modules of the same type in a multimodule
system.
Module Cumulative area
Mean Displays the cumulative calculated mean for the selected
module.
SD Displays the cumulative calculated SD for the selected
module.
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% CV Displays the cumulative calculated %CV for the selected
module.
N Displays the cumulative number of data points in the control
file for the selected module.
Range Displays the range of values in the control file for the selected
module.
System Cumulative area
Mean Displays the cumulative calculated mean for the data for all
modules of the same type in a multimodule system.
SD Displays the cumulative calculated SD for the data for all
modules of the same type in a multimodule system.
% CV Displays the cumulative calculated %CV for the data for all
modules of the same type in a multimodule system.
N Displays the cumulative number of data points in the control
file for all modules of the same type in a multimodule system.
Range Displays the range of values in the control file for all modules
of the same type in a multimodule system.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Previous Displays the previous item when multiple items are selected.
Next Displays the next item when multiple items are selected.
Related information...
Control Summary Details screen, page 650
Descriptions of screen elements, page 127
Clear Control Failure flyout element descriptions
In the Clear Control Failure flyout, the operator can clear a control failure.
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Elements
Comment Used to enter a required comment when a control failure is
cleared.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Quality Control Summary screen, page 648
Create a Levey-Jennings graph
Perform this procedure to create a Levey-Jennings graph to monitor quality control activity.
NOTE: The Levey-Jennings graph is not displayed if the values for expected mean and expected
standard deviation (1 SD) are not defined for the control.
1. On the menu bar, tap QC.
On the Quality Control Summary screen, the quality control (QC) summary data for all
modules is displayed.
2. Perform one of the following steps:
– To create a Levey-Jennings graph for the same assay, control name, and lot number
for a maximum of four modules of the same type in a multimodule system, proceed to
step 3.
– To display the QC summary data for one module, tap a Module button.
NOTE: Tap module 6 to display the QC summary data for calculated assays.
3. To enter a date range, type a value in the Date Range box and type a value in the To box.
NOTE: The default date range is composed of the last 31 days, including the current date.
4. Tap Update.
NOTE: Control results that were run between and on the entered dates are included in the
QC summary data.
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5. In the list of QC summary data, tap a maximum of six assay control levels for the same
assay, control name, and lot number.
NOTE: To filter the list of QC summary data, tap Search.
A maximum of three Levey-Jennings graphs can be viewed on the Levey-Jennings (Graph)
screen at the same time for the same module, control name, and lot number. Use the scroll
bar to display the remaining graphs.
6. Tap Graph.
NOTE: The Graph button is unavailable if more than one assay or lot number is selected on
the Quality Control Summary screen.
7. On the Levey-Jennings (Graph) screen, tap a comparison type in the Comparison Type
drop-down list:
– None: A comparison method is not used.
– Manufacturer: This method compares the expected mean and expected SD to the
manufacturer's mean and SD that are configured for the control.
NOTE: If Manufacturer is configured, the manufacturer's mean and SD are displayed
as the Comparison Mean and Comparison SD elements on the left side of the Levey-
Jennings (Graph) screen. A dashed line indicates the manufacturer's mean on the
graph.
– Module Cumulative: This method compares the expected mean and expected SD to
the cumulative mean and cumulative SD of the selected module.
NOTE: If Module Cumulative is configured, the module cumulative mean and module
cumulative SD are displayed as the Comparison Mean and Comparison SD elements
on the left side of the Levey-Jennings (Graph) screen. A dashed line indicates the
module cumulative mean on the graph.
– System Cumulative: This method compares the expected mean and expected SD to
the cumulative mean and cumulative SD of all modules in a multimodule system.
NOTE: If System Cumulative is configured, the system cumulative mean and system
cumulative SD are displayed as the Comparison Mean and Comparison SD elements
on the left side of the Levey-Jennings (Graph) screen. A dashed line indicates the
system cumulative mean on the graph.
8. To return to the Quality Control Summary screen, tap QC Summary.
NOTE: The previous selections for module, assay, control name, lot number, control level,
and date range are displayed on the Quality Control Summary screen.
9. To create a Levey-Jennings graph for another assay, repeat steps 2, page 654 through 8,
page 655.
Related information...
Quality Control Summary screen, page 648
Display the value for a Levey-Jennings point, page 646
Exclude or include a Levey-Jennings point, page 646
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View the details for a Levey-Jennings point, page 647
Add a comment to a Levey-Jennings point, page 647
Clear a control failure
Operator access level System administrator
Perform this procedure to clear a control failure when the control material cannot be repeated to
obtain an acceptable value.
The control failure can occur as the result of a value that exceeds a control range or a
Westgard rule failure.
1. On the menu bar, tap QC.
On the Quality Control Summary screen, the quality control (QC) summary data for all
modules is displayed.
2. To display the QC summary data for one module, tap a Module button.
NOTE: Tap module 6 to display the QC summary data for calculated assays.
3. In the list of QC summary data, tap an assay control level that has a control failure.
NOTE: An assay control level that has a control failure is displayed in red text on the Quality
Control Summary screen.
4. Tap Clear Control Failure.
5. In the Comment box in the Clear Control Failure flyout, type a comment.
6. To save the comment and return to the Quality Control Summary screen, tap Done.
NOTE: After the control failure is cleared, the text of the assay control level is displayed in
black.
Related information...
Quality Control Summary screen, page 648
View the quality control (QC) summary data
Perform this procedure to view the quality control (QC) summary data for a specific control
level.
NOTE: The QC summary data is not displayed if the values for expected mean and expected
standard deviation (1 SD) are not defined for the control.
1. On the menu bar, tap QC.
On the Quality Control Summary screen, the QC summary data for all modules is displayed.
2. Perform one of the following steps:
– To view the QC summary data for the same assay, control name, and lot number for a
maximum of four modules of the same type in a multimodule system, proceed to step 3.
– To display the QC summary data for one module, tap a Module button.
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NOTE: Tap module 6 to display the QC summary data for calculated assays.
3. To enter a date range, type a value in the Date Range box and type a value in the To box.
NOTE: The default date range is composed of the last 31 days, including the current date.
4. Tap Update.
NOTE: Control results that were run between and on the entered dates are included in the
QC summary data.
Related information...
Quality Control Summary screen, page 648
View the control summary details
Perform this procedure to view the control summary details for a specific control level.
NOTE: The quality control (QC) summary data is not displayed if the values for expected mean
and expected standard deviation (1 SD) are not defined for the control.
1. On the menu bar, tap QC.
On the Quality Control Summary screen, the QC summary data for all modules is displayed.
2. To display the QC summary data for one module, tap a Module button.
NOTE: Tap module 6 to display the QC summary data for calculated assays.
3. To enter a date range, type a value in the Date Range box and type a value in the To box.
NOTE: The default date range is composed of the last 31 days, including the current date.
4. Tap Update.
NOTE: Control results that were run between and on the entered dates are included in the
QC summary data.
5. In the list of QC summary data, tap one or more assay control levels.
6. Tap Details.
7. If more than one assay control level was selected, tap Next or Previous on the Control
Summary Details screen to display each assay control level.
8. To return to the Quality Control Summary screen, tap Done.
Related information...
Quality Control Summary screen, page 648
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Print flyout Section 5
Print flyout
Screen images, reports generated by the system, and Abbott Mail documentation can be printed
or can be saved as a portable document format (PDF) file. The system can be configured to
print or save the following reports automatically:
• Calibration details
• Result list
• Sample laboratory
• Maintenance
Reports and Abbott Mail documentation are available from related screens. The following table
provides the report availability:
To print the ... Access the ...
Abbott Mail Log Report System Logs screen
Absorbance Data Report (c- Results screen
series)
Assay Information Report • Assay Parameters screen
• Install/Uninstall Assays screen
Assay Insert Report • Abbott Mail Inbox screen
• Reagent Cartridge Details screen
Assay Installation Report • Assay Parameters screen
• Install/Uninstall Assays screen
• Abbott Mail Inbox screen
Assay Parameter Report Assay Parameters screen
Calibration Details Report Calibration Status screen
Calibration Summary Report Calibration Status screen
Calibrator Value Sheet • Calibrator Set screen
NOTE: A calibrator value sheet is available only for a calibrator lot
that was created from an imported file.
• Abbott Mail Inbox screen
Configuration Log Report System Logs screen
Control Insert Report Control Create/Edit screen
Diagnostic History Report Procedures Log screen
Exception List Report Results screen
Information Log Report System Logs screen
Inventory Log Report System Logs screen
Levey Jennings Report Levey-Jennings screen
Licenses Report Utilities screen
Maintenance History Report Procedures Log screen
Notifications Log Report System Logs screen
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To print the ... Access the ...
Order List Report Orders screen
Print Verification Report Printers screen
Procedure Report Procedures screen
QC Analysis Report Quality Control Summary screen
QC Summary Report Quality Control Summary screen
Reagent Status Report Reagent screen
Rerun List Report Orders screen
Result Details Report Results screen
Result List Report Results screen
Sample Laboratory Report Sample Status screen
System Log Report System Logs screen
System Update Details Report System Update screen
System Update Letter • Abbott Mail Inbox screen
• System Update screen
System Update List Report System Update screen
User Access Log Report System Logs screen
User-Defined Maintenance User-Defined Maintenance screen
Details Report
Related information...
Operating instructions, page 427
Print flyout element descriptions, page 659
Report File Location window element descriptions, page 661
Print a report, page 662
Print a screen image, page 663
Print flyout element descriptions
Print Options
Displays the print options for report selections.
Print Location Displays a drop-down list of the following options:
• Configured printer
• Print to File
Copies Displays a drop-down list of the number of copies that can be
selected to print. The default is one copy. A maximum of five
copies can be selected.
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Print Selection Displays the print selection options: All Items or Selected
Items.
If no items were selected on the previous screen, the default
is the All Items option. The Selected Items option is
unavailable.
If one or more items were selected on the previous screen,
the default is the Selected Items option. The All Items option
is available.
Report Selection Displays a list of the reports that are available to print. A
preview of the selected report is displayed before the report is
printed.
PDF viewer area
Displays a preview of a portable document format (PDF) file that is downloaded or imported.
Rotate Used to rotate the PDF document clockwise or
counterclockwise.
Page Displays the number of pages in the PDF document. Each
page of the document can be viewed by tapping the Previous
Page button or the Next Page button or by typing a page
number to display to a specific page.
Zoom Used to increase or decrease the size of the PDF document
by tapping the Zoom In button or the Zoom Out button, by
typing a document size, or by tapping a document size in the
drop-down list.
Fit Used to resize the PDF document to fit the window width ( )
and enable the scroll bar, or to resize the document to fit one
full page in the window ( ).
Find Used to find a word or phrase in the PDF document. The Find
Previous button and the Find Next button are used to browse
the document to find the word or phrase.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Print Prints the selected reports.
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Previous Navigates to the previous PDF document if more than one
document was selected.
Next Navigates to the next PDF document if more than one
document was selected.
Text Size Increases or decreases the size of text displayed. This
function button is not displayed with the PDF viewer.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Print flyout, page 658
Report File Location window element descriptions
The Report File Location window displays the drive and folders that are used to save a report file
as a portable document format (PDF) file.
Elements
button The Previous Folder button navigates to the previously
selected folder.
button The Selected Folders button displays all previously selected
folders.
Folder Name Displays the currently selected folder.
button The Home button navigates to the C drive folder.
Name Displays the name of the drive or folder.
Last Update Displays the date and time that the files in the folder were last
updated.
Function buttons
OK Saves the file and closes the window.
Cancel Cancels the operation and closes the window.
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? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Print flyout, page 658
Print a report
Required materials USB flash drive (Print to File option only)
Perform this procedure to print a system-generated report to a configured printer or to save the
report as a portable document format (PDF) file.
1. On a screen, tap one or more items to include in the report.
NOTE: Items are printed in the order in which they are displayed on the screen. If a specific
item is not selected, all items are printed.
2. Tap Print.
3. In the Print flyout, choose a printer or tap Print to File in the Print Location drop-down list.
4. In the Copies drop-down list, tap the number of copies to print (printer only).
5. Tap a Print Selection option.
NOTE: If one or more items were not selected, All items is the only available option.
6. In the Report Selection list, tap a report.
7. Tap Print.
8. If Print to File was selected in the Print Location drop-down list, perform the following
steps to indicate the file destination:
a. Insert a USB flash drive.
b. Tap the appropriate USB flash drive.
c. Tap the destination folder.
d. Tap OK.
e. Remove the USB flash drive.
9. To return to the screen, tap Done.
Related information...
Print flyout, page 658
User-Defined Maintenance screen, Create/Edit tab element descriptions, page 315
Reagents screen, page 533
Abbott Mail Inbox screen, page 479
Insert and remove a USB flash drive, page 671
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View the reaction graph and absorbance data for a result (c-series), page 634
Print a screen image
Required materials USB flash drive (Print to File option only)
Perform this procedure to print a screen image to save graphical or troubleshooting information.
1. On the screen header, tap the Abbott A button .
2. If the system is configured to save the print screen output as a file, perform the following
steps to indicate the file destination:
a. Tap the appropriate USB flash drive.
b. Tap the destination folder.
c. To save the file to the destination folder, tap OK.
To cancel the save function, tap Cancel.
Related information...
Print flyout, page 658
Configure the print screen file output destination, page 198
Insert and remove a USB flash drive, page 671
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Search flyout
In the Search flyout, the operator can search for specific data by entering search criteria.
Related information...
Operating instructions, page 427
Search for or filter data, page 664
Reagents screen, Search flyout element descriptions, page 539
Orders screen, Search flyout element descriptions, page 586
Sample Status screen, Search flyout element descriptions, page 606
Search for or filter data
Perform this procedure to search for specific data or to filter data on a screen.
1. On a screen, tap Search.
2. In the Search flyout, enter the search criteria.
To limit the search results, enter more criteria.
NOTE: Data is filtered based on the results that contain the criteria entered.
For example, if 123 is entered in the SID box, all search results that contain 123 are
displayed. The search results can include SID numbers 12345, 45123, and 41235.
3. To search for and display the filtered data, tap Done.
4. To display all records, tap Clear Filter.
Related information...
Search flyout, page 664
Edit a user, page 162
Inactivate or activate a user, page 163
Manage user PINs, page 165
Verify vial inventory data, page 522
Reagents screen, page 533
Suspend and access a sample that has tests in process, page 575
Add a comment to an order, page 590
Add a test to a specimen order, page 600
Delete a test from a sample order, page 602
Add a comment to a result or an exception, page 612
Rerun a test or an exception for a specimen or control, page 612
Release a specimen result or a control result, page 614
Delete a sample result or an exception, page 635
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Archive the calibrations, page 669
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Archive flyout Section 5
Archive flyout
In the Archive flyout, the operator can archive specimen results, control results, or calibrations.
Related information...
Operating instructions, page 427
Archive flyout element descriptions, page 666
Archive File Location window element descriptions, page 667
Archive the results, page 668
Archive the calibrations, page 669
Archive flyout element descriptions
The Archive flyout is used to archive data.
Elements
Archive Options
Archive Selection Displays the archive options. The Archive flyout has three
options:
All Items This option archives data within a
defined date range.
Incremental This option archives data that does not
have a status of Archived within a
defined date range.
Selected Items This option archives selected data.
From Used to enter a start date. A start date is available only for
the All Items option and the Incremental option.
To Used to enter an end date. An end date is available only for
the All Items option and the Incremental option.
Archive Mode Displays the archive modes. The Archive flyout has two
archive modes:
Only Archive This option saves archived data to a
USB flash drive.
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Archive & Delete This option deletes data after all the
selected data has been archived to a
USB flash drive.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Archive Archives data and closes the flyout.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Archive flyout, page 666
Archive File Location window element descriptions
The Archive File Location window displays the drive and folders that are used to save an
archive file.
Elements
button The Previous Folder button navigates to the previously
selected folder.
Folder Name Displays the currently selected folder.
button The Home button navigates to the C drive folder.
Name Displays the name of the drive or folder.
Last Update Displays the date and time that files in the folder were last
updated.
Function buttons
OK Saves the file and closes the window.
Cancel Cancels the operation and closes the window.
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Archive flyout Section 5
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Archive flyout, page 666
Archive the results
Required materials USB flash drive
Perform this procedure to archive specimen and control results on a USB flash drive.
NOTE: The results are archived in an Excel file format and can be imported into a spreadsheet.
The archived results cannot be viewed on the Alinity ci-series.
1. Insert the USB flash drive.
2. On the menu bar, tap Results.
The Unreleased tab of the Results screen is the default.
3. To archive released samples or released controls, tap the appropriate tab.
4. In the list on the tab, tap one or more results (or tap Select All).
NOTE: To filter the list of results, tap Search.
5. Tap Archive.
6. Under Archive Options in the Archive flyout, tap an Archive Selection option:
– All items: This option archives all results within a defined date range.
To enter a date range, tap From and enter a start date, tap To and enter an end date,
or enter both a start date and an end date.
– Incremental: This option archives all results that do not have a status of Archived within
a defined date range.
To enter a date range, tap From and enter a start date, tap To and enter an end date,
or enter both a start date and an end date.
– Selected items: This option is available only if results were selected in step 4.
7. Tap an Archive Mode option:
– Only Archive: This option saves archived results to a USB flash drive.
– Archive & Delete: This option deletes results after all the selected results have been
archived to a USB flash drive.
NOTE: Results with a status of Pending Transmission or Pending Collation are not
deleted.
8. Tap Archive.
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9. On the Archive File Location screen, tap the USB flash drive and folder to which to archive
the results.
10. Tap OK.
11. When a confirmation message is displayed, tap one of the following buttons:
– Tap Yes to complete the archive process.
– Tap No to close the Archive flyout.
12. Remove the USB flash drive.
Related information...
Archive flyout, page 666
Delete a quality control, page 302
Results screen, page 616
Insert and remove a USB flash drive, page 671
Archive the calibrations
Required materials USB flash drive
Perform this procedure to archive active and inactive calibrations on a USB flash drive.
NOTE: The calibrations are archived in an Excel file format and can be imported into a
spreadsheet. The archived calibrations cannot be viewed on the Alinity ci-series.
1. Insert the USB flash drive.
2. On the menu bar, tap CAL.
The Current tab of the Calibration Status screen displays the calibration data for all
modules.
3. On the Calibration Status screen, tap the Historical tab.
4. On the Historical tab of the Calibration Status screen, tap one or more calibrations (or tap
Select All).
NOTE: To filter the list of calibrations, tap Search.
5. Tap Archive.
6. Under Archive Options in the Archive flyout, tap an Archive Selection option:
– All items: This option archives all calibrations within a defined date range.
To enter a date range, tap From and enter a start date, tap To and enter an end date,
or enter both a start date and an end date.
– Incremental: This option archives all calibrations that do not have a status of Archived
within a defined date range.
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To enter a date range, tap From and enter a start date, tap To and enter an end date,
or enter both a start date and an end date.
– Selected items: This option is available only if calibrations were selected in step 4.
7. Tap an Archive Mode option:
– Only Archive: This option saves archived calibrations to a USB flash drive.
– Archive & Delete: This option deletes inactive calibrations after all the selected
calibrations have been archived to a USB flash drive.
NOTE: If Archive & Delete is selected, only calibrations that have a status of Inactive are
deleted. If calibrations that have a status of Active are selected, an informational message
notifies the operator that calibrations are not deleted.
8. Tap Archive.
9. On the Archive File Location screen, tap the USB flash drive and folder to which to archive
the calibrations.
10. Tap OK.
11. When a confirmation message is displayed, tap one of the following buttons:
– Tap Yes to complete the archive process.
– Tap No to close the Archive flyout.
12. Remove the USB flash drive.
Related information...
Archive flyout, page 666
Search for or filter data, page 664
Insert and remove a USB flash drive, page 671
Calibration review, page 701
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Section 5 Insert and remove a USB flash drive
Insert and remove a USB flash drive
Perform this procedure to insert a USB flash drive into a USB port and to remove the USB flash
drive from the USB port on the user interface computer.
NOTE: USB flash drives that are software encrypted with password protection are not permitted
for use on the Alinity ci-series.
1. Open the system control module (SCM) front door.
2. Insert the USB flash drive into a USB port.
3. After the procedure that uses the USB flash drive is completed, remove the USB flash drive
from the USB port.
4. Close the SCM front door.
Related information...
Operating instructions, page 427
Import a system update, page 339
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Insert and remove a USB flash drive Section 5
Import users, page 163
Export users, page 164
Configure an automatic backup, page 220
Import calibrator data (c-series), page 261
View or print a calibrator value sheet (c-series), page 267
Install assay files, page 272
Install procedure files, page 314
Export a user-defined maintenance procedure, page 321
Perform a manual backup, page 326
Copy a backup to a USB flash drive, page 327
Retrieve a troubleshooting package, page 345
Print a 1D reagent bar code report (c-series), page 555
Print a report, page 662
Print a screen image, page 663
Archive the results, page 668
Archive the calibrations, page 669
Export assay files (c-series), page 278
Import assay files (c-series), page 279
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Section 6 Calibration procedures
Introduction
Calibration is the process used to analyze calibrators of a known concentration, to record
system response values, and to plot measured values against the known concentration.
Before performing sample processing, calibrate all assays.
Related information...
Calibration guidelines, page 674
Calibration types and methods, page 675
Calibration storage, page 699
Calibration review, page 701
Operating instructions, page 427
Create a calibration order, page 599
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Calibration guidelines Section 6
Calibration guidelines
After an assay is installed that requires a calibration, an active calibration must be generated. A
calibration is not required every time that an assay is run. However, a recalibration is required
with certain variables.
Mandatory assay A calibration must be performed when:
calibration
• A new reagent lot number is used.
• Assay documentation states that a calibration is required
when a reagent cartridge is changed.
• Documentation that accompanies a new version of an
existing assay file states that a calibration is required.
• A new assay file that requires a calibration is installed.
• The calibration has expired.
Optional assay A calibration may need to be performed when:
calibration
• Assay control values do not meet required specifications.
For specific information about quality control, see the
manufacturer's documentation.
• Certain system maintenance procedures or component
replacement procedures are performed.
• Certain errors occur. To determine whether a
recalibration is required when an error occurs, see assay-
specific message codes.
Running all levels of appropriate controls is recommended when an assay is calibrated.
Related information...
Calibration procedures, page 673
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Section 6 Calibration types and methods
Calibration types and methods
Calibration types and methods define the system-specific processes that are used to create a
calibration curve or determine a cutoff value.
Related information...
Calibration procedures, page 673
Calibration method (c-series potentiometric), page 675
Calibration types and methods (c-series photometric), page 680
Calibration types and methods (i-series), page 690
Calibration method (c-series potentiometric)
The potentiometric calibration method is used to calculate results for the ICT assays of sodium
(Na+), potassium (K+), and chloride (Cl-). Serum and urine calibrators are available for use and
contain known concentrations of electrolytes. The serum calibrators are protein-based materials.
The urine calibrators are aqueous-based materials that span a greater concentration range.
The millivolts measured by each electrode of the ICT module are plotted against the known
concentration of electrolyte in the calibrator. The slope of the calibration is expressed as a
percentage of the ideal slope. Electrolyte determinations are made at 37°C. Therefore, the ideal
slope of the electrode is 100% (61.5 millivolts per decade).
The potentiometric calibration method is specific to these assays, is defined in the system
software, and has three components:
• Electromotive force measurement
• Slope calculation
• Sample measurement
Related information...
Calibration types and methods, page 675
Electromotive force measurement (c-series potentiometric), page 675
Slope calculation (c-series potentiometric), page 676
Sample measurement (c-series potentiometric), page 678
Electromotive force measurement (c-series potentiometric)
The electromotive force measurement uses the potential difference between the electromotive
force of an unknown sample and the electromotive force of the ICT Reference Solution,
measured immediately after the sample, to determine the electrolyte concentration.
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Figure 146: Electromotive force calculation
Where:
E Electromotive force expressed in millivolts
T Time
ΔEi Potential difference between the sample and the ICT
Reference Solution for each electrode
Ei Potential of each electrode (i) in contact with the sample
i Ion of interest (Na+, K+, and Cl-)
EB Potential of each electrode (i) in contact with the ICT
Reference Solution
Related information...
Calibration method (c-series potentiometric), page 675
Slope calculation (c-series potentiometric)
The slope calculation uses the potential differences between the electromotive forces of two
calibrators and the electromotive force of the ICT Reference Solution and compares them to the
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calibrator concentrations to generate a calibration curve. When the calculation occurs, the
system software generates two graphs:
• A calibration graph that shows the relationship between the ion concentration and the
electromotive force
• An electrode response curve during calibration
Figure 147: Relationship between the ion concentration and the electromotive force
Electromotive force is derived from the Nernst equation:
E = E0 + S logCi:
Where:
E Electromotive force expressed in millivolts
E0 Electromotive force under standard conditions
S Slope (millivolts per decade) of each electrode
CL, CH Concentration of low and high calibrators
CN Concentration of the ICT Reference Solution
ΔEL, ΔEH Potential difference between the ICT Reference Solution and
the calibrator for each electrode
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logCi Logarithm of the concentration of the ion of interest
Figure 148: Electrode response curve during calibration
Where:
E Electromotive force expressed in millivolts
ΔEL, ΔEH Potential difference between the ICT Reference Solution and
the calibrator for each electrode
T Time
EL Electromotive force of the low calibrator
EH Electromotive force of the high calibrator
EN, EN' Electromotive force of the ICT Reference Solution
Related information...
Calibration method (c-series potentiometric), page 675
Sample measurement (c-series potentiometric)
The sample measurement uses the following data to determine the electrolyte (ICT)
concentration in an unknown sample:
• The difference between the electromotive forces of the unknown sample and the ICT
Reference Solution
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• The difference between the electromotive forces of the low calibrator and the ICT
Reference Solution
• The slope of the specific ICT electrode
The electrolyte concentration is calculated by using the following equation:
− 𝝙𝗘𝗟 / 𝗦
𝗖𝗶 = 𝗖𝗟 × 𝟭𝟬 𝝙𝗘𝗶
Figure 149: Electrode response curve during sample measurement
Where:
Ci Concentration of the ion of interest in the sample
CL Concentration of the ion of interest in the low calibrator
(baseline for sample calculations)
ΔEi Difference in the electrode potential when exposed to the
sample and the ICT Reference Solution
ΔEL Difference in the ICT electrode potential when exposed to the
ICT Reference Solution and the low calibrator during
calibration
S Slope of the ICT electrode of interest
EN Electromotive force of the ICT Reference Solution
Ei Electrode potential of the sample for the ion of interest
E Electromotive force expressed in millivolts
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T Time
ICT index
An index solution can be used to compensate for differences between ICT modules, day-to-day
instrument variations, and matrix differences between calibrators and patient samples. The index
solution is a sample with a known concentration and is used during calibration of an ICT analyte.
After calibration is completed, sample measurements are adjusted automatically.
Measured sample values are adjusted by using the following equation:
Conc' = Conc - (Comp' - Comp)
Where:
Conc' Adjusted ICT sample value
Conc Measured ICT sample value (not adjusted)
Comp' Measured value of the index solution
Comp Nominal index concentration (known value)
(Comp' - Comp) Adjustment value
The measured value of the index solution for the specific analyte is calculated by using the
following equation:
− 𝝙𝗘𝗟 / 𝗦
𝗖𝗶 = 𝗖𝗟 × 𝟭𝟬 𝝙𝗘𝗶
NOTE: When the index concentration is set to zero, the index value is not calculated.
Related information...
Calibration method (c-series potentiometric), page 675
Calibration types and methods (c-series photometric)
Two c-series assay calibration types, full and adjustment, apply only to photometric assays and
indicate whether a calibration curve is created or adjusted.
The photometric calibration methods use measured absorbance values to plot a calibration curve
or to determine a cutoff value.
The system software provides six full calibration methods and three adjustment calibration types.
The type and method are defined in each assay parameter file.
For information about calibration types and methods for an assay, see the assay documentation.
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Related information...
Calibration types and methods, page 675
Full calibration (c-series photometric), page 681
Adjustment calibration (c-series photometric), page 687
Full calibration (c-series photometric)
A full calibration for an assay is the measurement of a reagent blank and all specified data
points. The absorbance value for each point is plotted against the known concentration and the
system software generates a new calibration curve. Unknown samples are then evaluated
against the calibration curve.
A full calibration is necessary to update the full calibration interval.
Related information...
Calibration types and methods (c-series photometric), page 680
Absorbance method (c-series photometric), page 681
Factor method (c-series photometric), page 681
Linear method (c-series photometric), page 682
Logit-4 method (c-series photometric), page 684
Spline method (c-series photometric), page 685
Use factor and blank method (c-series photometric), page 687
Absorbance method (c-series photometric)
The absorbance data reduction method uses the comparison between the absorbance of the
sample and the absorbance of water to calculate results. For end-point assays, the data is
expressed as absorbance. For rate assays, the data is expressed as the rate of absorbance
change per minute.
Related information...
Full calibration (c-series photometric), page 681
Factor method (c-series photometric)
The factor data reduction method uses a reagent blank and a fixed calibration factor value to
calculate results. This method is applicable to assays for which the reaction is linear and stable
across all reagent lots. This method is used to measure enzyme activity in a sample at a
predictable and steady rate that can be determined for the chromophore, wavelengths, and
processing module in use.
The enzyme activity or the sample concentration is calculated by using the following equation:
X = (A - Ablk) x Factor
Where:
X Activity or concentration of the unknown sample
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A Absorbance or absorbance change of the unknown sample
Ablk Absorbance or absorbance change of the reagent blank
Factor Calibration factor
Related information...
Full calibration (c-series photometric), page 681
Linear method (c-series photometric)
The linear data reduction method uses a reagent blank and one to six calibrators to generate a
point-to-point calibration curve. The slope is calculated for each segment of the curve between
calibrator levels.
Figure 150: Linear calibration curve for six calibrators
Where:
Abs Absorbance
Conc Concentration
blk Concentration of the reagent blank
C1 to C6 Concentration of the calibrator
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Ablk Absorbance or absorbance change of the reagent blank
Ac1 to Ac6 Absorbance or absorbance change of the calibrator
The absorbance or absorbance change that is measured for the sample determines which of the
following equations are used to calculate the sample concentration.
When A ≤ Ac1, X = F1 x (A - Ablk) + blk
𝗖𝟭 − 𝗯𝗹𝗸
𝗙𝟭 = 𝗔𝗰𝟭 − 𝗔𝗯𝗹𝗸
When Ac1 < A ≤ Ac2, X = F2 x (A - Ac1) + C1
𝗖𝟮 − 𝗖𝟭
𝗙𝟮 = 𝗔𝗰𝟮 − 𝗔𝗰𝟭
When Ac2 < A ≤ Ac3, X = F3 x (A - Ac2) + C2
𝗖𝟯 − 𝗖𝟮
𝗙𝟯 = 𝗔𝗰𝟯 − 𝗔𝗰𝟮
When Ac3 < A ≤ Ac4, X = F4 x (A - Ac3) + C3
𝗖𝟰 − 𝗖𝟯
𝗙𝟰 = 𝗔𝗰𝟰 − 𝗔𝗰𝟯
When Ac4 < A ≤ Ac5, X = F5 x (A - Ac4) + C4
𝗖𝟱 − 𝗖𝟰
𝗙𝟱 = 𝗔𝗰𝟱 − 𝗔𝗰𝟰
When Ac5 < A, X = F6 x (A - Ac5) + C5
𝗖𝟲 − 𝗖𝟱
𝗙𝟲 = 𝗔𝗰𝟲 − 𝗔𝗰𝟱
Where:
A Absorbance or absorbance change of the unknown sample
Ac1 to Ac6 Absorbance or absorbance change of the calibrator
Ablk Absorbance or absorbance change of the reagent blank
X Concentration of the unknown sample
C1 to C6 Concentration of the calibrator
blk Concentration of the reagent blank
F1 to F6 Cal factor (1/slope)
Related information...
Full calibration (c-series photometric), page 681
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Logit-4 method (c-series photometric)
The logit-4 data reduction method uses a reagent blank and three to six calibrators to generate
a calibration curve. This method is applicable to assays for which the absorbance or absorbance
change increases as the calibrator concentration increases.
Figure 151: Logit-4 calibration curve for three to six calibrators
Where:
Abs Absorbance
Conc Concentration
blk Concentration of the reagent blank
C1 to C(N) Concentration of the calibrator
X Concentration of the unknown sample
Ablk Absorbance or absorbance change of the reagent blank
Ac1 to Ac(N) Absorbance or absorbance change of the calibrator
A Absorbance or absorbance change of the unknown sample
An approximation is calculated by using the following equation:
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𝗞𝗰
𝗔 = 𝟭
+ 𝗔𝗯𝗹𝗸
𝟭 +
𝗲 𝗮 + 𝗯 × 𝗹𝗻𝗫
Where:
A Absorbance or absorbance change of the unknown sample
Kc, a, b Constants of the approximation expression
Ablk Approximate value of the absorbance or absorbance change
of the reagent blank
X Concentration of the unknown sample
ln Natural log
When the concentration is near zero, the logit-4 calibration curve converges asymptotically
toward the absorbance or absorbance change of the reagent blank as the concentration
approaches zero. A graph may not show this convergence if the scale is too large.
The approximation expression is simple and the constant is determined through an approximation
by nonlinear regression. Therefore, the curve may not consistently pass through the absorbance
(or absorbance change) data points of the calibrator.
A parameter is available to detect an error if the standard deviation of the absorbance or
absorbance change of the calibrators exceeds a specified value.
Related information...
Full calibration (c-series photometric), page 681
Spline method (c-series photometric)
The spline data reduction method uses a reagent blank and three to six calibrators to generate a
calibration curve. The concentration axis of the calibration curve graph is divided into multiple
sections. The sections correspond to the concentrations of the calibrators. Each section of the
curve is interpolated by using a polynomial equation so that the adjoining sections are connected
smoothly.
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Figure 152: Spline calibration curve for three to six calibrators
Where:
Abs Absorbance
Conc Concentration
blk Concentration of the reagent blank
C1 to C(N) Concentration of the calibrator
Ablk Absorbance or absorbance change of the reagent blank
Ac1 to Ac(N) Absorbance or absorbance change of the calibrator
An interpolation is calculated by using the following polynomial equation:
A = a(n) + b(n) x X + c(n) x X2 + d(n) x X3
Where:
A Absorbance or absorbance change of the unknown sample
a(n), b(n), c(n), d(n) Constants of the approximation expression
X Concentration of the unknown sample
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Related information...
Full calibration (c-series photometric), page 681
Use factor and blank method (c-series photometric)
The use factor and blank data reduction method uses the factor and reagent blank of a
calibration curve generated for another assay (reference assay) to calculate results. This
method is used when two or more assays use the same reagent. The reference assay is defined
in an assay parameter file.
The unknown sample concentration is calculated by using the following equation:
𝗔 − 𝗔𝗯𝗹𝗸′
𝗫 = 𝗔𝗰𝟭′ − 𝗔𝗯𝗹𝗸′
× 𝗖𝟭′
Where:
X Concentration of the unknown sample
A Absorbance or absorbance change of the unknown sample
Ac1' Absorbance or absorbance change of the calibrator used for
the reference test
Ablk' Absorbance or absorbance change of the reagent blank used
for the reference test
C1' Concentration of the calibrator used for the reference test
Related information...
Full calibration (c-series photometric), page 681
Adjustment calibration (c-series photometric)
An adjustment calibration uses one of the following measurement options:
• A new measurement of a reagent blank
• A new measurement of one or more specific points of a full calibration curve
• A new measurement of a reagent blank and one or more specific points of a full calibration
curve
The system software uses the new measurements to adjust the existing calibration data points
and then generates a new calibration curve.
The adjustment calibration interval is updated when either a full calibration or a designated
adjustment calibration is performed.
The c-series provides the following adjustment options:
• Blank adjustment
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• 1-point adjustment
• 2-point adjustment
Related information...
Calibration types and methods (c-series photometric), page 680
Blank adjustment (c-series photometric), page 688
1-point adjustment (c-series), page 688
2-point adjustment (c-series), page 689
Create a calibration order, page 599
Blank adjustment (c-series photometric)
In a blank adjustment, the system reanalyzes only the reagent blank. The following steps show
how the calibration curve is adjusted with the new reagent blank data. The calibration curve is
plotted as absorbance (Abs) versus concentration (Conc).
Step Description
1 The system software performs the new measurement (Ablk')
for the reagent blank (Ablk).
2 The new reagent blank absorbance value (Ablk') replaces the
previous value and the curve adjusts up or down based on the
new reagent blank value.
3 The system software generates a new calibration curve.
Related information...
Adjustment calibration (c-series photometric), page 687
1-point adjustment (c-series)
In a 1-point adjustment, the system reanalyzes one calibrator. The calibrator used is defined on
the Calibration tab of the Assay Parameters screen. The following steps show how the
calibration is adjusted with the new calibrator data. The calibration is plotted as absorbance
(Abs) versus concentration (Conc).
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Step Description
1 The system performs the new measurement (A2') for the
designated adjustment calibrator (A2).
2 A ratio (R) that compares the new (A2') and previous (A2)
absorbance data is calculated:
All other calibrators (A1 and A3) are adjusted by using the
calculated ratio. The adjusted absorbance values are A1' and
A3'. The reagent blank is not adjusted.
3 The system software uses the adjusted data points to
generate a new calibration.
Related information...
Adjustment calibration (c-series photometric), page 687
2-point adjustment (c-series)
In a 2-point adjustment, the system reanalyzes the reagent blank and one calibrator. The
calibrator used is defined on the Calibration tab of the Assay Parameters screen. The following
steps show how the calibration is adjusted with the new calibrator data. The calibration is plotted
as absorbance (Abs) versus concentration (Conc).
Step Description
1 The system performs the new measurement (Ablk') for the
reagent blank (Ablk).
The system performs the new measurement (A2') for the
designated adjustment calibrator (A2).
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Step Description
2 The new reagent blank absorbance value (Ablk') replaces the
previous value and the curve adjusts up or down based on the
change in the reagent blank.
A ratio (R) that compares the new (A2') and previous (A2)
absorbance data is calculated:
All other calibrators (A1 and A3) are adjusted by using the
calculated ratio. The adjusted absorbance values are A1' and
A3'.
3 The system software uses the adjusted data points to
generate a new calibration.
Related information...
Adjustment calibration (c-series photometric), page 687
Calibration types and methods (i-series)
A calibration type indicates whether a new calibration curve is created, a master reference curve
is adjusted, or a cutoff value is created for i-series assays on a processing module. The system
software uses a specific calibration method to create each calibration. The type and method are
defined in each assay parameter file and are specific to the assay. For a detailed description of
assay calibrators and calibration types and methods for an assay, see the assay documentation.
Related information...
Calibration types and methods, page 675
Full calibration (i-series), page 691
Adjustment calibration (i-series), page 694
Index calibration (i-series), page 698
Reference method (i-series), page 698
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Full calibration (i-series)
A full calibration is a measurement of six points specified for a quantitative assay plotted against
known concentrations. The system software uses calibration data to generate a calibration curve
that is specific to a processing module. A full calibration is created by using one of the three
calibration (data reduction) methods that the Alinity i-series provides.
Related information...
Calibration types and methods (i-series), page 690
Point-to-point method (i-series), page 691
Linear regression method (i-series), page 691
4PLC methods (i-series), page 693
Point-to-point method (i-series)
The point-to-point data reduction method uses the average relative light unit (RLU) value
obtained for each calibrator compared to the calibrator concentration (Conc) to generate a
calibration curve. A straight line is used to connect each point. The slope is calculated for each
line segment. Concentrations of unknown samples are calculated from the line segment that
brackets sample RLU values.
Figure 153: Point-to-point data reduction method
For example, if a sample has an RLU value between the RLU values for calibrator B and
calibrator C, the unknown sample concentration is calculated by using the following equation:
𝗖𝗼𝗻𝗰 (𝗖) − 𝗖𝗼𝗻𝗰 (𝗕)
𝗖𝗼𝗻𝗰 (𝗫) = 𝗥𝗟𝗨 (𝗖) − 𝗥𝗟𝗨 (𝗕)
× 𝗥𝗟𝗨 (𝗫) − 𝗥𝗟𝗨 (𝗕) + 𝗖𝗼𝗻𝗰 (𝗕)
Related information...
Full calibration (i-series), page 691
Linear regression method (i-series)
The linear regression data reduction method uses the linear relationship between the relative
light unit (RLU) value and the concentration of the analyte in the sample to generate a
calibration curve. The curve is calculated by using the following equation:
RLU = Intercept (b) + Slope (m) x Concentration (Conc)
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Figure 154: Linear regression data reduction method
The unknown specimen concentration is calculated by using the following equation:
𝗥𝗟𝗨 − 𝗯
𝗖𝗼𝗻𝗰 = 𝗺
Slope (m) and intercept (b) are obtained from the calibration. To calculate the slope and the
intercept, the system software minimizes the sum of squares of the difference between an
observed value and a predicted value (by the regression equation) for all calibrators. The
following equations show the calculations:
𝗦 𝘅𝘅 × 𝗦 𝘆 − 𝗦 𝘅 × 𝗦 𝘅𝘆
𝗯 = 𝝙
𝗦 × 𝗦 𝘅𝘆 − 𝗦 𝘅 × 𝗦 𝘆
𝗺 = 𝝙
𝝙 = 𝗦 × 𝗦𝘅𝘅 − 𝗦𝟮𝘅
𝟭
𝗦 = 𝝨 𝟮
𝞂𝗶
𝘅𝗶
𝘀𝘅 = 𝝨
𝞂 𝟮𝗶
𝘆𝗶
𝗦𝘆 = 𝝨
𝞂 𝟮𝗶
𝘅 𝟮𝗶
𝗦𝘅𝘅 = 𝝨
𝞂 𝟮𝗶
𝘅𝗶 × 𝘆𝗶
𝗦𝘅𝘆 = 𝝨
𝞂 𝟮𝗶
Where:
σi Standard deviation associated with a calibrator
xi Observed calibrator concentration
yi Observed calibrator RLU value
Related information...
Full calibration (i-series), page 691
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4PLC methods (i-series)
Data reduction methods for four-parameter logistic curve fit or four-parameter logistic calibration
(4PLC) use the difference between predicted and observed calibrator concentrations (Conc) or
signals to generate a calibration curve.
A 4PLC curve is calculated by using the following equation:
𝗣𝟮
𝗥𝗟𝗨 = 𝗣𝟭 +
𝗣𝟯 + 𝗖𝗼𝗻𝗰 𝗣𝟰
Four parameters (P1 through P4) control the shape of the curve. Based on the data generated,
a 4PLC curve can be sigmoidal (S-shaped) or can have a shape with no second bend.
The following list shows how the four parameters are used:
P1 Defines the signal at an infinite concentration
𝗣𝟮
𝗣
Defines the maximum theoretical range of a relative light unit
𝟯
(RLU) value from zero concentration to infinity
𝟭
𝗣𝟰
𝗫𝟱𝟬 = 𝗣𝟯 Defines the concentration that yields a signal midway between
the highest possible signal and the lowest possible signal
P4 Determines whether the curve is S-shaped. The curve is S-
shaped when P4 is greater than 1.
These parameters are calculated to find the P values that generate a curve with the lowest sum
of squares:
𝟭
𝗣𝟮 𝗣𝟰
𝗖𝗼𝗻𝗰 = 𝗥𝗟𝗨 − 𝗣𝟭
− 𝗣𝟯
The 4PLC data reduction methods are an x residual minimization (x-weighted) method and a y
residual minimization (y-weighted) method.
4PLC with x residual minimization (x-weighted) method
The 4PLC with x residual minimization (x-weighted) method uses the difference between
predicted and observed calibrator concentrations to generate a calibration curve. To generate a
curve with the lowest possible sum of squares, the four parameters are calculated by using the
following equation:
𝘅𝗶 − 𝘅𝗶 𝟮
𝝨 𝞂𝗶
Where:
xi Observed calibrator concentration
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𝘅𝗶 Predicted calibrator concentration
σi Standard deviation associated with a calibrator
4PLC with y residual minimization (y-weighted) method
The 4PLC with y residual minimization (y-weighted) method uses the difference between
predicted and observed calibrator signals to generate a calibration curve. To generate a curve
with the lowest possible sum of squares, the four parameters are calculated by using the
following equation:
𝘆𝗶 − 𝘆𝗶 𝟮
𝝨 = 𝞂𝗶
Where:
yi Observed calibrator signal (RLU value)
𝘆𝗶 Predicted calibrator signal (RLU value)
σi Standard deviation associated with a calibrator
Related information...
Full calibration (i-series), page 691
Adjustment calibration (i-series)
An adjustment (adjust) calibration is a measurement of two points of a master reference curve
specified for an assay. The system software uses master calibration data to generate a
calibration curve that is specific to a processing module when quantitative assays are used.
A two-point adjust calibration assay has master calibration data encoded within a two-
dimensional bar code on the reagent cartridge label. After the operator loads a reagent cartridge
on a processing module, the system performs a scan and stores master calibration data in the
system software. The stored data is specific for the assay, but the data must be adjusted to fit a
specific processing module. Therefore, the operator must run two calibrators.
The Alinity i-series provides four methods of calibration adjustment.
Related information...
Calibration types and methods (i-series), page 690
Ratio technique methods (i-series), page 695
Linear transformation method (i-series), page 696
Parameter method (i-series), page 696
Curve shape methods (i-series), page 697
Create a calibration order, page 599
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Ratio technique methods (i-series)
The ratio technique adjustment methods compare the relative light unit (RLU) value of calibrators
to the corresponding calibrator values from a master calibration curve. This technique is used
when the lower end of the calibration curve has different characteristics than the rest of the
curve, but the general behavior of the curve is still proportional and linear.
Ratios are calculated for calibrator 1 and calibrator 2 by using the following equations:
𝗖𝟭
𝗥𝟭 = 𝗠𝟭
Where:
R1 Ratio 1
C1 RLU value measured for calibrator 1
M1 RLU value stored in a reagent bar code for a calibrator that
corresponds to calibrator 1
𝗖𝟮
𝗥𝟮 = 𝗠𝟮
Where:
R2 Ratio 2
C2 RLU value measured for calibrator 2
M2 RLU value stored in a reagent bar code for a calibrator that
corresponds to calibrator 2
The system software uses two types of ratio techniques, A and AB. The type that is used
depends on which master calibrator level is multiplied by ratio 1 and ratio 2.
Both types of ratio techniques produce estimates of RLU values. The following calculations are
used to determine the estimates:
Ratio A technique The RLU value stored in the reagent bar code for calibrator A
adjustment method is multiplied by ratio 1.
The RLU value stored in the reagent bar code for calibrators
B through F is multiplied by ratio 2.
Ratio AB technique The RLU value stored in the reagent bar code for calibrators
adjustment method A and B is multiplied by ratio 1.
The RLU value stored in the reagent bar code for calibrators
C through F is multiplied by ratio 2.
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The estimates of instrument-specific RLU values are used to generate the calibration curve.
Related information...
Adjustment calibration (i-series), page 694
Linear transformation method (i-series)
The linear transformation adjustment method assumes a linear relationship between the
calibrator relative light unit (RLU) values that are generated by the system and the master
calibration information that is stored in a reagent bar code.
The following equations show an example of this method. The slope and the intercept that
describe the linear relationship are based on the RLU values of calibrator 1 and calibrator 2 that
are generated by the system and on the corresponding RLU values that are stored in the reagent
bar code.
The slope (m) and the intercept (b) are calculated by using the following equations:
𝗖𝟮 − 𝗖𝟭
𝗺 = 𝗠𝟮 − 𝗠𝟭
𝗖𝟮 − 𝗖𝟭
𝗯 = 𝗖𝟭 − 𝗠𝟭 × 𝗠𝟮 − 𝗠𝟭
Where:
C Calibrator
M Master
Instrument-specific RLU values for the six calibrators in the master calibration can be estimated
by using the following equation:
Calibrator1 = Master1 x Slope + Intercept
The estimates of the instrument-specific RLU values for the six calibrators are used to generate
a calibration curve by using the appropriate calibration curve model.
Related information...
Adjustment calibration (i-series), page 694
Parameter method (i-series)
The parameter adjustment method uses relative light unit (RLU) values that are stored in a
reagent bar code for calibrators A through F to determine the four-parameter logistic curve fit or
four-parameter logistic calibration (4PLC) parameters of a master calibration. Calibrator 1 and
calibrator 2 adjusters are used to provide an instrument-specific calibration curve that is based
on the parameters.
For this method, the residual sum of squares is calculated by using the following equation:
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𝗣 𝗷 − 𝗣𝗷 𝟮 𝘆𝗶 − 𝘆𝗶 𝟮
𝝨 𝞂𝗷
+ 𝝨 𝞂𝗶
Where:
𝗣𝗷 Population average parameter
Pj System-specific parameter
σj Standard deviation parameter
𝘆𝗶 Predicted calibrator signal
yi Observed calibrator signal
σi Standard deviation of a calibrator signal
Related information...
Adjustment calibration (i-series), page 694
Curve shape methods (i-series)
The curve shape adjustment methods use relative light unit (RLU) values that are stored in a
reagent bar code for calibrators A through F to determine the four-parameter logistic curve fit or
four-parameter logistic calibration (4PLC) parameters of a master calibration. Calibrator 1 and
calibrator 2 adjusters are used to provide an instrument-specific calibration curve that is based
on the shape of the curve.
For this method, the residual sum of squares is calculated by using the following equation:
𝗦𝗷 − 𝗦𝗷 𝟮 𝘆𝗶 − 𝘆𝗶 𝟮
𝝨 𝞂𝗷
+ 𝝨 𝞂𝗶
Where:
𝗦𝗷 Population average shape parameter
Sj System-specific shape parameter
σj Standard deviation shape parameter
𝘆𝗶 Predicted calibrator signal
yi Observed calibrator signal
σi Standard deviation of a calibrator signal
Related information...
Adjustment calibration (i-series), page 694
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Index calibration (i-series)
An index calibration is a measurement of one point or two points specified for a qualitative
assay. The system software uses calibration data to generate an index (cutoff) value that is
specific to a processing module.
Related information...
Calibration types and methods (i-series), page 690
Cutoff assay method (i-series), page 698
Cutoff assay method (i-series)
The cutoff assay data reduction method measures relative light unit (RLU) values and calculates
a cutoff value. This method uses a one-point or two-point calibration to calculate the point
(cutoff) value where reactive and nonreactive samples are differentiated. Cutoff formulas can
use addition, subtraction, and multiplication, and constants can be added. After the cutoff value
is calculated, the unknown sample RLU value is divided by the cutoff value to determine a cutoff
ratio (index).
The system software uses the following cutoff calibration methods:
One-point qualitative This method uses one calibrator in the index formula. Based
(index formula) on the cutoff formula, the calibrator can be either reactive or
method nonreactive for an assay.
The following example is a one-point cutoff formula where a
and b are assay-specific constants:
Cutoff = a x Calibrator RLU + b
Two-point qualitative This method uses two calibrators in the index formula. The
(index formula) calibrator concentrations are based on the cutoff formula.
method
The following example is a two-point cutoff formula where a
and b are assay-specific constants:
Cutoff = a x Calibrator 1 RLU + Calibrator 2 RLU - b
Related information...
Index calibration (i-series), page 698
Reference method (i-series)
The reference data reduction method uses a calibration curve generated for another assay
(reference assay) to calculate results. This method is used when two or more assays use the
same reagent. The reference assay is defined in an assay parameter file.
Related information...
Calibration types and methods (i-series), page 690
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Calibration storage
The Alinity ci-series stores active, inactive, and failed calibrations.
Related information...
Calibration procedures, page 673
Active calibration storage, page 699
Inactive calibration storage, page 700
Failed calibration storage, page 700
Active calibration storage
The system stores active calibrations according to the following guidelines:
• A calibration that is specific to a processing module is stored as the active calibration for
the reagent lot. If the system is configured to require calibration by cartridge, the calibration
is stored as the active calibration for the reagent lot and cartridge combination.
• If the system is configured to require quality control to run after a calibration is generated,
the status of the calibration is Pending QC.
NOTE: A calibration that has a status of Pending QC is considered to be an active
calibration that cannot be used to process tests until one level of quality control is
completed.
• The active calibration replaces any previous calibrations that have a status of Active,
Expired, Overridden, Overridden Lot, or Pending QC. For previous calibrations that have
these statuses, their statuses change to Inactive.
• The system automatically uses the active calibration as the default calibration for the
onboard reagent lot or the onboard reagent lot and cartridge combination.
• Stored calibrations that have a status of Failed are deleted for the reagent lot, or the
reagent lot and cartridge combination, that is specific to a processing module.
• One active calibration is stored for a maximum of four different reagent lots, or four
different reagent lot and cartridge combinations, for each assay on a processing module.
• When a fifth reagent lot or a fifth reagent lot and cartridge combination is calibrated
successfully, the system replaces the oldest active calibration and the status of the
calibration changes to Inactive.
• Stored active calibrations are deleted when the corresponding assay file is deleted.
NOTE: On the Calibration Details screen, the statuses of active calibrations can be manually
changed to Failed.
Related information...
Calibration storage, page 699
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Fail a calibration, page 710
Inactive calibration storage
The system stores the previous calibration as an inactive calibration when a new calibration is
generated for the reagent lot, or the reagent lot and cartridge combination, that is specific to a
processing module. Inactive calibrations are stored for a maximum of 3 months.
All calibrations are deleted from the system when the last cartridge of a reagent master lot is
deleted. The system deletes reagents when the reagent cartridge storage capacity is exceeded.
In addition, reagents are deleted when c-series user-defined assays are deleted manually.
Related information...
Calibration storage, page 699
Failed calibration storage
The system stores a failed calibration until an active calibration or another failed calibration is
generated for the reagent lot, or the reagent lot and cartridge combination, that is specific to a
processing module.
Related information...
Calibration storage, page 699
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Calibration review
An assay calibration run must pass calibration verification before the system stores the
calibration. The status of each calibration is displayed on the Current tab and the Historical tab
of the Calibration Status screen.
Related information...
Calibration procedures, page 673
System calibration verification, page 701
Calibration Status screen, page 702
Descriptions of calibration statuses, page 708
View the assay calibration status, page 709
Fail a calibration, page 710
Archive the calibrations, page 669
System calibration verification
After calibrators are processed, the system verifies the results by comparing them to the
calibration parameters and calibration validity checks that are specific to an assay. If the results
of a calibration fall within the specified range for the assay, the new calibration replaces any
previous calibration and the status of the previous calibration changes to Inactive. If the results
of a calibration fall outside the specified range for the assay, the status of the new calibration is
Failed. If the assay has an existing calibration, the calibration is not replaced. Unless otherwise
indicated, calibration statuses are displayed on the Current tab and the Historical tab of the
Calibration Status screen, and include the following options:
Active The calibrator values fall within the assay specifications. The
system software calculates patient and control test results
from this calibration.
Pending QC The calibrator values fall within the assay specifications. The
system is configured to require quality control to run after a
calibration is generated, and no control sample has
completed. When one control level for the assay is
completed, a calibration status of Active is displayed.
NOTE: A completed control does not require the control result
to fall within the configured specifications.
Failed The calibrator values fall outside the assay specifications. If a
reagent lot has an existing active calibration, the system
software calculates patient and control test results from the
existing active calibration.
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Inactive This status is associated with an older, previously active
calibration that was replaced by a more recent calibration.
This status is displayed only on the Historical tab of the
Calibration Status screen.
Related information...
Calibration review, page 701
Calibration Status screen
On the Calibration Status screen, the operator can view a list of the calibration statuses for
assays and reagent lots that are loaded on the system.
The operator can perform the following functions:
• Search for specific calibrations based on specified search criteria.
• Access calibration details.
• Fail a calibration.
• Print a calibration report.
Related information...
Calibration review, page 701
Calibration Status screen element descriptions, page 702
Calibration Status Details screen, page 704
Calibration Status screen element descriptions
Current tab, Historical tab
The Current tab displays the current calibration information for reagents loaded on the system
based on the last reagent scan. The Historical tab displays all calibration information on the
system for up to 3 months.
Elements
Module bar Used to select all modules or an individual module to view
information. The Module bar is available only on the Current
tab.
An amber badge is displayed on the module number when a
calibration is within 1 hour of expiration.
A red badge is displayed on the module number when a
calibration has expired or failed.
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Module Displays the module on which the calibration was ordered and
processed. The module number is displayed only when the All
button is selected.
Assay Displays the name of the assay.
Calibration Method Displays the data reduction method defined for the assay.
The following c-series methods are displayed:
• Abs (Absorbance)
• Factor
• Linear
• Logit-4
• Spline
• Use Cal Factor Blank
The following i-series methods are displayed:
• Point to Point
• Linear Regression
• 4PLC X
• 4PLC Y
• 4PLC X Transform
• Qual 1 Point
• Qual 2 Point
• Reference
• No Cal
Reagent Lot Displays the lot number of the reagent.
Cal Date/Time Displays the completion date and time of the calibration.
Status Displays the calibration status of the reagent lot.
Expiration Date/Time Displays the expiration date and time of the full or adjustment
calibration.
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Function buttons
Select All Selects or deselects all items in a list. The button switches
between Select All and Deselect All.
Search Displays the Search flyout.
Print Displays the Print flyout.
Archive Displays the Archive flyout. This function button is displayed
only on the Historical tab.
Details Navigates to the Details screen for the selected items on the
current screen.
Transmit Sends selected test results to the host computer.
Text Size Increases or decreases the size of text displayed.
Related information...
Calibration Status screen, page 702
Descriptions of screen elements, page 127
Descriptions of calibration statuses, page 708
Calibration Status Details screen
On the Calibration Status Details screen, the operator can view the following information:
• Details for calibrations
• Calibration graphs only for c-series
The operator can fail a calibration.
Related information...
Calibration Status screen, page 702
Calibration Status Details screen element descriptions, page 704
Calibration Status Details screen element descriptions
The Calibration Status Details screen displays the details of the assay, reagent, and calibrator
information that are used to generate a calibration.
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Elements
Assay and Reagent Information area
Displays assay, reagent, operator, and instrument information.
Assay Name Displays the name of the assay.
Assay Number Displays the number defined for the assay. The assay number
must be the same number that is used for the host.
Assay Version Displays the version defined for the assay.
Reagent Lot Displays the lot number of the reagent cartridge.
Reagent SN Displays the serial number of the reagent cartridge.
Lot Expiration Displays the lot expiration date of the reagent cartridge.
Operator ID Displays the operator ID of the operator who was logged on
when the calibration was performed.
Processing Module Displays the module on which the calibration was ordered and
processed.
Module SN Displays the module serial number on which the calibration
was ordered and processed.
Calibration Information area
Displays the details of the calibration information.
Calibration Status Displays the calibration status of the reagent lot.
Calibration Type Displays the calibration type for the assay.
Calibration Method Displays the mathematical procedure used to analyze the
data.
Calibration Date/Time Displays the completion date and time of the calibration.
Calibrator Lot Displays the lot number of the calibrator used to calibrate the
assay.
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Lot Expiration Displays the lot expiration date of the calibrators used to
calibrate the assay.
Full Curve Expiration Displays the expiration date and time of the full calibration.
This element is available only for assays that have a defined
calibration interval.
Adjustment Curve Displays the expiration date and time of the adjustment
Expiration calibration. This element is available only for assays that have
a defined calibration interval.
Archive Status Displays the following status information:
Archived The data has been successfully
archived.
Not Archived The data has not been successfully
archived.
Archive Date/Time Displays the date and time that the data was archived.
Transmission Status Displays the transmission status information, which is used to
determine the progress of a transmission.
Transmission Date/ Displays the date and time that the archive record was
Time transmitted.
Message Code Displays the message code number and description.
Calibrator Results area
Displays the calibration details. Calibration information that is displayed varies based on the
assay type and the calibration method.
Current Calibration Displays the last active calibration. This information is
Curve displayed only for c-series.
Previous Calibration Displays the previous active calibration. This information is
Curve displayed only for c-series.
NOTE: A failed calibration will not be displayed.
Cutoff Displays the calculated cutoff value used for assay data
reduction.
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Cal 1 Ratio, Cal 2 Displays the ratios calculated for calibrator 1 and calibrator 2.
Ratio This information is displayed only for i-series.
Calibrator ID Displays the name of the calibrator level.
Conc Displays the concentration value for each calibrator level
defined in the assay parameters. Only the default units are
displayed.
Fit Conc Displays the fit curve concentration value for each calibrator
level defined in the assay parameters. Only the default units
are displayed.
%CV Displays the calculated percent coefficient of variation for the
calibrator.
Cal mV Displays the median millivolt value for each calibrator level.
This information is displayed only for c-series potentiometric
assays.
Absorbance Displays the median absorbance value for the calibrator level.
Factor Displays the calibration factor for the calibrator level.
Slope Displays the percent response of the integrated chip
technology (ICT) module for the low and high calibrators. This
information is displayed only for c-series potentiometric
assays.
Mean RLU Displays the mean relative light units (RLUs) of the calibrator
replicates.
Reference Cal RLU Displays the reference (master calibrator) data read from the
reagent bar code label.
Fit RLU Displays the fit curve RLU data for each calibrator.
Rep 1, Rep 2, Rep 3 Displays the absorbance value, the millivolt value, or the RLU
value for replicates 1, 2, and 3.
Rep 1 RLU, Rep 2 Displays the RLU value for replicates 1, 2, and 3.
RLU, Rep 3 RLU
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Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Fail Invalidates the current calibration.
Previous Displays the previous item when multiple items are selected.
Next Displays the next item when multiple items are selected.
Related information...
Calibration Status Details screen, page 704
Descriptions of calibration statuses, page 708
Descriptions of screen elements, page 127
Descriptions of calibration statuses
The following list provides descriptions of the calibration statuses. The statuses are described in
the order in which they are sorted. Unless otherwise indicated, the statuses are displayed on the
Current tab and the Historical tab of the Calibration Status screen:
Failed One of the following situations occurred:
• The calibration failed an assay-specific calibration
parameter or assay-specific calibration validity checks.
• The calibration was not completed successfully because
of a hardware error.
• The operator manually failed the calibration.
Expired The calibration exceeded the full interval or the adjustment
interval.
No Cal This status is displayed only on the Current tab of the
Calibration Status screen when one of the following situations
occurs:
• A calibration has not been run for the reagent lot, or the
reagent lot and cartridge combination, that is loaded on
the system.
• One or more c-series assay parameters were edited.
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• The c-series parameter that designates whether to
calibrate an assay by lot or cartridge was edited.
• One or more calibrator concentration values were edited.
Pending QC The system is configured to require quality control to run after
a calibration is generated. The calibration was completed
successfully and no control level has completed.
Overridden The operator has manually overridden an expired calibration.
Overridden Lot The system is configured to track the calibrator lot expiration
date and the operator has manually overridden an expired
calibrator lot.
In Process This status is displayed only on the Current tab of the
Calibration Status screen and indicates that a calibration
order is in process.
Active The calibration completed successfully and is not expired.
Inactive This status is displayed only on the Historical tab of the
Calibration Status screen when one of the following situations
occurs:
• A previously active calibration is replaced by a more
recent calibration.
• The number of supported active calibrations for a specific
processing module, assay, and reagent lot or reagent lot
and cartridge combination has been exceeded. The
oldest active calibration becomes inactive.
Related information...
Calibration review, page 701
Calibration Status Details screen element descriptions, page 704
Reagents screen, Search flyout element descriptions, page 539
Calibration Status screen element descriptions, page 702
View the assay calibration status
Perform this procedure to view the calibration status of an assay before sample processing is
initiated or when a status indicator is displayed.
NOTE: When no active calibration is stored, tests that are initiated become exceptions and are
not processed.
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Calibration procedures
Calibration review Section 6
1. On the menu bar, tap CAL.
The Current tab of the Calibration Status screen displays the calibration data for all
modules.
2. To display the data for one module, tap a Module button.
3. In the Status column, view the calibration statuses.
Related information...
Calibration review, page 701
Fail a calibration
Required instrument • Processing module: Stopped, Warming, or Idle
status
• Reagent and sample manager: Stopped or Idle
Perform this procedure to fail a calibration that has a status of Active or Pending QC and to
prevent subsequent result generation from the calibration for existing control and specimen
orders.
NOTE: The procedure cannot be performed on assays with calibration methods of Use Cal
Factor Blank (c-series) and Reference (i-series). The procedure can be performed from the
Historical tab of the Calibration Status screen.
1. On the menu bar, tap CAL.
The Current tab of the Calibration Status screen displays the calibration data for all
modules.
2. To display the data for one module, tap a Module button.
3. Tap one or more assays.
4. Tap Details.
5. On the Calibration Status Details screen, tap Fail for the selected calibration.
6. When a confirmation message is displayed, tap Yes.
7. If more than one calibration was selected, tap Next to go to each calibration, and then
repeat steps 5, page 710 and 6, page 710 for each calibration.
8. To return to the Calibration Status screen, tap Done.
After a calibration is failed, if a new assay calibration is ordered and specimen and control tests
are included, and the new assay calibration fails, the specimen and control tests become
exceptions.
Related information...
Calibration review, page 701
Active calibration storage, page 699
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Section 7 Operational precautions and limitations
Introduction
For optimal operator safety and accurate test results, comply with operational requirements,
precautions, and limitations. Failure to comply can affect system performance, and may cause
damage to the system or may adversely affect test results.
Related information...
General requirements, page 712
Precautions and requirements for system operation, page 713
Requirements for handling the consumables, page 714
Requirements for handling the specimens, page 716
Limitations of result interpretation, page 718
Operator responsibility, page 720
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Operational precautions and limitations
General requirements Section 7
General requirements
For optimal system performance, comply with the following general requirements of the system:
• Contact an Abbott Laboratories representative to install or relocate the system.
• Do not install the system near direct sunlight, heat, drafts, and heat-generating devices.
Exposure to heat and drafts can interfere with the system's ability to maintain an acceptable
operating temperature.
• Maintain the required space on all sides of the system. This space buffer is essential for the
following conditions:
– Adequate cooling of electrical components
– Accurate temperature control of the system
– Access for maintenance
– Access to disconnect the power cord when required
• Leave on the system power at all times unless instructed otherwise for a maintenance
procedure or a troubleshooting procedure, or unless an emergency situation occurs.
• Perform maintenance procedures as recommended later in this manual.
• Do not attempt any maintenance or repairs that are not specified in documentation provided
by Abbott Laboratories.
Related information...
Operational precautions and limitations, page 711
Service, maintenance, and diagnostics, page 739
System clearances, page 403
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Operational precautions and limitations
Section 7 Precautions and requirements for system operation
Precautions and requirements for system
operation
When operating the system, comply with the precautions and requirements for system operation.
Failure to comply may cause damage to the system or may adversely affect test results.
Related information...
Operational precautions and limitations, page 711
Precautions and requirements before operation, page 713
Precautions during operation, page 713
Precautions and requirements before operation
Before operating the system, comply with the following precautions and requirements:
• Thoroughly read this manual to become familiar with the system functionality and associated
hazards.
• Read the sections of the product documentation that contain the following information:
– Warnings and general precautions
– Safety precautions
– Precautions for handling
• Verify that adequate supplies and reagents are loaded on the system.
Related information...
Precautions and requirements for system operation, page 713
Precautions during operation
While operating the system, comply with the following precautions:
• Close all system doors and covers unless instructed otherwise for a maintenance procedure
or a troubleshooting procedure.
• Do not disconnect any electrical connection during normal system operation.
• Respond to system notifications that relate to waste levels during system processing.
Dispose of all waste in accordance with local, state, and national regulations.
Related information...
Precautions and requirements for system operation, page 713
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Operational precautions and limitations
Requirements for handling the consumables Section 7
Requirements for handling the consumables
For optimal operator safety and accurate test results, comply with the requirements for handling
the consumables.
For more information about handling the consumables, see the following documentation:
• Product package inserts
• Specific product labels
• Safety Data Sheets
Related information...
Operational precautions and limitations, page 711
Requirements for storage, page 714
Requirements for use, page 714
Requirements for storage
When storing reaction vessels, reagent cartridges, reagent replacement caps, and sample cups,
comply with the following requirements:
• Keep all consumables clean and dust-free.
• Store all consumables in their original containers so that information such as expiration
dates and lot numbers is available if necessary.
When storing reagents, calibrators, controls, and bulk solutions, comply with the following
requirements:
• Store reagents, calibrators, controls, and bulk solutions as instructed on their labels or in the
product documentation.
• Store reagents in an upright position. For more information, see the product documentation.
If reagents, calibrators, controls, or bulk solutions are received in a condition that is contrary to
the label recommendation or the product documentation, or are damaged, contact the local
representative or find country-specific contact information at abbottdiagnostics.com.
Related information...
Requirements for handling the consumables, page 714
Requirements for use
When using reaction vessels (RVs), reagent cartridges, reagent replacement caps, and sample
cups, comply with the following requirements:
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Operational precautions and limitations
Section 7 Requirements for handling the consumables
• Do not reuse or substitute consumables. Abbott Laboratories cannot accept responsibility for
system performance and test results when consumables are reused or have been
manufactured by anyone other than Abbott Laboratories.
• Use caution to prevent contamination and operator exposure when handling the RVs,
reagent replacement caps, and sample cups.
• Consider all used RVs, reagent cartridges, reagent replacement caps, and sample cups as
potentially infectious. Follow appropriate procedures for handling the consumables.
When using reagents, calibrators, controls, and bulk solutions, comply with the following
requirements:
• Do not substitute materials. Abbott Laboratories manufactures substances and components
according to quality standards that are controlled rigidly. Substitution of materials may
adversely affect system performance, test results, safety, and equipment life.
• Do not excessively mix or shake liquids, minimizing the formation of foam and bubbles.
• Do not pipette by mouth.
• Do not smoke, eat, drink, apply cosmetics, or handle contact lenses in areas where
specimens, reagents, calibrators, controls, or bulk solutions are handled.
• Consider all reagents, calibrators, and controls that contain human-sourced materials as
potentially infectious.
• Use caution to prevent contamination and operator exposure when handling the reagents,
calibrators, controls, and bulk solutions.
• Wear clean gloves to prevent contamination and operator exposure when placing reagent
cartridges on the system.
• Do not invert used reagent cartridges since this action causes reagent leakage and may
compromise test results.
• Verify that reagent cartridges are within the expiration date before loading them on the
system.
• Do not use reagents, calibrators, controls, and bulk solutions beyond their expiration dates.
• Do not use reagents on the system beyond the maximum number of cumulative days. For
more information, see the product documentation.
• Verify that bulk solutions are loaded in the appropriate position to ensure that test results
are not adversely affected.
• Do not mix reagents, calibrators, controls, and bulk solutions within a lot or between lots.
Related information...
Requirements for handling the consumables, page 714
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Operational precautions and limitations
Requirements for handling the specimens Section 7
Requirements for handling the specimens
For information about specimen collection, preparation, and storage, see the product
documentation. Consider all specimens as potentially infectious. In addition, consider all system
surfaces or components that have come in contact with specimens as potentially infectious.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
Requirements for collection
When collecting specimens, comply with the following requirements:
• Comply with all precautions for blood collection by venipuncture to prevent specimen
hemolysis.
• Verify that the correct specimen type is used. The system does not verify the specimen
type.
Requirements for preparation and storage
When preparing and storing specimens, comply with the following requirements:
• Inspect all specimens for bubbles. Remove bubbles with a clean applicator stick before
performing sample processing. Use a new applicator stick for each specimen to prevent
cross contamination.
• Verify that serum and plasma specimens do not contain fibrin, red blood cells, or other
particulate matter.
• For sample volume information, see the product documentation.
• Separate serum specimens or plasma specimens from clots, serum separators, or red blood
cells before freezing the specimens.
• Mix and centrifuge serum specimens or plasma specimens after any freeze-thaw cycle or to
remove red blood cells or other particulate matter. For information about limitations and
interfering substances, see the product documentation.
• Avoid multiple freeze-thaw cycles. After thawing a specimen, thoroughly mix it at a low
speed or gently invert it. Mixed specimens produce consistent test results.
• Remove closures from specimen tubes before loading the tubes on the reagent and sample
manager.
• After loading samples on the system, process the samples within the number of hours
specified in the product documentation to minimize evaporation effects.
Related information...
Operational precautions and limitations, page 711
Sample volume requirements, page 423
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Operational precautions and limitations
Section 7 Requirements for handling the specimens
Biological hazards, page 723
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Operational precautions and limitations
Limitations of result interpretation Section 7
Limitations of result interpretation
Test results must be used with other clinical data, such as symptoms, other test results, the
patient history, clinical impressions, the clinical evaluation information, and other diagnostic
procedures. Consider all data for patient care management.
If test results are inconsistent with the clinical evidence, additional testing is recommended to
confirm the results.
Errors can occur because of potential operator errors and system technology limitations.
Related information...
Operational precautions and limitations, page 711
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Section 8 Hazards
Introduction
To minimize the potential for harm to personnel and damage to the laboratory environment,
comply with the hazard and safety information.
This section contains supplemental information. Do not use the supplemental information to
supersede workplace safety requirements. Review any significant differences between the
supplemental information and the workplace safety requirements with management or a
workplace safety representative.
Related information...
Operator responsibility, page 720
Safety icons, page 721
Biological hazards, page 723
Chemical hazards, page 725
Waste handling and disposal, page 728
Spill cleanup, page 730
Requirements for decontamination, page 731
Electrical hazards, page 734
Mechanical hazards, page 735
Physical hazards, page 737
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Hazards
Operator responsibility Section 8
Operator responsibility
Use the system only according to its designed purpose. Operators must be trained before
operating the system. Failure to comply with safe-use instructions may cause personal injury,
harm the environment, damage the system, or adversely affect test results.
Any tool use to override interlocks must be controlled and distributed by the operator or the
operator's management.
Related information...
Hazards, page 719
Operational precautions and limitations, page 711
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Hazards
Section 8 Safety icons
Safety icons
Safety icons are used on the system and in the system documentation to identify potentially
dangerous conditions. Become familiar with these icons to know the type of potential hazard.
Table 42: Safety icons and descriptions
Icon Description
CAUTION: Biological RISKS
Identifies an activity or an area where you may be exposed to potentially infectious
material.
CAUTION: Possibility of electric shock
Indicates the possibility of electric shock if procedural controls or engineering
controls are not observed.
CAUTION: Hot Surface
Identifies an activity or an area where you may be exposed to hot surfaces.
CAUTION: Probe Stick Hazard
Identifies an activity or an area where you may be exposed to probes.
CAUTION
When used in this manual, this icon is accompanied by a description of the hazard
and a related-information reference to safety content in this section. Examples
include the following conditions:
• CAUTION: Lifting Hazard
Identifies an activity where you may be required to lift or move a heavy object.
• CAUTION: Moving Parts
Identifies an activity or an area where you may be exposed to moving parts.
• CAUTION: Chemical Hazard
Identifies an activity or an area where you may be exposed to hazardous
chemicals.
CAUTION: Disconnect Mains Plug
Identifies a main electrical disconnect.
Electrical and electronic equipment waste
Indicates that the item needs to be disposed of in a separate waste collection for
electrical and electronic equipment and must not be disposed of in the general
waste or trash.
Related information...
Hazards, page 719
Biological hazards, page 723
Electrical hazards, page 734
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Hazards
Safety icons Section 8
Probes and other sharps, page 737
Heavy objects, page 737
Mechanical hazards, page 735
Chemical hazards, page 725
Hot objects, page 738
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Hazards
Section 8 Biological hazards
Biological hazards
Exposure to potentially infectious materials may occur when the following activities are
performed:
• Handling of specimens, reagents, calibrators, and controls
• Spill cleanup
• Waste handling and disposal
• System relocation
• Maintenance procedures
• Decontamination procedures
• Component replacement procedures
Comply with the precautions to help minimize the impact of this exposure.
Related information...
Hazards, page 719
Precautions, page 723
Required consumables, page 133
Requirements for handling the specimens, page 716
Safety icons, page 721
Requirements for decontamination, page 731
Component replacement, page 827
Precautions
Consider as potentially infectious all products that are derived from human-sourced materials
and all system surfaces and components that have come in contact with human-sourced
materials. No known test method can offer complete assurance that products derived from
human-sourced materials do not transmit infection.
It is recommended that all potentially infectious materials are handled according to the OSHA
Standard on Bloodborne Pathogens1. Use Biosafety Level 22 or appropriate biosafety
practices3,4 for materials that contain or are suspected to contain infectious agents. Precautions
include the following actions:
• When handling human-sourced materials or contaminated system components:
– Wear gloves, a lab coat, and protective eyewear.
– Do not eat, drink, smoke, apply cosmetics, or handle contact lenses.
• Do not pipette by mouth.
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Hazards
Biological hazards Section 8
• Clean spills of potentially infectious materials and contaminated system components with a
quaternary ammonium detergent. Then mist or wipe the surface with 0.5% sodium
hypochlorite solution. Let the disinfectant remain on the surface for a minimum of 10
minutes of contact time.
• Decontaminate and dispose of all samples, reagents, and other potentially contaminated
materials in accordance with local, state, and national regulations.
Immediately clean an affected area if any exposure to biohazardous or potentially infectious
materials occurs:
Eyes Rinse with water for 15 minutes.
Mouth Rinse with water.
Skin Wash the affected area with soap and water. Apply alcohol,
povidone iodine, chlorhexidine, or another antiseptic.
Puncture wound Let the wound bleed freely. Wash the affected area with soap
and water.
Seek medical attention as soon as possible for appropriate follow-up.
Bibliography references
1. US Department of Labor, Occupational Safety and Health Administration, 29 CFR Part
1910.1030, Bloodborne pathogens.
2. US Department of Health and Human Services. Biosafety in Microbiological and Biomedical
Laboratories. 5th ed. Washington, DC: US Government Printing Office; December 2009.
3. World Health Organization. Laboratory Biosafety Manual. 3rd ed. Geneva: World Health
Organization; 2004.
4. Clinical and Laboratory Standards Institute (CLSI). Protection of Laboratory Workers From
Occupationally Acquired Infections; Approved Guideline--Fourth Edition. CLSI Document
M29-A4. Wayne, PA: CLSI; 2014.
Related information...
Biological hazards, page 723
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Hazards
Section 8 Chemical hazards
Chemical hazards
Exposure to hazardous chemicals may occur when consumables are handled.
To minimize any exposure to hazardous chemicals, follow the instructions provided in the
following documentation:
• Product package inserts
• Specific product labels
• Safety Data Sheets (SDSs)
When the Alinity ci-series is installed and is used correctly, system design features further
reduce exposure levels.
System products are classified and labeled in accordance with the Globally Harmonized System
of Classification and Labelling of Chemicals (GHS) as implemented in regional regulations.
Examples of regional regulations include the U.S. OSHA Hazard Communication Standard (HCS)
and the European Regulation (EC) 1272/2008 on classification, labelling, and packaging of
substances and mixtures (CLP).
Pictograms (red-bordered diamonds), signal words (such as Warning and Danger), hazard
statements (H), and precautionary statements (P) are included on respective product labeling.
Other country-specific warnings and precautions may also be included on product labeling.
For SDSs, contact the local representative or find country-specific contact information at
abbottdiagnostics.com.
Related information...
Hazards, page 719
General precautions, page 725
Sodium azide, page 726
Sensitizers, page 727
Required consumables, page 133
Safety icons, page 721
General precautions
In general, comply with the following precautions when handling chemicals:
• Consult the Safety Data Sheets for safe-use instructions and precautions.
• Avoid contact with skin and eyes. If contact with material is anticipated, wear impervious
gloves and protective clothing and eyewear.
• Maintain good housekeeping. Do not eat, drink, or store food and beverages in areas where
chemicals are used.
• Immediately clean spilled fluids.
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Hazards
Chemical hazards Section 8
• Seek medical attention if irritation or signs of toxicity occur after exposure.
CAUTION: This product contains chemicals known to the state of California to
cause cancer and birth defects or other reproductive harm.
• For information related to Article 33 of the EU REACH regulation (EC 1907/2006,
Registration, Evaluation, Authorisation, and Restriction of Chemicals), go to pmis.abbott.com.
For website logon issues, contact Abbott Laboratories at abbott.REACH@abbott.com.
• To view the China RoHS 2 Hazardous Substance tables, in accordance with the People’s
Republic of China Electronic Industry Standard SJ/T 11364-2014, go to
abbottdiagnostics.com/registration-ous (select Technical Library > Other Reference
Documents > China RoHS Hazardous Substance Tables).
Related information...
Chemical hazards, page 725
Sodium azide
Some products contain sodium azide. Comply with the following precautions when using
products or handling waste that contains sodium azide:
• Do not use any chemical or product with a pH below 6 to disinfect waste that contains
sodium azide. Hydrazoic acid, a highly toxic gas, is released when the pH is lower than 6.
Normal operation of the system uses small amounts of sodium azide with other reagent
components and does not generate hydrazoic acid at levels that are harmful to the operator.
• Thoroughly flush drains with water several times each day to prevent the formation of
potentially explosive metal azides on lead components, copper components, brass
components, or the solder in laboratory plumbing if product waste or instrument waste is
released to a drain. More information about azides in laboratory drains is available in
Current Intelligence Bulletin No.13: Explosive Azide Hazard (August 16, 1976), a publication
issued by the U.S. National Institute for Occupational Safety and Health (NIOSH). For a copy
of this bulletin, contact the local representative or go to one of the following websites:
– cdc.gov/niosh
Search for the bulletin title.
– abbottdiagnostics.com
Go to the international website or the U.S. website. Select Support/Technical Library/
Other Reference Documents.
Related information...
Chemical hazards, page 725
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Hazards
Section 8 Chemical hazards
Sensitizers
Some products contain low levels of ingredients that are reported to be sensitizers. Sensitizers
can stimulate allergic reactions in some people. The allergic reactions may occur with the first
exposure or only after repeated exposures. Methylisothiazolones, which are used as
preservatives in some products, have been associated with the stimulation of allergic skin
reactions (allergic contact dermatitis). Certain enzymatic cleansers may stimulate allergic
reactions in the respiratory systems of people who are sensitive to the ingredients.
To reduce the potential for exposure to sensitizers, comply with the following precautions:
• Use good laboratory techniques to minimize spatters, spills, and other aerosolization of
liquids and powders, particularly when pouring or transferring materials.
• Wear impervious gloves and other personal protective equipment that is appropriate for
biomedical laboratories.
• Immediately remove gloves if they are damaged or contaminated.
• Wash hands after removing gloves and immediately before putting on a fresh pair of gloves.
• Handle containers at a comfortable height that is below chest level.
Related information...
Chemical hazards, page 725
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Hazards
Waste handling and disposal Section 8
Waste handling and disposal
Each facility has the responsibility to label all waste containers and to characterize its waste
stream to confirm that waste is disposed of in accordance with local, state, and national
regulations.
Related information...
Hazards, page 719
Liquid wastes that contain (potentially) infectious materials, page 728
Batteries, page 729
Replace bulk solutions and update the inventory, page 508
Empty the high-concentration waste bottle and update the inventory (c-series), page 514
Remove the RV waste and update the inventory (i-series), page 515
Liquid wastes that contain (potentially) infectious materials
To meet institutional or local requirements for the decontamination or disinfection of liquid
wastes that contain infectious or potentially infectious materials, consider the following
precautions:
• Select a disinfectant that is effective against bloodborne infectious agents and against other
microbial agents that may be prevalent in the local population. A disinfectant that is effective
against Mycobacterium tuberculosis generally is effective against all known viruses and non-
spore-forming bacteria and is suitable for most clinical laboratory situations.
• Select a disinfectant and a method that do not bubble, effervesce, or generate aerosols.
• Do not use any chemical or product with a pH below 6. The use of materials with a pH
below 6 generates highly toxic hydrazoic acid gas if wastes from the materials contain
sodium azide.
• Do not use any chemical or product for disinfection that contains any metal. This precaution
prevents the creation of highly explosive metal azides in wastes that may contain sodium
azide.
• Obtain and review the manufacturer's safety information before using any disinfectant.
• Use disinfectants according to the manufacturer's directions (for example, do not use
excess disinfectant). Failure to follow the manufacturer's directions may cause unexpected
effects.
• Do not use a disinfectant if the facility, the equipment, and other protective measures are
not appropriate for safe use with the disinfectant.
• Autoclaving is not recommended for materials contaminated with products that contain
chemicals that are hazardous by inhalation at low concentrations (for example, cyanides).
• Wear appropriate personal protective equipment (such as gloves, a lab coat, and eyewear)
when performing decontamination activities.
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Hazards
Section 8 Waste handling and disposal
Related information...
Waste handling and disposal, page 728
Batteries
The European Battery Directive requires separate collection of spent batteries to facilitate
recycling and protect the environment.
The system contains batteries that are not intended for the operator to service or remove. Only
an Abbott Laboratories representative or a qualified individual may remove the batteries in the
system at the end of the life of the system and may dispose of them in accordance with local
regulations for separate collection of spent batteries.
Contact the local representative or find country-specific contact information at
abbottdiagnostics.com.
Related information...
Waste handling and disposal, page 728
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Hazards
Spill cleanup Section 8
Spill cleanup
Clean spills according to established biosafety practices and follow instructions in the Safety
Data Sheets. In general, safe work practices for spill cleanup include the following requirements:
1. Wear appropriate personal protective equipment, such as gloves, a lab coat, and eyewear.
2. Absorb the spill with an absorbent material.
3. Wipe the spill area with a quaternary ammonium detergent.
4. Mist or wipe the spill area with 0.5% sodium hypochlorite solution. Let the disinfectant
remain on the surface for a minimum of 10 minutes of contact time.
5. Dispose of all absorbent material and wipes according to local, state, and national
regulations.
Related information...
Hazards, page 719
Requirements for decontamination, page 731
Component replacement, page 827
Unscheduled cleaning, page 772
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Hazards
Section 8 Requirements for decontamination
Requirements for decontamination
Sodium hypochlorite and other disinfectants are typically hazardous chemicals that react with
many chemicals, materials, and living tissues. To reduce the potential for exposure to
disinfectants, comply with the following general precautions:
• Obtain and review the manufacturer's safety information before using any disinfectant.
• Wear appropriate personal protective equipment (such as gloves, a lab coat, and eyewear)
when performing decontamination activities.
Related information...
Hazards, page 719
Preparation of sodium hypochlorite solutions, page 731
Sodium hypochlorite stability, page 732
System relocation, page 153
Biological hazards, page 723
Spill cleanup, page 730
Clean and decontaminate external components, page 773
Clean and decontaminate the bar code scanner, page 773
Clean and decontaminate the monitor, page 774
Preparation of sodium hypochlorite solutions
To calculate the number of parts of water required to mix with one part of manufacturer-supplied
sodium hypochlorite solution, use the following equation:
𝗕 − 𝗔
𝗫 = 𝗔
Where:
A Percent of sodium hypochlorite solution that is wanted
B Percent of sodium hypochlorite (active or available chlorine)
in manufacturer-supplied sodium hypochlorite solution
X Number of parts of water required to mix with one part of
manufacturer-supplied sodium hypochlorite (active or
available chlorine) solution
Example:
A = 0.5%
B = 5%
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Hazards
Requirements for decontamination Section 8
𝟱% − 𝟬.𝟱%
𝗫 = 𝟬.𝟱%
= 𝟵
Mix one part of sodium hypochlorite with nine parts of water.
To calculate the volume of sodium hypochlorite required to make a specific volume of sodium
hypochlorite solution, use the following equation:
𝗔 × 𝗩𝟮
𝗩𝟭 = 𝗕
Where:
A Percent of sodium hypochlorite solution that is wanted
B Percent of sodium hypochlorite (active or available chlorine)
in manufacturer-supplied sodium hypochlorite solution
V1 Volume of manufacturer-supplied sodium hypochlorite solution
V2 Total volume that is wanted
Example:
A = 0.5%
B = 5%
V2 = 1000 mL (1 L)
𝟬.𝟱% × 𝟭𝟬𝟬𝟬 𝗺𝗟
𝗩𝟭 = 𝟱%
= 𝟭𝟬𝟬 𝗺𝗟
Mix 100 mL of manufacturer-supplied sodium hypochlorite solution with 900 mL of water to make
1 L of sodium hypochlorite solution.
Related information...
Requirements for decontamination, page 731
Sodium hypochlorite stability
Use a freshly prepared solution of sodium hypochlorite for decontamination. Sodium hypochlorite
needs to be prepared fresh daily to ensure that the solution contains a sufficient quantity of
active compound (for example, chlorine) to be effective. The amount of active chlorine in sodium
hypochlorite solutions, for example, is reduced by the following factors:
• The presence of organic matter in the water used for dilution
• The temperature at which the solution is stored
• The type and size of the container and closure
• The frequency and nature of use
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Hazards
Section 8 Requirements for decontamination
If a facility has data that demonstrates a longer shelf-life is valid under the specific conditions of
solution preparation and storage in the facility, prepare solutions in advance and store them.
Related information...
Requirements for decontamination, page 731
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Hazards
Electrical hazards Section 8
Electrical hazards
The system does not pose uncommon electrical hazards to operators if it is installed and is
operated without alteration, and if it is connected to a power source that meets the required
specifications.
Basic electrical hazard awareness is essential to the safe operation of the system. Only qualified
personnel may perform electrical servicing.
Elements of electrical safety include the following requirements:
• Inspect cables that connect to the system for signs of wear and damage.
• Use only approved power cords and electrical accessories, such as the cords and
accessories that are supplied with the system, to protect against electric shock.
• Use an appropriately grounded electrical outlet of correct voltage and current-handling
capability.
• Determine and resolve the cause of a blown fuse or a tripped circuit breaker before
resuming system operation.
• Do not disconnect any electrical connections or service any electrical and internal
components while the system power is on.
• Keep liquids away from all connectors of electrical and communication components.
• Do not touch any switches or outlets with wet hands.
• Keep the floor dry and clean under and near the system.
• Use a ground fault circuit interrupter when working in a wet environment.
• Immediately clean liquid spills. Turn off the system power and disconnect the system power
cord before cleaning major liquid spills.
Related information...
Hazards, page 719
Electrical specifications and requirements, page 403
Safety icons, page 721
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Hazards
Section 8 Mechanical hazards
Mechanical hazards
The Alinity ci-series is an automated system that operates by computer control. As with most
automated equipment, the potential for injury and bodily harm from moving mechanical
components is present when system operation occurs.
To minimize mechanical hazards, the system provides guards to protect against accidental
contact with moving components and incorporates safety features in the hardware.
The system requires the operator to accurately position all specimens, reagents, calibrators,
controls, sample cups, and tubes on the system. Be sure to correctly position sample cups,
tubes, and reagent cartridges before any operation is initiated.
Although the system is equipped with safety features to stop the lowering of probes, do not
reach into the processing center during system operation. To interrupt a run, follow the operating
instructions in this manual.
The top of the RSM transport is equipped with white light-emitting diodes (LEDs) as visual safety
indicators. The LEDs provide visibility to the RSM transport position and movement at all times.
Do not reach into the path of the RSM transport at any time. Do not run the system unless at
least one LED is illuminated. If neither LED is illuminated, contact Customer Service to resolve
the failure.
If necessary for maintenance and diagnostic procedures, interlocks can be overridden by an
Abbott Laboratories representative or trained operators only by using the procedure key. Be
aware that potential mechanical hazards and Biological RISK may be present. Be aware of
moving parts. Do not reach into the paths of moving parts.
During system operation, the operator may be exposed to the following moving components:
• Pipettors and probes
• Sample transport
• RV loader assembly
• Wash aspiration probes
• Processing center
• Processing module pumps
Elements of mechanical safety include the following requirements:
• Keep all protective covers and barriers in the appropriate positions.
• Do not perform manual tasks on the work surface of the system.
• Do not insert any parts of the body into an area of mechanical movement during system
operation.
• Do not wear articles of clothing or accessories that can catch on the system.
• Empty pockets of items that can fall into the system.
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Mechanical hazards Section 8
• Be aware that reflex actions can occur and cause injury in the event of a system
malfunction or an unexpected sequence of movements.
• Use caution when performing procedures for adjustment, maintenance, cleaning, and repair.
• Use caution when loading sample racks or sample trays.
• Use caution when loading reagent cartridges.
• Use caution when moving full waste containers.
Related information...
Hazards, page 719
Operating instructions, page 427
Safety icons, page 721
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Section 8 Physical hazards
Physical hazards
Use safe practices to avoid injury when any exposure to potential physical hazards occurs.
Related information...
Hazards, page 719
Probes and other sharps, page 737
Heavy objects, page 737
Hot objects, page 738
Tripping hazards, page 738
Probes and other sharps
Probes are sharp and may be contaminated with infectious material. Avoid contact with tips of
probes. Although the system is equipped with safety features to stop the lowering of probes, do
not reach into the processing center during system operation.
In general, minimize the use of sharps and glassware. Use mechanical means to remove
contaminated, broken glassware. Dispose of sharps in an appropriately labeled, puncture-
resistant, leakproof container before treatment and disposal.
Related information...
Physical hazards, page 737
Safety icons, page 721
Heavy objects
The system is a heavy instrument. Confirm that adequate help is available before relocating the
system. For information about the relocation of the system, contact an Abbott Laboratories
representative.
Obtain adequate help or use mechanical devices to move or lift heavy items.
Use the following techniques to help reduce the risk of injury when lifting objects:
• Keep the head up and the back straight. Bend at the hips and knees.
• Bring the load as near to the body as possible and keep the load directly in front of the
body.
• Tighten the abdominal muscles, push the feet down into the ground, and straighten the
knees (that is, lift with the legs, not with the back).
• Do not twist and reach to the side or twist and lift. Instead, move the feet to turn the body.
• Bend at the knees by using only the leg muscles and place the load in the appropriate
location.
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Physical hazards Section 8
• Try to perform lifts at waist height with the elbows near the body.
Related information...
Physical hazards, page 737
Safety icons, page 721
Hot objects
The lamp and the lamp housing may be hot. Before replacing the lamp, power off the c-series
processing module. Wait a minimum of 5 minutes so that the lamp and the lamp housing can
cool. Wear gloves if necessary.
Related information...
Physical hazards, page 737
Safety icons, page 721
Tripping hazards
The Alinity ci-series is equipped with a power cord for each processing module, several
computer cables, and water and waste tubing for the system control module. To avoid a tripping
hazard, ensure that the cords, cables, and tubing in high-traffic areas are routed safely.
Related information...
Physical hazards, page 737
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Section 9 Service, maintenance, and diagnostics
Introduction
The appropriate service, maintenance, and diagnostics of the system are some of the most
important aspects of a complete quality assurance program. A thorough service, maintenance,
and diagnostic program:
• Minimizes downtime.
• Maintains records for inspection and accreditation.
• Maintains system performance to provide optimal test results.
Related information...
Maintenance and diagnostics, page 740
Component replacement, page 827
Troubleshooting, page 917
General requirements, page 712
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Maintenance and diagnostics Section 9
Maintenance and diagnostics
The system software provides a user-friendly interface to perform and track maintenance and
diagnostic activities.
The Procedures screen displays maintenance and diagnostic procedures that can be performed.
After initiating a procedure, follow step-by-step instructions through the procedure to completion.
The online log indicates the date and time that the procedure is completed. The performance of
the procedure is tracked in the online log.
If a maintenance procedure or a diagnostic procedure requires the cover interlocks to be
overridden by using the procedure key, the interlocks can be overridden only by trained
operators. Be aware that potential mechanical hazards and Biological RISK may be present. Be
aware of moving parts. Do not reach into the paths of moving parts.
Related information...
Service, maintenance, and diagnostics, page 739
Procedures screen, page 740
Procedures Log screen, page 752
Maintenance and diagnostic procedure statuses, page 757
Maintenance procedure descriptions, page 758
Unscheduled cleaning, page 772
Diagnostic procedure descriptions, page 775
Procedures screen
On the Procedures screen, the operator can view the following information:
• Scheduled maintenance procedures to perform by category
• Available diagnostic procedures to perform by category
• In-process maintenance procedures or in-process diagnostic procedures
A trained operator can perform the following functions:
• Access details for a maintenance procedure or a diagnostic procedure.
• Perform a maintenance procedure or a diagnostic procedure.
• Print a maintenance procedure or a diagnostic procedure.
• Access maintenance logs or diagnostic logs.
Related information...
Maintenance and diagnostics, page 740
Procedures screen element descriptions, page 741
Version Details for Procedure flyout element descriptions, page 743
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Section 9 Maintenance and diagnostics
Perform Procedure screen, page 744
Perform Procedure screen element descriptions, page 745
Descriptions of procedure key settings, page 746
Use a procedure key to perform a procedure, page 747
Perform a maintenance procedure or a diagnostic procedure, page 750
Return to a maintenance procedure or a diagnostic procedure in process, page 752
Procedures screen element descriptions
Maintenance tab, Diagnostics tab
The Maintenance tab displays maintenance procedures that can be performed for a selected
module. The Diagnostics tab displays diagnostic procedures that can be performed for a
selected module. Maintenance and diagnostic procedures are grouped by categories. Category
tabs are displayed on the right side of the Procedures screen.
Elements
Module bar Used to select an individual module to perform maintenance
or diagnostic procedures.
An amber badge is displayed on the module number when a
maintenance or diagnostic procedure is in process and
requires an operator response.
A red badge is displayed on the module number when one or
more maintenance procedures are overdue.
Procedure Displays a list of the procedures that can be performed for
the selected module. The procedures are grouped by
categories. The Minus button next to each category
collapses or expands the list of procedures associated with
the category.
Last Performed Displays the date and time that the procedure was last
performed.
Operator ID Displays the operator ID that is logged onto the system when
the procedure was performed.
Category tabs The following categories are displayed for maintenance
procedures if applicable:
• All
• To Do
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Maintenance and diagnostics Section 9
• Daily
• Weekly
• Monthly
• Quarterly
• Semiyearly
• Yearly
• As Needed
The following categories are displayed for diagnostic
procedures:
• Optics
• Pipettors
• Fluidics-Wash
• Temperature
• RV Loader (only for i-series)
• Process Path (only for i-series)
• Sample Manager
• Reagent Manager
• Modules
• Utilities
• Reaction Mechanisms (only for c-series)
• ICT (only for c-series)
Function buttons
Log button Navigates to the Procedures Log screen.
Print Displays the Print flyout.
Details Displays the Version Details for Procedure flyout.
Perform Navigates to the Perform Procedure screen.
In Process tab
The In Process tab displays the maintenance or diagnostic procedure that is in process for a
selected module.
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Section 9 Maintenance and diagnostics
Elements
Module bar Used to select an individual module to view the status of a
procedure that is in process.
An amber badge is displayed on the module number when a
maintenance or diagnostic procedure is in process and
requires an operator response.
Procedure Displays the procedure that is in process for the selected
module.
Status Displays the status of the maintenance or diagnostic
procedure.
Time Started Displays the date and time that the procedure was started.
Function buttons
Continue Navigates to the Perform Procedure screen of the
maintenance or diagnostic procedure that is in process.
Related information...
Procedures screen, page 740
Descriptions of screen elements, page 127
Version Details for Procedure flyout element descriptions
The Version Details for Procedure flyout provides the version details of the selected
maintenance or diagnostic procedure.
Version Details area
Procedure Displays the number and name of the selected procedure.
Description Provides a short description of the selected procedure.
Current Version Displays the current version of the selected procedure.
Category Displays the category of the selected procedure.
Status to Perform Displays the instrument status of the processing module that
Procedure is necessary to perform the selected procedure.
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Operator Access Level Displays the operator access level that is necessary to
perform the selected procedure.
Procedure Key Setting Displays the procedure key setting that is necessary to
perform the selected procedure.
Last Performed Details area
Version Displays the version of the selected procedure when the
procedure was last performed. If the procedure has not been
performed, the element is blank.
Completion Date Displays the date and time that the selected procedure was
last performed. If the procedure has not been performed, the
element is blank.
Operator ID Displays the identification of the operator logged onto the
system when the selected procedure was performed. If the
procedure has not been performed, the element is blank.
Completion Status Displays the last status of the selected procedure. If the
procedure has not been performed, the element is blank.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Procedures screen, page 740
Maintenance and diagnostic procedure statuses, page 757
Perform Procedure screen
On the Perform Procedure screen, the operator can view the following information for a
procedure in process:
• Procedure category and name
• Procedure status
• Procedure description
The operator can perform the following functions:
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• Continue the procedure.
• Close the screen to perform a procedure on another module.
• Access other screens.
• Quit the procedure.
Related information...
Procedures screen, page 740
Perform Procedure screen element descriptions
Displays information about the procedure and step-by-step instructions for performing the
procedure.
Elements
Type Displays the type of procedure being performed:
• Maintenance
• Diagnostic
Category Displays the maintenance or diagnostic category for the
procedure.
Procedure Displays the procedure number and name.
Status Displays the status of the maintenance or diagnostic
procedure.
Instructions Displays step-by-step instructions to perform the maintenance
or diagnostic procedure.
User Input Displays the buttons and fields to continue the procedure or
provide user input.
Activity Displays the activity of the module while performing the
procedure.
Results Displays the results of the procedure.
Function buttons
Show Video Displays the Show Video flyout.
Show Picture Displays the Show Picture flyout.
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Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Quit Cancels selections or entries and displays the Done button to
exit the procedure.
Print Displays the Print flyout.
Related information...
Procedures screen, page 740
Descriptions of screen elements, page 127
Descriptions of procedure key settings
The procedure key provides access to the front and rear processing center covers of the Alinity
ci-series processing modules and the reagent and sample manager (RSM) when maintenance
procedures, diagnostic procedures, and component replacement procedures are in process. The
procedure documentation includes the procedure key settings.
NOTE: For procedures that require a processing module and the RSM, the procedure keys for
the processing module and the system control module (SCM) need to be positioned at the
designated procedure key settings.
The following list provides descriptions of the procedure key settings:
Off The setting is indicated by the black dot on the procedure
lock. To perform a procedure, the procedure key is not
required to be inserted into the procedure lock.
Required On The setting is indicated by the white dot on the procedure
lock. To perform a procedure, the procedure key must be
inserted into the procedure lock and must be positioned at the
On setting.
Optional On The procedure key is or is not inserted into the procedure
lock. If the procedure key is inserted, the key can be
positioned at the setting for On or Off. However, access to the
front and rear processing center covers is permitted only
when the procedure key is inserted and is positioned at the
On setting. If the front or rear processing center cover is lifted
during the procedure when the procedure key is positioned at
the Off setting or when the key is not inserted, the instrument
statuses of the processing module and the RSM transition to
Stopped and power is removed from the following module
components:
• c-series: Sample pipettor
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Section 9 Maintenance and diagnostics
• i-series: Sample, R1, and R2 pipettors
• RSM: RSM transport
Related information...
Procedures screen, page 740
Procedure key, page 50
Use a procedure key to perform a procedure
Required instrument Stopped or Idle
status
Perform this procedure to adjust the procedure key setting on the Alinity c processing module,
the Alinity i processing module, and the system control module (SCM). A procedure key is
provided for use with a maintenance procedure, a diagnostic procedure, or a component
replacement procedure. To determine the procedure key setting for a specific procedure, see
the procedure documentation.
When the processing module procedure key is positioned at the On setting, access to the front
and rear processing center covers of the processing module is permitted when the procedure is
in process. The SCM procedure key is required for procedures that use the reagent and sample
manager (RSM) and require access to the front processing center cover.
NOTE: When procedures are performed with the procedure key positioned at the On setting,
important safety features are bypassed and the operator may be exposed to one or more of the
following potential hazards:
• CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
• CAUTION: Chemical Hazard. This activity or area exposes you to a chemical
hazard.
• CAUTION: Moving Parts. This activity or area may expose you to moving parts.
• CAUTION: Probe Stick Hazard. This activity or area may expose you to probes.
Be aware of moving parts. Do not reach into the processing center during system operation.
1. To access each procedure lock, perform the following steps:
– Open the front electronics door of the processing module.
– Open the SCM front door.
2. Insert the procedure key into the procedure lock, and then turn the key to the On (white dot)
setting.
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Maintenance and diagnostics Section 9
Figure 155: Procedure key for the SCM
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Section 9 Maintenance and diagnostics
Figure 156: Procedure key for the Alinity c
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Maintenance and diagnostics Section 9
Figure 157: Procedure key for the Alinity i
3. Perform the procedure that requires the procedure key.
4. Turn the procedure key to the Off setting (black dot), and then remove the key.
5. Close the front electronics door of the processing module and the SCM front door.
Related information...
Procedures screen, page 740
Procedure key, page 50
Perform a maintenance procedure or a diagnostic procedure
Perform this procedure to perform and track maintenance and diagnostic procedures.
The Maintenance tab includes scheduled procedures to perform and as-needed cleaning
procedures to perform.
The Diagnostics tab includes procedures that can be used to confirm the status of assemblies
and mechanisms to help identify and resolve operational problems.
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Section 9 Maintenance and diagnostics
CAUTION: Maintenance and diagnostic procedures may expose operators to one or
more potentially hazardous conditions. Untrained operators must not perform these
procedures.
1. On the menu bar, tap Procedures.
The default is the Maintenance tab. To perform diagnostic procedures, tap the Diagnostics
tab.
NOTE: If Procedures is not an icon on the menu bar, tap System, and then tap
Procedures.
2. On the Procedures screen, tap a Module button.
The Maintenance tab displays To Do procedures. The Diagnostics tab displays All
procedures.
3. On the right side of the Procedures screen, tap a tab.
4. Under Procedure, tap a procedure.
5. Tap Perform.
On the Perform Procedure screen, a procedure description is displayed in the Instructions
box. If a procedure is selected by mistake, tap Quit to exit the procedure.
6. To perform the procedure, tap the Proceed user input button.
7. Follow the instructions in the Instructions box.
Some procedures have pictures and videos to use as aids to perform the procedure. The
Show Video button and the Show Picture button are displayed when pictures and videos
are available.
8. To leave the procedure while it is in process, tap any icon on the menu bar.
The system software provides the ability to perform a procedure on a different module or to
use other areas of the user interface while a procedure runs in the background. When a
procedure requires an operator response, an amber badge is displayed on the Procedures
icon.
NOTE: The In Process tab of the Procedures screen displays procedures in process.
9. To print a procedure report, tap Print.
10. To complete the procedure, tap Done.
Related information...
Procedures screen, page 740
Maintenance procedure descriptions, page 758
Diagnostic procedure descriptions, page 775
Return to a maintenance procedure or a diagnostic procedure in process, page 752
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Maintenance and diagnostics Section 9
Return to a maintenance procedure or a diagnostic procedure in process
Perform this procedure to return to the Perform Procedure screen of an in-process maintenance
procedure or an in-process diagnostic procedure. The operator must return to this screen to
provide a response when required or to complete the procedure.
1. On the menu bar, tap Procedures.
NOTE: If a procedure requires a response, the In Process tab is displayed. If the tab is not
displayed, tap the In Process tab.
2. On the Procedures screen, tap a Module button.
3. Under Procedure, tap an in-process procedure.
4. Tap Continue.
5. On the Perform Procedure screen, follow the instructions in the Instructions box.
6. To print a procedure report, tap Print.
7. To complete the procedure, tap Done.
Related information...
Procedures screen, page 740
Perform a maintenance procedure or a diagnostic procedure, page 750
Procedures Log screen
On the Procedures Log screen, the operator can view information about maintenance and
diagnostic procedures that were performed. The system stores data for a maximum of 2 years.
The operator can perform the following functions:
• Approve a log.
• Print a log.
• Add a comment to a procedure.
Related information...
Maintenance and diagnostics, page 740
Procedures Log screen, Maintenance tab element descriptions, page 753
Procedures Log screen, Diagnostics tab element descriptions, page 754
Details for Log flyout element descriptions, page 755
Add a comment to a maintenance procedure or a diagnostic procedure, page 756
Approve a maintenance log, page 757
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Section 9 Maintenance and diagnostics
Procedures Log screen, Maintenance tab element descriptions
Maintenance tab
The Maintenance tab displays the maintenance logs. The following list explains the descriptive
elements of the maintenance logs:
• A gray box indicates that the procedure has a status of Scheduled, Pending, Canceled, Not
Performed, or Failed. If the procedure is performed multiple times on the same day, the
status of the last performed procedure is displayed.
Tap the box to display the Details for Log flyout.
• A blue box indicates that the procedure has been performed and has a status of Completed.
Tap the box to display the Details for Log flyout.
• An asterisk (*) within the box indicates that a comment has been entered for the procedure
in the Details for Log flyout.
• A number within the box indicates that the procedure was performed multiple times on the
same day.
• No box indicates that the procedure was not performed or scheduled for that day.
Elements
Module bar Used to select an individual module to view the maintenance
logs.
Procedure Displays the name of the maintenance procedure.
Status Displays the approval status of the selected maintenance log.
The statuses are Approved and Unapproved.
Operator ID Displays the identification of the operator who approved the
log. The element is blank if the log has not been approved.
Approval Date/Time Displays the date and time that the log was approved. The
element is blank if the log has not been approved.
Activity Month Displays the month and year for the log displayed.
Back and Forward Navigate to the previous or next maintenance log.
buttons
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Function buttons
Procedures Navigates to the Procedures screen.
Print Displays the Print flyout.
Approve Used to approve the maintenance log for the month displayed.
Related information...
Procedures Log screen, page 752
Descriptions of screen elements, page 127
Procedures Log screen, Diagnostics tab element descriptions
Diagnostics tab
The Diagnostics tab displays the diagnostic logs. The following list explains the descriptive
elements of the diagnostic logs:
• A gray box indicates procedures that did not complete successfully. If the procedure is
performed multiple times on the same day, the status of the last performed procedure is
displayed.
Tap the box to display the Details for Log flyout.
• A blue box indicates that the procedure has been performed and has a status of Completed.
Tap the box to display the Details for Log flyout.
• An asterisk (*) within the box indicates that a comment has been entered for the procedure
in the Details for Log flyout.
• A number within the box indicates that the procedure was performed multiple times on the
same day.
• No box indicates that the procedure was not performed or scheduled for that day.
Elements
Module bar Used to select an individual module to view the diagnostic
logs.
Procedure Displays the name of the diagnostic procedure.
Activity Month Displays the month and year for the log displayed.
Back and Forward Navigates to the previous or next diagnostic log.
buttons
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Function buttons
Procedures Navigates to the Procedures screen.
Print Displays the Print flyout.
Related information...
Procedures Log screen, page 752
Descriptions of screen elements, page 127
Details for Log flyout element descriptions
The Details for Log flyout provides details of the selected maintenance or diagnostic procedure.
Elements
Procedure Displays the name of the selected maintenance or diagnostic
procedure.
Version Displays the version number of the procedure.
Category Displays the category of the maintenance or diagnostic
procedure.
Operator ID Displays the identification of the operator logged onto the
system when the procedure was performed. For maintenance
logs, the element is blank if the procedure has a status of
Scheduled, Pending, or Not Performed.
Completion Date Displays the date and time that the procedure is completed.
For maintenance logs, the element is blank if the procedure
has a status of Scheduled, Pending, or Not Performed.
Completion Status Displays the final status of the completed procedure.
Comment Used to enter comments for the selected procedure.
Results Displays results generated for the selected procedure.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
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Cancel Cancels selections or entries and displays the previously
viewed screen or flyout.
Print Displays the Print flyout.
Previous Displays the previously viewed details for the log. The button
is displayed only when the procedure is performed multiple
times on the same day.
Next Displays the next details for the log. The button is displayed
only when the procedure is performed multiple times on the
same day.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Procedures Log screen, page 752
Add a comment to a maintenance procedure or a diagnostic procedure
Perform this procedure to add a comment to a procedure listed in the maintenance log or the
diagnostic log. Add comments as needed to document the following information:
• Why a maintenance procedure was not completed when scheduled
• Why a procedure failed or was repeated
• Why a nonscheduled procedure was performed
1. On the menu bar, tap Procedures.
NOTE: If Procedures is not an icon on the menu bar, tap System, and then tap Procedures.
2. On the Procedures screen, tap Log.
3. On the Log screen, tap a Module button.
4. In the Activity Month area, tap the Right Arrow and Left Arrow buttons to display the
needed month.
5. Under Procedure, find the needed procedure.
If the procedure is not displayed on the screen, flick up and down to view more procedures.
6. To display the procedure in the Details for Log flyout, tap a date for the procedure.
7. If the procedure was performed multiple times on that date, tap Next or Previous to display
the details for each time that the procedure was performed.
8. In the Comments box, type a comment.
9. To save the comment and return to the Log screen, tap Done.
To discard the comment and return to the Log screen, tap Cancel.
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Related information...
Procedures Log screen, page 752
Approve a maintenance log
Operator access level System administrator
Perform this procedure to approve a monthly maintenance log.
NOTE: The maintenance log can be approved on the first day of the next month.
1. On the menu bar, tap Procedures.
NOTE: If Procedures is not an icon on the menu bar, tap System, and then tap Procedures.
2. On the Maintenance tab of the Procedures screen, tap Log.
3. In the Activity Month area, tap the Left Arrow and Right Arrow buttons to display the
needed month.
4. Tap Approve.
5. When a confirmation message is displayed, tap Yes.
The status of the maintenance log changes from not approved to approved and displays the
operator ID and the approval date and time.
Related information...
Procedures Log screen, page 752
Maintenance and diagnostic procedure statuses
Maintenance and diagnostic procedure status refers to the completion status of a procedure.
Procedures have the following completion statuses:
Scheduled A maintenance procedure is scheduled for a future date.
Pending A maintenance procedure is scheduled for the current date.
Completed The procedure is completed. For procedures that produce
results with pass-or-fail criteria, all results passed.
User Canceled Quit is selected before the procedure is completed.
Failed The procedure generated an error or a failed result.
Blank The procedure has not been performed.
Running The procedure is in process.
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Waiting user response The procedure in process requires an operator response.
Not performed The maintenance procedure was not performed on the date
due.
Related information...
Maintenance and diagnostics, page 740
Version Details for Procedure flyout element descriptions, page 743
Maintenance procedure descriptions
Maintenance procedures are grouped first by module type and then by category. The type of
module determines the categories and procedures that are available. Each category is
represented by a tab on the right side of the Maintenance tab of the Procedures screen.
The To Do tab displays scheduled procedures for the selected module.
The All tab displays all procedures for the selected module. Each additional tab represents a
frequency (for example, Daily or Weekly). Any procedure that is displayed can be performed
even if it is not scheduled.
Related information...
Maintenance and diagnostics, page 740
Maintenance suggestions, page 758
Processing module maintenance procedures (c-series), page 759
Processing module maintenance procedures (i-series), page 768
Reagent and sample manager (RSM) maintenance procedures, page 771
Perform a maintenance procedure or a diagnostic procedure, page 750
Maintenance suggestions
The appropriate maintenance of the system is important. Abbott Laboratories provides
suggestions for efficient strategies to perform maintenance procedures and reduce downtime.
When scheduling and performing maintenance procedures:
• Schedule maintenance procedures for times when the workflow is slow.
• Verify that adequate supplies are loaded, or are available to load, on the system before
initiating a maintenance procedure.
• Perform procedures within a maintenance category on different shifts or days. To avoid
scheduling these procedures for the same day, perform some of them early to stagger the
schedule.
NOTE: All maintenance procedures must be completed on or before the due date.
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Related information...
Maintenance procedure descriptions, page 758
Processing module maintenance procedures (c-series)
Maintenance procedures for the c-series processing module are grouped by the module type
and by frequency categories on the Maintenance tab of the Procedures screen.
Related information...
Maintenance procedure descriptions, page 758
Daily maintenance procedures (c-series), page 759
Weekly maintenance procedures (c-series), page 760
Monthly maintenance procedures (c-series), page 760
Quarterly maintenance procedures (c-series), page 761
As-needed maintenance procedures (c-series), page 765
Daily maintenance procedures (c-series)
Daily maintenance procedures are required on the c-series processing module.
Related information...
Processing module maintenance procedures (c-series), page 759
5501 Daily Maintenance (c-series), page 759
5501 Daily Maintenance (c-series)
Perform this Daily maintenance procedure to complete the following tasks:
• Flush the water lines of the sample, the reagent, and the cuvette washer.
• Exchange the water in the water bath.
• Add Water Bath Additive to the water bath.
• Wash the ICT module with ICT Reference Solution and Cleaning Solution.
• Drain and fill the ICT Reference Solution cup.
• Wash the sample and reagent probes and the mixers with Acid Probe Wash and Detergent
A.
• Clean the sample probe, the R2 probe, and the mixers with Cleaning Solution.
• Clean the sample probe exterior (only for whole blood).
Estimated time 12 minutes
Required materials • c-series Maintenance Solutions, LN 08P9870, LN
08P9871 (USA)
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• Purified water (required only for systems with whole blood
applications)
• Cotton swabs (required only for systems with whole blood
applications)
Required instrument Warming or Idle
status
Procedure key setting Processing module: Required On
Related information...
Daily maintenance procedures (c-series), page 759
Use a procedure key to perform a procedure, page 747
Maintenance solutions (c-series), page 139
Solutions used in daily operations (c-series), page 513
Weekly maintenance procedures (c-series)
Weekly maintenance procedures are required on the c-series processing module.
Related information...
Processing module maintenance procedures (c-series), page 759
5601 Clean Cuvettes with Detergent A (c-series), page 760
5601 Clean Cuvettes with Detergent A (c-series)
Perform this Weekly maintenance procedure to wash all cuvettes and to fill them with Detergent
A solution.
Estimated time 30 minutes
Required materials None
Required instrument Warming or Idle
status
Procedure key setting Processing module: Required On
Related information...
Weekly maintenance procedures (c-series), page 760
Use a procedure key to perform a procedure, page 747
Monthly maintenance procedures (c-series)
Monthly maintenance procedures are required on the c-series processing module.
Related information...
Processing module maintenance procedures (c-series), page 759
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5701 Clean ICT Drain Tip (c-series), page 761
5701 Clean ICT Drain Tip (c-series)
Perform this Monthly maintenance procedure to clean the ICT drain tip.
Estimated time 2 minutes
Required materials • Lint-free tissue
• Purified water
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Off
Related information...
Monthly maintenance procedures (c-series), page 760
Use a procedure key to perform a procedure, page 747
Quarterly maintenance procedures (c-series)
Quarterly maintenance procedures are required on the c-series processing module.
Related information...
Processing module maintenance procedures (c-series), page 759
5801 Sample Syringe Maintenance (c-series), page 761
5802 Wash Solution Syringe Maintenance (c-series), page 762
5803 Reagent Syringe Maintenance (c-series), page 763
5804 Change 1 mL Syringes (c-series), page 763
5805 Check and Change ICT Check Valves (c-series), page 764
5806 Change Lamp (c-series), page 764
5807 Check and Clean High-Concentration Waste Sensor (c-series), page 765
5801 Sample Syringe Maintenance (c-series)
Perform this Quarterly maintenance procedure to replace the sample syringe O-ring and sample
syringe seal tips 1 and 2.
Estimated time 12 minutes
Required materials • Phillips screwdriver
• Slotted screwdriver
• 10 mm wrench
• Absorbent towel
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• Sample and Wash Solution Syringe O-ring, LN 09D5203
• Sample and Wash Solution Syringe Seal Tip #1, LN
09D3703
• Sample and Wash Solution Syringe Seal Tip #2, LN
09D3803
• Cotton swabs
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Optional On
Related information...
Quarterly maintenance procedures (c-series), page 761
Use a procedure key to perform a procedure, page 747
5802 Wash Solution Syringe Maintenance (c-series)
Perform this Quarterly maintenance procedure to replace the wash solution syringe O-ring and
wash solution syringe seal tips 1 and 2.
Estimated time 22 minutes
Required materials • Phillips screwdriver
• Slotted screwdriver
• 10 mm wrench
• Absorbent towel
• Sample and Wash Solution Syringe O-ring, LN 09D5203
• Sample and Wash Solution Syringe Seal Tip #1, LN
09D3703
• Sample and Wash Solution Syringe Seal Tip #2, LN
09D3803
• Cotton swabs
Required instrument Warming or Idle
status
Procedure key setting Processing module: Optional On
Related information...
Quarterly maintenance procedures (c-series), page 761
Use a procedure key to perform a procedure, page 747
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5803 Reagent Syringe Maintenance (c-series)
Perform this Quarterly maintenance procedure to replace the reagent syringe O-rings and
reagent syringe seal tips 1 and 2.
Estimated time 22 minutes
Required materials • Phillips screwdriver
• Slotted screwdriver
• 15 mm wrench
• Absorbent towel
• Reagent Syringe O-ring, LN 09D5303
• Reagent Syringe Seal Tip #1, LN 09D3903
• Reagent Syringe Seal Tip #2, LN 09D4004
• Cotton swabs
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Optional On
Related information...
Quarterly maintenance procedures (c-series), page 761
Use a procedure key to perform a procedure, page 747
5804 Change 1 mL Syringes (c-series)
Perform this Quarterly maintenance procedure to change the 1 mL syringes on the following
pumps:
• ICT Reference Solution pump
• ICT aspiration pump
• Wash solution pump
Estimated time 14 minutes
Required materials • Seven 1 mL syringes, LN 09D4103 (If the system is not
configured to use the ICT module, only three 1 mL
syringes are required.)
• Absorbent towels
Required instrument Warming or Idle
status
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Procedure key setting Processing module: Optional On
Related information...
Quarterly maintenance procedures (c-series), page 761
Use a procedure key to perform a procedure, page 747
5805 Check and Change ICT Check Valves (c-series)
Perform this Quarterly maintenance procedure to change the ICT aspiration check valve and to
test the functionality of the ICT Reference Solution check valves.
Estimated time 18 minutes
Required materials • Absorbent towel
• ICT check valve, LN 09D3503
• Beaker that is large enough to hold the 1 mL syringe and
the check valve
• Purified water
Required instrument Warming or Idle
status
Procedure key setting Processing module: Optional On
Related information...
Quarterly maintenance procedures (c-series), page 761
Use a procedure key to perform a procedure, page 747
5806 Change Lamp (c-series)
Perform this Quarterly maintenance procedure to change the lamp.
Estimated time 15 minutes
Required materials • Phillips screwdriver
• Slotted screwdriver
• Gloves
• Source lamp, LN 09D4503
• Lint-free tissue (optional)
• Ethanol (optional)
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Off
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Related information...
Quarterly maintenance procedures (c-series), page 761
Use a procedure key to perform a procedure, page 747
5807 Check and Clean High-Concentration Waste Sensor (c-series)
Perform this Quarterly maintenance procedure to test the functionality of the high-concentration
waste sensor and to clean the sensor.
NOTE: This procedure is required only if the high-concentration waste bottle is installed.
Estimated time 10 minutes
Required materials • Absorbent towels
• 0.5% sodium hypochlorite solution
• Beaker that is large enough to hold the high-
concentration waste sensor
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Off
Related information...
Quarterly maintenance procedures (c-series), page 761
Use a procedure key to perform a procedure, page 747
As-needed maintenance procedures (c-series)
The operator can perform as-needed maintenance procedures for the c-series processing
module to clean cuvettes and module-specific reagent and sample manager (RSM) mechanisms
when messages codes and observed problems associated with the cuvettes and the module-
specific RSM are diagnosed.
Related information...
Processing module maintenance procedures (c-series), page 759
5901 Clean Wash Cups (c-series) (FSE Logon), page 765
5905 Internal Decontamination (c-series) (FSE Logon), page 766
5910 Wash Cuvettes (c-series), page 767
5925 Manual RSM Loading Area and Positioners Cleaning (c-series), page 767
5901 Clean Wash Cups (c-series) (FSE Logon)
Perform this As-Needed maintenance procedure to clean the processing module wash cups and
waste areas.
Estimated time 45 minutes
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Required materials • Phillips screwdriver
• Slotted screwdriver
• 3 mm hex wrench
• 175 mL 2.5% sodium hypochlorite solution
• Lint-free tissue
• Two syringes that can dispense 25 mL
• Container that can dispense 100 mL
• Cotton swabs
• Gauze squares
• Purified water
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Required On
Related information...
As-needed maintenance procedures (c-series), page 765
5905 Internal Decontamination (c-series) (FSE Logon)
Perform this As-Needed maintenance procedure to decontaminate the processing module
internally.
Estimated time 3 hours
Required materials • 10 L 0.5% sodium hypochlorite solution
• 10 L container to prepare the 0.5% sodium hypochlorite
solution
• 10 L container to drain the internal water tank
• Container to fill the internal water tank with 0.5% sodium
hypochlorite solution
• Two disposable 20 mL syringes with blunt-tipped needles
• Tube with a fitting and funnel to fill the internal water tank
• Cotton swabs
• Purified water
• #1 Phillips screwdriver
• #2 Phillips screwdriver
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• c-series Maintenance Solutions, LN 08P9870
• Absorbent towels
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Required On
Related information...
As-needed maintenance procedures (c-series), page 765
Use a procedure key to perform a procedure, page 747
5910 Wash Cuvettes (c-series)
Perform this As-Needed maintenance procedure to wash all cuvettes with Alkaline Wash, Acid
Wash, and water.
Estimated time 16 minutes
Required materials None
Required instrument Warming or Idle
status
Procedure key setting Processing module: Optional On
Related information...
As-needed maintenance procedures (c-series), page 765
Use a procedure key to perform a procedure, page 747
5925 Manual RSM Loading Area and Positioners Cleaning (c-series)
Perform this As-Needed maintenance procedure to clean manually the loading area, sample
positioners, and reagent positioner of the module-specific reagent and sample manager (RSM).
Estimated time 4 minutes (This time does not include the 10 minutes of
contact time that is required for 0.5% sodium hypochlorite
solution.)
Required materials • 0.5% sodium hypochlorite solution
• Quaternary ammonium detergent
• Lint-free tissue
Required instrument Stopped, Warming, or Idle
status
Procedure key setting • System control module: Required On
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• Processing module: Required On
Related information...
As-needed maintenance procedures (c-series), page 765
Use a procedure key to perform a procedure, page 747
Processing module maintenance procedures (i-series)
Maintenance procedures for the i-series processing module are grouped by the module type and
by frequency categories on the Maintenance tab of the Procedures screen.
Related information...
Maintenance procedure descriptions, page 758
Daily maintenance procedures (i-series), page 768
Weekly maintenance procedures (i-series), page 769
As-needed maintenance procedures (i-series), page 770
Daily maintenance procedures (i-series)
Daily maintenance procedures are required on the i-series processing module.
Related information...
Processing module maintenance procedures (i-series), page 768
2500 Daily Maintenance (i-series), page 768
2500 Daily Maintenance (i-series)
Perform this Daily maintenance procedure to complete the following tasks:
• Clean and condition the sample pipettor probe.
• Clean wash zone 1 probes and wash zone 2 probes with 0.5% sodium hypochlorite solution.
• Flush and prime the Pre-Trigger Solution and the Trigger Solution.
Estimated time 23 minutes
Required materials • Maintenance Cleaning Cartridge, LN 02R5240
• 0.5% sodium hypochlorite solution
• Measuring device that can deliver 25 mL
• Probe Conditioning Solution, LN 01R5840 (in the reagent
carousel)
Required instrument Warming or Idle
status
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Procedure key setting • System control module: Optional On
• Processing module: Optional On
Related information...
Daily maintenance procedures (i-series), page 768
Weekly maintenance procedures (i-series)
Weekly maintenance procedures are required on the i-series processing module.
Related information...
Processing module maintenance procedures (i-series), page 768
2620 Manual Pipettor Probe Cleaning (i-series), page 769
2625 Manual Wash Zone Probe Cleaning (i-series), page 769
2630 Manual Wash Cup Cleaning (i-series), page 770
2620 Manual Pipettor Probe Cleaning (i-series)
Perform this Weekly maintenance procedure to remove manually the salt buildup from the
outside of the reagent 1, reagent 2, and sample pipettor probes.
Estimated time 4 minutes
Required materials • Purified water
• Cotton swabs
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Required On
Related information...
Weekly maintenance procedures (i-series), page 769
2625 Manual Wash Zone Probe Cleaning (i-series)
Perform this Weekly maintenance procedure to remove manually the salt buildup from the wash
zone 1 and wash zone 2 probes.
Estimated time 4 minutes
Required materials • Purified water
• Cotton swabs
Required instrument Stopped, Warming, or Idle
status
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Procedure key setting Processing module: Required On
Related information...
Weekly maintenance procedures (i-series), page 769
2630 Manual Wash Cup Cleaning (i-series)
Perform this Weekly maintenance procedure to remove manually the salt buildup from the
reagent 1, reagent 2, and sample wash cups and the wash cup baffles.
Estimated time 8 minutes
Required materials • Purified water
• Cotton swabs
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Required On
Related information...
Weekly maintenance procedures (i-series), page 769
As-needed maintenance procedures (i-series)
The operator can perform as-needed maintenance procedures for the i-series processing
module to clean and decontaminate the processing module or module-specific reagent and
sample manager (RSM) mechanisms after a spill has occurred or when message codes and
observed problems associated with the processing module or the module-specific RSM are
diagnosed.
Related information...
Processing module maintenance procedures (i-series), page 768
2900 Internal Decontamination (i-series) (CSC Logon), page 770
2925 Manual RSM Loading Area and Positioner Cleaning (i-series), page 771
2900 Internal Decontamination (i-series) (CSC Logon)
Perform this As-Needed maintenance procedure to decontaminate the wash buffer fluidics
system. This procedure completes the following tasks:
• Flushes all pumps and fluid lines with air, 0.5% sodium hypochlorite solution, purified water,
and wash buffer
• Coats all probes with probe conditioning solution
Estimated time 2 hours
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Required materials • 2.5 L purified water
• 6 L 0.5% sodium hypochlorite solution
• Empty 1 L container
• Absorbent towel
• Probe Conditioning Solution, LN 01R5840 (in the reagent
carousel)
Required instrument Warming or Idle
status
Procedure key setting Processing module: Optional On
Related information...
As-needed maintenance procedures (i-series), page 770
2925 Manual RSM Loading Area and Positioner Cleaning (i-series)
Perform this As-Needed maintenance procedure to clean manually the loading area, sample
positioners, and reagent positioner of the module-specific reagent and sample manager (RSM).
Estimated time 4 minutes (This time does not include the 10 minutes of
contact time that is required for 0.5% sodium hypochlorite
solution.)
Required materials • 0.5% sodium hypochlorite solution
• Quaternary ammonium detergent
• Lint-free tissue
Required instrument Stopped, Warming, or Idle
status
Procedure key setting • System control module: Required On
• Processing module: Required On
Related information...
As-needed maintenance procedures (i-series), page 770
Reagent and sample manager (RSM) maintenance procedures
Maintenance procedures for the reagent and sample manager are grouped by the module type
and by frequency categories on the Maintenance tab of the Procedures screen.
Related information...
Maintenance procedure descriptions, page 758
As-needed maintenance procedure (RSM), page 772
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As-needed maintenance procedure (RSM)
The operator can perform the as-needed maintenance procedure for the reagent and sample
manager (RSM) to clean RSM mechanisms after a spill has occurred or when message codes
and observed problems associated with the RSM are diagnosed.
Related information...
Reagent and sample manager (RSM) maintenance procedures, page 771
2920 Manual RSM Transport Cleaning, page 772
2920 Manual RSM Transport Cleaning
Perform this As-Needed maintenance procedure to clean manually the bar code reader mirror
and transport arm of the reagent and sample manager (RSM).
Estimated time 4 minutes (This time does not include the 10 minutes of
contact time that is required for 0.5% sodium hypochlorite
solution.)
Required materials • 0.5% sodium hypochlorite solution (This option is only for
the RSM transport arm.)
• Quaternary ammonium detergent (This option is only for
the RSM transport arm.)
• Isopropyl alcohol (This option is only for the RSM bar
code reader mirror.)
• Microfiber cloth (This option is only for the RSM bar code
reader mirror.)
• Lint-free tissue
Required instrument Stopped, Warming, or Idle
status
Procedure key setting System control module: Required On
Related information...
As-needed maintenance procedure (RSM), page 772
Unscheduled cleaning
Some system components may need to be cleaned or decontaminated because of normal use
from daily system operations or because of spills.
Related information...
Maintenance and diagnostics, page 740
Clean and decontaminate external components, page 773
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Clean and decontaminate the bar code scanner, page 773
Clean and decontaminate the monitor, page 774
Spill cleanup, page 730
Clean and decontaminate external components
Required materials • Lint-free tissues
• 0.5% sodium hypochlorite solution
• Quaternary ammonium detergent
Perform this procedure to clean and decontaminate the following components:
• Processing module external surfaces
• System control module external surfaces
• RV waste container (i-series)
• Sample racks
• Vial racks
• Trays
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
1. Wipe the surface area with a quaternary ammonium detergent.
2. Mist or wipe the surface area with 0.5% sodium hypochlorite solution. Let the disinfectant
remain on the surface for a minimum of 10 minutes of contact time.
3. Dispose of all absorbent material and wipes according to local, state, and national
regulations.
Related information...
Unscheduled cleaning, page 772
Requirements for decontamination, page 731
Clean and decontaminate the bar code scanner
Required materials • Soft lint-free tissues
• 0.5% sodium hypochlorite solution
• Quaternary ammonium detergent
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Required instrument Stopped, Warming, or Idle
status
Perform this procedure to clean and decontaminate the bar code scanner.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
1. Wipe the surface area and scan window of the bar code scanner with a quaternary
ammonium detergent.
2. Mist or wipe the surface area and the scan window with 0.5% sodium hypochlorite solution.
Let the disinfectant remain on the surface for a minimum of 10 minutes of contact time.
3. Dispose of all absorbent material and wipes according to local, state, and national
regulations.
Related information...
Unscheduled cleaning, page 772
Requirements for decontamination, page 731
Clean and decontaminate the monitor
Required materials • Soft lint-free tissues
• 0.5% sodium hypochlorite solution
• Quaternary ammonium detergent
Perform this procedure to clean and decontaminate the monitor.
NOTE: Before the procedure is performed, the monitor must be powered off. Thoroughly read
the procedure and print a copy of it to use as a reference.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
1. Power off the monitor. Do not wipe the screen while the monitor is turned on.
2. Wipe the screen with a quaternary ammonium detergent.
3. Mist or wipe the screen with 0.5% sodium hypochlorite solution. Let the disinfectant remain
on the screen for a minimum of 10 minutes of contact time.
4. When the screen is dry, power on the monitor.
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5. Dispose of all absorbent material and wipes according to local, state, and national
regulations.
Related information...
Unscheduled cleaning, page 772
Requirements for decontamination, page 731
Print a topic from the operations manual, page 43
Diagnostic procedure descriptions
Diagnostic procedures are grouped first by module type and then by category. The type of
module determines the categories and procedures that are available. Each category is
represented by a tab on the right side of the Diagnostics tab of the Procedures screen.
The All tab displays all procedures for the selected module. Each additional tab represents a
functional subsection of the system.
Related information...
Maintenance and diagnostics, page 740
Processing module diagnostic procedures (c-series), page 775
Processing module diagnostic procedures (i-series), page 793
Reagent and sample manager (RSM) diagnostic procedures, page 823
Perform a maintenance procedure or a diagnostic procedure, page 750
Processing module diagnostic procedures (c-series)
Diagnostic procedures for the c-series processing module are grouped by functional categories
on the Diagnostics tab of the Procedures screen.
Related information...
Diagnostic procedure descriptions, page 775
Optics diagnostic procedures (c-series), page 776
Pipettor diagnostic procedures (c-series), page 778
Fluidics-wash diagnostic procedures (c-series), page 781
Temperature diagnostic procedures (c-series) , page 784
Sample manager diagnostic procedures (c-series), page 785
Reagent manager diagnostic procedures (c-series), page 785
Module diagnostic procedures (c-series), page 786
Reaction mechanism diagnostic procedures (c-series) , page 789
ICT diagnostic procedures (c-series), page 791
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Optics diagnostic procedures (c-series)
The operator may need to perform optics diagnostic procedures when optics components are
replaced or when message codes and observed problems associated with the optics are
diagnosed.
Related information...
Processing module diagnostic procedures (c-series), page 775
4001 Optics Trigger Sensor Check (c-series), page 776
4002 Absorbance Reads (c-series), page 776
4003 Optics Total Test and ICT Data (c-series) (CSC Logon), page 777
4004 Beam Height Alignment (c-series) (FSE Logon), page 777
4001 Optics Trigger Sensor Check (c-series)
Perform this Optics diagnostic procedure to test the functionality of the optics trigger sensor.
Estimated time 4 minutes
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Required On
Related information...
Optics diagnostic procedures (c-series), page 776
Use a procedure key to perform a procedure, page 747
4002 Absorbance Reads (c-series)
Perform this Optics diagnostic procedure to measure absorbance readings and to generate a
printed report for manually pipetted samples.
Estimated time 11 minutes for each cuvette segment that is used
Required materials • Sample
• Calibrated pipettor with disposable tips that can dispense
160 µL to 250 µL
Required instrument Idle
status
Procedure key setting Processing module: Required On
Related information...
Optics diagnostic procedures (c-series), page 776
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Use a procedure key to perform a procedure, page 747
4003 Optics Total Test and ICT Data (c-series) (CSC Logon)
Perform this Optics diagnostic procedure to test the variability in the optical readings and to
provide data for the optical and ICT channels.
If the logon for CSC is used, the operator can perform the following procedures:
• Quick Test
• Dark Current
• Blocked and Unblocked Reads
• Auto Gain
• AD Read
• AD Range
If the logon for FSE is used, the operator can perform all tests that are available for the CSC
logon and the following procedures:
• Drift Test
• Combined Blocked and Unblocked Reads and Drift Test
Estimated time 5 minutes to 30 minutes based on the selected tests
Required materials • Total Protein reagent (only for the Quick Test), LN
07P5220
• Calibrated manual pipettor that can dispense from 160 µL
through 250 µL
• Disposable pipettor tips
• Phillips screwdriver
Required instrument Warming or Idle
status
Procedure key setting Processing module: Required On
Related information...
Optics diagnostic procedures (c-series), page 776
Use a procedure key to perform a procedure, page 747
4004 Beam Height Alignment (c-series) (FSE Logon)
Perform this Optics diagnostic procedure to generate optical readings that are used to align the
light beam height in the cuvette.
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Estimated time 5 minutes to 15 minutes (This procedure requires 5 minutes if
an adjustment is not necessary.)
Required materials • Beam height alignment tool
• 3 mm hex wrench
• 2.5 mm hex wrench
• #1 Phillips screwdriver
• Slotted screwdriver
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Required On
Related information...
Optics diagnostic procedures (c-series), page 776
Use a procedure key to perform a procedure, page 747
Pipettor diagnostic procedures (c-series)
The operator may need to perform pipettor diagnostic procedures when pipettor components are
replaced or when message codes and observed problems associated with the pipettor are
diagnosed.
Related information...
Processing module diagnostic procedures (c-series), page 775
4101 Crash Sensor Alignment (c-series) (FSE Logon), page 778
4102 Sample Pipettor Calibration (c-series), page 779
4103 R1 Pipettor Calibration (c-series), page 779
4104 R2 Pipettor Calibration (c-series), page 779
4105 Sample Probe and Rack Alignment Test (c-series) (CSC Logon), page 780
4106 Component Move (c-series), page 780
4101 Crash Sensor Alignment (c-series) (FSE Logon)
Perform this Pipettors diagnostic procedure to align the crash sensor for the sample pipettor, the
R1 pipettor, or the R2 pipettor.
Estimated time 5 minutes for each pipettor
Required materials #1 Phillips screwdriver
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Required On
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Related information...
Pipettor diagnostic procedures (c-series), page 778
Use a procedure key to perform a procedure, page 747
4102 Sample Pipettor Calibration (c-series)
Perform this Pipettors diagnostic procedure to calibrate the sample pipettor.
Estimated time 7 minutes
Required materials • Cuvette Segment Alignment Tool, LN 04S7001
• Tap water
• Lint-free tissue
• Slotted screwdriver
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Required On
Related information...
Pipettor diagnostic procedures (c-series), page 778
Use a procedure key to perform a procedure, page 747
4103 R1 Pipettor Calibration (c-series)
Perform this Pipettors diagnostic procedure to calibrate the R1 pipettor.
Estimated time 5 minutes
Required materials • Cuvette Segment Alignment Tool, LN 04S7001
• Tap water
• Lint-free tissue
• Slotted screwdriver
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Required On
Related information...
Pipettor diagnostic procedures (c-series), page 778
Use a procedure key to perform a procedure, page 747
4104 R2 Pipettor Calibration (c-series)
Perform this Pipettors diagnostic procedure to calibrate the R2 pipettor.
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Estimated time 5 minutes
Required materials • Cuvette Segment Alignment Tool, LN 04S7001
• Tap water
• Lint-free tissue
• Slotted screwdriver
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Required On
Related information...
Pipettor diagnostic procedures (c-series), page 778
Use a procedure key to perform a procedure, page 747
4105 Sample Probe and Rack Alignment Test (c-series) (CSC Logon)
Perform this Pipettors diagnostic procedure to visualize the sample probe position at the sample
aspiration location.
Estimated time 3 minutes
Required materials • Sample rack
• Six sample tubes
• Saline
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Required On
Related information...
Pipettor diagnostic procedures (c-series), page 778
Use a procedure key to perform a procedure, page 747
4106 Component Move (c-series)
Perform this Pipettors diagnostic procedure to move the sample, R1, and R2 pipettors and the
mixers for component replacement and troubleshooting.
Estimated time 1 minute
Required materials None
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Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Required On
Related information...
Pipettor diagnostic procedures (c-series), page 778
Use a procedure key to perform a procedure, page 747
Fluidics-wash diagnostic procedures (c-series)
The operator may need to perform fluidics-wash diagnostic procedures when components from
the following systems are replaced or when message codes and observed problems associated
with the following systems are diagnosed:
• Bulk solutions
• Cuvette washer
• Pumps and valves
• Wash cups
Related information...
Processing module diagnostic procedures (c-series), page 775
4202 Wash Cup Test (c-series) (FSE Logon), page 781
4205 Flush Water Lines (c-series), page 782
4206 Flush Bulk Solutions (c-series), page 782
4207 Move Cuvette Washer (c-series), page 783
4208 Probe and Mixer Wash (c-series), page 783
4209 Internal Probe Wash Pump Test (c-series) (FSE Logon), page 783
4202 Wash Cup Test (c-series) (FSE Logon)
Perform this Fluidics-Wash diagnostic procedure to measure the water flow from the following
wash cups:
• Sample wash cup
• Whole blood wash cup
• Reagent wash cup
• Mixer wash cup
NOTE: Adjustment of the wash cup flow volume can only be performed on the sample wash cup.
Estimated time 40 minutes
Required materials • 50 mL graduated cylinder
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• #1 Phillips screwdriver
• Slotted screwdriver
• 100 mL beaker
• Absorbent towels
• Adhesive tape
Required instrument Idle
status
Procedure key setting Processing module: Required On
Related information...
Fluidics-wash diagnostic procedures (c-series), page 781
Use a procedure key to perform a procedure, page 747
4205 Flush Water Lines (c-series)
Perform this Fluidics-Wash diagnostic procedure to flush the sample, reagent, and cuvette
washer water lines.
Estimated time 2 minutes
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Optional On
Related information...
Fluidics-wash diagnostic procedures (c-series), page 781
Use a procedure key to perform a procedure, page 747
4206 Flush Bulk Solutions (c-series)
Perform this Fluidics-Wash diagnostic procedure to flush the following bulk solutions:
• Acid Wash
• Alkaline Wash
• ICT Reference Solution
Estimated time 3 minutes
Required materials None
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Required instrument Warming or Idle
status
Procedure key setting Processing module: Optional On
Related information...
Fluidics-wash diagnostic procedures (c-series), page 781
Use a procedure key to perform a procedure, page 747
4207 Move Cuvette Washer (c-series)
Perform this Fluidics-Wash diagnostic procedure to vertically move the cuvette washer.
Estimated time 2 minutes
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Required On
Related information...
Fluidics-wash diagnostic procedures (c-series), page 781
Use a procedure key to perform a procedure, page 747
4208 Probe and Mixer Wash (c-series)
Perform this Fluidics-Wash diagnostic procedure to wash mixers, sample probes, and reagent
probes with water, Acid Probe Wash solution, Detergent A solution, or Detergent B solution.
Estimated time 3 minutes
Required materials None
Required instrument Warming or Idle
status
Procedure key setting Processing module: Required On
Related information...
Fluidics-wash diagnostic procedures (c-series), page 781
Use a procedure key to perform a procedure, page 747
4209 Internal Probe Wash Pump Test (c-series) (FSE Logon)
Perform this Fluidics-Wash diagnostic procedure to test the functionality and adjust the water
flow of the internal probe wash pump.
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Estimated time • 8 minutes without adjustment
• 1 hour with adjustment
Required materials • 4 mm hex wrench
• Adjustable (or Crescent) wrench
• Phillips screwdriver
• 10 mL graduated cylinder
• Absorbent towels
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Required On
Related information...
Fluidics-wash diagnostic procedures (c-series), page 781
Use a procedure key to perform a procedure, page 747
Temperature diagnostic procedures (c-series)
The operator may need to perform temperature diagnostic procedures when temperature
components are replaced or when message codes and observed problems associated with c-
series module temperatures are diagnosed.
Related information...
Processing module diagnostic procedures (c-series), page 775
4301 Temperature Status (c-series), page 784
4301 Temperature Status (c-series)
Perform this Temperature diagnostic procedure to display the temperature and status of the
following module components:
• Processing module interior
• Reagent carousel
• Water bath
Estimated time 1 minute
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Off
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Related information...
Temperature diagnostic procedures (c-series) , page 784
Use a procedure key to perform a procedure, page 747
Sample manager diagnostic procedures (c-series)
The operator may need to perform sample manager diagnostic procedures when reagent and
sample manager (RSM) components are replaced or when message codes and observed
problems associated with the RSM are diagnosed. These procedures are located on the
Procedures screen of the c-series processing module.
Related information...
Processing module diagnostic procedures (c-series), page 775
1631 Sample Positioner Test (c-series), page 785
1631 Sample Positioner Test (c-series)
Perform this Sample Manager diagnostic procedure to test the functionality of the sample
positioner motors.
Estimated time 2 minutes
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting • System control module: Optional On
• Processing module: Optional On
Related information...
Sample manager diagnostic procedures (c-series), page 785
Use a procedure key to perform a procedure, page 747
Reagent manager diagnostic procedures (c-series)
The operator may need to perform reagent manager diagnostic procedures when reagent supply
center components are replaced or when message codes and observed problems associated
with the reagent supply center are diagnosed.
Related information...
Processing module diagnostic procedures (c-series), page 775
4701 Reagent Carousel Home (c-series), page 786
4703 Reagent Supply Center Test (c-series), page 786
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4701 Reagent Carousel Home (c-series)
Perform this Reagent Manager diagnostic procedure to rotate the reagent carousel to the home
position.
Estimated time 1 minute
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Optional On
Related information...
Reagent manager diagnostic procedures (c-series), page 785
Use a procedure key to perform a procedure, page 747
4703 Reagent Supply Center Test (c-series)
Perform this Reagent Manager diagnostic procedure to test the functionality of the following
items:
• Reagent positioner
• Reagent transport
• Reagent carousel
Estimated time 6 minutes for the full-function test
Required materials Two c-series Reagent Cartridges, Black (Large), LN 04S1720;
or two reagent cartridges
Required instrument Stopped, Warming, or Idle
status
Procedure key setting • System control module: Required On
• Processing module: Required On
Related information...
Reagent manager diagnostic procedures (c-series), page 785
Use a procedure key to perform a procedure, page 747
Module diagnostic procedures (c-series)
The operator may need to perform module diagnostic procedures when message codes and
observed problems associated with the c-series module are diagnosed.
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Related information...
Processing module diagnostic procedures (c-series), page 775
4801 Module Initialization (c-series), page 787
4802 Robotics Test Tool (c-series) (FSE Logon), page 787
4803 Voltage Test (c-series), page 788
4804 Save or Restore DAQ Data (c-series) (FSE Logon), page 788
4801 Module Initialization (c-series)
Perform this Modules diagnostic procedure to initialize the selected processing module.
Estimated time 1 minute
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Optional On
Related information...
Module diagnostic procedures (c-series), page 786
Use a procedure key to perform a procedure, page 747
4802 Robotics Test Tool (c-series) (FSE Logon)
Perform this Modules diagnostic procedure to run commands for the following components:
• Cuvette washer
• ICT unit
• Mixer 1 and mixer 2
• Reagent 1, reagent 2, and sample pipettors
• Reaction carousel
• Reagent carousel
• Water bath
Estimated time Variable
Required materials • Cuvette washer alignment tool
• ICT Reference Solution cup alignment tool
• ICT cuvette alignment tool
• Mixer alignment tool
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• Phillips screwdriver
• Sample racks*
• Saline*
• Sample cup or tube*
* These items are required only if the sample positioners are
tested.
Required instrument Stopped, Warming, or Idle
status
Procedure key setting • System control module: Required On
• Processing module: Required On
Related information...
Module diagnostic procedures (c-series), page 786
Use a procedure key to perform a procedure, page 747
4803 Voltage Test (c-series)
Perform this Modules diagnostic procedure to test voltages of the following power supplies:
• +5 V
• +11.5 V
• +12 V
• +15 V
• -15 V
• +24 V
Estimated time 1 minute
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Off
Related information...
Module diagnostic procedures (c-series), page 786
Use a procedure key to perform a procedure, page 747
4804 Save or Restore DAQ Data (c-series) (FSE Logon)
Perform this Modules diagnostic procedure to complete the following tasks:
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• Save the robotics alignment data from the data acquisition (DAQ) board to the central
processing unit (CPU) board.
• Load the robotics data from the CPU board to the DAQ board.
• Clear the DAQ board memory.
• View the step table data for each robotic position. Enter the data from the Toshiba step
table attachment that is provided with each instrument.
Estimated time Variable
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Off
Related information...
Module diagnostic procedures (c-series), page 786
Use a procedure key to perform a procedure, page 747
Reaction mechanism diagnostic procedures (c-series)
The operator may need to perform reaction mechanism diagnostic procedures when reaction
mechanism components are replaced or when message codes and observed problems
associated with reaction mechanism components are diagnosed.
Related information...
Processing module diagnostic procedures (c-series), page 775
5001 Mixer Alignment (c-series) (FSE Logon), page 789
5002 Mixer Vibration Test (c-series), page 790
5003 Clean Cuvettes - Manually (c-series), page 790
5004 Reaction Carousel Home and Move (c-series), page 791
5005 Exchange Water in Bath (c-series), page 791
5001 Mixer Alignment (c-series) (FSE Logon)
Perform this Reaction Mechanisms diagnostic procedure to align the mixers over wash cups and
cuvettes.
Estimated time 30 minutes
Required materials Mixer alignment tool
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Required On
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Related information...
Reaction mechanism diagnostic procedures (c-series) , page 789
Use a procedure key to perform a procedure, page 747
5002 Mixer Vibration Test (c-series)
Perform this Reaction Mechanisms diagnostic procedure to test the vibration of mixer 1 and
mixer 2 at low and high frequencies.
Estimated time 2 minutes
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Required On
Related information...
Reaction mechanism diagnostic procedures (c-series) , page 789
Use a procedure key to perform a procedure, page 747
5003 Clean Cuvettes - Manually (c-series)
Perform this Reaction Mechanisms diagnostic procedure to clean the cuvettes manually.
Estimated time • 10 minutes for one segment
• 35 minutes for all segments
Required materials • Slotted screwdriver
• Detergent A, LN 08P9670
• Cotton swabs
• Purified water
• Clean, residue-free container in which to submerge the
segments
• Lint-free tissue
• Gloves
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Required On
Related information...
Reaction mechanism diagnostic procedures (c-series) , page 789
Use a procedure key to perform a procedure, page 747
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5004 Reaction Carousel Home and Move (c-series)
Perform this Reaction Mechanisms diagnostic procedure to rotate the reaction carousel
counterclockwise by one cuvette or one cuvette segment.
Estimated time 1 minute
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Optional On
Related information...
Reaction mechanism diagnostic procedures (c-series) , page 789
Use a procedure key to perform a procedure, page 747
5005 Exchange Water in Bath (c-series)
Perform this Reaction Mechanisms diagnostic procedure to drain and fill the water bath and to
add Water Bath Additive.
Estimated time 11 minutes
Required materials c-series Maintenance Solutions, LN 08P9870, LN 08P9871
(USA)
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Optional On
Related information...
Reaction mechanism diagnostic procedures (c-series) , page 789
Use a procedure key to perform a procedure, page 747
ICT diagnostic procedures (c-series)
The operator may need to perform ICT diagnostic procedures when ICT components are
replaced or when message codes and observed problems associated with the ICT unit are
diagnosed.
Related information...
Processing module diagnostic procedures (c-series), page 775
5101 Flush ICT Reference Solution Cup (c-series), page 792
5102 Flush ICT Module (c-series), page 792
5103 ICT Alignment (c-series) (FSE Logon), page 792
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5101 Flush ICT Reference Solution Cup (c-series)
Perform this ICT diagnostic procedure to flush the ICT Reference Solution cup.
Estimated time 2 minutes
Required materials None
Required instrument Warming or Idle
status
Procedure key setting Processing module: Optional On
Related information...
ICT diagnostic procedures (c-series), page 791
Use a procedure key to perform a procedure, page 747
5102 Flush ICT Module (c-series)
Perform this ICT diagnostic procedure to flush the ICT module with ICT Reference Solution.
Estimated time 3 minutes
Required materials None
Required instrument Warming or Idle
status
Procedure key setting Processing module: Required On
Related information...
ICT diagnostic procedures (c-series), page 791
Use a procedure key to perform a procedure, page 747
5103 ICT Alignment (c-series) (FSE Logon)
Perform this ICT diagnostic procedure to align the ICT probe.
Estimated time 8 minutes
Required materials • ICT reference cup alignment tool
• ICT cuvette alignment tool
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Required On
Related information...
ICT diagnostic procedures (c-series), page 791
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Use a procedure key to perform a procedure, page 747
Processing module diagnostic procedures (i-series)
Diagnostic procedures for the i-series processing module are grouped by functional categories
on the Diagnostics tab of the Procedures screen.
Related information...
Diagnostic procedure descriptions, page 775
Optics diagnostic procedures (i-series), page 793
Pipettor diagnostic procedures (i-series), page 795
Fluidics-wash diagnostic procedures (i-series), page 804
Temperature diagnostic procedures (i-series), page 816
RV loader diagnostic procedures (i-series), page 816
Process path diagnostic procedures (i-series), page 817
Sample manager diagnostic procedures (i-series), page 819
Reagent manager diagnostic procedures (i-series), page 820
Module diagnostic procedures (i-series), page 821
Utilities diagnostic procedures (i-series) (CSC Logon), page 822
Optics diagnostic procedures (i-series)
The operator may need to perform optics diagnostic procedures when optics components are
replaced or when message codes and observed problems associated with the optics are
diagnosed.
Related information...
Processing module diagnostic procedures (i-series), page 793
1000 Optics Background (i-series), page 793
1005 Shutter Test (i-series), page 794
1045 Optics Verification (i-series) (FSE Logon), page 794
1000 Optics Background (i-series)
Perform this Optics diagnostic procedure to determine optics background readings. This
procedure generates the following readings:
• Background with no reaction vessel (RV)
• Background with an empty RV
• Background with Pre-Trigger Solution in the RV
For the procedure to pass, raw counts must be between 3 relative light units (RLUs) and
500 RLUs. In addition, specifications of the software background quality checks must not
generate an error.
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Estimated time 8 minutes
Required materials None
Required instrument Warming or Idle
status
Procedure key setting Processing module: Optional On
Related information...
Optics diagnostic procedures (i-series), page 793
Use a procedure key to perform a procedure, page 747
1005 Shutter Test (i-series)
Perform this Optics diagnostic procedure to test the functionality of the shutter.
Estimated time 1 minute
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Off
Related information...
Optics diagnostic procedures (i-series), page 793
Use a procedure key to perform a procedure, page 747
1045 Optics Verification (i-series) (FSE Logon)
Perform this Optics diagnostic procedure to confirm that the optics is functioning correctly.
To confirm normalization and linearity factors, the system performs five readings from the three
levels of optics verification solution and compares the readings to each standard solution value.
The three readings used are 376 amol, 1504 amol, and 94,000 amol. The system also confirms
background levels.
NOTE: For the thawing instructions, see the Optics Verifier Solution documentation.
Estimated time 18 minutes
Required materials Optics Verifier Solution, LN 01R3560 (thawed)
Required instrument Warming or Idle
status
Procedure key setting • System control module: Optional On
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• Processing module: Optional On
Related information...
Optics diagnostic procedures (i-series), page 793
Use a procedure key to perform a procedure, page 747
Pipettor diagnostic procedures (i-series)
The operator may need to perform pipettor diagnostic procedures when pipettor components are
replaced or when message codes and observed problems associated with the pipettor are
diagnosed.
Related information...
Processing module diagnostic procedures (i-series), page 793
1100 Pipettor Motors Test (i-series), page 795
1105 Pipettor Syringe and Pump Test (i-series), page 796
1111 Sample Pipettor Check and Calibration (i-series), page 796
1112 R1 Pipettor Check and Calibration (i-series), page 797
1113 R2 Pipettor Check and Calibration (i-series), page 797
1120 Sample Pipettor Syringe Precision and Accuracy (i-series), page 798
1121 R1 Pipettor Syringe Precision and Accuracy (i-series), page 799
1122 R2 Pipettor Syringe Precision and Accuracy (i-series), page 800
1130 Sample Pipettor Pump Precision and Accuracy (i-series), page 800
1131 R1 Pipettor Pump Precision and Accuracy (i-series), page 801
1132 R2 Pipettor Pump Precision and Accuracy (i-series), page 802
1160 Liquid Level Sense Test, page 803
1100 Pipettor Motors Test (i-series)
Perform this Pipettors diagnostic procedure to test the functionality of theta and Z motors of
sample, R1, and R2 pipettors.
Estimated time • 2 minutes for each pipettor
• 3 minutes for all pipettors
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Optional On
Related information...
Pipettor diagnostic procedures (i-series), page 795
Use a procedure key to perform a procedure, page 747
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1105 Pipettor Syringe and Pump Test (i-series)
Perform this Pipettors diagnostic procedure to test the functionality of the following components
of sample, R1, and R2 pipettors:
• Syringe motors
• Syringe valves
• 100 µL buffer pumps
Estimated time 1 minute
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Optional On
Related information...
Pipettor diagnostic procedures (i-series), page 795
Use a procedure key to perform a procedure, page 747
1111 Sample Pipettor Check and Calibration (i-series)
Perform this Pipettors diagnostic procedure to complete the following tasks:
• Set the position of the sample probes that are necessary to aspirate and dispense
specimens during assay processing.
• Determine the probe straightness.
If the logon for FSE is used, a prealignment option is available. Perform this option to set the
sample probe position to the wash cup. The probe is approximately aligned to allow an initial
system flush.
Estimated time • 6 minutes for pipettor calibration
• 4 minutes for probe straightness
• 4 minutes for wash cup prealignment
Required materials • Water (purified or tap)
• Lint-free tissue
Required instrument Stopped, Warming, or Idle
status
Procedure key setting • System control module: Required On
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• Processing module: Required On
Related information...
Pipettor diagnostic procedures (i-series), page 795
Use a procedure key to perform a procedure, page 747
1112 R1 Pipettor Check and Calibration (i-series)
Perform this Pipettors diagnostic procedure to complete the following tasks:
• Set the position of the R1 probe that is necessary to aspirate and dispense reagents during
assay processing.
• Determine the probe straightness.
If the logon for FSE is used, a prealignment option is available. Perform this option to set the R1
probe position to the wash cup. The probe is approximately aligned to allow an initial system
flush.
Estimated time • 6 minutes for pipettor calibration
• 4 minutes for probe straightness
• 4 minutes for wash cup prealignment
Required materials • Water (purified or tap)
• Lint-free tissue
• Cotton swab
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Required On
Related information...
Pipettor diagnostic procedures (i-series), page 795
Use a procedure key to perform a procedure, page 747
1113 R2 Pipettor Check and Calibration (i-series)
Perform this Pipettors diagnostic procedure to complete the following tasks:
• Set the position of the R2 probe that is necessary to aspirate and dispense reagents during
assay processing.
• Determine the probe straightness.
If the logon for FSE is used, a prealignment option is available. Perform this option to set the R2
probe position to the wash cup. The probe is approximately aligned to allow an initial system
flush.
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Estimated time • 6 minutes for pipettor calibration
• 4 minutes for probe straightness
• 4 minutes for wash cup prealignment
Required materials • Water (purified or tap)
• Lint-free tissue
• Cotton swab
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Optional On
Related information...
Pipettor diagnostic procedures (i-series), page 795
Use a procedure key to perform a procedure, page 747
1120 Sample Pipettor Syringe Precision and Accuracy (i-series)
Perform this Pipettors diagnostic procedure to confirm visually the precision and accuracy of the
sample pipettor syringe aspiration and dispense.
The sample pipettor aspirates and dispenses 50 µL of tap water or saline into five reaction
vessels (RVs) five times each. The operator accurately dispenses 250 µL of tap water or saline
into a reference RV. Compare each RV that was pipetted by the system to the reference RV to
determine if the correct volume was dispensed.
If the logon for CSC or FSE is used, a gravimetric option is available. Perform this option to
measure gravimetrically the precision and accuracy of the aspiration and dispense. For this
option, 50 µL of tap water or saline is aspirated and dispensed into 15 preweighed RVs.
After the weight of the RV is subtracted, each result must be from 46.0 µL (46.0 mg) through
51.0 µL (51.0 mg) and the percent coefficient of variation (%CV) must be less than or equal to
1.0%.
Estimated time 8 minutes
11 minutes for a gravimetric measurement (This time does not
include the time needed to weigh the RVs or to perform a
flush.)
Required materials • Sample cup
• Sample rack
• Tap water or saline
• Calibrated manual pipettor that can pipette 250 µL
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• Analytical balance (gravimetric option only)
Required instrument Warming or Idle
status
Procedure key setting Processing module: Required On
Related information...
Pipettor diagnostic procedures (i-series), page 795
Use a procedure key to perform a procedure, page 747
1121 R1 Pipettor Syringe Precision and Accuracy (i-series)
Perform this Pipettors diagnostic procedure to confirm visually the precision and accuracy of the
R1 pipettor syringe aspiration and dispense.
The R1 pipettor aspirates and dispenses 50 µL of tap water or saline into five reaction vessels
(RVs) five times each. The operator accurately dispenses 250 µL of tap water or saline into a
reference RV. Compare each RV that was pipetted by the system to the reference RV to
determine if the correct volume was dispensed.
If the logon for CSC or FSE is used, a gravimetric option is available. Perform this option to
measure gravimetrically the precision and accuracy of the aspiration and dispense. For this
option, 50 µL of tap water or saline is aspirated and dispensed into 15 preweighed RVs.
After the weight of the RV is subtracted, each result must be from 46.0 µL (46.0 mg) through
51.0 µL (51.0 mg) and the percent coefficient of variation (%CV) must be less than or equal to
1.0%.
Estimated time 10 minutes
12 minutes for a gravimetric measurement (This time does not
include the time needed to weigh the RVs or to perform a
flush.)
Required materials • Diagnostics Kit, LN 01R5940
• Tap water or saline
• Calibrated manual pipettor that can pipette 250 µL
• Analytical balance (gravimetric option only)
Required instrument Warming or Idle
status
Procedure key setting Processing module: Required On
Related information...
Pipettor diagnostic procedures (i-series), page 795
Use a procedure key to perform a procedure, page 747
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1122 R2 Pipettor Syringe Precision and Accuracy (i-series)
Perform this Pipettors diagnostic procedure to confirm visually the precision and accuracy of the
R2 pipettor syringe aspiration and dispense.
The R2 pipettor aspirates and dispenses 50 µL of tap water or saline into five reaction vessels
(RVs) five times each. The operator accurately dispenses 250 µL of tap water or saline into a
reference RV. Compare each RV that was pipetted by the system to the reference RV to
determine if the correct volume was dispensed.
If the logon for CSC or FSE is used, a gravimetric option is available. Perform this option to
measure gravimetrically the precision and accuracy of the aspiration and dispense. For this
option, 50 µL of tap water or saline is aspirated and dispensed into 15 preweighed RVs.
After the weight of the RV is subtracted, each result must be from 46.0 µL (46.0 mg) through
51.0 µL (51.0 mg) and the percent coefficient of variation (%CV) must be less than or equal to
1.0%.
Estimated time 10 minutes
12 minutes for a gravimetric measurement (This time does not
include the time needed to weigh the RVs or to perform a
flush.)
Required materials • Diagnostics Kit, LN 01R5940
• Tap water or saline
• Calibrated manual pipettor that can pipette 250 µL
• Analytical balance (gravimetric option only)
Required instrument Warming or Idle
status
Procedure key setting Processing module: Required On
Related information...
Pipettor diagnostic procedures (i-series), page 795
Use a procedure key to perform a procedure, page 747
1130 Sample Pipettor Pump Precision and Accuracy (i-series)
Perform this Pipettors diagnostic procedure to confirm visually the precision and accuracy of the
sample pipettor pump dispense.
The sample pipettor dispenses 1000 µL of wash buffer (bypassing the syringe) into each of five
reaction vessels (RVs). The operator accurately dispenses 1000 µL of water (tap or purified) into
a reference RV. Compare each RV that was pipetted by the system to the reference RV to
determine if the correct volume was dispensed.
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If the logon for CSC or FSE is used, a gravimetric option is available. Perform this option to
measure gravimetrically the precision and accuracy of the dispense. For this option, 1000 µL of
wash buffer is dispensed into 15 preweighed RVs.
After the weight of the RV is subtracted, each result must be from 950 µL (950 mg) through
1050 µL (1050 mg).
Estimated time 5 minutes
13 minutes for a gravimetric measurement (This time does not
include the time needed to weigh the RVs or to perform a
flush.)
Required materials • Water (tap or purified)
• Calibrated manual pipettor that can pipette 900 µL
• Analytical balance (gravimetric option only)
Required instrument Warming or Idle
status
Procedure key setting Processing module: Required On
Related information...
Pipettor diagnostic procedures (i-series), page 795
Use a procedure key to perform a procedure, page 747
1131 R1 Pipettor Pump Precision and Accuracy (i-series)
Perform this Pipettors diagnostic procedure to confirm visually the precision and accuracy of the
R1 pipettor pump dispense.
The R1 pipettor dispenses 1000 µL of wash buffer (bypassing the syringe) into each of five
reaction vessels (RVs). The operator accurately dispenses 1000 µL of water (tap or purified) into
a reference RV. Compare each RV that was pipetted by the system to the reference RV to
determine if the correct volume was dispensed.
If the logon for CSC or FSE is used, a gravimetric option is available. Perform this option to
measure gravimetrically the precision and accuracy of the dispense. For this option, 1000 µL of
wash buffer is dispensed into 15 preweighed RVs.
After the weight of the RV is subtracted, each result must be from 950 µL (950 mg) through
1050 µL (1050 mg).
Estimated time 5 minutes
13 minutes for a gravimetric measurement (This time does not
include the time needed to weigh the RVs or to perform a
flush.)
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Required materials • Water (tap or purified)
• Calibrated manual pipettor that can pipette 900 µL
• Analytical balance (gravimetric option only)
Required instrument Warming or Idle
status
Procedure key setting Processing module: Required On
Related information...
Pipettor diagnostic procedures (i-series), page 795
Use a procedure key to perform a procedure, page 747
1132 R2 Pipettor Pump Precision and Accuracy (i-series)
Perform this Pipettors diagnostic procedure to confirm visually the precision and accuracy of the
R2 pipettor pump dispense.
The R2 pipettor dispenses 1000 µL of wash buffer (bypassing the syringe) into each of five
reaction vessels (RVs). The operator accurately dispenses 1000 µL of water (tap or purified) into
a reference RV. Compare each RV that was pipetted by the system to the reference RV to
determine if the correct volume was dispensed.
If the logon for CSC or FSE is used, a gravimetric option is available. Perform this option to
measure gravimetrically the precision and accuracy of the dispense. For this option, 1000 µL of
wash buffer is dispensed into 15 preweighed RVs.
After the weight of the RV is subtracted, each result must be from 950 µL (950 mg) through
1050 µL (1050 mg).
Estimated time 5 minutes
13 minutes for a gravimetric measurement (This time does not
include the time needed to weigh the RVs or to perform a
flush.)
Required materials • Water (tap or purified)
• Calibrated manual pipettor that can pipette 900 µL
• Analytical balance (gravimetric option only)
Required instrument Warming or Idle
status
Procedure key setting Processing module: Required On
Related information...
Pipettor diagnostic procedures (i-series), page 795
Use a procedure key to perform a procedure, page 747
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Section 9 Maintenance and diagnostics
1160 Liquid Level Sense Test
Perform this Pipettors diagnostic procedure to test the ability of a probe to detect liquid in
sample positioners, the process path, the pretreatment path, and the reagent carousel.
For each of the following positions, tests for noise and for the liquid level sense response
between air and fluid are performed:
• Sample positioner inner lane
• Sample positioner outer lane
• Sample pretreatment RV 48
• R1 inner reagent carousel
• R1 middle reagent carousel
• R1 outer reagent carousel
• R1 pretreatment RV 2
• R2 inner reagent carousel
• R2 middle reagent carousel
Estimated time • 1 minute for each position
• 7 minutes for all positions
Required materials Materials can vary based on the option that is selected:
• Diagnostics Kit, LN 01R5940
• Sample rack
• Sample cup
• Tap water or saline
Required instrument Warming or Idle
status
Procedure key setting • System control module: Optional On
• Processing module: Optional On
Related information...
Pipettor diagnostic procedures (i-series), page 795
Use a procedure key to perform a procedure, page 747
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Fluidics-wash diagnostic procedures (i-series)
The operator may need to perform fluidics-wash diagnostic procedures when components from
the following systems are replaced or when message codes and observed problems associated
with the following systems are diagnosed:
• Pre-Trigger
• Trigger
• Wash cup
• Wash zone
• Waste
Related information...
Processing module diagnostic procedures (i-series), page 793
1200 Flush and Prime Fluidics (i-series), page 804
1202 Wash Cup Valves Test (i-series), page 805
1203 Long-Term Shutdown (i-series) (CSC Logon), page 805
1204 Waste Valve and Pump Test (i-series) (FSE Logon), page 806
1206 Pre-Trigger and Trigger Valves and Pumps Test (i-series), page 806
1208 Wash Zone Valves, Pumps, and Motors Test (i-series), page 807
1210 Pre-Trigger Precision and Accuracy (i-series), page 807
1211 Trigger Precision and Accuracy (i-series), page 808
1221 Wash Zone 1 Precision and Accuracy (i-series), page 809
1222 Wash Zone 2 Precision and Accuracy (i-series), page 809
1231 Wash Zone 1 Residual Volume (i-series), page 810
1232 Wash Zone 2 Residual Volume (i-series), page 811
1241 Particle Capture Wash Zone 1 (i-series) (CSC Logon), page 812
1242 Particle Capture Wash Zone 2 (i-series) (CSC Logon), page 812
1250 Vacuum Diagnostics (i-series) (FSE Logon), page 813
1261 Wash Zone 1 Wash Monitoring (i-series), page 813
1262 Wash Zone 2 Wash Monitoring (i-series), page 814
1270 Bulk Solutions Motors and Sensors Test (i-series), page 815
1200 Flush and Prime Fluidics (i-series)
Perform this Fluidics-Wash diagnostic procedure to complete the following tasks:
• Flush one or all pipettors, wash zones, and Pre-Trigger and Trigger systems.
• Flush and prime one or all wash zones and Pre-Trigger and Trigger systems.
• Prime the wash buffer dilution assembly.
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Estimated time 1 minute to 10 minutes based on the selected option
Required materials None
Required instrument Warming or Idle
status
Procedure key setting Processing module: Optional On
Related information...
Fluidics-wash diagnostic procedures (i-series), page 804
Use a procedure key to perform a procedure, page 747
1202 Wash Cup Valves Test (i-series)
Perform this Fluidics-Wash diagnostic procedure to test the functionality of sample, R1, and R2
wash cup valves.
Estimated time • 1 minute for each valve
• 3 minutes for all valves
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Optional On
Related information...
Fluidics-wash diagnostic procedures (i-series), page 804
Use a procedure key to perform a procedure, page 747
1203 Long-Term Shutdown (i-series) (CSC Logon)
Perform this Fluidics-Wash diagnostic procedure to prepare the processing module to be shut
down for more than 7 days. This procedure completes the following tasks:
• Flushes all pumps and fluid lines with air and deionized water and with air again
• Removes all reaction vessels if requested
Estimated time 1 hour and 45 minutes
Required materials • 3 L purified water
• Absorbent towel
• Empty 1 L container
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Required instrument Warming or Idle
status
Procedure key setting Processing module: Required On
Related information...
Fluidics-wash diagnostic procedures (i-series), page 804
Use a procedure key to perform a procedure, page 747
1204 Waste Valve and Pump Test (i-series) (FSE Logon)
Perform this Fluidics-Wash diagnostic procedure to test the functionality of the following
components:
• Waste pump
• Vacuum pump
• Accumulator drain valve
• Fluid separator drain valve
Estimated time 1 minute to 2 minutes based on the selected option
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Off
Related information...
Fluidics-wash diagnostic procedures (i-series), page 804
Use a procedure key to perform a procedure, page 747
1206 Pre-Trigger and Trigger Valves and Pumps Test (i-series)
Perform this Fluidics-Wash diagnostic procedure to test the functionality of the following Pre-
Trigger and Trigger components:
• Dispense pumps
• Dispense pump direction valves
• Manifold valves
Estimated time 1 minute to 2 minutes based on the selected option
Required materials None
Required instrument Stopped, Warming, or Idle
status
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Procedure key setting Processing module: Off
Related information...
Fluidics-wash diagnostic procedures (i-series), page 804
Use a procedure key to perform a procedure, page 747
1208 Wash Zone Valves, Pumps, and Motors Test (i-series)
Perform this Fluidics-Wash diagnostic procedure to test the functionality of the following wash
zone components:
• Manifold valves
• Waste valves
• Dispense pump direction valves
• Motors
• Dispense pumps
Estimated time 1 minute to 2 minutes based on the selected option
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Required On
Related information...
Fluidics-wash diagnostic procedures (i-series), page 804
Use a procedure key to perform a procedure, page 747
1210 Pre-Trigger Precision and Accuracy (i-series)
Perform this Fluidics-Wash diagnostic procedure to confirm visually the precision and accuracy
of the Pre-Trigger dispense.
The system dispenses 100 µL of Pre-Trigger Solution into five reaction vessels (RVs) three times
each. The operator accurately dispenses 300 µL of water (tap or purified) into a reference RV.
Compare each RV that was pipetted by the system to the reference RV to determine if the
correct volume was dispensed.
If the logon for CSC or FSE is used, a gravimetric option is available. Perform this option to
measure gravimetrically the precision and accuracy of the dispense. For this option, 100 µL of
Pre-Trigger Solution is dispensed into 15 preweighed RVs.
After the weight of the RV is subtracted, each result must be from 95 µL (95 mg) through 105 µL
(105 mg) and the percent coefficient of variation (%CV) must be less than or equal to 1.0%.
Estimated time 5 minutes
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9 minutes for a gravimetric measurement (This time does not
include the time needed to weigh the RVs or to perform a
flush.)
Required materials • Water (tap or purified)
• Calibrated manual pipettor that can pipette 300 µL
• Analytical balance (gravimetric option only)
Required instrument Warming or Idle
status
Procedure key setting Processing module: Required On
Related information...
Fluidics-wash diagnostic procedures (i-series), page 804
Use a procedure key to perform a procedure, page 747
1211 Trigger Precision and Accuracy (i-series)
Perform this Fluidics-Wash diagnostic procedure to confirm visually the precision and accuracy
of the Trigger dispense.
The system dispenses 300 µL of Trigger Solution into five reaction vessels (RVs) three times
each. The operator accurately dispenses 900 µL of water (tap or purified) into a reference RV.
Compare each RV that was pipetted by the system to the reference RV to determine if the
correct volume was dispensed.
If the logon for CSC or FSE is used, a gravimetric option is available. Perform this option to
measure gravimetrically the precision and accuracy of the dispense. For this option, 300 µL of
Trigger Solution is dispensed into 15 preweighed RVs.
After the weight of the RV is subtracted, each result must be from 285 µL (285 mg) through
315 µL (315 mg) and the percent coefficient of variation (%CV) must be less than or equal to
1.0%.
Estimated time 5 minutes
10 minutes for a gravimetric measurement (This time does not
include the time needed to weigh the RVs or to perform a
flush.)
Required materials • Water (tap or purified)
• Calibrated manual pipettor that can pipette 900 µL
• Analytical balance (gravimetric option only)
Required instrument Warming or Idle
status
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Procedure key setting Processing module: Required On
Related information...
Fluidics-wash diagnostic procedures (i-series), page 804
Use a procedure key to perform a procedure, page 747
1221 Wash Zone 1 Precision and Accuracy (i-series)
Perform this Fluidics-Wash diagnostic procedure to confirm visually the precision and accuracy
of the wash zone 1 dispense.
The system dispenses 200 µL of wash buffer into 15 reaction vessels (RVs) four times each.
The operator accurately dispenses 800 µL of water (tap or purified) into a reference RV.
Compare each RV that was pipetted by the system to the reference RV to determine if the
correct volume was dispensed.
If the logon for CSC or FSE is used, a gravimetric option is available. Perform this option to
measure gravimetrically the precision and accuracy of the dispense. For this option, 400 µL of
wash buffer is dispensed into 15 preweighed RVs.
After the weight of the RV is subtracted, each result must be from 360 µL (360 mg) through
440 µL (440 mg) and the percent coefficient of variation (%CV) must be less than or equal to
2%.
Estimated time 8 minutes
10 minutes for a gravimetric measurement (This time does not
include the time needed to weigh the RVs or to perform a
flush.)
Required materials • Water (tap or purified)
• Calibrated manual pipettor than can pipette 800 µL
• Analytical balance (gravimetric option only)
Required instrument Warming or Idle
status
Procedure key setting Processing module: Required On
Related information...
Fluidics-wash diagnostic procedures (i-series), page 804
Use a procedure key to perform a procedure, page 747
1222 Wash Zone 2 Precision and Accuracy (i-series)
Perform this Fluidics-Wash diagnostic procedure to confirm visually the precision and accuracy
of the wash zone 2 dispense.
The system dispenses 200 µL of wash buffer into 15 reaction vessels (RVs) four times each.
The operator accurately dispenses 800 µL of water (tap or purified) into a reference RV.
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Compare each RV that was pipetted by the system to the reference RV to determine if the
correct volume was dispensed.
If the logon for CSC or FSE is used, a gravimetric option is available. Perform this option to
measure gravimetrically the precision and accuracy of the dispense. For this option, 400 µL of
wash buffer is dispensed into 15 preweighed RVs.
After the weight of the RV is subtracted, each result must be from 360 µL (360 mg) through
440 µL (440 mg) and the percent coefficient of variation (%CV) must be less than or equal to
2%.
Estimated time 8 minutes
10 minutes for a gravimetric measurement (This time does not
include the time needed to weigh the RVs or to perform a
flush.)
Required materials • Water (tap or purified)
• Calibrated manual pipettor that can pipette 800 µL
• Analytical balance (gravimetric option only)
Required instrument Warming or Idle
status
Procedure key setting Processing module: Required On
Related information...
Fluidics-wash diagnostic procedures (i-series), page 804
Use a procedure key to perform a procedure, page 747
1231 Wash Zone 1 Residual Volume (i-series)
Perform this Fluidics-Wash diagnostic procedure to confirm visually the residual liquid volume
that remains in a reaction vessel (RV) after a wash zone 1 dispense and aspiration.
Wash zone 1 dispenses wash buffer into 5 RVs and then aspirates the wash buffer. The operator
removes the RV from the process path and observes the amount of remaining fluid in the RV.
The final RV must have approximately two drops of fluid in the bottom of the RV and must not
have any evidence of splashing.
If the logon for CSC or FSE is used, a gravimetric option is available. Perform this option to
measure gravimetrically the residual liquid volume that remains in the RV after the dispense and
aspiration.
After the weight of the RV is subtracted, the average weight of the 15 RVs must be less than
9 µL (9 mg) and the standard deviation must be less than 2 µL (2 mg).
Estimated time 7 minutes
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15 minutes for a gravimetric measurement (This time does not
include the time needed to weigh the RVs.)
Required materials None
NOTE: An analytical balance is required for the gravimetric
option.
Required instrument Warming or Idle
status
Procedure key setting Processing module: Required On
Related information...
Fluidics-wash diagnostic procedures (i-series), page 804
Use a procedure key to perform a procedure, page 747
1232 Wash Zone 2 Residual Volume (i-series)
Perform this Fluidics-Wash diagnostic procedure to confirm visually the residual liquid volume
that remains in a reaction vessel (RV) after a wash zone 2 dispense and aspiration.
Wash zone 2 dispenses wash buffer into 5 RVs and then aspirates the wash buffer. The operator
removes the RV from the process path and observes the amount of remaining fluid in the RV.
The final RV must have approximately two drops of fluid in the bottom of the RV and must not
have any evidence of splashing.
If the logon for CSC or FSE is used, a gravimetric option is available. Perform this option to
measure gravimetrically the residual liquid volume that remains in the RV after the dispense and
aspiration.
After the weight of the RV is subtracted, the average weight of the 15 RVs must be less than
9 µL (9 mg) and the standard deviation must be less than 2 µL (2 mg).
Estimated time 7 minutes
15 minutes for a gravimetric measurement (This time does not
include the time needed to weigh the RVs.)
Required materials None
NOTE: An analytical balance is required for the gravimetric
option.
Required instrument Warming or Idle
status
Procedure key setting Processing module: Required On
Related information...
Fluidics-wash diagnostic procedures (i-series), page 804
Use a procedure key to perform a procedure, page 747
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1241 Particle Capture Wash Zone 1 (i-series) (CSC Logon)
Perform this Fluidics-Wash diagnostics procedure to confirm visually that microparticles are
captured on the walls of reaction vessels (RVs) after the RVs are washed at wash zone 1.
During this procedure, microparticles are dispensed into 15 RVs. The microparticles are washed
so that five RVs are aspirated with probe 1, five RVs are aspirated with probe 2, and five RVs
are aspirated with probe 3. The operator removes the RVs from the process path and visually
inspects them. Washed particles adhere to the inside walls of the RVs.
Estimated time 15 minutes
Required materials Reagent cartridge
NOTE: After a reagent cartridge is used for this procedure,
the cartridge cannot be used for assay processing.
Required instrument Warming or Idle
status
Procedure key setting • System control module: Required On
• Processing module: Required On
Related information...
Fluidics-wash diagnostic procedures (i-series), page 804
Use a procedure key to perform a procedure, page 747
1242 Particle Capture Wash Zone 2 (i-series) (CSC Logon)
Perform this Fluidics-Wash diagnostics procedure to confirm visually that microparticles are
captured on the walls of reaction vessels (RVs) after the RVs are washed at wash zone 2.
During this procedure, microparticles are dispensed into 15 RVs. The microparticles are washed
so that five RVs are aspirated with probe 1, five RVs are aspirated with probe 2, and five RVs
are aspirated with probe 3. The operator removes the RVs from the process path and visually
inspects them. Washed particles adhere to the inside walls of the RVs.
Estimated time 15 minutes
Required materials Reagent cartridge
NOTE: After a reagent cartridge is used for this procedure,
the cartridge cannot be used for assay processing.
Required instrument Warming or Idle
status
Procedure key setting • System control module: Required On
• Processing module: Required On
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Related information...
Fluidics-wash diagnostic procedures (i-series), page 804
Use a procedure key to perform a procedure, page 747
1250 Vacuum Diagnostics (i-series) (FSE Logon)
Perform this Fluidics-Wash diagnostic procedure to complete the following tasks:
• Perform a vacuum system leak check.
• Perform a vacuum pump integrity check.
• Perform a vacuum stress test.
• Perform a vacuum sensor read test.
• Open and close the vacuum valves.
• Drain the vacuum system.
• Perform a waste pump test.
Estimated time 1 minute to 10 minutes based on the selected option
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Required On
Related information...
Fluidics-wash diagnostic procedures (i-series), page 804
Use a procedure key to perform a procedure, page 747
1261 Wash Zone 1 Wash Monitoring (i-series)
Perform this Fluidics-Wash diagnostic procedure to complete the following tasks:
• Calibrate the wash zone 1 wash monitoring system.
• Confirm the functionality of wash zone 1 aspiration and dispense.
The Calibration and Test option is used to perform the following tasks:
• The R1 pipettor dispenses wash buffer at the following volumes into 15 reaction vessels
(RVs):
– 500 µL of wash buffer into five RVs for probe 1
– 1000 µL of wash buffer into five RVs for probe 2
– 1000 µL of wash buffer into five RVs for probe 3
• Wash zone 1 aspirated liquid from the RVs and the wash monitoring system is calibrated.
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• If the calibration passes, the wash monitoring test is performed to verify the calibration.
The Test option is used to perform the following tasks:
• Wash zone 1 dispenses wash buffer at the following volumes into nine RVs:
– 500 µL of wash buffer into three RVs for probe 1
– 1000 µL of wash buffer into three RVs for probe 2
– 1000 µL of wash buffer into three RVs for probe 3
• Liquid is aspirated from the RV.
During aspiration, the functionality of aspiration and dispense is evaluated.
Estimated time 10 minutes for calibration and test
6 minutes only for test
Required materials None
Required instrument Warming or Idle
status
Procedure key setting Processing module: Optional On
Related information...
Fluidics-wash diagnostic procedures (i-series), page 804
Use a procedure key to perform a procedure, page 747
1262 Wash Zone 2 Wash Monitoring (i-series)
Perform this Fluidics-Wash diagnostic procedure to complete the following tasks:
• Calibrate the wash zone 2 wash monitoring system.
• Confirm the functionality of wash zone 2 aspiration and dispense.
The Calibration and Test option is used to perform the following tasks:
• The R1 pipettor dispenses wash buffer at the following volumes into 15 reaction vessels
(RVs):
– 500 µL of wash buffer into five RVs for probe 1
– 1000 µL of wash buffer into five RVs for probe 2
– 1000 µL of wash buffer into five RVs for probe 3
• Wash zone 2 aspirated liquid from the RVs and the wash monitoring system is calibrated.
• If the calibration passes, the wash monitoring test is performed to verify the calibration.
The Test option is used to perform the following tasks:
• Wash zone 2 dispenses wash buffer at the following volumes into nine RVs:
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– 500 µL of wash buffer into three RVs for probe 1
– 1000 µL of wash buffer into three RVs for probe 2
– 1000 µL of wash buffer into three RVs for probe 3
• Liquid is aspirated from the RV.
During aspiration, the functionality of aspiration and dispense is evaluated.
Estimated time 10 minutes for calibration and test
8 minutes only for test
Required materials None
Required instrument Warming or Idle
status
Procedure key setting Processing module: Optional On
Related information...
Fluidics-wash diagnostic procedures (i-series), page 804
Use a procedure key to perform a procedure, page 747
1270 Bulk Solutions Motors and Sensors Test (i-series)
Perform this Fluidics-Wash diagnostic procedure to test the functionality of the bulk solution level
sensors.
If the logon for FSE is used, a transfer pump option is available.
Estimated time • 1 minute to obtain the current fluid level for all sensors
• 3 minutes to test the functionality of each level sensor
• 7 minutes to test the functionality of each transfer pump
motor
Required materials Absorbent towel
Empty container
Purified water
Required instrument Warming or Idle
status
Procedure key setting Processing module: Off
Related information...
Fluidics-wash diagnostic procedures (i-series), page 804
Use a procedure key to perform a procedure, page 747
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Maintenance and diagnostics Section 9
Temperature diagnostic procedures (i-series)
The operator may need to perform temperature diagnostic procedures when temperature
components are replaced or when message codes and observed problems associated with i-
series module temperatures are diagnosed.
Related information...
Processing module diagnostic procedures (i-series), page 793
1300 Temperature Status (i-series), page 816
1300 Temperature Status (i-series)
Perform this Temperature diagnostic procedure to read and display processing module
temperatures and to evaluate the temperature reads at the following positions:
• Process path
• Pre-Trigger and Trigger manifold
• Wash zones
• Reagent supply center
If the logon for CSC or FSE is used, the ambient temperature status is tested and is displayed.
Estimated time 1 minute
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Off
Related information...
Temperature diagnostic procedures (i-series), page 816
Use a procedure key to perform a procedure, page 747
RV loader diagnostic procedures (i-series)
The operator may need to perform RV loader diagnostic procedures when RV loader
components are replaced or when message codes and observed problems associated with the
RV loader are diagnosed.
Related information...
Processing module diagnostic procedures (i-series), page 793
1400 RV Loader and Sensors Test (i-series), page 816
1400 RV Loader and Sensors Test (i-series)
Perform this RV Loader diagnostic procedure to complete the following tasks:
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• Home RV loader motors.
• Test RV loader sensors.
• Manually unload reaction vessels from the linear queue.
Estimated time 8 minutes
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Required On
Related information...
RV loader diagnostic procedures (i-series), page 816
Use a procedure key to perform a procedure, page 747
Process path diagnostic procedures (i-series)
The operator may need to perform process path diagnostic procedures when process path
components are replaced or when message codes and observed problems associated with the
process path are diagnosed.
Related information...
Processing module diagnostic procedures (i-series), page 793
1505 Diverter Test (i-series), page 817
1510 Vortexer Test (i-series), page 818
1515 Process Path Motors Test (i-series), page 818
1520 RV Load and Unload Test (i-series), page 819
1505 Diverter Test (i-series)
Perform this Process Path diagnostic procedure to test the functionality of the following
diverters:
• Load diverter (LD)
• STAT diverter (STD)
• Wash zone diverter (WZD)
• Pretreatment unload diverter (pUD)
Estimated time • 1 minute for each diverter
• 4 minutes for all diverters
Required materials None
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Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Off
Related information...
Process path diagnostic procedures (i-series), page 817
Use a procedure key to perform a procedure, page 747
1510 Vortexer Test (i-series)
Perform this Process Path diagnostic procedure to test the functionality of the following
vortexers:
• Reagent 1 pipettor vortexer (VTXR1)
• Reagent 2 pipettor vortexer (VTXR2)
• Pre-Trigger vortexer (VTXPT)
• Pretreatment vortexer (pVTX)
Estimated time • 1 minute for each vortexer
• 4 minutes for all vortexers
Required materials None
Required instrument Warming or Idle
status
Procedure key setting Processing module: Off
Related information...
Process path diagnostic procedures (i-series), page 817
Use a procedure key to perform a procedure, page 747
1515 Process Path Motors Test (i-series)
Perform this Process Path diagnostic procedure to test the functionality of the process path and
pretreatment path motors.
Estimated time 1 minute
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Optional On
Related information...
Process path diagnostic procedures (i-series), page 817
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Use a procedure key to perform a procedure, page 747
1520 RV Load and Unload Test (i-series)
Perform this Process Path diagnostic procedure to load and unload reaction vessels (RVs) from
the process path and pretreatment path.
Estimated time 3 minutes to 7 minutes based on the selected option
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Optional On
Related information...
Process path diagnostic procedures (i-series), page 817
Use a procedure key to perform a procedure, page 747
Sample manager diagnostic procedures (i-series)
The operator may need to perform sample manager diagnostic procedures when reagent and
sample manager (RSM) components are replaced or when message codes and observed
problems associated with the RSM are diagnosed. These procedures are located on the
Procedures screen of the i-series processing module.
Related information...
Processing module diagnostic procedures (i-series), page 793
1630 Sample Positioner Test (i-series), page 819
1630 Sample Positioner Test (i-series)
Perform this Sample Manager diagnostic procedure to test the functionality of sample positioner
motors.
Estimated time 2 minutes
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting • System control module: Optional On
• Processing module: Optional On
Related information...
Sample manager diagnostic procedures (i-series), page 819
Use a procedure key to perform a procedure, page 747
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Maintenance and diagnostics Section 9
Reagent manager diagnostic procedures (i-series)
The operator may need to perform reagent manager diagnostic procedures when reagent supply
center components are replaced or when message codes and observed problems associated
with the reagent supply center are diagnosed.
Related information...
Processing module diagnostic procedures (i-series), page 793
1703 Reagent Supply Center Test (i-series), page 820
1715 Reagent Carousel and Reagent Transport Calibration (i-series), page 820
1703 Reagent Supply Center Test (i-series)
Perform this Reagent Manager diagnostic procedure to test the functionality of the following
items:
• Reagent positioner
• Reagent transport
• Reagent carousel
• Dispersion motor
Estimated time 6 minutes for the full-function test
Required materials Diagnostics Kit, LN 01R5940 (two cartridges); or two reagent
cartridges
Required instrument Warming or Idle
status
Procedure key setting • System control module: Required On
• Processing module: Required On
Related information...
Reagent manager diagnostic procedures (i-series), page 820
Use a procedure key to perform a procedure, page 747
1715 Reagent Carousel and Reagent Transport Calibration (i-series)
Perform this Reagent Manager diagnostic procedure to calibrate the reagent transport to the
reagent carousel to accurately load reagent cartridges and vial racks in the reagent carousel.
Estimated time 4 minutes
Required materials None
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Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Optional On
Related information...
Reagent manager diagnostic procedures (i-series), page 820
Use a procedure key to perform a procedure, page 747
Module diagnostic procedures (i-series)
The operator may need to perform module diagnostic procedures when message codes and
observed problems associated with the i-series module are diagnosed.
Related information...
Processing module diagnostic procedures (i-series), page 793
1830 Buffer Run (i-series), page 821
1890 Processing Module Initialization (i-series), page 822
1830 Buffer Run (i-series)
Perform this Modules diagnostic procedure to run one-step and two-step assay protocols by
using tap water or saline instead of reagents. When troubleshooting is performed for system
failures, assay processing can be simulated without the use of reagents.
Estimated time Variable time based on the number of tests that are ordered.
The minimum completion time is 30 minutes.
Required materials • Diagnostics Kit, LN 01R5940 (two cartridges)
• Tap water or saline
• Sample racks
• Sample cups or tubes
Required instrument Warming or Idle
status
Procedure key setting • System control module: Off
• Processing module: Off
NOTE: To perform this procedure, the procedure key for the
system control module and the processing module must be
positioned at the Off setting. This procedure simulates assay
processing and the procedure key cannot be positioned at the
On setting during assay processing.
Related information...
Module diagnostic procedures (i-series), page 821
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Use a procedure key to perform a procedure, page 747
1890 Processing Module Initialization (i-series)
Perform this Modules diagnostic procedure to observe the i-series processing module during an
initialization.
Estimated time 3 minutes
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting Processing module: Required On
Related information...
Module diagnostic procedures (i-series), page 821
Use a procedure key to perform a procedure, page 747
Utilities diagnostic procedures (i-series) (CSC Logon)
The operator may need to perform utility diagnostic procedures to support other procedures.
Related information...
Processing module diagnostic procedures (i-series), page 793
1910 Gravimetric Calculations (i-series) (CSC Logon), page 822
1910 Gravimetric Calculations (i-series) (CSC Logon)
Perform this Utilities diagnostic procedure to calculate and record the results for the following
diagnostic procedures:
• 1120 Sample Pipettor Syringe Precision and Accuracy
• 1121 R1 Pipettor Syringe Precision and Accuracy
• 1122 R2 Pipettor Syringe Precision and Accuracy
• 1130 Sample Pipettor Pump Precision and Accuracy
• 1131 R1 Pipettor Pump Precision and Accuracy
• 1132 R2 Pipettor Pump Precision and Accuracy
• 1210 Pre-Trigger Precision and Accuracy
• 1211 Trigger Precision and Accuracy
• 1221 Wash Zone 1 Precision and Accuracy
• 1222 Wash Zone 2 Precision and Accuracy
• 1231 Wash Zone 1 Residual Volume
• 1232 Wash Zone 2 Residual Volume
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Estimated time Variable time based on the number of calculations that are
performed
Required materials None
Required instrument Any status
status
Procedure key setting Processing module: Off
Related information...
Utilities diagnostic procedures (i-series) (CSC Logon), page 822
Use a procedure key to perform a procedure, page 747
Reagent and sample manager (RSM) diagnostic procedures
Reagent and sample manager (RSM) diagnostic procedures are grouped in the Sample Manager
category on the Diagnostics tab of the Procedures screen. The operator may need to perform
sample manager diagnostic procedures when RSM components are replaced or when message
codes and observed problems associated with the RSM are diagnosed.
Related information...
Diagnostic procedure descriptions, page 775
1600 RSM Transport Calibration, page 823
1610 Reagent and Sample Manager Test, page 824
1620 RSM Bar Code Reader Test, page 824
1635 RSM Transport Test, page 825
1690 Reagent and Sample Manager Initialization, page 825
1600 RSM Transport Calibration
Perform this Sample Manager diagnostic procedure to calibrate the RSM transport to the
following assemblies:
• Sample positioner
• Reagent positioner
• Loading area
Estimated time 6 minutes
Required materials • Sample rack
• Reagent cartridge
Required instrument Stopped, Warming, or Idle
status
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Procedure key setting • System control module: Required On
• Processing module: Required On
Related information...
Reagent and sample manager (RSM) diagnostic procedures, page 823
Use a procedure key to perform a procedure, page 747
1610 Reagent and Sample Manager Test
Perform this Sample Manager diagnostic procedure to test the functionality of the following
components:
• RSM transport
• Sample positioner (inner and outer lanes)
• Reagent positioner
• Loading area lights and sensors
Estimated time • 3 minutes for the RSM transport full-function test
• 1 minute for individual tests
Required materials • Racks
• Reagent cartridge
Required instrument Stopped, Warming, or Idle
status
Procedure key setting • System control module: Optional On
• Processing module: Optional On
Related information...
Reagent and sample manager (RSM) diagnostic procedures, page 823
Use a procedure key to perform a procedure, page 747
1620 RSM Bar Code Reader Test
Perform this Sample Manager diagnostic procedure to test the functionality of the RSM bar code
reader.
Estimated time Variable time based on the number of bar codes that are
scanned
Required materials • Racks
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• Bar-coded tubes
• Reagent cartridge
Required instrument Stopped, Warming, or Idle
status
Procedure key setting System control module: Optional On
Related information...
Reagent and sample manager (RSM) diagnostic procedures, page 823
Use a procedure key to perform a procedure, page 747
1635 RSM Transport Test
Perform this Sample Manager diagnostic procedure to test the functionality of the following RSM
transport components:
• Motors
• Rack pick sensor
• Rack detect sensor
• Bar code reader
Estimated time 2 minutes
Required materials Sample rack or vial rack
Required instrument Stopped, Warming, or Idle
status
Procedure key setting System control module: Required On
Related information...
Reagent and sample manager (RSM) diagnostic procedures, page 823
Use a procedure key to perform a procedure, page 747
1690 Reagent and Sample Manager Initialization
Perform this Sample Manager diagnostic procedure to observe the reagent and sample manager
during an initialization.
Estimated time 1 minute
Required materials None
Required instrument Stopped, Warming, or Idle
status
Procedure key setting System control module: Required On
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Related information...
Reagent and sample manager (RSM) diagnostic procedures, page 823
Use a procedure key to perform a procedure, page 747
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Section 9 Component replacement
Component replacement
Some system components may need to be replaced because of normal wear from daily system
operation.
The laboratory has a responsibility to maintain an adequate supply of replacement parts. List
numbers are provided in the procedures only for guidance and are subject to change.
When replacing components, comply with the following general safety precautions:
• Dispose of replaced components and materials that are used during component
replacement (for example, absorbent towels or lint-free tissues) according to the laboratory
waste disposal procedures of the facility.
• When drips or leaks occur, clean up the liquid and decontaminate the surface if necessary.
If a component replacement procedure requires the cover interlocks to be overridden by using
the procedure key, the interlocks can be overridden only by trained operators. Be aware that
potential mechanical hazards and Biological RISK may be present. Be aware of moving parts. Do
not reach into the paths of moving parts.
Related information...
Service, maintenance, and diagnostics, page 739
Processing center component replacement (c-series), page 827
Supply and pump center component replacement (c-series), page 864
Processing center component replacement (i-series), page 892
Supply center component replacement (i-series), page 904
Optional component replacement, page 912
Biological hazards, page 723
Spill cleanup, page 730
Processing center component replacement (c-series)
Certain processing center components may need to be replaced because of normal wear from
daily system operation. The following illustration shows the location of each replaceable
component. Step-by-step instructions are provided for each replaceable component.
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Figure 158: Processing center components (c-series)
Legend:
1. Sample probe (S)
2. Mixer 2
3. ICT module
4. Lamp
5. Mixer 1
6. Cuvette dry tip
7. Cuvette segment
8. Reagent probe (R1)
9. ICT probe
10. Reagent probe (R2)
Related information...
Component replacement, page 827
Replace the sample probe (c-series), page 829
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Replace the reagent probes (c-series), page 832
Replace the sample probe tubing (c-series), page 837
Replace the reagent probe tubing (c-series), page 840
Replace the lamp or the lamp plate (c-series), page 844
Replace the cuvette segments (c-series), page 848
Replace the cuvette dry tip (c-series), page 852
Replace the mixers (c-series), page 855
Replace the ICT module or the ICT probe (c-series), page 859
Replace the sample probe (c-series)
NOTE: Recording and tracking the date of the sample probe installation is recommended to
ensure that the sample probe is not used for longer than the following intervals:
• Six months for systems that use whole blood assays
• One year for systems that do not use whole blood assays
To replace the sample probe, perform the following procedures:
• Removal, page 830
– Remove the sample probe, page 830
• Replacement, page 831
– Install the sample probe, page 831
• Verification, page 832
– Calibrate the sample pipettor, page 832
Estimated time 20 minutes
Required materials • Slotted screwdriver
• Absorbent towel
Required instrument Idle
status
Procedure key setting Processing module: Required On
Replacement parts • Sample probe, LN 04S5101
• Sample probe screw, LN 04S5301 (optional)
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Probe Stick Hazard. This activity or area may expose you to probes.
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CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
Removal
Remove the sample probe
1. Insert the procedure key into the processing module procedure lock and turn the key to the
On setting.
2. Lift the rear processing center cover to access the sample probe.
3. To move the sample pipettor to the rear of the processing module, initiate Pipettors
diagnostic procedure 4106 Component Move (c-series), page 780.
4. To remove the sample pipettor cover, gently squeeze the squeeze points to release the
locking tabs and lift the cover.
5. Place an absorbent towel under the probe tip.
6. Use a slotted screwdriver to slightly loosen the probe screw.
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7. Loosen, but do not remove, the probe screw by hand until the probe releases from the
sample pipettor.
8. Loosen, but do not remove, the screw that secures the sample probe grounding wire.
9. Detach the grounding wire.
10. Gently disconnect the tubing from the top of the probe.
Replacement
Install the sample probe
1. Attach the tubing to the top of the new sample probe.
NOTE: Do not flare or stretch the tubing. The tubing needs to fit firmly on the sample probe
but must not be pushed past the bend of the probe so that the tubing does not become too
loose. If the tubing is loose or if the probe has been replaced several times by using the
same tubing, replacing the sample probe tubing is recommended.
2. Position the new sample probe on the alignment pins. Verify that the probe plate is flush
with the plate on the sample pipettor.
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3. Remove the probe screw from the old sample probe and insert the screw into the new
sample probe. Tighten the screw by hand to secure the probe.
4. Stabilize the pipettor and tighten the screw with the slotted screwdriver.
5. Attach the new sample probe grounding wire and tighten the screw.
NOTE: Ensure that the connector for the new sample probe grounding wire is positioned
under the ring-shaped connector.
6. Remove the absorbent towel under the probe tip.
7. To return the sample pipettor to the home position, complete Pipettors diagnostic procedure
4106 Component Move (c-series), page 780.
8. Perform Fluidics-Wash diagnostic procedure 4205 Flush Water Lines (c-series), page 782.
While performing the flush, inspect the sample probe for drips and inspect the sample probe
tubing and connections for leaks. If drips or leaks are observed, repeat the installation
procedure.
9. Gently replace the pipettor cover. Ensure that the tubing is not pinched or kinked below the
pipettor cover.
10. Press down on the end of the cover over the pipettor shaft until the cover snaps into
position.
The pipettor cover must be seated completely to ensure correct liquid level sense operation.
Verification
Calibrate the sample pipettor
1. Perform Pipettors diagnostic procedure 4102 Sample Pipettor Calibration (c-series), page
779.
2. Close the rear processing center cover.
3. Turn the procedure key to the Off setting and remove the key from the processing module
procedure lock.
4. Perform quality control testing to verify the system performance before reporting sample
results.
Related information...
Processing center component replacement (c-series), page 827
Use a procedure key to perform a procedure, page 747
Replace the reagent probes (c-series)
To replace one or more reagent probes, perform the following procedures:
• Removal, page 834
– Remove the reagent probe, page 834
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• Replacement, page 835
– Install the reagent probe, page 835
• Verification, page 836
– Calibrate the reagent pipettor, page 836
Estimated time 20 minutes
Required materials • Slotted screwdriver
• Absorbent towel
Required instrument • Processing module: Idle
status
• Reagent and sample manager: Idle (only if replacing the
R1 probe)
Procedure key setting Processing module: Required On
Replacement parts • Reagent probe, LN 04S4901
• Reagent probe screw, LN 04S5401 (optional)
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Probe Stick Hazard. This activity or area may expose you to probes.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
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Removal
Remove the reagent probe
1. Insert the procedure key into the processing module procedure lock and turn the key to the
On setting.
2. Lift the appropriate processing center cover:
– To replace the R1 probe, lift the front processing center cover.
– To replace the R2 probe, lift the rear processing center cover.
3. To move the reagent pipettor to the reagent aspiration position, initiate Pipettors diagnostic
procedure 4106 Component Move (c-series), page 780.
4. To remove the reagent pipettor cover, squeeze the squeeze points to release the locking
tabs and lift the cover.
5. Place an absorbent towel under the probe tip.
6. Use a slotted screwdriver to slightly loosen the probe screw.
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7. Loosen, but do not remove, the probe screw by hand until the probe releases from the
reagent pipettor.
8. Loosen, but do not remove, the screw that secures the reagent probe grounding wire.
9. Detach the grounding wire.
10. Gently disconnect the tubing from the top of the probe.
Replacement
Install the reagent probe
1. Attach the tubing to the top of the new reagent probe.
NOTE: Do not flare or stretch the tubing. The tubing needs to fit firmly on the reagent probe
but must not be pushed past the bend of the probe so that the tubing does not become too
loose. If the tubing is loose or if the probe has been replaced several times by using the
same tubing, replacing the reagent probe tubing is recommended.
2. Position the new reagent probe on the alignment pins. Verify that the probe plate is flush
with the plate on the reagent pipettor.
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3. Remove the probe screw from the old reagent probe and insert the screw into the new
reagent probe. Tighten the screw by hand to secure the probe.
4. Stabilize the pipettor and tighten the screw with the slotted screwdriver.
5. Attach the new reagent probe grounding wire and tighten the screw.
NOTE: Ensure that the connector for the new reagent probe grounding wire is positioned
under the ring-shaped connector.
6. Remove the absorbent towel under the probe tip.
7. To return the reagent pipettor to the home position, complete Pipettors diagnostic procedure
4106 Component Move (c-series), page 780.
8. Perform Fluidics-Wash diagnostic procedure 4205 Flush Water Lines (c-series), page 782.
While performing the flush, inspect the reagent probe for drips and inspect the reagent
probe tubing and connections for leaks. If drips or leaks are observed, repeat the installation
procedure.
9. Gently replace the pipettor cover:
– Insert the rear of the pipettor cover into the pipettor and press backward to fully seat
the tabs.
– Align the tabs at the front end of the pipettor cover and press down until the tabs snap
into position.
– Ensure that the tubing is not pinched or kinked below the pipettor cover.
10. Stabilize the pipettor so that it does not drop and damage the probe. Press down on the
middle of the pipettor cover to confirm that it is seated completely.
The pipettor cover must be seated completely to ensure correct liquid level sense operation.
Verification
Calibrate the reagent pipettor
1. Perform the appropriate Pipettors diagnostic procedure:
– 4103 R1 Pipettor Calibration (c-series), page 779
– 4104 R2 Pipettor Calibration (c-series), page 779
2. Close the appropriate processing center cover:
– For the R1 probe, close the front processing center cover.
– For the R2 probe, close the rear processing center cover.
3. Turn the procedure key to the Off setting and remove the key from the processing module
procedure lock.
4. Perform quality control testing to verify the system performance before reporting sample
results.
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Section 9 Component replacement
Related information...
Processing center component replacement (c-series), page 827
Use a procedure key to perform a procedure, page 747
Replace the sample probe tubing (c-series)
To replace the sample probe tubing, perform the following procedures:
• Removal, page 838
– Remove the sample probe tubing, page 838
• Replacement, page 839
– Install the sample probe tubing, page 839
• Verification, page 840
– Run quality control samples, page 840
Estimated time 15 minutes
Required materials Absorbent towel
Required instrument Idle
status
Procedure key setting Processing module: Required On
Replacement parts Sample probe tubing
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Probe Stick Hazard. This activity or area may expose you to probes.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
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Removal
Remove the sample probe tubing
1. Insert the procedure key into the processing module procedure lock and turn the key to the
On setting.
2. Lift the rear processing center cover to access the sample probe.
3. To remove the sample pipettor cover, gently squeeze the squeeze points to release the
locking tabs and lift the cover.
4. Unscrew the tubing from the probe tubing connector. Ensure that the black O-ring inside the
tubing connector remains in position.
5. Gently disconnect the tubing from the top of the probe. Use the absorbent towel to absorb
any water from the end of the probe tubing.
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Replacement
Install the sample probe tubing
1. Attach the end of the new tubing to the top of the sample probe.
NOTE: Do not flare or stretch the tubing. The tubing needs to fit firmly on the sample probe
but must not be pushed past the bend of the probe so that the tubing does not become too
loose.
2. Verify that the black O-ring is inside the probe tubing connector.
3. Screw the opposite end of the tubing into the tubing connector.
4. Perform Fluidics-Wash diagnostic procedure 4205 Flush Water Lines (c-series), page 782.
While performing the flush, inspect the sample probe for drips and inspect the sample probe
tubing and connections for leaks. If drips or leaks are observed, repeat the installation
procedure.
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5. Gently replace the pipettor cover. Ensure that the tubing is not pinched or kinked below the
pipettor cover.
6. Press down on the end of the cover over the pipettor shaft until the cover snaps into
position.
The pipettor cover must be seated completely to ensure correct liquid level sense operation.
7. Close the rear processing center cover.
8. Turn the procedure key to the Off setting and remove the key from the processing module
procedure lock.
Verification
Run quality control samples
Perform quality control testing to verify the system performance before reporting sample results.
Related information...
Processing center component replacement (c-series), page 827
Use a procedure key to perform a procedure, page 747
Replace the reagent probe tubing (c-series)
To replace the reagent probe tubing, perform the following procedures:
• Removal, page 841
– Remove the reagent probe tubing, page 841
• Replacement, page 842
– Install the reagent probe tubing, page 842
• Verification, page 843
– Run quality control samples, page 843
Estimated time 15 minutes
Required materials Absorbent towel
Required instrument • Processing module: Idle
status
• Reagent and sample manager: Idle (only if replacing the
R1 probe tubing)
Procedure key setting Processing module: Required On
Replacement parts Reagent probe tubing, LN 04S5001
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CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Probe Stick Hazard. This activity or area may expose you to probes.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
Removal
Remove the reagent probe tubing
1. Insert the procedure key into the processing module procedure lock and turn the key to the
On setting.
2. Lift the appropriate processing center cover:
– To replace the R1 probe tubing, lift the front processing center cover.
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– To replace the R2 probe tubing, lift the rear processing center cover.
3. To move the reagent pipettor to the reagent aspiration position, initiate Pipettors diagnostic
procedure 4106 Component Move (c-series), page 780.
4. Place an absorbent towel under the probe tip.
5. To remove the reagent pipettor cover, squeeze the squeeze points to release the locking
tabs and lift the cover.
6. Observe the position of the tubing in the routing guides.
7. Gently disconnect the tubing from the top of the probe.
8. Gently disconnect the metal connector from the reagent pipettor tubing. Ensure that the
protective sleeve remains on the reagent pipettor tubing.
Replacement
Install the reagent probe tubing
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1. Attach the end of the new tubing with the metal connector to the reagent pipettor tubing.
Verify that the metal connector is inserted into the reagent pipettor tubing and the protective
sleeve.
2. Position the tubing in the routing guides.
3. Attach the other end of new tubing to the reagent probe.
NOTE: Do not flare or stretch the tubing. The tubing needs to fit firmly on the reagent probe
but must not be pushed past the bend of the probe so that the tubing does not become too
loose.
4. Remove the absorbent towel under the probe tip.
5. To return the reagent pipettor to the home position, complete Pipettors diagnostic procedure
4106 Component Move (c-series), page 780.
6. Perform Fluidics-Wash diagnostic procedure 4205 Flush Water Lines (c-series), page 782.
While performing the flush, inspect the reagent probe for drips and inspect the reagent
probe tubing and connections for leaks. If drips or leaks are observed, repeat the installation
procedure.
7. Gently replace the pipettor cover:
– Insert the rear of the pipettor cover into the pipettor and press backward to fully seat
the tabs.
– Align the tabs at the front end of the pipettor cover and press down until the tabs snap
into position.
– Ensure that the tubing is not pinched or kinked below the pipettor cover.
8. Stabilize the pipettor so that it does not drop and damage the probe. Press down on the
middle of the pipettor cover to confirm that it is seated completely.
The pipettor cover must be seated completely to ensure correct liquid level sense operation.
9. Close the appropriate processing center cover:
– For the R1 probe tubing, close the front processing center cover.
– For the R2 probe tubing, close the rear processing center cover.
10. Turn the procedure key to the Off setting and remove the key from the processing module
procedure lock.
Verification
Run quality control samples
Perform quality control testing to verify the system performance before reporting sample results.
Related information...
Processing center component replacement (c-series), page 827
Use a procedure key to perform a procedure, page 747
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Replace the lamp or the lamp plate (c-series)
To replace the lamp or the lamp plate, perform the following procedures:
• Removal, page 845
– Remove the lamp or lamp plate, page 845
• Replacement, page 847
– Install the lamp and the lamp plate, page 847
• Verification, page 848
– Run quality control samples, page 848
Estimated time 15 minutes (This time does not include the 30-minute lamp
warm-up period that is required after replacement.)
Required materials • Phillips screwdriver
• Slotted screwdriver
• 3 mm hex wrench
• Gloves
• Lint-free tissue (optional)
• Ethanol (optional)
Required instrument Stopped or Idle
status
Procedure key setting Processing module: Off
Replacement parts Source lamp, LN 09D4503
To document the lamp change in the maintenance log, perform Quarterly maintenance
procedure 5806 Change Lamp (c-series), page 764.
CAUTION: Possibility of electric shock. This activity or area may expose you to
electrical shock.
CAUTION: Hot Surface. This activity or area may expose you to hot surfaces.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
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Removal
Remove the lamp or lamp plate
1. Power off the processing module by using the main power breaker that is located at the rear
of the module.
NOTE: Do not remove the lamp or the lamp plate when the processing module is powered
on.
2. After turning off the power, wait a minimum of 5 minutes so that the lamp and the lamp
housing can cool.
3. Lift the rear processing center cover.
4. Remove the two screw covers from the rear access panel.
5. Perform one of the following steps to loosen the screws to remove the rear access panel:
– Use the 3 mm hex wrench to loosen the captive hex screws.
– Use the slotted screwdriver to loosen the captive screws.
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6. Remove the rear access panel.
7. Use the slotted screwdriver to loosen the slotted screw on the lamp cover to remove the
cover.
8. Remove the lamp cables from the plastic clamp.
9. Locate the lamp terminal block and lift up both ends of the transparent cover to remove the
cover.
10. Use the Phillips screwdriver to completely loosen the two captive screws that secure the
lamp cables to the lamp terminal block.
11. Raise the screws and lower the lamp cables completely to disengage the cables from the
bottom of the screws.
12. Locate the lamp housing and ensure that it is cool before proceeding to the next step.
13. Completely loosen the tall thumbscrew on the lamp plate. If necessary, use the slotted
screwdriver.
14. Lift the lamp plate out of the lamp housing.
15. Use the slotted screwdriver to loosen the thumbscrew so that the lamp can be removed
from the lamp plate.
16. Remove the lamp and cable from the lamp plate.
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Replacement
Install the lamp and the lamp plate
IMPORTANT: Wear gloves to perform the following steps. Residual oil from an ungloved hand on
the glass surface of the lamp shortens the lamp life. If the glass surface needs to be cleaned,
use lint-free tissue and ethanol.
1. To install the lamp on the lamp plate, align the pins on the lamp plate with the holes on the
new lamp. Ensure that the lamp filament is perpendicular to the lamp plate.
2. With the lamp seated completely on the pins, use the slotted screwdriver to tighten the
screw on the lamp plate.
3. To insert the lamp assembly into the lamp housing, press the assembly against the leaf
spring, and then lower the assembly into the housing. Ensure that the lamp assembly is
seated completely in the lamp housing.
4. Verify that the lamp cables exit the lamp housing through the slot behind the lamp and that
the cables are not pinched by the lamp plate.
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5. Press down on the lamp plate and tighten the thumbscrew to secure the plate to the lamp
housing.
6. On the terminal block, lift the Phillips screws and insert the cables under the screws.
7. Use the Phillips screwdriver to tighten the two captive screws and to secure the two lamp
cables to the terminal block.
8. Replace the transparent cover on the terminal block.
9. Replace the lamp cables in the plastic clamp.
10. Replace the lamp cover and tighten the slotted screw.
11. Install the rear access panel.
12. Perform one of the following steps to secure the rear access panel:
– Use the 3 mm hex wrench to tighten the captive hex screws.
– Use the slotted screwdriver to tighten the captive screws.
13. Replace the two screw covers.
14. Close the rear processing center cover.
15. Power on the processing module.
NOTE: To ensure the appropriate initialization of the processing module, the system control
module power must be turned on before the processing module power is turned on.
16. Let the lamp warm up for 30 minutes before performing assay processing.
Verification
Run quality control samples
Perform quality control testing to verify the system performance before reporting sample results.
Related information...
Processing center component replacement (c-series), page 827
Use a procedure key to perform a procedure, page 747
Replace the cuvette segments (c-series)
To replace one or more cuvette segments, perform the following procedures:
• Removal, page 850
– Remove the cuvette segment, page 850
• Replacement, page 851
– Clean and install the cuvette segment, page 851
• Verification, page 852
– Verify that the cuvette segment is installed correctly, page 852
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Estimated time 15 minutes
Required materials • Detergent A, LN 08P9670
• Lint-free, absorbent towel
• Cotton swabs
• Slotted screwdriver
• Purified water
• Clean, residue-free container in which to submerge the
cuvette segments
• Gloves
Required instrument Idle
status
Procedure key setting Processing module: Required On
Replacement parts Cuvette segment, LN 04S4701
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
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Removal
Remove the cuvette segment
1. Insert the procedure key into the processing module procedure lock and turn the key to the
On setting.
2. Lift the rear processing center cover to access the reaction carousel.
3. Identify the location of the first cuvette segment to replace in the reaction carousel.
4. To rotate the reaction carousel so that the appropriate cuvette segment is located at the
rear of the processing module, perform Reaction Mechanism diagnostic procedure 5004
Reaction Carousel Home and Move (c-series), page 791.
5. Use the slotted screwdriver to loosen the slotted screw on the top of the cuvette segment to
remove the segment from the reaction carousel.
6. Dispose of the used cuvette segment.
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7. Repeat steps 4, page 850 through 6, page 850 until all the cuvette segments to replace are
removed.
Replacement
Clean and install the cuvette segment
IMPORTANT: Wear gloves to perform the following steps. Residual oil from an ungloved hand
can cause imprecise optical readings.
1. Remove the new cuvette segment from the shipping container and place the segment on a
lint-free, absorbent towel.
2. Wet a cotton swab with Detergent A and clean the inside and outside of all the cuvettes in
the cuvette segment.
3. Fill a clean, residue-free container with enough purified water to completely submerge the
cuvette segment.
4. Rinse the cuvette segment in the purified water to remove the Detergent A. Drain any
excess purified water from the cuvettes.
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5. Dry the top of the cuvette segment, especially the slotted edges, to remove any remaining
purified water.
6. Position the cuvette segment on the reaction carousel alignment pins.
NOTE: To ensure optimal performance throughout the life span of the c-series processing
module, the cuvettes need to be replaced after 12 years of use.
7. Tighten the slotted screw by hand on the cuvette segment.
8. Gently tighten the slotted screw with a slotted screwdriver.
9. Repeat steps 1, page 851 through 8, page 852 until all the cuvette segments to replace are
cleaned and are installed.
10. Close the rear processing center cover.
11. Turn the procedure key to the Off setting and remove the key from the processing module
procedure lock.
Verification
Verify that the cuvette segment is installed correctly
Perform Reaction Mechanism diagnostic procedure 5004 Reaction Carousel Home and Move (c-
series), page 791.
Related information...
Processing center component replacement (c-series), page 827
Use a procedure key to perform a procedure, page 747
Replace the cuvette dry tip (c-series)
To replace the cuvette dry tip, perform the following procedures:
• Removal, page 853
– Remove the cuvette dry tip, page 853
• Replacement, page 854
– Install the cuvette dry tip, page 854
• Verification, page 855
– Wash the cuvettes, page 855
Estimated time 15 minutes
Required materials • Metric ruler
• Gloves
Required instrument • Processing module: Idle
status
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• Reagent and sample manager: Idle
Procedure key setting Processing module: Required On
Replacement parts Cuvette dry tip, LN 04S5201
IMPORTANT: Wear gloves to perform the following steps. Residual oil from an ungloved hand
interferes with the appropriate drying function of the cuvette dry tip.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
Removal
Remove the cuvette dry tip
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1. Insert the procedure key into the processing module procedure lock and turn the key to the
On setting.
2. Lift the front processing center cover.
3. Loosen the black knurled knob at the left side of the cuvette washer until the cuvette
washer assembly can be lifted from the mounting bracket.
4. Lift the cuvette washer assembly and rotate it so that the white cuvette dry tip can be
accessed easily.
NOTE: The cuvette washer nozzles are attached to the nozzle mounting plate. The screws
that secure the cuvette washer nozzles to the mounting plate do not need to be removed.
5. To remove the cuvette dry tip, pull the tip off the metal nozzle.
6. Dispose of the used cuvette dry tip.
Replacement
Install the cuvette dry tip
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1. Gently install the new cuvette dry tip. Carefully and appropriately orient the cuvette dry tip.
NOTE: The cuvette dry tip and the cuvette are both rectangular in shape. Install the cuvette
dry tip so that it fits into the cuvette.
2. Position the bottom of the cuvette dry tip 61 mm ± 0.5 mm from the underside of the cuvette
washer assembly.
3. Position the cuvette washer assembly on the alignment pins, and then tighten the black
knurled knob.
4. To return the cuvette washer assembly and the reaction carousel to the home position,
perform Fluidics-Wash diagnostic procedure 4207 Move Cuvette Washer (c-series), page
783.
5. Verify the rectangular orientation and alignment of the cuvette dry tip with the cuvette.
NOTE: If the cuvette dry tip needs to be adjusted, wear gloves. Residual oil from an
ungloved hand interferes with the appropriate drying function of the cuvette dry tip.
6. On the Perform Procedure screen, tap Down to move the cuvette washer assembly
downward.
7. Verify that the cuvette dry tip is correctly aligned and that it moves smoothly into the
cuvettes.
8. To move the cuvette washer assembly upward, tap Up.
9. To end the procedure, tap End Procedure.
10. To complete the procedure, tap Done on the Perform Procedure screen.
11. Close the front processing center cover.
12. Turn the procedure key to the Off setting and remove the key from the processing module
procedure lock.
Verification
Wash the cuvettes
1. Perform As-Needed maintenance procedure 5910 Wash Cuvettes (c-series), page 767.
2. Perform quality control testing to verify the system performance before reporting sample
results.
Related information...
Processing center component replacement (c-series), page 827
Use a procedure key to perform a procedure, page 747
Replace the mixers (c-series)
To replace one or both mixers, perform the following procedures:
• Removal, page 857
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– Remove the mixer, page 857
• Replacement, page 858
– Install the mixer, page 858
• Verification, page 858
– Verify the mixer function, page 858
Estimated time 5 minutes
Required instrument • Processing module: Idle
status
• Reagent and sample manager: Idle (only if replacing
mixer 1)
Procedure key setting Processing module: Required On
Replacement parts Mixer, LN 09D5903
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
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Removal
Remove the mixer
1. Insert the procedure key into the processing module procedure lock and turn the key to the
On setting.
2. Lift the appropriate processing center cover:
– To replace mixer 1, lift the front processing center cover.
– To replace mixer 2, lift the rear processing center cover.
3. To unplug the mixer cable, pinch the white connector.
4. Loosen the thumbscrew on the top of the mixer assembly.
5. Remove the mixer.
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Replacement
Install the mixer
1. Align the new mixer so that the flat side faces away from the mixer arm.
2. Align the positioning pins on the top of the mixer with the holes on the mixer arm. Tighten
the thumbscrew until the top of the mixer is flush with the mixer arm.
3. Attach the mixer cable connector to the white connector on the mixer assembly.
NOTE: The mixer cable connector is keyed and can be inserted only one way.
Verification
Verify the mixer function
1. Perform Reaction Mechanism diagnostic procedure 5002 Mixer Vibration Test (c-series),
page 790.
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2. Close the appropriate processing center cover:
– For mixer 1, close the front processing center cover.
– For mixer 2, close the rear processing center cover.
3. Turn the procedure key to the Off setting and remove the key from the processing module
procedure lock.
4. Perform quality control testing to verify the system performance before reporting sample
results.
Related information...
Processing center component replacement (c-series), page 827
Use a procedure key to perform a procedure, page 747
Replace the ICT module or the ICT probe (c-series)
To replace the ICT module or the ICT probe, perform the following procedures:
• Removal, page 860
– Remove the ICT module or the ICT probe, page 860
• Replacement, page 862
– Install the ICT module and the ICT probe, page 862
• Verification, page 863
– Calibrate the ICT assays, page 863
Estimated time 15 minutes
Required materials Absorbent towel
Required instrument Processing module: Idle
status
Procedure key setting Processing module: Off
Replacement parts • ICT Module, LN 09D2804
• ICT Probe, LN 09D6304
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Probe Stick Hazard. This activity or area may expose you to probes.
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Removal
Remove the ICT module or the ICT probe
1. To replace the ICT probe, proceed to step 7, page 861.
2. To replace the ICT module, verify that the new ICT module is within the expiration date on
the ICT module box. Do not use an expired ICT module.
NOTE: When the ICT module is replaced, the c-series processing module tracks and
maintains a record of the serial number, the expiration date, the warranty sample count, and
the warranty days on the system.
The warranty for the ICT module is 20,000 samples or 3 months after installation, whichever
occurs first.
3. On the menu bar, tap Supplies.
4. On the Supplies screen, tap a Module button.
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5. Use the bar code scanner to scan the two-dimensional (2D) bar code on the Alinity c label
of the new ICT module box.
Under Supply Details in the ICT Module flyout, the system automatically updates the ICT
module with the serial number and expiration date of the new module.
To enter manually the lot number and the expiration date, perform the following steps:
a. Tap Update for the ICT module.
b. Under Supply Details in the ICT Module flyout, enter the serial number and the
expiration date.
NOTE: Entry of the expiration date is optional. If the expiration date is not provided,
expiration tracking for the module is disabled.
c. Tap Replace.
6. When a confirmation message is displayed, perform one of the following steps:
– Tap Yes to continue and confirm that calibrations for all ICT assays are inactivated.
Instructions to replace the ICT module are displayed.
– Tap No to continue without saving the changes. Tap Done to return to the Supplies
screen.
7. Lift the rear processing center cover to access the ICT unit.
8. Loosen the two captive thumbscrews that secure the black plate on the top of the unit.
9. Remove the black plate.
10. Place an absorbent towel under the probe tip.
11. Loosen the thumbscrew on the side of the ICT holder until the ICT module can be lifted
upward.
12. To disconnect the black electrical connector from the side of the module, pull the connector
straight out of the module.
13. Verify that the black electrical connector is disconnected completely from the ICT module.
14. Lift the ICT module until the connectors on the side of the ICT module clear the ICT holder.
IMPORTANT: To avoid damage to the ICT probe, do not lift the ICT module and the probe
all the way out of the ICT holder.
15. Gently unscrew the ICT module to disconnect it from the top connector.
16. Lift the ICT module and the ICT probe straight upward and out of the ICT holder.
17. Unscrew the ICT probe holder from the ICT module.
18. Inspect the ports on the ICT module. The yellow O-rings must be present.
IMPORTANT: If the c-series processing module is run without the yellow O-rings in the
appropriate position, sample results may be adversely affected.
19. If the ICT module will be replaced, dispose of the used module.
If the ICT module will not be replaced, set aside the module for use with the new ICT probe.
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20. Remove the ICT probe from the probe holder.
21. If the ICT probe will be replaced, dispose of the used probe.
If the ICT probe will not be replaced, set aside the probe for use with the new ICT module.
Replacement
Install the ICT module and the ICT probe
1. To replace the ICT module, remove the new ICT module from the box.
2. Disconnect and discard the plastic tubing that is attached to both ends of the ICT module.
3. Inspect the ports on the ICT module. The yellow O-rings must be present.
IMPORTANT: If the system is run without the yellow O-rings in the appropriate position,
sample results may be adversely affected.
4. Align the ICT module so that the gap between the side connectors is on top of the module
and the module label is facing upward and is legible.
5. Place the ICT probe into the ICT probe holder.
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6. Attach the ICT probe holder and ICT probe to the bottom of the ICT module. Do not
overtighten the ICT probe holder.
IMPORTANT: The O-rings may twist and obstruct the flow through the ICT module if the ICT
probe holder connection is overtightened.
7. Insert the ICT module with the ICT probe into the ICT probe holder until the connectors on
the side of the module are located above the top of the holder.
8. Rotate the ICT module to reattach the module to the top port and to the connector. Do not
overtighten the ICT module.
9. Lower the ICT module until the module is seated completely and the module connectors are
aligned with the slot in the ICT holder.
10. Gently reconnect the black electrical connector to the ICT module connectors. Ensure that
the ICT module is plugged completely into the connector.
11. Press down on the ICT module and simultaneously tighten the side thumbscrew until the
module is secure. Do not overtighten the thumbscrew to prevent damage to the ICT module.
12. To flush the ICT module, perform one of the following steps:
– If the ICT module was replaced, tap Flush ICT in the ICT Module flyout.
– If the ICT probe was replaced, perform ICT diagnostic procedure 5102 Flush ICT
Module (c-series), page 792.
13. During the flush, perform the following steps:
– Inspect the tubing from the ICT module for bubbles.
– Inspect the ICT probe to ensure that it does not drip.
NOTE: If bubbles or drips are observed, see Processing module observed problems (c-
series), page 1264.
14. Replace the black plate and tighten the two captive thumbscrews.
15. If the ICT module was replaced, tap Done in the ICT Module flyout.
16. Close the rear processing center cover.
Verification
Calibrate the ICT assays
1. Perform a calibration for the ICT assays.
2. Perform quality control testing to verify the calibration.
Related information...
Processing center component replacement (c-series), page 827
Supplies screen element descriptions (c-series), page 501
Use a procedure key to perform a procedure, page 747
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Supply and pump center component replacement (c-series)
Certain supply and pump center components may need to be replaced because of normal wear
from daily system operation. The following illustration shows the location of each replaceable
component. Step-by-step instructions are provided for each replaceable component.
Figure 159: Supply and pump center components (c-series)
Legend:
1. Sample syringe
2. Reagent syringes
3. Wash solution syringes
4. Wash solution pump syringes (1 mL) and check valves
5. ICT Reference Solution pump syringes (1 mL) and check valves
6. ICT aspiration pump syringes (1 mL) and check valve
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Related information...
Component replacement, page 827
Replace the 1 mL syringes (c-series), page 865
Replace the check valves (c-series), page 868
Replace the wash solution syringe O-ring and seal tips 1 and 2 (c-series), page 871
Replace the reagent syringe O-ring and seal tips 1 and 2 (c-series), page 878
Replace the sample syringe O-ring and seal tips 1 and 2 (c-series) , page 885
Replace the 1 mL syringes (c-series)
To replace the 1 mL syringes on the ICT Reference Solution pump, the ICT aspiration pump,
and the wash solution pump, perform the following procedures:
• Removal, page 866
– Remove the 1 mL syringe, page 866
• Replacement, page 867
– Install the 1 mL syringe, page 867
• Verification, page 868
– Run quality control samples, page 868
Estimated time 14 minutes
Required materials Absorbent towel
Required instrument Idle
status
Procedure key setting Processing module: Optional On
NOTE: The procedure key setting depends on the location of
the 1 mL syringe to be replaced. See step 3 of Remove the
1 mL syringe, page 866.
Replacement parts 1 mL syringe, LN 09D4103
To replace all 1 mL syringes and to document the procedure in the maintenance log, perform
Quarterly maintenance procedure 5804 Change 1 mL Syringes (c-series), page 763.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
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Removal
Remove the 1 mL syringe
1. Open the bulk solution door.
2. Identify the 1 mL syringe to replace:
– ICT Reference Solution pump
– ICT aspiration pump
– Wash solution pump
3. If the 1 mL syringe to replace is located on the ICT Reference Solution pump or the ICT
aspiration pump, insert the procedure key into the processing module procedure lock and
turn the key to the On setting.
4. To remove the clear plunger shield from the pump, remove the two black knobs.
5. Pull the 1 mL syringe forward to remove it from the syringe holder.
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6. Place an absorbent towel under the pump area to absorb any liquid.
7. Unscrew the syringe assembly from the check valve.
Replacement
Install the 1 mL syringe
1. Screw the new syringe assembly onto the check valve.
2. Install the 1 mL syringe. Ensure that the plunger flange and the bottom of the syringe barrel
are aligned in the syringe holder.
3. Reinstall the clear plunger shield and secure it with the black knobs. Tighten the black
knobs by hand.
4. Remove the absorbent towel from the pump area.
5. Perform the following diagnostic procedures to remove any air that may be present:
– For the ICT Reference Solution pump and the ICT aspiration pump, perform ICT
diagnostic procedure 5102 Flush ICT Module (c-series), page 792.
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– For the wash solution pump, perform Fluidics-Wash diagnostic procedure 4206 Flush
Bulk Solutions (c-series), page 782.
6. Inspect the syringe tubing and connections for drips and leaks during the flush. If drips or
leaks are observed, repeat the installation procedure.
7. If the procedure key was turned on, turn the key to the Off setting and remove the key from
the processing module procedure lock.
8. Close the bulk solution door.
Verification
Run quality control samples
Perform quality control testing to verify the system performance before reporting sample results.
Related information...
Supply and pump center component replacement (c-series), page 864
Use a procedure key to perform a procedure, page 747
Replace the check valves (c-series)
To replace the check valves on the ICT Reference Solution pump, the ICT aspiration pump, or
the wash solution pump, perform the following procedures:
• Removal, page 869
– Remove the check valve, page 869
• Replacement, page 870
– Install the check valve, page 870
• Verification, page 871
– Run quality control samples, page 871
Estimated time 15 minutes
Required materials Absorbent towel
Required instrument Idle
status
Procedure key setting Processing module: Optional On
NOTE: The procedure key setting depends on the location of
the check valve to be replaced. See step 3 of Remove the
check valve, page 869.
Replacement parts • ICT Check Valve, LN 09D3503
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• Wash Solution Check Valve, LN 09D3403
To replace the ICT check valves and to document the procedure in the maintenance log,
perform Quarterly maintenance procedure 5805 Check and Change ICT Check Valves (c-series),
page 764.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
Removal
Remove the check valve
1. Open the bulk solution door.
2. Identify the check valve to replace:
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– ICT Reference Solution check valve
– ICT aspiration check valve
– Wash solution check valve
3. To replace one of the ICT check valves, insert the procedure key into the processing
module procedure lock and turn the key to the On setting.
4. To remove the clear plunger shield from the pump, remove the two black knobs.
5. Pull the 1 mL syringe forward to remove it from the syringe holder.
6. Place an absorbent towel under the pump area to absorb any liquid.
7. Disconnect the top and side tubing from the check valve.
8. Unscrew the check valve from the syringe.
Replacement
Install the check valve
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1. Install the new check valve onto the syringe and tighten the valve by hand.
2. Reattach the tubing to the side and top ports on the check valve and tighten the tubing by
hand.
3. Install the syringe. Ensure that the plunger flange and the bottom of the syringe barrel are
aligned in the syringe holder.
4. Remove the absorbent towel from the pump area.
5. Reinstall the clear plunger shield and secure it with the black knobs. Tighten the black
knobs by hand.
6. Perform the following diagnostic procedures to remove any air that may be present:
– For the ICT Reference Solution pump and the ICT aspiration pump, perform ICT
diagnostic procedure 5102 Flush ICT Module (c-series), page 792.
– For the wash solution pump, perform Fluidics-Wash diagnostic procedure 4206 Flush
Bulk Solutions (c-series), page 782.
7. Inspect the syringe tubing and check valve connections for drips and leaks during the flush.
If drips or leaks are observed, repeat the installation procedure.
8. If the procedure key was turned on, turn the key to the Off setting and remove the key from
the processing module procedure lock.
9. Close the bulk solution door.
Verification
Run quality control samples
Perform quality control testing to verify the system performance before reporting sample results.
Related information...
Supply and pump center component replacement (c-series), page 864
Use a procedure key to perform a procedure, page 747
Replace the wash solution syringe O-ring and seal tips 1 and 2 (c-series)
To replace the wash solution syringe O-ring and seal tips 1 and 2, perform the following
procedures:
• Removal, page 873
– Remove the wash solution syringe, page 873
– Remove the seal tips and the O-ring, page 874
• Replacement, page 876
– Install the seal tips and the O-ring, page 876
– Install the wash solution syringe, page 877
• Verification, page 878
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– Run quality control samples, page 878
Estimated time 22 minutes
Required materials • Phillips screwdriver
• Slotted screwdriver
• 10 mm wrench
• Absorbent towels
• Cotton swabs
Required instrument Processing module: Idle
status
Procedure key setting Processing module: Off
Replacement parts • Sample and Wash Solution Syringe O-ring, LN 09D5203
• Sample and Wash Solution Syringe Seal Tip #1, LN
09D3703
• Sample and Wash Solution Syringe Seal Tip #2, LN
09D3803
To replace the O-rings and seal tips for both wash solution syringes and to document the
procedure in the maintenance log, perform Quarterly maintenance procedure 5802 Wash
Solution Syringe Maintenance (c-series), page 762.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
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Removal
Remove the wash solution syringe
1. Open the bulk solution door and locate the wash solution pump.
2. Unscrew the two black knobs to remove the clear plastic plunger shield.
3. Pull the three 1 mL syringes forward to remove them from the white syringe holder. Do not
disconnect the tubing from the syringes.
4. Place the three 1 mL syringes to the left side of the white syringe holder.
5. Use the Phillips screwdriver to unscrew the two Phillips screws to remove the white syringe
holder.
6. Use the slotted screwdriver to loosen the slotted screw that secures the clear syringe block.
NOTE: The screw is captive and cannot be removed completely.
7. Pull the clear syringe block forward to remove it from the syringe drive.
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8. Place absorbent towels under the clear syringe block to absorb any liquid when the tubing is
disconnected.
9. Disconnect the tubing labeled 2 and labeled 3 from the top and front of the clear syringe
block.
NOTE: Ensure that the black O-rings remain in the clear syringe block after the tubing is
disconnected.
10. Identify the wash solution syringe for which the O-ring and seal tips will be replaced.
Remove the seal tips and the O-ring
1. Use the 10 mm wrench to loosen the nut that secures the syringe plunger to the bottom of
the clear syringe block.
2. Turn the nut by hand until the syringe plunger can be removed from the clear syringe block.
The plunger assembly includes the following parts in order:
a. O-ring
b. Seal tip 2
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c. Spacer
d. Seal tip 1
e. Spring
f. Nut
g. Plunger with the plunger flange
The O-ring can remain in the syringe when the plunger assembly is removed.
3. Remove and discard the following items:
– O-ring
– Seal tip 2
– Seal tip 1
NOTE: Do not discard the spacer. Set aside the spacer and the remainder of the plunger
assembly parts.
Do not remove the spring from the nut.
4. Dry the interior of the syringe barrel with a cotton swab. Dry the plunger completely with an
absorbent towel if liquid is present.
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Replacement
Install the seal tips and the O-ring
1. Install seal tip 1 on the plunger so that the seal tip sits above the spring with the open side
away from the spring.
2. Install the spacer so that it fits into the open side of seal tip 1.
3. Install seal tip 2 on top of the spacer with the open side toward the spacer.
4. Install the O-ring so that it fits into the groove of seal tip 2. Do not push the O-ring out of
alignment. The O-ring must sit flat against the inside of the clear syringe block.
5. Press lightly to push all the components together.
6. Install the plunger assembly into the clear syringe block.
7. Tighten by hand the nut that holds the plunger assembly in the clear syringe block until the
nut is tight.
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NOTE: The nut must be flush with the clear syringe block. If the nut binds when tightening it,
do not apply excessive force. Back out the nut one turn. Then, push in the nut to apply
pressure against the spring and continue to tighten the nut.
8. Use the 10 mm wrench to further tighten the nut, but do not overtighten it.
Install the wash solution syringe
1. Ensure that the black O-rings remain in the clear syringe block.
2. Reattach the knurled connection for the tubing labeled 2 to the top left opening of the clear
syringe block.
3. Reattach the knurled connection for the tubing labeled 3 to the top right opening of the clear
syringe block.
4. Reattach the knurled connection for the tubing labeled 2 from the 1 mL syringe to the front
left opening of the clear syringe block.
5. Reattach the knurled connection for the tubing labeled 3 from the 1 mL syringe to the front
right opening of the clear syringe block.
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6. Remove the absorbent towels under the clear syringe block.
7. Place the wash solution syringe block on the alignment pins and tighten the slotted screw by
hand until the screw is tight.
8. Further tighten the slotted screw with the slotted screwdriver.
9. Ensure that the plunger flanges are seated on the metal block beneath the syringes.
10. Replace the white syringe holder and tighten the two Phillips screws with the Phillips
screwdriver.
11. Verify that the 1 mL syringe tubing connections did not loosen during the removal and
replacement procedure.
12. Reinstall the 1 mL syringes into the syringe holder in the following order:
a. For the 1 mL syringe with tubing labeled 2, place the syringe in the left syringe holder
position.
b. For the 1 mL syringe with no tubing label, place the syringe in the center syringe holder
position.
c. For the 1 mL syringe with tubing labeled 3, place the syringe in the right syringe holder
position.
13. Ensure that the 1 mL syringe plunger flanges and the bottom of the syringe barrels are
aligned in the syringe holder.
14. Attach the clear plastic plunger shield and tighten the two black knobs by hand.
15. To remove any air that may be present, perform Fluidics-Wash diagnostic procedure 4205
Flush Water Lines (c-series), page 782.
16. Inspect the syringe tubing and connections for drips and leaks during the flush. If drips or
leaks are observed, repeat the installation procedure.
17. Close the bulk solution door.
Verification
Run quality control samples
Perform quality control testing to verify the system performance before reporting sample results.
Related information...
Supply and pump center component replacement (c-series), page 864
Use a procedure key to perform a procedure, page 747
Replace the reagent syringe O-ring and seal tips 1 and 2 (c-series)
To replace the reagent syringe O-ring and seal tips 1 and 2, perform the following procedures:
• Removal, page 880
– Remove the reagent syringe, page 880
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– Remove the seal tips and the O-ring, page 881
• Replacement, page 883
– Install the seal tips and the O-ring, page 883
– Install the reagent syringe, page 884
• Verification, page 885
– Run quality control samples, page 885
Estimated time 22 minutes
Required materials • Phillips screwdriver
• Slotted screwdriver
• 15 mm wrench
• Absorbent towels
• Cotton swabs
Required instrument Processing module: Idle
status
Procedure key setting Processing module: Off
Replacement parts • Reagent syringe O-ring, LN 09D5303
• Reagent Syringe Seal Tip #1, LN 09D3903
• Reagent Syringe Seal Tip #2, LN 09D4004
To replace the O-rings and seal tips for both the R1 and R2 reagent syringes and to document
the procedure in the maintenance log, perform Quarterly maintenance procedure 5803 Reagent
Syringe Maintenance (c-series), page 763.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
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Removal
Remove the reagent syringe
1. Open the bulk solution door and locate the syringe cover for the sample and reagent
syringes.
2. Remove the sample and reagent syringe tubing from the clamps on the syringe cover.
3. Use the Phillips screwdriver to loosen the two Phillips screws enough to pull the cover away
from the syringes.
4. Identify the reagent syringe for which the O-rings and seal tips will be replaced.
5. Use the slotted screwdriver to loosen the slotted screw that secures the syringe block. Do
not attempt to remove the syringe block.
6. Use the slotted screwdriver to loosen the slotted screw that holds the syringe bracket over
the syringe plunger. Do not remove the screw or the syringe bracket.
7. Pull the reagent syringe away from the syringe drive and the syringe bracket.
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8. Place an absorbent towel under the reagent syringe to absorb any liquid.
9. Unscrew the knurled connections at the top and side of the syringe block to disconnect the
tubing.
NOTE: Ensure that the black O-rings remain in the syringe block after the tubing is
disconnected.
Remove the seal tips and the O-ring
1. Use the 15 mm wrench to loosen the nut that secures the syringe plunger to the bottom of
the syringe block.
2. Turn the nut by hand until the syringe plunger can be removed from the syringe block.
The plunger assembly includes the following parts in order:
a. O-ring
b. Seal tip 2
c. Spacer
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d. Seal tip 1
e. Spring
f. Nut
g. Plunger with the plunger flange
The O-ring can remain in the syringe when the plunger assembly is removed.
3. Remove and discard the following items:
– O-ring
– Seal tip 2
– Seal tip 1
NOTE: Do not discard the spacer. Set aside the spacer and the remainder of the plunger
assembly parts.
Do not remove the spring from the nut.
4. Dry the interior of the syringe barrel with a cotton swab. Dry the plunger completely with an
absorbent towel if liquid is present.
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Replacement
Install the seal tips and the O-ring
1. Install seal tip 1 on the plunger so that the seal tip sits above the spring with the open side
away from the spring.
2. Install the spacer so that it fits into the open side of seal tip 1.
3. Install seal tip 2 on top of the spacer with the open side toward the spacer.
4. Install the O-ring so that it fits into the groove of seal tip 2. Do not push the O-ring out of
alignment. The O-ring must sit flat against the inside of the syringe block.
5. Press lightly to push all the components together.
6. Install the plunger assembly into the syringe block.
7. Tighten by hand the nut that holds the plunger assembly in the syringe block until the nut is
tight.
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NOTE: The nut must be flush with the syringe block. If the nut binds when tightening it, do
not apply excessive force. Back out the nut one turn. Then, push in the nut to apply
pressure against the spring and continue to tighten the nut.
8. Use the 15 mm wrench to further tighten the nut, but do not overtighten it.
Install the reagent syringe
1. Ensure that the black O-rings remain in the syringe block.
2. Reattach the knurled connections at the top and side of the syringe block to connect the
tubing.
3. Remove the absorbent towel from the syringe drive area.
4. Insert the plunger flange into the syringe bracket. Align the reagent syringe block with the
pin on the syringe drive.
5. Push the reagent syringe block onto the syringe drive. Ensure that the syringe plunger is
pushed back into the U-shape of the syringe bracket.
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6. Place the syringe block on the alignment pin and tighten the slotted screw by hand until the
screw is tight.
7. Further tighten the slotted screw with the slotted screwdriver.
8. Use the slotted screwdriver to tighten the slotted screw that holds the syringe bracket to the
syringe drive.
9. Replace the syringe cover and tighten the two Phillips screws with the Phillips screwdriver.
10. Replace the sample and reagent syringe tubing in the clamps on the syringe cover.
11. To remove any air that may be present, perform Fluidics-Wash diagnostic procedure 4205
Flush Water Lines (c-series), page 782.
12. Inspect the syringe tubing and connections for drips and leaks during the flush. If drips or
leaks are observed, repeat the installation procedure.
13. Close the bulk solution door.
Verification
Run quality control samples
Perform quality control testing to verify the system performance before reporting sample results.
Related information...
Supply and pump center component replacement (c-series), page 864
Use a procedure key to perform a procedure, page 747
Replace the sample syringe O-ring and seal tips 1 and 2 (c-series)
To replace the sample syringe O-ring and seal tips 1 and 2, perform the following procedures:
• Removal, page 887
– Remove the sample syringe, page 887
– Remove the seal tips and the O-ring, page 888
• Replacement, page 890
– Install the seal tips and the O-ring, page 890
– Install the sample syringe, page 891
• Verification, page 892
– Run quality control samples, page 892
Estimated time 12 minutes
Required materials • Phillips screwdriver
• Slotted screwdriver
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• 10 mm wrench
• Absorbent towels
• Cotton swabs
Required instrument Processing module: Idle
status
Procedure key setting Processing module: Off
Replacement parts • Sample and Wash Solution Syringe O-ring, LN 09D5203
• Sample and Wash Solution Syringe Seal Tip #1, LN
09D3703
• Sample and Wash Solution Syringe Seal Tip #2, LN
09D3803
To replace the O-ring and seal tips for the sample syringe and to document the procedure in the
maintenance log, perform Quarterly maintenance procedure 5801 Sample Syringe Maintenance
(c-series), page 761.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
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Removal
Remove the sample syringe
1. Open the bulk solution door and locate the syringe cover for the sample and reagent
syringes.
2. Remove the sample and reagent syringe tubing from the clamps on the syringe cover.
3. Use the Phillips screwdriver to loosen the two Phillips screws enough to pull the cover away
from the syringes.
4. Identify the sample syringe.
5. Use the slotted screwdriver to loosen the slotted screw that secures the syringe block. Do
not attempt to remove the syringe block.
6. Use the slotted screwdriver to loosen the slotted screw that holds the syringe bracket over
the syringe plunger. Do not remove the screw or the syringe bracket.
7. Pull the sample syringe away from the syringe drive and the syringe bracket.
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8. Place an absorbent towel under the sample syringe to absorb any liquid.
9. Unscrew the knurled connections at the top and side of the syringe block to disconnect the
tubing.
NOTE: Ensure that the black O-rings remain in the syringe block after the tubing is
disconnected.
Remove the seal tips and the O-ring
1. Use the 10 mm wrench to loosen the nut that secures the syringe plunger to the bottom of
the syringe block.
2. Turn the nut by hand until the syringe plunger can be removed from the syringe block.
The plunger assembly includes the following parts in order:
a. O-ring
b. Seal tip 2
c. Spacer
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d. Seal tip 1
e. Spring
f. Nut
g. Plunger with the plunger flange
The O-ring can remain in the syringe when the plunger assembly is removed.
3. Remove and discard the following items:
– O-ring
– Seal tip 2
– Seal tip 1
NOTE: Do not discard the spacer. Set aside the spacer and the remainder of the plunger
assembly parts.
Do not remove the spring from the nut.
4. Dry the interior of the syringe barrel with a cotton swab. Dry the plunger completely with an
absorbent towel if liquid is present.
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Replacement
Install the seal tips and the O-ring
1. Install seal tip 1 on the plunger so that the seal tip sits above the spring with the open side
away from the spring.
2. Install the spacer so that it fits into the open side of seal tip 1.
3. Install seal tip 2 on top of the spacer with the open side toward the spacer.
4. Install the O-ring so that it fits into the groove of seal tip 2. Do not push the O-ring out of
alignment. The O-ring must sit flat against the inside of the syringe block.
5. Press lightly to push all the components together.
6. Install the plunger assembly into the syringe block.
7. Tighten by hand the nut that holds the plunger assembly in the syringe block until the nut is
tight.
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NOTE: The nut must be flush with the syringe block. If the nut binds when tightening it, do
not apply excessive force. Back out the nut one turn. Then, push in the nut to apply
pressure against the spring and continue to tighten the nut.
8. Use the 10 mm wrench to further tighten the nut, but do not overtighten it.
Install the sample syringe
1. Ensure that the black O-rings remain in the syringe block.
2. Reattach the knurled connections at the top and side of the syringe block to connect the
tubing.
3. Remove the absorbent towel from the syringe drive area.
4. Insert the plunger flange into the syringe bracket. Align the sample syringe block with the pin
on the syringe drive.
5. Push the sample syringe block onto the syringe drive. Ensure that the syringe plunger is
pushed back into the U-shape of the bracket.
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6. Place the syringe block on the alignment pin and tighten the slotted screw by hand until the
screw is tight.
7. Further tighten the slotted screw with the slotted screwdriver.
8. Use the slotted screwdriver to tighten the slotted screw that holds the syringe bracket to the
syringe drive.
9. Replace the syringe cover and tighten the two Phillips screws with the Phillips screwdriver.
10. Replace the sample and reagent syringe tubing in the clamps on the syringe cover.
11. To remove any air that may be present, perform Fluidics-Wash diagnostic procedure 4205
Flush Water Lines (c-series), page 782.
12. Inspect the syringe tubing and connections for drips and leaks during the flush. If drips or
leaks are observed, repeat the installation procedure.
13. Close the bulk solution door.
Verification
Run quality control samples
Perform quality control testing to verify the system performance before reporting sample results.
Related information...
Supply and pump center component replacement (c-series), page 864
Use a procedure key to perform a procedure, page 747
Processing center component replacement (i-series)
Certain processing center components may need to be replaced because of normal wear from
daily system operation. The following illustration shows the location of each replaceable
component. Step-by-step instructions are provided for each replaceable components.
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Figure 160: Processing center components (i-series)
Legend:
1. Wash zone 2 probes (WZ2)
2. Sample pipettor probe (S)
3. Wash zone 1 probes (WZ1)
4. Liquid waste arm probe
5. Reagent pipettor probe (R1)
6. Reagent pipettor probe (R2)
Related information...
Component replacement, page 827
Replace a sample or reagent pipettor probe (i-series), page 894
Replace the wash zone probes (i-series), page 897
Replace the liquid waste arm probe (i-series), page 900
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Replace a sample or reagent pipettor probe (i-series)
To replace a sample or reagent pipettor probe, perform the following procedures:
• Removal, page 895
– Remove the pipettor probe, page 895
• Replacement, page 896
– Install the pipettor probe, page 896
• Verification, page 897
– Perform a pipettor probe calibration, page 897
Estimated time 20 minutes
Required materials Absorbent towel
Required instrument Warming or Idle
status
Procedure key setting Processing module: Required On
Replacement parts Pipettor Probe, LN 03R9601
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Probe Stick Hazard. This activity or area may expose you to probes.
CAUTION: Moving Parts. This activity or area may expose you to moving parts.
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Removal
Remove the pipettor probe
1. Insert the procedure key into the processing module procedure lock and turn the key to the
On setting.
2. Lift the rear processing center cover to access the pipettor probe.
3. Place an absorbent towel under the probe tubing connection.
4. Loosen the metal fitting on the probe and remove the probe tubing from the probe.
5. Rotate the probe retainer counterclockwise until it clears the probe.
6. Lift the probe and remove it from the boom arm.
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Replacement
Install the pipettor probe
1. Slide the pipettor probe into the boom arm.
2. Rotate the probe retainer clockwise until the probe is secured.
3. Align the probe tubing with the probe and tighten the probe fitting by hand.
4. To remove any air that may be present, perform Fluidics-Wash diagnostic procedure 1200
Flush and Prime Fluidics (i-series), page 804, Flush Wash Buffer, All option.
While performing the flush, inspect the probe for drips and inspect the probe tubing and
connections for leaks. If drips or leaks are observed, repeat the installation procedure.
5. Remove the absorbent towel.
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Verification
Perform a pipettor probe calibration
1. Perform the appropriate Pipettor diagnostic procedure:
– 1111 Sample Pipettor Check and Calibration (i-series), page 796
– 1112 R1 Pipettor Check and Calibration (i-series), page 797
– 1113 R2 Pipettor Check and Calibration (i-series), page 797
2. Close the rear processing center cover.
3. Turn the procedure key to the Off setting and remove the key from the processing module
procedure lock.
Related information...
Processing center component replacement (i-series), page 892
Use a procedure key to perform a procedure, page 747
Replace the wash zone probes (i-series)
To replace one or more wash zone probes, perform the following procedures:
• Removal, page 898
– Remove the wash zone probe, page 898
• Replacement, page 899
– Install the wash zone probe, page 899
• Verification, page 900
– Calibrate and test the wash monitoring, page 900
Estimated time 20 minutes
Required materials None
Required instrument Warming or Idle
status
Procedure key setting Processing module: Required On
Replacement parts Wash Zone Probe, LN 04S6601
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Probe Stick Hazard. This activity or area may expose you to probes.
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CAUTION: Moving Parts. This activity or area may expose you to moving parts.
Removal
Remove the wash zone probe
1. Insert the procedure key into the processing module procedure lock and turn the key to the
On setting.
2. Lift the rear processing center cover to access the wash zone probes.
3. Locate the wash zone probe to replace on the appropriate wash zone.
4. To disconnect the electrical connector from the WZ ASP cable, press the connector tab and
pull apart the electrical connector and the connector tab.
5. Unscrew the thumbscrew that secures the probe block assembly to the wash zone elevator
assembly.
6. Lift the probe block assembly to access the wash zone probe tubing.
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7. To disconnect the wash zone probe tubing from the wash zone probes, gently pull the tubing
and slide it off each probe.
8. Invert the probe block assembly so that the wash zone probes are facing upward.
9. Unscrew the two thumbscrews that secure the wash zone monitor housing (black) to the
probe housing (blue). Do not disconnect the two assemblies.
10. With the wash zone monitor housing and the probe housing still connected, invert the probe
block assembly so that the wash zone probes are facing downward.
11. Disconnect the wash zone monitor housing from the probe housing.
12. Remove the wash zone probe.
Replacement
Install the wash zone probe
1. Slide the wash zone probe into the probe housing (blue).
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2. Align the L-shaped cutout of the wash zone monitor housing (black) with the L-shaped
cutout of the probe housing. Guide the wash zone probes into the probe channel in the
wash zone monitor housing.
3. With the wash zone monitor housing and the probe housing connected, invert the probe
block assembly so that the wash zone probes are facing upward.
4. Tighten the two thumbscrews that secure the wash zone monitor housing to the probe
housing.
5. Push the wash zone probe tubing onto the wash zone probe until the tubing passes the ridge
on the probe.
NOTE: Position the tubing halfway between the bend and the ridge of the probe.
6. To install the probe block assembly on the wash zone elevator assembly, align the holes on
the probe block assembly with the pins on the wash zone elevator assembly.
7. Tighten the thumbscrew that secures the probe block assembly to the wash zone elevator
assembly.
8. To reconnect the electrical connector to the WZ ASP cable, align the notch on the electrical
connector with the connector tab.
Verification
Calibrate and test the wash monitoring
Perform the appropriate Fluidics-Wash diagnostic procedure:
• 1261 Wash Zone 1 Wash Monitoring (i-series), page 813, Calibrate and Test option
• 1262 Wash Zone 2 Wash Monitoring (i-series), page 814, Calibrate and Test option
Related information...
Processing center component replacement (i-series), page 892
Use a procedure key to perform a procedure, page 747
Replace the liquid waste arm probe (i-series)
To replace the waste arm probe, perform the following procedures:
• Removal, page 902
– Remove the liquid waste arm probe, page 902
• Replacement, page 903
– Install the liquid waste arm probe, page 903
• Verification, page 903
– Perform a wash zone prime, page 903
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Estimated time 10 minutes
Required materials None
Required instrument Warming or Idle
status
Procedure key setting Processing module: Required On
Replacement parts Wash Zone Probe, LN 04S6601
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Probe Stick Hazard. This activity or area may expose you to probes.
CAUTION: Moving Parts. This activity or area may expose you to moving parts.
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Removal
Remove the liquid waste arm probe
1. Insert the procedure key into the processing module procedure lock and turn the key to the
On setting.
2. Lift the front processing center cover to access the liquid waste arm probe.
3. Remove the liquid waste arm probe tubing from the tubing clips on the liquid waste arm.
4. Lift the probe and remove it from the front of the liquid waste arm.
5. To disconnect the liquid waste arm probe tubing from the probe, gently pull the tubing and
slide it off the probe.
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Replacement
Install the liquid waste arm probe
1. Push the liquid waste arm probe tubing onto the liquid waste arm probe until the tubing
passes the ridge on the probe.
NOTE: Position the tubing halfway between the bend and the ridge of the probe.
2. Slide the probe into the front of the liquid waste arm until the probe is seated completely.
3. Insert the liquid waste arm probe tubing into the tubing clips on the liquid waste arm.
Verification
Perform a wash zone prime
1. Perform Fluidics-Wash diagnostic procedure 1200 Flush and Prime Fluidics (i-series), page
804, Flush and Prime Manifolds, Wash Zone 1 option.
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While performing the prime, observe the liquid waste arm probe tubing and confirm that
liquid is dispensed through the tubing.
2. Close the front processing center cover.
3. Turn the procedure key to the Off setting and remove the key from the processing module
procedure lock.
Related information...
Processing center component replacement (i-series), page 892
Use a procedure key to perform a procedure, page 747
Supply center component replacement (i-series)
Certain supply center components may need to be replaced because of normal wear from daily
system operation. The following illustration shows the location of each replaceable component.
Step-by-step instructions are provided for each replaceable component.
Figure 161: Bulk solution reservoir components (i-series)
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Legend:
1. Concentrated Wash Buffer level sensor
2. Pre-Trigger Solution level sensor
3. Trigger Solution level sensor
Figure 162: Pump drawer component (i-series)
Legend:
1. Diluted wash buffer level sensor
Related information...
Component replacement, page 827
Replace the level sensor for Pre-Trigger Solution, Trigger Solution, or Concentrated Wash Buffer
(i-series), page 906
Replace the diluted wash buffer level sensor (i-series), page 909
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Replace the level sensor for Pre-Trigger Solution, Trigger Solution, or Concentrated Wash
Buffer (i-series)
To replace the level sensor for Pre-Trigger Solution, Trigger Solution, or Concentrated Wash
Buffer, perform the following procedures:
• Removal, page 907
– Remove the bulk solution level sensor, page 907
• Replacement, page 908
– Install the bulk solution level sensor, page 908
• Verification, page 909
– Verify the functionality of the bulk solution level sensors, page 909
Estimated time 15 minutes
Required materials Absorbent towel
Required instrument Warming or Idle
status
Procedure key setting Processing module: Off
Replacement parts Level sensor, bulk solution, LN 04S6801
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
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Removal
Remove the bulk solution level sensor
1. Open the bulk solution door and pull out the reservoir tray.
NOTE: Use caution when handling the bulk solution level sensors. Avoid applying stress on
the wiring and connector.
2. Disconnect the electrical connector from the appropriate bulk solution level sensor.
3. Use an absorbent towel to absorb any spills.
4. Unscrew the two tubing fittings from the bulk solution level sensor.
5. Unscrew the bulk solution level sensor cap.
6. Remove the bulk solution level sensor from the reservoir.
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Replacement
Install the bulk solution level sensor
1. Place the bulk solution level sensor into the container.
2. Tighten the bulk solution level sensor cap.
3. Connect the tubing from the bulk solution transfer pump to the input connector (labeled with
an arrow that points toward the connector) on the bulk solution level sensor.
4. Connect the tubing from the syringe pump to the output connector (labeled with an arrow
that points away from the connector) on the bulk solution level sensor.
5. Connect the electrical connector of the bulk solution level sensor.
6. Start the processing module.
7. To remove any air that may be present, perform Fluidics-Wash diagnostic procedure 1200
Flush and Prime Fluidics (i-series), page 804 for the appropriate bulk solution.
Perform one of the following procedure options:
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– Flush Pre-Trigger and Trigger
– Prime Dilution Assembly
While performing the flush, inspect the tubing and connections of the bulk solution level
sensor for drips and leaks. If drips or leaks are observed, repeat the installation procedure.
8. Slide the reservoir bottle tray into the bulk solution reservoir area and close the bulk solution
door.
Verification
Verify the functionality of the bulk solution level sensors
Perform Fluidics-Wash diagnostic procedure 1270 Bulk Solutions Motors and Sensors Test (i-
series), page 815, Read All Sensors option.
Related information...
Supply center component replacement (i-series), page 904
Start the processing module and the reagent and sample manager (RSM), page 447
Replace the diluted wash buffer level sensor (i-series)
To replace the level sensor for the diluted wash buffer, perform the following procedures:
• Removal, page 910
– Remove the diluted wash buffer level sensor, page 910
• Replacement, page 911
– Install the diluted wash buffer level sensor, page 911
• Verification, page 912
– Verify the functionality of the diluted wash buffer level sensor, page 912
Estimated time 15 minutes
Required materials • Absorbent tissue
• Lock ring release tool
Required instrument Warming or Idle
status
Procedure key setting Processing module: Off
Replacement parts Level Sensor, Diluted Wash Buffer, LN 04S6901
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
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CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
Removal
Remove the diluted wash buffer level sensor
1. Remove the rear fluidics panel and pull out the pump drawer.
NOTE: Use caution when handling the diluted wash buffer level sensor. Avoid applying
stress on the wiring and connector.
2. Disconnect the electrical connector from the diluted wash buffer level sensor.
3. Use absorbent tissue to absorb any spills.
4. Insert the lock ring release tool between the tube fitting and the diluted wash buffer level
sensor.
5. Press the lock ring release tool toward the diluted wash buffer level sensor and pull the
tubing straight out of the level sensor.
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6. Repeat steps 4, page 910 and 5, page 910 to remove the remaining tubing.
7. Unscrew the diluted wash buffer level sensor cap.
8. Remove the diluted wash buffer level sensor from the reservoir.
Replacement
Install the diluted wash buffer level sensor
1. Place the diluted wash buffer level sensor into the container.
2. Tighten the diluted wash buffer level sensor cap.
3. Connect the tubing from the buffer waste valve (located at the top of the dilution assembly
tray) to the input connector (labeled with an arrow that points toward the connector) on the
diluted wash buffer level sensor.
4. Align the tubing connector with the fitting and press the connector straight into the fitting.
5. Connect the tubing from the manifold in the pump drawer to the output connector (labeled
with an arrow that points away from the connector) on the diluted wash buffer level sensor.
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6. Align the tubing connector with the fitting and press the connector straight into the fitting.
7. Slightly pull the connector to confirm that it is connected completely.
8. Connect the electrical connector of the diluted wash buffer level sensor.
9. Start the processing module.
10. To remove any air that may be present, perform Fluidics-Wash diagnostic procedure 1200
Flush and Prime Fluidics (i-series), page 804, Flush Wash Buffer option.
While performing the flush, inspect the tubing and connections of the diluted wash buffer
level sensor for drips and leaks. If drips or leaks are observed, repeat the installation
procedure.
11. Slide the pump drawer into the rear fluidics area and replace the rear fluidics panel.
Verification
Verify the functionality of the diluted wash buffer level sensor
Perform Fluidics-Wash diagnostic procedure 1270 Bulk Solutions Motors and Sensors Test (i-
series), page 815, Read All Sensors option.
Related information...
Supply center component replacement (i-series), page 904
Start the processing module and the reagent and sample manager (RSM), page 447
Optional component replacement
Certain optional components may need to be replaced because of normal wear from daily
system operation.
Step-by-step instructions are provided for each replaceable component.
Related information...
Component replacement, page 827
Replace the external waste pump (i-series), page 912
Replace the external waste pump (i-series)
To replace the external waste pump, perform the following procedures:
• Removal, page 913
– Remove the external waste pump, page 913
• Replacement, page 914
– Install the external waste pump, page 914
• Verification, page 915
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– Perform a flush procedure, page 915
Estimated time 20 minutes
Required materials None
Required instrument Warming or Idle
status
Procedure key setting Processing module: Off
Replacement parts External Waste Pump, LN 04S7401
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
Removal
Remove the external waste pump
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1. Power off the external waste pump.
2. Unplug the power cord from the external waste pump.
3. Disconnect the waste outlet quick disconnect.
4. Disconnect the inlet quick disconnect.
Replacement
Install the external waste pump
1. Move the voltage switch on the external waste pump assembly to the correct position (115 V
or 230 V) according to the voltage requirements of the country.
2. Attach the power cord.
3. Connect the inlet lines.
4. Connect the outlet waste line.
5. Power on the external waste pump.
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6. Press and hold the manual operation switch until the pump turns on.
7. Release the manual operation switch to leave the pump in Automatic mode.
Verification
Perform a flush procedure
Perform the appropriate Fluidics-Wash diagnostic procedure consecutive times to verify that the
external waste pump turns on and transports the waste fluid to the drain:
• 4205 Flush Water Lines (c-series), page 782
• 1200 Flush and Prime Fluidics (i-series), page 804, Flush Wash Buffer, All option
Related information...
Optional component replacement, page 912
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NOTES
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Section 10 Troubleshooting
Introduction
Problems with the Alinity ci-series are characterized by symptoms. Troubleshooting tools,
references, and suggested techniques help to trace the symptom to one or more root causes.
After determining the root cause, perform the corrective actions to resolve the problem.
Related information...
Approach to troubleshooting, page 918
Alert Center flyout, page 927
System Logs screen, page 930
Message codes, page 941
Observed problems, page 1263
Miscellaneous corrective action procedures, page 1290
Service, maintenance, and diagnostics, page 739
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Approach to troubleshooting Section 10
Approach to troubleshooting
To identify and resolve operational problems, become thoroughly familiar with normal system
operation. Effective troubleshooting requires a logical, step-by-step approach to resolve
problems. This approach focuses on the following activities:
• Observation, recognition, and categorization of symptoms
• Identification of the probable cause
• Systematic elimination of each potential problem (from the most likely problem to the least
likely problem)
The following troubleshooting model describes a five-step approach to define symptoms, identify
problems, and implement solutions. To troubleshoot the system, include considerations that are
appropriate to the laboratory environment.
1. Observe and recognize symptoms.
To analyze and resolve a problem, investigate what is incorrect and observe what is correct.
Symptoms help to identify the problem area and to eliminate areas that operate correctly.
Examples of symptoms include:
– Message codes.
– Observed problems such as a noise, a fluid leak, a monitor that flickers, or a trend in
controls.
2. Categorize symptoms.
To eliminate symptoms automatically as probable causes, classify symptoms by categories.
Categories of symptoms include:
– System
– Reagents
– Operator
– Environmental
3. Isolate the root cause and create a plan of action.
Based on the probable causes that are identified, devise a plan that first addresses the most
likely cause and then progresses to the least likely cause.
Address one probable cause at a time to isolate the resolution, and then apply the resolution
to a specific problem. Diagnostic resources and tools include:
– Message codes and messages.
– System logs.
– Control information.
– Maintenance and diagnostic procedures.
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– This manual or the Help. Specific reference topics include the following sections in this
manual:
• Troubleshooting
• Service, maintenance, and diagnostics
• Performance characteristics and specifications
• Principles of operation
– The product documentation such as reagent and consumable information.
4. Resolve the problem.
Carefully perform the required steps to resolve the problem. Problems can be resolved by
the following actions:
– Make adjustments, such as tighten connections.
– Perform a calibration.
– Replace or repair system components.
– Run new controls.
5. Verify that the resolution worked.
Verify that symptoms do not occur:
– Perform the appropriate verification procedure.
– Confirm control values if appropriate.
If symptoms continue to occur, perform the steps to resolve the next most likely problem. Repeat
this process until the problem is resolved.
Related information...
Troubleshooting, page 917
System troubleshooting variables (c-series), page 919
System troubleshooting variables (i-series), page 921
Reagent troubleshooting variables (c-series), page 923
Reagent troubleshooting variables (i-series), page 924
Operator troubleshooting variables, page 925
Environmental troubleshooting variables, page 926
System troubleshooting variables (c-series)
The system category is a high-level group of symptoms that relate to system performance. This
category contains more specific subcategories or variables. Trace an error or a problem to one
of these variables to begin to isolate the probable cause.
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Approach to troubleshooting Section 10
Fluidics subsystems
Fluidics subsystems are hardware components that control the precision and accuracy of liquid
level sensing, aspiration, and dispense. In addition, these components distribute the fluids used
to wash the probes:
Examples • Pipettors and probes
• Pressure monitors
• Syringes and valves
• Tubing
• Processing module circuit boards
• Pumps
• ICT unit
Symptoms • LLS and fluidics message codes (3000-3999)
• Imprecise results or erratic results
Optical subsystem
The optical subsystem has hardware components that control concise and accurate optical
readings:
Examples • Lamp
• Heat absorbing filter
• Lenses
• Cuvettes
• Water bath
• Optics
Symptoms • Optical read message codes (4000-4999)
• Shift in values
Hardware
The hardware has mechanical components that move consumables and samples through the
system and distribute power and electrical signals:
Examples • Reagent carousel
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• Reaction carousel
• Sensors
• RSM bar code reader
Symptoms • Robotics and sensor message codes (5000-5999)
• Bar code read message codes (4000-4999)
• Homing failures, jams, and step losses
Software
The software has computer instructions that interpret the system and assay information,
calculate results, and provide the interface to control the system hardware:
Examples System, assay, maintenance, and diagnostic software
Symptoms • Software message codes (9000-9999)
• Inability to power on the system control module
Consumables
Consumables are supplies that are necessary to run assays:
Examples • Sample cups
• Bulk solutions
• Reagent cartridges
• Onboard solutions
Symptoms Imprecise results or erratic results
Related information...
Approach to troubleshooting, page 918
System troubleshooting variables (i-series)
The system category is a high-level group of symptoms that relate to system performance. This
category contains more specific subcategories or variables. Trace an error or a problem to one
of these variables to begin to isolate the probable cause.
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Approach to troubleshooting Section 10
Fluidics subsystems
Fluidics subsystems are hardware components that control the precision and accuracy of liquid
level sensing, aspiration, and dispense. In addition, these components distribute the fluids used
to wash the probes:
Examples • Pipettors and probes
• Liquid level sense (LLS) antennae
• Syringes and valves
• Pumps
Symptoms • LLS and fluidics message codes (3000-3999)
• Imprecise results or erratic results
Optical subsystem
The optical subsystem has hardware components that control concise and accurate optical
readings:
Examples • Optics
• Shutter
• Read magnet
Symptoms • Optical read message codes (4000-4999)
• Shift in values
Hardware
The hardware has mechanical components that move consumables and samples through the
system and distribute power and electrical signals:
Examples • Reagent carousel
• Sensors
• RV loader
• RSM bar code reader
Symptoms • Robotics and sensor message codes (5000-5999)
• Bar code read message codes (4000-4999)
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• Homing failures, jams, and step losses
Software
The software has computer instructions that interpret the system and assay information,
calculate results, and provide the interface to control the system hardware:
Examples System, assay, maintenance, and diagnostic software
Symptoms • Software message codes (9000-9999)
• Inability to power on the system control module
Consumables
Consumables are supplies that are necessary to run assays:
Examples • Sample cups
• Bulk solutions
• Reaction vessels
Symptoms Imprecise results or erratic results
Related information...
Approach to troubleshooting, page 918
Reagent troubleshooting variables (c-series)
The reagent category is a high-level group of symptoms that relate to the processing of results.
This category contains more specific subcategories or variables. Trace an error or a problem to
one of these variables to begin to isolate the probable cause.
Reagent kits
Reagent kits contain consumables that detect and measure the specific analyte presence or
concentration in samples:
Examples • Reagents
• Sample diluents
• Pretreatments
Symptoms • Controls that fall outside the range
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Approach to troubleshooting Section 10
• Trends and shifts in control results or patient results
Calibrators
Calibrators are samples with known concentrations of analytes that are used to create the
calibration against which samples are measured:
Examples Analyte-specific and multiconstituent calibrators
Symptoms Shifts in control results and patient results
Controls
Controls are samples with known concentrations of analytes that are used for performance
monitoring within a clinical range:
Examples Analyte-specific and multiconstituent controls
Symptoms • Controls that fall outside the range
• Imprecise control results
• Trends and shifts in control results or patient results
Related information...
Approach to troubleshooting, page 918
Reagent troubleshooting variables (i-series)
The reagent category is a high-level group of symptoms that relate to the processing of results.
This category contains more specific subcategories or variables. Trace an error or a problem to
one of these variables to begin to isolate the probable cause.
Reagent cartridges
Reagent cartridges contain consumables that detect and measure the specific analyte presence
or concentration in samples:
Examples • Antibody-coated microparticles
• Conjugate
• Assay-specific diluent
Symptoms • Controls that fall outside the range
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• Trends and shifts in control results or patient results
Calibrators
Calibrators are samples with known concentrations of analytes that are used to create the
calibration against which samples are measured:
Examples Analyte-specific calibrators
Symptoms Shifts in control results and patient results
Controls
Controls are samples with known concentrations of analytes that are used for performance
monitoring within a clinical range:
Examples Analyte-specific and multiconstituent controls
Symptoms • Controls that fall outside the range
• Imprecise control results
• Trends and shifts in control results or patient results
Related information...
Approach to troubleshooting, page 918
Operator troubleshooting variables
The operator category is a group of symptoms that relate to correct system operation and
maintenance. Within this category, the actions of one operator or multiple operators can result in
a variety of symptoms:
Examples A new user and a trained operator
Symptoms • Bubbles in reagents or samples
• Particulate matter or fibrin in samples
• General message codes (0001-0999)
• Assay-specific message codes (1000-1999)
• Message codes that are generated because of incorrect
maintenance or incorrect component replacement
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Approach to troubleshooting Section 10
Related information...
Approach to troubleshooting, page 918
Environmental troubleshooting variables
The environmental category is a high-level group of symptoms that relate to the processing of
results. This category contains more specific subcategories or variables. Trace an error or a
problem to one of these variables to begin to isolate the probable cause.
Physical requirements
Physical requirements identify the environmental conditions that are needed for optimal system
performance:
Examples • Room temperature and humidity
• Location and instrument clearances
• Water quality
Symptoms • Temperature message codes (7000-7999)
• Inadequate airflow
Electrical requirements
Electrical requirements identify the power requirements that are needed for optimal system
performance and optical readings:
Examples Power outlet, voltages, and dedicated line
Symptom Loss of power to the system
Host interface components
Host interface components enable communication between the host interface and the Alinity ci-
series:
Examples Ports, cables, and connections
Symptoms Communication message codes (8000-8999)
Related information...
Approach to troubleshooting, page 918
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Section 10 Alert Center flyout
Alert Center flyout
In the Alert Center flyout, the operator can view the following information:
• The last 25 alerts and notifications.
• The probable cause and corrective action for a message.
The operator can clear all messages in the Alert Center flyout.
Related information...
Troubleshooting, page 917
Alert Center flyout element descriptions, page 927
View the probable cause and corrective action for a message, page 928
View additional messages that are associated with a message, page 928
Delete a message from the Alert Center, page 929
Alert Center flyout element descriptions
The Alert Center flyout displays alert and notification messages for system problems that require
attention. The Alert Center stores a maximum of 25 messages that are sorted based on newest
to oldest. Messages are displayed in the Alert Center until they are cleared.
Elements
All tab Displays all alert and notification messages generated.
Alerts tab Displays all alert messages generated.
Notifications tab Displays all notification messages generated.
Function buttons
Done Saves changes and either displays the previously viewed
screen or closes the flyout.
Clear All Displays a message requesting confirmation to clear all
messages in the Alert Center. Individual messages can be
cleared by tapping the X in the upper-right corner of the
message. Cleared messages are retained in system logs.
Show Logs Navigates to the System Logs screen.
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Alert Center flyout Section 10
? Message Displays Help from the operations manual for the selected
message code.
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
Alert Center flyout, page 927
View the probable cause and corrective action for a message
Perform this procedure to view the probable cause and corrective action for a message.
1. On the menu bar, tap Alert Center.
2. In the Alert Center flyout, tap a message to view.
NOTE: To display older messages, slide the horizontal scroll bar to the right side of the
flyout. To filter the list of messages, tap the Alerts tab or the Notifications tab.
3. Tap ? Message.
The probable cause and corrective action in the operations manual is displayed for the
selected message.
Related information...
Alert Center flyout, page 927
View additional messages that are associated with a message
Perform this procedure to view additional messages that are associated with a message that is
displayed in the Alert Center.
1. On the menu bar, tap Alert Center.
2. In the Alert Center flyout, tap a message to view.
NOTE: To display older messages, slide the horizontal scroll bar to the right side of the
flyout. To filter the list of messages, tap the Alerts tab or the Notifications tab.
3. Tap Show Logs.
On the System Logs screen, the selected message is displayed. If additional messages are
associated with the selected message, a Plus button is displayed at the left side of the
Date/Time column.
4. Tap to display the additional messages.
Related information...
Alert Center flyout, page 927
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Section 10 Alert Center flyout
Delete a message from the Alert Center
Perform this procedure to delete a message from the Alert Center.
1. On the menu bar, tap Alert Center.
2. In the Alert Center flyout, tap a message to delete.
NOTE: To display older messages, slide the horizontal scroll bar to the right side of the
flyout. To filter the list of messages, tap the Alerts tab or the Notifications tab.
3. To delete the message, tap the Close button in the upper-right corner of the message
box.
Related information...
Alert Center flyout, page 927
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System Logs screen Section 10
System Logs screen
On the System Logs screen, the operator can view the following logs:
• All messages: A record of all system messages that can be used to troubleshoot problems
associated with system performance and results reporting
• Alerts and notifications: A record of noncritical messages
• Informational: A record of informational messages
• Inventory: A record of supply-related messages
• User access: A record of new users that have been created, edits to user data, and logon
and logoff events
• Configuration: A record of changes to configuration
• Host: A record of host interface communication messages
• Abbott Mail: A record of Abbott Mail activities and status messages
The operator can perform the following functions:
• Print a log.
• Search for specific log data.
Related information...
Troubleshooting, page 917
System Logs screen, All Messages tab element descriptions, page 930
System Logs screen, Notifications/Alerts tab element descriptions, page 932
System Logs screen, Informational tab element descriptions, page 933
System Logs screen, Inventory tab element descriptions, page 934
System Logs screen, User Access tab element descriptions, page 935
System Logs screen, Configuration tab element descriptions, page 936
System Logs screen, Host tab element descriptions, page 937
System Logs screen, Abbott Mail tab element descriptions, page 938
Message Details For flyout element descriptions, page 939
Descriptions of message types, page 940
System Logs screen, All Messages tab element descriptions
The All Messages tab displays all message codes generated by the system. Message codes
can be filtered by message types and message categories by selecting the appropriate tab.
930 Alinity ci-series Operations Manual
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Section 10 System Logs screen
Elements
button Displays the Message Details For flyout.
Date/Time Displays the date and time that the message code was
generated.
Module Displays the number of the module that generated the
message code.
Message Displays the message code number and description. In the
first column, a Plus button associated with the message
code indicates that related message codes with additional
details are available.
Message Type Displays the type of message code generated. The All
Messages tab has four message types:
• Alert
• Critical
• Informational
• Notification
Category Displays the related message category. The All Messages
tab has five message categories:
• Inventory
• User Access
• Configuration
• Host
• Abbott Mail
Function buttons
Print Displays the Print flyout.
Search Displays the Search flyout.
Message Help Displays Help from the operations manual for the selected
message code.
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System Logs screen Section 10
Text Size Increases or decreases the size of text displayed.
Related information...
System Logs screen, page 930
Descriptions of screen elements, page 127
System Logs screen, Notifications/Alerts tab element descriptions
The Notifications/Alerts tab displays alert, critical, and notification message codes.
Elements
button Displays the Message Details For flyout.
Date/Time Displays the date and time that the message code was
generated.
Module Displays the number of the module that generated the
message code.
Message Displays the message code number and description. In the
first column, a Plus button associated with the message
code indicates that related message codes with additional
details are available.
Message Type Displays the type of message code generated. The
Notifications/Alerts tab has three message types:
• Alert
• Critical
• Notification
Category Displays the related message category. The Notifications/
Alerts tab has five message categories:
• Inventory
• User Access
• Configuration
• Host
• Abbott Mail
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Section 10 System Logs screen
Function buttons
Print Displays the Print flyout.
Search Displays the Search flyout.
Message Help Displays Help from the operations manual for the selected
message code.
Text Size Increases or decreases the size of text displayed.
Related information...
System Logs screen, page 930
Descriptions of screen elements, page 127
System Logs screen, Informational tab element descriptions
The Informational tab displays informational message codes.
Elements
button Displays the Message Details For flyout.
Date/Time Displays the date and time that the message code was
generated.
Module Displays the number of the module that generated the
message code.
Message Displays the message code number and description. In the
first column, a Plus button associated with the message
code indicates that related message codes with additional
details are available.
Category Displays the related message category. The Informational tab
has five message categories:
• Inventory
• User Access
• Configuration
• Host
• Abbott Mail
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System Logs screen Section 10
Function buttons
Print Displays the Print flyout.
Search Displays the Search flyout.
Message Help Displays Help from the operations manual for the selected
message code.
Text Size Increases or decreases the size of text displayed.
Related information...
System Logs screen, page 930
Descriptions of screen elements, page 127
System Logs screen, Inventory tab element descriptions
The Inventory tab displays message codes related to inventory.
Elements
button Displays the Message Details For flyout.
Date/Time Displays the date and time that the message code was
generated.
Module Displays the number of the module that generated the
message code.
Message Displays the message code number and description. In the
first column, a Plus button associated with the message
code indicates that related message codes with additional
details are available.
Message Type Displays the type of message code generated. The Inventory
tab has four message types:
• Alert
• Critical
• Informational
• Notification
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Section 10 System Logs screen
Supply Name Displays the name of the supply item associated with the
message code.
Operator ID Displays the ID of the operator logged onto the system when
the message code was generated.
Function buttons
Print Displays the Print flyout.
Search Displays the Search flyout.
Message Help Displays Help from the operations manual for the selected
message code.
Text Size Increases or decreases the size of text displayed.
Related information...
System Logs screen, page 930
Descriptions of screen elements, page 127
System Logs screen, User Access tab element descriptions
The User Access tab displays message codes related to user access.
Elements
button Displays the Message Details For flyout.
Date/Time Displays the date and time that the message code was
generated.
Message Displays the message code number and description. In the
first column, a Plus button associated with the message
code indicates that related message codes with additional
details are available.
Message Type Displays the type of message code generated. The User
Access tab has four message types:
• Alert
• Critical
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System Logs screen Section 10
• Informational
• Notification
Function buttons
Print Displays the Print flyout.
Search Displays the Search flyout.
Message Help Displays Help from the operations manual for the selected
message code.
Text Size Increases or decreases the size of text displayed.
Related information...
System Logs screen, page 930
Descriptions of screen elements, page 127
System Logs screen, Configuration tab element descriptions
The Configuration tab displays message codes related to configuration.
Elements
button Displays the Message Details For flyout.
Date/Time Displays the date and time that the message code was
generated.
Module Displays the number of the module that generated the
message code.
Message Displays the message code number and description. In the
first column, a Plus button associated with the message
code indicates that related message codes with additional
details are available.
Message Type Displays the type of message code generated. The
Configuration tab has four message types:
• Alert
• Critical
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Section 10 System Logs screen
• Informational
• Notification
Operator ID Displays the ID of the operator logged onto the system when
the message code was generated.
Function buttons
Print Displays the Print flyout.
Search Displays the Search flyout.
Message Help Displays Help from the operations manual for the selected
message code.
Text Size Increases or decreases the size of text displayed.
Related information...
System Logs screen, page 930
Descriptions of screen elements, page 127
System Logs screen, Host tab element descriptions
The Host tab displays message codes related to host communications.
Elements
button Displays the Message Details For flyout.
Date/Time Displays the date and time that the message code was
generated.
Message Displays the message code number and description. In the
first column, a Plus button associated with the message
code indicates that related message codes with additional
details are available.
Message Type Displays the type of message code generated. The Host tab
has four message types:
• Alert
• Critical
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System Logs screen Section 10
• Informational
• Notification
Function buttons
Print Displays the Print flyout.
Search Displays the Search flyout.
Message Help Displays Help from the operations manual for the selected
message code.
Text Size Increases or decreases the size of text displayed.
Related information...
System Logs screen, page 930
Descriptions of screen elements, page 127
System Logs screen, Abbott Mail tab element descriptions
The Abbott Mail tab displays message codes related to Abbott Mail.
Elements
button Displays the Message Details For flyout.
Date/Time Displays the date and time that the message code was
generated.
Message Displays the message code number and description. In the
first column, a Plus button associated with the message
code indicates that related message codes with additional
details are available.
Message Type Displays the type of message code generated. The Abbott
Mail tab has four message types:
• Alert
• Critical
• Informational
• Notification
938 Alinity ci-series Operations Manual
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Section 10 System Logs screen
Mail Category Displays the type of Abbott Mail item associated with the
message code. The Abbott Mail tab has four mail categories:
• Assay File
• Assay Insert
• System Update
• Calibrator Data
Operator ID Displays the ID of the operator logged onto the system when
the message code was generated.
Function buttons
Print Displays the Print flyout.
Search Displays the Search flyout.
Message Help Displays Help from the operations manual for the selected
message code.
Text Size Increases or decreases the size of text displayed.
Related information...
System Logs screen, page 930
Descriptions of screen elements, page 127
Message Details For flyout element descriptions
The Message Details For flyout displays additional message codes that provide detailed
information related to the primary message code.
Elements
Date/Time Displays the date and time that the message code was
generated.
Message Type Displays the type of message code generated. The Message
Details For flyout has four message types:
• Alert
• Critical
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System Logs screen Section 10
• Informational
• Notification
Message Displays the message code number and description.
Function buttons
? Displays Help from the operations manual for the active
screen, flyout, or message code.
Related information...
System Logs screen, page 930
Descriptions of message types
Message type information is used to determine the severity of a message code.
The following list provides descriptions of the message types. The message types are described
in the order in which they are sorted:
Alert The message is displayed in the Alert Center flyout and
indicates a condition that affects the system's ability to
generate results.
Critical The message is displayed in a pop-up window and indicates a
critical condition that requires immediate corrective action.
Informational The message is displayed only in system logs and indicates
an additional message associated with an alert message or
information that is tracked but does not require corrective
action.
Notification The message is displayed in the Alert Center flyout and
indicates a condition that can affect the system's ability to
generate results if the condition is not resolved.
Related information...
System Logs screen, page 930
940 Alinity ci-series Operations Manual
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Section 10 Message codes
Message codes
Message codes are divided into 10 sections that reflect the major categories in which errors may
occur. Probable causes and associated corrective actions are provided for each message code.
If the corrective actions for a message code do not resolve the problem, contact the local
representative or find country-specific contact information at abbottdiagnostics.com.
NOTE: Corrective actions may involve hazardous activity. Use caution to minimize operator
exposure and to prevent personal injury or system damage. Examples of hazardous activities
include:
• The replacement of system probes.
• The use of reagents, calibrators, controls, and specimens.
• The removal of physical obstructions.
• The removal of system waste.
Related information...
Troubleshooting, page 917
General message codes (0001-0999), page 941
Assay-specific message codes (1000-1999), page 988
Maintenance and diagnostic message codes (2000-2999), page 1047
Level sense and fluidics message codes (3000-3999), page 1068
Optics and bar code reader message codes (4000-4999), page 1123
Robotics and sensor message codes (5000-5999), page 1132
Support system message codes (6000-6999), page 1201
Temperature message codes (7000-7999), page 1202
Computer hardware peripheral message codes (8000-8999), page 1208
Software message codes (9000-9999), page 1224
General message codes (0001-0999)
The general message code category includes message codes from 0001 through 0999.
Related information...
Message codes, page 941
0106, page 945
0108, page 946
0109, page 946
0110, page 946
0117, page 946
Alinity ci-series Operations Manual 941
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Message codes Section 10
0118, page 947
0139, page 947
0145, page 947
0146, page 947
0147, page 948
0148, page 948
0149, page 949
0150, page 949
0151, page 949
0152, page 950
0153, page 950
0154, page 950
0155, page 950
0156, page 951
0157, page 951
0158, page 951
0159, page 952
0160, page 952
0161, page 952
0169, page 953
0172, page 953
0173, page 953
0177, page 954
0178, page 954
0197, page 954
0200, page 955
0201, page 955
0202, page 955
0203, page 955
0204, page 956
0206, page 956
0207, page 956
0208, page 957
0209, page 957
0210, page 957
0211, page 957
0212, page 958
0213, page 958
0214, page 958
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Section 10 Message codes
0215, page 958
0217, page 959
0218, page 959
0220, page 959
0221, page 960
0222, page 960
0223, page 960
0224, page 960
0225, page 961
0226, page 961
0227, page 961
0228, page 961
0229, page 962
0230, page 962
0231, page 962
0232, page 962
0233, page 963
0234, page 963
0235, page 963
0236, page 964
0237, page 964
0238, page 964
0248, page 964
0250, page 965
0251, page 965
0252, page 965
0253, page 965
0254, page 966
0255, page 966
0256, page 966
0257, page 966
0258, page 967
0259, page 967
0260, page 967
0261, page 968
0262, page 968
0263, page 968
0264, page 968
0265, page 969
Alinity ci-series Operations Manual 943
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Message codes Section 10
0266, page 969
0267, page 969
0268, page 970
0269, page 970
0270, page 970
0271, page 970
0272, page 971
0273, page 971
0274, page 972
0600, page 972
0601, page 972
0602, page 972
0603, page 973
0604, page 973
0605, page 973
0606, page 973
0607, page 974
0608, page 974
0622, page 974
0623, page 974
0626, page 975
0627, page 975
0628, page 975
0656, page 975
0657, page 976
0658, page 976
0659, page 976
0660, page 976
0661, page 977
0662, page 977
0663, page 977
0664, page 978
0665, page 978
0666, page 978
0667, page 978
0679, page 979
0680, page 979
0681, page 979
0682, page 980
944 Alinity ci-series Operations Manual
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Section 10 Message codes
0683, page 980
0684, page 980
0685, page 981
0686, page 981
0689, page 981
0690, page 981
0691, page 982
0692, page 982
0693, page 982
0694, page 982
0695, page 983
0696, page 983
0697, page 983
0698, page 984
0699, page 984
0700, page 984
0701, page 984
0702, page 985
0703, page 985
0704, page 985
0705, page 985
0706, page 985
0707, page 986
0708, page 986
0709, page 986
0710, page 986
0711, page 987
0712, page 987
0713, page 987
0714, page 988
Message code: 0106
Authentication failed. Operator ID (0) inactive.
0 = Operator ID
Probable cause Corrective action
An inactive operator ID was entered. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Alinity ci-series Operations Manual 945
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Message codes Section 10
Message code: 0108
Authentication failed. Operator ID (0) invalid.
0 = Operator ID
Probable cause Corrective action
An invalid operator ID was entered. Enter the correct operator ID.
Related information...
General message codes (0001-0999), page 941
Message code: 0109
An unexpected error (0) occurred while exporting user data.
0 = Error description
Probable cause Corrective action
User export failed because of an unexpected error. A Review the specific message text. Perform the
specific error description is provided where available. corrective action for the specific message text.
Related information...
General message codes (0001-0999), page 941
Message code: 0110
An unexpected error (0) occurred while importing user data.
0 = Error
Probable cause Corrective action
The data file is damaged or corrupted. Repeat the data import procedure with a new file.
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
General message codes (0001-0999), page 941
Message code: 0117
Unable to retrieve log. Invalid log file type (0) or invalid log name (1).
0 = File type
1 = Log name
Probable cause Corrective action
The requested log file cannot be retrieved by Abbottlink. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
General message codes (0001-0999), page 941
946 Alinity ci-series Operations Manual
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Section 10 Message codes
Message code: 0118
Authentication failed. (0) for operator ID (1) invalid.
0 = PIN or password
1 = Operator ID
Probable cause Corrective action
The authentication failed. The supplied credential was Status message. No corrective action is required.
invalid.
Related information...
General message codes (0001-0999), page 941
Message code: 0139
Unable to perform automatic system backup. Instrument is not in the correct status.
Probable cause Corrective action
An automatic backup was not performed. Perform a manual backup, page 326 or wait until the
next scheduled automatic backup.
Related information...
General message codes (0001-0999), page 941
Message code: 0145
Unable to perform requested operation. Cuvette segment alignment tool detected in cuvette (0).
0 = Cuvette
Probable cause Corrective action
The cuvette segment alignment tool was not removed 1. Remove the cuvette segment alignment tool.
after a pipettor calibration procedure was performed.
2. Place the cuvette segment into the position.
Water is present on the slotted edges of a cuvette Dry the slotted edge of the cuvette segment.
segment.
The cuvette tab is broken. Replace the cuvette segments (c-series), page 848.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
General message codes (0001-0999), page 941
Message code: 0146
Run request denied. (0).
0 = Initialization error
Probable cause Corrective action
A processing module cover is open. Close the processing module cover that is open, and
then transition the module to the Running status.
Alinity ci-series Operations Manual 947
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Message codes Section 10
Probable cause Corrective action
A previous hardware failure prevented the Run 1. Review the message log for the messages that
initialization. The module transitioned to the Stopped occurred at the same time as this message.
status. Perform the corrective action.
2. Reinitialize the processing module. Perform Start
the processing module and the reagent and sample
manager (RSM), page 447.
The water in the water bath is not circulating because Change the water bath. Perform Reaction Mechanisms
the system was idle for an extended period of time. diagnostic procedure 5005 Exchange Water in Bath (c-
series), page 791.
The water bath is filling after an extended period of idle Verify that the temperature returns to specifications.
time. Perform Temperature diagnostic procedure 4301
Temperature Status (c-series), page 784.
The room temperature is outside specifications. Modify the room temperature to be within specifications.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
General message codes (0001-0999), page 941
Message code: 0147
Unable to perform requested operation. Remove racks from sample positioners on module (0).
0 = Module
Probable cause Corrective action
The initialization of the reagent and sample manager Remove racks from the sample positioners, page 1305.
(RSM) failed.
A physical interference is blocking the movement of the Locate and remove any physical obstruction.
RSM.
The module was unable to pick racks at the sample Perform Sample Manager diagnostic procedure 1600
positioners. RSM Transport Calibration, page 823.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
General message codes (0001-0999), page 941
Message code: 0148
Run initialization failed.
Probable cause Corrective action
Hardware failure. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
948 Alinity ci-series Operations Manual
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Section 10 Message codes
Related information...
General message codes (0001-0999), page 941
Message code: 0149
Unable to process test. Reagent cartridge unavailable.
Probable cause Corrective action
A reagent cartridge that was selected to be unloaded 1. Load the required reagent cartridge. Perform Load
had scheduled tests in process. cartridges on the reagent and sample manager
(RSM), page 527.
2. Rerun the test. Perform Rerun a test or an
exception for a specimen or control, page 612.
Related information...
General message codes (0001-0999), page 941
Message code: 0150
Unable to process test. Previous processing module error.
Probable cause Corrective action
A processing module error occurred. 1. Review the message log for messages that
occurred at the same time as this message.
Perform the corrective action.
2. Rerun the test. Perform Rerun a test or an
exception for a specimen or control, page 612.
Related information...
General message codes (0001-0999), page 941
Message code: 0151
Duplicate rack detected on module (0) position (1).
0 = Module
1 = Position
Probable cause Corrective action
A rack with a duplicate rack ID is already loaded on the • Remove the second rack with the duplicate rack ID.
system. After the first rack on the instrument with the
duplicate rack ID is completed processing and is
unloaded, the second rack can be reloaded.
• Load the samples from the rack with the duplicate
rack ID into a rack with a different rack ID, and
then load the rack on the reagent and sample
manager.
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Message codes Section 10
Related information...
General message codes (0001-0999), page 941
Message code: 0152
Unable to process test. Rack removed before access was granted.
Probable cause Corrective action
The rack was removed from the reagent and sample 1. Rerun the test. Perform Rerun a test or an
manager (RSM) after the test was scheduled but before exception for a specimen or control, page 612.
aspiration could occur.
2. Reload the rack into the RSM.
Related information...
General message codes (0001-0999), page 941
Message code: 0153
Unable to process test. ICT Reference Solution empty.
Probable cause Corrective action
The ICT Reference Solution bottle is empty. Load a new bottle and update the inventory. Perform
Replace bulk solutions and update the inventory, page
508.
The Supplies screen was not updated when the ICT Update the inventory. Perform Replace bulk solutions
Reference Solution bottle was replaced. and update the inventory, page 508.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
General message codes (0001-0999), page 941
Message code: 0154
Unable to process test. Rack removed from RSM before access granted.
Probable cause Corrective action
The rack was removed from the reagent and sample 1. Rerun the test. Perform Rerun a test or an
manager (RSM). exception for a specimen or control, page 612.
2. Reload the rack into the RSM.
Related information...
General message codes (0001-0999), page 941
Message code: 0155
Unable to load reagent cartridge in RSM position (0). No assay installed.
0 = RSM position
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Section 10 Message codes
Probable cause Corrective action
The assay file is not installed on the system. Install the assay. Perform Install assay files, page 272.
NOTE: Assay files are available at
abbottdiagnostics.com or can be requested through
Abbott Mail.
Related information...
General message codes (0001-0999), page 941
Message code: 0156
Unable to load reagent cartridge in RSM position (0). All reagent carousel positions are full.
0 = RSM position
Probable cause Corrective action
The reagent carousel is full. 1. Unload a reagent cartridge before new reagent
cartridges are loaded. Perform Unload racks and
cartridges from a reagent carousel to the RSM,
page 557.
2. Load a new reagent cartridge. Perform Load
cartridges on the reagent and sample manager
(RSM), page 527.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
General message codes (0001-0999), page 941
Message code: 0157
Unable to load reagent cartridge in RSM position (0). Reagent cartridge empty.
0 = RSM position
Probable cause Corrective action
No tests or volume remain for the indicated reagent Load a new reagent cartridge or load a reagent
cartridge. cartridge that has tests or volume remaining. Perform
Load cartridges on the reagent and sample manager
(RSM), page 527.
Related information...
General message codes (0001-0999), page 941
Message code: 0158
Unable to perform requested operation. Remove rack from reagent positioner.
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Message codes Section 10
Probable cause Corrective action
A rack was found on the reagent positioner. 1. Remove the rack from the reagent positioner.
2. Reinitialize the reagent and sample manager.
Perform Start the processing module and the
reagent and sample manager (RSM), page 447.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
General message codes (0001-0999), page 941
Message code: 0159
Reagent load error.
Probable cause Corrective action
The reagent and sample manager (RSM) is in the Reinitialize the RSM. Perform Start the processing
Stopped status. module and the reagent and sample manager (RSM),
page 447.
The reagent cartridge was removed from the RSM Load a new reagent cartridge. Perform Load cartridges
before access was granted. on the reagent and sample manager (RSM), page 527.
The reagent cartridge is damaged. Load a new reagent cartridge. Perform Load cartridges
on the reagent and sample manager (RSM), page 527.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
General message codes (0001-0999), page 941
Message code: 0160
Reagent unload error.
Probable cause Corrective action
The reagent and sample manager (RSM) is in the Reinitialize the RSM. Perform Start the processing
Stopped status. module and the reagent and sample manager (RSM),
page 447.
A physical interference is blocking the reagent cartridge. Locate and remove any physical obstruction.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
General message codes (0001-0999), page 941
Message code: 0161
Unable to process test. Water bath level low or temperature out of range.
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Section 10 Message codes
Probable cause Corrective action
The water bath level is low. Perform Reaction Mechanisms diagnostic procedure
5005 Exchange Water in Bath (c-series), page 791.
The water bath temperature is outside specifications. 1. Review the message log for messages that
occurred at the same time as this message.
Perform the corrective action.
2. Rerun the test. Perform Rerun a test or an
exception for a specimen or control, page 612.
Related information...
General message codes (0001-0999), page 941
Message code: 0169
Reagent access cover removed.
Probable cause Corrective action
The reagent access cover was removed. Replace the reagent access cover.
Reagent access cover sensor failure. Contact Customer Service to resolve any hardware
failure.
Related information...
General message codes (0001-0999), page 941
Message code: 0172
Unable to process test. Processing module not in Running status.
Probable cause Corrective action
The operator stopped the processing module before Reinitialize the processing module. Perform Start the
processing began. processing module and the reagent and sample manager
(RSM), page 447.
Hardware failure. 1. Review the message log for messages that
occurred at the same time as this message.
Perform the corrective action.
2. Rerun the test. Perform Rerun a test or an
exception for a specimen or control, page 612.
Related information...
General message codes (0001-0999), page 941
Message code: 0173
Unable to process test. Reagent sample manager not in Running status.
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Message codes Section 10
Probable cause Corrective action
The operator stopped the reagent and sample manager Reinitialize the RSM. Perform Start the processing
(RSM) before processing began. module and the reagent and sample manager (RSM),
page 447.
Hardware failure. 1. Review the message log for messages that
occurred at the same time as this message.
Perform the corrective action.
2. Rerun the test. Perform Rerun a test or an
exception for a specimen or control, page 612.
Related information...
General message codes (0001-0999), page 941
Message code: 0177
Unable to perform automatic system backup. Automatic backup disabled.
Probable cause Corrective action
The automatic backup is disabled. Enable the automatic backup. Perform Configure an
automatic backup, page 220.
Related information...
General message codes (0001-0999), page 941
Message code: 0178
Invalid order for SID (0). Rack/position (1/2) already contains order for SID (3).
0 = SID
1 = Rack ID
2 = Position
3 = SID
Probable cause Corrective action
An order exists for the indicated rack and position. Create an order that uses a different rack and position.
Related information...
General message codes (0001-0999), page 941
Message code: 0197
FSE logon required to complete initial system configuration settings.
Probable cause Corrective action
An FSE logon is required to change the module Contact Customer Service.
configuration.
Related information...
General message codes (0001-0999), page 941
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Section 10 Message codes
Message code: 0200
Unable to process test. Rack transport error.
Probable cause Corrective action
An error occurred with the RSM transport when a rack Rerun the test. Perform Rerun a test or an exception for
was transported. a specimen or control, page 612.
The rack is damaged. Replace the damaged rack.
The RSM transport is out of alignment. Perform Sample Manager diagnostic procedure 1600
RSM Transport Calibration, page 823.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
General message codes (0001-0999), page 941
Message code: 0201
Start or Run request denied. Module is not in the correct status.
Probable cause Corrective action
An attempt was made to start or run the module when Repeat the request to start or run the module when the
the system was in an incorrect instrument status. system is in a status of Stopped, Idle, or Pausing.
Related information...
General message codes (0001-0999), page 941
Message code: 0202
Unable to process test. Process path disabled.
Probable cause Corrective action
An error occurred on the process path or pretreatment 1. Review the message log for messages that
path. occurred at the same time as this message.
Perform the corrective action.
2. Rerun the test. Perform Rerun a test or an
exception for a specimen or control, page 612.
Related information...
General message codes (0001-0999), page 941
Message code: 0203
Processing module initialization failed. No RV unloader detected.
Probable cause Corrective action
The RV unloader was not detected during initialization. Verify that the RV unloader is in the correct position.
See Process path (Alinity i), page 97 to locate the RV
unloader.
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Message codes Section 10
Probable cause Corrective action
The RV unloader is not seated correctly. Reseat the RV unloader.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
General message codes (0001-0999), page 941
Message code: 0204
Reagent access cover removed.
Probable cause Corrective action
The reagent access cover was removed. Status message. Reagents in the reagent carousel are
removed, scanned, and replaced.
Related information...
General message codes (0001-0999), page 941
Message code: 0206
Unable to execute command. Operator requested Stop or hardware error.
Probable cause Corrective action
The operator transitioned the instrument to the Stopped 1. Resolve the reason the instrument was transitioned
status. to the Stopped status.
2. Start the processing module and the reagent and
sample manager (RSM), page 447.
Communication error. Review the message log for messages that occurred at
the same time as this message. Perform the corrective
action.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
General message codes (0001-0999), page 941
Message code: 0207
Start initialization failed.
Probable cause Corrective action
Hardware failure. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
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Section 10 Message codes
Related information...
General message codes (0001-0999), page 941
Message code: 0208
RSM initialization failed.
Probable cause Corrective action
Hardware failure. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
General message codes (0001-0999), page 941
Message code: 0209
Start or Run initialization failed.
Probable cause Corrective action
Hardware failure. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
General message codes (0001-0999), page 941
Message code: 0210
Module transitioning to Pausing status. (0) failed.
0 = Mechanism
Probable cause Corrective action
Hardware failure. • Review the specific message text. Perform the
corrective action for the specific message text.
• Contact Customer Service to resolve any hardware
failure.
Related information...
General message codes (0001-0999), page 941
Message code: 0211
Rack detected at module (1) position (0). Remove rack. This position is not available.
0 = Position
1 = Module
Probable cause Corrective action
A rack was loaded in a position that is already in use. Remove the rack that was loaded in a position that is
already in use.
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Message codes Section 10
Related information...
General message codes (0001-0999), page 941
Message code: 0212
Rack ID (0) removed from module (2) position (1) before access granted.
0 = Rack ID
1 = Position
2 = Module
Probable cause Corrective action
The rack was removed before access was granted. Tests with a scheduled status become exceptions.
Reorder the tests.
Related information...
General message codes (0001-0999), page 941
Message code: 0213
Unable to load reagent cartridge in RSM position (0). Reagent cartridge is for the (1) processing module.
0 = RSM position
1 = Module
Probable cause Corrective action
No processing module is available for the reagent type. Load a new reagent cartridge for the correct module
type.
Related information...
General message codes (0001-0999), page 941
Message code: 0214
Unable to process test. Sample diluent insufficient or not available.
Probable cause Corrective action
The required sample diluent is empty or expired. Load a new onboard solution cartridge. Perform Load
onboard solutions and sample diluents on the reagent
and sample manager (RSM) (c-series), page 530.
Related information...
General message codes (0001-0999), page 941
Message code: 0215
Unable to process test. Reagent cartridge for assay number (0) version (1) has insufficient volume or is
unusable.
0 = Assay number
1 = Assay version
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Section 10 Message codes
Probable cause Corrective action
The indicated reagent cartridge is empty or expired. Load a new reagent cartridge. Perform Load cartridges
on the reagent and sample manager (RSM), page 527.
Related information...
General message codes (0001-0999), page 941
Message code: 0217
Unable to create order for sample in rack ID (0). Position ordered (2) does not match position scanned
(1).
0 = Rack ID
1 = Position scanned
2 = Position ordered
Probable cause Corrective action
The control sample was found in a different position in Verify that the control sample is in the correct position in
the rack. the rack.
Related information...
General message codes (0001-0999), page 941
Message code: 0218
Unable to process test. Module (0) not available.
0 = Module
Probable cause Corrective action
The processing module transitioned to a status of Start the processing module and the reagent and sample
Offline or Stopped when tests were in process. manager (RSM), page 447.
Related information...
General message codes (0001-0999), page 941
Message code: 0220
No pending orders found for SID (0) in rack ID (1) position (2).
0 = SID
1 = Rack ID
2 = Position
Probable cause Corrective action
No orders were found for a bar-coded sample in a Create an order for the bar-coded sample.
priority position.
Related information...
General message codes (0001-0999), page 941
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Message codes Section 10
Message code: 0221
Priority order for SID (0) in rack ID (1) position (2) loaded in RSM routine position. SID will not be
processed as priority sample.
0 = SID
1 = Rack ID
2 = Position
Probable cause Corrective action
Samples that are designated as STAT must be priority Load STAT samples in a priority position of the reagent
loaded to be processed as STAT samples. and sample manager.
Related information...
General message codes (0001-0999), page 941
Message code: 0222
Module initialization failed after fault condition detected.
Probable cause Corrective action
The initialization failed. Cycle power to the processing module and the reagent
and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
General message codes (0001-0999), page 941
Message code: 0223
Unable to process test. Instrument status is not Running or Processing.
Probable cause Corrective action
The processing module is no longer in the Running Perform Start the processing module and the reagent
status or the Processing status. and sample manager (RSM), page 447 for the
appropriate module.
Related information...
General message codes (0001-0999), page 941
Message code: 0224
Run request denied. RV waste container not present.
Probable cause Corrective action
The RV waste container is not present in a processing Replace the RV waste container.
module.
Related information...
General message codes (0001-0999), page 941
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Section 10 Message codes
Message code: 0225
Unable to process test. Hardware error.
Probable cause Corrective action
Hardware failure. 1. Review the message log for messages that
occurred at the same time as this message.
Perform the corrective action.
2. Rerun a test or an exception for a specimen or
control, page 612.
Related information...
General message codes (0001-0999), page 941
Message code: 0226
Reagent access cover removed.
Probable cause Corrective action
The reagent access cover is missing. 1. Replace the reagent access cover.
2. Start the processing module and the reagent and
sample manager (RSM), page 447.
The reagent access cover sensor failed. Contact Customer Service to resolve any hardware
failure.
Related information...
General message codes (0001-0999), page 941
Message code: 0227
Rack or cartridge detected on module (0) RSM position (1). This position is not available. Remove rack.
0 = Module
1 = RSM position
Probable cause Corrective action
A rack or cartridge was loaded in a position that is Remove the rack or cartridge that was loaded in the
already in use. indicated bay and position that is already in use.
Related information...
General message codes (0001-0999), page 941
Message code: 0228
Rack or cartridge detected on module (0) RSM position (1) without a tray.
0 = Module
1 = RSM position
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Message codes Section 10
Probable cause Corrective action
A rack or cartridge was detected on the loading area Remove the rack or cartridge from the loading area.
without a tray. Place the rack or cartridge in a tray, and then load the
tray on the reagent and sample manager of the
processing module.
Related information...
General message codes (0001-0999), page 941
Message code: 0229
Tray on module (0) bay (1) removed before access was granted.
0 = Module
1 = RSM bay
Probable cause Corrective action
The tray was removed from the loading area of the Load the tray into the bay indicated on the processing
processing module before access was granted. module. Do not remove trays before access is granted.
Related information...
General message codes (0001-0999), page 941
Message code: 0230
Unable to process test. Control lot expired.
Probable cause Corrective action
The control is expired. Load a new control.
Related information...
General message codes (0001-0999), page 941
Message code: 0231
Number of unreleased results reached limit. New orders will not be accepted.
Probable cause Corrective action
The limit of the number of unreleased results has been Delete or release results, controls, or exceptions before
reached. new orders are created. Perform Delete a sample result
or an exception, page 635 and Transmit a result or an
exception to the host, page 635.
Related information...
General message codes (0001-0999), page 941
Message code: 0232
Unable to process test. Sample removed from system.
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Section 10 Message codes
Probable cause Corrective action
The rack or tray was removed from the reagent and 1. Load the rack on the RSM. Perform Load racks on
sample manager (RSM) before the access indicator was the reagent and sample manager (RSM), page 526.
activated.
2. Rerun the exception. Perform Rerun a test or an
exception for a specimen or control, page 612.
Related information...
General message codes (0001-0999), page 941
Message code: 0233
Unable to process test. Reagent onboard solution cartridge empty.
Probable cause Corrective action
The R1 onboard solution cartridge is empty. Load a new onboard solution cartridge. Perform Prepare
onboard solutions (c-series), page 551 or Load onboard
solutions and sample diluents on the reagent and sample
manager (RSM) (c-series), page 530.
Related information...
General message codes (0001-0999), page 941
Message code: 0234
Unable to process test. Reagent onboard solution cartridge empty.
Probable cause Corrective action
The R2 onboard solution cartridge is empty. Load a new onboard solution cartridge. Perform Prepare
onboard solutions (c-series), page 551 or Load onboard
solutions and sample diluents on the reagent and sample
manager (RSM) (c-series), page 530.
Related information...
General message codes (0001-0999), page 941
Message code: 0235
RSM load error for a two-cartridge reagent set. Unload reagent cartridges in RSM positions (0) and (1).
0 = RSM position
1 = RSM position
Probable cause Corrective action
A two-cartridge reagent set did not load successfully. Unload and reload the reagent cartridges from the
reagent and sample manager. Perform Load cartridges
on the reagent and sample manager (RSM), page 527.
A reagent cartridge is damaged. Load a new reagent cartridge. Perform Load cartridges
on the reagent and sample manager (RSM), page 527.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
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Message codes Section 10
Related information...
General message codes (0001-0999), page 941
Message code: 0236
Number of unreleased results reached 90% of the allowable limit.
Probable cause Corrective action
The number of unreleased results reached 90% Release or delete unreleased specimen results, control
capacity. results, or exceptions on the system. Perform Delete a
sample result or an exception, page 635.
Related information...
General message codes (0001-0999), page 941
Message code: 0237
Unable to process test. Reagent cartridge unavailable.
Probable cause Corrective action
A reagent cartridge was scheduled to be unloaded when 1. Prepare reagent cartridges, page 548.
tests were in process.
2. Load a new reagent cartridge for the assay.
Perform Load cartridges on the reagent and sample
manager (RSM), page 527.
3. Rerun the exception. Perform Rerun a test or an
exception for a specimen or control, page 612.
Related information...
General message codes (0001-0999), page 941
Message code: 0238
Unable to perform requested operation. Remove rack from reagent positioner.
Probable cause Corrective action
A rack was found on the reagent positioner. Remove the rack from the reagent positioner.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
General message codes (0001-0999), page 941
Message code: 0248
Unable to add order. SID (0) exists with different sample type.
0 = SID
Probable cause Corrective action
An order exists for the SID using a different sample type Create the order using the same sample type. Perform
(calibrator, control, or specimen). Create a specimen order, page 595.
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Section 10 Message codes
Related information...
General message codes (0001-0999), page 941
Message code: 0250
Unable to update order for SID (1). Manual dilution factor (0) is different than manual dilution factor for
pending order.
0 = Manual dilution
1 = SID
Probable cause Corrective action
The manual dilution that was entered for the current Enter the same manual dilution that was entered for the
order is different from the manual dilution that was pending order. Perform Create a specimen order, page
entered for the pending order. 595.
Related information...
General message codes (0001-0999), page 941
Message code: 0251
Invalid order. Calibration order already exists for SID (0) in rack ID/position (1/2).
0 = SID
1 = Rack ID
2 = Position
Probable cause Corrective action
A calibration order already exists for the rack ID and Create the calibration order using a different rack ID and
position. position. Perform Create a calibration order, page 599.
Related information...
General message codes (0001-0999), page 941
Message code: 0252
Invalid order. SID (0) exists for previously ordered sample.
0 = SID
Probable cause Corrective action
An attempt was made to create a new order for an SID Create the new order for the SID with a different rack ID
without a rack ID and position. An order already exists and position. Perform Create a specimen order, page
for the SID. 595.
Related information...
General message codes (0001-0999), page 941
Message code: 0253
Unable to create order. HIL replicate or calculated assay (0) already exists for sample.
0 = HIL or calculated assay
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Message codes Section 10
Probable cause Corrective action
An attempt was made to order a replicate for HIL or a Complete the test for the existing order before the
calculated assay when an order already exists. replicate is ordered.
Related information...
General message codes (0001-0999), page 941
Message code: 0254
Duplicate rack ID (0) detected.
0 = Rack ID
Probable cause Corrective action
The rack ID is already loaded on the reagent and Load the samples in a rack with a different rack ID and
sample manager (RSM). load the rack on the RSM.
Related information...
General message codes (0001-0999), page 941
Message code: 0255
Sample with pending priority order loaded in rack ID (0) position (1).
0 = Rack ID
1 = Position
Probable cause Corrective action
Samples that are designated as STAT must be priority Load STAT samples in a priority position of the reagent
loaded to be processed as STAT samples. and sample manager.
Related information...
General message codes (0001-0999), page 941
Message code: 0256
A tray has been removed from the RSM on module (0) that is needed to place the rack back in RSM
position (1).
0 = Module
1 = RSM position
Probable cause Corrective action
A tray with racks in process has been removed from the Load trays on the reagent and sample manager (RSM),
reagent and sample manager (RSM). page 524.
Related information...
General message codes (0001-0999), page 941
Message code: 0257
(0) cover opened when module status is Running or Processing.
0 = Processing center cover
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Section 10 Message codes
Probable cause Corrective action
A processing center cover was opened. 1. Close the processing center cover.
2. Perform Start the processing module and the
reagent and sample manager (RSM), page 447.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
General message codes (0001-0999), page 941
Message code: 0258
RSM stopped. Front processing center cover opened.
Probable cause Corrective action
A front processing center cover was opened while the 1. Close the processing center cover.
reagent and sample handler was in a Running status.
2. Perform Start the processing module and the
reagent and sample manager (RSM), page 447.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
General message codes (0001-0999), page 941
Message code: 0259
Unable to delete all selected results. Result is either a constituent of a calculated assay or pending
transmission to the host.
Probable cause Corrective action
An attempt was made to delete an assay that is a • Delete or edit the calculated assay before the
constituent assay for a calculated assay. constituent assay is deleted.
• Wait until the results have been transmitted to the
host before the results are deleted.
Related information...
General message codes (0001-0999), page 941
Message code: 0260
Unable to process test. Calculated result exceeds limits.
Probable cause Corrective action
A calculated result cannot be computed. The result Modify the calculated result formula or the constituent
exceeds the numerical limit of the software. assay ranges. Perform Create a calculated assay, page
251.
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Message codes Section 10
Related information...
General message codes (0001-0999), page 941
Message code: 0261
Tray in bay (1) on module (0) has been unexpectedly removed.
0 = Module
1 = Bay
Probable cause Corrective action
A tray with racks in process was removed from the 1. Restart the RSM. Perform Start the processing
reagent and sample manager (RSM) before the access module and the reagent and sample manager
indicator was activated. (RSM), page 447.
2. Load trays on the reagent and sample manager
(RSM), page 524.
A tray is defective. Replace the tray.
Related information...
General message codes (0001-0999), page 941
Message code: 0262
A retest rule with the same name is already defined.
Probable cause Corrective action
The name of the retest rule already exists. Use a different name for the retest rule.
Related information...
General message codes (0001-0999), page 941
Message code: 0263
Operator ID (0) changed one or more module configuration parameters for module (1).
0 = Operator ID
1 = Module
Probable cause Corrective action
A change was made to the module configuration. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0264
Unable to create retest order. Assay not longer available on system.
Probable cause Corrective action
An assay that is required for a retest is not loaded on Install the assay. Perform Install assay files, page 272.
the system.
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Section 10 Message codes
Probable cause Corrective action
NOTE: Assay files are available on
abbottdiagnostics.com or can be requested through
Abbott Mail.
Related information...
General message codes (0001-0999), page 941
Message code: 0265
Unable to add order. Insufficient positions in rack ID (0) for all calibrators.
0 = Rack ID
Probable cause Corrective action
The number of positions required for the calibration Create the calibration order using a rack with the
exceeds the number of available positions in the rack. required number of available positions. Perform Create a
calibration order, page 599.
Related information...
General message codes (0001-0999), page 941
Message code: 0266
Run request denied. Reagent cartridges or racks are currently being loaded or unloaded from the
reagent carousel.
Probable cause Corrective action
Reagent cartridges or racks are in the process of Wait for the unload or load process to be completed
unloading from the reagent carousel or loading to the before requesting a run initialization.
reagent carousel.
Related information...
General message codes (0001-0999), page 941
Message code: 0267
Unable to create order. Invalid rack ID (0).
0 = Rack ID
Probable cause Corrective action
An invalid rack was used for the sample type. • To load aliquot tubes, primary tubes, or sample
cups that contain samples (specimens, calibrators,
or controls) into sample racks, perform Load
samples into sample racks, page 569.
• To load calibrator and control vials into vial racks,
perform Prepare and load vials into vial racks for
immediate use, page 572.
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Related information...
General message codes (0001-0999), page 941
Message code: 0268
Vial with bar code (0) is already loaded onboard.
0 = Vial bar code
Probable cause Corrective action
A vial with same bar code is already loaded on the Contact Customer Service to report the duplicate vial
system. bar code.
Related information...
General message codes (0001-0999), page 941
Message code: 0269
Onboard vial rack is on the RSM at location (0). Remove the rack and store in refrigerated storage.
0 = RSM location
Probable cause Corrective action
The onboard vial rack processing is completed. Remove the onboard vial rack and place the vials into
refrigerated storage. Perform Unload vials from the
reagent and sample manager (RSM), page 576.
Related information...
General message codes (0001-0999), page 941
Message code: 0270
Unable to process test. No processing module available.
Probable cause Corrective action
The requested assay is not installed on the system. Install the assay. Perform Install assay files, page 272.
NOTE: Assay files are available on
abbottdiagnostics.com or can be requested through
Abbott Mail.
Related information...
General message codes (0001-0999), page 941
Message code: 0271
Unknown calibrator or control bar code (0) found in rack ID (1) position (2). Onboard vial rack cannot be
loaded into reagent carousel.
0 = Control bar code
1 = Rack ID
2 = Position
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Probable cause Corrective action
The bar-coded vial is not positioned correctly in the vial Reposition vial in the vial rack.
rack.
The bar code is damaged. 1. Load a different calibrator or control vial.
2. Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
The calibrator or control was configured incorrectly or Verify that the calibrators or controls are configured on
has not been configured. the system. Perform Manually create a new calibrator
lot, page 260 or Manually create a new quality control
lot, page 295.
Related information...
General message codes (0001-0999), page 941
Message code: 0272
Unable to process test. Assay is not enabled.
Probable cause Corrective action
The requested assay is disabled. 1. Enable the assay. Perform Edit general settings of
assay parameters (c-series photometric), page 230,
Edit general settings of assay parameters (c-series
potentiometric), page 231, or Edit general settings
of assay parameters (i-series), page 232.
2. Rerun the test.
Related information...
General message codes (0001-0999), page 941
Message code: 0273
Power interrupted to RSM when the module was running. Discard samples in the rack if the rack is
located on the RSM transport.
Probable cause Corrective action
The main power to the reagent and sample manager 1. Discard the samples in the rack if the rack is
was interrupted while the module had a status of located on RSM transport.
Scheduled or Running.
2. Cycle power to the processing module and the
reagent and sample manager (RSM), page 432
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
General message codes (0001-0999), page 941
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Message code: 0274
Improper shutdown on user interface computer due to power interruption. Discard samples in rack if rack
is located on RSM transport.
Probable cause Corrective action
The main power source to the user interface computer 1. If the RSM transport was holding a rack at the time
was interrupted, which caused an improper shutdown. of the power loss, all samples on the rack should
be discarded.
2. Cycle power to the system, page 428
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
General message codes (0001-0999), page 941
Message code: 0600
Operator ID (0) created by (1).
0 = Operator ID
1 = Operator ID of user who performed the action
Probable cause Corrective action
A new operator ID was created. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0601
(0) deleted for operator ID (1) by (2).
0 = PIN or password
1 = Operator ID
2 = Operator ID of user who performed the action
Probable cause Corrective action
A PIN or a password was deleted for the operator ID. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0602
(0) created for operator ID (1) by (2).
0 = PIN or password
1 = Operator ID
2 = Operator ID of user who performed the action
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Probable cause Corrective action
A PIN or a password was created for the operator ID. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0603
Operator ID (0) inactivated by (1).
0 = Operator ID
1 = Operator ID of user who performed the action
Probable cause Corrective action
The status for an operator ID changed from active to Status message. No corrective action is required.
inactive.
Related information...
General message codes (0001-0999), page 941
Message code: 0604
Operator ID (0) reactivated by (1).
0 = Operator ID
1 = Operator ID of user who performed the action
Probable cause Corrective action
The status for an operator ID changed from inactive to Status message. No corrective action is required.
active.
Related information...
General message codes (0001-0999), page 941
Message code: 0605
Operator ID (0) changed from level (1) to level (2) by (3).
0 = Operator ID
1 = Original level name
2 = Current level name
3 = Operator ID of user who performed the action
Probable cause Corrective action
The level for an operator ID was changed. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0606
Operator ID (0) updated by (1).
0 = Operator ID
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1 = Operator ID of user who performed the action
Probable cause Corrective action
The first name or the last name of an operator ID was Status message. No corrective action is required.
changed.
Related information...
General message codes (0001-0999), page 941
Message code: 0607
Operator ID (0) logged on with a (1).
0 = Operator ID
1 = PIN or password
Probable cause Corrective action
The user logged on. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0608
Operator ID (0) logged off.
0 = Operator ID
Probable cause Corrective action
The user was logged off because another user logged Status message. No corrective action is required.
on.
Related information...
General message codes (0001-0999), page 941
Message code: 0622
System automatically requested (0).
0 = Mail category
Probable cause Corrective action
An automatic request for updated assay files was sent Status message. No corrective action is required.
to AbbottLink. When assay file versions are available, updates are sent
to Abbott Mail.
Related information...
General message codes (0001-0999), page 941
Message code: 0623
(0) (1) records archived.
0 = Number of records
1 = Archive report
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Probable cause Corrective action
The archive was completed. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0626
System language changed from (0) to (1).
0 = Current language
1 = Updated language
Probable cause Corrective action
The user configured a different language. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0627
Instrument status transitioned to Offline.
Probable cause Corrective action
The processing module is Offline. Start the processing module and the reagent and sample
manager (RSM), page 447.
Related information...
General message codes (0001-0999), page 941
Message code: 0628
Communication between the computer and instrument established. Instrument status transitioned to
Stopped.
Probable cause Corrective action
SCM communication was established with the Status message. No corrective action is required.
processing module.
Related information...
General message codes (0001-0999), page 941
Message code: 0656
No updated assays downloaded for automatically requested (0).
0 = Mail category
Probable cause Corrective action
An automatic request for updated assay files was sent Status message. No corrective action is required.
to AbbottLink and no updated assay files were available
to download.
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Related information...
General message codes (0001-0999), page 941
Message code: 0657
Unable to request (0) automatically. A manual request is currently pending.
0 = Mail category
Probable cause Corrective action
A manual request for assay files is pending. Only one Status message. No corrective action is required.
active request at a time can be performed. The automatic request is canceled and will be
performed in 7 days.
Related information...
General message codes (0001-0999), page 941
Message code: 0658
Operator ID (0) manually requested (1).
0 = Operator ID
1 = Mail category
Probable cause Corrective action
A manual file request was performed. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0659
System automatically requested the (1) for reagent lot (0).
0 = Reagent lot
1 = Mail category
Probable cause Corrective action
A new reagent lot was scanned and an automatic Status message. No corrective action is required.
request for the assay insert was sent to AbbottLink.
Related information...
General message codes (0001-0999), page 941
Message code: 0660
(1) is unavailable for reagent lot (0).
0 = Reagent lot
1 = Mail category
Probable cause Corrective action
An error occurred when the assay insert was requested • To request the assay insert again, unload the
in Abbott Mail. reagent and reload the reagent.
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Probable cause Corrective action
• Refer to the assay insert that was shipped with the
reagent kit or obtain the appropriate insert at
abbottdiagnostics.com.
The assay insert is not available in Abbott Mail. Refer to the assay insert that was shipped with the
reagent kit or obtain the appropriate insert at
abbottdiagnostics.com.
Related information...
General message codes (0001-0999), page 941
Message code: 0661
Operator ID (0) accepted mail item (1) for (2) number (3) revision (4).
0 = Operator ID
1 = Mail category
2 = Subject
3 = List number
4 = Revision
Probable cause Corrective action
The operator accepted a mail item. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0662
Operator ID (0) accepted mail item (1) for (2) number (3).
0 = Operator ID
1 = Mail category
2 = Subject
3 = TSB number
Probable cause Corrective action
The operator accepted a system update. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0663
Operator ID (0) declined mail item (1) for (2) number (3).
0 = Operator ID
1 = Mail category
2 = Subject
3 = TSB number
Probable cause Corrective action
The operator declined a system update. Status message. No corrective action is required.
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Related information...
General message codes (0001-0999), page 941
Message code: 0664
Operator ID (0) deleted mail item (1) for (2) number (3) revision (4).
0 = Operator ID
1 = Mail category
2 = Subject
3 = List number
4 = Revision
Probable cause Corrective action
The operator deleted a mail item. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0665
Operator ID (0) deleted mail item (1) for (2) number (3).
0 = Operator ID
1 = Mail category
2 = Subject
3 = TSB number
Probable cause Corrective action
The operator deleted a system update. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0666
Received mail item (0) for (1) number (2) revision (3).
0 = Mail category
1 = Subject
2 = List number
3 = Revision
Probable cause Corrective action
A new Abbott Mail item was received. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0667
Received mail item (0) for (1) number (2).
0 = Mail category
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1 = Subject
2 = List number
Probable cause Corrective action
A new Abbott Mail item was received. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0679
(0) already exists for reagent lot (1).
0 = Mail category
1 = Reagent lot
Probable cause Corrective action
A new reagent lot was loaded on the system. The assay Status message. No corrective action is required.
insert for the new reagent lot already exists on the
system and is assigned to reagent cartridges of the new
reagent lot.
Related information...
General message codes (0001-0999), page 941
Message code: 0680
Unable to accept mail item for (0) number (1) revision (2). (3) no longer available.
0 = Subject
1 = List number
2 = Revision
3 = Mail category
Probable cause Corrective action
The reagent lot that is associated with the assay insert Status message. The Abbott Mail item has been deleted.
is no longer stored on the system. The associated assay
insert has been deleted and is not available to be
accepted.
Related information...
General message codes (0001-0999), page 941
Message code: 0681
Processing module stopped during water bath automatic fill.
Probable cause Corrective action
The water source supply was interrupted. 1. Verify that the water source supply is functioning.
2. Perform 4205 Flush Water Lines (c-series), page
782.
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Probable cause Corrective action
The water source supply is restricted. 1. Verify that the tubing from the water source is not
crimped or blocked.
2. Perform 4205 Flush Water Lines (c-series), page
782.
The incoming purified water pressure is too low. Increase the incoming purified water pressure to be
within specifications.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
General message codes (0001-0999), page 941
Message code: 0682
Processing module status Stopped. (0) open.
0 = Cover
Probable cause Corrective action
A processing module cover was opened during a run. 1. Close the processing module cover.
2. Restart the run.
A processing module cover was opened when a Tap OK on the screen. No corrective action is required.
diagnostic procedure was in process.
The processing module cover sensor failed. Contact Customer Service to resolve any hardware
failure.
Related information...
General message codes (0001-0999), page 941
Message code: 0683
Processing module configured for exhibition mode.
Probable cause Corrective action
The CPU board is configured for exhibition mode. Contact Customer Service to resolve any hardware
failure.
Related information...
General message codes (0001-0999), page 941
Message code: 0684
Unable to process test. Sample suspend requested.
Probable cause Corrective action
The sample was suspended. The tests were sent to Rerun the sample. Perform Rerun a test or an exception
exception and not processed. for a specimen or control, page 612.
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Related information...
General message codes (0001-0999), page 941
Message code: 0685
Reagent cartridge in position (0) has expired.
0 = Position
Probable cause Corrective action
The reagent cartridge has expired. Load a new reagent cartridge. Perform Prepare reagent
cartridges, page 548 and Load cartridges on the reagent
and sample manager (RSM), page 527.
Related information...
General message codes (0001-0999), page 941
Message code: 0686
Reagent cartridge in position (0) has exceeded onboard stability time.
0 = Position
Probable cause Corrective action
The onboard stability time for the reagent cartridge has Load a new reagent cartridge. Perform Prepare reagent
been exceeded. cartridges, page 548 and Load cartridges on the reagent
and sample manager (RSM), page 527.
Related information...
General message codes (0001-0999), page 941
Message code: 0689
Assay (0) number (1) version (2) is required for reagent lot (3) and is ready to be accepted from Abbott
Mail.
0 = Assay name
1 = Assay number
2 = Assay version
3 = Reagent lot
Probable cause Corrective action
The assay file version is not loaded on the system. 1. Download the assay file version from Abbott Mail.
Perform Manually request assay files, page 493.
2. Install the assay. Perform Install assay files, page
272.
Related information...
General message codes (0001-0999), page 941
Message code: 0690
Assay (0) number (1) version (2) is required for reagent lot (3) and is available for installation.
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0 = Assay name
1 = Assay number
2 = Assay version
3 = Reagent lot
Probable cause Corrective action
The required assay file version is not installed on the Install the required assay file. Perform Install assay files,
system. page 272.
Related information...
General message codes (0001-0999), page 941
Message code: 0691
Starting creation of weekly backup (0).
0 = Backup name
Probable cause Corrective action
The weekly backup is in progress. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0692
Starting creation of daily system backup (0).
0 = Backup name
Probable cause Corrective action
The automatic daily backup is in progress. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0693
Control configuration category (1) changed from (2) to (3) by operator ID (0).
0 = Operator ID
1 = Control configuration item
2 = Changed from
3 = Changed to
Probable cause Corrective action
The control configuration was updated. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0694
Control lot expired for control (0) lot (1).
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0 = Control name
1 = Control lot
Probable cause Corrective action
The control lot number that was scanned has expired. Load a new control lot number. Perform Prepare and
load vials into vial racks for onboard storage, page 549.
Related information...
General message codes (0001-0999), page 941
Message code: 0695
Control (0) lot (1) not found.
0 = Control name
1 = Control lot
Probable cause Corrective action
The control is empty for the specified lot. Load a new control. Perform Prepare and load vials into
vial racks for onboard storage, page 549.
A control lot is not configured for the SID. • Configure the correct control lot information.
Perform Manually create a new quality control lot,
page 295.
• Load a different control lot.
Related information...
General message codes (0001-0999), page 941
Message code: 0696
No reagent cartridge available to process control (0) lot (1) for assay (2) version (3) module (4).
0 = Control name
1 = Control lot
2 = Assay name
3 = Assay version
4 = Module
Probable cause Corrective action
The required reagent cartridge is not loaded on the Load a reagent cartridge for the requested assay.
processing module.
Related information...
General message codes (0001-0999), page 941
Message code: 0697
Westgard rule (2) for assay (1) changed from (3) to (4) by operator ID (0).
0 = Operator ID
1 = Assay name
2 = Westgard rule
3 = Changed from
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4 = Changed to
Probable cause Corrective action
The Westgard rule configuration was updated. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0698
Control configuration changed for (0) parameter (1) from (2) to (3) by operator ID (4).
0 = Control configuration item
1 = Parameter
2 = Changed from
3 = Changed to
4 = Operator ID
Probable cause Corrective action
The control configuration was updated. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0699
CPU firmware update in progress. Please wait.
Probable cause Corrective action
A CPU firmware update is in progress. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0700
CPU firmware update complete. The system will automatically cycle power to the c-series module.
Probable cause Corrective action
The CPU firmware update is completed. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0701
DAQ firmware update complete. Cycle power on the c-series module to complete the update.
Probable cause Corrective action
The DAQ firmware update is completed. Cycle power on the c-series module to complete the
update. Perform Cycle power to the processing module
and the reagent and sample manager (RSM), page 432.
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Section 10 Message codes
Related information...
General message codes (0001-0999), page 941
Message code: 0702
DAQ firmware update in progress. Please wait.
Probable cause Corrective action
A DAQ firmware update is in progress. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0703
Module (0) added.
0 = Module
Probable cause Corrective action
A new module was added and configured. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0704
(0) panel deleted.
0 = Panel
Probable cause Corrective action
All assays within a panel have been deleted. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0705
Assay uninstalled. (0) panel updated.
0 = Panel
Probable cause Corrective action
An assay within a panel has been removed. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0706
Reagent access cover removal detected.
Probable cause Corrective action
The reagent access cover was removed. Replace the reagent access cover.
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Message codes Section 10
Probable cause Corrective action
The reagent access cover sensor failed. Contact Customer Service to resolve any hardware
failure.
Related information...
General message codes (0001-0999), page 941
Message code: 0707
(0) assay result for SID (1) deleted by operator ID (2).
0 = Assay name
1 = SID
2 = Operator ID
Probable cause Corrective action
The operator deleted an unreleased result. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0708
Instrument status transitioned to (0).
0 = Instrument status
Probable cause Corrective action
The module status has changed. Status message. No corrective action is required.
Related information...
General message codes (0001-0999), page 941
Message code: 0709
Processing center cover opened.
Probable cause Corrective action
One or both of the processing covers are open. 1. Close the processing cover that is open.
2. Start the processing module and the reagent and
sample manager (RSM), page 447.
Related information...
General message codes (0001-0999), page 941
Message code: 0710
Automatically reposition samples for retest is disabled. System ordered retest will not be processed for
assay (0) SID (1).
0 = Assay name
1 = SID
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Section 10 Message codes
Probable cause Corrective action
The option to reposition samples automatically for To enable the option to reposition samples automatically
retesting was turned off. for retesting, perform Configure reagent and sample
manager module settings, page 174.
Related information...
General message codes (0001-0999), page 941
Message code: 0711
The same lot of this (0) is already available for installation for (1) LN (2) lot (3).
0 = Calibrator mail item
1 = Subject
2 = LN
3 = Lot
Probable cause Corrective action
The operator attempted to accept a calibrator mail item Status message. No corrective action is required.
that is already available for installation.
Related information...
General message codes (0001-0999), page 941
Message code: 0712
The same lot of this (0) is already installed for (1) LN (2) lot (3).
0 = Calibrator mail item
1 = Subject
2 = LN
3 = Lot
Probable cause Corrective action
The operator attempted to accept a calibrator mail item Status message. No corrective action is required.
that is already installed.
Related information...
General message codes (0001-0999), page 941
Message code: 0713
Received same lot of this (0) that is installed or available for install for (1) LN (2) lot (3).
0 = Mail category
1 = Subject
2 = LN
3 = Lot
Probable cause Corrective action
The calibrator file was already available or installed Status message. No corrective action required.
before the AbbottLink request was sent.
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Related information...
General message codes (0001-0999), page 941
Message code: 0714
Instrument status transitioned to offline while a maintenance or diagnostic procedure was running.
Probable cause Corrective action
An unexpected error occurred during the running of the 1. Reinitialize the processing module. Perform Start
maintenance or diagnostic procedure. the processing module and the reagent and sample
manager (RSM), page 447.
2. Rerun the maintenance or diagnostic procedure.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
General message codes (0001-0999), page 941
Assay-specific message codes (1000-1999)
The assay-specific message code category includes message codes from 1000 through 1999.
Related information...
Message codes, page 941
1000, page 992
1001, page 992
1002, page 992
1003, page 993
1004, page 993
1006, page 993
1037, page 993
1038, page 995
1039, page 996
1040, page 997
1041, page 998
1042, page 999
1043, page 1000
1044, page 1001
1045, page 1002
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1046, page 1002
1047, page 1003
1060, page 1003
1061, page 1004
1062, page 1005
1063, page 1005
1064, page 1005
1065, page 1006
1066, page 1007
1067, page 1008
1068, page 1008
1069, page 1008
1070, page 1009
1071, page 1010
1072, page 1010
1075, page 1010
1076, page 1011
1089, page 1012
1090, page 1012
1091, page 1012
1092, page 1013
1093, page 1013
1094, page 1013
1095, page 1013
1096, page 1014
1097, page 1014
1098, page 1015
1099, page 1015
1100, page 1015
1101, page 1016
1102, page 1016
1103, page 1016
1104, page 1017
1105, page 1017
1106, page 1017
1107, page 1017
1108, page 1018
1109, page 1018
1110, page 1018
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Message codes Section 10
1111, page 1018
1112, page 1019
1113, page 1019
1114, page 1019
1115, page 1019
1116, page 1020
1117, page 1020
1119, page 1020
1120, page 1020
1122, page 1021
1123, page 1021
1124, page 1022
1125, page 1022
1126, page 1022
1127, page 1023
1128, page 1023
1129, page 1023
1130, page 1023
1131, page 1024
1132, page 1024
1133, page 1024
1134, page 1025
1135, page 1025
1136, page 1025
1137, page 1025
1138, page 1026
1139, page 1026
1140, page 1026
1141, page 1026
1142, page 1027
1143, page 1027
1144, page 1027
1146, page 1028
1147, page 1028
1148, page 1028
1149, page 1029
1150, page 1029
1151, page 1029
1152, page 1030
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Section 10 Message codes
1153, page 1030
1154, page 1030
1155, page 1030
1156, page 1031
1157, page 1031
1158, page 1031
1159, page 1032
1160, page 1032
1161, page 1032
1162, page 1032
1163, page 1033
1164, page 1033
1165, page 1033
1166, page 1034
1167, page 1034
1169, page 1034
1170, page 1035
1171, page 1035
1172, page 1035
1173, page 1036
1400, page 1036
1401, page 1036
1402, page 1037
1403, page 1037
1404, page 1037
1405, page 1038
1406, page 1038
1415, page 1038
1600, page 1038
1601, page 1039
1602, page 1039
1603, page 1040
1604, page 1040
1605, page 1041
1606, page 1042
1607, page 1043
1608, page 1043
1609, page 1043
1610, page 1044
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Message codes Section 10
1611, page 1045
1612, page 1046
1613, page 1046
1614, page 1046
1615, page 1047
Message code: 1000
Calibration failed for assay (0) number (1). Did not complete results for all calibrator levels.
0 = Assay name
1 = Assay number
Probable cause Corrective action
The required number of replicates for a calibrator failed Review the specific message text for the calibrator
to complete because of an error. failure. Perform the corrective action for the specific
message text for the calibrator failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1001
Calibration failed for assay (0) number (1). Calibrators incorrectly loaded.
0 = Assay name
1 = Assay number
Probable cause Corrective action
The calibrator is not performing as expected. Open a new calibrator.
The reagent is not performing as expected. Load a new reagent.
The wrong calibrator was used or the calibrator was Place fresh calibrators into clean sample cups or tubes.
loaded incorrectly. Verify that the calibrators are placed in the correct
positions.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1002
Calibration failed for assay (0) number (1). Unable to generate a calibration.
0 = Assay name
1 = Assay number
Probable cause Corrective action
The calibrator is not performing as expected. Open a new calibrator.
The reagent cartridge not is performing as expected. Load a new reagent.
Related information...
Assay-specific message codes (1000-1999), page 988
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Section 10 Message codes
Message code: 1003
Unable to install assay (1) number (0) version (2). An equal or higher version already installed.
0 = Assay number
1 = Assay name
2 = Assay version
Probable cause Corrective action
The operator attempted to install an assay whose If the older assay version is required:
version is older than that of the installed assay. • Uninstall the most recently installed assay version.
• Install the older assay version.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1004
Unable to delete assay (1) number (0) version (2). Orders pending or tests processing for this assay.
0 = Assay number
1 = Assay name
2 = Assay version
Probable cause Corrective action
The operator attempted to delete an assay that has Complete or delete the pending orders before the assay
orders pending or tests in process. is deleted.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1006
Unable to install assay (1) number (0) version (2). Instrument status must be Offline, Stopped, Idle, or
Warming.
0 = Assay number
1 = Assay name
2 = Assay version
Probable cause Corrective action
The operator attempted to install an assay when the Transition the instrument status to Idle, Stopped, or
instrument was not in the correct status. Offline to install an assay.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1037
Unable to calculate result, rate reaction linearity failure.
Probable cause Corrective action
The sample concentration is too high. Dilute and rerun the sample. For more information, see
the assay documentation.
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Message codes Section 10
Probable cause Corrective action
The lamp was not seated correctly when it was Replace the lamp or the lamp plate (c-series), page 844.
replaced. Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764:
• Ensure that the lamp is seated correctly against the
lamp plate and in the housing.
• Ensure that the lamp cables are secured by the
screws in terminal block.
The lamp is not performing as expected. Replace the lamp or the lamp plate (c-series), page 844.
Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
The cuvettes are dirty. Clean the cuvettes. Perform Reaction Mechanisms
diagnostic procedure 5003 Clean Cuvettes - Manually
(c-series), page 790.
The cuvette washer is not functioning correctly. 1. Perform As-Needed maintenance procedure 5910
Wash Cuvettes (c-series), page 767. Observe the
cuvette washer nozzles for drops or leaks.
2. Inspect the high-concentration waste pump tubing
for blockage.
a. Open the front processing center cover.
b. Locate the high-concentration waste pump.
c. Inspect the input tubing from the cuvette
washer to the pump and the output tubing from
the pump to the high-concentrated waste. To
view the location of the high-concentration
waste pump, see Reaction carousel hardware
(Alinity c), page 73.
If a blockage is observed, contact Customer
Service.
The cuvette dry tip is damaged. Replace the cuvette dry tip (c-series), page 852.
Debris is present in the water bath incubator. Perform Reaction Mechanisms diagnostic procedure
5005 Exchange Water in Bath (c-series), page 791.
The R2 pipettor is out of alignment. Perform Pipettors diagnostic procedure 4104 R2 Pipettor
Calibration (c-series), page 779.
Bubbles is present in the water bath incubator because Decrease the incoming purified water pressure to be
of the pressure of the incoming water. within specifications.
Bubbles is present in the water bath incubator because Contact Customer Service to resolve any hardware
of a high gas content of the incoming water. failure.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
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Section 10 Message codes
Message code: 1038
Unable to calculate result, insufficient absorbance reads within absorbance range.
Probable cause Corrective action
The sample concentration is too high. Dilute and rerun the sample. For more information, see
the assay documentation.
The sample is lipemic. Ultra-centrifuge the sample and rerun the infranatant.
For more information, see the assay documentation.
Bubbles or foam are present on the surface of the • Remove bubbles or foam from the surface of the
reagent. reagent by using a clean applicator stick for each
bottle.
• Allow the reagent cartridge to sit for the
recommended hold time. For more information, see
the assay documentation.
The reagent probe is damaged. Replace the reagent probes (c-series), page 832.
The lamp was not seated correctly when it was Replace the lamp or the lamp plate (c-series), page 844.
replaced. Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764:
• Ensure that the lamp is seated correctly against the
lamp plate and in the housing.
• Ensure that the lamp cables are secured by the
screws in terminal block.
The lamp is not performing as expected. Replace the lamp or the lamp plate (c-series), page 844.
Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
The reagent is not performing as expected. Load a new reagent cartridge.
The cuvettes are dirty. Clean the cuvettes. Perform Reaction Mechanisms
diagnostic procedure 5003 Clean Cuvettes - Manually
(c-series), page 790.
The cuvette washer is not functioning correctly. 1. Perform As-Needed maintenance procedure 5910
Wash Cuvettes (c-series), page 767. Observe the
cuvette washer nozzles for drops or leaks.
2. Inspect the high-concentration waste pump tubing
for blockage.
a. Open the front processing center cover.
b. Locate the high-concentration waste pump.
c. Inspect the input tubing from the cuvette
washer to the pump and the output tubing from
the pump to the high-concentrated waste. To
view the location of the high-concentration
waste pump, see Reaction carousel hardware
(Alinity c), page 73.
If a blockage is observed, contact Customer
Service.
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Message codes Section 10
Probable cause Corrective action
The cuvette dry tip is damaged. Replace the cuvette dry tip (c-series), page 852.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1039
Unable to calculate result. Absorbance exceeded optical limits.
Probable cause Corrective action
The sample concentration is too high. Dilute and rerun the sample. For more information, see
the assay documentation.
The sample is lipemic. Ultra-centrifuge the sample and rerun the infranatant.
For more information, see the assay documentation.
The lamp was not seated correctly when it was Replace the lamp or the lamp plate (c-series), page 844.
replaced. Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764:
• Ensure that the lamp is seated correctly against the
lamp plate and in the housing.
• Ensure that the lamp cables are secured by the
screws in terminal block.
The lamp is not performing as expected. Replace the lamp or the lamp plate (c-series), page 844.
Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
The cuvettes are dirty. Clean the cuvettes. Perform Reaction Mechanisms
diagnostic procedure 5003 Clean Cuvettes - Manually
(c-series), page 790.
The cuvette washer is not functioning correctly. 1. Perform As-Needed maintenance procedure 5910
Wash Cuvettes (c-series), page 767. Observe the
cuvette washer nozzles for drops or leaks.
2. Inspect the high-concentration waste pump tubing
for blockage.
a. Open the front processing center cover.
b. Locate the high-concentration waste pump.
c. Inspect the input tubing from the cuvette
washer to the pump and the output tubing from
the pump to the high-concentrated waste. To
view the location of the high-concentration
waste pump, see Reaction carousel hardware
(Alinity c), page 73.
If a blockage is observed, contact Customer
Service.
The cuvette dry tip is damaged. Replace the cuvette dry tip (c-series), page 852.
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Section 10 Message codes
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1040
Unable to calculate result. No absorbance reads within absorbance range.
Probable cause Corrective action
The sample concentration is too high. Dilute and rerun the sample. For more information, see
the assay documentation.
The sample is lipemic. Ultra-centrifuge the sample and rerun the infranatant.
For more information, see the assay documentation.
Bubbles or foam are present on the surface of the Remove bubbles or foam from the surface of the
reagent. reagent by using a clean applicator stick.
The reagent probe is damaged. Replace the reagent probe. Perform Replace a sample
or reagent pipettor probe (i-series), page 894.
The lamp was not seated correctly when it was Replace the lamp or the lamp plate (c-series), page 844.
replaced. Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764:
• Ensure that the lamp is seated correctly against the
lamp plate and in the housing.
• Ensure that the lamp cables are secured by the
screws in terminal block.
The lamp is not performing as expected. Replace the lamp or the lamp plate (c-series), page 844.
Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
The cuvettes are dirty. Clean the cuvettes. Perform Reaction Mechanisms
diagnostic procedure 5003 Clean Cuvettes - Manually
(c-series), page 790.
The cuvette washer is not functioning correctly. 1. Perform As-Needed maintenance procedure 5910
Wash Cuvettes (c-series), page 767. Observe the
cuvette washer nozzles for drops or leaks.
2. Inspect the high-concentration waste pump tubing
for blockage.
a. Open the front processing center cover.
b. Locate the high-concentration waste pump.
c. Inspect the input tubing from the cuvette
washer to the pump and the output tubing from
the pump to the high-concentrated waste. To
view the location of the high-concentration
Alinity ci-series Operations Manual 997
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Message codes Section 10
Probable cause Corrective action
waste pump, see Reaction carousel hardware
(Alinity c), page 73.
If a blockage is observed, contact Customer
Service.
The cuvette dry tip is damaged. Replace the cuvette dry tip (c-series), page 852.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1041
Unable to calculate result. Reaction check failure.
Probable cause Corrective action
The sample concentration is too high. Dilute and rerun the sample. For more information, see
the assay documentation.
NOTE: View the reaction graph to confirm the high
sample concentration. Perform View the reaction graph
and absorbance data for a result (c-series), page 634.
Sample interferences (such as hemolysis or lipemia) Visually inspect the sample for possible interference
occurred. because of hemolysis, icterus, or turbidity, and then
perform one of the following actions:
• Redraw and rerun the sample if an interference is
observed.
• Rerun the sample if no interference is observed.
NOTE: View the sample interference indices to
determine increased interference levels, or view the
reaction graph to confirm abnormal absorbance
readings during the Blank read time (compare the
error to a normal result). Perform View the reaction
graph and absorbance data for a result (c-series),
page 634.
A high anticoagulant to plasma ratio is present (such as Redraw the sample into a anticoagulant tube that is
the sample tube is not filled adequately). adequately filled or use a serum sample. For more
information, see the assay documentation.
If an error occurs for calibration samples:
The wrong calibrator was used or the calibrator was Place new calibrators into clean sample cups or tubes
loaded incorrectly. to ensure they are placed in the correct positions.
Repeat the calibration.
The calibrators are not performing as expected. Open a new calibrator.
The reagent is not performing as expected. Load a new reagent cartridge.
If an error occurs for all samples:
998 Alinity ci-series Operations Manual
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Section 10 Message codes
Probable cause Corrective action
The lamp was not seated correctly when it was Replace the lamp or the lamp plate (c-series), page 844.
replaced. Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764:
• Ensure that the lamp is seated correctly against the
lamp plate and in the housing.
• Ensure that the lamp cables are secured by the
screws in terminal block.
The lamp is not performing as expected. Replace the lamp or the lamp plate (c-series), page 844.
Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1042
Unable to calculate result. ICT reference solution voltage drift error.
Probable cause Corrective action
The black electrical connector for the ICT module is Reseat the connection. Perform Replace the ICT module
loose or not connected. or the ICT probe (c-series), page 859.
The ICT probe is not connected correctly. Tighten the probe to the ICT module by hand. Perform
Replace the ICT module or the ICT probe (c-series),
page 859.
The ICT aspiration tubing is not connected correctly. Tighten the tubing connections at the top of the ICT
module and at the top of the 1 mL syringes in the ICT
aspiration pump.
The ICT Reference Solution tubing is not connected Tighten the connections at the top and at the side of
correctly. each check valve in the ICT Reference Solution pump.
The ICT check valves are not connected correctly. Tighten the connections to the 1 mL syringes in the ICT
Reference Solution pump and in the ICT aspiration
pump.
The ICT check valves are not functioning. Perform Quarterly maintenance procedure 5805 Check
and Change ICT Check Valves (c-series), page 764.
The 1 mL syringes in the ICT aspiration pump or the ICT Reseat the 1 mL syringes.
Reference Solution pump are not seated correctly.
The 1 mL syringes in the ICT aspiration pump or the ICT Perform Quarterly maintenance procedure 5804 Change
Reference Solution pump are leaking. 1 mL Syringes (c-series), page 763.
The ICT module is expired or has exceeded time or Replace the ICT module. Perform Replace the ICT
sample warranty (> 3 months after installation or > module or the ICT probe (c-series), page 859.
20,000 samples).
The ICT module is not performing as expected. Replace the ICT module. Perform Replace the ICT
module or the ICT probe (c-series), page 859.
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Message codes Section 10
Probable cause Corrective action
The ICT Reference Solution is not performing as 1. Replace the ICT Reference Solution bottle. Perform
expected. Replace bulk solutions and update the inventory,
page 508.
2. Perform ICT diagnostics procedure 5101 Flush ICT
Reference Solution Cup (c-series), page 792.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1043
Unable to calculate result. Final RLU read is outside the specification of the highest calibrator.
Probable cause Corrective action
The RLU read is outside the specifications for the
descending curve assay.
If an error occurs for one sample:
The sample concentration is too high. Dilute and rerun the sample. For more information, see
the assay documentation.
The sample contains an interfering substance. 1. See the section on limitations of the procedure and
specific performance characteristics in the assay-
specific documentation.
2. Redraw and rerun the sample if an interference is
observed.
A sample handling error occurred. • Follow the sample handling instructions in the
assay-specific documentation.
• Rerun the sample.
• Source a different sample.
If an error occurs for more than one sample:
The Pre-Trigger Solution and Trigger Solution tubing 1. Empty the reservoirs. Rinse the reservoirs and
assemblies are switched. floats with purified water, and then remove excess
water.
2. Replace the Pre-Trigger Solution and Trigger
Solution bottles. Perform Replace bulk solutions
and update the inventory, page 508.
3. Perform the Fluidics-Wash diagnostic procedure
1200 Flush and Prime Fluidics (i-series), page 804.
The level sensor is not installed correctly. 1. Adjust the level sensor in the Pre-Trigger Solution
or Trigger Solution bottle so the level sensor is fully
seated in the reservoir.
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Section 10 Message codes
Probable cause Corrective action
2. Perform Fluidics-Wash diagnostic procedure 1200
Flush and Prime Fluidics (i-series), page 804.
The Pre-Trigger Solution or Trigger Solution volume is Replace the Pre-Trigger Solution or Trigger Solution and
too low. update the inventory.
Hardware failure: Contact Customer Service to resolve any hardware
• The Pre-Trigger or Trigger pump failed. failure.
• The Pre-Trigger or Trigger valve failed.
• The Pre-Trigger or Trigger tubing connections are
loose.
• The temp-optics control board has a poor
connection or has failed.
• The optics failed.
• The shutter failed.
• The Pre-Trigger or Trigger manifold failed.
• The Pre-Trigger vortexer failed.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1044
Unable to calculate result. Final RLU read is outside the specification of the lowest calibrator.
Probable cause Corrective action
The RLU read is outside the specifications for the
ascending curve assay.
If an error occurs for one sample:
Normal for some nonreactive samples. 1. Follow the sample handling instructions in the
assay-specific documentation.
2. Rerun the sample.
3. Source a different sample.
4. Contact Customer Service.
A sample handling error occurred. • Follow the sample handling instructions in the
assay-specific documentation.
• Rerun the sample.
• Source a different sample.
If an error occurs for more than one sample:
The Pre-Trigger Solution and Trigger Solution tubing 1. Empty the reservoirs. Rinse the reservoirs and
assemblies are switched. floats with purified water, and then remove excess
water.
2. Replace the Pre-Trigger Solution and Trigger
Solution bottles. Perform Replace bulk solutions
and update the inventory, page 508.
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Troubleshooting
Message codes Section 10
Probable cause Corrective action
3. Perform the Fluidics-Wash diagnostic procedure
1200 Flush and Prime Fluidics (i-series), page 804.
The level sensor is not installed correctly. 1. Adjust the level sensor in the Pre-Trigger Solution
or Trigger Solution bottle so the level sensor is fully
seated in the reservoir.
2. Perform Fluidics-Wash diagnostic procedure 1200
Flush and Prime Fluidics (i-series), page 804.
The Pre-Trigger Solution or Trigger Solution volume is Replace the Pre-Trigger Solution or Trigger Solution and
too low. update the inventory.
Hardware failure: Contact Customer Service to resolve any hardware
• The Pre-Trigger or Trigger pump failed. failure.
• The Pre-Trigger or Trigger valve failed.
• The Pre-Trigger or Trigger tubing connections are
loose.
• The temp-optics control board has a poor
connection or has failed.
• The optics failed.
• The shutter failed.
• The Pre-Trigger or Trigger manifold failed.
• The Pre-Trigger vortexer failed.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1045
An equal or higher version of this (3) is already available for installation for (0) number (1) revision (2).
0 = Subject
1 = List number
2 = Revision
3 = Mail category
Probable cause Corrective action
The operator attempted to accept an assay file that is a • Accept the higher version of the assay file.
lower version than another unaccepted assay file. Only • To accept the lower version of the assay file,
the highest version of available assay files can be delete the higher version before accepting the
accepted. lower version.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1046
An equal or higher version of this (3) is already installed for (0) number (1) revision (2).
0 = Subject
1 = List number
2 = Revision
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Troubleshooting
Section 10 Message codes
3 = Mail category
Probable cause Corrective action
The operator attempted to accept an assay file that is a Status message. To accept the lower version of the
lower version than another installed assay file. Only the assay file, perform one of the following corrective
highest version of available assay files can be accepted. actions:
• Uninstall the higher version of the assay file.
NOTE: When an assay file is uninstalled,
calibrations for the assay file and any assay
configuration including controls are deleted.
• Delete the assay file.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1047
Received lower or equal version of an (3) than is installed or is available to install for (0) number (1)
revision (2).
0 = Subject
1 = List number
2 = Revision
3 = Mail category
Probable cause Corrective action
A manual request or an automatic request for an assay Status message. No corrective action is required.
file was in process. Before the system received the
assay file, an assay file of the same or higher version
was installed on the system.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1060
Unable to calculate result. mV reading outside measurable range of ICT unit.
Probable cause Corrective action
The black electrical connector for the ICT module is Reseat the black electrical connector to the ICT module.
loose or not connected.
The ICT module O-rings are missing or are not seated Ensure the ICT module O-rings are present and are
correctly. seated correctly. If necessary, perform Replace the ICT
module or the ICT probe (c-series), page 859.
The ICT probe is not connected correctly. Tighten the probe to the ICT module by hand. Perform
Replace the ICT module or the ICT probe (c-series),
page 859.
The ICT aspiration tubing is not connected correctly. Tighten the tubing connections at the top of the ICT
module and at the top of the 1 mL syringes in the ICT
aspiration pump.
Alinity ci-series Operations Manual 1003
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Troubleshooting
Message codes Section 10
Probable cause Corrective action
The ICT Reference Solution tubing is not connected Tighten the tubing connections at the top and at the side
correctly. of each check valve in the ICT Reference Solution
pump.
The ICT check valves are not connected correctly. Tighten the connections to the 1 mL syringes in the ICT
Reference Solution pump and in the ICT aspiration
pump.
The ICT check valves are not functioning. Perform Quarterly maintenance procedure 5805 Check
and Change ICT Check Valves (c-series), page 764.
The 1 mL syringes in the ICT aspiration pump or the ICT Reseat the 1 mL syringes.
Reference Solution pump are not seated correctly.
The 1 mL syringes in the ICT aspiration pump or the ICT Perform Quarterly maintenance procedure 5804 Change
Reference Solution pump are leaking. 1 mL Syringes (c-series), page 763.
The ICT module is expired, has exceeded time, or has Replace the ICT module or the ICT probe (c-series),
exceeded sample warranty (greater than 3 months after page 859.
installation or greater than 20,000 samples).
The ICT module is not performing as expected. Replace the ICT module or the ICT probe (c-series),
page 859.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1061
Unable to calculate result. Endpoint absorbance reads unstable.
Probable cause Corrective action
Debris or bubbles are present in the water bath because 1. Perform Reaction Mechanism diagnostic procedure
of the pressure or the high gas content of the incoming 5005 Exchange Water in Bath (c-series), page 791.
water.
2. Verify that the incoming purified water pressure is
within specifications.
3. If bubbles remain present, contact Customer
Service.
The lamp was not seated correctly when it was Repeat the lamp replacement procedure. Perform
replaced. Replace the lamp or the lamp plate (c-series), page 844.
• Ensure the lamp is seated correctly against the
lamp plate and in the housing.
• Ensure the lamp cables are secured by the screws
in terminal block.
The lamp is not performing as expected. Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
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Section 10 Message codes
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1062
Unable to calculate result. Convergence error.
Probable cause Corrective action
The sample absorbance lies between two segments of Rerun the sample.
the Spline calibration curve, and the result cannot be
calculated.
An invalid Spline calibration curve was generated. Recalibrate the assay.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1063
Unable to calculate result. Absorbance below calibration curve lower limit.
Probable cause Corrective action
The sample concentration is too low. Rerun the sample.
Bubbles or foam are present on the surface of the Remove bubbles or foam from the surface of the
reagent. reagent by using a clean applicator stick for each bottle.
The reagent probe is damaged. Replace the reagent probes (c-series), page 832.
The lamp was not seated correctly when it was Repeat the lamp replacement procedure. Perform
replaced. Replace the lamp or the lamp plate (c-series), page 844.
• Ensure the lamp is seated correctly against the
lamp plate and in the housing.
• Ensure the lamp cables are secured by the screws
in terminal block.
The lamp is not performing as expected. Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
The reagent is not performing as expected. Load a new reagent cartridge.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1064
Unable to calculate result. Absorbance exceeds highest calibrator.
Probable cause Corrective action
The sample concentration is too high. Dilute and rerun the sample.
The sample is lipemic. Ultra-centrifuge the sample and rerun the infranatant.
For more information, see the assay documentation.
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Message codes Section 10
Probable cause Corrective action
The lamp is not performing as expected. Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
The cuvette washer is not functioning correctly. 1. Perform As-Needed maintenance procedure 5910
Wash Cuvettes (c-series), page 767. Observe the
cuvette washer nozzles for drops or leaks.
2. Inspect the high-concentration waste pump tubing
for blockage.
a. Open the front processing center cover.
b. Locate the high-concentration waste pump.
c. Inspect the input tubing from the cuvette
washer to the pump and the output tubing from
the pump to the high-concentrated waste. To
view the location of the high-concentration
waste pump, see Reaction carousel hardware
(Alinity c), page 73.
If a blockage is observed, contact Customer
Service.
The cuvette dry tip is damaged. Replace the cuvette dry tip (c-series), page 852.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1065
Unable to calculate result. Flex read absorbance invalid for calibration.
Probable cause Corrective action
The incorrect calibrator or calibrators were used, or the 1. Load the correct calibrator.
calibrator or calibrators were loaded incorrectly.
2. Repeat the calibration.
The reagent is not performing as expected. Load a new reagent cartridge.
The lamp was not seated correctly when it was Replace the lamp or the lamp plate (c-series), page 844.
replaced. Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764:
• Ensure the lamp is seated correctly against the
lamp plate and in the housing.
• Ensure the lamp cables are secured by the screws
in terminal block.
The lamp is not performing as expected. Replace the lamp or the lamp plate (c-series), page 844.
Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
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Section 10 Message codes
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1066
Unable to calculate calibrator result. Insufficient absorbance reads within absorbance range.
Probable cause Corrective action
The reagent probe is damaged. Replace the reagent probes (c-series), page 832.
The lamp was not seated correctly when it was Replace the lamp or the lamp plate (c-series), page 844.
replaced. Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764:
• Ensure the lamp is seated correctly against the
lamp plate and in the housing.
• Ensure the lamp cables are secured by the screws
in terminal block.
The lamp is not performing as expected. Replace the lamp or the lamp plate (c-series), page 844.
Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
The reagent is not performing as expected. Load a new reagent cartridge.
The cuvettes are dirty. Perform Reaction Mechanisms diagnostic procedure
5003 Clean Cuvettes - Manually (c-series), page 790.
The cuvette washer is not functioning correctly. 1. Perform As-Needed maintenance procedure 5910
Wash Cuvettes (c-series), page 767. Observe the
cuvette washer nozzles for drops or leaks.
2. Inspect the high-concentration waste pump tubing
for blockage.
a. Open the front processing center cover.
b. Locate the high-concentration waste pump.
c. Inspect the input tubing from the cuvette
washer to the pump and the output tubing from
the pump to the high-concentrated waste. To
view the location of the high-concentration
waste pump, see Reaction carousel hardware
(Alinity c), page 73.
If a blockage is observed, contact Customer
Service.
The cuvette dry tip is damaged. Replace the cuvette dry tip (c-series), page 852.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
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Message codes Section 10
Message code: 1067
Unable to calculate result. Absorbance collection error.
Probable cause Corrective action
The lamp was not seated correctly when it was Replace the lamp or the lamp plate (c-series), page 844.
replaced. Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764:
• Ensure the lamp is seated correctly against the
lamp plate and in the housing.
• Ensure the lamp cables are secured by the screws
in terminal block.
The lamp is not performing as expected. Replace the lamp or the lamp plate (c-series), page 844.
Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1068
Unable to calculate result. Assay configuration error.
Probable cause Corrective action
The combined sample and reagent volume is less than If the assay uses a photometric read point of less than
80 μL at a defined read time. 19, for any defined read time, verify that the combined
sample and reagent volume defined for the sample or
diluted sample, the R1 reagent, or the R1 water is
greater than or equal to 80 μL.
An assay parameter setting is defined incorrectly. Verify that the assay settings are configured correctly in
the assay parameter file. See Edit calibration settings of
assay parameters (c-series photometric), page 235.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1069
Unable to calculate result. Invalid mathematical calculation.
Probable cause Corrective action
The sample concentration is too low. Rerun the sample.
Bubbles or foam are present on the surface of the Remove bubbles or foam from the surface of the
reagent. reagent by using a clean applicator stick for each bottle.
The reagent probe is damaged. Replace the reagent probes (c-series), page 832.
The lamp was not seated correctly when it was Repeat the lamp replacement procedure. Perform
replaced. Quarterly maintenance procedure 5806 Change Lamp
(c-series), page 764:
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Section 10 Message codes
Probable cause Corrective action
• Ensure that the lamp is seated correctly against the
lamp plate and in the housing.
• Ensure that the lamp cables are secured by the
screws in terminal block.
The calibration is not optimal. Recalibrate the assay.
The lamp is not performing as expected. Replace the lamp or the lamp plate (c-series), page 844.
Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
The reagent is not performing as expected. Load a new reagent cartridge.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1070
Unable to calculate result. ICT Reference Solution voltage out of range.
Probable cause Corrective action
The ICT module O-rings are missing or are not seated Ensure that the O-rings are present and are seated
correctly. correctly. If necessary, perform Replace the ICT module
or the ICT probe (c-series), page 859.
The ICT probe is not connected correctly. Tighten the probe to the ICT module by hand. Replace
the ICT module or the ICT probe (c-series), page 859.
The ICT aspiration tubing is not connected correctly. Tighten the tubing connections at the top of the ICT
module and at the top of the 1 mL syringes in the ICT
aspiration pump.
The ICT Reference Solution tubing is not connected Tighten the tubing connections at the top and at the side
correctly. of each check valve in the ICT Reference Solution
pump.
The ICT check valves are not connected correctly. Tighten the connections to the 1 mL syringes in the ICT
Reference Solution pump and in the ICT aspiration
pump.
The ICT check valves are not functioning. Perform Quarterly maintenance procedure 5805 Check
and Change ICT Check Valves (c-series), page 764.
The 1 mL syringes in the ICT aspiration pump or the ICT Reseat the 1 mL syringes.
Reference Solution pump are not seated correctly.
The 1 mL syringes in the ICT aspiration pump or the ICT Perform Quarterly maintenance procedure 5804 Change
Reference Solution pump are leaking. 1 mL Syringes (c-series), page 763.
The ICT module is expired, has exceeded time, or has Replace the ICT module or the ICT probe (c-series),
exceeded sample warranty (greater than 3 months after page 859.
installation or greater than 20,000 samples).
The ICT module is not performing as expected. Replace the ICT module or the ICT probe (c-series),
page 859.
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Message codes Section 10
Probable cause Corrective action
The ICT Reference Solution is not performing as 1. Replace the ICT Reference Solution bottle.
expected.
2. 5102 Flush ICT Module (c-series), page 792.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1071
Unable to calculate result. Calibration curve allows multiple solutions.
Probable cause Corrective action
The calibration is not optimal. Recalibrate the assay.
The reagent is not performing as expected. Load a new reagent cartridge.
The lamp is not performing as expected. Replace the lamp or the lamp plate (c-series), page 844.
Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1072
Unable to calculate result. Processing module response outside of defined range.
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1075
ICT measurement error for (0).
0 = Electrode
Probable cause Corrective action
The black electrical connector for the ICT module is Reseat the connection. Perform Replace the ICT module
loose or not connected. or the ICT probe (c-series), page 859.
The ICT probe is not connected correctly. Tighten the probe to the ICT module by hand. Perform
Replace the ICT module or the ICT probe (c-series),
page 859.
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Section 10 Message codes
Probable cause Corrective action
The ICT aspiration tubing is not connected correctly. Tighten the tubing connections at the top of the ICT
module and at the top of the 1 mL syringes in the ICT
aspiration pump.
The ICT check valves are not connected correctly. Tighten the connections to the 1 mL syringes in the ICT
Reference Solution pump and in the ICT aspiration
pump.
The ICT check valves are not functioning. Perform Quarterly maintenance procedure 5805 Check
and Change ICT Check Valves (c-series), page 764.
The 1 mL syringes in the ICT aspiration pump or the ICT Reseat the 1 mL syringes.
Reference Solution pump are not seated correctly.
The 1 mL syringes in the ICT aspiration pump or the ICT Perform Quarterly maintenance procedure 5804 Change
Reference Solution pump are leaking. 1 mL Syringes (c-series), page 763.
The ICT module is expired or has exceeded time or Replace the ICT module. Perform Replace the ICT
sample warranty (> 3 months after installation or > module or the ICT probe (c-series), page 859.
20,000 samples).
The ICT module is not performing as expected. Replace the ICT module. Perform Replace the ICT
module or the ICT probe (c-series), page 859.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1076
ICT DAC adjustment measurement range failed for (0).
0 = ICT DAC error
Probable cause Corrective action
The black electrical connector for the ICT module is Reseat the connection. Perform Replace the ICT module
loose or not connected. or the ICT probe (c-series), page 859.
The ICT probe is not connected correctly. Tighten the probe to the ICT module by hand. Perform
Replace the ICT module or the ICT probe (c-series),
page 859.
The ICT aspiration tubing is not connected correctly. Tighten the tubing connections at the top of the ICT
module and at the top of the 1 mL syringes in the ICT
aspiration pump.
The ICT check valves are not connected correctly. Tighten the connections to the 1 mL syringes in the ICT
Reference Solution pump and in the ICT aspiration
pump.
The ICT check valves are not functioning. Perform Quarterly maintenance procedure 5805 Check
and Change ICT Check Valves (c-series), page 764.
The 1 mL syringes in the ICT aspiration pump or the ICT Reseat the 1 mL syringes.
Reference Solution pump are not seated correctly.
The 1 mL syringes in the ICT aspiration pump or the ICT Perform Quarterly maintenance procedure 5804 Change
Reference Solution pump are leaking. 1 mL Syringes (c-series), page 763.
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Message codes Section 10
Probable cause Corrective action
The ICT module is expired or has exceeded time or Replace the ICT module. Perform Replace the ICT
sample warranty (> 3 months after installation or > module or the ICT probe (c-series), page 859.
20,000 samples).
The ICT module is not performing as expected. Replace the ICT module. Perform Replace the ICT
module or the ICT probe (c-series), page 859.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1089
Unable to delete assay number (0) version (1). Assay referenced by one or more assays.
0 = Assay number
1 = Assay version
Probable cause Corrective action
An attempt was made to delete an assay that is Delete the assay parameter file that references the
referenced in another assay parameter file. assay before the assay is deleted.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1090
Unable to install assay. Invalid calibrator parameter for assay (2) number (0) version (1).
0 = Assay number
1 = Assay version
2 = Assay name
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1091
Unable to install assay. No module is configured for assay (2) number (0) version (1).
0 = Assay number
1 = Assay version
2 = Assay name
Probable cause Corrective action
An attempt was made to install an assay that is not Configure the system with the appropriate module and
supported by the module configuration. install the assay.
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Section 10 Message codes
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1092
Unable to process test. Assay number (0) version (1) not calibrated.
0 = Assay number
1 = Assay version
Probable cause Corrective action
An attempt was made to process a control or sample Calibrate the assay. Perform Create a calibration order,
when the assay is not calibrated. page 599.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1093
Unable to process test. ICT module not configured.
Probable cause Corrective action
An attempt was made to process an ICT sample when Configure the ICT module. Perform Configure c-series
the ICT module is not configured on the processing module settings , page 174.
module.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1094
Unable to process test. No reagent cartridge available for assay number (0) version (1).
0 = Assay number
1 = Assay version
Probable cause Corrective action
The required reagent cartridge is not available on the Load a new reagent cartridge. Perform Load cartridges
selected processing module. All of the reagent kits on on the reagent and sample manager (RSM), page 527.
the module for the assay are empty, expired, not
calibrated, or disabled.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1095
Westgard rule (0) failed for assay (1)/(2) control (3)/(5)/(4) on module (6).
0 = Westgard rule
1 = Assay name
2 = Assay version
3 = Control name
4 = Control lot
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Message codes Section 10
5 = Control level
6 = Module
Probable cause Corrective action
A control received a Westgard rule failure flag. 1. Review the QC results for the specified control.
2. See Controls out of range (c-series), page 1272 of
the sample results observed problems for the
corrective action. See Controls out of range (i-
series), page 1277 of the sample results observed
problems for the corrective action.
3. Rerun the same control level or levels after the
corrective action is performed.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1096
Westgard rule (0) warning for assay (1)/(2) control (3)/(5)/(4) on module (6).
0 = Westgard rule
1 = Assay name
2 = Assay version
3 = Control name
4 = Control lot
5 = Control level
6 = Module
Probable cause Corrective action
A control received a Westgard rule warning flag. 1. Review the QC results for the specified control.
2. See Controls out of range (c-series), page 1272 of
the sample results observed problems for the
corrective action. See Controls out of range (i-
series), page 1277 of the sample results observed
problems for the corrective action.
3. Rerun the same control level or levels after the
corrective action is performed.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1097
Unable to delete assay (0) from control (1). Pending orders exist for this assay.
0 = Assay
1 = Control
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Section 10 Message codes
Probable cause Corrective action
An attempt was made to delete an assay when pending Delete the pending order or wait until the orders are
or running orders exist for the assay. completed before the assay is deleted.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1098
Unable to delete assay (0) from Control (1) / Level (3) / Lot (2). Pending orders exist for this assay.
0 = Assay
1 = Control name
2 = Control level
3 = Control lot
Probable cause Corrective action
An attempt was made to delete an assay when pending Delete the pending order or wait until the orders are
or running orders exist for the assay. completed before the assay is deleted.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1099
Unable to process test. Constituent assay (0) number (1) can not be system ordered. System ordering
disabled.
0 = Constituent assay
1 = Constituent assay number
Probable cause Corrective action
The calculated assay that was ordered does not support Order the calculated assay and the constituent assay
constituent assays ordered by the system. with the correct dilutions.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1100
Unable to process test. Constituent assay (0) number (1) can not be system ordered. Offline dilution not
supported.
0 = Constituent assay
1 = Constituent assay number
Probable cause Corrective action
A calculated assay was ordered for a manually diluted Order the calculated assay for a sample that is
sample. The calculated assay has a constituent assay undiluted or that uses an automated dilution protocol.
that does not support a manual dilution.
Related information...
Assay-specific message codes (1000-1999), page 988
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Message codes Section 10
Message code: 1101
Unable to process test. Constituent assay (0) number (1) can not be system ordered. Assay disabled.
0 = Assay name
1 = Assay number
Probable cause Corrective action
The constituent assay is disabled. 1. Enable the required assay. Perform Edit general
settings of assay parameters (c-series photometric),
page 230, Edit general settings of assay parameters
(c-series potentiometric), page 231, or Edit general
settings of assay parameters (i-series), page 232.
2. Rerun the test.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1102
Unable to calculate result. Constituent assay (0) number (1) result not found.
0 = Constituent assay
1 = Constituent assay number
Probable cause Corrective action
A constituent result was deleted before other Reorder the constituent assay.
constituents of a calculated result completed.
The constituent result was flagged outside the Rerun the constituent assay with a manual or automatic
measuring interval of the assay. dilution if one is available. Perform Rerun a test or an
exception for a specimen or control, page 612.
One of the constituent results became an exception. 1. Determine and correct the cause of the exception.
2. Rerun the sample.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1103
Unable to calculate result. Constituent assay (0) number (1) result out of range.
0 = Constituent assay
1 = Constituent assay number
Probable cause Corrective action
A constituent result was outside of the constituent range Status message. No corrective action is required.
that is specified in the calculated assay parameters.
Related information...
Assay-specific message codes (1000-1999), page 988
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Section 10 Message codes
Message code: 1104
Unable to calculate result. No constituent results exist to calculate results.
Probable cause Corrective action
The constituent results that are required to calculate the Rerun the calculated assay. Perform Rerun a test or an
results were used by a calculated result that was exception for a specimen or control, page 612.
previously reported.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1105
Unable to calculate result. More than one reagent lot used to process constituent assays.
Probable cause Corrective action
Constituent assays of a calculated assay that use the 1. Verify that adequate inventory of the same reagent
same reagent cartridge were not run on the same lot is on the reagent carousel.
reagent lot number.
2. Rerun the calculated assay. Perform Rerun a test
or an exception for a specimen or control, page
612.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1106
Unable to process test. Primary indirect (0) assay result not found.
0 = Assay
Probable cause Corrective action
A primary indirect photometric test replicate was not Repeat the test order.
found.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1107
Unable to process test. Secondary indirect (0) assay result not found.
0 = Assay
Probable cause Corrective action
A secondary indirect photometric test replicate was not Repeat the test order.
found.
Related information...
Assay-specific message codes (1000-1999), page 988
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Message codes Section 10
Message code: 1108
Unable to calculate result. Constituent result not available.
Probable cause Corrective action
A constituent result was deleted before other Reorder the constituent assay.
constituents of a calculated result completed.
The constituent result was flagged outside the Rerun the constituent assay with a manual or automatic
measuring interval of the assay. dilution if one is available. Perform Rerun a test or an
exception for a specimen or control, page 612.
One of the constituent results became an exception. 1. Determine and correct the cause of the exception.
2. Rerun the sample.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1109
Unable to calculate result. (0) result exceeds maximum allowable limit.
0 = Result
Probable cause Corrective action
The calculated result cannot be determined because the Modify the calculated result formula or constituent assay
result exceeds the numerical limit. ranges. Perform Create a calculated assay, page 251.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1110
Unable to process test. Required number of probe washes not completed.
Probable cause Corrective action
The required number of probe washes did not occur. Rerun a test or an exception for a specimen or control,
page 612.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1111
Unable to delete assay from calibrator set (0). Pending orders exist.
0 = Calibrator set
Probable cause Corrective action
A pending order exists for the calibrator set. Complete or delete the pending orders before the assay
from the calibrator set is deleted.
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Section 10 Message codes
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1112
Unable to delete calibrator lot for calibrator set (0). Pending orders exist.
0 = Calibrator set
Probable cause Corrective action
A pending order exists for the calibrator set. Complete or delete the pending orders before the lot for
the calibrator set is deleted.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1113
Unable to delete calibrator set (0). Pending orders exist.
0 = Calibrator set
Probable cause Corrective action
A pending order exists for the calibrator set. Complete or delete the pending orders before the
calibrator set is deleted.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1114
Invalid assay name. Assay name already exists for a different assay number.
Probable cause Corrective action
The assay name already exists. Configure a new assay name or uninstall the assay with
the duplicate name. Perform Uninstall assay files, page
274.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1115
Invalid linearity range. Low linearity value must be lower than the high linearity value.
Probable cause Corrective action
The configured low linearity value is greater than the Configure the low linearity to a value lower than the high
high linearity value. linearity value.
Related information...
Assay-specific message codes (1000-1999), page 988
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Message codes Section 10
Message code: 1116
Configuration for calibrator set (0) parameter (1) edited from (2) to (3) by operator ID (4).
0 = Calibrator set
1 = Parameter
2 = Original value
3 = New value
4 = Operator ID
Probable cause Corrective action
A calibrator set parameter has been modified. Status message. No corrective action is required.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1117
Assay (0) number (1) version (2) edited by operator ID (3).
0 = Assay name
1 = Assay number
2 = Assay version
3 = Operator ID
Probable cause Corrective action
One or more assay parameters have been modified. Status message. No corrective action is required.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1119
Calibration failed for assay (0) lot (1) on module (2). System shutdown occurred.
0 = Assay name
1 = Lot
2 = Module
Probable cause Corrective action
An unexplained system shutdown occurred. Cycle power to the system, page 428.
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1120
Unable to process order for (1) control lot (0) assay (2) version (3). Assay not installed.
0 = Control lot
1 = Control level
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Section 10 Message codes
2 = Assay name
3 = Assay version
Probable cause Corrective action
The assay is not installed on the system. Install the assay on the system and configure the control
lot before the order is processed. Perform Install assay
files, page 272 and Manually create a new quality
control lot, page 295.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1122
Unable to create calibration order for cal set (0) lot (1). Some of the calibrator levels not loaded or
processing module not available.
0 = Calibrator set
1 = Calibrator lot
Probable cause Corrective action
Some calibrator vial levels are not loaded in the rack. Load all required calibrator vial levels in the rack.
Perform Load racks on the reagent and sample manager
(RSM), page 526.
The processing module is not in the Running status. Verify that the processing module is in the Running
status.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1123
Unable to process test. No reagent cartridges available.
Probable cause Corrective action
No reagent cartridges are calibrated for the assay. 1. Calibrate the assay for the reagent cartridge.
Perform Prepare and load vials into vial racks for
immediate use, page 572 and Load racks on the
reagent and sample manager (RSM), page 526.
2. Rerun the test. Perform Rerun a test or an
exception for a specimen or control, page 612.
A calibration failed when an order was in process. 1. Calibrate the assay for the reagent cartridge.
Perform Prepare and load vials into vial racks for
immediate use, page 572 and Load racks on the
reagent and sample manager (RSM), page 526.
2. Rerun the test. Perform Rerun a test or an
exception for a specimen or control, page 612.
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Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1124
Unable to process test. Calibrators not loaded in the same rack.
Probable cause Corrective action
All calibrator vial levels are not loaded in the same rack. 1. Verify that all calibrator vial levels are loaded in the
same rack. Perform Prepare and load vials into vial
racks for immediate use, page 572.
2. Load the rack on the reagent and sample manager.
Perform Load racks on the reagent and sample
manager (RSM), page 526.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1125
Reagent cartridge in position (0) disabled due to control failure.
0 = Reagent carousel position
Probable cause Corrective action
The reagent cartridge was disabled by the system 1. Review the results for the specific control.
because of a quality control failure.
2. Rerun the same control level for the specific
reagent cartridge.
3. Load and run a new control sample. Perform
Prepare and load vials into vial racks for immediate
use, page 572 and Load racks on the reagent and
sample manager (RSM), page 526.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1126
Unable to process test. Calibrator lot (0) for assay number (1) version (2) expired.
0 = Calibrator lot
1 = Assay number
2 = Assay version
Probable cause Corrective action
The calibrator lot is expired. Load a new calibrator lot. Perform Prepare and load
vials into vial racks for immediate use, page 572 and
Load racks on the reagent and sample manager (RSM),
page 526.
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Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1127
Unable to process test. Calibrator or control in onboard vial rack ID (0) in reagent carousel position (1) is
insufficient or expired.
0 = Rack ID
1 = Reagent carousel position
Probable cause Corrective action
The calibrator or control material on the system is Load new calibrator or control vials. Perform Prepare
insufficient or expired. and load vials into vial racks for immediate use, page
572 and Load racks on the reagent and sample manager
(RSM), page 526.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1128
Unable to add calculated assay. The calculation formula (0) is invalid.
0 = Formula
Probable cause Corrective action
A valid formula is not entered for a calculated assay. Enter a valid formula for the calculated assay. Perform
Create a calculated assay, page 251.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1129
Unable to create order for (2) control level (1) lot (0). Control lot expired.
0 = Control lot
1 = Control level
2 = Control name
Probable cause Corrective action
The control lot is expired. Manually create a new quality control lot, page 295.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1130
Unable to create order for (2) control level (1) lot (0). No expiration date configured for control lot.
0 = Control lot
1 = Control level
2 = Control name
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Message codes Section 10
Probable cause Corrective action
The control lot configuration is missing a required Manually create a new quality control lot, page 295.
expiration date.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1131
Invalid order for (2) control level (1) lot (0). Order exists for rack ID (3) position (4).
0 = Control lot
1 = Control level
2 = Control name
3 = Rack ID
4 = Position
Probable cause Corrective action
An order already exists for the rack or position. • Process the existing order.
• Reorder the test by using a different position or
rack.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1132
Reagent cartridge at location (0) re-enabled by control set (1) level (2).
0 = Location
1 = Control set
2 = Level
Probable cause Corrective action
The QC is within range. The reagent cartridge has been Status message. No corrective action is required.
re-enabled.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1133
No control order created for (2) level (1) lot (0).
0 = Control lot
1 = Control level
2 = Control name
Probable cause Corrective action
No control order is due. Status message. No corrective action is required.
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Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1134
Reagent cartridge in position (0) disabled by operator (1).
0 = Reagent carousel position
1 = Operator ID
Probable cause Corrective action
The operator disabled a reagent cartridge. Status message. No corrective action is required.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1135
Reagent cartridge in position (0) re-enabled by operator (1).
0 = Reagent carousel position
1 = Operator ID
Probable cause Corrective action
The operator enabled a reagent cartridge. Status message. No corrective action is required.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1136
Reagent cartridge stability for assay (0) lot (1) SN (2) has been updated with Alinity PRO data.
0 = Assay name
1 = Lot
2 = SN
Probable cause Corrective action
The reagent cartridge stability has been updated with Status message. No corrective action is required.
Alinity PRO data.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1137
Reagent cartridge test count for assay (0) lot (1) SN (2) has been updated with Alinity PRO data.
0 = Assay name
1 = Lot
2 = SN
Probable cause Corrective action
The reagent cartridge test count has been updated with Status message. No corrective action is required.
Alinity PRO data.
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Message codes Section 10
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1138
Reagent cartridge liquid level for assay (0) lot (1) SN (2) has been updated with Alinity PRO data.
0 = Assay name
1 = Lot
2 = SN
Probable cause Corrective action
The reagent cartridge liquid level has been updated with Status message. No corrective action is required.
Alinity PRO data.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1139
Calibrator stability for assay (0) lot (1) SN (2) has been updated with Alinity PRO data.
0 = Assay name
1 = Lot
2 = SN
Probable cause Corrective action
The calibrator stability has been updated with Alinity Status message. No corrective action is required.
PRO data.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1140
Calibrator test count for assay (0) lot (1) SN (2) has been updated with Alinity PRO data.
0 = Assay name
1 = Lot
2 = SN
Probable cause Corrective action
The calibrator test count has been updated with Alinity Status message. No corrective action is required.
PRO data.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1141
Control stability for assay (0) lot (1) SN (2) has been updated with Alinity PRO data.
0 = Assay name
1 = Lot
2 = SN
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Section 10 Message codes
Probable cause Corrective action
The control stability has been updated with Alinity PRO Status message. No corrective action is required.
data.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1142
Control test count for assay (0) lot (1) SN (2) has been updated with Alinity PRO data.
0 = Assay name
1 = Lot
2 = SN
Probable cause Corrective action
The control test count has been updated with Alinity Status message. No corrective action is required.
PRO data.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1143
Retest rule (0) for assay (1) number (2) version (3) deleted because all target assays have been
deleted.
0 = Retest rule
1 = Assay name
2 = Assay number
3 = Assay version
Probable cause Corrective action
The system was unable to perform the retest rule. The Install the required assays to complete the retest rule.
required assays are not installed. Perform Install assay files, page 272.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1144
Retest rule (0) for assay (1) number (2) version (3) modified because an assay required for this rule was
deleted.
0 = Retest rule
1 = Assay name
2 = Assay number
3 = Assay version
Probable cause Corrective action
The system was unable to perform the retest rule. The Install the required assays to complete the retest rule.
required assays were deleted. Perform Install assay files, page 272.
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Message codes Section 10
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1146
Reagent cartridge assay (0) lot (1) SN (2) inventory information is questionable. Cartridge will not be
tracked for inventory sharing.
0 = Assay name
1 = Lot
2 = SN
Probable cause Corrective action
Inventory tracking is invalid for the specified reagent Manual inventory tracking is required for the reagent
cartridges. cartridges.
• A two-cartridge reagent set does not match the set
in Alinity PRO.
• The reagent cartridge was loaded on a different
instrument, and the reagent cartridge unload was
not recorded.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1147
Calibrator for assay (0) lot (1) SN (2) inventory information is questionable. Calibrator will not be tracked
for inventory sharing.
0 = Assay name
1 = Lot
2 = SN
Probable cause Corrective action
Inventory tracking is invalid for the specified calibrator. Manual inventory tracking is required for the calibrator
• The calibrator bottle serial number does not match lot.
the serial number in Alinity PRO.
• The calibrator has been loaded on another
instrument, and the calibrator unload was not
recorded.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1148
Control for assay (0) lot (1) SN (2) inventory information is questionable. Control will not be tracked for
inventory sharing.
0 = Assay name
1 = Lot
2 = SN
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Section 10 Message codes
Probable cause Corrective action
Inventory tracking is invalid for the specified control. Manual inventory tracking is required for the control lot.
• The control bottle serial number does not match
the serial number in Alinity PRO.
• The control has been loaded on another instrument,
and the control unload was not recorded.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1149
Automated calibration order failed for calibrator set (0) lot (1) level (2).
0 = Calibrator set
1 = Calibrator lot
2 = Calibrator level
Probable cause Corrective action
The calibration order failed for the specified calibrator Additional messages that are associated with this
set. message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1150
Calibrator set (0) lot (1) expired.
0 = Calibrator set
1 = Calibrator lot
Probable cause Corrective action
The calibrator lot is expired. • Use a different calibrator lot.
• Configure a new calibrator lot. Perform Create a
new calibrator lot from a bar code, page 259 and
Manually create a new calibrator lot, page 260.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1151
Operator ID (0) manually failed calibration.
0 = Operator ID
Probable cause Corrective action
The operator manually failed a calibration. Status message. No corrective action is required.
Alinity ci-series Operations Manual 1029
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Message codes Section 10
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1152
Calibrator lot mismatch.
Probable cause Corrective action
The calibrator order does not match the calibrator vial Create the calibration order using the correct lot
lot number. number. Perform Create a calibration order, page 599.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1153
Unable to process test. Onboard calibrators or controls not available for rack ID (0).
0 = Rack ID
Probable cause Corrective action
The onboard calibrator vials or control vials have Load new onboard calibrator vials or control vials.
inadequate volume to process the tests.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1154
Onboard vial (0) is (1).
0 = Vial bar code
1 = Vial status
Probable cause Corrective action
The indicated onboard vial volume is almost empty. Verify vial inventory data, page 522.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1155
Unable to process test. Error in formula (0) for calculated assay.
0 = Calculated assay formula
Probable cause Corrective action
The formula for the calculated assay is incorrect. Verify the formula configured for the calculated assay.
Perform Create a calculated assay, page 251.
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
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Section 10 Message codes
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1156
Unable to create control order. Invalid control lot (0) or level (1).
0 = Control lot
1 = Control level
Probable cause Corrective action
The control lot or level scanned is not configured. Configure the control for the lot number and level.
Perform Manually create a new quality control lot, page
295.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1157
Remaining tests for assay (0) lot (1) SN (2) has been updated with Alinity PRO data.
0 = Assay name
1 = Lot
2 = SN
Probable cause Corrective action
The remaining tests have been updated with Alinity PRO Status message. No corrective action is required.
data.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1158
(0) lot (1) SN (2) has invalid inventory sharing data. Material will not be tracked for inventory sharing.
0 = Calibrator or control name
1 = Calibrator or control lot
2 = SN
Probable cause Corrective action
Inventory tracking is invalid for the specified calibrator or Manually track the calibrator or control inventory.
control.
• Inventory tracking is invalid for the specified
calibrator or control.
• Calibrator or control bottle serial number does not
match the bottle serial number in Alinity PRO.
Related information...
Assay-specific message codes (1000-1999), page 988
Alinity ci-series Operations Manual 1031
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Message codes Section 10
Message code: 1159
(0) lot (1) SN (2) stability has been updated with Alinity PRO shared inventory data.
0 = Calibrator or control name
1 = Calibrator or control lot
2 = SN
Probable cause Corrective action
The calibrator or control stability has been updated with Status message. No corrective action is required.
Alinity PRO data.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1160
Remaining tests for (0) lot (1) SN (2) has been updated with Alinity PRO data.
0 = Calibrator or control name
1 = Calibrator or control lot
2 = SN
Probable cause Corrective action
The remaining tests for the calibrator or control have Status message. No corrective action is required.
been updated with Alinity PRO data.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1161
(0) lot (1) SN (2) status updated. Status (3) stability (4).
0 = Calibrator or control name
1 = Calibrator or control lot
2 = SN
3 = Status
4 = Stability
Probable cause Corrective action
The calibrator or control expiration or stability status has Status message. No corrective action is required.
been updated with Alinity PRO data.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1162
Retest rule (0) deleted for assay (1) number (2) version (3). No target assays installed.
0 = Retest rule name
1 = Assay name
2 = Assay number
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Section 10 Message codes
3 = Assay version
Probable cause Corrective action
The retest rule was deleted. Status message. No corrective action is required.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1163
Target assay (0) deleted from retest rule (1) for assay (2) number (3) version (4). Target assay no
longer installed.
0 = Target assay name
1 = Retest rule
2 = Assay name
3 = Assay number
4 = Assay version
Probable cause Corrective action
A target assay for a retest rule was deleted. Status message. No corrective action is required.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1164
Onboard stability time was lowered to (1) for calibration set (0).
0 = Onboard stability time
1 = Calibration set name
Probable cause Corrective action
The onboard stability time for a calibration set was Status message. No corrective action is required.
edited by the operator.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1165
Calibration expired for assay (0) lot (1) on module (2).
0 = Assay name
1 = Lot
2 = Module
Probable cause Corrective action
The calibration has exceeded the expiration date for the Calibrate the reagent lot again.
assay.
Related information...
Assay-specific message codes (1000-1999), page 988
Alinity ci-series Operations Manual 1033
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Message codes Section 10
Message code: 1166
Calibration failed for assay (0) lot (1) on module (2).
0 = Assay name
1 = Lot
2 = Module
Probable cause Corrective action
The wrong calibrator was used or the calibrator was 1. Place new calibrator vials into racks or new
loaded incorrectly. calibrator into clean sample cups or tubes. Verify
that the vials are placed in the correct positions.
2. Repeat the calibration.
The calibrators are not performing as expected. 1. Open new calibrator bottles or vials.
2. Repeat the calibration.
The reagent is not performing as expected. 1. Load a new reagent cartridge. Perform Load
cartridges on the reagent and sample manager
(RSM), page 527
2. Repeat the calibration.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1167
No calibration exists for assay (0) lot (1) on module (2).
0 = Assay name
1 = Lot
2 = Module
Probable cause Corrective action
There is no active calibration for the assay on the Calibrate the assay for the specified lot on the module.
module.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1169
Reagent cartridge (0) in reagent carousel position (1) is empty.
0 = Reagent cartridge
1 = Reagent carousel position
Probable cause Corrective action
The required reagent cartridge is empty, and no other Load a new reagent cartridge for the required assay.
reagent cartridges are loaded on the reagent carousel Perform Load cartridges on the reagent and sample
for this assay. manager (RSM), page 527
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Section 10 Message codes
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1170
Reagent cartridge in reagent carousel positions (3) are low. Remaining test count is (2).
2 = Remaining tests
3 = Reagent carousel position
Probable cause Corrective action
The remaining tests for the reagent cartridge are low. Load a new reagent cartridge for the required assay.
Perform Load cartridges on the reagent and sample
manager (RSM), page 527
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1171
Control failures for assay (0) control (1) lot (2) level (3) on module (4) were cleared by operator ID (5).
Comment (6).
0 = Assay name
1 = Control name
2 = Control lot
3 = Control level
4 = Module
5 = Operator ID
6 = Comment
Probable cause Corrective action
The control failures for the specified assays were Status message. No corrective action is required.
cleared by the operator.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1172
Configuration for onboard cal / QC positions have changed. At least one reagent carousel position has a
reagent cartridge or rack loaded in the position.
Probable cause Corrective action
The configured onboard Cal and QC positions are Unload the reagent cartridge or rack that is occupying
occupied by a reagent cartridge or rack. the reserved positions. Perform Unload reagents from
the reagent and sample manager (RSM), page 558 and
Load cartridges on the reagent and sample manager
(RSM), page 527).
Related information...
Assay-specific message codes (1000-1999), page 988
Alinity ci-series Operations Manual 1035
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Message codes Section 10
Message code: 1173
(0) material (1) is expired.
0 = Vial material
1 = Vial bar code
Probable cause Corrective action
The vial material is expired. Load new vial material. Perform Prepare and load vials
into vial racks for immediate use, page 572
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1400
Calibration failed for assay (0) number (1). (2).
0 = Assay name
1 = Assay number
2 = Validity check name
Probable cause Corrective action
The calibrator is not performing as expected. Open a new calibrator.
The reagent is not performing as expected. Load a new reagent.
The wrong calibrator was used or the calibrator was Place fresh calibrators into clean sample cups or tubes.
loaded incorrectly. Verify that the calibrators are placed in the correct
positions.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1401
Unable to process test. Background read failure.
Probable cause Corrective action
The ambient light level is too high. • Verify that all the system panels are correctly
installed.
• Block the system from direct sunlight.
The Pre-Trigger Solution or the Trigger Solution is not Empty the Pre-Trigger Solution reservoir or the Trigger
performing as expected. Solution reservoir and replace the Pre-Trigger Solution
or the Trigger Solution.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Empty the bulk solution reservoirs (i-series), page 1297
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Section 10 Message codes
Message code: 1402
Unable to process test. Activated read failure.
Probable cause Corrective action
The Pre-Trigger Solution or the Trigger Solution is not Empty the Pre-Trigger Solution reservoir or the Trigger
performing as expected. Solution reservoir and replace the Pre-Trigger Solution
or the Trigger Solution.
The ambient light level is too high. • Verify that all the system panels are correctly
installed.
• Block the system from direct sunlight.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Empty the bulk solution reservoirs (i-series), page 1297
Message code: 1403
Unable to process test. Final read failure.
Probable cause Corrective action
The Pre-Trigger Solution or the Trigger Solution is not Empty the Pre-Trigger Solution reservoir or the Trigger
performing as expected. Solution reservoir and replace the Pre-Trigger Solution
or the Trigger Solution.
The ambient light level is too high. • Verify that all the system panels are correctly
installed.
• Block the system from direct sunlight.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Empty the bulk solution reservoirs (i-series), page 1297
Message code: 1404
Calibration failed for assay (0) number (1). Correlation coefficient out of range.
0 = Assay name
1 = Assay number
Probable cause Corrective action
The calibrator is not performing as expected. Open a new calibrator.
The reagent is not performing as expected. Load a new reagent.
Related information...
Assay-specific message codes (1000-1999), page 988
Alinity ci-series Operations Manual 1037
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Message codes Section 10
Message code: 1405
Calibration failed for assay (0) number (1). Intercept out of range.
0 = Assay name
1 = Assay number
Probable cause Corrective action
The calibrator is not performing as expected. Open a new calibrator.
The reagent is not performing as expected. Load a new reagent.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1406
Calibration failed for assay (0) number (1). Cal 1 or Cal 2 final read below specifications.
0 = Assay name
1 = Assay number
Probable cause Corrective action
The calibrator is not performing as expected. Open a new calibrator.
The reagent is not performing as expected. Load a new reagent.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1415
Calibration for assay (1) reagent lot (2) on module (3) expires in (0) hours.
0 = Number of hours
1 = Assay name
2 = Lot
3 = Module
Probable cause Corrective action
The calibration expires in the specified number of hours. 1. Prepare and load the appropriate calibrators in a
rack. Perform Prepare and load vials into vial racks
for immediate use, page 572.
2. Load the rack on the reagent and sample manager.
Perform Load racks on the reagent and sample
manager (RSM), page 526.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1600
Calibration failed for assay (0) number (1). Assay configuration error.
0 = Assay name
1038 Alinity ci-series Operations Manual
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Section 10 Message codes
1 = Assay number
Probable cause Corrective action
The combined sample and reagent volume is less than If the assay uses a photometric read point of less than
80 μL at a defined read time. 19, for any defined read time, verify that the combined
sample and reagent volume defined for the sample or
diluted sample, the R1 reagent, or the R1 water is
greater than or equal to 80 μL.
The assay has been configured with no calibrator set 1. Select or configure a calibrator set for the assay.
when one was previously defined.
2. Recalibrate the assay.
An assay setting is defined incorrectly. Verify that the assay configuration settings are
configured correctly. See Edit calibration settings of
assay parameters (c-series photometric), page 235.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1601
Calibration failed for assay (0) number (1). Convergence error.
0 = Assay name
1 = Assay number
Probable cause Corrective action
Bubbles or foam are present on top of the sample. Remove bubbles or foam from the surface of the
sample.
The incorrect calibrator was used, or the calibrator was 1. Load the correct calibrator.
loaded incorrectly.
2. Repeat the calibration.
The reaction mode is incorrectly defined. Select the appropriate reaction mode.
The dispense system is not performing correctly. Verify that the dispense components are functioning
correctly.
The lamp is not performing as expected. Replace the lamp or the lamp plate (c-series), page 844.
Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
The reagent is not performing as expected. Load a new reagent cartridge.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1602
Calibration failed for assay (0) number (1).
0 = Assay name
1 = Assay number
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Message codes Section 10
Probable cause Corrective action
The required assay parameter is not defined for a c- Compare the following assay parameter settings to the
series assay. default assay parameter settings to determine which
parameter is missing a value:
• All calibrator value fields (including blank and water
concentration)
• Blank absorbance range lower limit
• Blank absorbance range upper limit
• Expected calibration factor
• Expected calibration factor tolerance percent
• Span absorbance range lower limit
• Span absorbance range upper limit
Software error. If the error continues, contact Customer Service. Provide
information about the operation that was attempted
when the error occurred.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1603
Calibration failed for assay (0) number (1). Calibrator deviation too large.
0 = Assay name
1 = Assay number
Probable cause Corrective action
Bubbles are present in the calibrator sample cup. Remove any bubbles from the sample cup.
The dispense system is not performing correctly. Verify that the dispense components are functioning
correctly.
The lamp is not performing as expected. Replace the lamp or the lamp plate (c-series), page 844.
Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
The calibrator is not performing as expected. Load a new calibrator.
The reagent is not performing as expected. Load a new reagent cartridge.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1604
Calibration failed for assay (0) number (1). Maximum curve fit too large.
0 = Assay name
1 = Assay number
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Troubleshooting
Section 10 Message codes
Probable cause Corrective action
The incorrect calibrator was used, or the calibrator was 1. Load the correct calibrator in the correct order.
loaded incorrectly.
2. Repeat the calibration.
The dispense system is not performing correctly. Verify that the dispense components are functioning
correctly.
The lamp is not performing as expected. Replace the lamp or the lamp plate (c-series), page 844.
Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
The calibrator is not performing as expected. Load a new calibrator.
The reagent is not performing as expected. Load a new reagent cartridge.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1605
Calibration failed for assay (0) number (1). Calibration factor out of range.
0 = Assay name
1 = Assay number
Probable cause Corrective action
The calibrator concentration values are incorrectly Verify that the correct values for the lot number of the
defined. calibrator are used.
The incorrect calibrator was used, or the calibrator was 1. Load the correct calibrator.
loaded incorrectly.
2. Repeat the calibration.
The calibrators were on the system for an extended Load new calibrators into clean sample cups or tubes.
period of time.
The dispense system is not performing correctly. Verify that the dispense components are functioning
correctly.
The lamp is not performing as expected. Replace the lamp or the lamp plate (c-series), page 844.
Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
The calibrator is not performing as expected. Load a new calibrator.
The reagent is not performing as expected. Load a new reagent cartridge.
The expected cal factor or expected cal factor tolerance If a re-evaluation of the expected cal factor is needed
percent values need to be re-evaluated. for the laboratory, perform the following steps:
1. Collect cal factor values from multiple calibration
curves, or review calibration curve details reports
for recent historical curves. (A thorough study
requires multiple cartridges and multiple reagent
lots.) During this collection period, ensure the
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Message codes Section 10
Probable cause Corrective action
control values that are run against those cal factors
are in range and do not display trends or shifts.
2. Average the acceptable cal factors, and enter the
mean in the expected cal factor field.
3. If the average expected cal factor is correct and
the control values have been in range, consider
slightly increasing the expected cal factor tolerance
percent.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1606
Calibration failed for assay (0) number (1). Slope outside of defined range.
0 = Assay name
1 = Assay number
Probable cause Corrective action
The ICT module is expired, has exceeded time, or has Replace the ICT module or the ICT probe (c-series),
exceeded sample warranty (greater than 3 months after page 859.
installation or greater than 20,000 samples).
The incorrect calibrator was used, or the calibrator was 1. Load the correct calibrator in the correct order.
loaded incorrectly.
2. Repeat the calibration.
The ICT module O-rings are missing or are not seated Ensure the O-rings are present and are seated correctly.
correctly. If necessary, perform Replace the ICT module or the ICT
probe (c-series), page 859.
The ICT probe is not connected correctly. Tighten the tubing connections at the top of the ICT
module and at the top of the 1 mL syringes in the ICT
aspiration pump.
The ICT Reference Solution tubing is not connected Tighten the tubing connections at the top and at the side
correctly. of each check valve in the ICT Reference Solution
pump.
The ICT check valves are not connected correctly. Tighten the connections to the 1 mL syringes in the ICT
Reference Solution pump and in the ICT aspiration
pump.
The ICT check valves are not functioning. Perform Quarterly maintenance procedure 5805 Check
and Change ICT Check Valves (c-series), page 764.
The 1 mL syringes in the ICT aspiration pump or the ICT Reseat the 1 mL syringes.
Reference Solution pump are not seated correctly.
The 1 mL syringes in the ICT aspiration pump or the ICT Perform 5804 Change 1 mL Syringes (c-series), page
Reference Solution pump are leaking. 763.
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Section 10 Message codes
Probable cause Corrective action
The ICT module is not performing as expected. Replace the ICT module or the ICT probe (c-series),
page 859.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1607
Calibration failed for assay (0) number (1). Insufficient calibrator replicates.
0 = Assay name
1 = Assay number
Probable cause Corrective action
The required number of replicates for a calibrator failed Review the specific message text to determine the
to complete because of an error. reason for the failed calibrator replicates. Refer to the
corrective action for the specific message text.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1608
Calibration failed for assay (0) number (1). Invalid mathematical calculation.
0 = Assay name
1 = Assay number
Probable cause Corrective action
The incorrect calibrator was used, or the calibrator was 1. Load the correct calibrator.
loaded incorrectly.
2. Repeat the calibration.
The dispense system is not performing correctly. Verify that the dispense components are functioning
correctly.
The lamp is not performing as expected. Replace the lamp or the lamp plate (c-series), page 844.
Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
The calibrator is not performing as expected. Load a new calibrator.
The reagent is not performing as expected. Load a new reagent cartridge.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1609
Calibration failed for assay (0) number (1). Blank absorbance out of range.
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Message codes Section 10
0 = Assay name
1 = Assay number
Probable cause Corrective action
The water quality is below specifications. Verify that the purity of the purified water is within
specifications.
The calibrator is not performing as expected if the blank Load a new calibrator.
calibrator is defined to use a zero concentration
calibrator rather than water.
The reagent is not performing as expected. Load a new reagent cartridge.
The lamp was not seated correctly when it was Replace the lamp or the lamp plate (c-series), page 844.
replaced. Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
• Ensure that the lamp is seated correctly against the
lamp plate and in the housing.
• Ensure that the lamp cables are secured by the
screws in terminal block.
The lamp is not performing as expected. Replace the lamp or the lamp plate (c-series), page 844.
Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
The cuvettes are dirty. Perform Reaction Mechanisms diagnostic procedure
5003 Clean Cuvettes - Manually (c-series), page 790.
The cuvette dry tip is damaged. Replace the cuvette dry tip (c-series), page 852.
Debris is present in the water bath incubator. Perform Reaction Mechanisms diagnostic procedure
5005 Exchange Water in Bath (c-series), page 791.
Bubbles are present in the water bath incubator because Contact Customer Service to resolve any hardware
of a high gas content of the incoming water. failure.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1610
Calibration failed for assay (0) number (1). Defined span out of range.
0 = Assay name
1 = Assay number
Probable cause Corrective action
Bubbles are present in the calibrator sample cup. Remove any bubbles from the sample cup.
The incorrect calibrator was used, or the calibrator was 1. Load the correct calibrator.
loaded incorrectly.
2. Repeat the calibration.
The dispense system is not performing correctly. Verify that the dispense components are functioning
correctly.
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Section 10 Message codes
Probable cause Corrective action
The lamp is not performing as expected. Replace the lamp or the lamp plate (c-series), page 844.
Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
The calibrator is not performing as expected. Load a new calibrator.
The reagent is not performing as expected. Load a new reagent cartridge.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1611
Calibration failed for assay (0) number (1). Slope too low.
0 = Assay name
1 = Assay number
Probable cause Corrective action
The ICT module is expired, has exceeded time, or has Replace the ICT module or the ICT probe (c-series),
exceeded sample warranty (greater than 3 months after page 859.
installation or greater than 20,000 samples).
The incorrect calibrator was used, or the calibrator was 1. Load the correct calibrator.
loaded incorrectly.
2. Repeat the calibration.
The ICT module O-rings are missing or are not seated Ensure the O-rings are present and are seated correctly.
correctly. If necessary, perform Replace the ICT module or the ICT
probe (c-series), page 859.
The ICT probe is not connected correctly. Tighten the probe to the ICT module by hand. Perform
Replace the ICT module or the ICT probe (c-series),
page 859.
The ICT aspiration tubing is not connected correctly. Tighten the tubing connections at the top of the ICT
module and at the top of the 1 mL syringes in the ICT
aspiration pump.
The ICT Reference Solution tubing is not connected Tighten the connections at the top and at the side of
correctly. each check valve in the ICT Reference Solution pump.
The ICT check valves are not connected correctly. Tighten the connections to the 1 mL syringes in the ICT
Reference Solution pump and in the ICT aspiration
pump.
The ICT check valves are not functioning. Perform Quarterly maintenance procedure 5805 Check
and Change ICT Check Valves (c-series), page 764.
The 1 mL syringes in the ICT aspiration pump or the ICT Reseat the 1 mL syringes.
Reference Solution pump are not seated correctly.
The 1 mL syringes in the ICT aspiration pump or the ICT Perform Quarterly maintenance procedure 5804 Change
Reference Solution pump are leaking. 1 mL Syringes (c-series), page 763.
The ICT module is not performing as expected. Replace the ICT module or the ICT probe (c-series),
page 859.
Alinity ci-series Operations Manual 1045
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Message codes Section 10
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1612
Calibration failed for assay (0) number (1). Results not completed for all calibrator levels.
0 = Assay name
1 = Assay number
Probable cause Corrective action
The required number of replicates for a calibrator failed Review the specific message text for the failed
to complete because of an error. calibrator replicates. Perform the the corrective action
for the specific message text.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1613
Calibration failed for assay (0) number (1). Concentration out of range for ICT index.
0 = Assay name
1 = Assay number
Probable cause Corrective action
The incorrect index calibrator was used for calibration. Load the correct calibrator.
The index calibrator is not performing as expected. Load new calibrator vials.
The index concentration or index range is defined Define the correct index concentration and index range
incorrectly. in the assay parameters.
Related information...
Assay-specific message codes (1000-1999), page 988
Message code: 1614
Calibration failed for assay (0) number (1). Insufficient calibrator replicates.
0 = Assay name
1 = Assay number
Probable cause Corrective action
The required number of replicates for a calibrator failed Review the specific message text for the failed
to complete because of an error. calibrator replicates. Perform the the corrective action
for the specific message text.
Related information...
Assay-specific message codes (1000-1999), page 988
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Section 10 Message codes
Message code: 1615
Unable to perform adjustment calibration. No full calibration exists for assay (0) number (1) version (2)
reagent lot (3).
0 = Assay name
1 = Assay number
2 = Assay version
3 = Reagent lot
Probable cause Corrective action
A full calibration does not exist for the specified assay. Perform a full calibration. Perform Create a calibration
order, page 599.
Related information...
Assay-specific message codes (1000-1999), page 988
Maintenance and diagnostic message codes (2000-2999)
The maintenance and diagnostic message code category includes message codes from 2000
through 2999.
Related information...
Message codes, page 941
2050, page 1049
2057, page 1049
2058, page 1049
2059, page 1050
2060, page 1050
2062, page 1050
2075, page 1050
2076, page 1051
2077, page 1051
2081, page 1051
2082, page 1052
2083, page 1052
2084, page 1052
2085, page 1052
2087, page 1053
2089, page 1053
2090, page 1053
2091, page 1053
2092, page 1054
Alinity ci-series Operations Manual 1047
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Message codes Section 10
2093, page 1054
2094, page 1054
2095, page 1054
2096, page 1055
2100, page 1055
2101, page 1055
2102, page 1056
2103, page 1056
2104, page 1056
2105, page 1056
2500, page 1057
2501, page 1057
2502, page 1057
2503, page 1057
2505, page 1058
2506, page 1058
2507, page 1058
2509, page 1059
2510, page 1059
2511, page 1059
2512, page 1060
2513, page 1060
2514, page 1060
2515, page 1060
2516, page 1061
2518, page 1061
2519, page 1061
2520, page 1062
2521, page 1062
2522, page 1063
2523, page 1063
2524, page 1063
2525, page 1063
2526, page 1064
2527, page 1064
2528, page 1064
2529, page 1065
2530, page 1065
2531, page 1065
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Section 10 Message codes
2532, page 1066
2533, page 1066
2534, page 1066
2535, page 1067
2536, page 1067
2537, page 1067
2538, page 1068
2539, page 1068
Message code: 2050
Run request denied. Insufficient supply inventory.
Probable cause Corrective action
Insufficient inventory exists to process tests. Load the required inventory items on the system and
update the inventory. Perform Verify the supply and
waste inventory, page 508.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2057
High concentration waste bottle full.
Probable cause Corrective action
The high-concentration waste bottle is full. Empty the high-concentration waste bottle and update
the inventory (c-series), page 514.
The high-concentration waste bottle float switch is dirty. Perform Quarterly maintenance procedure 5807 Check
and Clean High-Concentration Waste Sensor (c-series),
page 765.
The float switch cable has a poor connection. Reseat the float switch cable to the module and to the
high-concentration waste bottle.
The float switch cable failed. Replace the float switch cable.
The float switch failed. Replace the high-concentration waste bottle.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2058
Alkaline Wash empty.
Probable cause Corrective action
The Alkaline Wash reservoir and the Alkaline Wash Replace the Alkaline Wash bottle. Perform Replace bulk
bottle are empty. solutions and update the inventory, page 508.
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Message codes Section 10
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2059
Acid Wash empty.
Probable cause Corrective action
The Acid Wash reservoir and the Acid Wash bottle are Replace Acid Wash bottle. Perform Replace bulk
empty. solutions and update the inventory, page 508.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2060
RV waste chute full.
Probable cause Corrective action
The RV waste chute is designed to hold approximately 1. Replace the empty solid waste container.
50 used reaction vessels when the solid waste container
2. Update the Supplies screen if necessary.
is removed to be emptied.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2062
Unable to process test. ICT Reference Solution empty.
Probable cause Corrective action
The ICT Reference Solution bottle is empty. Replace the ICT Reference Solution bottle. Perform
Replace bulk solutions and update the inventory, page
508.
NOTE: The replacement of a new lot number of ICT
Reference Solution must be performed in the Idle status.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2075
Unable to transfer ICT Reference Solution to reservoir. (0).
0 = Transfer error
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Section 10 Message codes
Probable cause Corrective action
The ICT Reference Solution bottle is empty. Replace the ICT Reference Solution bottle. Perform
Replace bulk solutions and update the inventory, page
508.
NOTE: The replacement of a new lot number of ICT
Reference Solution must be performed in the Idle status.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2076
Reagent carousel scan error.
Probable cause Corrective action
Hardware failure. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2077
ICT module has expired.
Probable cause Corrective action
The ICT module is expired. Replace the ICT module. Perform Replace the ICT
module or the ICT probe (c-series), page 859.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2081
Run request denied for module (1). (0) empty.
0 = Inventory item
1 = Module
Probable cause Corrective action
The indicated inventory item supply is empty. Load the required inventory items on the system and
update the inventory. Perform Verify the supply and
waste inventory, page 508.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Alinity ci-series Operations Manual 1051
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Message codes Section 10
Message code: 2082
Run request denied for module (0). (1) expired.
0 = Inventory item
1 = Module
Probable cause Corrective action
The indicated inventory item supply is expired. Load the required inventory items on the system and
update the inventory. Perform Verify the supply and
waste inventory, page 508.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2083
Expiration date updated for (0) to (1) for module (2).
0 = Inventory item
1 = Expiration date
2 = Module
Probable cause Corrective action
The indicated inventory item expiration date was Status message. No corrective action is required.
changed by the operator.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2084
Lot updated for (0) to (1) for module (2).
0 = Inventory item
1 = Updated lot
2 = Module
Probable cause Corrective action
The indicated inventory item lot number was changed by Status message. No corrective action is required.
the operator.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2085
Processing module (0) status changed to Pausing. Liquid waste container full.
0 = Module
Probable cause Corrective action
The liquid waste container is full. Empty and replace the liquid waste container. Perform
Verify the supply and waste inventory, page 508.
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Section 10 Message codes
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2087
(0) level low on module (1).
0 = Inventory item
1 = Module
Probable cause Corrective action
The indicated inventory item supply is low. Load the required inventory items on the system and
update the inventory. Perform Verify the supply and
waste inventory, page 508.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2089
RV waste container full on module (0).
0 = Module
Probable cause Corrective action
The RV waste container is full. Remove the RV waste and update the inventory (i-series),
page 515.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2090
(0) lot (1) expired on processing module (2).
0 = Inventory item
1 = Lot
2 = Module
Probable cause Corrective action
The indicated inventory item is expired. Load the required inventory items on the system and
update the inventory. Perform Verify the supply and
waste inventory, page 508.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2091
(0) lot (1) onboard stability expired on module (2) .
0 = Inventory item
1 = Lot
2 = Module
Alinity ci-series Operations Manual 1053
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Message codes Section 10
Probable cause Corrective action
The indicated inventory stability is expired. Load the required inventory items on the system and
update the inventory. Perform Verify the supply and
waste inventory, page 508.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2092
Replace supply for (0) lot (1) on module (2).
0 = Inventory item
1 = Lot
2 = Module
Probable cause Corrective action
The indicated supply item is empty or expired. Load the required inventory items on the system and
update the inventory. Perform Verify the supply and
waste inventory, page 508.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2093
ICT module replaced on module (0). Previous ICT module SN (1) had sample count of (3) and days on
board (2).
Probable cause Corrective action
The ICT module replacement procedure is completed. Status message. No corrective action is required.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2094
(0) reservoir empty.
0 = Bulk solution reservoir
Probable cause Corrective action
The bulk solution bottle reservoir is empty. Replace bulk solutions and update the inventory, page
508.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2095
No (0) bottle loaded in bulk solution storage area.
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Troubleshooting
Section 10 Message codes
0 = Bulk solution
Probable cause Corrective action
The bulk solution bottle inventory is empty, has reached Replace bulk solutions and update the inventory, page
the onboard stability expiration date, or is expired. 508.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2096
RV waste container near full on module (0).
0 = Module ID
Probable cause Corrective action
The RV waste container is near capacity. Remove the RV waste and update the inventory (i-series),
page 515.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2100
Unable to process test. Bulk solution (0) insufficient or expired.
0 = Bulk solution
Probable cause Corrective action
The bulk solution inventory is empty or expired. Replace bulk solutions and update the inventory, page
508.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2101
Module (1) (0) inventory discrepancy. Update supplies.
0 = Inventory item
1 = Module
Probable cause Corrective action
The expected inventory does not match the available On the processing module, repeat Initiate or resume
inventory because of a database restore or service sample processing, page 574.
activity.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Alinity ci-series Operations Manual 1055
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Message codes Section 10
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2102
Module (1) (0) inventory empty.
0 = Inventory item
1 = Module
Probable cause Corrective action
The bulk solution reservoir and the bulk solution bottle Replace the bulk solution bottle. Perform Replace bulk
are empty. solutions and update the inventory, page 508.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2103
ICT module warranty expired for SN (1) on module (0). (2) days onboard. (3) samples processed.
0 = Module
1 = Serial number
2 = Days on board
3 = Samples processed
Probable cause Corrective action
The ICT module has exceeded the warranty period of 3 Replace the ICT module. Perform Replace the ICT
months onboard or 20,000 samples. module or the ICT probe (c-series), page 859.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2104
(1) inventory low on module (0). Module is pausing.
0 = Module
1 = Bulk solution
Probable cause Corrective action
The specified inventory item is almost empty. Verify the supply and waste inventory, page 508.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2105
Onboard solution lot (0) created for (1).
0 = Onboard solution lot
1 = Onboard solution
Probable cause Corrective action
A new onboard solution lot number was created. Status message. No corrective action is required.
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Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2500
(0) (1) version (2) uninstalled by (3).
0 = Procedure number
1 = Procedure name
2 = Procedure version
3 = Operator ID
Probable cause Corrective action
The selected procedure was uninstalled. Status message. No corrective action is required.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2501
Unable to install (0) (1) version (2). A higher version already installed.
0 = Procedure number
1 = Procedure name
2 = Procedure version
Probable cause Corrective action
A higher version of the procedure is already installed. • No corrective action is required if the request was
made in error.
• To install a lower version, uninstall the procedure
and then install the necessary version.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2502
(0) (1) version (2) installed.
0 = Procedure number
1 = Procedure name
2 = Procedure version
Probable cause Corrective action
The selected procedure was installed. Status message. No corrective action is required.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2503
Unable to uninstall (0) (1) version (2). Procedure is in process.
0 = Procedure number
1 = Procedure name
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Message codes Section 10
2 = Procedure version
Probable cause Corrective action
The operator attempted to uninstall a procedure while Uninstall the procedure after the procedure is
the procedure is in process. completed.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2505
User canceled (0) (1).
0 = Procedure number
1 = Procedure name
Probable cause Corrective action
The operator canceled the procedure. Status message. No corrective action is required.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2506
Unable to install (0) (1) version (2). Procedure is running.
0 = Procedure number
1 = Procedure name
2 = Procedure version
Probable cause Corrective action
An installation was attempted while a procedure is Perform the installation after the procedure is
running. completed.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2507
(0) (1) failed.
0 = Procedure number
1 = Procedure name
Probable cause Corrective action
A system error message occurred. • Review the message text for the error indicated in
the Activity box or Results box on the Perform
Procedure screen. Perform the corrective action for
the specific error message text.
• If the procedure is completed and is not running,
the message text can be reviewed for the specific
procedure in the Details for Log flyout on the Logs
screen.
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Probable cause Corrective action
The acceptance criteria that is specified in the Correct the issue that caused the failure and repeat the
procedure was not met. procedure.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2509
System software version not compatible. Requires version (0). Version (1) is installed.
0 = Software version required
1 = Software version installed
Probable cause Corrective action
The procedure requires a newer version of system Contact Customer Service. Provide information about
software. the operation that was attempted when the error
occurred.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2510
User-defined maintenance procedure (0) (1) version (2) created by (3).
0 = Procedure number
1 = Procedure name
2 = Procedure version
3 = Operator ID
Probable cause Corrective action
A user-defined maintenance procedure was created. Status message. No corrective action is required.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2511
User-defined maintenance procedure (0) (1) version (2) updated by (3).
0 = Procedure number
1 = Procedure name
2 = Procedure version
3 = Operator ID
Probable cause Corrective action
A user-defined maintenance procedure was updated. Status message. No corrective action is required.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
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Message codes Section 10
Message code: 2512
(0) (1) version (2) exported to (3).
0 = Procedure number
1 = Procedure name
2 = Procedure version
3 = USB flash drive
Probable cause Corrective action
A user-defined maintenance procedure was exported. Status message. No corrective action is required.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2513
One or more maintenance procedures are overdue. System is pausing.
Probable cause Corrective action
A maintenance procedure is overdue. Perform any overdue maintenance procedures.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2514
User selected (0) (1) version (2) to be excluded from the import.
0 = Procedure number
1 = Procedure name
2 = Procedure version
Probable cause Corrective action
A procedure was excluded from the import. Status message. No corrective action is required.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2515
Unable to perform (0) (1) version (2). Procedure is running on module (3).
0 = Procedure number
1 = Procedure name
2 = Procedure version
3 = Module
Probable cause Corrective action
The maintenance or diagnostic procedure is already in 1. Wait until the procedure is completed.
progress.
2. To end the procedure, tap Quit on the screen.
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Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2516
Unable to perform (0) (1) version (2). Module (3) is in an incorrect state.
0 = Procedure number
1 = Procedure name
2 = Procedure version
3 = Module
Probable cause Corrective action
The module is not in the correct status that is defined in Transition the module to the correct status to perform
the maintenance or diagnostic procedure. the procedure.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2518
Unable to install procedure. English language file corrupted or not found.
Probable cause Corrective action
The maintenance or diagnostic procedure file is Repeat the installation with a new copy of the
corrupted. procedure.
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2519
Sample pipettor calibration failed.
Probable cause Corrective action
The cuvette alignment tool is not seated correctly in the Reseat the cuvette segment alignment tool on the
reaction carousel. alignment pins in the reaction carousel. Install the
cuvette alignment tool in the reaction carousel.
The cuvette alignment tool is not present. Install the cuvette alignment tool in the reaction
carousel.
The pipettor cover, the probe screw, or the probe 1. Remove the pipettor cover.
ground wire screw is loose.
2. Tighten the probe screw and the probe ground wire
screw with a slotted screwdriver.
3. Replace the pipettor cover and verify that the cover
is seated firmly on the end of the pipettor shaft.
The sample probe is dirty or is damaged. • Clean the sample probe.
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Message codes Section 10
Probable cause Corrective action
• Replace the sample probe (c-series), page 829.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2520
R1 pipettor calibration failed.
Probable cause Corrective action
The cuvette alignment tool is not seated correctly in the Reseat the cuvette segment alignment tool on the
reaction carousel. alignment pins in the reaction carousel. Install the
cuvette alignment tool in the reaction carousel.
The cuvette alignment tool is not present. Install the cuvette alignment tool in the reaction
carousel.
The R1 pipettor cover, the probe screw, or the probe 1. Remove the pipettor cover.
ground wire screw is loose.
2. Tighten the probe screw and the probe ground wire
screw with a slotted screwdriver.
3. Replace the pipettor cover and verify that the cover
is seated firmly on the end of the pipettor shaft.
The R1 probe is dirty or is damaged. • Clean the R1 probe.
• Replace the reagent probes (c-series), page 832.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2521
R2 pipettor calibration failed.
Probable cause Corrective action
The cuvette alignment tool is not seated correctly in the Reseat the cuvette segment alignment tool on the
reaction carousel. alignment pins in the reaction carousel. Install the
cuvette alignment tool in the reaction carousel.
The cuvette alignment tool is not present. Install the cuvette alignment tool in the reaction
carousel.
The R2 pipettor cover, the probe screw, or the probe 1. Remove the pipettor cover.
ground wire screw is loose.
2. Tighten the probe screw and the probe ground wire
screw with a slotted screwdriver.
3. Replace the pipettor cover and verify that the cover
is seated firmly on the end of the pipettor shaft.
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Probable cause Corrective action
The R2 probe is dirty or is damaged. • Clean the R2 probe.
• Replace the reagent probes (c-series), page 832.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2522
Reagent carousel calibration failed.
Probable cause Corrective action
The reagent carousel calibration failed. Perform Reagent Manager diagnostic procedure 4703
Reagent Supply Center Test (c-series), page 786.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2523
Reagent transport calibration failed.
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2524
Light beam alignment failed.
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2525
Instrument status is displayed as Maintenance. While running a procedure the instrument status was
internally changed to (0).
0 = Instrument status
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Message codes Section 10
Probable cause Corrective action
The instrument is in the Maintenance status. Status message. No corrective action is required.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2526
Procedure (0) (1) version (2) installed successfully. Unable to copy files to internal location.
0 = Procedure number
1 = Procedure name
2 = Procedure version
Probable cause Corrective action
The system was unable to copy the procedure to an Contact Customer Service. Provide information about
internal hard drive after the procedure was installed the operation that was attempted when the error
from a USB flash drive. occurred.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2527
Unable to install library file (0). (1) error.
0 = File name
1 = Error
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2528
(1) error occurred processing (0) system update package.
0 = System update package file
1 = Error
Probable cause Corrective action
An error occurred when the maintenance and diagnostic Reinstall the system update package that contains the
procedure file was installed during a system update. maintenance and diagnostic procedure file.
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
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Section 10 Message codes
Message code: 2529
(0) pipettor calibration error.
0 = Pipettor
Probable cause Corrective action
The pipettor calibration failed. The probe is out of Verify that the targets and the probe are clean. Perform
alignment. Pipettors diagnostic procedure 1111 Sample Pipettor
Check and Calibration (i-series), page 796, 1112 R1
Pipettor Check and Calibration (i-series), page 797, or
1113 R2 Pipettor Check and Calibration (i-series), page
797.
The probe is damaged. Replace a sample or reagent pipettor probe (i-series),
page 894.
Hardware failure. Review the specific message text. Perform the
corrective action for the specific message text.
Contact Customer Service to resolve any hardware
failure.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2530
(0) positioner calibration error.
0 = Positioner
Probable cause Corrective action
Hardware failure. • Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
• Contact Customer Service to resolve any hardware
failure.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2531
(0) pipettor ground calibration error.
0 = Pipettor
Probable cause Corrective action
Hardware failure. • Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
• Contact Customer Service to resolve any hardware
failure.
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Message codes Section 10
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2532
(0) pipettor reagent carousel calibration error.
0 = Pipettor
Probable cause Corrective action
The pipettor calibration failed. The probe is out of Verify that the targets and the probe are clean. Perform
alignment. Pipettors diagnostic procedure 1112 R1 Pipettor Check
and Calibration (i-series), page 797 or 1113 R2 Pipettor
Check and Calibration (i-series), page 797.
The probe is damaged. Replace the R1 or R2 pipettor probe. Perform Replace a
sample or reagent pipettor probe (i-series), page 894.
Hardware failure. Review the specific message text. Perform the
corrective action for the specific message text.
Contact Customer Service to resolve any hardware
failure.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2533
(0) positioner lane calibration error.
0 = Positioner
Probable cause Corrective action
Hardware failure. • Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
• Contact Customer Service to resolve any hardware
failure.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2534
RV loader upper hopper empty.
Probable cause Corrective action
The RV loader upper hopper is empty. Replenish reaction vessels (RVs) and update the
inventory (i-series), page 517.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
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Section 10 Message codes
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2535
Reagent carousel and transport calibration error.
Probable cause Corrective action
Hardware failure. • Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
• Contact Customer Service to resolve any hardware
failure.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2536
Probe straightness check failed. Offsets (0).
0 = Offsets
Probable cause Corrective action
The probe failed the straightness check of the probe Repeat Pipettors diagnostic procedure 1111 Sample
calibration procedure. Pipettor Check and Calibration (i-series), page 796, 1112
R1 Pipettor Check and Calibration (i-series), page 797,
or 1113 R2 Pipettor Check and Calibration (i-series),
page 797.
The probe is damaged. Replace the probe. Perform Replace a sample or
reagent pipettor probe (i-series), page 894.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2537
Calibration target not found.
Probable cause Corrective action
The calibration target was not found. Repeat Pipettors diagnostic procedure 1111 Sample
Pipettor Check and Calibration (i-series), page 796, 1112
R1 Pipettor Check and Calibration (i-series), page 797,
or 1113 R2 Pipettor Check and Calibration (i-series),
page 797. During the calibration, verify that all
calibration targets are cleaned with water (purified or
tap).
Hardware failure. Contact Customer Service to resolve any hardware
failure.
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Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2538
Reagent carousel calibration failed.
Probable cause Corrective action
A hardware error occurred. The reagent carousel Additional messages that are associated with this
calibration failed. message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Message code: 2539
Reagent carousel and reagent transport calibration failed.
Probable cause Corrective action
The reagent carousel and the reagent transport Additional messages that are associated with this
calibration failed. message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Maintenance and diagnostic message codes (2000-2999), page 1047
Level sense and fluidics message codes (3000-3999)
The level sense and fluidics message code category includes message codes from 3000
through 3999.
Related information...
Message codes, page 941
3002, page 1072
3003, page 1072
3004, page 1072
3005, page 1073
3006, page 1073
3007, page 1074
3008, page 1074
3009, page 1075
3010, page 1075
3011, page 1075
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Section 10 Message codes
3012, page 1076
3013, page 1076
3014, page 1077
3019, page 1077
3020, page 1078
3021, page 1078
3022, page 1079
3023, page 1079
3033, page 1080
3034, page 1080
3035, page 1081
3036, page 1081
3037, page 1082
3038, page 1082
3039, page 1083
3040, page 1083
3041, page 1083
3042, page 1084
3043, page 1084
3044, page 1084
3045, page 1085
3046, page 1085
3047, page 1086
3048, page 1086
3049, page 1087
3050, page 1087
3051, page 1088
3052, page 1089
3201, page 1089
3202, page 1090
3203, page 1090
3213, page 1090
3214, page 1091
3215, page 1091
3302, page 1092
3303, page 1092
3304, page 1092
3305, page 1092
3306, page 1092
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Message codes Section 10
3307, page 1093
3308, page 1093
3309, page 1093
3310, page 1093
3417, page 1094
3418, page 1094
3419, page 1094
3420, page 1095
3421, page 1095
3422, page 1095
3423, page 1095
3424, page 1096
3425, page 1096
3426, page 1096
3427, page 1097
3428, page 1097
3429, page 1098
3430, page 1098
3431, page 1099
3436, page 1099
3437, page 1099
3446, page 1100
3447, page 1101
3448, page 1101
3449, page 1101
3450, page 1102
3451, page 1102
3452, page 1103
3453, page 1103
3454, page 1104
3455, page 1104
3456, page 1104
3457, page 1105
3458, page 1105
3459, page 1106
3460, page 1106
3461, page 1107
3462, page 1107
3463, page 1108
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Section 10 Message codes
3601, page 1108
3603, page 1108
3604, page 1109
3605, page 1109
3607, page 1109
3608, page 1109
3609, page 1110
3610, page 1110
3611, page 1110
3612, page 1111
3613, page 1111
3614, page 1111
3615, page 1112
3616, page 1112
3617, page 1112
3618, page 1112
3619, page 1113
3630, page 1113
3631, page 1114
3640, page 1114
3641, page 1114
3642, page 1114
3643, page 1115
3644, page 1115
3645, page 1115
3646, page 1115
3647, page 1116
3648, page 1116
3650, page 1116
3651, page 1117
3652, page 1117
3653, page 1118
3654, page 1118
3655, page 1118
3656, page 1119
3657, page 1119
3658, page 1119
3659, page 1120
3660, page 1120
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Message codes Section 10
3661, page 1120
3662, page 1121
3663, page 1121
3664, page 1122
3665, page 1123
Message code: 3002
Alkaline Wash level sensor failed.
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3003
Acid Wash level sensor failed.
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3004
Liquid too high for R1 pipettor at position (0).
0 = Position
Probable cause Corrective action
Bubbles or foam are present on the surface of the Remove bubbles or foam from the surface of the
reagent. reagent by using a clean applicator stick for each bottle.
The reagent probe is dirty. Perform Fluidics-Wash diagnostic procedure 4208 Probe
and Mixer Wash (c-series), page 783.
The pipettor cover, the probe screw, or the probe 1. Remove the pipettor cover.
ground wire screw is loose.
2. Tighten the probe screw and the probe ground wire
screw with a slotted screwdriver.
3. Replace the pipettor cover. Ensure the cover is
seated firmly on the end of the pipettor above the
pipettor shaft.
The reagent probe is out of alignment. Perform Pipettors diagnostic procedure 4103 R1 Pipettor
Calibration (c-series), page 779.
The reagent probe is damaged. Replace the reagent probes (c-series), page 832.
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Section 10 Message codes
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3005
Liquid too low for R1 pipettor at position (0).
0 = Position
Probable cause Corrective action
No reagent cartridge is present, or the reagent cartridge Load cartridges on the reagent and sample manager
is empty. (RSM), page 527.
The reagent probe is dirty. Perform Fluidics-Wash diagnostic procedure 4208 Probe
and Mixer Wash (c-series), page 783.
The pipettor cover, the probe screw, or the probe 1. Remove the pipettor cover.
ground wire screw is loose.
2. Tighten the probe screw and the probe ground wire
screw with a slotted screwdriver.
3. Replace the pipettor cover. Ensure the cover is
seated firmly on the end of the pipettor above the
pipettor shaft.
The reagent probe is out of alignment. Perform Pipettors diagnostic procedure 4103 R1 Pipettor
Calibration (c-series), page 779.
The reagent probe is damaged. Replace the reagent probes (c-series), page 832.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3006
Liquid not found for R1 pipettor at position (0).
0 = Position
Probable cause Corrective action
No reagent cartridge is present, or the reagent cartridge Load cartridges on the reagent and sample manager
is empty. (RSM), page 527.
Bubbles or foam are present on the surface of the Remove bubbles or foam from the surface of the
reagent. reagent by using a clean applicator stick for each bottle.
The reagent probe is dirty. Perform Fluidics-Wash diagnostic procedure 4208 Probe
and Mixer Wash (c-series), page 783.
The pipettor cover, the probe screw, or the probe 1. Remove the pipettor cover.
ground wire screw is loose.
2. Tighten the probe screw and the probe ground wire
screw with a slotted screwdriver.
3. Replace the pipettor cover. Ensure the cover is
seated firmly on the end of the pipettor above the
pipettor shaft.
The reagent probe is out of alignment. Perform Pipettors diagnostic procedure 4103 R1 Pipettor
Calibration (c-series), page 779.
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Message codes Section 10
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3007
Liquid too low for R2 pipettor at position (0).
0 = Position
Probable cause Corrective action
No reagent cartridge is present, or the reagent cartridge Load cartridges on the reagent and sample manager
is empty. (RSM), page 527.
The reagent probe is dirty. Perform Fluidics-Wash diagnostic procedure 4208 Probe
and Mixer Wash (c-series), page 783.
The pipettor cover, the probe screw, or the probe 1. Remove the pipettor cover.
ground wire screw is loose.
2. Tighten the probe screw and the probe ground wire
screw with a slotted screwdriver.
3. Replace the pipettor cover. Ensure the cover is
seated firmly on the end of the pipettor above the
pipettor shaft.
The reagent probe is out of alignment. Perform Pipettors diagnostic procedure 4104 R2 Pipettor
Calibration (c-series), page 779.
The reagent probe is damaged. Replace the reagent probes (c-series), page 832.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3008
Liquid not found for R2 pipettor at position (0).
0 = Position
Probable cause Corrective action
No reagent cartridge is present, or the reagent cartridge Load cartridges on the reagent and sample manager
is empty. (RSM), page 527.
Bubbles or foam are present on the surface of the Remove bubbles or foam from the surface of the
reagent. reagent by using a clean applicator stick for each bottle.
The reagent probe is dirty. Perform Fluidics-Wash diagnostic procedure 4208 Probe
and Mixer Wash (c-series), page 783.
The pipettor cover, the probe screw, or the probe 1. Remove the pipettor cover.
ground wire screw is loose.
2. Tighten the probe screw and the probe ground wire
screw with a slotted screwdriver.
3. Replace the pipettor cover. Ensure the cover is
seated firmly on the end of the pipettor above the
pipettor shaft.
The reagent probe is out of alignment. Perform Pipettors diagnostic procedure 4104 R2 Pipettor
Calibration (c-series), page 779.
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Section 10 Message codes
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3009
Liquid too high for R2 pipettor at position (0).
0 = Position
Probable cause Corrective action
Bubbles or foam are present on the surface of the Remove bubbles or foam from the surface of the
reagent. reagent by using a clean applicator stick for each bottle.
The reagent probe is dirty. Perform Fluidics-Wash diagnostic procedure 4208 Probe
and Mixer Wash (c-series), page 783.
The pipettor cover, the probe screw, or the probe 1. Remove the pipettor cover.
ground wire screw is loose.
2. Tighten the probe screw and the probe ground wire
screw with a slotted screwdriver.
3. Replace the pipettor cover. Ensure the cover is
seated firmly on the end of the pipettor above the
pipettor shaft.
The reagent probe is out of alignment. Perform Pipettors diagnostic procedure 4104 R2 Pipettor
Calibration (c-series), page 779.
The reagent probe is damaged. Replace the reagent probes (c-series), page 832.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3010
Unable to process test. Reagent cartridge empty or had LLS error.
Probable cause Corrective action
The reagent cartridge is empty or has an LLS error. 1. Verify the reagent carousel inventory, page 547. If
necessary, replace the reagent cartridge.
2. Rerun the test.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3011
Unable to process test. Liquid too high for R1 pipettor.
Probable cause Corrective action
Bubbles or foam are present on the surface of the Remove bubbles or foam from the surface of the
reagent. reagent by using a clean applicator stick for each bottle.
The pipettor cover, the probe screw, or the probe 1. Remove the pipettor cover.
ground wire screw is loose.
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Message codes Section 10
Probable cause Corrective action
2. Tighten the probe screw and the probe ground wire
screw with a slotted screwdriver.
3. Replace the pipettor cover. Ensure the cover is
seated firmly on the end of the pipettor above the
pipettor shaft.
The reagent probe is out of alignment. Perform Pipettors diagnostic procedure 4103 R1 Pipettor
Calibration (c-series), page 779.
The reagent probe is damaged. Replace the reagent probes (c-series), page 832.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3012
Unable to process test. Liquid contact broken during aspiration for R1 pipettor.
Probable cause Corrective action
Bubbles or foam are present on the surface of the Remove bubbles or foam from the surface of the
reagent. reagent by using a clean applicator stick for each bottle.
The reagent probe is dirty. Perform Fluidics-Wash diagnostic procedure 4208 Probe
and Mixer Wash (c-series), page 783.
The pipettor cover, the probe screw, or the probe 1. Remove the pipettor cover.
ground wire screw is loose.
2. Tighten the probe screw and the probe ground wire
screw with a slotted screwdriver.
3. Replace the pipettor cover. Ensure the cover is
seated firmly on the end of the pipettor above the
pipettor shaft.
The reagent probe is out of alignment. Perform Pipettors diagnostic procedure 4103 R1 Pipettor
Calibration (c-series), page 779.
The reagent probe is damaged. Replace the reagent probes (c-series), page 832.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3013
Unable to process test. Liquid contact broken during aspiration for R2 pipettor.
Probable cause Corrective action
Bubbles or foam are present on the surface of the Remove bubbles or foam from the surface of the
reagent. reagent by using a clean applicator stick for each bottle.
The reagent probe is dirty. Perform Fluidics-Wash diagnostic procedure 4208 Probe
and Mixer Wash (c-series), page 783.
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Section 10 Message codes
Probable cause Corrective action
The pipettor cover, the probe screw, or the probe 1. Remove the pipettor cover.
ground wire screw is loose.
2. Tighten the probe screw and the probe ground wire
screw with a slotted screwdriver.
3. Replace the pipettor cover. Ensure the cover is
seated firmly on the end of the pipettor above the
pipettor shaft.
The reagent probe is out of alignment. Perform Pipettors diagnostic procedure 4104 R2 Pipettor
Calibration (c-series), page 779.
The reagent probe is damaged. Replace the reagent probes (c-series), page 832.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3014
ICT Reference Solution level sensor failed.
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3019
Unable to process test. Liquid not found for R1 pipettor.
Probable cause Corrective action
No reagent cartridge is present, or the reagent cartridge Load cartridges on the reagent and sample manager
is empty. (RSM), page 527.
Bubbles or foam are present on the surface of the Remove bubbles or foam from the surface of the
reagent. reagent by using a clean applicator stick for each bottle.
The reagent probe is dirty. Perform Fluidics-Wash diagnostic procedure 4208 Probe
and Mixer Wash (c-series), page 783.
The pipettor cover, the probe screw, or the probe 1. Remove the pipettor cover.
ground wire screw is loose.
2. Tighten the probe screw and the probe ground wire
screw with a slotted screwdriver.
3. Replace the pipettor cover. Ensure the cover is
seated firmly on the end of the pipettor above the
pipettor shaft.
The reagent probe is out of alignment. Perform Pipettors diagnostic procedure 4103 R1 Pipettor
Calibration (c-series), page 779.
The reagent probe is damaged. Replace the reagent probes (c-series), page 832.
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Message codes Section 10
Probable cause Corrective action
The water quality is below specifications. Verify that the purified water purity is within
specifications.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3020
Unable to process test. Liquid not found for R2 pipettor.
Probable cause Corrective action
No reagent cartridge is present, or the reagent cartridge Load cartridges on the reagent and sample manager
is empty. (RSM), page 527.
Bubbles or foam are present on the surface of the Remove bubbles or foam from the surface of the
reagent. reagent by using a clean applicator stick for each bottle.
The reagent probe is dirty. Perform Fluidics-Wash diagnostic procedure 4208 Probe
and Mixer Wash (c-series), page 783.
The pipettor cover, the probe screw, or the probe 1. Remove the pipettor cover.
ground wire screw is loose.
2. Tighten the probe screw and the probe ground wire
screw with a slotted screwdriver.
3. Replace the pipettor cover. Ensure the cover is
seated firmly on the end of the pipettor above the
pipettor shaft.
The reagent probe is out of alignment. Perform Pipettors diagnostic procedure 4104 R2 Pipettor
Calibration (c-series), page 779.
The reagent probe is damaged. Replace the reagent probes (c-series), page 832.
The water quality is below specifications. Verify that the purified water purity is within
specifications.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3021
Unable to process test. Liquid too high for R2 pipettor.
Probable cause Corrective action
Bubbles or foam are present on the surface of the Remove bubbles or foam from the surface of the
reagent. reagent by using a clean applicator stick for each bottle.
The reagent probe is dirty. Perform Fluidics-Wash diagnostic procedure 4208 Probe
and Mixer Wash (c-series), page 783.
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Troubleshooting
Section 10 Message codes
Probable cause Corrective action
The pipettor cover, the probe screw, or the probe 1. Remove the pipettor cover.
ground wire screw is loose.
2. Tighten the probe screw and the probe ground wire
screw with a slotted screwdriver.
3. Replace the pipettor cover. Ensure the cover is
seated firmly on the end of the pipettor above the
pipettor shaft.
The reagent probe is out of alignment. Perform Pipettors diagnostic procedure 4104 R2 Pipettor
Calibration (c-series), page 779.
The reagent probe is damaged. Replace the reagent probes (c-series), page 832.
The water quality is below specifications. Verify that the purified water purity is within
specifications.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3022
Unable to process test due to previous aspiration error on sample.
Probable cause Corrective action
A pressure monitor error was generated during the Review the specific message text. Perform the
aspiration of the sample for a previous test. corrective action for the specific message text.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3023
Unable to process test. Liquid too high for sample pipettor at rack.
Probable cause Corrective action
The sample cup or tube contains too much liquid. Load a sample cup or tube that contains the correct
amount of sample. See Sample volume requirements,
page 423.
Bubbles or foam are present on the surface of the Remove bubbles or foam from the surface of the
sample. sample by using a clean disposable pipette or applicator
stick.
The sample pipettor probe is dirty. Perform Fluidics-Wash diagnostic procedure 4208 Probe
and Mixer Wash (c-series), page 783.
The pipettor cover, the probe screw, or the probe 1. Remove the pipettor cover.
ground wire screw is loose.
2. Tighten the probe screw and the probe ground wire
screw with a slotted screwdriver.
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Message codes Section 10
Probable cause Corrective action
3. Replace the pipettor cover. Ensure the cover is
seated firmly on the end of the pipettor above the
pipettor shaft.
The sample pipettor probe is out of alignment. Perform Pipettors diagnostic procedure 4102 Sample
Pipettor Calibration (c-series), page 779.
The sample pipettor probe is damaged. Replace the sample probe (c-series), page 829.
The water quality is below specifications. Verify that the purified water purity is within
specifications.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3033
LLS error occurred for (0) on module (1).
0 = Onboard solution
1 = Module
Probable cause Corrective action
The sample onboard wash solutions level is low or Verify that adequate sample onboard wash solutions
empty. inventory is available and is not expired. Perform Verify
the supply and waste inventory, page 508.
The sample probe is damaged. Replace the sample probe (c-series), page 829.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3034
Liquid not found for (0) pipettor in (5) reagent carousel position (4).
0 = Pipettor
4 = Reagent carousel position
5 = Location
Probable cause Corrective action
A reagent carousel inventory item is empty. Load a new reagent carousel inventory item.
The reagent probe is not straight. Perform Pipettors diagnostic procedure 1112 R1 Pipettor
Check and Calibration (i-series), page 797 or 1113 R2
Pipettor Check and Calibration (i-series), page 797.
The reagent probe is not positioned correctly. Perform Pipettors diagnostic procedure 1112 R1 Pipettor
Check and Calibration (i-series), page 797 or 1113 R2
Pipettor Check and Calibration (i-series), page 797.
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Section 10 Message codes
Probable cause Corrective action
The reagent probe is damaged. Replace the reagent probe. Perform Replace a sample
or reagent pipettor probe (i-series), page 894.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3035
Liquid not found at (0) pipettor in (3) reagent carousel position (5).
0 = Pipettor
3 = Location
5 = Reagent carousel position
Probable cause Corrective action
No reagent cartridge is present or the reagent cartridge Load the reagent or replace the empty reagent
is empty. cartridge.
Bubbles or foam are present on the surface of the Place reagent cartridges in an upright position before
reagent. use to allow bubbles that may have formed to dissipate.
The reagent probe is dirty. Perform Weekly maintenance procedure 2620 Manual
Pipettor Probe Cleaning (i-series), page 769.
The reagent probe is out of alignment. Perform Pipettors diagnostic procedure 1112 R1 Pipettor
Check and Calibration (i-series), page 797 or 1113 R2
Pipettor Check and Calibration (i-series), page 797.
The reagent probe is damaged. Replace the reagent probe. Perform Replace a sample
or reagent pipettor probe (i-series), page 894.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3036
Liquid not found at (0) pipettor in (4) reagent carousel position (2).
0 = Pipettor
2 = Reagent carousel position
4 = Location
Probable cause Corrective action
No reagent cartridge is present or the reagent cartridge Load the reagent or replace the empty reagent
is empty. cartridge.
Bubbles or foam are present on the surface of the Place reagent cartridges in an upright position before
reagent. use to allow bubbles that may have formed to dissipate.
The reagent probe is dirty. Perform Weekly maintenance procedure 2620 Manual
Pipettor Probe Cleaning (i-series), page 769.
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Message codes Section 10
Probable cause Corrective action
The reagent probe is out of alignment. Perform Pipettors diagnostic procedure 1112 R1 Pipettor
Check and Calibration (i-series), page 797 or 1113 R2
Pipettor Check and Calibration (i-series), page 797.
The reagent probe is damaged. Replace the reagent probe. Perform Replace a sample
or reagent pipettor probe (i-series), page 894.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3037
Liquid not found at (0) pipettor in (5) reagent carousel position (4).
0 = Pipettor
5 = Location
4 = Reagent carousel position
Probable cause Corrective action
The probe traveled too far into the liquid after the initial Rerun the test. Perform Rerun a test or an exception for
fluid contact. a specimen or control, page 612.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3038
Liquid too low at (0) pipettor in (5) reagent carousel position (4).
0 = Pipettor
4 = Reagent carousel position
5 = Location
Probable cause Corrective action
No reagent cartridge is present or the reagent cartridge Load the reagent or replace the empty reagent
is empty. cartridge.
Bubbles or foam are present on the surface of the Place reagent cartridges in an upright position before
reagent. use to allow bubbles that may have formed to dissipate.
The reagent probe is dirty. Perform Weekly maintenance procedure 2620 Manual
Pipettor Probe Cleaning (i-series), page 769.
The reagent probe is out of alignment. Perform Pipettors diagnostic procedure 1112 R1 Pipettor
Check and Calibration (i-series), page 797 or 1113 R2
Pipettor Check and Calibration (i-series), page 797.
The reagent probe is damaged. Replace the reagent probe. Perform Replace a sample
or reagent pipettor probe (i-series), page 894.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
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Section 10 Message codes
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3039
Unable to process test. Maximum number of LLS errors exceeded for reagent cartridge.
Probable cause Corrective action
LLS, aspiration, or movement restrictions are detected Review the system logs for messages that occurred at
for the indicated pipettor. the same time as this message. Perform the corrective
action for the specific message text.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3040
Unable to process test. Onboard solution cartridge is empty or had LLS error.
Probable cause Corrective action
The onboard solution cartridge is empty. Prepare and load a new onboard solution cartridge.
Perform Prepare onboard solutions (c-series), page 551
and Load cartridges on the reagent and sample manager
(RSM), page 527.
Bubbles or foam are present on the surface of the Remove bubbles or foam from the surface of the
reagent. reagent by using a clean applicator stick.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3041
Liquid not found for (0) pipettor in (4).
0 = Pipettor
1 = Location
Probable cause Corrective action
An error occurred during a liquid level sense seek.
The sample probe is out of alignment. Perform the Probe Straightness option of Pipettors
diagnostic procedure 1111 Sample Pipettor Check and
Calibration (i-series), page 796.
The sample probe is damaged. Replace the sample probe. Perform Replace a sample or
reagent pipettor probe (i-series), page 894.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
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Message codes Section 10
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3042
Liquid not found for (0) pipettor in (5).
0 = Pipettor
1 = Location
Probable cause Corrective action
An error occurred during a liquid level sense seek.
A sample cup or tube is not present. Verify that a sample cup or tube is present.
The sample volume in the sample cup or tube was Place adequate sample in the cup or tube. See Sample
inadequate. volume requirements, page 423.
The sample probe is out of alignment. Perform the Calibration option of Pipettors diagnostic
procedure 1111 Sample Pipettor Check and Calibration
(i-series), page 796.
The sample probe is damaged. Replace the sample probe. Perform Replace a sample or
reagent pipettor probe (i-series), page 894.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3043
Liquid too low for (0) pipettor in (5).
0 = Pipettor
1 = Location
Probable cause Corrective action
The sample volume in the sample cup or tube is Place adequate sample in the cup or tube. See Sample
inadequate. volume requirements, page 423.
The sample probe is out of alignment. Perform Pipettors diagnostic procedure 1111 Sample
Pipettor Check and Calibration (i-series), page 796.
The sample probe is damaged. Replace the sample probe. Perform Replace a sample or
reagent pipettor probe (i-series), page 894.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3044
Liquid not found for (0) pipettor in (5).
0 = Pipettor
1 = Location
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Troubleshooting
Section 10 Message codes
Probable cause Corrective action
The probe traveled too far into the liquid after the initial
fluid contact.
The probe clamp is loose. Tighten probe clamp by hand.
The probe is out of alignment. Perform the Probe Straightness option of Pipettors
diagnostics procedure 1111 Sample Pipettor Check and
Calibration (i-series), page 796.
The probe is damaged. Replace the sample probe. Perform Replace a sample or
reagent pipettor probe (i-series), page 894.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3045
Unable to process test. Liquid contact broken during aspiration for (0) pipettor in (5).
0 = Pipettor
1 = Location
Probable cause Corrective action
Bubbles or foam are present on top of the liquid. Remove bubbles or foam from the surface of the
sample using a clean disposable pipette or applicator
stick.
The sample cup or tube is tilted in the rack. Reposition the sample cup or tube in the rack so that it
is not tilted.
A drop of liquid is present on the side of the sample cup Transfer the sample to a new sample cup or tube.
or tube.
A drop of liquid is present on the end of the probe. Tighten the probe tubing connections by hand.
The sample probe is out of alignment. Perform Pipettors diagnostic procedure 1111 Sample
Pipettor Check and Calibration (i-series), page 796.
The sample probe is damaged. Replace the sample probe. Perform Replace a sample or
reagent pipettor probe (i-series), page 894.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3046
Liquid not found for (0) pipettor in (5).
0 = Pipettor
1 = Location
Probable cause Corrective action
A sample cup or tube is not present. Verify that a sample cup or tube is present.
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Message codes Section 10
Probable cause Corrective action
The sample volume in the sample cup or tube is Place adequate sample in the cup or tube. See Sample
inadequate. volume requirements, page 423.
The sample probe is out of alignment. Perform Pipettors diagnostic procedure 1111 Sample
Pipettor Check and Calibration (i-series), page 796.
The sample probe is damaged. Replace the sample probe. Perform Replace a sample or
reagent pipettor probe (i-series), page 894.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3047
Liquid not found for (0) pipettor in (2).
0 = Pipettor
1 = Location
Probable cause Corrective action
A sample cup or tube is not present. Verify that a sample cup or tube is present.
The sample volume in the sample cup or tube is Place adequate sample in the cup or tube. See Sample
inadequate. volume requirements, page 423.
Bubbles, foam, or fibrin clots are present in the sample. Remove bubbles, foam, or fibrin clots by using a clean
disposable pipette or applicator stick.
A drop of liquid is present on the side of the sample cup Transfer the sample to a new sample cup or tube.
or tube.
A drop of liquid is present on the end of the probe. Tighten the probe tubing connections by hand.
The sample probe is out of alignment. Perform Pipettors diagnostic procedure 1111 Sample
Pipettor Check and Calibration (i-series), page 796.
The sample probe is damaged. Replace the sample probe. Perform Replace a sample or
reagent pipettor probe (i-series), page 894.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3048
Maximum number of LLS errors exceeded in reagent cartridge (0) position located in reagent carousel
position (1).
0 = Bottle
1 = Reagent carousel position
Probable cause Corrective action
Consecutive liquid level sense errors were detected for Additional messages that are associated with this
the indicated reagent cartridge. message can be used to determine the appropriate
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Troubleshooting
Section 10 Message codes
Probable cause Corrective action
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3049
Liquid too low for sample at (0).
0 = Pipetting location
Probable cause Corrective action
A sample cup or tube is not present. Verify that the sample cup or tube is present.
The sample volume in the sample cup or tube was Place adequate sample in the sample cup or tube.
inadequate.
The pipettor cover, the probe screw, or the probe 1. Remove the pipettor cover.
ground wire screw is loose.
2. Tighten the probe screw and the probe ground wire
screw with a slotted screwdriver.
3. Replace the pipettor cover and verify that the cover
is seated firmly on the end of the pipettor shaft.
A sample probe is out of alignment. Perform Pipettors diagnostic procedure 4102 Sample
Pipettor Calibration (c-series), page 779.
A sample probe is damaged. Replace the sample probe (c-series), page 829.
The water quality is below specifications. Verify that the purified water purity is within
specifications. See Processing module water and liquid
waste specifications and requirements (c-series), page
407.
• The liquid level sense board threshold voltage is Contact Customer Service to resolve any hardware
out of range. failure.
• The liquid level sense cable is defective.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3050
Liquid not found for sample at (0).
0 = Pipetting location
Probable cause Corrective action
A sample cup or tube is not present. Verify that the sample cup or tube is present.
The sample volume in the sample cup or tube was Place adequate sample in the sample cup or tube.
inadequate.
Bubbles or foam are present on the top of the liquid. Remove bubbles or foam from the surface of the
sample by using a clean disposable pipette or applicator
stick.
Alinity ci-series Operations Manual 1087
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Troubleshooting
Message codes Section 10
Probable cause Corrective action
The pipettor cover, the probe screw, or the probe 1. Remove the pipettor cover.
ground wire screw is loose.
2. Tighten the probe screw and the probe ground wire
screw with a slotted screwdriver.
3. Replace the pipettor cover and verify that the cover
is seated firmly on the end of the pipettor shaft.
A sample probe is out of alignment. Perform Pipettors diagnostic procedure 4102 Sample
Pipettor Calibration (c-series), page 779.
A sample probe is damaged. Replace the sample probe (c-series), page 829.
The water quality is below specifications. Verify that the purified water purity is within
specifications. See Processing module water and liquid
waste specifications and requirements (c-series), page
407.
• The liquid level sense board threshold voltage is Contact Customer Service to resolve any hardware
out of range. failure.
• The liquid level sense cable is defective.
• The liquid level sense board is defective.
• A connector on the SCM board is loose.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3051
Liquid contact broken during aspiration for sample at (0).
0 = Pipetting location
Probable cause Corrective action
Bubbles or foam are present on the top of the liquid. Remove bubbles or foam from the surface of the
sample by using a clean disposable pipette or applicator
stick.
The sample cup or tube is tilted in the rack. Reposition the sample cup or tube in the rack.
A drop of liquid is present on the side of the sample cup Transfer the sample to a new sample cup or tube.
or tube.
The pipettor cover, the probe screw, or the probe 1. Remove the pipettor cover.
ground wire screw is loose.
2. Tighten the probe screw and the probe ground wire
screw with a slotted screwdriver.
3. Replace the pipettor cover and verify that the cover
is seated firmly on the end of the pipettor shaft.
A sample probe is out of alignment. Perform Pipettors diagnostic procedure 4102 Sample
Pipettor Calibration (c-series), page 779.
A sample probe is damaged. Replace the sample probe (c-series), page 829.
The sample probe tubing connections are loose or Tighten the tubing connections or replace the tubing.
leaking.
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Section 10 Message codes
Probable cause Corrective action
The sample probe tubing is damaged. Replace the sample probe tubing (c-series), page 837.
The water quality is below specifications. Verify that the purified water purity is within
specifications. See Processing module water and liquid
waste specifications and requirements (c-series), page
407.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3052
Liquid sensed too high for sample at (0).
0 = Pipetting location
Probable cause Corrective action
Too much sample is present in the sample cup or tube. Place adequate sample in the sample cup or tube. See
the assay-specific sample volume requirements.
Bubbles or foam are present on the top of the liquid. Remove bubbles or foam from the surface of the
sample by using a clean disposable pipette or applicator
stick.
The pipettor cover, the probe screw, or the probe 1. Remove the pipettor cover.
ground wire screw is loose.
2. Tighten the probe screw and the probe ground wire
screw with a slotted screwdriver.
3. Replace the pipettor cover and verify that the cover
is seated firmly on the end of the pipettor shaft.
A sample probe is out of alignment. Perform Pipettors diagnostic procedure 4102 Sample
Pipettor Calibration (c-series), page 779.
A sample probe is damaged. Replace the sample probe (c-series), page 829.
The water quality is below specifications. Verify that the purified water purity is within
specifications. See Processing module water and liquid
waste specifications and requirements (c-series), page
407.
• The liquid level sense board threshold voltage is Contact Customer Service to resolve any hardware
out of range. failure.
• The liquid level sense cable is defective.
• The liquid level sense board is defective.
• A connector on the SCM board is loose.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3201
Degasser pressure high.
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Troubleshooting
Message codes Section 10
Probable cause Corrective action
The incoming purified water pressure is high or has a Verify that the incoming purified water pressure is within
high gas content. specification.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3202
Pressure monitoring error on (0) pipettor during wash.
0 = Pipettor
Probable cause Corrective action
The pipettor is obstructed. Replace a sample or reagent pipettor probe (i-series),
page 894.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3203
Pressure monitoring error on (0) pipettor at reagent carousel position (3) (5).
0 = Pipettor
3 = Reagent carousel position
5 = Location
Probable cause Corrective action
Bubbles or foam are present on the surface of the Place reagent cartridges in an upright position before
reagent. use to allow bubbles that may have formed to dissipate.
The reagent probe is dirty. Perform Weekly maintenance procedure 2620 Manual
Pipettor Probe Cleaning (i-series), page 769.
The reagent probe is out of alignment. Perform Pipettors diagnostic procedure 1112 R1 Pipettor
Check and Calibration (i-series), page 797 or 1113 R2
Pipettor Check and Calibration (i-series), page 797.
The reagent probe is damaged. Replace the reagent probe. Perform Replace a sample
or reagent pipettor probe (i-series), page 894.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3213
(3) pipettor wash pressure error.
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Troubleshooting
Section 10 Message codes
3 = Pipettor
Probable cause Corrective action
Communication error. Cycle power to the processing module and the reagent
and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3214
Pressure monitor communication error for (2) pipettor.
2 = Pipettor
Probable cause Corrective action
Communication error. Cycle power to the processing module and the reagent
and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3215
Pressure monitoring error for (0) pipettor in (5).
0 = Pipettor
1 = Location
Probable cause Corrective action
A sample cup or tube is not present. Verify that a sample cup or tube is present.
The sample volume in the sample cup or tube is Place adequate sample in the sample cup or tube. See
inadequate. Sample volume requirements, page 423.
Bubbles, foam, or fibrin clots are present in the sample. Remove bubbles, foam, or fibrin clots by using a clean
disposable pipette or applicator stick.
A drop of liquid is present on the side of the sample cup Transfer the sample to a new sample cup or tube.
or tube.
A drop of liquid is present on the end of the probe. Tighten the probe tubing connections by hand.
The sample probe is out of alignment. Perform Pipettors diagnostic procedure 1111 Sample
Pipettor Check and Calibration (i-series), page 796.
The sample probe is damaged. Replace the sample probe. Perform Replace a sample or
reagent pipettor probe (i-series), page 894.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
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Message codes Section 10
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3302
Liquid too high in vacuum and waste accumulator.
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3303
Vacuum system failed. Vacuum sensor base too low.
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3304
Vacuum system failed. Vacuum pressure too high.
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3305
Vacuum system failed. Vacuum pressure error.
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3306
Vacuum system failed. Liquid too high.
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Troubleshooting
Section 10 Message codes
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3307
Vacuum system failed. Vacuum too low.
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3308
Vacuum (0) error.
0 = Error
Probable cause Corrective action
Vacuum error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3309
Vacuum system pressure error.
Probable cause Corrective action
Hardware failure. • Review the message history log for errors that
occurred at the same time as this message.
Perform corrective actions for the specific message
text.
• Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3310
Vacuum system failed. Waste pump pressure too low.
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Message codes Section 10
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3417
Pressure monitor board communications error. (0) (1) (2).
0 = Communication error
1 = Numeric code
2 = Dispense channel
Probable cause Corrective action
Communication error. Cycle power to the processing module and the reagent
and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3418
(0) pipettor dispense error.
0 = Pipettor
Probable cause Corrective action
Pipettor error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3419
Trigger dispense failed.
Probable cause Corrective action
Trigger dispense error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
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Troubleshooting
Section 10 Message codes
Message code: 3420
Wash zone (0) aspiration error.
0 = Wash zone
Probable cause Corrective action
Wash zone aspiration error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3421
Wash zone (0) pump fill error.
0 = Wash zone
Probable cause Corrective action
Wash zone pump fill error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3422
Wash zone (0) dispense failed.
0 = Wash zone
Probable cause Corrective action
Wash zone dispense error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3423
Cuvette washer water volume (0). Cuvette (1) volume (2).
0 = Volume
1 = Cuvette
2 = Volume
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Message codes Section 10
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3424
(0) pipettor aspiration error.
0 = Pipettor
Probable cause Corrective action
Pipettor aspiration error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3425
(0) pipettor sensor error.
0 = Pipettor
Probable cause Corrective action
Pipettor sensor error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3426
R1 aspiration error at position (0).
0 = Position
Probable cause Corrective action
The reagent probe tubing connections are loose or Replace the reagent probe tubing (c-series), page 840.
leaking.
Bubbles or foam are present on the surface of the Remove bubbles or foam from the surface of the
reagent. reagent by using a clean applicator stick for each bottle.
The reagent probe is dirty. Perform Fluidics-Wash diagnostic procedure 4208 Probe
and Mixer Wash (c-series), page 783.
The reagent probe is out of alignment. Perform Pipettors diagnostic procedure 4103 R1 Pipettor
Calibration (c-series), page 779.
The reagent probe is damaged. Replace the reagent probes (c-series), page 832.
1096 Alinity ci-series Operations Manual
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Troubleshooting
Section 10 Message codes
Probable cause Corrective action
The reagent cartridge level is low or empty. Load cartridges on the reagent and sample manager
(RSM), page 527.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3427
R2 aspiration error at position (0).
0 = Position
Probable cause Corrective action
The reagent probe tubing connections are loose or Replace the reagent probe tubing (c-series), page 840.
leaking.
Bubbles or foam are present on the surface of the Remove bubbles or foam from the surface of the
reagent. reagent by using a clean applicator stick for each bottle.
The reagent probe is dirty. Perform Fluidics-Wash diagnostic procedure 4208 Probe
and Mixer Wash (c-series), page 783.
The reagent probe is out of alignment. Perform Pipettors diagnostic procedure 4104 R2 Pipettor
Calibration (c-series), page 779.
The reagent probe is damaged. Replace the reagent probes (c-series), page 832.
The reagent cartridge level is low or empty. Load cartridges on the reagent and sample manager
(RSM), page 527.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3428
Unable to process test. R1 aspiration error.
Probable cause Corrective action
Bubbles or foam are present on the surface of the Remove bubbles or foam from the surface of the
reagent. reagent by using a clean applicator stick for each bottle.
The reagent probe is dirty. Perform Fluidics-Wash diagnostic procedure 4208 Probe
and Mixer Wash (c-series), page 783.
The reagent probe is out of alignment. Perform Pipettors diagnostic procedure 4104 R2 Pipettor
Calibration (c-series), page 779.
The reagent probe is damaged. Replace the reagent probes (c-series), page 832.
The reagent cartridge level is low or empty. Load cartridges on the reagent and sample manager
(RSM), page 527.
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Message codes Section 10
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3429
Unable to process test. R2 aspiration error.
Probable cause Corrective action
Bubbles or foam are present on the surface of the Remove bubbles or foam from the surface of the
reagent. reagent by using a clean applicator stick for each bottle.
The reagent probe is dirty. Perform Fluidics-Wash diagnostic procedure 4208 Probe
and Mixer Wash (c-series), page 783.
The reagent probe is out of alignment. Perform Pipettors diagnostic procedure 4104 R2 Pipettor
Calibration (c-series), page 779.
The reagent probe is damaged. Replace the reagent probes (c-series), page 832.
The reagent cartridge level is low or empty. Load cartridges on the reagent and sample manager
(RSM), page 527.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3430
Unable to process test. Sample aspiration error.
Probable cause Corrective action
Bubbles, foam, or fibrin clots are present in the sample. • Remove bubbles or foam by using a clean
disposable pipette or applicator stick.
• Remove fibrin clots by using an applicator stick or
by recentrifuging the sample.
The sample volume in the sample cup or tube is Place adequate sample in the sample cup or tube. See
inadequate. Sample volume requirements, page 423.
The sample probe is out of alignment. Perform Pipettors diagnostic procedure 4102 Sample
Pipettor Calibration (c-series), page 779.
The sample probe is damaged. Replace the sample probe (c-series), page 829.
A drop of liquid is on the side of the sample cup or tube. Transfer the sample to a new sample cup or tube.
A drop of liquid is on the end of the probe. Tighten the tubing connection by hand.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
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Section 10 Message codes
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3431
Wash monitoring communication error on (2).
2 = Board
Probable cause Corrective action
Communication error. Cycle power to the processing module and the reagent
and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3436
ICT reference aspiration check error (0).
0 = Error
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3437
Unable to process test. Liquid contact broken during aspiration for sample pipettor at rack.
Probable cause Corrective action
Bubbles or foam are present on top of the liquid. Remove bubbles or foam from the surface of the
sample by using a clean disposable pipette applicator
stick.
The sample cup or tube is not seated correctly in the Reseat the sample cup or tube in the rack.
rack.
A drop of liquid is on the side of the sample cup or tube. Transfer the sample to a new sample cup or tube.
The sample probe is dirty. Perform Fluidics-Wash diagnostic procedure 4208 Probe
and Mixer Wash (c-series), page 783.
The pipettor cover, the probe screw, or the probe 1. Remove the pipettor cover.
ground wire screw is loose.
2. Tighten the probe screw and the probe ground wire
screw with a slotted screwdriver.
3. Replace the pipettor cover. Ensure the cover is
seated firmly on the end of the pipettor above the
pipettor shaft.
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Message codes Section 10
Probable cause Corrective action
The sample probe is out of alignment. Perform Pipettors diagnostic procedure 4102 Sample
Pipettor Calibration (c-series), page 779.
The sample probe is damaged. Replace the sample probe (c-series), page 829.
The sample probe tubing connections are loose or • Tighten the tubing connections by hand.
leaking. • Replace the sample probe tubing (c-series), page
837.
The water quality is below specifications. Verify that the purified water purity is within
specifications.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3446
Air during aspiration for (0) pipettor in (5) reagent carousel position (3).
0 = Pipettor
3 = Pipetting location
5 = Reagent carousel position
Probable cause Corrective action
The reagent probe tubing connections are loose or • Tighten the reagent probe tubing connections by
leaking. hand.
• Replace the reagent probe tubing (c-series), page
840.
Bubbles or foam are present on the surface of the • Verify that the reagent cartridge sat for an hour
reagent. after the cartridge was mixed before the cartridge
is loaded on the reagent and sample manager.
• Load a new reagent cartridge.
The reagent probe is dirty. Perform Weekly maintenance procedure 2620 Manual
Pipettor Probe Cleaning (i-series), page 769.
The reagent probe is out of alignment. 1. Perform Pipettors diagnostic procedure 1112 R1
Pipettor Check and Calibration (i-series), page 797.
2. Perform Pipettors diagnostic procedure 1113 R2
Pipettor Check and Calibration (i-series), page 797.
The reagent probe is damaged. Replace a sample or reagent pipettor probe (i-series),
page 894.
The reagent cartridge level is low or empty. Load cartridges on the reagent and sample manager
(RSM), page 527.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
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Troubleshooting
Section 10 Message codes
Message code: 3447
Air during aspiration for (0) pipettor in (5) reagent carousel position (3).
0 = Pipettor
3 = Pipetting location
5 = Reagent carousel position
Probable cause Corrective action
The reagent probe tubing connections are loose or • Tighten the reagent probe tubing connections by
leaking. hand.
• Replace the reagent probe tubing (c-series), page
840.
Bubbles or foam are present on the surface of the • Verify that the reagent cartridge sat for an hour
reagent. after the cartridge was mixed before the cartridge
is loaded on the reagent and sample manager.
• Load a new reagent cartridge.
The reagent probe is dirty. Perform Weekly maintenance procedure 2620 Manual
Pipettor Probe Cleaning (i-series), page 769.
The reagent probe is out of alignment. 1. Perform Pipettors diagnostic procedure 1112 R1
Pipettor Check and Calibration (i-series), page 797.
2. Perform Pipettors diagnostic procedure 1113 R2
Pipettor Check and Calibration (i-series), page 797.
The reagent probe is damaged. Replace a sample or reagent pipettor probe (i-series),
page 894.
The reagent cartridge level is low or empty. Load cartridges on the reagent and sample manager
(RSM), page 527.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3448
Pre-Trigger dispense error.
Probable cause Corrective action
The Pre-Trigger Solution dispense volume is inadequate. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3449
Unable to process test. Sample aspiration error.
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Message codes Section 10
Probable cause Corrective action
Bubbles, foam, or fibrin clots are present in the sample. • Remove bubbles or foam by using a clean
disposable pipette or applicator stick.
• Remove fibrin clots by using an applicator stick or
by recentrifuging the sample.
The sample volume in the sample cup or tube is Place adequate sample in the sample cup or tube. See
inadequate. Sample volume requirements, page 423.
The sample cup or tube is not seated correctly in the Ensure that the sample cup or tube is seated correctly
sample rack. in the sample rack.
The sample probe is obstructed. Perform Replace a sample or reagent pipettor probe (i-
series), page 894.
The sample probe is out of alignment. Perform Pipettors diagnostic procedure 1111 Sample
Pipettor Check and Calibration (i-series), page 796.
The sample probe is damaged. Replace a sample or reagent pipettor probe (i-series),
page 894.
The sample probe tubing failed. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3450
(2) dispense monitoring error (0) (1).
0 = Board
1 = Error
2 = Mechanism
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3451
Wash monitoring failed to detect liquid at wash zone (0) position (1). Expected dispensed volume (3).
0 = Wash zone
1 = Position
3 = Expected dispense volume
Probable cause Corrective action
No liquid is present in the reaction vessel at the wash • Repeat the sample that generated the error.
zone. • Perform Fluidics-Wash diagnostic procedure 1221
Wash Zone 1 Precision and Accuracy (i-series),
page 809 or Fluidics-Wash diagnostic procedure
1222 Wash Zone 2 Precision and Accuracy (i-
series), page 809.
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Troubleshooting
Section 10 Message codes
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3452
Wash monitoring failed at wash zone (0) position (1). (3) volume dispensed. Expected volume range (4)
to (5).
0 = Wash zone
1 = Position
3 = Volume dispensed
4 = Expected range
5 = Expected range
Probable cause Corrective action
The wash zone tubing connections are loose or leaking. Reconnect the wash zone tubing to the affected probe
for the indicated wash zone.
A wash zone probe is obstructed. Replace the wash zone probes (i-series), page 897.
The wash zone assembly is not seated correctly. 1. Loosen the knurled screws that secure the wash
zone assembly to the process path cover.
2. Reseat the wash zone assembly.
3. Tighten the knurled screws.
The knurled screws that secure the wash zone assembly 1. Tighten the four knurled screws that secure the
to the process path are loose. wash zone elevator assembly to the process path.
2. Tighten the two knurled screws that secure the
wash zone assembly to the wash zone elevator
assembly.
A wash zone probe is out of alignment. Remove the wash zone probe. Realign the wash zone
probe in the wash zone probe housing. Perform Replace
the wash zone probes (i-series), page 897.
The wash monitoring system is not calibrated. Perform the Calibration and Test option of Fluidics-
Wash diagnostic procedure 1261 Wash Zone 1 Wash
Monitoring (i-series), page 813 or 1262 Wash Zone 2
Wash Monitoring (i-series), page 814.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3453
Wash monitoring failed at wash zone (0) position (1). LLS value (3) below expected value (4).
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Troubleshooting
Message codes Section 10
0 = Wash zone
1 = Position
3 = LLS valve
4 = Expected value
Probable cause Corrective action
The wash zone tubing connections are loose or leaking. Reconnect the wash zone tubing to the affected probe
for the indicated wash zone.
A wash zone probe is obstructed. Replace the wash zone probes (i-series), page 897.
The wash monitoring system is not calibrated. Perform the Calibration and Test option of Fluidics-
Wash diagnostic procedure 1261 Wash Zone 1 Wash
Monitoring (i-series), page 813 or 1262 Wash Zone 2
Wash Monitoring (i-series), page 814.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3454
(0) pipettor trigger dispense error.
0 = Pipettor
Probable cause Corrective action
The Trigger Solution dispense volume is inadequate. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3455
(0) dispense error.
0 = Mechanism
Probable cause Corrective action
Dispense error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3456
Wash monitoring failed at wash zone (0) probe (1).
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Troubleshooting
Section 10 Message codes
0 = Wash zone
1 = Probe
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3457
(0) pipettor trigger wash error.
0 = Pipettor
Probable cause Corrective action
Pipettor trigger wash error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3458
Maximum number of consecutive wash monitoring errors at wash zone (0) exceeded.
0 = Wash zone
Probable cause Corrective action
The tubing is connected incorrectly to the wash zone Reconnect the tubing to the affected probes for the
probes. indicated wash zone.
A wash zone probe is obstructed. Replace the wash zone probes (i-series), page 897.
The wash zone assembly is not seated correctly. 1. Loosen the knurled screws that secure the wash
zone assembly to the process path cover.
2. Reseat the wash zone assembly.
3. Tighten the knurled screws.
The knurled screws that secure the wash zone assembly 1. Tighten the four knurled screws that secure the
to the process path are loose. wash zone elevator assembly to the process path.
2. Tighten the two knurled screws that secure the
wash zone assembly to the wash zone elevator
assembly.
A wash zone probe is out of alignment. Remove the wash zone probe. Realign the wash zone
probe in the wash zone probe housing. Perform Replace
the wash zone probes (i-series), page 897.
The wash monitoring system is not calibrated. Perform the Calibration and Test option of Fluidics-
Wash diagnostic procedure 1261 Wash Zone 1 Wash
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Message codes Section 10
Probable cause Corrective action
Monitoring (i-series), page 813 or 1262 Wash Zone 2
Wash Monitoring (i-series), page 814.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3459
Unable to process test. Aspiration error for (0) pipettor in (5).
0 = Pipettor
1 = Location
Probable cause Corrective action
A sample cup or tube is not present. Verify that a sample cup or tube is present.
The sample volume in the sample cup or tube is Place adequate sample in the sample cup or tube. See
inadequate. Sample volume requirements, page 423.
Bubbles, foam, or fibrin clots are present in the sample. Remove bubbles, foam, or fibrin clots by using a clean
disposable pipette or applicator stick.
A drop of liquid is present on the side of the sample cup Transfer the sample to a new sample cup or tube.
or tube.
A drop of liquid is present on the end of the probe. Tighten the probe tubing connections by hand.
The sample probe is out of alignment. Perform Pipettors diagnostic procedure 1111 Sample
Pipettor Check and Calibration (i-series), page 796.
The sample probe is damaged. Replace the sample probe. Perform Replace a sample or
reagent pipettor probe (i-series), page 894.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3460
Aspiration error for sample at (0).
0 = Pipetting location
Probable cause Corrective action
Bubbles or foam are present on the top of the liquid. Remove bubbles or foam from the surface of the
sample by using a clean disposable pipette or applicator
stick.
The sample volume in the sample cup or tube was Place adequate sample in the sample cup or tube.
inadequate.
The sample cup or tube is tilted in the rack. Reposition the sample cup or tube in the rack.
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Section 10 Message codes
Probable cause Corrective action
A sample probe is out of alignment. Perform Pipettors diagnostic procedure 4102 Sample
Pipettor Calibration (c-series), page 779.
A sample probe is damaged. Replace the sample probe (c-series), page 829.
A drop of liquid is present on the side of the sample cup Transfer the sample to a new sample cup or tube.
or tube.
A drop of liquid is present on the end of the probe. Tighten the sample tubing connection by hand.
Hardware failure: Contact Customer Service to resolve any hardware
• The pressure monitoring (PM) sensor is defective. failure.
• The PM sensor cable is disconnected.
• The PM board is defective.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3461
Unable to process test. Pressure monitoring error detected during the sample aspiration.
Probable cause Corrective action
Bubbles or foam are present on the top of the liquid. Remove bubbles or foam from the surface of the
sample by using a clean disposable pipette or applicator
stick.
The sample volume in the sample cup or tube was Place adequate sample in the sample cup or tube. See
inadequate. Sample volume requirements, page 423.
A drop of liquid is present on the side of the sample cup Transfer the sample to a new sample cup or tube.
or tube.
A drop of liquid is present on the end of the probe. Tighten the probe fitting for the tubing by hand.
A sample probe is out of alignment. Perform Pipettors diagnostic procedure 1111 Sample
Pipettor Check and Calibration (i-series), page 796.
A probe is damaged. Replace a sample or reagent pipettor probe (i-series),
page 894.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3462
Automatic probe wash failed for sample or R1 probe during aspiration.
Probable cause Corrective action
The onboard wash solutions are empty or insufficient. Verify that adequate onboard solutions are loaded.
Perform Verify the supply and waste inventory, page 508
and Verify the reagent carousel inventory, page 547.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
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Message codes Section 10
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3463
Automatic probe wash failed for R2 probe during aspiration.
Probable cause Corrective action
The onboard wash solutions are empty or insufficient. Verify that adequate onboard solutions are loaded.
Perform Verify the reagent carousel inventory, page 547.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3601
Low concentration waste tank full.
Probable cause Corrective action
The drainage tubing or the overflow tubing is crimped. Reposition the drainage tubing or the overflow tubing so
that it is not crimped.
The waste tubing is too high. Adjust the waste tubing so it is less than 100 mm (4 in.)
from the ground.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3603
(0) transfer error.
0 = Bulk solution
Probable cause Corrective action
Hardware failure. • Review the specific message text. Perform the
corrective action for the specific message text.
• Contact Customer Service to resolve any hardware
failure.
Software error. If the error continues, contact Customer Service. Provide
information about the operation that was attempted
when the error occurred.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
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Section 10 Message codes
Message code: 3604
Diluted wash buffer transfer error.
Probable cause Corrective action
The diluted wash buffer level sensor is not connected Reseat the connection to the diluted wash buffer level
correctly. sensor.
The diluted wash buffer tubing is crimped. Reposition the diluted wash buffer tubing so that it is not
crimped.
The diluted wash buffer level sensor is damaged. Contact Customer Service to resolve any hardware
failure.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3605
Fluidics initialization error.
Probable cause Corrective action
Hardware failure. • Review the specific message text. Perform the
corrective action for the specific message text.
• Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3607
(0) failed.
0 = Sensor
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3608
Diluted wash buffer fill failed.
Probable cause Corrective action
Diluted wash buffer fill failure. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
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Message codes Section 10
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3609
Wash buffer dilution assembly flush failed.
Probable cause Corrective action
Wash buffer dilution assembly flush failure. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3610
Wash buffer dilution assembly initialization failed.
Probable cause Corrective action
Wash buffer dilution assembly initialization error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3611
Conductivity error during (0). Conductivity (2) temperature (3).
0 = Fill or flush
2 = Conductivity
3 = Temperature
Probable cause Corrective action
The purified water quality is below specifications. Verify that the purified water purity is within
specifications.
The water temperature is too low. Verify that the water temperature is within specifications.
The water valve is turned off or damaged. Verify that the water valve is turned on and is not
damaged.
The water pressure is too low. Increase the incoming purified water pressure to be
within specifications. See Processing module water and
liquid waste specifications and requirements (i-series),
page 408.
The conductivity sensor failed. Contact Customer Service to resolve any hardware
failure.
The conductivity sensor board failed. Contact Customer Service to resolve any hardware
failure.
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Section 10 Message codes
Probable cause Corrective action
The lower controller board failed. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3612
(0) pipettor flush error.
0 = Pipettor
Probable cause Corrective action
The vacuum accumulator is not seated correctly in the Verify that the vacuum accumulator is seated correctly
drawer. in the drawer.
Communication error. Cycle power to the system, page 428.
The wasted accumulator sensor failed. Contact Customer Service to resolve any hardware
failure.
The sensor float failed. Contact Customer Service to resolve any hardware
failure.
The sensor cable failed. Contact Customer Service to resolve any hardware
failure.
The lower controller board failed. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3613
(0) pipettor flush error.
0 = Pipettor
Probable cause Corrective action
Pipettor flush error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3614
(0) wash error.
0 = Mechanism
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Message codes Section 10
Probable cause Corrective action
Wash error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3615
Wash zone (0) flush failed.
0 = Wash zone
Probable cause Corrective action
Wash zone flush failure. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3616
Waste pump error.
Probable cause Corrective action
Waste pump error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3617
Waste pump high pressure condition detected.
Probable cause Corrective action
The waste line is obstructed. Verify that the waste line is not obstructed.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3618
Bulk solutions transfer error.
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Section 10 Message codes
Probable cause Corrective action
The fluid transfer operation failed. • Update the inventory again on the Supply Status
screen.
• Cycle power to the system, page 428.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3619
(0) flow error detected during transfer.
0 = Bulk solution
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3630
ICT reference filling check error. (0).
0 = Empty or failed
Probable cause Corrective action
The ICT Reference Solution bottle is empty. Replace the ICT Reference Solution bottle. Perform
Replace bulk solutions and update the inventory, page
508.
The ICT Reference Solution tubing is not connected Tighten the tubing connections at the top and at the side
correctly. of each check valve in the ICT Reference Solution
pump.
ICT Reference Solution tubing is crimped or damaged. Ensure the ICT Reference Solution tubing is not crimped
or damaged.
The ICT check valves are not connected correctly. Tighten the connections to the 1 mL syringes in the ICT
Reference Solution pump.
The ICT check valves are not functioning. Replace the check valves (c-series), page 868.
The 1 mL syringes in the ICT Reference Solution pump Reseat the 1 mL syringes.
are not seated correctly.
The 1 mL syringes in the ICT Reference Solution pump Replace the 1 mL syringes (c-series), page 865.
are leaking.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
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Message codes Section 10
Message code: 3631
Unexpected sensor status for internal water tank.
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3640
Flush failed.
Probable cause Corrective action
Flush failure. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3641
(0) fluidics error.
0 = Mechanism
Probable cause Corrective action
Fluidics error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3642
(0) fluidics error.
0 = Mechanism
Probable cause Corrective action
Fluidics error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
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Section 10 Message codes
Message code: 3643
Waste pressure sensor error.
Probable cause Corrective action
Water pressure sensor error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3644
Conductivity temperature sensor failed. Temperature (1). Range (2) to (3).
1 = Temperature
2 = Expected range
3 = Expected range
Probable cause Corrective action
The conductivity sensor connection failed. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3645
Conductivity sensor failed. Conductivity (1) corrected conductivity (2) temperature (3). Range (4) to (5).
1 = Conductivity
2 = Corrected conductivity
3 = Temperature
4 = Expected range
5 = Expected range
Probable cause Corrective action
The conductivity sensor connection failed. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3646
Conductivity sensor failed. Conductivity (1) corrected conductivity (2) temperature (3). Range (4) to (5).
1 = Conductivity
2 = Corrected conductivity
3 = Temperature
4 = Expected range
5 = Expected range
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Message codes Section 10
Probable cause Corrective action
The conductivity sensor connection failed. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3647
(0) transfer too slow.
0 = Bulk solution
Probable cause Corrective action
The tubing connections are loose, leaking, or crimped. Tighten the tubing connections. Perform Replace the
level sensor for Pre-Trigger Solution, Trigger Solution, or
Concentrated Wash Buffer (i-series), page 906.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3648
(0) fluid transfer failed on module (1).
0 = Bulk solution
1 = Module
Probable cause Corrective action
The bulk solution bottle is empty. Verify that the bulk solution bottle in the door is seated
correctly and has enough fluid for a full transfer.
Perform Replace bulk solutions and update the inventory,
page 508.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3650
(0) pipettor failed to aspirate wash buffer.
0 = Pipettor
Probable cause Corrective action
A hardware error occurred. The pipettor is unable to Additional messages that are associated with this
aspirate wash buffer. message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
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Section 10 Message codes
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3651
(0) reservoir filling process failed.
0 = Bulk solution reservoir
Probable cause Corrective action
The fluid transfer failed. Verify that the bulk solution bottle on the door is seated
correctly and has enough fluid for a full transfer.
Replace bulk solutions and update the inventory, page
508.
The level sensor connections are loose. Verify that the reservoir level sensor connections are
functioning correctly.
The level sensor is damaged. • Replace the level sensor if it is cracked or leaking.
• Start the processing module and the reagent and
sample manager (RSM), page 447. Repeat the
transfer.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3652
(0) reservoir partially filled.
0 = Bulk solution reservoir
Probable cause Corrective action
The fluid transfer failed. Verify that the bulk solution bottle on the door is seated
correctly and has enough fluid for a full transfer.
Replace bulk solutions and update the inventory, page
508.
The level sensor connections are loose. Verify that the reservoir level sensor connections are
functioning correctly.
The level sensor is damaged. • Replace the level sensor if it is cracked or leaking.
• Start the processing module and the reagent and
sample manager (RSM), page 447. Repeat the
transfer.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
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Message codes Section 10
Message code: 3653
Conductivity out of range during (0). Conductivity (1) corrected conductivity (2) temperature (3). Range
(4)-(5).
0 = Flush or reconstitution
1 = Conductivity value
2 = Corrected conductivity value
3 = Temperature
4 = Low range
5 = High range
Probable cause Corrective action
The Concentrated Wash Buffer bottle in the door is Replace the Concentrated Wash Buffer bottle and
empty. update the inventory. Perform Replace bulk solutions
and update the inventory, page 508.
The Concentrated Wash Buffer tubing from the Reposition the wash buffer tubing so that it is not
Concentrated Wash Buffer reservoir to the syringe pump crimped or obstructed. Perform Replace the level sensor
is crimped. for Pre-Trigger Solution, Trigger Solution, or
Concentrated Wash Buffer (i-series), page 906.
The purified water line is turned off. Verify that the purified water line is turned on.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3654
Accumulator low sensor not detecting fluid.
Probable cause Corrective action
Hardware failure. • Review the message history log for errors that
occurred at the same time as this message.
Perform corrective actions for the specific message
text.
• Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3655
Vacuum and waste accumulator not draining in expected time.
Probable cause Corrective action
Hardware failure. • Review the message history log for errors that
occurred at the same time as this message.
Perform corrective actions for the specific message
text.
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Section 10 Message codes
Probable cause Corrective action
• Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3656
Automatic probe wash failed for (1).
1 = Sample onboard wash solution
Probable cause Corrective action
The sample probe wash failed. Verify that adequate sample onboard wash solutions
inventory is available and is not expired. Perform Verify
the supply and waste inventory, page 508.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3657
Sample probe wash dispense failed for (1).
1 = Sample onboard wash solution
Probable cause Corrective action
The sample probe wash failed. Verify that adequate sample onboard wash solutions
inventory is available and is not expired. Perform Verify
the supply and waste inventory, page 508.
The sample probe tubing is crimped or obstructed. Perform Replace the sample probe tubing (c-series),
page 837.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3658
Unexpected sensor status for internal water tank.
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
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Message codes Section 10
Message code: 3659
Internal water tank filling error.
Probable cause Corrective action
Maintenance is being performed on the purified water Do not operate the system while the purified water
system. system is undergoing cleaning or maintenance.
The water source supply was interrupted. Verify that the water source is functioning correctly.
Perform Fluidics-Wash diagnostic procedure 4205 Flush
Water Lines (c-series), page 782.
The water source supply is restricted. Verify that the tubing from the water source is not
crimped or obstructed. Perform Fluidics-Wash diagnostic
procedure 4205 Flush Water Lines (c-series), page 782.
The incoming purified water pressure is too low. Increase the incoming purified water pressure to be
within specifications. See Processing module water and
liquid waste specifications and requirements (c-series),
page 407.
Air bubbles are present in the water supply tubing. Verify the tubing connections. Perform Fluidics-Wash
diagnostic procedure 4205 Flush Water Lines (c-series),
page 782.
• The supply water tubing is disconnected. Contact Customer Service to resolve any hardware
• The incoming On/Off valve failed. failure.
• The float sensor is disconnected or defective.
• The AC/DC driver board is defective.
• The AC/DC controller board is defective.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3660
Transfer pump error detected on (2) pump (3).
2 = Board
3 = Pump
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3661
Internal water tank is empty.
Probable cause Corrective action
The water source supply was interrupted. Verify that the purified water system is functioning.
Perform Fluidics-Wash diagnostic procedure 4205 Flush
Water Lines (c-series), page 782.
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Section 10 Message codes
Probable cause Corrective action
The water source supply is obstructed. Verify that the purified water system tubing is not
crimped or obstructed. Perform Fluidics-Wash diagnostic
procedure 4205 Flush Water Lines (c-series), page 782.
The incoming water pressure is too low. Increase the incoming water pressure to within be
specifications. See Processing module characteristics
(c-series), page 392.
The incoming water pressure is too high. Decrease the incoming water pressure to within be
specifications. See Processing module characteristics
(c-series), page 392.
Air bubbles are present in the water source supply. 1. Verify that the purified water system tubing
connections are functioning correctly.
2. Perform Fluidics-Wash diagnostic procedure 4205
Flush Water Lines (c-series), page 782.
Maintenance is being performed on the purified water Do not operate the system while the purified water
system. system is undergoing cleaning or maintenance.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3662
Internal water tank overflow detected.
Probable cause Corrective action
Hardware failure. Contact Customer Service to investigate and resolve the
hardware failures related to the incoming water on/off
valve and the internal water tank float sensor.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3663
Internal water tank failed to fill.
Probable cause Corrective action
The water source supply was interrupted. Verify that the purified water system is functioning.
Perform Fluidics-Wash diagnostic procedure 4205 Flush
Water Lines (c-series), page 782.
The water source supply is obstructed. Verify that the tubing from the purified water system is
not crimped or obstructed. Perform Fluidics-Wash
diagnostic procedure 4205 Flush Water Lines (c-series),
page 782.
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Message codes Section 10
Probable cause Corrective action
The incoming water pressure is too low. Increase the incoming water pressure to within
specifications. See Processing module characteristics
(c-series), page 392.
The incoming water pressure is too high. Decrease the incoming water pressure to within
specifications. See Processing module characteristics
(c-series), page 392.
Air bubbles are present in the water source supply. 1. Verify that the purified water system tubing
connections are functioning correctly.
2. Perform Fluidics-Wash diagnostic procedure 4205
Flush Water Lines (c-series), page 782.
Maintenance is being performed on the purified water Do not operate the system while the purified water
system. system is undergoing cleaning or maintenance.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Message code: 3664
Internal water tank failed to fill to the middle sensor.
Probable cause Corrective action
The water source supply was interrupted. Verify that the purified water system is functioning.
Perform Fluidics-Wash diagnostic procedure 4205 Flush
Water Lines (c-series), page 782.
The water source supply is obstructed. Verify that the purified water system tubing is not
crimped or obstructed. Perform Fluidics-Wash diagnostic
procedure 4205 Flush Water Lines (c-series), page 782.
The incoming water pressure is too low. Increase the incoming water pressure to within be
specifications. See Processing module characteristics
(c-series), page 392.
Air bubbles are present in the water source supply. 1. Verify that the purified water system tubing
connections are functioning correctly.
2. Perform Fluidics-Wash diagnostic procedure 4205
Flush Water Lines (c-series), page 782.
Maintenance is being performed on the purified water Do not operate the system while the purified water
system. system is undergoing cleaning or maintenance.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
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Section 10 Message codes
Message code: 3665
Induction heating error on (2) (3).
2 = Board
3 = Motor
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Level sense and fluidics message codes (3000-3999), page 1068
Optics and bar code reader message codes (4000-4999)
The optics and bar code reader message code category includes message codes from 4000
through 4999.
Related information...
Message codes, page 941
4000, page 1124
4011, page 1124
4012, page 1124
4013, page 1124
4014, page 1125
4015, page 1125
4016, page 1125
4017, page 1125
4018, page 1126
4019, page 1126
4301, page 1126
4308, page 1126
4309, page 1127
4310, page 1127
4311, page 1127
4312, page 1128
4313, page 1128
4314, page 1128
4315, page 1129
4400, page 1129
4401, page 1129
4402, page 1130
Alinity ci-series Operations Manual 1123
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Message codes Section 10
4403, page 1130
4404, page 1130
4405, page 1131
4406, page 1131
4703, page 1131
4704, page 1132
Message code: 4000
Zero read detected.
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4011
Optics read error.
Probable cause Corrective action
Optics read error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4012
Optics initialization error.
Probable cause Corrective action
Optics initialization error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4013
Optics read data retrieval error.
Probable cause Corrective action
Optics read data retrieval error. Additional messages that are associated with this
message can be used to determine the appropriate
1124 Alinity ci-series Operations Manual
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Section 10 Message codes
Probable cause Corrective action
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4014
Optics zero read error.
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4015
Background read error.
Probable cause Corrective action
Background read error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4016
Activated read error.
Probable cause Corrective action
Activated read error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4017
Optics error.
Probable cause Corrective action
Optics error. Additional messages that are associated with this
message can be used to determine the appropriate
Alinity ci-series Operations Manual 1125
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Message codes Section 10
Probable cause Corrective action
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4018
Optics communication error.
Probable cause Corrective action
Optics communication error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4019
Optics check failed during initialization.
Probable cause Corrective action
The optics linearity or the normalization values are not Configure i-series module settings, page 175.
entered correctly on the Module screen for the Alinity i
processing module.
The CMIA reader failed. Contact Customer Service to resolve any hardware
failure.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4301
RSM bar code reader communication error (0).
0 = Communication error
Probable cause Corrective action
Communication error. Cycle power to the system, page 428.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4308
Bar code scan error on rack.
1126 Alinity ci-series Operations Manual
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Troubleshooting
Section 10 Message codes
Probable cause Corrective action
Bar code scan error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4309
Bar code scan error for rack at module (0) position (1).
0 = Module
1 = Position
Probable cause Corrective action
The rack is missing a bar code or the bar code is Reinsert the rack into the reagent and sample manager
damaged. or use a different rack.
The bar code reader is dirty. Clean the RSM bar code reader.
Perform As-Needed maintenance procedure 2920
Manual RSM Transport Cleaning, page 772.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4310
Bar code read error for rack in RSM position (0).
0 = RSM position
Probable cause Corrective action
The rack is missing a bar code or the bar code is Reinsert the rack into the reagent and sample manager
damaged. or use a different rack.
The bar code reader is dirty. Clean the RSM bar code reader.
Perform As-Needed maintenance procedure 2920
Manual RSM Transport Cleaning, page 772.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4311
Unable to read SID bar code in rack ID (0) position (1).
0 = Rack ID
1 = Position
Alinity ci-series Operations Manual 1127
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Message codes Section 10
Probable cause Corrective action
The tube is not correctly positioned in the rack. Place the tube in the rack so the bar code is visible
through the slot.
A bar code is damaged. Use a new bar code.
A bar code parameter configuration error occurred. Change sample bar code settings , page 185.
The RSM bar code reader is dirty. Clean the RSM bar code reader.
The bar code reader failed. Contact Customer Service to resolve any hardware
failure.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4312
Unable to read SID (0) bar code. Bar code contains invalid characters.
0 = SID
Probable cause Corrective action
The sample ID contains an invalid character. Use valid characters only. Valid characters are defined
by Abbott Laboratories as A through Z, a through z, 0
through 9, and special characters.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4313
Unable to process test. SID (0) does not match bar code (1) in rack ID (2) position (3).
0 = SID
1 = Bar code
2 = Rack ID
3 = Position
Probable cause Corrective action
The SID in the rack and position does not match the SID Load the tube with the correct SID in the rack and
in the order. position.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4314
Unable to load reagent cartridge in RSM position (0). Bar code label cannot be read.
0 = Reagent carousel position
Probable cause Corrective action
The reagent bottle bar code label is dirty. Clean the bar code label.
The reagent bottle bar code label is damaged. Load a new reagent cartridge. Perform Load cartridges
on the reagent and sample manager (RSM), page 527.
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Section 10 Message codes
Probable cause Corrective action
The bar code reader is dirty. Clean the bar code reader. Perform Reagent and
Sample Manager (RSM) maintenance procedure 2920
Manual RSM Transport Cleaning, page 772.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4315
Reagent cartridge scanned in RSM position (0) is already loaded on the reagent carousel at position (1).
0 = RSM position
1 = Reagent carousel position
Probable cause Corrective action
A reagent cartridge with the same bar code is already Load a new reagent cartridge. Perform Load cartridges
loaded on the reagent carousel. on the reagent and sample manager (RSM), page 527.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4400
Unable to process test. Lamp failed.
Probable cause Corrective action
The lamp was not seated correctly when it was Repeat Replace the lamp or the lamp plate (c-series),
replaced. page 844. Perform Quarterly maintenance procedure
5806 Change Lamp (c-series), page 764:
• Ensure that the lamp is seated correctly against the
lamp plate and in the lamp housing.
• Ensure that the lamp cables are secured by the
screws to the lamp terminal block.
The lamp is not performing as expected. Replace the lamp or the lamp plate (c-series), page 844.
Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4401
Optics system error. (0).
0 = Optics error
Alinity ci-series Operations Manual 1129
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Message codes Section 10
Probable cause Corrective action
The lamp was not seated correctly when it was Repeat Replace the lamp or the lamp plate (c-series),
replaced. page 844. Perform Quarterly maintenance procedure
5806 Change Lamp (c-series), page 764:
• Ensure that the lamp is seated correctly against the
lamp plate and in the lamp housing.
• Ensure that the lamp cables are secured by the
screws to the lamp terminal block.
The lamp is not performing as expected. Replace the lamp or the lamp plate (c-series), page 844.
Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
The water bath level is low. Perform Reaction Mechanisms diagnostic procedure
5005 Exchange Water in Bath (c-series), page 791.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4402
Optics trigger sensor error.
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4403
Optics system warning. Fluctuation detected.
Probable cause Corrective action
The lamp was not seated correctly when it was Repeat Quarterly maintenance procedure 5806 Change
replaced. Lamp (c-series), page 764.
The lamp is not performing as expected. Replace the lamp or the lamp plate (c-series), page 844.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4404
Optics system failed. Fluctuation above maximum range.
1130 Alinity ci-series Operations Manual
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Troubleshooting
Section 10 Message codes
Probable cause Corrective action
The lamp was not seated correctly when it was Repeat Quarterly maintenance procedure 5806 Change
replaced. Lamp (c-series), page 764.
The lamp is not performing as expected. Replace the lamp or the lamp plate (c-series), page 844.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4405
ADC over range at lamp check. (0).
0 = ADC error
Probable cause Corrective action
The lamp was not seated correctly when it was Repeat Quarterly maintenance procedure 5806 Change
replaced. Lamp (c-series), page 764.
The lamp is not performing as expected. Replace the lamp or the lamp plate (c-series), page 844.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4406
Optics system error. Lamp intensity too high.
Probable cause Corrective action
The lamp was not seated correctly when it was Repeat Quarterly maintenance procedure 5806 Change
replaced. Lamp (c-series), page 764.
The lamp is not performing as expected. Replace the lamp or the lamp plate (c-series), page 844.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4703
Cuvette integrity check failed on cuvette (0).
0 = Cuvette number
Probable cause Corrective action
The cuvettes are dirty. Clean the cuvettes. Perform Weekly Maintenance
procedure 5601 Clean Cuvettes with Detergent A (c-
series), page 760.
Alinity ci-series Operations Manual 1131
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Troubleshooting
Message codes Section 10
Probable cause Corrective action
The cuvette is damaged. Replace the cuvette segment. Perform Replace the
cuvette segments (c-series), page 848
The lamp was not seated correctly when it was Perform Quarterly maintenance procedure 5806 Change
replaced. Lamp (c-series), page 764:
• Ensure that the lamp is seated correctly against the
lamp plate and in the housing.
• Ensure that the lamp cables are secured by the
screws in terminal block.
The lamp is not performing as expected. Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
The water or wash solutions are not aspirated or Clean cuvette washer nozzles.
dispensed correctly into the reaction cuvettes.
Bubbles are present in the water bath incubator because Decrease the incoming purified water pressure to be
of the pressure of the incoming water. within specifications. See Processing module water and
liquid waste specifications and requirements (c-series),
page 407.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Message code: 4704
DAQ board failed.
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Optics and bar code reader message codes (4000-4999), page 1123
Robotics and sensor message codes (5000-5999)
The robotics and sensor message code category includes message codes from 5000 through
5999.
Related information...
Message codes, page 941
5006, page 1138
5007, page 1138
5008, page 1139
5009, page 1139
1132 Alinity ci-series Operations Manual
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Section 10 Message codes
5010, page 1139
5013, page 1140
5014, page 1140
5015, page 1140
5016, page 1140
5017, page 1141
5018, page 1141
5019, page 1141
5020, page 1141
5021, page 1142
5022, page 1142
5110, page 1142
5111, page 1143
5112, page 1143
5113, page 1144
5114, page 1144
5115, page 1144
5116, page 1144
5117, page 1145
5119, page 1145
5125, page 1145
5126, page 1145
5127, page 1146
5128, page 1146
5129, page 1146
5130, page 1146
5131, page 1147
5132, page 1147
5133, page 1147
5210, page 1148
5211, page 1148
5212, page 1148
5213, page 1149
5214, page 1149
5215, page 1149
5216, page 1149
5217, page 1150
5218, page 1150
5219, page 1150
Alinity ci-series Operations Manual 1133
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Message codes Section 10
5220, page 1150
5221, page 1151
5222, page 1151
5223, page 1151
5224, page 1152
5225, page 1152
5228, page 1152
5229, page 1152
5230, page 1153
5231, page 1153
5232, page 1153
5306, page 1154
5307, page 1154
5308, page 1154
5309, page 1154
5310, page 1155
5311, page 1155
5500, page 1155
5501, page 1155
5502, page 1156
5648, page 1156
5649, page 1156
5650, page 1157
5651, page 1158
5652, page 1158
5653, page 1158
5654, page 1159
5655, page 1159
5656, page 1159
5657, page 1160
5658, page 1160
5659, page 1160
5660, page 1161
5661, page 1161
5662, page 1161
5663, page 1162
5664, page 1162
5665, page 1162
5666, page 1162
1134 Alinity ci-series Operations Manual
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Section 10 Message codes
5667, page 1163
5668, page 1163
5669, page 1163
5670, page 1163
5671, page 1164
5672, page 1164
5673, page 1164
5674, page 1165
5675, page 1165
5676, page 1165
5677, page 1166
5678, page 1166
5679, page 1166
5680, page 1166
5681, page 1167
5682, page 1167
5683, page 1167
5684, page 1167
5685, page 1168
5686, page 1168
5687, page 1168
5688, page 1168
5689, page 1169
5690, page 1169
5691, page 1169
5692, page 1170
5693, page 1170
5694, page 1170
5695, page 1170
5696, page 1171
5697, page 1171
5698, page 1172
5722, page 1172
5723, page 1172
5724, page 1173
5725, page 1173
5726, page 1173
5727, page 1173
5728, page 1173
Alinity ci-series Operations Manual 1135
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Troubleshooting
Message codes Section 10
5729, page 1174
5731, page 1174
5732, page 1174
5733, page 1174
5734, page 1175
5735, page 1175
5736, page 1175
5744, page 1175
5745, page 1176
5747, page 1176
5748, page 1177
5749, page 1177
5750, page 1177
5751, page 1177
5752, page 1178
5753, page 1178
5754, page 1178
5755, page 1179
5756, page 1179
5757, page 1179
5758, page 1179
5759, page 1180
5760, page 1180
5761, page 1180
5762, page 1180
5763, page 1181
5764, page 1181
5765, page 1181
5766, page 1181
5767, page 1182
5768, page 1182
5769, page 1182
5770, page 1182
5771, page 1183
5772, page 1183
5773, page 1183
5774, page 1184
5775, page 1184
5776, page 1184
1136 Alinity ci-series Operations Manual
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Troubleshooting
Section 10 Message codes
5777, page 1184
5778, page 1185
5779, page 1185
5780, page 1185
5781, page 1185
5782, page 1186
5783, page 1186
5784, page 1186
5785, page 1186
5786, page 1187
5787, page 1187
5788, page 1187
5789, page 1187
5790, page 1188
5791, page 1188
5792, page 1189
5793, page 1189
5794, page 1189
5795, page 1189
5796, page 1190
5797, page 1190
5798, page 1190
5799, page 1191
5800, page 1191
5801, page 1191
5802, page 1192
5803, page 1192
5804, page 1192
5805, page 1193
5806, page 1193
5807, page 1193
5808, page 1194
5809, page 1194
5810, page 1194
5811, page 1195
5812, page 1195
5813, page 1195
5814, page 1196
5815, page 1196
Alinity ci-series Operations Manual 1137
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Troubleshooting
Message codes Section 10
5816, page 1196
5817, page 1197
5818, page 1197
5819, page 1197
5820, page 1198
5821, page 1198
5822, page 1198
5823, page 1198
5824, page 1199
5825, page 1199
5826, page 1199
5827, page 1199
5828, page 1200
5829, page 1200
5830, page 1200
5831, page 1200
5832, page 1201
5833, page 1201
Message code: 5006
RSM transport theta motor failed.
Probable cause Corrective action
An error was detected with the RSM transport. Cycle power to the processing module and the reagent
and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5007
(0) servo drive error (1).
0 = Motor
1 = Motor error
Probable cause Corrective action
An error was detected with a servo drive motor. Cycle power to the processing module and the reagent
and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
1138 Alinity ci-series Operations Manual
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Troubleshooting
Section 10 Message codes
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5008
(0) motor communications error (1) (2).
0 = Motor
1 = Driver error
2 = Driver error number
Probable cause Corrective action
An error occurred with motor communications. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5009
(0) servo drive error (1) (2).
0 = Motor
1 = Driver error
2 = Driver error number
Probable cause Corrective action
An error was detected with the servo driver. Cycle power to the processing module and the reagent
and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5010
Step loss detected on wash zone (0).
0 = Wash zone
Probable cause Corrective action
A physical obstruction is blocking the movement of the Locate and remove any physical obstruction.
wash zone.
The wash zone probes are out of alignment. Remove the wash zone probes and realign the probes in
the wash zone probe housing. Perform Replace the
wash zone probes (i-series), page 897.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Alinity ci-series Operations Manual 1139
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Troubleshooting
Message codes Section 10
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5013
(0) motor error.
0 = Motor
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5014
(0) servo motor error.
0 = Motor
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5015
(0) concurrency error.
0 = Motor
Probable cause Corrective action
An error was detected during motor movement. Cycle power to the processing module and the reagent
and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5016
(0) error during homing.
0 = Motor
Probable cause Corrective action
An error was detected during motor movement. Cycle power to the processing module and the reagent
and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
1140 Alinity ci-series Operations Manual
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Troubleshooting
Section 10 Message codes
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5017
(0) time-out error.
0 = Motor
Probable cause Corrective action
An error was detected during motor movement. Cycle power to the processing module and the reagent
and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5018
Number of specified pulses for (0) motor out of range.
0 = Motor
Probable cause Corrective action
An error was detected during motor movement. Cycle power to the processing module and the reagent
and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5019
(0) sensor error.
0 = Sensor
Probable cause Corrective action
An error was detected during motor movement. Cycle power to the processing module and the reagent
and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5020
(0) movement error.
0 = Motor
Alinity ci-series Operations Manual 1141
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Troubleshooting
Message codes Section 10
Probable cause Corrective action
An error was detected during motor movement. Cycle power to the processing module and the reagent
and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5021
(0) drive starting status error.
0 = Motor
Probable cause Corrective action
An error was detected during motor movement. Cycle power to the processing module and the reagent
and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5022
(0) controller failed.
0 = Motor
Probable cause Corrective action
An error was detected during motor movement. Cycle power to the processing module and the reagent
and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5110
Water bath level low.
Probable cause Corrective action
The system power is off. 1. Power on the processing module, page 436 or
Power on the reagent and sample manager (RSM),
page 444.
2. Fill the water bath. Perform either 5501 Daily
Maintenance (c-series), page 759 or Reaction
mechanism diagnostic procedure 5005 Exchange
Water in Bath (c-series), page 791.
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Section 10 Message codes
Probable cause Corrective action
The water source supply was interrupted. 1. Verify that the water source supply is functioning.
2. Perform 4205 Flush Water Lines (c-series), page
782.
The pressure of the incoming purified water is too low. Increase the incoming purified water pressure to be
within specifications. See Processing module water and
liquid waste specifications and requirements (c-series),
page 407.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5111
Cuvette washer upper limit not found.
Probable cause Corrective action
A physical obstruction is blocking the movement of the Look for and remove any physical obstructions.
cuvette washer.
The black knob that holds the cuvette washer is loose. Tighten the black knob.
The dry tip of the cuvette washer is not aligned Align the cuvette dry tip. Perform Replace the cuvette
correctly. dry tip (c-series), page 852.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5112
Cuvette washer lower limit not found.
Probable cause Corrective action
A physical obstruction is blocking the movement of the Look for and remove any physical obstructions.
cuvette washer.
The black knob that holds the cuvette washer is loose. Tighten the black knob.
The dry tip of the cuvette washer is not aligned Align the cuvette dry tip. Perform Replace the cuvette
correctly. dry tip (c-series), page 852.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
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Message code: 5113
No RV detected in process path. Processing module status Stopped.
Probable cause Corrective action
The reaction vessel was not detected on the process Contact Customer Service to resolve any hardware
path during initialization. failure.
The RV sensor is dirty or defective. Contact Customer Service to resolve any hardware
failure.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5114
No reagent cartridge or rack detected at reagent carousel position (0).
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5115
(0) pick sensor failed.
0 = Sensor
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5116
No reagent cartridge or rack detected on module (0) position (1).
0 = Module
1 = Position
Probable cause Corrective action
The rack or reagent cartridge was inserted incorrectly. Insert the rack or reagent cartridge correctly.
The rack or reagent cartridge is damaged. Replace the rack or reagent cartridge.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
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Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5117
Reagent transport pick sensor failed.
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5119
(0) sensor failed.
0 = Sensor
Probable cause Corrective action
Communication error. Cycle power to the system, page 428.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5125
Reagent transport sensor error.
Probable cause Corrective action
The reagent transport sensor is dirty. Use a cotton swab and purified water to clean the
reagent transport sensors that are located on the
reagent transport picker head.
The reagent transport sensor failed. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5126
Shutter sensor error. Shutter open sensor status (0) shutter close sensor status (1).
0 = Open sensor status
1 = Closed sensor status
Probable cause Corrective action
Shutter sensor failure. Cycle power to the processing module and the reagent
and sample manager (RSM), page 432.
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Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5127
Reagent transport cartridge present sensor error during initialization.
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5128
(0) board (1) sensor failed.
0 = Board
1 = Sensor
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5129
Unable to load reagent cartridge or rack in reagent carousel. Reagent carousel sensor error at position
(0).
0 = Reagent carousel position
Probable cause Corrective action
The RSM transport is unable to load the reagent Perform Reagent Manager diagnostic procedure 4703
cartridge after several attempts because of a sensor Reagent Supply Center Test (c-series), page 786.
error.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5130
Unable to load reagent cartridge or rack in reagent carousel position (0). Reagent transport pick sensor
error.
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0 = Reagent carousel position
Probable cause Corrective action
The RSM transport is unable to load the reagent Perform Reagent Manager diagnostic procedure 4703
cartridge after several attempts because of a sensor Reagent Supply Center Test (c-series), page 786.
error.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5131
Unable to load reagent cartridge or rack in reagent carousel. Latch sensor error at position (0).
0 = Reagent carousel position
Probable cause Corrective action
The RSM transport is unable to load the reagent Perform Reagent Manager diagnostic procedure 4703
cartridge after several attempts because of a sensor Reagent Supply Center Test (c-series), page 786.
error.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5132
Unable to unload reagent cartridge or rack from reagent carousel position (0). Latch sensor error.
0 = Reagent carousel position
Probable cause Corrective action
The RSM transport is unable to load the reagent Perform Reagent Manager diagnostic procedure 4703
cartridge after several attempts because of a sensor Reagent Supply Center Test (c-series), page 786.
error.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5133
Unable to unload reagent cartridge or rack from reagent carousel position (0). Reagent transport pick
sensor error.
0 = Reagent carousel position
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Probable cause Corrective action
The RSM transport is unable to load the reagent Perform Reagent Manager diagnostic procedure 4703
cartridge after several attempts because of a sensor Reagent Supply Center Test (c-series), page 786.
error.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5210
Memory check error on (0) board.
0 = Board
Probable cause Corrective action
A communication failure with the CPU board has Cycle power to the processing module and the reagent
occurred. and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5211
(0) Ethernet error.
0 = Board
Probable cause Corrective action
Communication error. Cycle power to the system, page 428.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5212
POST error on processing module. (0) (1).
0 = Board
1 = Board status
Probable cause Corrective action
A communication failure with the PM board has Cycle power to the processing module and the reagent
occurred. and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
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Section 10 Message codes
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5213
Analog channel error on (2) (3).
2 = Sensor
3 = Board
Probable cause Corrective action
Communication error. Cycle power to the system, page 428.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5214
Wash buffer dilution assembly error on lower controller board.
Probable cause Corrective action
Communication error. Cycle power to the system, page 428.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5215
Initialization error on (2) (3).
2 = Motor
3 = Board
Probable cause Corrective action
Communication error. Cycle power to the system, page 428.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5216
Board configuration error on (2).
2 = Board
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Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5217
Power up error on (2).
2 = Board
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5218
Vortexer error on (2) (3).
2 = Motor
3 = Board
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5219
Error on (2) LED (3).
2 = Board
3 = LED number
Probable cause Corrective action
Hardware failure. • Cycle power to the processing module and the
reagent and sample manager (RSM), page 432.
• Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5220
LLS command error on (2).
2 = Board
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Section 10 Message codes
Probable cause Corrective action
Hardware failure. • Cycle power to the processing module and the
reagent and sample manager (RSM), page 432.
• Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5221
Motor error on (2) (3).
2 = Motor
3 = Board
Probable cause Corrective action
Communication error. • Cycle power to the system, page 428.
• Contact Customer Service to resolve any hardware
failure.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5222
Status error on (2) (3).
2 = Motor
3 = Board
Probable cause Corrective action
Communication error. • Cycle power to the system, page 428.
• Contact Customer Service to resolve any hardware
failure.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5223
Optics command error temp-optics board.
Probable cause Corrective action
Hardware failure. • Cycle power to the system, page 428.
• Contact Customer Service to resolve any hardware
failure.
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Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5224
Motor settings error on (2) (3).
2 = Motor
3 = Board
Probable cause Corrective action
Hardware failure. • Cycle power to the system, page 428.
• Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5225
Storage media error.
Probable cause Corrective action
A communication failure with the CPU board has • Cycle power to the system, page 428.
occurred. • Contact Customer Service to resolve any hardware
failure.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5228
(0) board firmware error (1) (2).
0 = Board
1 = Board Error
2 = Error
Probable cause Corrective action
An error occurred with the firmware on the specified Additional messages that are associated with this
board. message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5229
Board communication error.
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Section 10 Message codes
Probable cause Corrective action
A communication error occurred with a board. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5230
Board failed during POST.
Probable cause Corrective action
The initialization of the processing module failed. Cycle power to the processing module and the reagent
and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5231
PHM error (0) (1) detected on control board.
0 = PHM error
1 = PHM error
Probable cause Corrective action
A hardware error was detected on a control board. If the error continues, contact Customer Service. Provide
information about the operation that was attempted
NOTE: Frequent occurrences of this message code may
when the error occurred.
indicate a pending hardware failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5232
(0) offline.
0 = Board
Probable cause Corrective action
The RSM load control board is Offline. Cycle power to the specified module. Perform Cycle
power to the processing module and the reagent and
sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
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Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5306
(0) vortexer did not disengage from RV.
0 = Vortexer
Probable cause Corrective action
• The cable for the specified vortexer had a failed or Contact Customer Service to resolve any hardware
poor connection. failure.
• The vortexer is not in the specified position.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5307
(0) vortexer did not engage with RV.
0 = Vortexer
Probable cause Corrective action
• The cable for the specified vortexer had a failed or Contact Customer Service to resolve any hardware
poor connection. failure.
• The vortexer is not in the specified position.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5308
(0) vortexer mixing error.
0 = Vortexer
Probable cause Corrective action
Hardware failure. Additional messages can be associated with this
message to determine the appropriate corrective action.
View additional messages that are associated with a
message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5309
(0) vortexer did not reach required speed.
0 = Vortexer
Probable cause Corrective action
• The cable for the specified vortexer had a failed or Contact Customer Service to resolve any hardware
poor connection. failure.
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Probable cause Corrective action
• The vortexer is not in the specified position.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5310
(0) vortexer initialization failed.
0 = Vortexer
Probable cause Corrective action
The vortexer failed to initialize. Additional messages can be associated with this
message to determine the appropriate corrective action.
View additional messages that are associated with a
message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5311
Maximum number of consecutive mixing errors exceeded for (0) vortexer.
0 = Vortexer
Probable cause Corrective action
The vortexer failed. • Verify that the cable for the specified vortexer is
correctly connected.
• Perform Process Path diagnostic procedure 1510
Vortexer Test (i-series), page 818.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5500
(0) diverter failed.
0 = Diverter
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5501
(0) diverter error. Diverter did not return to rest position.
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0 = Diverter
Probable cause Corrective action
The diverter failed. Start the processing module and the reagent and sample
manager (RSM), page 447. Perform Process Path
diagnostic procedure 1505 Diverter Test (i-series), page
817.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5502
(0) diverter error. Diverter did not move to active position.
0 = Diverter
Probable cause Corrective action
The diverter failed. Start the processing module and the reagent and sample
manager (RSM), page 447. Perform Process Path
diagnostic procedure 1505 Diverter Test (i-series), page
817.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5648
Water bath drain error. (0).
0 = Drain error
Probable cause Corrective action
The water bath drain tubing is crimped. Reposition the water bath drain tubing so that the tubing
is not crimped.
The external drain is obstructed. Remove the obstruction from the external drain.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5649
Water bath fill time exceeded.
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Section 10 Message codes
Probable cause Corrective action
The water source supply was interrupted. 1. Verify that the water source supply is functioning.
2. Perform 4205 Flush Water Lines (c-series), page
782.
The water source supply is obstructed. 1. Verify that the tubing from the water source is not
crimped or obstructed.
2. Perform 4205 Flush Water Lines (c-series), page
782.
The pressure of the incoming purified water is too low. Increase the incoming purified water pressure to be
within specifications. See Processing module water and
liquid waste specifications and requirements (c-series),
page 407.
Air bubbles are present in the water supply tubing. 1. Verify the tubing connections.
2. Perform Fluidics-Wash diagnostic procedure 4205
Flush Water Lines (c-series), page 782.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5650
Water bath automatic fill failed.
Probable cause Corrective action
The water source supply was interrupted. 1. Verify that the water source supply is functioning.
2. Perform 4205 Flush Water Lines (c-series), page
782.
The water source supply is obstructed. 1. Verify that the tubing from the water source is not
crimped or obstructed.
2. Perform 4205 Flush Water Lines (c-series), page
782.
The pressure of the incoming purified water is too low. Increase the incoming purified water pressure to be
within specifications. See Processing module water and
liquid waste specifications and requirements (c-series),
page 407.
Air bubbles are present in the water supply tubing. 1. Verify the tubing connections.
2. Perform Fluidics-Wash diagnostic procedure 4205
Flush Water Lines (c-series), page 782.
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Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5651
Cuvette washer movement restricted at position (0) step number (1).
0 = Position
1 = Step number
Probable cause Corrective action
A physical obstruction is blocking the movement of the Look for and remove any physical obstructions.
cuvette washer.
The black knob that holds the cuvette washer is loose. Tighten the black knob.
The dry tip of the cuvette washer is not aligned Align the cuvette dry tip. Perform Replace the cuvette
correctly. dry tip (c-series), page 852.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5652
Reagent carousel load failed. Latch error at position (0).
0 = Reagent carousel position
Probable cause Corrective action
The reagent latch failed on the reagent carousel. Contact Customer Service to resolve any hardware
error.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5653
Reagent carousel move failed.
Probable cause Corrective action
The reagent carousel move failed on the reagent Contact Customer Service to resolve any hardware
carousel motor. error.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
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Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5654
Reagent carousel monitoring error.
Probable cause Corrective action
An error occurred with the reagent carousel. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5655
RSM transport error on module (0) position (1).
0 = Module
1 = Position
Probable cause Corrective action
The rack transfer failed at the load area. 1. Remove the rack.
2. Reinitialize the reagent and sample manager.
Perform Start the processing module and the
reagent and sample manager (RSM), page 447.
3. Perform Sample Manager diagnostic procedure
1600 RSM Transport Calibration, page 823.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5656
Pick error at sample positioner (0) lane on module (1).
0 = Lane
1 = Module
Probable cause Corrective action
The RSM transport is unable to pick up the rack after 1. Remove the rack from the sample positioner.
several attempts.
2. Reinitialize the reagent and sample manager.
Perform Start the processing module and the
reagent and sample manager (RSM), page 447.
3. Perform Sample Manager diagnostic procedure
1600 RSM Transport Calibration, page 823.
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Message codes Section 10
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5657
Pick error at reagent positioner on module (0).
0 = Module
Probable cause Corrective action
The reagent transport is unable to pick up the reagent Remove the reagent cartridge from the reagent
cartridge from the reagent positioner. positioner and rescan the reagent carousel.
The RSM transport is not calibrated. Perform Sample Manager diagnostic procedure 1600
RSM Transport Calibration, page 823.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5658
Pick error at loading area on module (0) position (1).
0 = Module
1 = Position
Probable cause Corrective action
The rack or reagent cartridge was inserted incorrectly Insert the rack or reagent cartridge correctly.
on the reagent and sample manager.
The rack or reagent cartridge is damaged. Replace the rack or reagent cartridge.
The RSM transport is not calibrated. Perform Sample Manager diagnostic procedure 1600
RSM Transport Calibration, page 823.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5659
Reagent positioner close failed.
Probable cause Corrective action
The reagent positioner is jammed or obstructed. 1. Clear the jam or obstruction.
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Section 10 Message codes
Probable cause Corrective action
2. Cycle power to the processing module and the
reagent and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5660
Reagent positioner open failed.
Probable cause Corrective action
The reagent positioner is jammed or obstructed. Clear the jam or obstruction and reinitialize the reagent
and sample manager.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5661
Reagent cartridge or rack no longer detected on reagent transport.
Probable cause Corrective action
The reagent transport sensor is dirty. Use a cotton swab and purified water to clean the
reagent transport sensors that are located on the
reagent transport picker head.
The reagent transport sensor failed. 1. Remove the rack or reagent cartridge from the
reagent transport.
2. Cycle power to the processing module and the
reagent and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5662
Reagent transport failed to load reagent cartridge or rack in reagent carousel.
Probable cause Corrective action
An error occurred with the reagent transport. Additional messages that are associated with this
message can be used to determine the appropriate
Alinity ci-series Operations Manual 1161
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Message codes Section 10
Probable cause Corrective action
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5663
Reagent cartridge or rack load/unload error detected. Successful recovery performed.
Probable cause Corrective action
An error occurred when a reagent cartridge or rack was Status message. No corrective action is required.
loaded or unloaded.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5664
Reagent transport failed to unload reagent cartridge or rack from reagent carousel.
Probable cause Corrective action
An error occurred when a reagent cartridge or rack was Additional messages that are associated with this
unloaded. message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5665
Reagent carousel dispersion failed.
Probable cause Corrective action
Initialization error. Start the processing module and the reagent and sample
manager (RSM), page 447.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5666
RV loader linear queue error.
Probable cause Corrective action
An error occurred with the RV loader linear queue. Additional messages that are associated with this
message can be used to determine the appropriate
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Probable cause Corrective action
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5667
Pipettor Z motion error.
Probable cause Corrective action
Hardware failure. • Reinitialize the processing module. Perform Start
the processing module and the reagent and sample
manager (RSM), page 447.
• Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5668
(0) pipettor initialization error.
Probable cause Corrective action
Pipettor initialization error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5669
(0) pipettor monitoring error.
Probable cause Corrective action
An error occurred with the pipettor. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5670
Unable to perform load or unload operation due to previous mechanical failure.
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Probable cause Corrective action
A previous hardware failure prevented the loading or 1. Review the message log for messages that
unloading operation to occur. occurred at the same time as this message.
Perform the corrective action.
2. Reinitialize the processing module. Perform Start
the processing module and the reagent and sample
manager (RSM), page 447.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5671
Process path initialization failed.
Probable cause Corrective action
Process path initialization failed. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5672
Reagent supply center load error at processing module.
Probable cause Corrective action
A reagent carousel load error occurred. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5673
Reagent supply center load error at RSM.
Probable cause Corrective action
A load error occurred at the reagent and sample Additional messages that are associated with this
manager. message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
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Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5674
Reagent carousel operation failed.
Probable cause Corrective action
An error occurred with the reagent carousel. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5675
Unable to pick up reagent cartridge or rack from (0).
0 = Location
Probable cause Corrective action
The reagent transport is unable to pick up the reagent Remove the reagent cartridge from the reagent
cartridge from the reagent positioner. positioner and rescan the reagent carousel.
The reagent carousel and reagent transport are not Perform Reagent Manager diagnostic procedure 1715
calibrated. Reagent Carousel and Reagent Transport Calibration (i-
series), page 820.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5676
Unable to load reagent cartridge or rack at (0).
0 = Location
Probable cause Corrective action
The reagent transport is unable to pick up the reagent Remove the reagent cartridge from the reagent
cartridge from the reagent positioner. positioner and rescan the reagent carousel.
The reagent carousel and reagent transport are not Perform Reagent Manager diagnostic procedure 1715
calibrated. Reagent Carousel and Reagent Transport Calibration (i-
series), page 820.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
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Message code: 5677
Reagent supply center unload error at processing module.
Probable cause Corrective action
An error occurred when a reagent cartridge or rack was Additional messages that are associated with this
unloaded from the reagent carousel. message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5678
Reagent supply center unload error at RSM.
Probable cause Corrective action
An error occurred when a reagent cartridge or rack was Additional messages that are associated with this
unloaded from the reagent carousel. message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5679
RV detected in process path when attempting to load an RV.
Probable cause Corrective action
The RV sensor is dirty or defective. Contact Customer Service to resolve any hardware
failure.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5680
RV loader conveyor error.
Probable cause Corrective action
An error occurred with the RV loader conveyor. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
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Section 10 Message codes
Message code: 5681
RV loader initialization error.
Probable cause Corrective action
RV loader initialization error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5682
RV load error. RV detected on picker arm after load attempted.
Probable cause Corrective action
A reaction vessel (RV) was detected on the RV pick and • Remove the RV from the RV pick and place
place assembly after an attempt to load the RV in the assembly.
process path. • Start the processing module and the reagent and
sample manager (RSM), page 447.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5683
RV pick and place movement error.
Probable cause Corrective action
RV pick and place movement error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5684
RSM transport pick error at sample positioner.
Probable cause Corrective action
An RSM transport pick error occurred at the sample Additional messages that are associated with this
positioner. message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
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Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5685
RSM transport place error at sample positioner.
Probable cause Corrective action
An RSM transport place error occurred at the sample Additional messages that are associated with this
positioner. message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5686
Rack or reagent cartridge load error on RSM.
Probable cause Corrective action
A load error occurred on the reagent and sample Additional messages that are associated with this
manager. message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5687
Rack or reagent cartridge load error on reagent positioner.
Probable cause Corrective action
A load error occurred at the reagent positioner. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5688
RV waste error.
Probable cause Corrective action
RV waste error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
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Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5689
Sample pipettor movement restricted.
Probable cause Corrective action
The stopper is not removed from the sample tube. Remove the stopper from the sample tube.
The sample volume in the sample cup or tube was Place adequate sample in the sample cup or tube. See
inadequate. Sample volume requirements, page 423.
The sample cup or tube was not correctly placed in the Ensure the sample cup or tube is fully seated into the
rack. sample rack and is positioned straight.
A physical obstruction is blocking the movement of the Locate and remove any physical obstruction.
sample pipettor.
The sample probe is out of alignment. Perform Pipettor diagnostics procedure 4102 Sample
Pipettor Calibration (c-series), page 779.
The sample probe is damaged. Replace the sample probe (c-series), page 829.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5690
Sample pipettor movement restricted at rack.
Probable cause Corrective action
The stopper is not removed from the sample tube. Remove the stopper from the sample tube.
The sample volume in the sample cup or tube was Place adequate sample in the sample cup or tube. See
inadequate. Sample volume requirements, page 423.
The sample cup or tube was not correctly placed in the Ensure the sample cup or tube is fully seated into the
rack. sample rack and is positioned straight.
A physical obstruction is blocking the movement of the Locate and remove any physical obstruction.
sample pipettor.
The sample probe is out of alignment. Perform Pipettor diagnostics procedure 4102 Sample
Pipettor Calibration (c-series), page 779.
The sample probe is damaged. Replace the sample probe (c-series), page 829.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5691
Unable to process test. Water bath level low.
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Probable cause Corrective action
A water bath level or temperature error occurred while • Review the specific message text. Perform the
the system was processing the test. corrective action for the specific message text.
• Rerun the test. Perform Rerun a test or an
exception for a specimen or control, page 612.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5692
R1 pipettor upper limit not found at position (1).
1 = Position
Probable cause Corrective action
A communication failure with the SMC board has Cycle power to the processing module and the reagent
occurred. and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5693
R2 pipettor upper limit not found at position (1).
1 = Position
Probable cause Corrective action
A communication failure with the SMC board has Cycle power to the processing module and the reagent
occurred. and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5694
Reagent carousel inventory check error.
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5695
Unable to process test. R1 pipettor movement restricted.
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Probable cause Corrective action
The reagent cartridge is empty. Load a new reagent.
A physical interference is blocking the movement of the Locate and remove any physical obstruction.
R1 reagent pipettor.
The R1 reagent pipettor probe is out of alignment. Perform Pipettors diagnostic procedure 4103 R1 Pipettor
Calibration (c-series), page 779.
The R1 reagent pipettor probe is damaged. Replace the reagent probes (c-series), page 832.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5696
Unable to process test. R2 pipettor movement restricted.
Probable cause Corrective action
The reagent cartridge is empty. Load a new reagent.
A physical interference is blocking the movement of the Locate and remove any physical obstruction.
R2 reagent pipettor.
The R2 reagent pipettor probe is out of alignment. Perform Pipettors diagnostic procedure 4104 R2 Pipettor
Calibration (c-series), page 779.
The R2 reagent pipettor probe is damaged. Replace the reagent probes (c-series), page 832.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5697
Sample pipettor movement restricted at rack.
Probable cause Corrective action
The stopper is not removed from the sample tube. Remove the stopper from the sample tube.
The sample volume in the sample cup or tube was Place adequate sample in the sample cup or tube. See
inadequate. Sample volume requirements, page 423.
The sample cup or tube was not correctly placed in the Ensure the sample cup or tube is fully seated into the
rack. sample rack and is positioned straight.
A physical obstruction is blocking the movement of the Locate and remove any physical obstruction.
sample pipettor.
The sample probe is out of alignment. Perform Pipettor diagnostics procedure 4102 Sample
Pipettor Calibration (c-series), page 779.
The sample probe is damaged. Replace the sample probe (c-series), page 829.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
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Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5698
Unable to process test. Sample pipettor vertical homing failed.
Probable cause Corrective action
A physical interference is blocking the movement of the 1. Locate and remove any physical obstruction.
sample pipettor.
2. Rerun the test. Perform Rerun a test or an
exception for a specimen or control, page 612.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5722
Reagent cartridge or rack not found at reagent carousel position (1).
1 = Position
Probable cause Corrective action
The reagent cartridge is damaged. Replace the reagent cartridge.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5723
Reagent cartridge or rack at reagent carousel position (1) no longer detected by reagent transport.
1 = Position
Probable cause Corrective action
The RSM transport arm is dirty. Clean the RSM transport arm.
RSM transport sensor failure. Clean the RSM transport sensor.
The RSM transport is out of alignment. Perform Sample Manager diagnostic procedure 1600
RSM Transport Calibration, page 823.
Reagent carousel reagent pack detector failure. Contact Customer Service to resolve any hardware
failure.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
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Message code: 5724
Mixer 1 high frequency vibration error.
Probable cause Corrective action
Mixer 1 is damaged. Replace the mixers (c-series), page 855.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5725
Mixer 1 low frequency vibration error.
Probable cause Corrective action
Mixer 1 is damaged. Replace the mixers (c-series), page 855.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5726
Mixer 1 vibration error.
Probable cause Corrective action
Mixer 1 is damaged. Replace the mixers (c-series), page 855.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5727
Mixer 2 high frequency vibration error.
Probable cause Corrective action
Mixer 2 is damaged. Replace the mixers (c-series), page 855.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5728
Mixer 2 low frequency vibration error.
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Message codes Section 10
Probable cause Corrective action
Mixer 2 is damaged. Replace the mixers (c-series), page 855.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5729
Mixer 2 vibration error.
Probable cause Corrective action
Mixer 2 is damaged. Replace the mixers (c-series), page 855.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5731
ICT unit lower limit not found at ICT Reference Solution cup.
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5732
ICT unit obstacle detected at ICT Reference Solution cup.
Probable cause Corrective action
A physical interference is blocking the movement of the Locate and remove any physical obstruction.
ICT unit.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5733
ICT unit upper limit not found at ICT Reference Solution cup.
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Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5734
ICT unit lower limit not found at cuvette.
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5735
ICT unit obstacle detected at cuvette.
Probable cause Corrective action
A physical interference is blocking the movement of the Locate and remove any physical obstruction.
ICT unit.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5736
ICT unit upper limit not found at cuvette.
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5744
R1 pipettor movement restricted at (0) position (1).
0 = Location
1 = Position
Probable cause Corrective action
The reagent cartridge is empty. Load a new reagent.
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Probable cause Corrective action
A physical interference is blocking the movement of the Locate and remove any physical obstruction.
R1 reagent pipettor.
The R1 reagent pipettor probe is out of alignment. Perform Pipettors diagnostic procedure 4103 R1 Pipettor
Calibration (c-series), page 779.
The R1 reagent pipettor probe is damaged. Replace the reagent probes (c-series), page 832.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5745
R2 pipettor movement restricted at (0) position (1).
0 = Location
1 = Position
Probable cause Corrective action
The reagent cartridge is empty. Load a new reagent.
A physical interference is blocking the movement of the Locate and remove any physical obstruction.
R2 reagent pipettor.
The R2 reagent pipettor probe is out of alignment. Perform Pipettors diagnostic procedure 4104 R2 Pipettor
Calibration (c-series), page 779.
The R2 reagent pipettor probe is damaged. Replace the reagent probes (c-series), page 832.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5747
Unload to (0) reagent cartridge at position (1) within specified time.
0 = Reagent cartridge
1 = Position
Probable cause Corrective action
The reagent cartridge is damaged. Replace the reagent cartridge.
The reagent cartridge was not loaded or unloaded Perform Sample Manager diagnostic procedure 1600
during the specific time. RSM Transport Calibration, page 823.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
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Section 10 Message codes
Message code: 5748
Reagent transport (0) error at reagent carousel position (1).
0 = Error
1 = Position
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5749
Shutter move error.
Probable cause Corrective action
An error occurred with the shutter. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5750
Reagent carousel or dispersion motor homing failed.
Probable cause Corrective action
The reagent carousel or the dispersion motor failed to Cycle power to the processing module and the reagent
move to the home position. and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5751
(2) board (3) (0) (1) error.
0 = Error
1 = Error
2 = Board
3 = Board DIO
Probable cause Corrective action
Hardware failure. • Cycle power to the processing module and the
reagent and sample manager (RSM), page 432.
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Probable cause Corrective action
• Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5752
Process path move error on (0) lane.
0 = Process path lane
Probable cause Corrective action
The process path move failed. • Initiate or resume sample processing.
• Cycle power to the processing module and the
reagent and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5753
Reagent transport failed.
Probable cause Corrective action
The reagent cartridge is damaged. Replace the reagent cartridge.
The RSM transport arm sensor is dirty. Perform As-Needed maintenance procedure 2920
Manual RSM Transport Cleaning, page 772.
The RSM transport is out of alignment. Perform Sample Manager diagnostic procedure 1600
RSM Transport Calibration, page 823.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5754
RSM transport initialization error.
Probable cause Corrective action
RSM transport initialization error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
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Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5755
RV linear queue empty.
Probable cause Corrective action
The RV hopper is empty. Replenish reaction vessels (RVs) and update the
inventory (i-series), page 517.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5756
Process path jam recovery on (0) successful.
Probable cause Corrective action
RV jam recovery was performed successfully. Status message. No corrective action is required.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5757
Process path jam recoveries on (0) excessive.
0 = Process path lane
Probable cause Corrective action
RV jam recoveries in the process path have exceeded Contact Customer Service to resolve any hardware
the allowable limit. failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5758
Process path jam recovery successful on (0). Process path may require servicing.
0 = Process path lane
Probable cause Corrective action
An RV was jammed in the process path. A recovery was performed to clear the RV jam. Frequent
occurrences of this message may indicate a pending
hardware failure. Contact Customer Service to resolve
any hardware failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
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Message code: 5759
(2) (3) solenoid error.
2 = Board
3 = Solenoid
Probable cause Corrective action
Hardware failure. • Cycle power to the processing module and the
reagent and sample manager (RSM), page 432.
• Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5760
Servo module error (0) (1).
0 = Error
1 = Error
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5761
Prime error.
Probable cause Corrective action
An error occurred during a prime of the Pre-Trigger and Initiate or resume sample processing.
Trigger manifold.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5762
Wash zone (0) initialization failed.
0 = Wash zone
Probable cause Corrective action
Wash zone initialization error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
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Section 10 Message codes
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5763
(0) pipettor homing failed.
0 = Pipettor
Probable cause Corrective action
A homing error occurred on the specified pipettor. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5764
RSM transport homing error.
Probable cause Corrective action
RSM transport homing error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5765
RSM transport Z error.
Probable cause Corrective action
RSM transport Z error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5766
RSM transport X error.
Probable cause Corrective action
RSM transport X error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
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Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5767
RSM transport theta error.
Probable cause Corrective action
Hardware failure. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5768
RV load failed.
Probable cause Corrective action
A hardware error occurred and the RV loader failed. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5769
Step loss detected on (0).
0 = Motor
Probable cause Corrective action
Motor homing failure. Cycle power to the processing module and the reagent
and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5770
Step loss detected on (0).
0 = Motor
Probable cause Corrective action
A physical interference is blocking the movement of the 1. Locate and remove any physical obstruction.
component.
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Probable cause Corrective action
2. Cycle power to the processing module and the
reagent and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5771
(0) pipettor move error.
0 = Pipettor
Probable cause Corrective action
Pipettor move error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5772
Loading area pick error.
Probable cause Corrective action
Loading area pick error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5773
Reagent positioner pick error.
Probable cause Corrective action
Reagent positioner pick error. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
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Message code: 5774
RV loader orienter correction attempts excessive.
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5775
Sample positioner initialization error.
Probable cause Corrective action
Sample positioner initialization failed. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5776
RSM transport pick error.
Probable cause Corrective action
An RSM transport pick error occurred. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5777
RSM transport pick sensor error.
Probable cause Corrective action
An RSM transport pick sensor error occurred. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
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Message code: 5778
RSM transport error.
Probable cause Corrective action
An RSM transport error occurred. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5779
Reagent supply center initialization failed.
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5780
Priority button error.
Probable cause Corrective action
A priority button error occurred. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5781
Loading area position error.
Probable cause Corrective action
A position error occurred on the loading area. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
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Message codes Section 10
Message code: 5782
Loading area tray error.
Probable cause Corrective action
An error occurred when a tray was loaded on the Additional messages that are associated with this
reagent and sample manager. message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5783
Sample positioner error.
Probable cause Corrective action
A sample positioner error has occurred. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5784
Shutter error.
Probable cause Corrective action
A shutter error has occurred. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5785
Rack unload error at sample positioner.
Probable cause Corrective action
The RSM transport is unable to pick racks at the sample Additional messages that are associated with this
positioners. message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
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Section 10 Message codes
Message code: 5786
Sample positioner initialization error.
Probable cause Corrective action
Sample positioner initialization failed. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5787
RSM transport error from module (0) position (1) to module (2) position (3).
0 = Module
1 = Position
2 = Module
3 = Position
Probable cause Corrective action
An RSM transport error has occurred. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5788
RSM transport error moving to park position.
Probable cause Corrective action
A physical interference is blocking the RSM transport 1. Locate and remove any physical obstruction.
movement to the park position.
2. Reinitialize the processing module. Perform Start
the processing module and the reagent and sample
manager (RSM), page 447.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5789
Unable to process sample. RSM rack transport error.
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Probable cause Corrective action
An error occurred with the RSM transport when a rack Rerun the tests. Perform Rerun a test or an exception for
was transported. a specimen or control, page 612.
The RSM transport is out of alignment. Perform Sample Manager diagnostic procedure 1600
RSM Transport Calibration, page 823.
The rack is damaged. Replace the damaged rack.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5790
Pick error at loading area on module (0) position (1).
0 = Module
1 = RSM position
Probable cause Corrective action
The rack or reagent cartridge was inserted incorrectly. Insert the rack or reagent cartridge correctly.
The rack or reagent cartridge is damaged. Load a new rack or reagent cartridge.
The RSM transport arm is dirty. Perform Weekly maintenance procedure 2620 Manual
Pipettor Probe Cleaning (i-series), page 769.
The reagent and sample manager (RSM) is out of Perform Reagent and Sample Manager (RSM)
alignment. diagnostic procedure 1600 RSM Transport Calibration,
page 823.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5791
Place error at loading area on module (0) position (1).
0 = Module
1 = RSM position
Probable cause Corrective action
The reagent and sample manager (RSM) is out of Perform Reagent and Sample Manager (RSM)
alignment. diagnostic procedure 1600 RSM Transport Calibration,
page 823.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
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Section 10 Message codes
Message code: 5792
Unable to process test. Step loss detected for (0) pipettor at reagent carousel.
0 = Pipettor
Probable cause Corrective action
A physical obstruction is blocking the movement of the Locate and remove any physical obstruction.
pipettor.
The reagent cartridge is empty. Load a new reagent.
The reagent probe is out of alignment. Perform Pipettors diagnostic procedure 1112 R1 Pipettor
Check and Calibration (i-series), page 797 or 1113 R2
Pipettor Check and Calibration (i-series), page 797.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5793
Rack prematurely removed from RSM transport arm.
Probable cause Corrective action
A physical obstruction caused a rack transport failure. 1. Locate and remove any physical obstruction.
2. Perform Start the processing module and the
reagent and sample manager (RSM), page 447 for
the appropriate module.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5794
Reagent carousel load error.
Probable cause Corrective action
A hardware error occurred. An item was unable to load Additional messages that are associated with this
into the reagent carousel. message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5795
Reagent carousel unload error.
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Probable cause Corrective action
A hardware error occurred. An item was unable to Additional messages that are associated with this
unload from the reagent carousel. message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5796
Reagent positioner movement failed.
Probable cause Corrective action
The reagent positioner cannot open or close. Start the processing module and the reagent and sample
manager (RSM), page 447. Perform Reagent and
Sample Manager (RSM) diagnostic procedure 1610
Reagent and Sample Manager Test, page 824.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5797
(0) sample positioner movement error.
0 = Sample positioner
Probable cause Corrective action
A sample positioner movement error occurred. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5798
(0) sample positioner latch movement error.
0 = Sample positioner
Probable cause Corrective action
A sample positioner latch movement error occurred. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
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Section 10 Message codes
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5799
(0) sample positioner homing error.
0 = Sample positioner
Probable cause Corrective action
A sample positioner homing error occurred. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5800
(0) sample positioner initialization error.
0 = Sample positioner
Probable cause Corrective action
A sample positioner initialization error occurred. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5801
(0) sample positioner failed to latch rack in sample positioner pocket.
0 = Sample positioner
Probable cause Corrective action
The sample positioner failed to latch the rack in the 1. Remove the rack from the sample positioner.
sample positioner pocket.
2. Start the processing module and the reagent and
sample manager (RSM), page 447.
The rack is damaged. Use a different rack.
The reagent and sampler manager (RSM) is out of Perform Reagent and Sample Manager (RSM)
alignment. diagnostic procedure 1600 RSM Transport Calibration,
page 823.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
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Message codes Section 10
Message code: 5802
Processing module initialization failed. RV load check error.
Probable cause Corrective action
RVs are blocking the access path to the RV loader 1. Open the RV access door and stir the RVs in the
wheel. RV hopper by hand.
2. If the RVs are not picked up, wait until all tests in
process are completed.
3. Remove all the RVs from the RV hopper when the
instrument status of the processing module is Idle.
4. Inspect the path to the RV loader wheel and
remove any RVs.
The RV pickers on the RV orienter wheel are broken. Contact Customer Service to resolve any hardware
failure.
An RV is jammed in the linear queue. 1. If accessible, clear the RV jam in the linear queue.
2. Cycle power to the processing module and the
reagent and sample manager (RSM), page 432.
An RV pick and place assembly error occurred. Contact Customer Service to resolve any hardware
failure.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5803
RV load error. RV dropped from picker arm.
Probable cause Corrective action
No RV is detected on the picker arm. If the error occurs infrequently, no corrective action is
required.
Perform Process Path diagnostic procedure 1520 RV
Load and Unload Test (i-series), page 819.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5804
RV picker arm step loss error.
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Section 10 Message codes
Probable cause Corrective action
A physical obstruction is blocking the movement of the 1. Locate and remove any physical obstruction.
RV picker arm.
2. Start the processing module and the reagent and
sample manager (RSM), page 447.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5805
RV load error. No RV detected in linear queue after attempting to pick an RV.
Probable cause Corrective action
RV pick point sensor failure. Start the processing module and the reagent and sample
manager (RSM), page 447. If the error continues,
perform RV Loader diagnostic procedure 1400 RV
Loader and Sensors Test (i-series), page 816.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5806
RV load error. RV left in linear queue.
Probable cause Corrective action
No RV is detected on the picker arm. Start the processing module and the reagent and sample
manager (RSM), page 447. If the error continues,
perform RV Loader diagnostic procedure 1400 RV
Loader and Sensors Test (i-series), page 816.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5807
RVs have not been picked up by RV orienter for an extended period of time.
Probable cause Corrective action
RVs are blocking the access path to the RV loader 1. If the RVs are not picked when all tests in process
wheel. are completed, pause the processing module.
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Probable cause Corrective action
2. Perform Process Path diagnostic procedure 1520
RV Load and Unload Test (i-series), page 819.
3. Perform the Conveyor Motor option of the RV
Loader diagnostic procedure 1400 RV Loader and
Sensors Test (i-series), page 816.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5808
Sample positioner initialization error. Sample pipettor probe in sample cup/tube due to prior hardware
failure.
Probable cause Corrective action
The sample pipettor did not initialize correctly. Start the processing module and the reagent and sample
manager (RSM), page 447.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5809
Unable to process test. Pretreatment path disabled.
Probable cause Corrective action
The pretreatment path is disabled. • Start the processing module and the reagent and
sample manager (RSM), page 447.
• Review the message history log for errors that
occurred at the same time as this message.
Perform corrective actions for the specific message
text.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5810
Unable to process test. Wash zone 1 disabled.
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Section 10 Message codes
Probable cause Corrective action
A wash zone 1 error occurred. Review the System Logs for wash zone errors that
occurred at the same time as the message. Perform the
corrective action for the specific hardware message
text.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5811
RSM transport home flag not found.
Probable cause Corrective action
A physical obstruction is blocking the movement of the Locate and remove any physical obstruction.
RSM transport.
The RSM transport cable has a poor connection. Reseat the RSM transport sensor cable to the transport
circuit board.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5812
Unable to transfer onboard vial rack (0) on module (1) reagent carousel position (2).
0 = Rack ID
1 = Module
2 = Reagent carousel position
Probable cause Corrective action
The onboard vial rack was unable to transfer to or from Review the message history log for errors that occurred
the reagent carousel. at the same time as this message. Perform corrective
actions for the specific message text.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5813
Unable to turn on (0).
0 = Device
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
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Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5814
Unable to turn off (0).
0 = Device
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5815
(0) sample positioner move request failed during calibration.
0 = Sample positioner
Probable cause Corrective action
A physical obstruction is blocking the movement of the 1. Locate and remove any physical obstruction.
sample positioner.
2. Perform Reagent and Sample Manager (RSM)
diagnostic procedure 1600 RSM Transport
Calibration, page 823.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5816
Sample positioner move request failed during pipettor calibration.
Probable cause Corrective action
The reagent and sample manager (RSM) is obstructed. 1. Locate and remove any physical obstruction.
2. Reinitialize the RSM.
The RSM transport is out of alignment. Perform Reagent and Sample Manager (RSM)
diagnostic procedure 1600 RSM Transport Calibration,
page 823.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
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Section 10 Message codes
Message code: 5817
Unable to initialize module due to previous load or unload error. Remove reagent cartridge or rack with
load or unload error from reagent carousel.
Probable cause Corrective action
The reagent transport is unable to load or unload the 1. Remove the onboard vial rack or reagent cartridge
onboard vial rack or reagent cartridge from the reagent from the reagent carousel.
carousel.
2. Perform Start the processing module and the
reagent and sample manager (RSM), page 447 for
the appropriate module.
The onboard vial rack or reagent cartridge is damaged. Load a different onboard vial rack or reagent cartridge.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5818
Reagent transport error.
Probable cause Corrective action
An error occurred when the reagent transport moved. Reinitialize the reagent and sample manager. Perform
Start the processing module and the reagent and sample
manager (RSM), page 447.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5819
Reagent cartridge load error at reagent carousel position (0).
0 = Reagent carousel position
Probable cause Corrective action
The reagent cartridge is damaged. Load a new reagent cartridge. Perform Load cartridges
on the reagent and sample manager (RSM), page 527.
The reagent and sample manager (RSM) is out of Perform Reagent and Sample Manager (RSM)
alignment. diagnostic procedure 1600 RSM Transport Calibration,
page 823.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
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Message codes Section 10
Message code: 5820
Reagent cartridge unload error at reagent carousel position (0).
0 = Reagent carousel position
Probable cause Corrective action
The reagent cartridge is damaged. Load a new reagent cartridge. Perform Load cartridges
on the reagent and sample manager (RSM), page 527.
The reagent and sample manager (RSM) is out of Perform Reagent and Sample Manager (RSM)
alignment. diagnostic procedure 1600 RSM Transport Calibration,
page 823.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5821
Power supply error on voltage (1).
1 = Voltage
Probable cause Corrective action
The power supply voltage failed. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5822
Sample pipettor upper limit not found.
Probable cause Corrective action
The sample pipettor was physically pushed down from 1. Transition the processing module to a status of
its vertical home position. Stopped.
2. Perform Start the processing module and the
reagent and sample manager (RSM), page 447.
A physical interference is blocking the movement of the Locate and remove any physical obstruction.
sample pipettor.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5823
Mixer 1 lower limit not found.
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Section 10 Message codes
Probable cause Corrective action
Mixer 1 is damaged. Replace the mixers (c-series), page 855.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5824
Mixer 1 upper limit not found.
Probable cause Corrective action
Mixer 1 is damaged. Replace the mixers (c-series), page 855.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5825
Mixer 2 lower limit not found.
Probable cause Corrective action
Mixer 2 is damaged. Replace the mixers (c-series), page 855.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5826
Mixer 2 upper limit not found.
Probable cause Corrective action
Mixer 2 is damaged. Replace the mixers (c-series), page 855.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5827
Unable to initialize process path. Hardware error.
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Message codes Section 10
Probable cause Corrective action
The process path failed to initialize. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5828
Module initialization failed. Hardware error.
Probable cause Corrective action
The module failed to initialize. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5829
Processing center cover error.
Probable cause Corrective action
A processing center cover sensor error occurred. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5830
RSM transport safety LED has a defect.
Probable cause Corrective action
One of the RSM transport safety LEDs is defective. Status message. No corrective action is required.
NOTE: The safety LED should be replaced by the FSE
the next time the system is serviced.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5831
Both RSM transport safety LEDs have a defect.
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Probable cause Corrective action
Both of the RSM transport safety LEDs are defective. Contact Customer Service to replace the LEDs. The
safety LEDs must be replaced by an FSE.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5832
Unable to unload reagent cartridge or rack from reagent carousel position (0). Reagent cartridge or rack
in reagent positioner.
0 = Reagent carousel position
Probable cause Corrective action
A reagent cartridge or onboard vial rack is already 1. Remove the reagent cartridge or onboard vial rack
loaded in the reagent positioner. from the reagent positioner.
2. Perform Start the processing module and the
reagent and sample manager (RSM), page 447.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Message code: 5833
Unable to load reagent cartridge in RSM position (0).
0 = RSM position
Probable cause Corrective action
No processing module is available to load the reagent 1. Verify that a processing module is available with
cartridge. the required assay enabled.
2. Verify that an empty reagent carousel position is
available to load the reagent cartridge.
3. Reload the reagent cartridge on the reagent and
sample manager.
Related information...
Robotics and sensor message codes (5000-5999), page 1132
Support system message codes (6000-6999)
The support system message code category includes message codes from 6000 through 6999.
The following list provides examples of support systems:
• Uninterruptible power supply
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• Water supply
Related information...
Message codes, page 941
Temperature message codes (7000-7999)
The temperature message code category includes message codes from 7000 through 7999.
Related information...
Message codes, page 941
7010, page 1202
7011, page 1203
7012, page 1203
7013, page 1203
7014, page 1204
7015, page 1204
7016, page 1204
7017, page 1205
7018, page 1205
7020, page 1205
7021, page 1205
7022, page 1206
7023, page 1206
7024, page 1206
7025, page 1207
7026, page 1207
7027, page 1207
7028, page 1207
Message code: 7010
Water bath temperature out of range. Temperature (0).
0 = Temperature
Probable cause Corrective action
The water in the water bath is not circulating because Change the water in the water bath. Perform Daily
the system was idle for an extended period of time. maintenance procedure 5501 Daily Maintenance (c-
series), page 759.
The system was recently powered on. Check the temperature status to verify that the
temperature returns to specifications. Perform
Temperature diagnostic procedure 4301 Temperature
Status (c-series), page 784.
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Probable cause Corrective action
The water bath is filling after an extended idle time. Check the temperature status to verify that the
temperature returns to specifications. Perform
Temperature diagnostic procedure 4301 Temperature
Status (c-series), page 784.
The room temperature is too high. Modify the room temperature to be within specifications.
See Environmental specifications and requirements,
page 408.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Temperature message codes (7000-7999), page 1202
Message code: 7011
Ambient temperature out of range. Temperature (0).
0 = Temperature
Probable cause Corrective action
The room temperature is too low. Modify the room temperature to be within specification.
The room temperature is too high. Modify the room temperature to be within specification.
Related information...
Temperature message codes (7000-7999), page 1202
Message code: 7012
Temperature stability failed on (0).
0 = Mechanism
Probable cause Corrective action
The specified heater is unable to maintain the 1. Observe the temperature status to verify the
temperature within specification. temperature. Perform Temperature diagnostic
procedure 4301 Temperature Status (c-series),
page 784.
2. Contact Customer Service to resolve any hardware
error.
Related information...
Temperature message codes (7000-7999), page 1202
Message code: 7013
Unable to process test. Water bath temperature below minimum acceptable value.
Probable cause Corrective action
A water bath level or temperature error occurred while Review the specific message text. Perform the
the system was processing the test. corrective action for the specific message text.
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Related information...
Temperature message codes (7000-7999), page 1202
Message code: 7014
Unable to process test. Water bath temperature above maximum acceptable value.
Probable cause Corrective action
A water bath level or temperature error occurred while Review the specific message text. Perform the
the system was processing the test. corrective action for the specific message text.
Related information...
Temperature message codes (7000-7999), page 1202
Message code: 7015
Reagent carousel temperature (0) out of range (1).
0 = Temperature
1 = Low or High
Probable cause Corrective action
The room temperature is too low. Modify the room temperature to be within specification.
The room temperature is too high. Modify the room temperature to be within specification.
The system was powered on recently. Observe the temperature status to verify the
temperature. Perform Temperature diagnostic procedure
4301 Temperature Status (c-series), page 784.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Temperature message codes (7000-7999), page 1202
Message code: 7016
Reagent carousel temperature (0) out of range (1) while processing module powered off.
0 = Temperature
1 = Low or high
Probable cause Corrective action
The reagent carousel temperature was not maintained Observe the temperature status to verify the
while the processing module was powered off. temperature. Perform Temperature diagnostic procedure
4301 Temperature Status (c-series), page 784.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Temperature message codes (7000-7999), page 1202
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Section 10 Message codes
Message code: 7017
Reagent carousel temperature control hardware error on (0).
0 = Mechanism
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Temperature message codes (7000-7999), page 1202
Message code: 7018
Reagent carousel temperature controller board communication error.
Probable cause Corrective action
The module temperature controller board has a poor Cycle power to the processing module and the reagent
connection or has failed. and sample manager (RSM), page 432.
Contact Customer Service to resolve any hardware
failure.
Hardware failure. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Temperature message codes (7000-7999), page 1202
Message code: 7020
(2) (3) temperature error.
2 = Board
3 = Mechanism
Probable cause Corrective action
A temperature error occurred. Start the processing module and the reagent and sample
manager (RSM), page 447.
Communication or hardware failure. Cycle power to the processing module and the reagent
and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Temperature message codes (7000-7999), page 1202
Message code: 7021
(0) above maximum temperature.
0 = Mechanism
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Probable cause Corrective action
The room temperature is out of specifications. Modify the room temperature to be within specifications.
See Environmental specifications and requirements,
page 408.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Temperature message codes (7000-7999), page 1202
Message code: 7022
(0) below minimum temperature.
0 = Mechanism
Probable cause Corrective action
The room temperature is out of specifications. Modify the room temperature to be within specifications.
See Environmental specifications and requirements,
page 408.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Temperature message codes (7000-7999), page 1202
Message code: 7023
Reagent storage area coolant level low.
Probable cause Corrective action
The coolant level is low. Contact Customer Service to resolve any hardware
failure.
Related information...
Temperature message codes (7000-7999), page 1202
Message code: 7024
(0) temperature alarm. Temperature (1)
0 = Mechanism
1 = Temperature
Probable cause Corrective action
A temperature alert occurred. Status message. No corrective action is required.
Related information...
Temperature message codes (7000-7999), page 1202
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Message code: 7025
(0) temperature error.
0 = Mechanism
Probable cause Corrective action
A temperature error has occurred. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Temperature message codes (7000-7999), page 1202
Message code: 7026
Reagent storage area coolant error.
Probable cause Corrective action
A reagent storage area coolant error occurred. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 928.
Related information...
Temperature message codes (7000-7999), page 1202
Message code: 7027
Reagent storage area coolant level below middle level.
Probable cause Corrective action
The coolant level is nearing the low level. Contact Customer Service to resolve any hardware
failure.
Related information...
Temperature message codes (7000-7999), page 1202
Message code: 7028
Thermo-electric controller error (0).
0 = Error
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Temperature message codes (7000-7999), page 1202
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Message codes Section 10
Computer hardware peripheral message codes (8000-8999)
The computer hardware peripheral message code category includes message codes from 8000
through 8999. The following list provides examples of computer hardware peripherals:
• Host interface
• Computer and monitor
• Media
• Ports
Related information...
Message codes, page 941
8000, page 1209
8001, page 1209
8002, page 1210
8003, page 1210
8004, page 1210
8005, page 1210
8006, page 1211
8007, page 1211
8008, page 1211
8009, page 1211
8010, page 1211
8011, page 1212
8012, page 1212
8013, page 1212
8015, page 1212
8016, page 1213
8017, page 1213
8018, page 1213
8020, page 1214
8021, page 1214
8022, page 1215
8023, page 1215
8024, page 1215
8026, page 1216
8027, page 1216
8028, page 1217
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Section 10 Message codes
8029, page 1217
8030, page 1217
8034, page 1218
8036, page 1218
8037, page 1218
8038, page 1219
8040, page 1219
8041, page 1219
8042, page 1220
8043, page 1220
8044, page 1220
8045, page 1220
8046, page 1221
8047, page 1221
8048, page 1221
8049, page 1221
8050, page 1222
8052, page 1222
8053, page 1222
8054, page 1223
8055, page 1223
Message code: 8000
AbbottLink communications restored.
Probable cause Corrective action
The connection to AbbottLink was restored. Status message. No corrective action is required.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8001
AbbottLink communication is offline.
Probable cause Corrective action
AbbottLink communication is Offline. • Restart AbbottLink, page 478.
• Contact Customer Service to resolve the AbbottLink
failure.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
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Message codes Section 10
Message code: 8002
Status for (0) printer unavailable at this time.
0 = Printer
Probable cause Corrective action
The printer is not available. • Verify that the printer is plugged in, turned on, and
ready.
• Verify that the cable from the printer to the
computer is plugged in.
• Refer to the printer documentation for more
information.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8003
Unknown printer error occurred for (0) printer.
0 = Printer
Probable cause Corrective action
A printer error occurred. Refer to the printer documentation for more information.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8004
Printer error (0) occurred for (1) printer.
0 = Printer error
1 = Printer
Probable cause Corrective action
A printer error occurred. Refer to the printer documentation for more information.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8005
Host communication error. Message queue full for data pending transmission.
Probable cause Corrective action
The message queue is full. Clear the message queue and enable the host
connection on the Host Connection Status flyout.
Perform Enable or disable the host connection, page
474.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
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Message code: 8006
Host communication error. Unknown error occurred when transmitting data to host.
Probable cause Corrective action
An unknown error was detected when data was • Verify that the host communication is enabled on
transmitted to the host. the Host Connection Status flyout. Perform Enable
or disable the host connection, page 474.
• Cycle power to the system, page 428.
• Refer to the host communications documentation
for more information.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8007
Host message queue cleared by operator ID (0).
0 = Operator ID
Probable cause Corrective action
The message queue was cleared by the operator. Status message. No corrective action is required.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8008
Host connection disabled by opeator ID (0).
0 = Operator ID
Probable cause Corrective action
The operator disabled the host connection. Status message. No corrective action is required.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8009
Unable to send order query to host. Host connection disabled.
Probable cause Corrective action
The host connection is disabled. Enable the host connection on the Host Connection
Status flyout. Perform Enable or disable the host
connection, page 474.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8010
Host connection enabled by operator ID (0).
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0 = Operator ID
Probable cause Corrective action
The operator enabled the host connection. Status message. No corrective action is required.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8011
Host connection disabled. Message queue full.
Probable cause Corrective action
The message queue is full. Clear the message queue and enable the host
connection on the Host Connection Status flyout.
Perform Enable or disable the host connection, page
474.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8012
Invalid host cancellation request. SID (0) does not exist.
0 = SID
Probable cause Corrective action
The system received a cancellation request from the If the error occurs frequently with no explanation, verify
host on a test order that does not exist in the database. the function of the host interface.
The cancellation request by the host is ignored by the
system.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8013
Invalid host order for SID (0). Sample type of (1) invalid for order.
0 = SID
1 = Sample type
Probable cause Corrective action
The host order for the SID is for an invalid sample type. Verify that the host is sending only specimen and control
orders.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8015
Invalid host order for SID (0). Specified dilution (1) for assay (2) number (3) not available.
0 = SID
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Section 10 Message codes
1 = Dilution
2 = Assay name
3 = Assay number
Probable cause Corrective action
The host order for the SID contains a dilution that is not Verify that the host order uses a valid dilution.
available.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8016
Invalid host order for SID (0). No order data sent.
0 = SID
Probable cause Corrective action
The host order for the SID does not contain order data. Verify the order in the Host Connection Status flyout.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8017
Invalid host order for SID (0). Specified dilution (1) for assay (2) number (3) does not exist or is in
conflict with the specified dilution factor.
0 = SID
1 = Dilution
2 = Assay name
3 = Assay number
Probable cause Corrective action
The host order contains an invalid dilution option. Order a dilution that is available for the specified assay.
The dilution name is case sensitive. Verify that the host
dilution name is exactly the same as the dilution name in
the system software.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8018
Negative query response received for SID (0).
0 = SID
Probable cause Corrective action
• The SID was not recognized by the host. Verify that orders exist for the SID.
• The SID has no outstanding orders.
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Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8020
(0) request timed out.
0 = Mail category
Probable cause Corrective action
AbbottLink did not respond to an automatic request or a
manual request for an assay file within the required time
period.
AbbottLink response is slow. • The download speed capability of the laboratory
affects the amount of time needed to process a
request. The status of an assay file request can
remain as Pending for a maximum of 24 hours
before the request times out.
• If a manual request for an assay file failed, repeat
the manual request.
• If an automatic request for an assay file failed, the
system will automatically request the assay file
again in 7 days. No corrective action is required.
The status of AbbottLink is Disconnected.
• The Ethernet cable has a poor connection. • Reconnect the Ethernet cable.
• The Internet connection of the laboratory is not • Reestablish the Internet connection.
functioning.
• AbbottLink at Abbott Laboratories is not • Contact Customer Service. Provide information
functioning. about the operation that was attempted when the
error occurred.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8021
Communications error occurred while requesting (0).
0 = Mail category
Probable cause Corrective action
The status of AbbottLink is Disconnected. • Restart AbbottLink, page 478.
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
After the AbbottLink connection is reestablished, to
request the assay insert again, unload the reagent and
reload the reagent.
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Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8022
Unexpected response received for (0).
0 = Mail category
Probable cause Corrective action
An Abbott Mail item was received after a request for the Review the system logs for message code 8020.
item had previously timed out.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8023
Communications error occurred during (1) request for reagent lot (0).
0 = Reagent lot
1 = Mail category
Probable cause Corrective action
The status of AbbottLink is Disconnected. Refer to the assay insert that was shipped with the
reagent kit or obtain the appropriate insert at
abbottdiagnostics.com.
• Restart AbbottLink, page 478.
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
After the AbbottLink connection is reestablished, to
request the assay insert again, unload the reagent and
reload the reagent.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8024
(1) request timed out for reagent lot (0).
0 = Reagent lot
1 = Mail category
Probable cause Corrective action
AbbottLink did not respond to a request for an assay
insert within the required time period.
• AbbottLink response is slow. • The download speed capability of the laboratory
affects the amount of time needed to process a
request. The status of an assay insert request can
remain as Pending for a maximum of 24 hours
before the request times out.
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Probable cause Corrective action
• To request the assay insert again, unload the
reagent and reload the reagent.
• Refer to the assay insert that was shipped with the
reagent kit or obtain the appropriate insert at
abbottdiagnostics.com.
• The status of AbbottLink is Disconnected. • Restart AbbottLink, page 478.
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
• Refer to the assay insert that was shipped with the
reagent kit or obtain the appropriate insert at
abbottdiagnostics.com.
After the AbbottLink connection is reestablished, to
request the assay insert again, unload the reagent and
reload the reagent.
• The Ethernet cable has a poor connection. Reconnect the Ethernet cable.
• The Internet connection of the laboratory is not Reestablish the Internet connection.
functioning.
• AbbottLink at Abbott Laboratories is not Contact Customer Service. Provide information about
functioning. the operation that was attempted when the error
occurred.
• Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8026
File error (0) for mail item (1) for (2) number (3) revision (4).
0 = File error
1 = Mail category
2 = Subject
3 = Number
4 = Revision
Probable cause Corrective action
A problem occurred with an Abbott Mail item that was Contact Customer Service. Provide information about
downloaded. the operation that was attempted when the error
occurred.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8027
File error (0) for mail item (1) for (2) number (3) revision (4). Error (5).
0 = File error
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Section 10 Message codes
1 = Mail category
2 = Subject
3 = Number
4 = Revision
5 = Error
Probable cause Corrective action
A problem occurred with an Abbott Mail item that was Contact Customer Service. Provide information about
downloaded. the operation that was attempted when the error
occurred.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8028
File error (0) for mail item (1) for (2) number (3).
0 = File error
1 = Mail category
2 = Subject
3 = Number
Probable cause Corrective action
A problem occurred with an Abbott Mail item that was Contact Customer Service. Provide information about
downloaded. the operation that was attempted when the error
occurred.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8029
Unable to connect to host. Unknown communication error.
Probable cause Corrective action
An unknown error occurred when an attempt was made • Enable the host connection on the Host Connection
to connect to the host. Status flyout. Perform Enable or disable the host
connection, page 474.
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8030
(1) channel (0) status. Host connection disabled.
0 = Status
1 = Channel
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Message codes Section 10
Probable cause Corrective action
Informatics Communication Service error. • Enable the host connection on the Host Connection
Status flyout. Perform Enable or disable the host
connection, page 474.
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8034
Unable to print report. Printer error. Configuration option for automatic report printing turned off.
Probable cause Corrective action
Printer error. Resolve the printer error and set automatic report
generation to the default printer.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8036
Connection error between SCM and processing module. Error (0).
0 = Error
Probable cause Corrective action
Power to the processing module is turned off. Power on the processing module, page 436. Power on
the reagent and sample manager (RSM), page 444.
The processing module is in the process of powering on. Wait until the processing module is powered on and the
instrument status of the module is Stopped.
Communication error. If the processing module stopped running because of
the communication error, perform Cycle power to the
processing module and the reagent and sample manager
(RSM), page 432.
The CPU board has a poor connection or has failed. Contact Customer Service to resolve any hardware
failure.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8037
Invalid host order for SID (0). Assay (1) number (2) disabled.
0 = SID
1 = Assay name
2 = Assay number
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Section 10 Message codes
Probable cause Corrective action
The system received a test order from the host that 1. Determine the cause for the disabled assay.
requested an assay that is disabled.
2. Enable the assay and run the test.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8038
Invalid host order for SID (0). Assay number (1) not installed.
0 = SID
1 = Assay number
Probable cause Corrective action
The system received a test order from the host that Install assay files, page 272.
requested an assay that is not installed.
The assay number is incorrectly defined in the host. Edit the assay number in the host.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8040
Invalid host order. Order already exists for SID (0) assay (1) number (2) dilution (3).
0 = SID
1 = Assay name
2 = Assay number
3 = Dilution
Probable cause Corrective action
The system received an order from the host that If the error continues, verify that the host interface is functioning
already exists. The system ignored the new correctly.
order.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8041
Unspecified error received from host for SID (0) in Rack ID/Position (1/2) in RSM position (3).
0 = SID
1 = Rack ID
2 = Position
3 = RSM position
Probable cause Corrective action
An unspecified error was received from the host. Verify the host connection in the Host Connection Status
flyout.
Alinity ci-series Operations Manual 1219
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Message codes Section 10
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8042
Export error. Unable to export report to (0). Automatic report printing changed to Off.
0 = File location ID
Probable cause Corrective action
An error occurred when data was exported to a USB Resolve the error with the USB flash drive. After the
flash drive. The automatic report printing is turned off. error is resolved, configure the automatic report
generation option to be Save to File.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8043
Invalid host order for SID (0). Assay (1) number (2) is a correlation assay.
0 = SID
1 = Assay name
2 = Assay number
Probable cause Corrective action
The host attempted to request an order for a correlation Verify the host interface.
assay, but the host cannot request an order for a
correlation assay.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8044
Host message time-out error. Host connection disabled.
Probable cause Corrective action
The host did not receive a reply message within the Enable the host connection on the Host Connection
required time. Status flyout. Perform Enable or disable the host
connection, page 474.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8045
Unable to establish connection on communication channel. Host connection disabled.
Probable cause Corrective action
The system is unable to connect to the host. Enable the host connection on the Host Connection
Status flyout. Perform Enable or disable the host
connection, page 474.
1220 Alinity ci-series Operations Manual
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Troubleshooting
Section 10 Message codes
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8046
Host query time-out exceeded for SID (0) in rack ID (1) position (2) RSM position (3).
0 = SID
1 = Rack ID
2 = Position
3 = RSM position
Probable cause Corrective action
The order query was not acknowledged by the host. Verify that the host communication is enabled on the
Host Connection Status flyout. Perform Enable or disable
the host connection, page 474.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8047
Invalid host order. SID (0) contains invalid characters or is configured for a calibrator or control.
0 = SID
Probable cause Corrective action
The SID contains invalid characters. Verify the bar code format.
The SID for the specimen is already in use as a Verify the SID for the specimen.
calibrator SID or a control SID.
The bar code label does not meet specifications. Verify the bar code label meets specifications.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8048
Invalid host order. AWOS ID (0) already exists.
0 = AWOS ID
Probable cause Corrective action
The system received an order from the host, but the • Status message. No corrective action is required.
order already exists. The new order from the host is • If the error continues, contact Customer Service.
ignored. Provide information about the operation that was
attempted when the error occurred.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8049
Invalid host order for SID (0). Dilution protocol and manual dilution specified for assay (1) number (2).
0 = SID
Alinity ci-series Operations Manual 1221
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Message codes Section 10
1 = Assay name
2 = Assay number
Probable cause Corrective action
The host order contained both a manual dilution factor Edit the host order to contain either a manual dilution
and an automatic dilution factor. The order can only factor or an automatic dilution factor.
contain one dilution factor type.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8050
Invalid host order for SID (0). Specified manual dilution factor (1) is invalid or manual dilution is not
supported for assay (2) number (3).
0 = SID
1 = Dilution
2 = Assay name
3 = Assay number
Probable cause Corrective action
A manual dilution option is unavailable for the requested Edit the host order to remove the manual dilution factor.
assay.
The manual dilution factor is invalid for the requested Edit the host order to include a valid manual dilution
assay. factor.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8052
Invalid host cancellation request. No pending order for SID (2) assay number (0) dilution (1) AWOS ID
(3).
0 = Assay number
1 = Dilution
2 = SID
3 = AWOS ID
Probable cause Corrective action
The host cannot locate the order for cancellation. Status message. No corrective action is required.
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8053
Invalid host cancellation request. No pending order for SID (2) assay number (0) dilution (1).
1222 Alinity ci-series Operations Manual
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Troubleshooting
Section 10 Message codes
0 = Assay number
1 = Dilution
2 = SID
Probable cause Corrective action
The host cannot locate the order for cancellation. Status message. No corrective action is required.
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8054
File error (0) for mail item (1) for (2) number (3). Error (4).
0 = Mail file status
1 = Mail item
2 = Subject
3 = Number
4 = Error
Probable cause Corrective action
A problem occurred with an Abbott Mail item that was Contact Customer Service. Provide information about
downloaded. the operation that was attempted when the error
occurred.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Message code: 8055
Embedded computer (0) failed to boot up.
0 = Embedded computer
Probable cause Corrective action
The embedded computer failed to initialize. 1. Perform Cycle power to the processing module and
the reagent and sample manager (RSM), page 432
on the specified module.
2. If the embedded computer fails to initialize, perform
Cycle power to the system, page 428.
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Computer hardware peripheral message codes (8000-8999), page 1208
Alinity ci-series Operations Manual 1223
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Troubleshooting
Message codes Section 10
Software message codes (9000-9999)
The software message code category includes message codes from 9000 through 9999.
Related information...
Message codes, page 941
9000, page 1227
9001, page 1227
9002, page 1228
9003, page 1228
9005, page 1228
9008, page 1228
9009, page 1229
9010, page 1229
9011, page 1229
9303, page 1230
9304, page 1230
9305, page 1230
9306, page 1230
9307, page 1231
9308, page 1231
9309, page 1231
9310, page 1231
9311, page 1232
9314, page 1232
9315, page 1232
9316, page 1232
9324, page 1233
9325, page 1233
9329, page 1233
9330, page 1233
9337, page 1234
9339, page 1234
9340, page 1234
9341, page 1235
9346, page 1235
9348, page 1235
9349, page 1235
1224 Alinity ci-series Operations Manual
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Troubleshooting
Section 10 Message codes
9350, page 1236
9351, page 1236
9352, page 1236
9353, page 1236
9355, page 1237
9356, page 1237
9357, page 1237
9358, page 1237
9359, page 1238
9360, page 1238
9361, page 1238
9362, page 1239
9363, page 1239
9364, page 1239
9365, page 1239
9366, page 1240
9367, page 1240
9368, page 1240
9369, page 1241
9370, page 1241
9371, page 1241
9372, page 1241
9374, page 1242
9375, page 1242
9376, page 1242
9377, page 1242
9378, page 1243
9379, page 1243
9380, page 1243
9381, page 1243
9382, page 1244
9383, page 1244
9384, page 1244
9385, page 1245
9386, page 1245
9387, page 1245
9388, page 1246
9389, page 1246
9390, page 1246
Alinity ci-series Operations Manual 1225
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Message codes Section 10
9391, page 1246
9392, page 1247
9393, page 1247
9395, page 1247
9394, page 1248
9397, page 1248
9398, page 1248
9399, page 1248
9400, page 1249
9401, page 1249
9402, page 1249
9403, page 1249
9404, page 1250
9405, page 1250
9406, page 1250
9407, page 1250
9408, page 1251
9409, page 1251
9410, page 1251
9411, page 1251
9412, page 1252
9413, page 1252
9414, page 1252
9415, page 1252
9416, page 1253
9417, page 1253
9418, page 1253
9419, page 1253
9421, page 1254
9422, page 1254
9423, page 1254
9424, page 1254
9426, page 1255
9427, page 1255
9428, page 1255
9429, page 1256
9430, page 1256
9431, page 1256
9432, page 1257
1226 Alinity ci-series Operations Manual
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Section 10 Message codes
9433, page 1257
9434, page 1257
9435, page 1258
9436, page 1258
9437, page 1258
9438, page 1259
9439, page 1259
9440, page 1259
9441, page 1260
9442, page 1260
9443, page 1260
9444, page 1260
9445, page 1261
9446, page 1261
9447, page 1261
9448, page 1261
9449, page 1262
9999, page 1262
Message code: 9000
Call Abbott. Runtime error occurred while running (0) (1): (2).
0 = Procedure number
1 = Procedure name
2 = Exception message
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9001
Call Abbott. Procedure file (0) is invalid.
0 = Decryption error message
Probable cause Corrective action
Procedure file error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Alinity ci-series Operations Manual 1227
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Message codes Section 10
Message code: 9002
Runtime error occurred while (0) (1) was running. Consecutive command errors occurred.
0 = Procedure number
1 = Procedure name
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9003
Call Abbott. Unable to create or update (0) (1) version (2). Error occurred: (3).
0 = Procedure number
1 = Procedure name
2 = Procedure version
3 = Error description
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9005
Unable to export (0) (1) version (2) to (3). Error occurred: (4).
0 = Procedure number
1 = Procedure name
2 = Procedure version
3 = USB flash drive
4 = Error description
Probable cause Corrective action
An error occurred while exporting files to a USB flash Review the specific message text. Perform the
drive. corrective action for the specific message text.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9008
Software error. Pipettor operation detected a timing error.
1228 Alinity ci-series Operations Manual
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Troubleshooting
Section 10 Message codes
Probable cause Corrective action
A timing error occurred during a pipettor operation. Rerun the test. Perform Rerun a test or an exception for
a specimen or control, page 612.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9009
Lockstep operation detected a timing error between (0) and (1).
0 = Mechanism
1 = Mechanism
Probable cause Corrective action
The operator cannot perform an operation on the device Start the processing module and the reagent and sample
that was indicated because of a conflict with another manager (RSM), page 447.
device.
The operator selected the Stop button while the Start the processing module and the reagent and sample
instrument status of a processing module is Running. manager (RSM), page 447.
Previous hardware failure. Contact Customer Service to resolve any hardware
failure.
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9010
Call Abbott. Motor command sent to R1 pipettor when reagent carousel was rotating.
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9011
Call Abbott. Motor command sent to R2 pipettor when reagent carousel was rotating.
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Alinity ci-series Operations Manual 1229
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Troubleshooting
Message codes Section 10
Related information...
Software message codes (9000-9999), page 1224
Message code: 9303
Call Abbott. Calibration failed for assay (0) number (1). Unknown math model.
0 = Assay name
1 = Assay number
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9304
Invalid read interval during data processing.
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9305
Calibration failed for assay (0) number (1). Memory allocation error.
0 = Assay name
1 = Assay number
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9306
Call Abbott. Calibration adjustment method (0) is not defined.
0 = Calibration adjustment method
1230 Alinity ci-series Operations Manual
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Troubleshooting
Section 10 Message codes
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9307
Call Abbott. Calibration method (0) is not defined.
0 = Calibration method
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9308
Call Abbott. (0) formula contains unknown variables (1).
0 = Formula
1 = Unknown variable
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9309
Call Abbott. An AbbottLink request message contains invalid parameters.
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9310
Unable to retrieve requested (0) (1) log.
0 = Log component
Alinity ci-series Operations Manual 1231
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Troubleshooting
Message codes Section 10
1 = Log name
Probable cause Corrective action
The requested log file cannot be retrieved by AbbottLink. Perform the procedure to restart AbbottLink.
Time-out occurred during log file retrieval to AbbottLink. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9311
Call Abbott. Unexpected archive failure.
Probable cause Corrective action
An unexpected error occurred when an archive was • Archive the file again. Perform Archive the results,
attempted. page 668.
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9314
Call Abbott. Software ICS application error.
Probable cause Corrective action
An error occurred when the informatics reply was Contact Customer Service. Provide information about
processed. the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9315
Call Abbott. Software unable to convert message to HL7.
Probable cause Corrective action
A software error occurred with the HL7 communication. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9316
Call Abbott. Software version mismatch.
1232 Alinity ci-series Operations Manual
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Troubleshooting
Section 10 Message codes
Probable cause Corrective action
A software version mismatch error occurred. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9324
Error occurred setting mail language to (0). Mail language will default to English.
0 = Language
Probable cause Corrective action
The operator configured a mail language that is not • Cycle power to the system, page 428.
supported by the operating system. • If the error continues, contact Customer Service.
Provide information about the operation that was
attempted when the error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9325
Invalid mail language (0).
0 = Language
Probable cause Corrective action
An invalid mail language was detected during software • Cycle power to the system, page 428.
startup. • If the error continues, contact Customer Service.
Provide information about the operation that was
attempted when the error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9329
Call Abbott. Software database error.
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9330
Lockstep timing error on (0).
Alinity ci-series Operations Manual 1233
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Troubleshooting
Message codes Section 10
0 = Device
Probable cause Corrective action
The operator cannot perform an operation on the device Start the processing module and the reagent and sample
that was indicated because of a conflict with another manager (RSM), page 447.
device.
The operator selected the Stop button while the Start the processing module and the reagent and sample
instrument status of a processing module is Running or manager (RSM), page 447.
Processing.
Previous hardware failure. Contact Customer Service to resolve any hardware
failure.
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9337
Firmware update failed on (0) board.
0 = Board
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9339
File transfer error between SCM and processing module. Error (0).
0 = Transfer error
Probable cause Corrective action
Power to the processing module is turned off. Power on the processing module, page 436.
The processing module is in the process of powering on. Wait until the processing module is powered on and the
instrument status of the module is Stopped.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9340
Call Abbott. Unable to calculate result. Optical read data not received from processing module.
1234 Alinity ci-series Operations Manual
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Section 10 Message codes
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9341
Call Abbott. Invalid optical read data received from processing module.
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9346
Successfully updated database (0) from version (1) to version (2).
0 = Database
1 = Version from
2 = Version to
Probable cause Corrective action
The database was updated. Status message. No corrective action is required.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9348
Call Abbott. Software error.
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9349
CPU firmware update failed.
Alinity ci-series Operations Manual 1235
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Troubleshooting
Message codes Section 10
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9350
DAQ firmware update failed.
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9351
Unknown processing module error (0).
0 = Error
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9352
Unable to add backup data to backup file (0).
0 = Backup file
Probable cause Corrective action
The system is unable to perform a backup. 1. Cycle power to the system, page 428.
2. Perform a manual backup, page 326.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9353
Troubleshooting package was retrieved successfully.
1236 Alinity ci-series Operations Manual
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Section 10 Message codes
Probable cause Corrective action
A troubleshooting package was successfully retrieved. Status message. No corrective action is required.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9355
System backup completed with error.
Probable cause Corrective action
The backup process was completed, but the software • Copy a backup to a USB flash drive, page 327.
was unable to copy the backup to the specified location. • Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9356
System backup (0) copied to external storage location (1).
0 = Backup file name
1 = File location
Probable cause Corrective action
The backup has been copied to an external storage Status message. No corrective action is required.
location.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9357
System software version not compatible. Version (0) required but version (1) installed.
0 = Version required
1 = Version installed
Probable cause Corrective action
The system attempted to install an invalid assay version. Obtain a new assay file for installation. Perform Install
assay files, page 272.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9358
(1) occurred during backup process (0). Backup did not complete successfully.
0 = Backup process
1 = Error
Alinity ci-series Operations Manual 1237
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Troubleshooting
Message codes Section 10
Probable cause Corrective action
The system is unable to complete the backup 1. Cycle power to the system, page 428.
successfully.
2. Perform a manual backup, page 326.
3. Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9359
Unable to copy or export completed backup file to location. (0).
0 = File location
Probable cause Corrective action
A copy of the backup file exists at the export location. Select a different backup file or a different export
location.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9360
Unable to copy or export backup file. (0).
0 = Error
Probable cause Corrective action
The system was unable to copy the backup file because 1. Perform a manual backup, page 326.
the file does not exist on the system.
2. Copy a backup to a USB flash drive, page 327.
3. Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9361
Export of backup files completed successfully.
Probable cause Corrective action
The backup file was copied and exported successfully Status message. No corrective action is required.
to a USB flash drive.
Related information...
Software message codes (9000-9999), page 1224
1238 Alinity ci-series Operations Manual
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Troubleshooting
Section 10 Message codes
Message code: 9362
Unable to copy backup to external location. (0) error.
0 = Error
Probable cause Corrective action
The backup file was not copied to the external location. • Verify that the correct USB flash drive was
selected.
• Verify that the USB flash drive is not full.
• Use a new USB flash drive.
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9363
Software performed (0) during backup process.
0 = Database repair
Probable cause Corrective action
The software performed the indicated database repair Status message. No corrective action is required.
during the backup process.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9364
Unable to create backup file. (0) (1).
0 = File included in backup
1 = Error
Probable cause Corrective action
The system was unable to create a backup file. • Perform a manual backup, page 326.
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9365
Unable to perform system backup. System not in correct status.
Probable cause Corrective action
The instrument is not in the correct status to perform the • Perform a manual backup, page 326.
system backup.
Alinity ci-series Operations Manual 1239
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Message codes Section 10
Probable cause Corrective action
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9366
Unexpected (0) error occurred after backup failed.
0 = Error
Probable cause Corrective action
An unexpected error occurred after a backup process • Perform a manual backup, page 326.
failed. • Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9367
Unable to delete (0) from backup.
0 = File name
Probable cause Corrective action
The system was unable to delete a file during the • Perform a manual backup, page 326.
backup process. • Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9368
Unable to complete system restore. (1) error occurred while deleting the current database (0).
0 = Database name
1 = Error
Probable cause Corrective action
The current database cannot be deleted before the Contact Customer Service. Provide information about
database is restored. the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
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Section 10 Message codes
Message code: 9369
Maximum number of backups exceeded. (0) backup deleted from external storage.
0 = Backup file name
Probable cause Corrective action
The maximum number of external backups was Status message. No corrective action is required.
exceeded. The oldest backup was deleted.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9370
Maximum number of backups exceeded. (0) backup deleted from internal storage.
0 = Backup file name
Probable cause Corrective action
The maximum number of internal backups was Status message. No corrective action is required.
exceeded. The oldest backup is deleted.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9371
System restore not performed. Backup archive does not match (0) manifest file.
0 = Manifest file
Probable cause Corrective action
The manifest file for the backup does not match the • Restore the database from a previously stored
manifest file for the previously stored backup. backup.
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9372
System restore not performed. (0) manifest file invalid.
0 = Manifest file
Probable cause Corrective action
The manifest file could not be read. • Restore the database from a previously stored
backup.
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
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Message codes Section 10
Related information...
Software message codes (9000-9999), page 1224
Message code: 9374
Manual backup (0) initiated.
0 = Backup file name
Probable cause Corrective action
A manual backup was initiated. Status message. No corrective action is required.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9375
System backup (0) completed with error.
0 = Backup file name
Probable cause Corrective action
The system backup was completed successfully, but the • Perform a manual backup, page 326.
backup file contained warnings. • Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9376
Scheduled automatic backup not performed.
Probable cause Corrective action
The scheduled automatic backup was not performed Status message. No corrective action is required.
because the system was powered off.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9377
System restore not performed. Unable to extract data from (0) backup file.
0 = Backup file name
Probable cause Corrective action
Data was unable to be extracted from the backup file. • Restore the database from a different previously
stored backup.
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
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Section 10 Message codes
Related information...
Software message codes (9000-9999), page 1224
Message code: 9378
System restore not performed. (0) backup archive file not found.
0 = Backup file name
Probable cause Corrective action
The backup file could not be accessed. • Restore the database from a different previously
stored backup.
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9379
System restore (0) completed successfully.
0 = Backup file name
Probable cause Corrective action
The system restore was completed successfully. Status message. No corrective action is required.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9380
System restore not performed. (1) error occurred while restoring (0) database.
0 = Database name
1 = Error
Probable cause Corrective action
The current database could not be restored. • Restore the database from a different previously
stored backup.
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9381
System restore not performed. (1) error occurred while restoring (0) directory.
0 = Directory
1 = Error
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Message codes Section 10
Probable cause Corrective action
The current database could not be restored. • Restore the database from a different previously
stored backup.
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9382
System restore not performed. (1) error occurred while restoring (0) file.
0 = File name
1 = Error
Probable cause Corrective action
The current backup could not be restored. • Restore the database from a different previously
stored backup.
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9383
System restore not performed. Unable to extract manifest from (0) backup file.
0 = Backup file name
Probable cause Corrective action
The current database could not be restored. • Restore the database from a different previously
stored backup.
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9384
System restore not performed. Restore manifest does not match selected (0) backup.
0 = Backup file name
Probable cause Corrective action
The manifest file for the system restore does not match • Restore the database from a different previously
the manifest file for the selected backup. stored backup.
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Section 10 Message codes
Probable cause Corrective action
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9385
System restore not performed. Restore manifest (0) not found.
0 = Manifest file name
Probable cause Corrective action
The manifest file was not found during the system • Restore the database from a different previously
restore. stored backup.
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9386
System restore failed. Software unable to restore current backup due to (0) error.
0 = Error
Probable cause Corrective action
The current backup could not be restored. • Restore the database from a different previously
stored backup.
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9387
System backup failed. (0).
0 = Error
Probable cause Corrective action
The system backup could not be performed. • Perform a manual backup, page 326.
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
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Message codes Section 10
Related information...
Software message codes (9000-9999), page 1224
Message code: 9388
System restore from (0) backup started.
0 = Backup file name
Probable cause Corrective action
The system restore process was initiated. Status message. No corrective action is required.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9389
Unexpected error (0) occurred while performing automatic backup.
0 = Error
Probable cause Corrective action
An error occurred when an automatic backup was • Perform a manual backup, page 326.
performed. • Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9390
Unexpected error (0) occurred while performing backup.
0 = Error
Probable cause Corrective action
An error occurred when the backup was performed. • Perform a manual backup, page 326.
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9391
Unexpected error (0) occurred while performing file export.
0 = Error
Probable cause Corrective action
An error occurred when the procedure to copy a backup • Perform Copy a backup to a USB flash drive, page
to a USB flash drive was performed. 327.
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Section 10 Message codes
Probable cause Corrective action
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9392
Unexpected error (0) occurred while performing requested operation.
0 = Error
Probable cause Corrective action
An error occurred when the backup was performed. • Perform a manual backup, page 326.
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9393
Unexpected error (0) occurred while completing system restore.
0 = Error
Probable cause Corrective action
An error occurred during a cleaning of the internal • Cycle power to the system, page 428.
restore directory after a backup was restored. • Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9395
(1) error occurred while getting available backups and accessing (0) file.
0 = File name
1 = Error
Probable cause Corrective action
An error occurred when available backup files were • Perform a manual backup, page 326.
accessed. • Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
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Message code: 9394
System restore not performed. Unexpected error (0) occurred.
0 = Error
Probable cause Corrective action
An error occurred when the system restore was • Restore the database from a previously stored
performed. backup.
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9397
Unable to send CLI command. Instrument is offline.
Probable cause Corrective action
The instrument is Offline. Verify that the instrument is powered on.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9398
Timeout occurred waiting for CLI command response.
Probable cause Corrective action
The system was unable to perform the requested CLI Contact Customer Service. Provide information about
command. the operation that was attempted when the error
occurred.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9399
Unknown error sending CLI command.
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
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Section 10 Message codes
Message code: 9400
Unable to retrieve selected troubleshooting package.
Probable cause Corrective action
The USB flash drive storage capacity is full. Use a USB flash drive with enough storage capacity to
retrieve the troubleshooting package.
The system was unable to retrieve the troubleshooting Contact Customer Service. Provide information about
package. the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9401
Selected troubleshooting package partially retrieved.
Probable cause Corrective action
The USB flash drive does not have enough storage Use a USB flash drive with enough storage capacity to
capacity to retrieve the troubleshooting package. retrieve the troubleshooting package.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9402
(1) error occurred extracting (0) package.
0 = Package name
1 = Error
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9403
(1) error occurred signing (0) package.
0 = Package name
1 = Error
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
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Related information...
Software message codes (9000-9999), page 1224
Message code: 9404
(1) error occurred counter signing (0) package.
0 = Package name
1 = Error
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9405
(1) error occurred creating (0) package.
0 = Package name
1 = Error
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9406
(1) error occurred verifying (0) package.
0 = Package name
1 = Error
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9407
System update completed successfully.
Probable cause Corrective action
The system update completed successfully. Status message. No corrective action is required.
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Section 10 Message codes
Related information...
Software message codes (9000-9999), page 1224
Message code: 9408
Unable to connect to the system during the power on process. IP address (0) invalid.
0 = IP address
Probable cause Corrective action
The host IP address is invalid. 1. Verify the host IP address. Perform Verify the HL7
communication, page 1307 or Verify the ASTM
communication, page 1308.
2. Request the system package download.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9409
Unknown system update download request received for (0).
0 = System update file
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9410
System update (0) download requested.
0 = System update file
Probable cause Corrective action
A download was requested for a system update. Status message. No corrective action is required.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9411
Unable to retrieve selected troubleshooting package. System not in correct status.
Probable cause Corrective action
The instrument was not in the correct status when a Transition the instrument to the correct status to retrieve
troubleshooting package was retrieved. the troubleshooting package.
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Related information...
Software message codes (9000-9999), page 1224
Message code: 9412
Unexpected error occurred while scheduling automatic backup (0). Automatic backup function may not
be available.
0 = Automatic backup
Probable cause Corrective action
Software error. • Perform a manual backup, page 326.
• Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9413
Unable to complete installation of system update due to startup error (1). Telnet IP address (0).
0 = Telnet IP address
1 = Error
Probable cause Corrective action
The system update was unable to be completed Request the system update again.
because of a startup failure.
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9414
System update status changed to (0).
0 = System update status
Probable cause Corrective action
The system update status was changed. Status message. No corrective action is required.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9415
Processing module (c-series) error. (0) (1,4:X4)/(2,4:X4)/(3,4:X4).
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Section 10 Message codes
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9416
Call Abbott. Calibration file (0) error.
0 = File name
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9417
Unable to execute CLI command. Unknown return code (0).
0 = Return code
Probable cause Corrective action
An invalid CLI command was entered. Enter a valid CLI command.
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9418
Unable to process test. Internal software error.
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9419
Unable to process test. Incomplete results found during system startup.
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Probable cause Corrective action
An unexpected error occurred or the system stopped Rerun the test. Perform Rerun a test or an exception for
before the test result was completed. a specimen or control, page 612.
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9421
Unable to process test. Internal software error.
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9422
Software error. Configuration file read error (0).
0 = Error
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9423
(0) board firmware not updated.
0 = Board
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9424
Archive failed. Unexpected error.
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Section 10 Message codes
Probable cause Corrective action
The archive to the USB flash drive failed. Archive the file again with a different USB flash drive.
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9426
Error writing pipettor calibration data to file.
Probable cause Corrective action
The software is unable to store the pipettor calibration 1. Repeat the applicable pipettor diagnostic
data. procedure. Perform Pipettors diagnostic procedure
1111 Sample Pipettor Check and Calibration (i-
series), page 796, 1112 R1 Pipettor Check and
Calibration (i-series), page 797, or 1113 R2 Pipettor
Check and Calibration (i-series), page 797.
2. If the error continues, contact Customer Service.
Provide information about the operation that was
attempted when the error occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9427
Unable to execute CLI command. (0) command is invalid.
0 = CLI command
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9428
Unable to execute CLI command. (0) file is invalid.
0 = File name
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Message codes Section 10
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9429
(0) CLI command received an unspecified error response.
0 = CLI command
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9430
Unable to execute CLI command. Incorrect number of CLI parameters (0).
0 = Number of parameters
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9431
Unable to execute CLI command. Incorrect number of parameters (0).
0 = Number of parameters
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
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Section 10 Message codes
Probable cause Corrective action
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9432
Unable to execute CLI command. Incorrect parameter value (0).
0 = Parameter value
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9433
Unable to execute CLI command. (0) process is unavailable.
0 = Software process
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9434
Unable to execute CLI command. (0) failed.
0 = CLI error
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
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Related information...
Software message codes (9000-9999), page 1224
Message code: 9435
Software error. Control configuration corrupted for lot (0).
0 = Control lot
Probable cause Corrective action
An error occurred in the configured quality control file Manually create a new quality control lot, page 295.
for the indicated lot number.
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9436
CLI Command Error. (0).
0 = Error
Probable cause Corrective action
A hardware error occurred during a maintenance or 1. Review the specific message text. Perform the
diagnostic procedure. corrective action for the specific message text.
2. Contact Customer Service to resolve any hardware
failure.
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9437
Module (0) (1) failed.
0 = Module
1 = Firmware board
Probable cause Corrective action
The firmware upgrade was not completed. Cycle power to the indicated processing module.
Perform Cycle power to the processing module and the
reagent and sample manager (RSM), page 432.
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
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Section 10 Message codes
Related information...
Software message codes (9000-9999), page 1224
Message code: 9438
(0) initialization failed.
0 = Firmware board
Probable cause Corrective action
A hardware initialization error occurred. Cycle power to the processing module. Perform Cycle
power to the processing module and the reagent and
sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9439
Module (0) (1) upgrade error. CRC mismatch.
0 = Module
1 = Firmware board
Probable cause Corrective action
A firmware board error occurred during an upgrade. Cycle power to the indicated processing module.
Perform Cycle power to the processing module and the
reagent and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9440
Module (0) (1) upgrade error. File CRC mismatch.
0 = Module
1 = Firmware board
Probable cause Corrective action
A firmware board error occurred during an upgrade. Cycle power to the indicated processing module.
Perform Cycle power to the processing module and the
reagent and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Software message codes (9000-9999), page 1224
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Message codes Section 10
Message code: 9441
Module (0) (1) upgrade error. File unreadable.
0 = Module
1 = Firmware board
Probable cause Corrective action
A firmware board error occurred during an upgrade. Cycle power to the indicated processing module.
Perform Cycle power to the processing module and the
reagent and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9442
Module (0) (1) application offline.
0 = Module
1 = Firmware board
Probable cause Corrective action
The high availability monitor detected an error. Cycle power to the indicated processing module.
Perform Cycle power to the processing module and the
reagent and sample manager (RSM), page 432.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9443
Unable to process test. Unit conversion formula (0) error.
0 = Formula
Probable cause Corrective action
The unit conversion formula evaluation failed. Rerun the test. Perform Rerun a test or an exception for
a specimen or control, page 612.
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9444
Unable to open calibrator data file (0). Invalid file.
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Section 10 Message codes
0 = Calibrator data file
Probable cause Corrective action
Software error. The calibrator file is damaged or Contact Customer Service. Provide information about
corrupted. the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9445
Calibrator data file (0) not accessible.
0 = Calibrator data file
Probable cause Corrective action
Software error. The calibrator file is damaged or Contact Customer Service. Provide information about
corrupted. the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9446
Quality control data file (0) does not contain printable quality control insert.
0 = Control data file
Probable cause Corrective action
Software error. The file is damaged or corrupted. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9447
Call Abbott. Unsupported reagent at RSM location (0).
0 = RSM location
Probable cause Corrective action
The system is not configured to support the reagent. Contact Customer Service to resolve the software
configuration error.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9448
Embedded software (0) upgrade failed.
0 = Embedded computer
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Message codes Section 10
Probable cause Corrective action
The software upgrade for the embedded computer 1. Perform Cycle power to the processing module and
failed. the reagent and sample manager (RSM), page 432
on the specified module.
2. If the embedded computer upgrade failed, perform
Cycle power to the system, page 428.
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9449
Embedded computer file corrupted (0).
0 = Embedded computer
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
Message code: 9999
Call Abbott.
Probable cause Corrective action
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Related information...
Software message codes (9000-9999), page 1224
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Section 10 Observed problems
Observed problems
Observed problems provide information about problems that may occur on the system and
provide corrective actions that help to resolve the problems.
If the corrective actions for an observed problem do not resolve the problem, contact the local
representative or find country-specific contact information at abbottdiagnostics.com.
NOTE: Corrective actions may involve hazardous activity. Use caution to minimize operator
exposure and to prevent personal injury or system damage. Examples of hazardous activities
include:
• The replacement of system probes.
• The use of reagents, calibrators, controls, and specimens.
• The removal of physical obstructions.
• The removal of system waste.
Related information...
Troubleshooting, page 917
Processing module observed problems , page 1263
Processing module observed problems (c-series), page 1264
Processing module observed problems (i-series), page 1268
Sample results observed problems (c-series), page 1270
Sample results observed problems (i-series), page 1276
User interface (UI) computer observed problems, page 1287
Printer observed problems, page 1288
Processing module observed problems
Processing module observed problems include problems that may occur on a processing
module.
Related information...
Observed problems, page 1263
A procedure failed and a procedure item remained in the reagent carousel, page 1263
A procedure failed and a procedure item remained in the reagent carousel
Probable cause Corrective action
A procedure failed before a procedure item was • Verify that the processing module status with the
removed from the reagent carousel. procedure item is Idle, Running, or Processing.
If the processing module status is Stopped, perform
Start the processing module and the reagent and
sample manager (RSM), page 447.
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Observed problems Section 10
Probable cause Corrective action
• To transition the RSM status to Running, perform
Initiate or resume sample processing, page 574.
When the RSM status is Running, the procedure
item is removed from the reagent carousel.
Related information...
Processing module observed problems , page 1263
Processing module observed problems (c-series)
Processing module observed problems for c-series include problems that may occur on the c-
series processing module.
Related information...
Observed problems, page 1263
1 mL wash solution syringe leaks (c-series), page 1264
Bubbles in ICT module tubing (c-series), page 1265
Bubbles in sample or reagent probe tubing (c-series), page 1265
Bubbles in the sample or reagent syringes (c-series), page 1266
ICT probe leaks (c-series), page 1266
Lamp is not on (c-series), page 1266
Liquid at the top of the cuvettes after washing (c-series), page 1266
Mixer is bent or is making an unexpected noise (c-series), page 1267
Reagent probe tubing is discolored or contains precipitate (c-series), page 1267
Sample or reagent probe is damaged or clogged (c-series), page 1267
Sample or reagent probe tubing leaks (c-series), page 1267
Sample or reagent syringe leaks (c-series), page 1268
1 mL wash solution syringe leaks (c-series)
Probable cause Corrective action
The syringe is not tightened at the check valve Tighten the check valve connection.
connection.
The syringe plunger is damaged. Replace the 1 mL syringes (c-series), page 865.
The check valve is defective. Replace the check valves (c-series), page 868.
The tubing is crimped or damaged. Contact Customer Service to resolve any hardware
failure.
Related information...
Processing module observed problems (c-series), page 1264
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Section 10 Observed problems
Bubbles in ICT module tubing (c-series)
Probable cause Corrective action
The ICT Reference Solution reservoir is empty, but the 1. Replace the ICT Reference Solution bottle. Perform
bottle sensor failed to detect it. Replace bulk solutions and update the inventory,
page 508.
2. Contact Customer Service to resolve any hardware
failure.
The ICT module O-rings are not seated correctly. Reseat the ICT module O-rings.
The ICT probe is not connected correctly. Tighten the probe to the ICT module by hand.
The ICT aspiration tubing is not connected correctly. Tighten the tubing connections at the top of the ICT
module and at the top of the 1 mL syringes in the ICT
aspiration pump.
The ICT probe is damaged. Replace the ICT probe. Perform Replace the ICT module
or the ICT probe (c-series), page 859.
The ICT check valves are not functioning. Perform Quarterly maintenance procedure 5805 Check
and Change ICT Check Valves (c-series), page 764.
The 1 mL syringes in the ICT aspiration pump or ICT Reseat the 1 mL syringes.
Reference Solution pump are not seated correctly.
The 1 mL syringes in the ICT aspiration pump or in the Perform Quarterly maintenance procedure 5804 Change
ICT Reference Solution pump are leaking. 1 mL Syringes (c-series), page 763.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Processing module observed problems (c-series), page 1264
Bubbles in sample or reagent probe tubing (c-series)
Probable cause Corrective action
The tubing connection to the sample or reagent syringe Tighten the tubing connections to the syringe body.
is loose.
The probe tubing is damaged. Perform Replace the reagent probe tubing (c-series),
page 840 or Replace the sample probe tubing (c-series),
page 837.
A syringe seal or an O-ring have failed. Perform Quarterly maintenance procedure 5801 Sample
Syringe Maintenance (c-series), page 761 or 5803
Reagent Syringe Maintenance (c-series), page 763.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Processing module observed problems (c-series), page 1264
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Observed problems Section 10
Bubbles in the sample or reagent syringes (c-series)
Probable cause Corrective action
The tubing connection to the sample or reagent syringe Tighten the tubing connections to the syringe body.
is loose.
A syringe seal or an O-ring have failed. Perform Quarterly maintenance procedure 5801 Sample
Syringe Maintenance (c-series), page 761 or 5803
Reagent Syringe Maintenance (c-series), page 763.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Processing module observed problems (c-series), page 1264
ICT probe leaks (c-series)
Probable cause Corrective action
The ICT module O-rings are not seated correctly. Reseat the ICT module O-rings.
The ICT probe is not connected correctly. Tighten the probe to the ICT module by hand.
The ICT aspiration tubing is not connected correctly. Tighten the tubing connections.
The ICT probe is damaged. Replace the ICT probe. Perform Replace the ICT module
or the ICT probe (c-series), page 859.
Related information...
Processing module observed problems (c-series), page 1264
Lamp is not on (c-series)
Probable cause Corrective action
The cable terminals are not securely connected to the Perform Quarterly maintenance procedure 5806 Change
terminal block. Lamp (c-series), page 764.
The lamp is out. Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
Related information...
Processing module observed problems (c-series), page 1264
Liquid at the top of the cuvettes after washing (c-series)
Probable cause Corrective action
The cuvette washer is not functioning correctly. Perform Weekly maintenance procedure 5601 Clean
Cuvettes with Detergent A (c-series), page 760 and
observe the cuvette washer nozzles for hanging drops,
leaks, or blockage in the tubing.
The cuvette dry tip is damaged. Replace the cuvette dry tip (c-series), page 852.
The reagent probe is damaged. Replace the reagent probes (c-series), page 832.
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Section 10 Observed problems
Probable cause Corrective action
The reagent probe is out of alignment. Perform Pipettors diagnostic procedure 4103 R1 Pipettor
Calibration (c-series), page 779 or 4104 R2 Pipettor
Calibration (c-series), page 779.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Processing module observed problems (c-series), page 1264
Mixer is bent or is making an unexpected noise (c-series)
Probable cause Corrective action
A mixer is installed incorrectly or is out of alignment. Replace the mixers (c-series), page 855.
Related information...
Processing module observed problems (c-series), page 1264
Reagent probe tubing is discolored or contains precipitate (c-series)
Probable cause Corrective action
The reagent probe tubing is discolored or contains Replace the reagent probe tubing (c-series), page 840.
precipitate.
Related information...
Processing module observed problems (c-series), page 1264
Sample or reagent probe is damaged or clogged (c-series)
Probable cause Corrective action
Particulate matter in the sample caused an obstruction Use a cleaning wire to dislodge particulate matter from
in the probe. the probe.
The sample or the reagent probe is damaged. Replace the reagent probes (c-series), page 832 or
Replace the sample probe (c-series), page 829.
A syringe seal or an O-ring has failed. Perform Quarterly maintenance procedure 5801 Sample
Syringe Maintenance (c-series), page 761 or 5803
Reagent Syringe Maintenance (c-series), page 763.
Related information...
Processing module observed problems (c-series), page 1264
Sample or reagent probe tubing leaks (c-series)
Probable cause Corrective action
The sample or the reagent probe tubing is damaged. Replace the reagent probe tubing (c-series), page 840 or
Replace the sample probe tubing (c-series), page 837.
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Observed problems Section 10
Probable cause Corrective action
A syringe seal or an O-ring has failed. Perform Quarterly maintenance procedure 5801 Sample
Syringe Maintenance (c-series), page 761 or 5803
Reagent Syringe Maintenance (c-series), page 763.
Related information...
Processing module observed problems (c-series), page 1264
Sample or reagent syringe leaks (c-series)
Probable cause Corrective action
The tubing connection to the sample or reagent syringe Tighten the tubing connections to the sample or reagent
is loose. syringe.
A syringe seal or an O-ring has failed. Perform Quarterly maintenance procedure 5801 Sample
Syringe Maintenance (c-series), page 761 or 5803
Reagent Syringe Maintenance (c-series), page 763.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Processing module observed problems (c-series), page 1264
Processing module observed problems (i-series)
Processing module observed problems for i-series include problems that may occur on the i-
series processing module.
Related information...
Observed problems, page 1263
Wash zone 1 or wash zone 2 wash monitoring test failure (i-series), page 1268
Wash zone 1 or wash zone 2 wash monitoring calibration failure (i-series), page 1269
Wash zone 1 or wash zone 2 wash monitoring test failure (i-series)
Probable cause Corrective action
For aspiration failures:
• The wash zone assembly is not seated correctly. 1. Loosen the knurled screws that secure the wash
zone assembly to the process path cover.
2. Reseat the wash zone assembly.
3. Tighten the knurled screws.
• The knurled screws that secure the wash zone 1. Tighten the four knurled screws that secure the
assembly to the process path are loose. wash zone elevator assembly to the process path.
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Section 10 Observed problems
Probable cause Corrective action
2. Tighten the two knurled screws that secure the
wash zone assembly to the wash zone elevator
assembly.
• A wash zone probe is out of alignment. Remove the wash zone probe. Realign the wash zone
probe in the wash zone probe housing. Perform Replace
the wash zone probes (i-series), page 897.
• The wash zone tubing connections are loose or Reconnect the wash zone tubing to the affected probe
leaking. for the indicated wash zone.
• A wash zone probe is obstructed. Replace the wash zone probes (i-series), page 897.
• The wash monitoring system is not calibrated. Perform the Calibration and Test option of Fluidics-
Wash diagnostic procedure 1261 Wash Zone 1 Wash
Monitoring (i-series), page 813 or 1262 Wash Zone 2
Wash Monitoring (i-series), page 814.
• Hardware failure. Contact Customer Service to resolve any hardware
failure.
For dispense failures:
• Bubbles are present in the wash buffer tubing. Perform the Flush and Prime Manifolds option of
Fluidics-Wash diagnostic procedure 1200 Flush and
Prime Fluidics (i-series), page 804.
• The diluted wash buffer level sensor is cracked. Replace the diluted wash buffer level sensor (i-series),
page 909.
• The wash monitoring system is not calibrated. Perform the Calibration and Test option of Fluidics-
Wash diagnostic procedure 1261 Wash Zone 1 Wash
Monitoring (i-series), page 813 or 1262 Wash Zone 2
Wash Monitoring (i-series), page 814.
• Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Processing module observed problems (i-series), page 1268
Wash zone 1 or wash zone 2 wash monitoring calibration failure (i-series)
Probable cause Corrective action
For aspiration failures:
• A wash zone probe is out of alignment. Remove the wash zone probe. Realign the wash zone
probe in the wash zone probe housing. Perform Replace
the wash zone probes (i-series), page 897.
• The wash zone tubing connections are loose or Reconnect the wash zone tubing to the affected probe
leaking. for the indicated wash zone.
• A wash zone probe is obstructed. Replace the wash zone probes (i-series), page 897.
• Hardware failure. Contact Customer Service to resolve any hardware
failure.
For dispense failures:
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Observed problems Section 10
Probable cause Corrective action
• Bubbles are present in the wash buffer tubing. Perform the Flush and Prime Manifolds option of
Fluidics-Wash diagnostic procedure 1200 Flush and
Prime Fluidics (i-series), page 804.
• The diluted wash buffer level sensor is cracked. Replace the diluted wash buffer level sensor (i-series),
page 909.
• Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Processing module observed problems (i-series), page 1268
Sample results observed problems (c-series)
Observed problems for sample results include problems that occur with the sample results on
the c-series processing module.
Related information...
Observed problems, page 1263
A#1 result flag (c-series), page 1270
A#2 result flag (c-series), page 1271
All ICT results have similar values: Na = 140, K = 4.0, Cl = 100 mmol/L (c-series), page 1272
Controls out of range (c-series), page 1272
Depressed concentration: ICT results entire run (c-series), page 1273
Depressed concentration: ICT results single assay (c-series), page 1273
Depressed concentration: K+ results single assay (c-series), page 1273
Depressed concentration: Photometric results entire run (c-series), page 1274
Depressed concentration: Photometric results single assay (c-series), page 1274
Elevated concentration: ICT results entire run (c-series), page 1275
Elevated concentration: ICT results single assay (c-series), page 1275
Elevated concentration: Photometric results single assay (c-series), page 1275
FLEX result flag (c-series), page 1276
PSHH result flag (c-series), page 1276
A#1 result flag (c-series)
Probable cause Corrective action
The sample concentration is too high. Dilute and rerun the sample. For the dilution protocol,
see the assay-specific reagent package insert.
The sample is lipemic. Ultra-centrifuge the sample and rerun the infranatant.
For more information about sample integrity, see the
assay-specific reagent package insert.
The reagent probe is damaged. Replace the reagent probes (c-series), page 832.
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Section 10 Observed problems
Probable cause Corrective action
The lamp was not seated correctly when it was Perform Quarterly maintenance procedure 5806 Change
replaced. Lamp (c-series), page 764.
The lamp is not performing as expected. Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
The reagent is not performing as expected. Load a new reagent.
The cuvettes are dirty. Perform Weekly maintenance procedure 5601 Clean
Cuvettes with Detergent A (c-series), page 760.
The cuvette washer is not functioning correctly. Perform Weekly maintenance procedure 5601 Clean
Cuvettes with Detergent A (c-series), page 760 and
observe the cuvette washer nozzles for hanging drops or
leaks.
The cuvette dry tip is damaged. Replace the cuvette dry tip (c-series), page 852.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Sample results observed problems (c-series), page 1270
Descriptions of specimen result flags, page 630
Descriptions of quality control result flags, page 632
A#2 result flag (c-series)
Probable cause Corrective action
The sample concentration is too high. Dilute and rerun the sample. For the dilution protocol,
see the assay-specific reagent package insert.
The sample is lipemic. Ultra-centrifuge the sample and rerun the infranatant.
For more information about sample integrity, see the
assay-specific reagent package insert.
The reagent probe is damaged. Replace the reagent probes (c-series), page 832.
The lamp was not seated correctly when it was Perform Quarterly maintenance procedure 5806 Change
replaced. Lamp (c-series), page 764.
The lamp is not performing as expected. Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
The reagent is not performing as expected. Load a new reagent.
The cuvettes are dirty. Perform Weekly maintenance procedure 5601 Clean
Cuvettes with Detergent A (c-series), page 760.
The cuvette washer is not functioning correctly. Perform Weekly maintenance procedure 5601 Clean
Cuvettes with Detergent A (c-series), page 760 and
observe the cuvette washer nozzles for hanging drops or
leaks.
The cuvette dry tip is damaged. Replace the cuvette dry tip (c-series), page 852.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
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Observed problems Section 10
Related information...
Sample results observed problems (c-series), page 1270
Descriptions of specimen result flags, page 630
Descriptions of quality control result flags, page 632
All ICT results have similar values: Na = 140, K = 4.0, Cl = 100 mmol/L (c-series)
Probable cause Corrective action
The ICT module O-rings are not seated correctly. Reseat the ICT module O-rings.
The ICT probe is not connected correctly. Tighten the probe to the ICT module by hand.
The ICT aspiration tubing is not connected correctly. Tighten the tubing connections.
The ICT probe is damaged. Replace the ICT probe. Perform Replace the ICT module
or the ICT probe (c-series), page 859.
The ICT check valves are not connected correctly. Tighten the connections to the 1 mL syringes in the ICT
aspiration pump.
The ICT check valves are not functioning. Perform Quarterly maintenance procedure 5805 Check
and Change ICT Check Valves (c-series), page 764.
The 1 mL syringes in the ICT aspiration pump or ICT Reseat the 1 mL syringes.
Reference Solution pump are not seated correctly.
The 1 mL syringes in the ICT aspiration pump or in the Perform Quarterly maintenance procedure 5804 Change
ICT Reference Solution pump are leaking. 1 mL Syringes (c-series), page 763.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Sample results observed problems (c-series), page 1270
Controls out of range (c-series)
Probable cause Corrective action
The controls are expired or have exceeded the open vial Open a new control.
stability in the control package insert.
The controls were stored incorrectly or were not stored Open a new control.
according to the storage conditions in the control
package insert.
The controls were reconstituted incorrectly. If the controls require reconstitution, verify the condition
of the diluent, the water, or the pipettors. For information
about quality control reconstitution, see the control
package insert.
A change to the system has occurred: 1. Verify that the bulk solutions were loaded correctly
• New bulk solutions were loaded. if new bulk solutions were recently loaded.
• The component was replaced. 2. Verify that the components were replaced correctly
• The instrument was calibrated. if components were recently replaced.
3. Recalibrate the assay.
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Section 10 Observed problems
Probable cause Corrective action
The sample volume in the sample cup or tube is Place an adequate volume of the sample in the cup or
inadequate. tube. Refer to the assay-specific insert for required
volumes.
Scheduled maintenance is due. Perform and verify that all required maintenance is
completed.
The calibration is not optimal. Recalibrate the assay and repeat the controls.
The cuvette washer is malfunctioning. Contact Customer Service to resolve any hardware
failure.
Related information...
Sample results observed problems (c-series), page 1270
Depressed concentration: ICT results entire run (c-series)
Probable cause Corrective action
The ICT module is expired or has exceeded time or Replace the ICT module. Perform Replace the ICT
sample warranty (> 3 months after installation or > module or the ICT probe (c-series), page 859.
20,000 samples).
The ICT module is not performing as expected. Replace the ICT module. Perform Replace the ICT
module or the ICT probe (c-series), page 859.
Related information...
Sample results observed problems (c-series), page 1270
Depressed concentration: ICT results single assay (c-series)
Probable cause Corrective action
The sample volume in the sample cup or tube is Place an adequate volume of the sample in the cup or
inadequate. tube. Refer to the assay-specific reagent package insert
for required volumes.
The ICT module is expired or has exceeded time or Replace the ICT module. Perform Replace the ICT
sample warranty (> 3 months after installation or > module or the ICT probe (c-series), page 859.
20,000 samples).
The ICT module is not performing as expected. Replace the ICT module. Perform Replace the ICT
module or the ICT probe (c-series), page 859.
Related information...
Sample results observed problems (c-series), page 1270
Depressed concentration: K+ results single assay (c-series)
Probable cause Corrective action
The cuvettes are dirty. Perform Weekly maintenance procedure 5601 Clean
Cuvettes with Detergent A (c-series), page 760.
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Observed problems Section 10
Probable cause Corrective action
The ICT module is contaminated. Replace the ICT module. Perform Replace the ICT
module or the ICT probe (c-series), page 859.
Related information...
Sample results observed problems (c-series), page 1270
Depressed concentration: Photometric results entire run (c-series)
Probable cause Corrective action
The lamp was not seated correctly when it was Perform Quarterly maintenance procedure 5806 Change
replaced. Lamp (c-series), page 764.
The lamp is not performing as expected. Perform Quarterly maintenance procedure 5806 Change
Lamp (c-series), page 764.
The sample probe is damaged. Replace the sample probe (c-series), page 829.
The sample probe is out of alignment. Perform Pipettor diagnostics procedure 4102 Sample
Pipettor Calibration (c-series), page 779.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Sample results observed problems (c-series), page 1270
Depressed concentration: Photometric results single assay (c-series)
Probable cause Corrective action
The sample volume in the sample cup or tube is Place adequate sample in the cup or tube. Refer to the
inadequate. assay-specific reagent package insert for required
volumes.
The calibration is not optimal. Recalibrate the assay and repeat the controls.
The reagent is not performing as expected. Load a new reagent.
The water bath temperature is too low. Verify that the temperature is within specifications.
Perform Temperature diagnostic procedure 4301
Temperature Status (c-series), page 784.
Protein buildup has formed inside the reagent probe. Replace the reagent probes (c-series), page 832.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Sample results observed problems (c-series), page 1270
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Section 10 Observed problems
Elevated concentration: ICT results entire run (c-series)
Probable cause Corrective action
The ICT module is expired or has exceeded time or Replace the ICT module. Perform Replace the ICT
sample warranty (> 3 months after installation or > module or the ICT probe (c-series), page 859.
20,000 samples).
The ICT module is not performing as expected. Replace the ICT module. Perform Replace the ICT
module or the ICT probe (c-series), page 859.
Related information...
Sample results observed problems (c-series), page 1270
Elevated concentration: ICT results single assay (c-series)
Probable cause Corrective action
The ICT module is expired or has exceeded time or Replace the ICT module. Perform Replace the ICT
sample warranty (> 3 months after installation or > module or the ICT probe (c-series), page 859.
20,000 samples).
The ICT module is not performing as expected. Replace the ICT module. Perform Replace the ICT
module or the ICT probe (c-series), page 859.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Sample results observed problems (c-series), page 1270
Elevated concentration: Photometric results single assay (c-series)
Probable cause Corrective action
The calibration is not optimal. Recalibrate the assay and repeat the controls.
The reagent is not performing as expected. Load a new reagent.
The water bath temperature is too high. Verify that the water bath temperature is within
specifications. Perform Temperature diagnostic
procedure 4301 Temperature Status (c-series), page
784.
Protein buildup has formed inside the reagent probe. Replace the reagent probes (c-series), page 832.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Related information...
Sample results observed problems (c-series), page 1270
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Observed problems Section 10
FLEX result flag (c-series)
Probable cause Corrective action
The sample concentration is high. Evaluate the result before it is reported. The sample can
be diluted and rerun. For the dilution protocol, see the
assay-specific reagent package insert.
Related information...
Sample results observed problems (c-series), page 1270
Descriptions of specimen result flags, page 630
Descriptions of quality control result flags, page 632
PSHH result flag (c-series)
Probable cause Corrective action
The ICT sample that was run before this sample had a Rerun the sample to verify that there was no effect from
concentration outside the linear or defined extreme the previous sample.
range.
Related information...
Sample results observed problems (c-series), page 1270
Descriptions of specimen result flags, page 630
Descriptions of quality control result flags, page 632
Sample results observed problems (i-series)
Observed problems for sample results include problems that occur with the sample results on
the i-series processing module.
Related information...
Observed problems, page 1263
Controls out of range (i-series), page 1277
Depressed concentration: Entire run, direct assay, with decreased RLUs (i-series), page 1277
Depressed concentration: Entire run, indirect assay, with increased RLUs (i-series), page 1278
Depressed concentration: Single point, direct assay, with decreased RLUs (i-series), page 1279
Depressed concentration: Single point, indirect assay, with increased RLUs (i-series), page 1280
Elevated concentration: Entire run, direct assay, with increased RLUs (i-series), page 1282
Elevated concentration: Entire run, indirect assay, with decreased RLUs (i-series), page 1282
Elevated concentration: Single point, direct assay, with increased RLUs (i-series), page 1283
Elevated concentration: Single point, indirect assay, with decreased RLUs (i-series), page 1284
Erratic assay results (i-series), page 1285
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Troubleshooting
Section 10 Observed problems
Controls out of range (i-series)
Probable cause Corrective action
Controls are expired or have exceeded the open vial Open new controls.
stability in the control package insert.
Controls were stored incorrectly or were not stored Open new controls.
according to the storage conditions in the control
package insert.
Controls were incorrectly reconstituted. If controls require reconstitution, verify the condition of
the diluent, the water, or the pipettors. For information
about quality control reconstitution, see the control
package insert.
A change to the system has occurred: 1. Verify that the bulk solutions were loaded correctly
• New bulk solutions were loaded. if new bulk solutions were recently loaded.
• A component was replaced. 2. Verify that the components were replaced correctly
• The instrument was calibrated. if components were recently replaced.
3. Recalibrate the assay.
The sample volume in the sample cup or tube was Place adequate sample in the cup or tube. Refer to the
inadequate. assay-specific reagent package insert for required
volumes.
The wrong quality control lot was used. Use the correct quality control lot for the established
quality control ranges.
Establish new quality control ranges as required.
Scheduled maintenance is due. Perform all required maintenance.
The calibration is not optimal. Recalibrate the assay.
Related information...
Sample results observed problems (i-series), page 1276
Depressed concentration: Entire run, direct assay, with decreased RLUs (i-series)
Probable cause Corrective action
The wash zone assembly is leaking. Hardware failure.
The pipettor or wash zone assembly tubing connections Tighten the pipettor or wash zone assembly tubing
are loose. connections.
The diluted wash buffer level sensor assembly is Replace the diluted wash buffer level sensor (i-series),
cracked or leaking. page 909.
Bubbles are present in the wash buffer tubing. Perform Fluidics-Wash diagnostics procedure 1200
Flush and Prime Fluidics (i-series), page 804.
The wash zone probes are not seated correctly in the Reseat the wash zone probes. Perform Replace the
wash zone motor assembly. wash zone probes (i-series), page 897.
The wash zone probes are bent or damaged. Perform Replace the wash zone probes (i-series), page
897.
Alinity ci-series Operations Manual 1277
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Troubleshooting
Observed problems Section 10
Probable cause Corrective action
The wash buffer dispense at the wash zones is Perform Fluidics-Wash diagnostic procedure 1221 Wash
inadequate. Zone 1 Precision and Accuracy (i-series), page 809 or
1222 Wash Zone 2 Precision and Accuracy (i-series),
page 809.
The sample probe is obstructed. Perform the Flush Wash Buffer option of the Fluidics-
Wash diagnostic procedure 1200 Flush and Prime
Fluidics (i-series), page 804. Verify that the pipettors
dispense liquid and no leaks or bubbles are observed in
the tubing.
Perform Replace a sample or reagent pipettor probe (i-
series), page 894.
The vortexer failed. Contact Customer Service to resolve any hardware
failure.
Related information...
Sample results observed problems (i-series), page 1276
Depressed concentration: Entire run, indirect assay, with increased RLUs (i-series)
Probable cause Corrective action
The wash zone assembly is leaking. Hardware failure.
The pipettor or wash zone assembly tubing connections Tighten the pipettor or wash zone assembly tubing
are loose. connections.
The diluted wash buffer level sensor assembly is Replace the diluted wash buffer level sensor (i-series),
cracked or leaking. page 909.
Bubbles are present in the wash buffer tubing. Perform the Flush Wash Buffer option of the Fluidics-
Wash diagnostic procedure 1200 Flush and Prime
Fluidics (i-series), page 804.
The wash zone probes are not seated correctly in the Reseat the wash zone probes. Perform Replace the
probe block assembly. wash zone probes (i-series), page 897.
The wash zone probes are bent or damaged. Perform Replace the wash zone probes (i-series), page
897.
The wash buffer dispense at the wash zones is Perform Fluidics-Wash diagnostic procedure 1221 Wash
inadequate. Zone 1 Precision and Accuracy (i-series), page 809 or
1222 Wash Zone 2 Precision and Accuracy (i-series),
page 809.
The vortexer failed. Contact Customer Service to resolve any hardware
failure.
Related information...
Sample results observed problems (i-series), page 1276
1278 Alinity ci-series Operations Manual
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Troubleshooting
Section 10 Observed problems
Depressed concentration: Single point, direct assay, with decreased RLUs (i-series)
Probable cause Corrective action
The reagent was stored incorrectly. Load a new reagent.
The reagent was not mixed correctly when it was Upon receipt, gently invert the unopened reagent kit by
received. rotating it over and back for a full 180 degrees, five
times with the green label stripe facing up and then five
times with the green label stripe facing down. This
process ensures that the liquid covers all sides of the
bottles within the cartridges. During reagent shipment,
microparticles can settle on the reagent cartridge
septum.
The reagent is contaminated. Load a new reagent.
The Pre-Trigger Solution or the Trigger Solution sensor Replace the appropriate level sensor as required.
is cracked. Perform Replace the level sensor for Pre-Trigger
Solution, Trigger Solution, or Concentrated Wash Buffer
(i-series), page 906.
The Pre-Trigger Solution or the Trigger Solution Perform Fluidics-Wash diagnostic procedure 1210 Pre-
dispense is inadequate. Trigger Precision and Accuracy (i-series), page 807 or
1211 Trigger Precision and Accuracy (i-series), page
808.
The wash zone assembly is leaking. Hardware failure.
The diluted wash buffer level sensor assembly is Replace the diluted wash buffer level sensor (i-series),
cracked or leaking. page 909.
Bubbles are present in the wash buffer tubing. Perform the Flush Wash Buffer option of the Fluidics-
Wash diagnostic procedure 1200 Flush and Prime
Fluidics (i-series), page 804.
The wash zone probes are not seated correctly in the Reseat the wash zone probes. Perform Replace the
probe block assembly. wash zone probes (i-series), page 897.
The wash zone probes are bent or damaged. Replace the wash zone probes (i-series), page 897.
The wash buffer dispense at the wash zones is Perform Fluidics-Wash diagnostic procedure 1221 Wash
inadequate. Zone 1 Precision and Accuracy (i-series), page 809 or
1222 Wash Zone 2 Precision and Accuracy (i-series),
page 809.
The sample probe is obstructed. Perform the Flush Wash Buffer option of the Fluidics-
Wash diagnostic procedure 1200 Flush and Prime
Fluidics (i-series), page 804. Verify that the pipettors
dispense liquid and no leaks or bubbles are observed in
the tubing.
Replace the sample probe. Perform Replace a sample or
reagent pipettor probe (i-series), page 894.
The sample probe is damaged. Replace the sample probe. Perform Replace a sample or
reagent pipettor probe (i-series), page 894.
The sample probe is not positioned correctly. Perform the Calibration option of the Pipettor diagnostic
procedure 1111 Sample Pipettor Check and Calibration
(i-series), page 796.
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Troubleshooting
Observed problems Section 10
Probable cause Corrective action
Bubbles or foam are present on the surface of the Remove all bubbles or foam from the sample by using a
sample. clean disposable pipette or applicator stick.
The sample volume in the sample cup or tube is Place adequate sample in the cup or tube. Refer to the
inadequate. assay-specific reagent package insert for required
volumes.
The pipettor probes are not straight. Perform Pipettors diagnostic procedure 1111 Sample
Pipettor Check and Calibration (i-series), page 796, 1112
R1 Pipettor Check and Calibration (i-series), page 797,
or 1113 R2 Pipettor Check and Calibration (i-series),
page 797.
The pipettor probes are not aligned. Perform Pipettors diagnostic procedure 1111 Sample
Pipettor Check and Calibration (i-series), page 796, 1112
R1 Pipettor Check and Calibration (i-series), page 797,
or 1113 R2 Pipettor Check and Calibration (i-series),
page 797.
The syringe assembly or valve is leaking. Contact Customer Service to resolve any hardware
failure.
The pipettor aspiration or dispense is insufficient. Perform Pipettors diagnostic procedure 1120 Sample
Pipettor Syringe Precision and Accuracy (i-series), page
798, 1121 R1 Pipettor Syringe Precision and Accuracy (i-
series), page 799, or 1122 R2 Pipettor Syringe Precision
and Accuracy (i-series), page 800.
The R1 or the R2 probe is obstructed. Perform the Flush Wash Buffer option of the Fluidics-
Wash diagnostic procedure 1200 Flush and Prime
Fluidics (i-series), page 804. Verify that the pipettors
dispense liquid and no leaks or bubbles are observed in
the tubing.
Replace the appropriate probe. Perform Replace a
sample or reagent pipettor probe (i-series), page 894.
The R1 or the R2 pipettor probe is not positioned Perform the Calibration option of the Pipettors
correctly. diagnostic procedure 1112 R1 Pipettor Check and
Calibration (i-series), page 797 or 1113 R2 Pipettor
Check and Calibration (i-series), page 797.
The wash zone assembly is not seated correctly on the Contact Customer Service to resolve any hardware
process path. failure.
The vortexer failed. Contact Customer Service to resolve any hardware
failure.
Related information...
Sample results observed problems (i-series), page 1276
Depressed concentration: Single point, indirect assay, with increased RLUs (i-series)
Probable cause Corrective action
Bubbles or foam are present on the surface of the Remove all bubbles or foam from the sample by using a
sample. clean disposable pipette or applicator stick.
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Troubleshooting
Section 10 Observed problems
Probable cause Corrective action
The sample volume in the sample cup or tube is Place adequate sample in the cup or tube. Refer to the
inadequate. assay-specific reagent package insert for required
volumes.
The sample cup or tube was not placed correctly in the Reseat the sample cup or tube in the rack.
rack.
The sample probe is not positioned correctly. Perform the Calibration option of the Pipettors
diagnostic procedure 1111 Sample Pipettor Check and
Calibration (i-series), page 796.
The R2 pipettor tubing connections are loose. Tighten the R2 pipettor tubing connections.
The R2 pipettor is not positioned correctly. Perform the Calibration option of the Pipettors
diagnostic procedure 1113 R2 Pipettor Check and
Calibration (i-series), page 797.
The R2 syringe assembly or valve is leaking. Contact Customer Service to resolve any hardware
failure.
The wash zone assembly is not seated correctly on the Contact Customer Service to resolve any hardware
process path. failure.
The Pre-Trigger Solution or the Trigger Solution sensor Replace the appropriate level sensor as required.
is cracked. Perform Replace the level sensor for Pre-Trigger
Solution, Trigger Solution, or Concentrated Wash Buffer
(i-series), page 906.
Bubbles are present in the Pre-Trigger Solution or the Perform the Flush Wash Buffer option of the Fluidics-
Trigger Solution tubing. Wash diagnostic procedure 1200 Flush and Prime
Fluidics (i-series), page 804. Verify that the pipettors
dispense liquid and no leaks or bubbles are observed in
the tubing.
The Pre-Trigger Solution or the Trigger Solution Perform Fluidics-Wash diagnostic procedure 1210 Pre-
dispense is inadequate. Trigger Precision and Accuracy (i-series), page 807 or
1211 Trigger Precision and Accuracy (i-series), page
808.
The wash zone assembly is leaking. Hardware failure.
The wash zone probes are not seated correctly in the Reseat the wash zone probes. Perform Replace the
probe block assembly. wash zone probes (i-series), page 897.
The diluted wash buffer level sensor assembly is Replace the diluted wash buffer level sensor (i-series),
cracked. page 909.
Bubbles are present in the wash buffer tubing. Perform the Flush Wash Buffer option of the Fluidics-
Wash diagnostic procedure 1200 Flush and Prime
Fluidics (i-series), page 804.
The wash zone probes are bent or damaged. Replace the wash zone probes (i-series), page 897.
The wash buffer dispense at the wash zones is Perform Fluidics-Wash diagnostic procedure 1221 Wash
inadequate. Zone 1 Precision and Accuracy (i-series), page 809 or
1222 Wash Zone 2 Precision and Accuracy (i-series),
page 809.
Static electricity is present. Contact Customer Service to resolve any hardware
failure.
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Troubleshooting
Observed problems Section 10
Probable cause Corrective action
The vortexer failed. Contact Customer Service to resolve any hardware
failure.
Related information...
Sample results observed problems (i-series), page 1276
Elevated concentration: Entire run, direct assay, with increased RLUs (i-series)
Probable cause Corrective action
The wash zone assembly is leaking. Contact Customer Service to resolve any hardware
failure.
The diluted wash buffer level sensor is cracked. Replace the diluted wash buffer level sensor (i-series),
page 909.
Bubbles are present in the wash buffer tubing. Perform the Flush Wash Buffer option of the Fluidics-
Wash diagnostic procedure 1200 Flush and Prime
Fluidics (i-series), page 804.
The wash zone probes are not seated correctly in the Reseat the wash zone probes. Perform Replace the
probe block assembly. wash zone probes (i-series), page 897.
The wash zone probes are bent or damaged. Replace the wash zone probes (i-series), page 897.
The wash buffer dispense at the wash zones is Perform Fluidics-Wash diagnostic procedure 1221 Wash
inadequate. Zone 1 Precision and Accuracy (i-series), page 809 or
1222 Wash Zone 2 Precision and Accuracy (i-series),
page 809.
The vortexer failed. Contact Customer Service to resolve any hardware
failure.
Related information...
Sample results observed problems (i-series), page 1276
Elevated concentration: Entire run, indirect assay, with decreased RLUs (i-series)
Probable cause Corrective action
The wash zone assembly is leaking. Hardware failure.
The pipettor or wash zone assembly tubing connections Tighten the pipettor or wash zone assembly tubing
are loose. connections.
The diluted wash buffer level sensor is cracked. Replace the diluted wash buffer level sensor (i-series),
page 909.
Bubbles are present in the wash buffer tubing. Perform the Flush Wash Buffer option of the Fluidics-
Wash diagnostic procedure 1200 Flush and Prime
Fluidics (i-series), page 804.
The wash zone probes are not seated correctly in the Reseat the wash zone probes. Perform Replace the
probe block assembly. wash zone probes (i-series), page 897.
The wash zone probes are bent or damaged. Replace the wash zone probes (i-series), page 897.
The wash buffer dispense at the wash zones is Perform Fluidics-Wash diagnostic procedure 1221 Wash
inadequate. Zone 1 Precision and Accuracy (i-series), page 809 or
1282 Alinity ci-series Operations Manual
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Troubleshooting
Section 10 Observed problems
Probable cause Corrective action
1222 Wash Zone 2 Precision and Accuracy (i-series),
page 809.
The probe is obstructed. Perform the Flush Wash Buffer option of the Fluidics-
Wash diagnostic procedure 1200 Flush and Prime
Fluidics (i-series), page 804 and observe that the
pipettors dispense liquid and no leaks or bubbles are
observed in the tubing.
Replace the appropriate probe. Perform Replace a
sample or reagent pipettor probe (i-series), page 894.
The vortexer failed. Contact Customer Service to resolve any hardware
failure.
Related information...
Sample results observed problems (i-series), page 1276
Elevated concentration: Single point, direct assay, with increased RLUs (i-series)
Probable cause Corrective action
The reagent was stored incorrectly. Load a new reagent.
The reagent was not mixed correctly when it was Upon receipt, gently invert the unopened reagent kit by
received. rotating it over and back for a full 180 degrees, five
times with the green label stripe facing up and then five
times with the green label stripe facing down. This
process ensures that the liquid covers all sides of the
bottles within the cartridges. During reagent shipment,
microparticles can settle on the reagent cartridge
septum.
The Pre-Trigger Solution or the Trigger Solution sensor Replace the appropriate level sensor as required.
is cracked. Perform Replace the level sensor for Pre-Trigger
Solution, Trigger Solution, or Concentrated Wash Buffer
(i-series), page 906.
Bubbles are present in the tubing. Perform Fluidics-Wash diagnostic procedure 1200 Flush
and Prime Fluidics (i-series), page 804.
The Pre-Trigger Solution or the Trigger Solution Perform Fluidics-Wash diagnostic procedure 1210 Pre-
dispense is inadequate. Trigger Precision and Accuracy (i-series), page 807 or
1211 Trigger Precision and Accuracy (i-series), page
808.
The wash zone assembly is leaking. Hardware failure.
The diluted wash buffer level sensor is cracked. Replace the diluted wash buffer level sensor (i-series),
page 909.
The wash zone probes are not seated correctly in the Reseat the wash zone probes. Perform Replace the
probe block assembly. wash zone probes (i-series), page 897.
The wash zone probes are bent or damaged. Replace the wash zone probes (i-series), page 897.
The wash buffer dispense at the wash zones is Perform Fluidics-Wash diagnostic procedure 1221 Wash
inadequate. Zone 1 Precision and Accuracy (i-series), page 809 or
Alinity ci-series Operations Manual 1283
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Troubleshooting
Observed problems Section 10
Probable cause Corrective action
1222 Wash Zone 2 Precision and Accuracy (i-series),
page 809.
The probe is dirty or partially obstructed. Perform Fluidics-Wash diagnostic procedure 1200 Flush
and Prime Fluidics (i-series), page 804 and observe that
the pipettors dispense liquid and no leaks or bubbles are
observed in the tubing.
Replace the appropriate probe. Perform Replace a
sample or reagent pipettor probe (i-series), page 894.
The probe is damaged. Replace the appropriate probe. Perform Replace a
sample or reagent pipettor probe (i-series), page 894.
The sample probe is not positioned correctly. Perform Pipettors diagnostic procedure 1111 Sample
Pipettor Check and Calibration (i-series), page 796.
The R2 pipettor tubing connections are loose. Tighten the R2 pipettor tubing connections.
The R2 pipettor is not positioned correctly. Perform the Calibration option of the Pipettors
diagnostic procedure 1113 R2 Pipettor Check and
Calibration (i-series), page 797.
The R2 syringe assembly or valve is leaking. Contact Customer Service to resolve any hardware
failure.
Static electricity is present. Contact Customer Service to resolve any hardware
failure.
The vortexer failed. Contact Customer Service to resolve any hardware
failure.
Related information...
Sample results observed problems (i-series), page 1276
Elevated concentration: Single point, indirect assay, with decreased RLUs (i-series)
Probable cause Corrective action
The reagent was stored incorrectly. Load a new reagent.
The reagent was not mixed correctly when it was Upon receipt, gently invert the unopened reagent kit by
received. rotating it over and back for a full 180 degrees, five
times with the green label stripe facing up and then five
times with the green label stripe facing down. This
process ensures that the liquid covers all sides of the
bottles within the cartridges. During reagent shipment,
microparticles can settle on the reagent cartridge
septum.
Refer to the assay documentation for additional assay-
specific mixing instructions.
The Pre-Trigger Solution or the Trigger Solution sensor Replace the appropriate level sensor as required.
is cracked. Perform Replace the level sensor for Pre-Trigger
Solution, Trigger Solution, or Concentrated Wash Buffer
(i-series), page 906.
Bubbles are present in the tubing. Perform Fluidics-Wash diagnostic procedure 1200 Flush
and Prime Fluidics (i-series), page 804.
1284 Alinity ci-series Operations Manual
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Troubleshooting
Section 10 Observed problems
Probable cause Corrective action
The Pre-Trigger Solution or the Trigger Solution Perform Fluidics-Wash diagnostic procedure 1210 Pre-
dispense is inadequate. Trigger Precision and Accuracy (i-series), page 807 or
1211 Trigger Precision and Accuracy (i-series), page
808.
The wash zone assembly is leaking. Hardware failure.
The diluted wash buffer level sensor assembly is Replace the diluted wash buffer level sensor (i-series),
cracked or leaking. page 909.
The wash zone probes are not seated correctly in the Reseat the wash zone probes. Perform Replace the
probe block assembly. wash zone probes (i-series), page 897.
The wash zone probes are bent or damaged. Replace the wash zone probes (i-series), page 897.
The wash buffer dispense at the wash zones is Perform Fluidics-Wash diagnostic procedure 1221 Wash
inadequate. Zone 1 Precision and Accuracy (i-series), page 809 or
1222 Wash Zone 2 Precision and Accuracy (i-series),
page 809.
The probe is dirty or partially obstructed. Perform Fluidics-Wash diagnostic procedure 1200 Flush
and Prime Fluidics (i-series), page 804 and observe that
the pipettors dispense liquid and no leaks or bubbles are
observed in the tubing.
Replace the appropriate probe. Perform Replace a
sample or reagent pipettor probe (i-series), page 894.
The probe is damaged. Replace the appropriate probe. Perform Replace a
sample or reagent pipettor probe (i-series), page 894.
The sample probe is not positioned correctly. Perform Pipettors diagnostic procedure 1111 Sample
Pipettor Check and Calibration (i-series), page 796.
The syringe assembly or valve is leaking. Contact Customer Service to resolve any hardware
failure.
The R1 or R2 probe obstructed. Perform Fluidics-Wash diagnostic procedure 1200 Flush
and Prime Fluidics (i-series), page 804 and observe that
the pipettors dispense liquid and no leaks or bubbles are
observed in the tubing.
Replace the appropriate probe. Perform Replace a
sample or reagent pipettor probe (i-series), page 894.
The wash zone assembly is not seated correctly on the Contact Customer Service to resolve any hardware
process path. failure.
The optics or vortexer failed. Contact Customer Service to resolve any hardware
failure.
Related information...
Sample results observed problems (i-series), page 1276
Erratic assay results (i-series)
Probable cause Corrective action
The reagent was stored incorrectly. Load a new reagent.
The reagent is contaminated. Load a new reagent.
Alinity ci-series Operations Manual 1285
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Troubleshooting
Observed problems Section 10
Probable cause Corrective action
The reagent was not mixed correctly when it was Upon receipt, gently invert the unopened reagent kit by
received. rotating it over and back for a full 180 degrees, five
times with the green label stripe facing up and then five
times with the green label stripe facing down. This
process ensures that the liquid covers all sides of the
bottles within the cartridges. During reagent shipment,
microparticles can settle on the reagent cartridge
septum.
Refer to the assay documentation for additional assay-
specific mixing instructions.
Bubbles are present in the tubing. Perform Fluidics-Wash diagnostic procedure 1200 Flush
and Prime Fluidics (i-series), page 804.
The Pre-Trigger Solution or the Trigger Solution sensor Replace the appropriate level sensor as required.
is cracked. Perform Replace the level sensor for Pre-Trigger
Solution, Trigger Solution, or Concentrated Wash Buffer
(i-series), page 906.
The tubing connections are loose. Tighten the tubing connections.
The Pre-Trigger Solution or the Trigger Solution Perform Fluidics-Wash diagnostic procedure 1210 Pre-
dispense is inadequate. Trigger Precision and Accuracy (i-series), page 807 or
1211 Trigger Precision and Accuracy (i-series), page
808.
The wash zone assembly is leaking. Hardware failure.
The wash zone probes are not seated correctly in the Reseat the wash zone probes. Perform Replace the
probe block assembly. wash zone probes (i-series), page 897.
The diluted wash buffer level sensor assembly is Replace the diluted wash buffer level sensor (i-series),
cracked or leaking. page 909.
The wash zone probes are bent or damaged. Replace the wash zone probes (i-series), page 897.
The wash buffer dispense at the wash zones is Perform Fluidics-Wash diagnostic procedure 1221 Wash
inadequate. Zone 1 Precision and Accuracy (i-series), page 809 or
1222 Wash Zone 2 Precision and Accuracy (i-series),
page 809.
The sample was not collected or prepared correctly. • Follow the specimen collection and handling
instructions in the assay-specific reagent package
insert.
• Rerun the sample.
• Source another sample if the issue is not resolved.
The sample volume in the sample cup or tube is Place adequate sample in the cup or tube. Refer to the
inadequate. assay-specific insert for required volumes.
The sample contains fibrin clots or particulate matter. Examine samples for fibrin or other large particles.
Remove fibrin clots with a clean applicator stick or
centrifuge samples.
Bubbles or foam are present on the surface of the Remove all bubbles or foam from the sample by using a
sample. clean disposable pipette or applicator stick.
1286 Alinity ci-series Operations Manual
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Troubleshooting
Section 10 Observed problems
Probable cause Corrective action
The sample probe is not positioned correctly. Perform the Calibration option of the Pipettor diagnostic
procedure 1111 Sample Pipettor Check and Calibration
(i-series), page 796.
The pipettor probes are not straight. Perform the Probe Straightness option of the Pipettors
diagnostic procedure 1111 Sample Pipettor Check and
Calibration (i-series), page 796, 1112 R1 Pipettor Check
and Calibration (i-series), page 797, or 1113 R2 Pipettor
Check and Calibration (i-series), page 797.
The probe is not positioned correctly. Perform Pipettors diagnostic procedure 1111 Sample
Pipettor Check and Calibration (i-series), page 796, 1112
R1 Pipettor Check and Calibration (i-series), page 797,
or 1113 R2 Pipettor Check and Calibration (i-series),
page 797.
The probe is dirty or partially obstructed. Replace the appropriate probe. Perform Replace a
sample or reagent pipettor probe (i-series), page 894.
The probe is damaged. Replace the appropriate probe. Perform Replace a
sample or reagent pipettor probe (i-series), page 894.
The water quality is below specifications. Verify that the purified water purity is within
specifications.
The pipettor aspiration or dispense is insufficient. Perform Pipettors diagnostic procedure 1120 Sample
Pipettor Syringe Precision and Accuracy (i-series), page
798, 1121 R1 Pipettor Syringe Precision and Accuracy (i-
series), page 799, or 1122 R2 Pipettor Syringe Precision
and Accuracy (i-series), page 800.
Static electricity is present. Contact Customer Service to resolve any hardware
failure.
The vortexer failed. Contact Customer Service to resolve any hardware
failure.
Related information...
Sample results observed problems (i-series), page 1276
User interface (UI) computer observed problems
User interface (UI) computer observed problems include problems that occur with the system
software, the UI computer, or external systems (for example, the host, AbbottLink, and Alinity
PRO).
Related information...
Observed problems, page 1263
Assay files on the USB flash drive are missing, page 1288
User interface does not respond, page 1288
Alinity ci-series Operations Manual 1287
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Troubleshooting
Observed problems Section 10
Assay files on the USB flash drive are missing
Probable cause Corrective action
On the Available Files tab of the Install/Uninstall Assays If the assay is located on a USB flash drive, insert the
screen, the USB Flash Drive button was not selected. USB flash drive, and then tap the USB Flash Drive
button.
Assay files were not unzipped after the files were If more than one assay file package is selected from
downloaded from abbottdiagnostics.com. abbottdiagnostics.com, the files are available as a zip
file. The files must be unzipped before they are installed
on the Alinity system.
Related information...
User interface (UI) computer observed problems, page 1287
User interface does not respond
Probable cause Corrective action
Software error. 1. Open the system control module (SCM) front door.
2. Briefly press the power switch on the user interface
(UI) computer. The software shuts down and the UI
computer powers off.
3. Power on the UI computer.
4. Cycle power to the processing module and the
reagent and sample manager (RSM), page 432.
Related information...
User interface (UI) computer observed problems, page 1287
Printer observed problems
Printer observed problems include problems that may occur with the printer or while printing
reports.
Related information...
Observed problems, page 1263
Printer is not displayed in the print location drop-down list, page 1289
Print screen output is configured for the default printer but the print screen is saved to a file, page
1289
When reports are viewed as a PDF, a warning is displayed: "At least one signature has a problem",
page 1289
1288 Alinity ci-series Operations Manual
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Troubleshooting
Section 10 Observed problems
Printer is not displayed in the print location drop-down list
Probable cause Corrective action
A printer is not configured. Add a printer, page 180.
A printer is not verified. Verify a printer, page 182.
Related information...
Printer observed problems, page 1288
Print screen output is configured for the default printer but the print screen is saved to a file
Probable cause Corrective action
A default printer is not configured. Add a printer, page 180.
Related information...
Printer observed problems, page 1288
When reports are viewed as a PDF, a warning is displayed: "At least one signature has a
problem"
Probable cause Corrective action
The software used to view a portable document format View the description of the warning in the software. If
(PDF) file cannot identify the digital signature. the PDF file has not been modified since the digital
A file created on an Abbott instrument has a digital signature was applied, no further action is required.
signature. The digital signature allows an operator who
views the file to know if the file has been modified since
it was created.
Related information...
Printer observed problems, page 1288
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Miscellaneous corrective action procedures
Corrective action procedures are a series of steps that are recommended to resolve a probable
cause associated with a message code or an observed problem. These procedures are common
to more than one message code or observed problem.
Related information...
Troubleshooting, page 917
Processing module corrective action procedures, page 1290
Reagent and sample manager (RSM) corrective action procedure, page 1304
User interface (UI) computer corrective action procedures, page 1306
Processing module corrective action procedures
The operator may need to perform corrective action procedures for the processing module when
message codes and observed problems associated with the processing module are diagnosed.
Related information...
Miscellaneous corrective action procedures, page 1290
Manually unload a cartridge or rack from the reagent carousel, page 1290
Empty the bulk solution reservoirs (c-series), page 1293
Empty the bulk solution reservoirs (i-series), page 1297
Empty the diluted wash buffer reservoir (i-series), page 1301
Enable or disable the ICT module (c-series), page 1304
Disable a reagent cartridge, page 559
Enable a reagent cartridge, page 560
Manually unload a cartridge or rack from the reagent carousel
Required materials • #1 Phillips screwdriver
• Cartridge removal tool
Required instrument Processing module: Stopped
status
Procedure key setting Processing module: Off
Perform this procedure to remove a reagent cartridge or onboard vial rack that has a cartridge
status of Load Error.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
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CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
CAUTION: Probe Stick Hazard. This activity or area may expose you to probes.
1. Turn off all power to the processing module by moving the main power breaker at the rear
of the module to the off position.
2. Lift the front processing center cover to access the reagent supply center.
Figure 163: Manual removal of the reagent carousel cartridge (c-series)
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Figure 164: Manual removal of the reagent carousel cartridge (i-series)
3. Insert a #1 Phillips screwdriver into the small hole on the reagent positioner.
4. Firmly press down the screwdriver until the reagent positioner latch releases and moves
slightly to the left of the reagent positioner.
5. Gently push on the reagent positioner base to open the reagent positioner.
NOTE: Do not push on the reagent positioner pocket.
6. If the cartridge or rack is not secured in the reagent carousel, gently remove the cartridge or
rack from the reagent carousel through the opening in the reagent positioner.
7. If the cartridge or rack is secured in the reagent carousel and cannot be removed from the
reagent carousel, perform the following steps:
a. With a hand on the cartridge or rack, insert the cartridge removal tool into the reagent
carousel and press the reagent position spring latch toward the center of the reagent
carousel to release the cartridge or rack.
IMPORTANT: Before pressing the reagent position spring latch, secure the cartridge or
rack in the reagent position. If the cartridge or rack is not secured in the reagent
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position, the cartridge or rack can fall into the reagent carousel, causing the contents of
the cartridge or rack to spill.
b. Remove the cartridge or rack.
8. Close the front processing center cover.
9. Power on the processing module and the reagent and sample manager (RSM).
10. Start the processing module.
11. Load the cartridge or rack on the RSM.
NOTE: The cartridge or rack must be loaded on the system to reconcile the software
inventory.
12. Initiate sample processing for the RSM.
Related information...
Processing module corrective action procedures, page 1290
Empty the bulk solution reservoirs (c-series)
Required materials • Absorbent towels
• Purified water
Required instrument Warming or Idle
status
Procedure key setting Processing module: Off
Perform this procedure to remove the Alkaline Wash [1], the Acid Wash [2], or the ICT
Reference Solution [3] from the bulk solution reservoir when the bulk solution expires.
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CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
1. Open the bulk solution door and pull out the reservoir tray.
NOTE: Use caution when handling the bulk solution level sensors. Avoid applying stress on
the wiring and connector.
2. Disconnect the electrical connector from the appropriate bulk solution level sensor.
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3. Use absorbent towels to absorb any spills.
4. Unscrew the two tubing fittings from the bulk solution level sensor.
5. Unscrew the bulk solution level sensor cap.
6. Remove the bulk solution level sensor from the reservoir.
7. Remove the bulk solution reservoir from the reservoir bottle tray.
8. Empty the reservoir and rinse it with purified water.
9. Replace the reservoir in the reservoir bottle tray.
10. Place the bulk solution level sensor into the container.
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11. Tighten the bulk solution level sensor cap.
12. Connect the tubing from the bulk solution transfer pump (labeled IN) to the input connector
(labeled with an arrow that points toward the connector) on the bulk solution level sensor.
13. Connect the tubing from the syringe pump (labeled OUT) to the output connector (labeled
with an arrow that points away from the connector) on the bulk solution level sensor.
14. Connect the electrical connector of the bulk solution level sensor.
15. Confirm that a full bottle of the appropriate bulk solution is located on the bulk solution door.
Confirm that the bulk solution is within the expiration date on the bulk solution bottle label. If
necessary, replace the bulk solution and update the inventory.
16. Start the processing module.
17. While the system performs the bulk solution transfer, inspect the tubing and connections of
the bulk solution level sensor for drips and leaks. If drips or leaks are observed, repeat the
installation procedure.
18. To remove any air that may be present, perform Fluidics-Wash diagnostic procedure 4206
Flush Bulk Solutions (c-series), page 782.
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While performing the flush, inspect the tubing and connections of the bulk solution level
sensor for drips and leaks. If drips or leaks are observed, repeat the installation procedure.
19. Slide the reservoir bottle tray into the bulk solution reservoir area and close the bulk solution
door.
Related information...
Processing module corrective action procedures, page 1290
Empty the bulk solution reservoirs (i-series)
Required materials • Absorbent towels
• Purified water
Required instrument Warming or Idle
status
Procedure key setting Processing module: Off
Perform this procedure to remove the Concentrated Wash Buffer [1], the Trigger Solution [2], or
the Pre-Trigger Solution [3] from the bulk solution reservoir when the bulk solution expires.
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CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
1. Open the bulk solution door and pull out the reservoir tray.
NOTE: Use caution when handling the bulk solution level sensors. Avoid applying stress on
the wiring and connector.
2. Disconnect the electrical connector from the appropriate bulk solution level sensor.
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3. Use absorbent towels to absorb any spills.
4. Unscrew the two tubing fittings from the bulk solution level sensor.
5. Unscrew the bulk solution level sensor cap.
6. Remove the bulk solution level sensor from the reservoir.
7. Remove the bulk solution reservoir from the reservoir bottle tray.
8. Empty the reservoir and rinse it with purified water.
9. Replace the reservoir in the reservoir bottle tray.
10. Place the bulk solution level sensor into the container.
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11. Tighten the bulk solution level sensor cap.
12. Connect the tubing from the bulk solution transfer pump to the input connector (labeled with
an arrow that points toward the connector) on the bulk solution level sensor.
13. Connect the tubing from the syringe pump to the output connector (labeled with an arrow
that points away from the connector) on the bulk solution level sensor.
14. Connect the electrical connector of the bulk solution level sensor.
15. Confirm that a full bottle of the appropriate bulk solution is located on the bulk solution door.
Confirm that the bulk solution is within the expiration date on the bulk solution bottle label. If
necessary, replace the bulk solution and update the inventory.
16. Start the processing module.
17. While the system performs the bulk solution transfer, inspect the tubing and connections of
the bulk solution level sensor for drips and leaks. If drips or leaks are observed, repeat the
installation procedure.
18. To remove any air that may be present, perform Fluidics-Wash diagnostic procedure 1200
Flush and Prime Fluidics (i-series), page 804 for the appropriate bulk solution.
Perform one of the following procedure options:
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– Flush Pre-Trigger and Trigger
– Prime Dilution Assembly
While performing the flush, inspect the tubing and connections of the bulk solution level
sensor for drips and leaks. If drips or leaks are observed, repeat the installation procedure.
19. Slide the reservoir bottle tray into the bulk solution reservoir area and close the bulk solution
door.
Related information...
Processing module corrective action procedures, page 1290
Start the processing module and the reagent and sample manager (RSM), page 447
Replace bulk solutions and update the inventory, page 508
1401, page 1036
1402, page 1037
1403, page 1037
Empty the diluted wash buffer reservoir (i-series)
Required materials • Absorbent towels
• Purified water
Required instrument Warming or Idle
status
Procedure key setting Processing module: Off
Perform this procedure to remove the diluted wash buffer from the diluted wash buffer reservoir
when the wash buffer expires.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
1. Remove the rear fluidics panel and pull out the pump drawer.
NOTE: Use caution when handling the diluted wash buffer level sensor. Avoid applying
stress on the wiring and connector.
2. Disconnect the electrical connector from the diluted wash buffer level sensor.
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3. Use absorbent towels to absorb any spills.
4. Insert the lock ring release tool between the tube fitting and the diluted wash buffer level
sensor.
5. Press the lock ring release tool toward the diluted wash buffer level sensor and pull the
tubing straight out of the level sensor.
6. Repeat steps 4, page 1302 and 5, page 1302 to remove the remaining tubing.
7. Unscrew the diluted wash buffer level sensor cap.
8. Remove the diluted wash buffer level sensor from the reservoir.
9. Remove the diluted wash buffer reservoir from the pump drawer.
10. Empty the reservoir and rinse it with purified water.
11. Replace the reservoir in the pump drawer.
12. Place the diluted wash buffer level sensor into the container.
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13. Tighten the diluted wash buffer level sensor cap.
14. Connect the tubing from the buffer waste valve (located at the top of the dilution assembly
tray) to the input connector (labeled with an arrow that points toward the connector) on the
diluted wash buffer level sensor.
15. Align the tubing connector with the fitting and press the connector straight into the fitting.
16. Connect the tubing from the manifold in the pump drawer to the output connector (labeled
with an arrow that points away from the connector) on the diluted wash buffer level sensor.
17. Align the tubing connector with the fitting and press the connector straight into the fitting.
18. Slightly pull the connector to confirm that it is connected completely.
19. Connect the electrical connector of the diluted wash buffer level sensor.
20. Start the processing module.
21. While the diluted wash buffer reservoir is filled with diluted wash buffer, inspect the tubing
and connections of the diluted wash buffer level sensor for drips and leaks. If drips or leaks
are observed, repeat the installation procedure.
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22. To remove any air that may be present, perform Fluidics-Wash diagnostic procedure 1200
Flush and Prime Fluidics (i-series), page 804, Flush Wash Buffer option.
While performing the flush, inspect the tubing and connections of the diluted wash buffer
level sensor for drips and leaks. If drips or leaks are observed, repeat the installation
procedure.
23. Slide the pump drawer into the rear fluidics area and replace the rear fluidics panel.
Related information...
Processing module corrective action procedures, page 1290
Start the processing module and the reagent and sample manager (RSM), page 447
Enable or disable the ICT module (c-series)
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to enable or disable the ICT module.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap Modules.
3. Under Module Information on the Modules screen, tap a c-series module in the drop-down
list.
4. In the Installed area under ICT Module, tap one of the following options:
– Tap Yes to enable the ICT module.
– Tap No to disable the ICT module.
5. To save the edits to the module settings, tap Save.
To delete the edits to the module settings, tap Cancel.
6. To return to the Configure screen, tap Done.
Related information...
Processing module corrective action procedures, page 1290
Reagent and sample manager (RSM) corrective action procedure
The operator may need to perform the corrective action procedure for the reagent and sample
manager (RSM) when message codes and observed problems associated with the RSM are
diagnosed.
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Related information...
Miscellaneous corrective action procedures, page 1290
Remove racks from the sample positioners, page 1305
Remove racks from the sample positioners
Required instrument Stopped, Warming, or Idle
status
Perform this procedure to remove sample and vial racks from the inner and outer sample
positioners after one of the following situations occurs:
• Power to the processing module or the reagent and sample manager (RSM) is interrupted.
• An error has caused the instrument status of the processing module or the RSM to transition
unexpectedly to Stopped.
• A maintenance procedure or a diagnostic procedure has caused the instrument status of the
processing module or the RSM to transition unexpectedly to Stopped.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
1. Lift the front processing center cover.
2. Observe the inner sample positioner to determine if a rack is present.
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3. Gently push the sample positioner pocket to the front of the processing module until the
pocket touches the end of the lane and the pocket latch is pressed in.
4. Remove the rack.
5. Repeat steps 2, page 1305 through 4, page 1306 for the outer sample positioner.
6. Start the RSM to home the sample positioner pockets.
Related information...
Reagent and sample manager (RSM) corrective action procedure, page 1304
Start the processing module and the reagent and sample manager (RSM), page 447
User interface (UI) computer corrective action procedures
The operator may need to perform corrective action procedures for the user interface (UI)
computer when message codes and observed problems associated with the UI computer and the
host interface are diagnosed.
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Related information...
Miscellaneous corrective action procedures, page 1290
Verify the HL7 communication, page 1307
Verify the ASTM communication, page 1308
Enable or disable the host connection, page 474
Cancel pending transmissions, page 474
Transmit a result or an exception to the host, page 635
Verify the HL7 communication
Prerequisite • The host interface must be configured for HL7
communication.
• HL7 communication settings must be configured.
• The message queue must be empty.
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to verify the HL7 communication.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Computer tab.
3. On the Computer tab of the Configure screen, tap HL7 Communication.
4. On the HL7 Communication screen, tap Save/Test.
5. In the Connection Tests flyout, verify the test results that are displayed:
If all connection tests No additional action is required.
passed
If a connection test – Verify that the host interface option is configured for
failed or was not HL7 communication.
performed
– Verify that the HL7 communication settings are
accurate.
– Verify that the Ethernet cable from the user interface
computer to the host interface is connected.
6. To return to the HL7 Communication screen, tap Done.
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Related information...
User interface (UI) computer corrective action procedures, page 1306
Configure host settings, page 211
Configure HL7 communication settings, page 214
Verify the ASTM communication
Prerequisite • The host interface must be configured for ASTM
communication.
• ASTM communication settings must be configured.
• The message queue must be empty.
Required instrument Stopped, Warming, or Idle
status
Operator access level System administrator
Perform this procedure to verify the ASTM communication.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the Configure screen, tap the Computer tab.
3. On the Computer tab of the Configure screen, tap ASTM Communication.
4. On the ASTM Communication screen, tap Save/Test.
5. In the Connection Tests flyout, verify the test results that are displayed:
If all connection tests No additional action is required.
passed
If a connection test – Verify that the host interface option is configured for
failed or was not ASTM communication.
performed
– Verify that the ASTM communication settings are
accurate.
– Verify that the serial cable from the user interface
computer to the host interface is connected.
6. To return to the ASTM Communication screen, tap Done.
Related information...
User interface (UI) computer corrective action procedures, page 1306
Configure host settings, page 211
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Configure ASTM communication settings, page 217
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NOTES
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Appendix A Verification of assay claims
Introduction
Verification procedures are performed to verify Alinity ci-series assay claims. These procedures
are used only to verify that a method operates according to the manufacturer's claims. The
procedures are not intended to establish or validate the analytical performance of the method.
Not all procedures are required for each assay. For the manufacturer's claims that are specific
to the assay, see the assay documentation.
Related information...
Limit of blank, limit of detection, and limit of quantitation, page 1312
Precision, page 1329
Perform a calibration verification, page 1337
Verify the linearity, page 1341
Measuring interval, page 1345
Verify an automated dilution, page 1346
Method comparison, page 1351
Verify the reference range (expected values), page 1365
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Limit of blank, limit of detection, and limit of quantitation Appendix A
Limit of blank, limit of detection, and limit of
quantitation
Limit of blank (LoB), limit of detection (LoD), and limit of quantitation (LoQ) represent the
smallest concentration of a measurand that can be measured reliably by an analytical
procedure.
Procedures for LoB, LoD, and LoQ are developed from Clinical and Laboratory Standards
Institute (CLSI) document EP17-A2 and provide a recommended study design and statistical
analysis plan to verify that the manufacturer's claims for LoB, LoD, and LoQ can be met. The
procedures are used only to verify that a method operates according to the manufacturer's
claims. The procedures are not intended to establish or validate the analytical performance of
the method. When a laboratory has successfully completed this study, the laboratory has verified
that the method operates according to the manufacturer's claims for LoB, LoD, and LoQ.
For LoB, LoD, and LoQ data for assays on the Alinity ci-series, see the assay documentation.
Related information...
Verification of assay claims, page 1311
Verify a limit of blank (LoB) claim, page 1312
Verify a limit of detection (LoD) claim, page 1315
Limit of quantitation (LoQ), page 1318
Verify a limit of blank (LoB) claim
The following prerequisites are the minimum experimental design requirements:
• Reagent lot
• Instrument system
• 3 days
• Two blank samples (zero concentration levels)
NOTE: Ensure that the sample volume is adequate to test each sample a minimum of 10
times.
• Two replicates per sample per day
• Twenty replicates across all samples and days
NOTE: To yield the minimum requirement of 20 replicates, test the samples for 5 days. Based on
the available resources and time, the study design can be modified by increasing the number of
replicates or the number of samples such that a minimum of 20 measurable results are
generated across all samples and days.
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Appendix A Limit of blank, limit of detection, and limit of quantitation
Perform this procedure to verify a limit of blank (LoB) claim based on the definition from Clinical
and Laboratory Standards Institute (CLSI) document EP17-A2, which uses proportions of false
positives that are less than 5%.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
1. Test each sample in duplicate one time each day for 5 days.
2. Count the number of replicates that are greater than the LoB claim.
NOTE: For LoB data for assays on the Alinity ci-series, see the assay documentation.
For a sample size of 20 measurements, the LoB claim is verified if three or fewer replicates are
greater than the claim.
Related information...
Limit of blank, limit of detection, and limit of quantitation, page 1312
Limit of blank (LoB) worksheet (c-series), page 1313
Limit of blank (LoB) worksheet (i-series), page 1314
Verify a limit of detection (LoD) claim, page 1315
Limit of blank (LoB) worksheet (c-series)
Date: Analyte:
Instrument: Serial number:
Product Lot number Expiration date
Reagent
Calibrators
Controls
Acid Wash
Alkaline Wash
ICT Reference Solution
Diluent
Data
Replicate Concentration Replicate Concentration
1 11
2 12
3 13
4 14
5 15
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Replicate Concentration Replicate Concentration
6 16
7 17
8 18
9 19
10 20
Reference values
LoB claim measurand concentration:
For LoB data for assays on the system, see the assay documentation.
Results
Number of values > Manufacturer's LoB claim:
Comments:
Technologist: Date:
Reviewed by: Date:
Related information...
Verify a limit of blank (LoB) claim, page 1312
Limit of blank (LoB) worksheet (i-series)
Date: Analyte:
Instrument: Serial number:
Product Lot number Expiration date
Reagent
Calibrators
Controls
Pre-Trigger Solution
Trigger Solution
Wash buffer
Reaction vessel
Diluent
Data
Replicate Concentration Replicate Concentration
1 11
2 12
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Replicate Concentration Replicate Concentration
3 13
4 14
5 15
6 16
7 17
8 18
9 19
10 20
Reference values
LoB claim measurand concentration:
For LoB data for assays on the system, see the assay documentation.
Results
Number of values > Manufacturer's LoB claim:
Comments:
Technologist: Date:
Reviewed by: Date:
Related information...
Verify a limit of blank (LoB) claim, page 1312
Verify a limit of detection (LoD) claim
The associated limit of blank (LoB) claim is necessary to verify the limit of detection (LoD) claim.
Verify the LoB claim before verifying the LoD claim.
The following prerequisites are the minimum experimental design requirements:
• Reagent lot
• Instrument system
• 3 days
• Two samples at the LoD claim measurand concentration
NOTE: Samples can be spiked or can be diluted to obtain the correct concentration if the
spiked or diluted samples perform similarly to unaffected patient samples.
NOTE: Ensure that the sample volume is adequate to test each sample a minimum of 10
times.
• Two replicates per sample per day
• Twenty replicates across all samples and days
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Limit of blank, limit of detection, and limit of quantitation Appendix A
NOTE: To yield the minimum requirement of 20 replicates, test the samples for 5 days. Based on
the available resources and time, the study design can be modified by increasing the number of
replicates or the number of samples such that a minimum of 20 measurable results are
generated across all samples and days.
Perform this procedure to verify the LoD claim based on the definition from Clinical and
Laboratory Standards Institute (CLSI) document EP17-A2, which uses proportions of false
positives that are less than 5%.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
1. Test each sample in duplicate one time each day for 5 days.
2. Count the number of replicates that are less than the LoB claim.
NOTE: For LoB data for assays on the Alinity ci-series, see the assay documentation.
For a sample size of 20 measurements, the LoD claim is verified if three or fewer replicates are
less than the LoB claim.
Related information...
Limit of blank, limit of detection, and limit of quantitation, page 1312
Limit of detection (LoD) worksheet (c-series), page 1316
Limit of detection (LoD) worksheet (i-series), page 1317
Verify a limit of blank (LoB) claim, page 1312
Limit of detection (LoD) worksheet (c-series)
Date: Analyte:
Instrument: Serial number:
Product Lot number Expiration date
Reagent
Calibrators
Controls
Acid Wash
Alkaline Wash
ICT Reference Solution
Diluent
Data
Replicate Concentration Replicate Concentration
1 11
2 12
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Appendix A Limit of blank, limit of detection, and limit of quantitation
Replicate Concentration Replicate Concentration
3 13
4 14
5 15
6 16
7 17
8 18
9 19
10 20
Reference values
LoB claim measurand concentration:
LoD claim measurand concentration:
For LoB and LoD data for assays on the system, see the assay documentation.
Results
Number of values < Manufacturer's LoB claim:
Comments:
Technologist: Date:
Reviewed by: Date:
Related information...
Verify a limit of detection (LoD) claim, page 1315
Limit of detection (LoD) worksheet (i-series)
Date: Analyte:
Instrument: Serial number:
Product Lot number Expiration date
Reagent
Calibrators
Controls
Pre-Trigger Solution
Trigger Solution
Wash buffer
Reaction vessel
Diluent
Data
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Limit of blank, limit of detection, and limit of quantitation Appendix A
Replicate Concentration Replicate Concentration
1 11
2 12
3 13
4 14
5 15
6 16
7 17
8 18
9 19
10 20
Reference values
LoB claim measurand concentration:
LoD claim measurand concentration:
For LoB and LoD data for assays on the system, see the assay documentation.
Results
Number of values < Manufacturer's LoB claim:
Comments:
Technologist: Date:
Reviewed by: Date:
Related information...
Verify a limit of detection (LoD) claim, page 1315
Limit of quantitation (LoQ)
Limit of quantitation (LoQ) is defined in one of the following ways:
• The lowest concentration at which the total allowable error is met
• The lowest concentration at which precision and bias specifications are met independently
• The lowest concentration at which a given precision is met
To determine the definition and specifications that are used to establish the LoQ for assays on
the Alinity ci-series, see the assay documentation.
Related information...
Limit of blank, limit of detection, and limit of quantitation, page 1312
Verify a limit of quantitation (LoQ) claim based on the total allowable error method, page 1319
Verify a limit of quantitation (LoQ) claim based on the precision and bias method, page 1323
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Appendix A Limit of blank, limit of detection, and limit of quantitation
Limit of quantitation (LoQ) claim: Precision method, page 1328
Verify a limit of quantitation (LoQ) claim based on the total allowable error method
The following prerequisites are the minimum experimental design requirements:
• Reagent lot
• Instrument system
• 3 days
• Two samples with known values at the limit of quantitation (LoQ) claim measurand
concentration
NOTE: Concentration values can be obtained from external assignment (for example, a
reference standard) or can be determined by testing with a reference method. Samples can
be spiked or can be diluted to obtain the correct concentration.
NOTE: Ensure that the sample volume is adequate to test each sample a minimum of 10
times.
• Two replicates per sample per day
• Twenty replicates across all samples and days
NOTE: To yield the minimum requirement of 20 replicates, test the samples for 5 days. Based on
the available resources and time, the study design can be modified by increasing the number of
replicates or the number of samples such that a minimum of 20 measurable results are
generated across all samples and days.
Perform this procedure to verify the LoQ claim when the claim is defined as the lowest amount
of analyte in a sample that can be quantitatively determined based on the total allowable error or
based on independent precision and bias specifications. This procedure is based on
recommendations from Clinical and Laboratory Standards Institute (CLSI) document EP17-A2.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
1. Test each sample in duplicate one time each day for 5 days.
2. Obtain the total allowable error (TEa) goal for the assay from the assay documentation.
3. Calculate the tolerance interval around the target concentration for the sample by using one
of the following equations:
– If TEa is represented as a percentage:
Tolerance interval = A - [A x (B ÷ 100)] to A + [A x (B ÷ 100)]
Where:
A LoQ target concentration
B TEa
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Limit of blank, limit of detection, and limit of quantitation Appendix A
For example, if the target concentration is 5 ng/mL and the TEa is 20%, the tolerance
interval is 4 ng/mL to 6 ng/mL:
5 - [5 x (20 ÷ 100)] = 4 to 5 + [5 x (20 ÷ 100)] = 6
– If TEa is represented as an absolute number:
Tolerance interval = A - B to A + B
Where:
A LoQ target concentration
B TEa
For example, if the target concentration is 8 mg/dL and the TEa is 0.5 mg/dL, the
tolerance interval is 7.5 mg/dL to 8.5 mg/dL:
8 - 0.5 = 7.5 to 8 + 0.5 = 8.5
4. Compare each replicate to the tolerance interval and count the number of measurements
that fall outside the interval.
NOTE: For LoQ data for assays on the Alinity ci-series, see the assay documentation.
For a sample size of 20 measurements, the LoQ claim is verified if three or fewer replicates fall
outside the tolerance interval.
Related information...
Limit of quantitation (LoQ), page 1318
Limit of quantitation (LoQ): Total allowable error method worksheet (c-series), page 1320
Limit of quantitation (LoQ): Total allowable error method worksheet (i-series), page 1322
Limit of quantitation (LoQ): Total allowable error method worksheet (c-series)
Date: Analyte:
Instrument: Serial number:
Product Lot number Expiration date
Reagent
Calibrators
Controls
Acid Wash
Alkaline Wash
ICT Reference Solution
Diluent
Data
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Appendix A Limit of blank, limit of detection, and limit of quantitation
Replicate Concentration Replicate Concentration
1 11
2 12
3 13
4 14
5 15
6 16
7 17
8 18
9 19
10 20
Reference values
LoQ claim measurand concentration:
Total allowable error (TEa) claim:
For LoQ and TEa data for assays on the system, see the assay documentation.
Calculations
TEa represented as a percentage:
Tolerance interval = LoQ - [LoQ x (TEa ÷ 100)] to LoQ + [LoQ x (TEa ÷ 100)]
Lower limit:
− × 𝟣𝟢𝟢
=
Upper limit:
+ × 𝟣𝟢𝟢
=
TEa represented as an absolute number:
Tolerance interval = A - B to A + B
Lower limit:
− =
Upper limit:
+ =
Results
Tolerance interval:
Number of values that fall outside the tolerance interval:
Comments:
Technologist: Date:
Reviewed by: Date:
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Limit of blank, limit of detection, and limit of quantitation Appendix A
Related information...
Verify a limit of quantitation (LoQ) claim based on the total allowable error method, page 1319
Limit of quantitation (LoQ): Total allowable error method worksheet (i-series)
Date: Analyte:
Instrument: Serial number:
Product Lot number Expiration date
Reagent
Calibrators
Controls
Pre-Trigger Solution
Trigger Solution
Wash buffer
Reaction vessel
Diluent
Data
Replicate Concentration Replicate Concentration
1 11
2 12
3 13
4 14
5 15
6 16
7 17
8 18
9 19
10 20
Reference values
LoQ claim measurand concentration:
Total allowable error (TEa) claim:
For LoQ and TEa data for assays on the system, see the assay documentation.
Calculations
TEa represented as a percentage:
Tolerance interval = LoQ - [LoQ x (TEa ÷ 100)] to LoQ + [LoQ x (TEa ÷ 100)]
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Appendix A Limit of blank, limit of detection, and limit of quantitation
Lower limit:
− × 𝟣𝟢𝟢
=
Upper limit:
+ × 𝟣𝟢𝟢
=
TEa represented as an absolute number:
Tolerance interval = A - B to A + B
Lower limit:
− =
Upper limit:
+ =
Comments:
Technologist: Date:
Reviewed by: Date:
Related information...
Verify a limit of quantitation (LoQ) claim based on the total allowable error method, page 1319
Verify a limit of quantitation (LoQ) claim based on the precision and bias method
The following prerequisites are the minimum experimental design requirements:
• Reagent lot
• Instrument system
• 3 days
• Two samples with known values at the limit of quantitation (LoQ) claim measurand
concentration
NOTE: Concentration values can be obtained from external assignment (for example, a
reference standard) or can be determined by testing with a reference method. Samples can
be spiked or can be diluted to obtain the correct concentration.
NOTE: Ensure that the sample volume is adequate to test each sample a minimum of 10
times.
• Two replicates per sample per day
• Twenty replicates across all samples and days
NOTE: To yield the minimum requirement of 20 replicates, test the samples for 5 days. Based on
the available resources and time, the study design can be modified by increasing the number of
replicates or the number of samples such that a minimum of 20 measurable results are
generated across all samples and days.
Perform this procedure to verify the LoQ claim when the claim is defined as the lowest amount
of analyte in a sample that can be quantitatively determined based on independent precision and
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Limit of blank, limit of detection, and limit of quantitation Appendix A
bias specifications. This procedure is based on recommendations from Clinical and Laboratory
Standards Institute (CLSI) document EP17-A2.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
1. Test each sample in duplicate one time each day for 5 days.
2. Calculate the total allowable error (TEa) goal for the assay:
TEa = Precision x 2 + Bias
NOTE: Obtain the maximum allowable precision and bias values for assays from the assay
documentation.
3. Calculate the tolerance interval around the target concentration for the sample by using one
of the following equations:
– If TEa is represented as a percentage:
Tolerance interval = A - [A x (B ÷ 100)] to A + [A x (B ÷ 100)]
Where:
A LoQ target concentration
B TEa
For example, if the target concentration is 5 ng/mL and the TEa is 20%, the tolerance
interval is 4 ng/mL to 6 ng/mL:
5 - [5 x (20 ÷ 100)] = 4 to 5 + [5 x (20 ÷ 100)] = 6
– If TEa is represented as an absolute number:
Tolerance interval = A - B to A + B
Where:
A LoQ target concentration
B TEa
For example, if the target concentration is 8 mg/dL and the TEa is 0.5 mg/dL, the
tolerance interval is 7.5 mg/dL to 8.5 mg/dL:
8 - 0.5 = 7.5 to 8 + 0.5 = 8.5
4. Compare each replicate to the tolerance interval and count the number of measurements
that fall outside the interval.
NOTE: For LoQ data for assays on the Alinity ci-series, see the assay documentation.
For a sample size of 20 measurements, the LoQ claim is verified if three or fewer replicates fall
outside the tolerance interval.
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Appendix A Limit of blank, limit of detection, and limit of quantitation
Related information...
Limit of quantitation (LoQ), page 1318
Limit of quantitation (LoQ): Precision and bias method worksheet (c-series), page 1325
Limit of quantitation (LoQ): Precision and bias method worksheet (i-series), page 1326
Limit of quantitation (LoQ): Precision and bias method worksheet (c-series)
Date: Analyte:
Instrument: Serial number:
Product Lot number Expiration date
Reagent
Calibrators
Controls
Acid Wash
Alkaline Wash
ICT Reference Solution
Diluent
Data
Replicate Concentration Replicate Concentration
1 11
2 12
3 13
4 14
5 15
6 16
7 17
8 18
9 19
10 20
Reference values
LoQ claim measurand concentration:
Precision claim:
Bias claim:
For LoQ, precision, and bias data for assays on the system, see the assay documentation.
Calculations
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Limit of blank, limit of detection, and limit of quantitation Appendix A
TEa = Precision x 2 + Bias
× 𝟤 + =
TEa represented as a percentage:
Tolerance interval = LoQ - [LoQ x (TEa ÷ 100)] to LoQ + [LoQ x (TEa ÷ 100)]
Lower limit:
− × 𝟣𝟢𝟢
=
Upper limit:
+ × 𝟣𝟢𝟢
=
TEa represented as an absolute number:
Tolerance interval = A - B to A + B
Lower limit:
− =
Upper limit:
+ =
Results
TEa:
Tolerance interval:
Number of values that fall outside the tolerance interval:
Comments:
Technologist: Date:
Reviewed by: Date:
Related information...
Verify a limit of quantitation (LoQ) claim based on the precision and bias method, page 1323
Limit of quantitation (LoQ): Precision and bias method worksheet (i-series)
Date: Analyte:
Instrument: Serial number:
Product Lot number Expiration date
Reagent
Calibrators
Controls
Pre-Trigger Solution
Trigger Solution
Wash buffer
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Appendix A Limit of blank, limit of detection, and limit of quantitation
Product Lot number Expiration date
Reaction vessel
Diluent
Data
Replicate Concentration Replicate Concentration
1 11
2 12
3 13
4 14
5 15
6 16
7 17
8 18
9 19
10 20
Reference values
LoQ claim measurand concentration:
Precision claim:
Bias claim:
For LoQ, precision, and bias data for assays on the system, see the assay documentation.
Calculations
TEa = Precision x 2 + Bias
× 𝟤 + =
TEa represented as a percentage:
Tolerance interval = LoQ - [LoQ x (TEa ÷ 100)] to LoQ + [LoQ x (TEa ÷ 100)]
Lower limit:
− × 𝟣𝟢𝟢
=
Upper limit:
+ × 𝟣𝟢𝟢
=
TEa represented as an absolute number:
Tolerance interval = A - B to A + B
Lower limit:
− =
Upper limit:
+ =
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Limit of blank, limit of detection, and limit of quantitation Appendix A
Results
TEa:
Tolerance interval:
Number of values that fall outside the tolerance interval:
Comments:
Technologist: Date:
Reviewed by: Date:
Related information...
Verify a limit of quantitation (LoQ) claim based on the precision and bias method, page 1323
Limit of quantitation (LoQ) claim: Precision method
Limit of quantitation (LoQ) claims that are based only on a precision goal can be verified by
using the procedure to verify the precision at the LoQ claim measurand concentration.
NOTE: For LoQ data for assays on the Alinity ci-series, see the assay documentation.
Related information...
Limit of quantitation (LoQ), page 1318
Verify the precision, page 1329
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Appendix A Precision
Precision
Precision indicates how well an assay or a system provides the same result when a given
sample is tested repeatedly and over time. Specifically, within-run (repeatability) and within-
laboratory (total) precision are used to evaluate the performance of the assay or system. Within-
run precision provides a best-case estimate of the expected performance since the opportunity
for conditions to change during the course of the run is minimal. Within-laboratory precision is a
more realistic assessment of the performance because it incorporates performance over time.
The procedure to determine the precision is developed from Clinical and Laboratory Standards
Institute (CLSI) document EP15-A2. The procedure provides a recommended study design and
statistical analysis plan to verify that the manufacturer's claims for within-laboratory precision
can be met. Because the study design does not provide an adequate statistical basis to reject
the claims, the procedure is used only to verify that a method operates according to the
manufacturer's claims. The procedure is not intended to establish or validate the analytical
performance of the method. When a laboratory has successfully completed the study, the
laboratory has verified that the method operates according to the manufacturer's claims for
within-laboratory precision.
For precision data for assays on the Alinity ci-series, see the assay documentation.
Related information...
Verification of assay claims, page 1311
Verify the precision, page 1329
Evaluate the precision data, page 1330
Calculate a precision verification value, page 1332
Precision worksheet (c-series), page 1333
Precision worksheet (i-series), page 1335
Verify the precision
Required materials Two samples at different concentration levels
NOTE: The concentration levels need to be at or near the
medical decision points for the assay.
NOTE: Ensure that the sample volume is adequate to test
each sample 15 times.
Perform this procedure to verify the precision for an assay on the Alinity ci-series.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
1. Test each sample in triplicate one time each day for 5 days.
2. Test quality control (QC) samples in each day's run.
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Precision Appendix A
3. If quality control does not meet the acceptance criteria:
a. Reject the run.
b. Discard the data.
c. Correct the problem.
d. Retest the QC samples in an additional run.
After this procedure is completed, evaluate the precision data.
Related information...
Precision, page 1329
Evaluate the precision data, page 1330
Calculate a precision verification value, page 1332
Limit of quantitation (LoQ) claim: Precision method, page 1328
Evaluate the precision data
Required materials Two precision worksheets
Perform this procedure to evaluate the data that is generated from the following procedures:
• Verify the precision.
• Calculate a precision verification value.
NOTE: Use a separate worksheet for each sample concentration level. The statistical
calculations in this procedure and on the associated worksheet are from Clinical and Laboratory
Standards Institute (CLSI) document EP15-A2. These calculations are valid only according to the
conditions that are specified. As an alternative to performing the calculations manually, a
laboratory can use a software package that is designed to perform the calculations.
1. For each run, enter three replicate values (Xd1, Xd2, and Xd3) on lines 1 through 3 of the
worksheet.
d = The number that corresponds to the run day
2. Calculate the mean (𝖷d) of the three replicates and enter the value on line 4.
3. For each replicate, subtract the mean value from the replicate value:
a. Enter (Xd1 - 𝖷d) on line 5.
b. Enter (Xd2 - 𝖷d) on line 7.
c. Enter (Xd3 - 𝖷d) on line 9.
4. Square the values that were obtained in step 3:
a. Enter (Xd1 - 𝖷d)2 on line 6.
b. Enter (Xd2 - 𝖷d)2 on line 8.
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Appendix A Precision
c. Enter (Xd3 - 𝖷d)2 on line 10.
5. For each run, add the values that were obtained in step 4 and enter the sum on line 11.
6. Calculate the average variance (standard deviation squared) of the run (SD2run av):
– Add all of the values on line 11. If 5 runs were performed, divide the sum by 10 and
enter the new value on line 12.
– Add all of the values on line 11. If 7 runs were performed, divide the sum by 14 and
enter the new value on line 12.
7. Calculate the grand mean (=
𝗑 ):
– Add all of the mean values on line 4. If 5 runs were performed, divide the sum by 5 and
enter the new value on line 13.
– Add all of the mean values on line 4. If 7 runs were performed, divide the sum by 7 and
enter the new value on line 13.
8. For each run, subtract the grand mean value (line 13) from the mean value (line 4) and
enter (𝖷d - =
𝗑 ) on line 14.
9. For each run, square the value on line 14 and enter (𝖷d - =
𝗑 )2 on line 15.
10. Calculate the square root of the SD2run av and enter the value on line 16.
The value is the estimated repeatability standard deviation (sr).
11. Calculate the between-run variance term (sb2):
– Add all of the values on line 15. If 5 runs were performed, divide the sum by 4 and
enter the new value on line 17.
– Add all of the values on line 15. If 7 runs were performed, divide the sum by 6 and
enter the new value on line 17.
12. Calculate the standard deviation of the within-laboratory (total) precision and enter the value
on line 18:
𝟤
𝗌𝗅 = 𝟥
× 𝗌 𝟤𝗋 + 𝗌 𝟤𝖻
sr = The value on line 16
sb2 = The value on line 17
13. Compare the within-laboratory standard deviation (sl) from line 18 to the manufacturer’s
claim for within-laboratory standard deviation.
NOTE: If the manufacturer's within-laboratory precision claim is provided in terms of the
percent coefficient of variation (%CV), use the following equation to convert the %CV to a
standard deviation (SD) at the average concentration for all results for the material that is
tested:
Manufacturer's within-laboratory SD = Manufacturer's claim within-laboratory %CV x =
𝗑
(grand mean on line 13)
– If the calculated value is less than the claim value, the procedure demonstrates that the
precision data is consistent with the claim.
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Precision Appendix A
– If the calculated value is greater than the claim value, calculate a precision verification
value to determine whether the difference is statistically significant.
Related information...
Precision, page 1329
Verify the precision, page 1329
Calculate a precision verification value, page 1332
Precision worksheet (c-series), page 1333
Precision worksheet (i-series), page 1335
Calculate a precision verification value
Required materials The precision worksheet that contains the evaluated precision
data
When the calculated within-laboratory standard deviation exceeds the manufacturer's claim,
perform this procedure to determine whether the difference is statistically significant.
1. Calculate the effective degrees of freedom (T):
– For a procedure that requires 5 days and tests three replicates per day, use the
following equation:
𝟤
𝟤𝗌 𝟤𝗋 + ( 𝟥𝗌 𝟤𝖻 )
𝖳 =
𝟢.𝟦𝗌 𝟦𝗋 + 𝟤.𝟤𝟧 ( 𝗌 𝟤 ) 𝟤
𝖻
– For a procedure that requires 7 days and tests three replicates per day, use the
following equation:
𝟤𝗌 𝟤𝗋 + ( 𝟥𝗌 𝟤𝖻 ) 𝟤
𝖳 =
𝟢.𝟤𝟪𝟨𝗌 𝟦𝗋 + 𝟣.𝟧 ( 𝗌 𝟤 ) 𝟤
𝖻
2. Calculate the verification value:
– For a precision verification that requires 5 days and uses three replicates and two
concentration levels per day, use the following equation:
σ 𝗅 × 𝟦.𝟧𝟥
𝖵 = 𝖳
Where:
V Verification value
σl Manufacturer's within-laboratory (total) precision claim
T Degrees of freedom from step 1
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Appendix A Precision
– For a precision verification that requires 7 days and uses three replicates and two
concentration levels per day, use the following equation:
σ 𝗅 × 𝟧.𝟣𝟣
𝖵 = 𝖳
Where:
V Verification value
σl Manufacturer's within-laboratory (total) precision claim
T Degrees of freedom from step 1
3. Compare the estimated within-laboratory standard deviation (sl) from line 18 of the precision
worksheet to the verification value:
– If sl is less than or equal to the verification value, the precision data is consistent with
the claim and is verified.
– If sl is greater than the verification value and the evaluated precision data was
generated with a precision verification procedure that requires 5 days, perform two
additional data runs. Recalculate all statistics by repeating the procedure to evaluate
the precision data.
– If sl is greater than the verification value and the evaluated precision data was
generated with a precision verification procedure that requires 7 days, troubleshoot to
identify the cause of the imprecision. When the imprecision is resolved, repeat the
procedure to verify the precision.
Related information...
Precision, page 1329
Verify the precision, page 1329
Evaluate the precision data, page 1330
Precision worksheet (c-series), page 1333
Precision worksheet (i-series), page 1335
Precision worksheet (c-series)
Date: Analyte:
Instrument: Serial number:
Product Lot number Expiration date
Reagent
Calibrators
Controls
Acid Wash
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Precision Appendix A
Product Lot number Expiration date
Alkaline Wash
ICT Reference Solution
Diluent
Line Run 1 Run 2 Run 3 Run 4 Run 5 Optional run Optional run
(d=1) (d=2) (d=3) (d=4) (d=5) 6 (d=6) 7 (d=7)
Operator
1 Replicate 1 (Xd1)
2 Replicate 2 (Xd2)
3 Replicate 3 (Xd3)
4 Mean of run (𝖷d)
5 (Xd1 - 𝖷d)
6 (Xd1 - 𝖷d)2
7 (Xd2 - 𝖷d)
8 (Xd2 - 𝖷d)2
9 (Xd3 - 𝖷d)
10 (Xd3 - 𝖷d)2
11 Total of lines 6, 8, and 10
12 SD2run av
13 Grand mean (=
𝗑)
14 =
(𝖷 - 𝗑 )
d
15 (𝖷d - =
𝗑 )2
16 sr = √SD2run av
17 sb2
18 𝟤
𝗌𝗅 = 𝟥
× 𝗌 𝟤𝗋 + 𝗌 𝟤𝖻
Line Verification value calculations
1 T (5 days)
2 T (7 days)
3 Verification value (5 days)
4 Verification value (7 days)
Comments:
Technologist: Date:
Reviewed by: Date:
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Appendix A Precision
Related information...
Precision, page 1329
Evaluate the precision data, page 1330
Calculate a precision verification value, page 1332
Precision worksheet (i-series)
Date: Analyte:
Instrument: Serial number:
Product Lot number Expiration date
Reagent
Calibrators
Controls
Pre-Trigger Solution
Trigger Solution
Wash buffer
Reaction vessel
Diluent
Line Run 1 Run 2 Run 3 Run 4 Run 5 Optional run Optional run
(d=1) (d=2) (d=3) (d=4) (d=5) 6 (d=6) 7 (d=7)
Operator
1 Replicate 1 (Xd1)
2 Replicate 2 (Xd2)
3 Replicate 3 (Xd3)
4 Mean of run (𝖷d)
5 (Xd1 - 𝖷d)
6 (Xd1 - 𝖷d)2
7 (Xd2 - 𝖷d)
8 (Xd2 - 𝖷d)2
9 (Xd3 - 𝖷d)
10 (Xd3 - 𝖷d)2
11 Total of lines 6, 8, and 10
12 SD2run av
13 Grand mean (=
𝗑)
14 =
(𝖷 - 𝗑 )
d
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Precision Appendix A
Line Run 1 Run 2 Run 3 Run 4 Run 5 Optional run Optional run
(d=1) (d=2) (d=3) (d=4) (d=5) 6 (d=6) 7 (d=7)
15 (𝖷d - =
𝗑 )2
16 sr = √SD2run av
17 sb2
18 𝟤
𝗌𝗅 = 𝟥
× 𝗌 𝟤𝗋 + 𝗌 𝟤𝖻
Line Verification value calculations
1 T (5 days)
2 T (7 days)
3 Verification value (5 days)
4 Verification value (7 days)
Comments:
Technologist: Date:
Reviewed by: Date:
Related information...
Precision, page 1329
Evaluate the precision data, page 1330
Calculate a precision verification value, page 1332
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Appendix A Perform a calibration verification
Perform a calibration verification
The following prerequisites are the minimum experimental design requirements:
• Reagent lot
• Instrument system
• Sample at or near the lower limit of the measuring interval claim
• Sample with a concentration level that is near the midpoint or the clinically relevant area of
the assay range
• Sample with a concentration level that is within or below the upper limit of the measuring
interval claim
NOTE: If the sample concentration is above the high linearity, dilute the sample accordingly
to bring the concentration within the measuring interval.
Perform this procedure to confirm that the Alinity ci-series accurately measures samples within
the tolerance limits that are established.
This evaluation is based on the U.S. Clinical Laboratory Improvement Act (CLIA), 42 CFR 493.2;
and the laboratory quality management protocol of the College of American Pathologists (CAP),
Calibration Verification/Linearity Surveys--User's Guide 2009.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
1. Calibrate the assay.
2. Test each sample in triplicate.
3. Determine the tolerance limits at the target concentration for each sample:
– Half of the goal for total allowable error (TEa)
– Additional magnitude of error that the laboratory considers to be appropriate
For example, if the target concentration is 10 mg/dL and the TEa is 20%, the tolerance limit
around the target concentration is 10%. The lower tolerance limit is 9 mg/dL and the upper
tolerance limit is 11 mg/dL.
4. For each sample, calculate the percent difference (%D) for each measurement (Xi) with
respect to the target concentration (µ):
𝖷𝗂 − μ
%𝖣 = μ
× 𝟣𝟢𝟢
NOTE: The target concentration (µ) is the concentration of the reference method against
which the assay is calibrated or the value-assigned concentration.
5. Plot the %D versus the target concentration for each sample.
6. Plot the low and high tolerance limits versus the target concentration for each sample.
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Perform a calibration verification Appendix A
7. Join the points to generate the tolerance band.
The calibration verification evaluation is verified if the %D for each sample is within the tolerance
limits.
Related information...
Verification of assay claims, page 1311
Calibration verification worksheet (c-series), page 1338
Calibration verification worksheet (i-series), page 1339
Calibration verification worksheet (c-series)
Date: Analyte:
Instrument: Serial number:
Product Lot number Expiration date
Reagent
Calibrators
Controls
Acid Wash
Alkaline Wash
ICT Reference Solution
Diluent
Data
Sample Target Measured %Difference Lower tolerance Upper tolerance
concentration concentration limit limit
X1
X1
X1
X2
X2
X2
X3
X3
X3
Calculations
For each sample, calculate the percent difference (%D) for each measurement (Xi) with respect to the target
concentration (μ):
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Appendix A Perform a calibration verification
𝖷𝗂 − μ
%𝖣 = μ
× 𝟣𝟢𝟢
Comments:
Technologist: Date:
Reviewed by: Date:
Related information...
Perform a calibration verification, page 1337
Calibration verification worksheet (i-series)
Date: Analyte:
Instrument: Serial number:
Product Lot number Expiration date
Reagent
Calibrators
Controls
Pre-Trigger Solution
Trigger Solution
Wash buffer
Reaction vessel
Diluent
Data
Sample Target Measured %Difference Lower tolerance Upper tolerance
concentration concentration limit limit
X1
X1
X1
X2
X2
X2
X3
X3
X3
Calculations
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Perform a calibration verification Appendix A
For each sample, calculate the percent difference (%D) for each measurement (Xi) with respect to the target
concentration (μ):
𝖷𝗂 − μ
%𝖣 = μ
× 𝟣𝟢𝟢
Comments:
Technologist: Date:
Reviewed by: Date:
Related information...
Perform a calibration verification, page 1337
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Appendix A Verify the linearity
Verify the linearity
The following prerequisites are the minimum experimental design requirements:
• Reagent lot
• Instrument system
• Low sample pool with a concentration within 10% greater than the lower limit of the
measuring interval claim
• High sample pool with a concentration within 10% less than the upper limit of the measuring
interval claim
NOTE: Commercial linearity material can be used instead of the low and high sample pools.
A linearity study consists of testing a dilution series of known concentrations. Then, the
difference between the measured concentration and the expected or known concentration is
determined and is evaluated against defined specifications. Visual evaluation can be performed
by plotting the measured concentration against the expected or known concentration.
Perform this procedure to verify that the linearity of the assay is within the manufacturer's
claims. The procedure is a simplified version of the study in Clinical and Laboratory Standards
Institute (CLSI) document EP6-A.
NOTE: For linearity data for assays on the Alinity ci-series, see the assay documentation.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
1. Prepare the commercial linearity material if necessary.
As an alternative step, prepare dilutions of the pooled samples:
a. Prepare a low sample pool with a concentration within 10% greater than the lower limit
of the measuring interval claim. Label the sample as level 1.
b. Prepare a high sample pool with a concentration within 10% less than the upper limit of
the measuring interval claim. Label the sample as level 5.
c. Prepare a level 2 sample with three parts of level 1 and one part of level 5.
d. Prepare a level 3 sample with two parts of level 1 and two parts of level 5.
e. Prepare a level 4 sample with one part of level 1 and three parts of level 5.
2. In replicates of three, test each level of the commercial linearity material or the pooled
samples.
3. To evaluate the data, perform the following steps:
a. Calculate the replicate mean concentration for each sample level.
b. Calculate the expected concentration for each sample level.
If admixtures were prepared, use the following equation:
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Verify the linearity Appendix A
Expected concentration = (C1 x V1 + C5 x V5) ÷ (V1 + V5)
Where:
C1 Concentration of level 1
V1 Volume part of level 1
C5 Concentration of level 5
V5 Volume part of level 5
c. Plot the replicate mean for each sample level on the Y-axis and plot the corresponding
expected concentrations on the X-axis.
d. Observe the graph for evidence of nonlinearity.
e. Calculate the percent difference (%D) between the expected concentration (EC) and
the replicate mean (RM) for each sample level:
%D = 100 x (RM - EC) ÷ EC
The assay linearity is verified if the percent difference for each sample level is within the
manufacturer's linearity claim limits in the assay documentation.
Related information...
Verification of assay claims, page 1311
Linearity worksheet (c-series), page 1342
Linearity worksheet (i-series), page 1343
Linearity worksheet (c-series)
Date: Analyte:
Instrument: Serial number:
Product Lot number Expiration date
Reagent
Calibrators
Controls
Acid Wash
Alkaline Wash
ICT Reference Solution
Diluent
Data
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Appendix A Verify the linearity
Replicate Level 1 Level 2 Level 3 Level 4 Level 5
1
2
3
Data evaluation
Sample Expected Replicate mean %Difference Lower tolerance Upper tolerance
concentration limit limit
Level 1
Level 2
Level 3
Level 4
Level 5
Comments:
Technologist: Date:
Reviewed by: Date:
Related information...
Verify the linearity, page 1341
Linearity worksheet (i-series)
Date: Analyte:
Instrument: Serial number:
Product Lot number Expiration date
Reagent
Calibrators
Controls
Pre-Trigger Solution
Trigger Solution
Wash buffer
Reaction vessel
Diluent
Data
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Verify the linearity Appendix A
Replicate Level 1 Level 2 Level 3 Level 4 Level 5
1
2
3
Data evaluation
Sample Expected Replicate mean %Difference Lower tolerance Upper tolerance
concentration limit limit
Level 1
Level 2
Level 3
Level 4
Level 5
Comments:
Technologist: Date:
Reviewed by: Date:
Related information...
Verify the linearity, page 1341
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Appendix A Measuring interval
Measuring interval
Study results for linearity, precision, limit of quantitation (LoQ), and method comparison are used
to establish a measuring interval for an assay.
The Clinical and Laboratory Standards Institute (CLSI) Harmonized Terminology Database
defines the following terms:
Linear range "The range over which the testing systems results are
acceptably linear; that is, where nonlinear error is less than
the error criterion."
Measuring interval "Set of values of quantities of the same kind that can be
measured by a given measuring instrument or measuring
system with specified instrumental measurement uncertainty,
under defined conditions ([Joint Committee for Guides in
Metrology] 200:2012)."
Analytical "The range of analyte values that a method can directly
measurement range measure on the specimen without any dilution, concentration,
or other pretreatment, not part of the usual assay procedure."
Linear range, LoQ, and bias are performance characteristics. The measuring interval is derived
from these performance characteristics. To establish the measuring interval, a manufacturer
performs a linearity study so that samples encompass the entire measuring interval of the assay.
Samples that are assessed in precision and method comparison studies also encompass the
measuring interval of the assay.
Ultimately, the measuring interval is the range of concentration levels for which the assay has
been demonstrated to have acceptable linearity, precision, and bias. The extremes of the
measuring interval are limited by the LoQ on the lower end and by the upper linear limit on the
upper end.
Related information...
Verification of assay claims, page 1311
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Verify an automated dilution Appendix A
Verify an automated dilution
Prerequisite Obtain a sample with a concentration value at the upper limit
of the measuring interval for an assay. Perform sample testing
within the same run.
Perform this procedure to verify that dilutions performed by the Alinity ci-series are within
acceptance limits. A high-concentration sample at the upper limit of the measuring interval is
tested with the assay's undiluted sample protocol and with the automated dilution protocol.
Multiple replicate measurements are performed. The mean of the automated dilution protocol
results is compared to the expected diluted mean of the undiluted sample protocol results. The
difference between the means is determined and is evaluated against the acceptance criteria.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
NOTE: Ten replicate measurements are performed with both the undiluted sample protocol and
the automated dilution protocol. This number of replicates is adequate for most assays with a
repeatability percent coefficient of variation (%CV) of less than 8% and a bias requirement of
greater than or equal to 10%.
1. Obtain a high-concentration sample at the upper limit of the measuring interval.
2. If necessary, dilute the sample to ensure that the concentration is within the measuring
interval of the assay.
This sample is the prepared sample.
3. Calibrate the assay.
4. Perform 10 replicate measurements of the prepared sample with the undiluted sample
protocol.
Ensure that the sample volume is adequate to test the sample for 10 replicates.
5. Perform 10 replicate measurements of the prepared sample with the automated dilution
protocol.
Ensure that the sample volume is adequate to test the sample for 10 replicates.
6. To evaluate the data, perform the following steps:
a. Calculate the mean of the prepared sample replicates tested with the undiluted sample
protocol (US).
b. Calculate the mean of the prepared sample replicates tested with the automated
dilution protocol (DS).
c. Calculate the expected dilution concentration of the prepared sample tested with the
undiluted sample protocol (ES):
ES = US x Automated dilution factor
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Appendix A Verify an automated dilution
d. Calculate the difference (D) between the ES and the mean of the diluted sample
replicates (DS):
D = DS - ES
e. Calculate the percent difference (%D):
%D = 100 x (DS - ES) ÷ ES
The automated dilution protocol is verified if the calculated %D is within the limits of the
acceptable percent bias.
Related information...
Verification of assay claims, page 1311
Automated dilution verification worksheet (c-series), page 1347
Automated dilution verification worksheet (i-series), page 1348
Automated dilution verification worksheet (c-series)
Date: Analyte:
Instrument: Serial number:
Product Lot number Expiration date
Reagent
Calibrators
Controls
Acid Wash
Alkaline Wash
ICT Reference Solution
Diluent
Undiluted sample replicates
Replicate Concentration
1
2
3
4
5
6
7
8
9
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Verify an automated dilution Appendix A
Replicate Concentration
10
Diluted sample replicates
Replicate Concentration
1
2
3
4
5
6
7
8
9
10
Data evaluation
Step Task Value
1 Mean of prepared sample, undiluted (US)
2 Mean of prepared sample, autodiluted ________:________ (DS)
3 Expected dilution concentration (ES) = US x Automated dilution factor
4 Difference = DS - ES
5 %Difference = 100 x (DS - ES) ÷ ES
6 Lower acceptance limit (-)________%
7 Upper acceptance limit (+)________%
Comments:
Technologist: Date:
Reviewed by: Date:
Related information...
Verify an automated dilution, page 1346
Automated dilution verification worksheet (i-series)
Date: Analyte:
Instrument: Serial number:
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Appendix A Verify an automated dilution
Product Lot number Expiration date
Reagent
Calibrators
Controls
Pre-Trigger Solution
Trigger Solution
Wash buffer
Reaction vessel
Diluent
Undiluted sample replicates
Replicate Concentration
1
2
3
4
5
6
7
8
9
10
Diluted sample replicates
1
2
3
4
5
6
7
8
9
10
Data evaluation
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Verify an automated dilution Appendix A
Step Task Value
1 Mean of prepared sample, undiluted (US)
2 Mean of prepared sample, autodiluted ________:________ (DS)
3 Expected dilution concentration (ES) = US x Automated dilution factor
4 Difference = DS - ES
5 %Difference = 100 x (DS - ES) ÷ ES
6 Lower acceptance limit (-)________%
7 Upper acceptance limit (+)________%
Comments:
Technologist: Date:
Reviewed by: Date:
Related information...
Verify an automated dilution, page 1346
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Appendix A Method comparison
Method comparison
Method comparison is defined in one of the following ways:
Method comparison This evaluation determines the bias of an Alinity ci-series
for quantitative assay (the candidate assay) to a comparator assay.
assays
Method comparison This evaluation determines the level of agreement between an
for qualitative assays Alinity ci-series assay (the candidate assay) and a comparator
assay.
For specifications that are used for method comparison for the assays on the Alinity ci-series,
see the assay documentation.
Related information...
Verification of assay claims, page 1311
Perform a quantitative method comparison, page 1351
Perform a qualitative method comparison, page 1358
Perform a quantitative method comparison
The following prerequisites are the minimum experimental design requirements:
• Reagent lot
• Calibrator lot
• Control material lot
• Instrument system
• Forty specimens that encompass the measuring interval of both assays
NOTE: When possible, use biological specimens that are stored according to the specimen
storage claims. However, if specimens with concentrations in the upper limit of the measuring
interval are rare, testing samples can be prepared by supplementing low-concentration samples
with analyte from high-concentration samples.
Method comparison is a study conducted to determine the bias of a candidate assay to a
comparator assay. Two types of biases are determined: proportional bias and constant bias.
Proportional bias refers to the relative concentration change. Constant bias refers to the fixed
concentration change. Specimens from the intended population of the assay are sourced and
their concentrations are measured. Candidate assay measurements are compared to comparator
assay measurements across the assay measuring interval. Proportional bias, constant bias, and
strength of association are calculated. By definition, this study compares the candidate assay
quantification to the comparator assay quantification of the same analyte and the same quantity
of samples in the same matrix.
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Method comparison Appendix A
Perform this procedure to determine the quantitation bias of an Alinity ci-series assay (the
candidate assay) to a comparator assay. This study is based on Clinical and Laboratory
Standards Institute (CLSI) document EP09-A3.
NOTE: For method comparison data for assays on the Alinity ci-series, see the assay
documentation.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
1. Calibrate the assay on the Alinity ci-series and on the comparator assay instrument system.
2. Perform quality control testing on both assays to verify the calibration.
3. Test the 40 specimens in single replicates according to the corresponding assay
documentation.
NOTE: If the assay method requires each specimen to be tested in duplicate and the test
results to be averaged, the average test result constitutes one replicate. Sample preparation
and testing can be performed on multiple days. Each day, prepare and test the same
sample with both methods.
4. For each specimen, record the following results:
– Candidate assay result
– Comparator assay result
– Difference between the candidate assay result and the comparator assay result
(Comparator assay result - Candidate assay result)
5. To evaluate the data, perform the following steps:
a. Plot the data so that the candidate assay result is on the Y-axis and the comparator
assay result is on the X-axis.
b. Visually determine if the data displays a linear relationship.
c. For any result that is noticeably outside the line, retest the specimen with both assays.
If the result is confirmed, evaluate the specimen for possible cross-reactivity by either
method and remove the specimen from the study.
d. Calculate the following metrics by using regression analysis:
• Correlation coefficient: The closeness of results by both methods for each
specimen
• Slope: The proportional bias or concentration increase by the investigational
method for every unit increase by the comparator method
• Intercept: The systemic bias or constant bias at any concentration within the
measuring interval
NOTE: The most common regression methodology is least squares regression, which
requires that the error in the candidate assay is distributed normally and that no error is
present in the comparator assay. These criteria are not typically met because both
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Appendix A Method comparison
methods have errors. When the data shows increasing variability, weighted least
squares regression can be used to determine a more precise estimate of the bias (that
is, a smaller width of the 95% confidence interval). If no confidence interval is wanted,
both methodologies estimate the bias with the same trueness.
Passing-Bablok regression methodology does not use assumptions about the
distribution of errors. This nonparametric methodology is widely used in method
comparison studies. Deming regression methodology considers the variance of x and y,
and requires knowledge and input of the variability of both methods. A statistician may
be needed when the Passing-Bablok and Deming regression methodologies are used to
estimate biases. Generally, when the data is evenly distributed and has a relatively
constant variance, the least squares regression methodology yields biases that are
similar to the other methodologies.
e. Calculate the percent bias (%Bias) at each medical decision concentration (mdc):
Ymdc = Intercept + Slope • Xmdc
Biasmdc = Ymdc - Xmdc
%Biasmdc = Biasmdc ÷ Xmdc • 100
f. Plot the data in a scatterplot so that the average of the candidate assay result and
comparator assay result for each specimen is on the X-axis and the difference between
the candidate assay result and the average result is on the Y-axis.
Compare the method comparison results to the reference results provided in the candidate
assay documentation.
If specific data is unavailable, the method comparison study is acceptable for most assays if the
following criteria are met:
• The correlation coefficient value is greater than 0.90.
• The slope value is between 0.90 and 1.10.
• The intercept value is near zero.
• The percent bias value at each medical decision concentration is less than 10%.
Related information...
Method comparison, page 1351
Method comparison: Quantitative worksheet (c-series), page 1353
Method comparison: Quantitative worksheet (i-series), page 1356
Method comparison: Quantitative worksheet (c-series)
Date: Analyte:
Instrument: Serial number:
Product Lot number Expiration date
Reagent
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Method comparison Appendix A
Product Lot number Expiration date
Calibrators
Controls
Acid Wash
Alkaline Wash
ICT Reference Solution
Diluent
Data
Sample Comparator result (X-axis) Candidate result (Y-axis) Comparator result -
Candidate result
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
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Appendix A Method comparison
Sample Comparator result (X-axis) Candidate result (Y-axis) Comparator result -
Candidate result
27
28
29
30
31
32
33
34
35
36
37
38
39
40
Summary statistics
Regression Number of samples Slope Intercept Correlation
methodology coefficient
Least squares
Weighted least
squares
Passing-Bablok
Deming
Bias at the medical decision concentration
Medical decision concentration Concentration by candidate Bias %Bias
(Xmdc) method (Ymdc)
1
2
Comments:
Technologist: Date:
Reviewed by: Date:
Related information...
Perform a quantitative method comparison, page 1351
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Method comparison Appendix A
Method comparison: Quantitative worksheet (i-series)
Date: Analyte:
Instrument: Serial number:
Product Lot number Expiration date
Reagent
Calibrators
Controls
Pre-Trigger Solution
Trigger Solution
Wash buffer
Reaction vessel
Diluent
Data
Sample Comparator result (X-axis) Candidate result (Y-axis) Comparator result -
Candidate result
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
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Appendix A Method comparison
Sample Comparator result (X-axis) Candidate result (Y-axis) Comparator result -
Candidate result
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
Summary statistics
Regression Number of samples Slope Intercept Correlation
methodology coefficient
Least squares
Weighted least
squares
Passing-Bablok
Deming
Bias at the medical decision concentration
Medical decision concentration Concentration by candidate Bias %Bias
(Xmdc) method (Ymdc)
1
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Method comparison Appendix A
Medical decision concentration Concentration by candidate Bias %Bias
(Xmdc) method (Ymdc)
2
Comments:
Technologist: Date:
Reviewed by: Date:
Related information...
Perform a quantitative method comparison, page 1351
Perform a qualitative method comparison
The following prerequisites are the minimum experimental design requirements:
• Reagent lot
• Calibrator lot
• Control material lot
• Instrument system
• Forty positive samples and 40 negative samples
NOTE: Specimens, reference panels, proficiency-testing samples, or other samples
characterized by the same matrix as specified in the assay documentation can be used.
Perform this procedure to determine the level of agreement between an Alinity ci-series assay
(the candidate assay) and a comparator assay. The procedure does not determine or verify the
diagnostic accuracy of the assay method. This study is based on Clinical and Laboratory
Standards Institute (CLSI) document EP12-A2.
NOTE: For method comparison data for assays on the Alinity ci-series, see the assay
documentation.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
1. Calibrate the assay on the Alinity ci-series and on the comparator assay instrument system.
2. Perform quality control testing on both assays to verify the calibration.
3. Test the 40 positive samples and 40 negative samples in single replicates according to the
corresponding assay documentation.
NOTE: Sample preparation and testing can be performed on multiple days. Each day,
prepare and test the same sample with both methods.
4. For each sample, record the candidate assay result and the comparator assay result.
5. Count the number of positive results and negative results for each method, and then
summarize the results in a two-by-two table.
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Appendix A Method comparison
6. Calculate the following percent agreements:
– Positive percent agreement (PPA) = 100 x [a ÷ (a + c)]
– Negative percent agreement (NPA) = 100 x [d ÷ (b + d)]
– Overall percent agreement (OPA) = 100 x [(a + d) ÷ (a + b + c + d)]
Comparator Comparator
Positive Negative
Candidate a b
Positive
Candidate c d
Negative
Where:
a Number of samples that tested positive with both
methods
b Number of samples that tested positive with the
candidate method but tested negative with the
comparator method
c Number of samples that tested negative with the
candidate method but tested positive with the
comparator method
d Number of samples that tested negative with both
methods
Compare the PPA, NPA, and OPA results to the reference values in the candidate assay
documentation. The PPA and NPA results need to be compared to the laboratory's own criteria.
The PPA and NPA results can be compared to the candidate documentation only if the
laboratory uses the same comparator method.
Related information...
Method comparison, page 1351
Method comparison: Qualitative worksheet (c-series), page 1359
Method comparison: Qualitative worksheet (i-series), page 1362
Method comparison: Qualitative worksheet (c-series)
Date: Analyte:
Instrument: Serial number:
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Method comparison Appendix A
Product Lot number Expiration date
Reagent
Calibrators
Controls
Acid Wash
Alkaline Wash
ICT Reference Solution
Diluent
Data
Sample Candidate Comparator Sample Candidate Comparator
1 21
2 22
3 23
4 24
5 25
6 26
7 27
8 28
9 29
10 31
11 31
12 32
13 33
14 34
15 35
16 36
17 37
18 38
19 39
20 40
Sample Candidate Comparator Sample Candidate Comparator
1 21
2 22
3 23
4 24
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Appendix A Method comparison
Sample Candidate Comparator Sample Candidate Comparator
5 25
6 26
7 27
8 28
9 29
10 31
11 31
12 32
13 33
14 34
15 35
16 36
17 37
18 38
19 39
20 40
Data evaluation
Count the number of positive results and negative results, and then summarize the results in a two-by-two table.
Comparator Comparator
Positive Negative
Candidate a b
Positive
Candidate c d
Negative
a Number of samples that tested positive with both methods
b Number of samples that tested positive with the candidate method but tested negative with the
comparator method
c Number of samples that tested negative with the candidate method but tested positive with the
comparator method
d Number of samples that tested negative with both methods
Calculations
Calculate the following percent agreements:
Positive percent agreement (PPA) = 100 x [a ÷ (a + c)] =
Negative percent agreement (NPA) = 100 x [d ÷ (b + d)] =
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Method comparison Appendix A
Total percent agreement (TPA) = 100 x [(a + d) ÷ (a + b + c + d)] =
Comments:
Technologist: Date:
Reviewed by: Date:
Related information...
Perform a qualitative method comparison, page 1358
Method comparison: Qualitative worksheet (i-series)
Date: Analyte:
Instrument: Serial number:
Product Lot number Expiration date
Reagent
Calibrators
Controls
Pre-Trigger Solution
Trigger Solution
Wash buffer
Reaction vessel
Diluent
Data
Sample Candidate Comparator Sample Candidate Comparator
1 21
2 22
3 23
4 24
5 25
6 26
7 27
8 28
9 29
10 31
11 31
12 32
13 33
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Appendix A Method comparison
Sample Candidate Comparator Sample Candidate Comparator
14 34
15 35
16 36
17 37
18 38
19 39
20 40
Sample Candidate Comparator Sample Candidate Comparator
1 21
2 22
3 23
4 24
5 25
6 26
7 27
8 28
9 29
10 31
11 31
12 32
13 33
14 34
15 35
16 36
17 37
18 38
19 39
20 40
Data evaluation
Count the number of positive results and negative results, and then summarize the results in a two-by-two table.
Comparator Comparator
Positive Negative
Candidate a b
Positive
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Method comparison Appendix A
Candidate c d
Negative
a Number of samples that tested positive with both methods
b Number of samples that tested positive with the candidate method but tested negative with the
comparator method
c Number of samples that tested negative with the candidate method but tested positive with the
comparator method
d Number of samples that tested negative with both methods
Calculations
Calculate the following percent agreements:
Positive percent agreement (PPA) = 100 x [a ÷ (a + c)] =
Negative percent agreement (NPA) = 100 x [d ÷ (b + d)] =
Total percent agreement (TPA) = 100 x [(a + d) ÷ (a + b + c + d)] =
Comments:
Technologist: Date:
Reviewed by: Date:
Related information...
Perform a qualitative method comparison, page 1358
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Appendix A Verify the reference range (expected values)
Verify the reference range (expected values)
The following prerequisites are the minimum experimental design requirements:
• Reagent lot
• Instrument system
• Twenty unique specimens from reference individuals from the laboratory subject population
• One replicate per specimen
Perform this procedure to verify the reference range, based on the definition from Clinical and
Laboratory Standards Institute (CLSI) document EP28-A3, when the reference range represents
95% of the expected values from a specific group of subjects. Do not use the procedure to
establish the reference range of a method.
The laboratory needs to establish its own reference range of a method if substantial differences
in the geographic location or demographic variables are present between the manufacturer's
reference range population and the laboratory's population. These factors can cause differences
in reference values.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
1. Test one replicate per specimen.
2. Count the number of specimens that have concentration values that fall outside the
reference range.
NOTE: For reference range information for assays on the Alinity ci-series, see the Expected
Values section of the assay documentation.
3. Evaluate the results:
– If two or fewer results (≤ 10%) fall outside the reference range and test, the range is
verified.
– If three or four results fall outside the reference range, obtain an additional 20
reference specimens that are similar to the first 20 reference specimens but are
collected from different subjects:
• If four or fewer of the 40 specimens fall outside the reference range, the range is
verified.
• If five or more results fall outside the reference range, the range is not verified and
the laboratory needs to establish its own reference range.
– If five or more results fall outside the reference range, the range is not verified and the
laboratory needs to establish its own reference range.
Related information...
Verification of assay claims, page 1311
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Verification of assay claims
Verify the reference range (expected values) Appendix A
Reference range (expected values) worksheet (c-series), page 1366
Reference range (expected values) worksheet (i-series), page 1367
Reference range (expected values) worksheet (c-series)
Date: Analyte:
Instrument: Serial number:
Product Lot number Expiration date
Reagent
Calibrators
Controls
Acid Wash
Alkaline Wash
ICT Reference Solution
Diluent
Data
Sample Concentration Sample Concentration
1 11
2 12
3 13
4 14
5 15
6 16
7 17
8 18
9 19
10 20
Sample Concentration Sample Concentration
21 31
22 32
23 33
24 34
25 35
26 36
27 37
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Appendix A Verify the reference range (expected values)
Sample Concentration Sample Concentration
28 38
29 39
30 40
Reference values
Reference range (expected values):
For reference range information for assays on the system, see the Expected Values section of the assay
documentation.
Results
Number of values that are outside the reference range:
Comments:
Technologist: Date:
Reviewed by: Date:
Related information...
Verify the reference range (expected values), page 1365
Reference range (expected values) worksheet (i-series)
Date: Analyte:
Instrument: Serial number:
Product Lot number Expiration date
Reagent
Calibrators
Controls
Pre-Trigger Solution
Trigger Solution
Wash buffer
Reaction vessel
Diluent
Data
Sample Concentration Sample Concentration
1 11
2 12
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Verify the reference range (expected values) Appendix A
Sample Concentration Sample Concentration
3 13
4 14
5 15
6 16
7 17
8 18
9 19
10 20
Sample Concentration Sample Concentration
21 31
22 32
23 33
24 34
25 35
26 36
27 37
28 38
29 39
30 40
Reference values
Reference range (expected values):
For reference range information for assays on the system, see the Expected Values section of the assay
documentation.
Results
Number of values that are outside the reference range:
Comments:
Technologist: Date:
Reviewed by: Date:
Related information...
Verify the reference range (expected values), page 1365
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Appendix B List numbers
Introduction
List numbers are unique identifiers that are used to order products. The list numbers are
provided only for guidance and are subject to change. For the most current list numbers, contact
an Abbott Laboratories representative.
Related information...
Consumable list numbers, page 1370
Consumable list numbers (c-series), page 1371
Consumable list numbers (i-series), page 1372
Accessory list numbers, page 1373
Accessory list numbers (c-series), page 1374
Accessory list numbers (i-series), page 1377
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List numbers
Consumable list numbers Appendix B
Consumable list numbers
Consumables are replenishable items that are needed for sample processing on the Alinity ci-
series. To order the following consumables, contact an Abbott Laboratories representative.
For additional consumables that are specific to a processing module, see the appropriate
module type.
Table 43: Consumables
Item Quantity List number
Sample Cups 1000 per box 01R3801
Reagent Replacement Caps 100 per box 04R4701
Calibrator/Control Replacement Caps 100 per box 04R1001
Related information...
List numbers, page 1369
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List numbers
Appendix B Consumable list numbers (c-series)
Consumable list numbers (c-series)
Table 44: Consumables (c-series)
Item Quantity List number
ICT Reference Solution 4 x 975 mL 08P7640
Acid Wash 2 x 500 mL 08P7740
Alkaline Wash 2 x 500 mL 08P7840
Detergent A 10 cartridges 08P9670
Detergent B 10 cartridges 08P9770
Acid Probe Wash 10 cartridges 01R6070
ICT Module 1 09D2804
c-series Maintenance Solutions 10 cartridges 08P9870
c-series Reagent Cartridge, Black (Large) 10 cartridges 04S1720
Related information...
List numbers, page 1369
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List numbers
Consumable list numbers (i-series) Appendix B
Consumable list numbers (i-series)
Table 45: Consumables (i-series)
Item Quantity List number
Concentrated Wash Buffer 2x2L 06P1368
Pre-Trigger Solution 4 x 975 mL 06P1265
Trigger Solution 4 x 975 mL 06P1160
Probe Conditioning Solution 2 x 50 tests 01R5840
Reaction Vessels 4000 per box 06P1401
Related information...
List numbers, page 1369
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List numbers
Appendix B Accessory list numbers
Accessory list numbers
Accessories are items that are used for system installation and for maintenance and
troubleshooting procedures. Some spare accessories are used as needed for component
replacement.
For accessories that are specific to a processing module, see the appropriate module type.
Table 46: Accessories
Item Quantity List number
Tray 6 per box 04S6301
Sample Racks 10 per box 04R5201
Vial Rack 5 per box 04S6401
Onboard Vial Rack 5 per box 04S6501
External Waste Pump 1 04S7401
Hand Held Barcode Scanner 1 04S7701
Monitor 1 03R7201
Firewall 1 04S5601
Related information...
List numbers, page 1369
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List numbers
Accessory list numbers (c-series) Appendix B
Accessory list numbers (c-series)
Three accessory kits are available for the Alinity c-series:
• Accessory kit #1 contains items used for the installation of the system, items used to
perform maintenance and troubleshooting procedures, and some spare accessories for as-
needed component replacement.
• Accessory kit #2 contains some items used during the installation of the system and items
used to perform maintenance and troubleshooting procedures.
• The customer maintenance kit contains all accessories needed to perform scheduled
maintenance for 1 year.
An Abbott Laboratories representative orders the accessory kits for customers. To order
individual items, contact an Abbott Laboratories representative.
Table 47: Alinity c accessory kit #1, LN 03R6801
Item Quantity List number
Installation components:
• Filter, Water Bath 1 Not applicable (NA)
Maintenance components:
• Cuvette Segment Alignment Tool 1 04S7001
• Nozzle, Cleaning Wire 5 NA
• Phillips Screwdriver 1 NA
• Slotted Screwdriver 1 NA
• 10 mm/15 mm Wrench 1 NA
Spare components:
• Cuvette Dry Tip 1 04S5201
• Source Lamp 1 09D4503
• Sample and Wash Solution Syringe Seal Tip #1 1 09D3703
• Sample and Wash Solution Syringe Seal Tip #2 1 09D3803
• Reagent Syringe Seal Tip #1 2 09D3903
• Reagent Syringe Seal Tip #2 2 09D4004
• 1 mL Syringe 7 09D4103
• Sample Probe 1 04S5101
• Reagent Probe 1 04S4901
• Mixer 1 09D5903
• Sample and Wash Solution Syringe O-ring 2 09D5203
• Reagent Syringe O-ring 4 09D5303
• Sample Probe Tubing 1 01G4805
• Reagent Probe Tubing 1 04S5001
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List numbers
Appendix B Accessory list numbers (c-series)
Item Quantity List number
• ICT Probe 1 09D6304
• ICT Probe Holder 1 NA
• Sample Probe Screw 1 04S5301
• Reagent Probe Screw 1 04S5401
Table 48: Alinity c accessory kit #2, LN 03R6901
Item Quantity List number
Maintenance components:
• Flashlight 1 NA
• Microfiber Cloth 1 NA
• Screwdriver, #2 Phillips 1 NA
• Hex Wrench, 3 mm 1 NA
• Cartridge Removal Tool 1 NA
• Barcode Tool 1 (2 per bag) 06E6902
• 25 mL Graduated Cylinder 1 N/A
Installation components:
• Pressure Monitor PCB 1 NA
• Water and Waste Tubing 7 NA
• Hex Screws 7 NA
• Washers, Flat 7 NA
• Washers, Split Lock 7 NA
• Cable, CAT5E 1 NA
• Plastic cap 2 NA
• Tubing clamp 2 NA
Sample Tubes (16 mm x 100 mm) 2 NA
Sample Racks 30 NA
Vial Rack 10 NA
Onboard Vial Rack 5 NA
Tray 6 NA
Level Sensor, Bulk Solution 1 04S6801
Table 49: Customer maintenance kit, LN 04S4601
Item Quantity List number
ICT Check Valve 4 09D3503
Sample and Wash Solution Syringe Seal Tip #1 12 09D3703
Sample and Wash Solution Syringe Seal Tip #2 12 09D3803
Reagent Syringe Seal Tip #1 8 09D3903
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List numbers
Accessory list numbers (c-series) Appendix B
Item Quantity List number
Reagent Syringe Seal Tip #2 8 09D4004
1 mL Syringe 28 09D4103
Source Lamp 4 09D4503
Sample and Wash Solution Syringe O-ring 12 09D5203
Reagent Syringe O-ring 8 09D5303
Table 50: Additional accessories
Item Quantity List number
Cuvette Segment 1 04S4701
Sample Wash Solution Holder 1 04S7601
Wash Solution Check Valve 1 09D3403
High Concentration Waste Bottle 1 04T5801
High Concentration Waste Bottle Kit 1 04T5901
Related information...
List numbers, page 1369
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List numbers
Appendix B Accessory list numbers (i-series)
Accessory list numbers (i-series)
Table 51: Alinity i accessory kit, LN 03R6601
Item Quantity List number
Customer Maintenance Kit: 1 04S3701
• Flashlight 1 Not applicable (NA)
• Microfiber Cloth 1 NA
• Screwdriver, #1 Phillips 1 NA
• Screwdriver, #2 Phillips 1 NA
• Optics Cap 1 NA
• Thermistor Removal Wrench 1 NA
• Valve Removal Tool 1 NA
• Fuse Kit 1 NA
• Ground Strap 1 NA
• Reverse Tweezers 1 NA
• Hex Wrench Set (mm): 2.5, 3, 4, and 6 1 NA
• O-ring Removal Tool 1 NA
• Cartridge Removal Tool 1 NA
• Lock Ring Release Tool 1 NA
• Barcode Tool 2 (2 per bag) 06E6902
Bag, Biohazard 12 NA
25 mL Graduated Cylinder 1 NA
Sample Rack 30 NA
Vial Rack 10 NA
Onboard Vial Rack 5 NA
Tray 6 NA
Pipettor Probes 2 (2 per box) 03R9601
Wash Zone Probe 7 (1 per box) 08C9436
Probe Tubing, Wash Zone 1 3 (3 per bag) 04S5901
Probe Tubing, Wash Zone 2 3 (3 per bag) 04S6001
Probe Tubing, Waste Aspirate 1 04S6101
Baffle, Wash Cup 3 (3 per bag) 04S6201
Level Sensor, Bulk Solution 1 04S6801
Level Sensor, Diluted Wash Buffer 1 04S6901
Installation items:
• Waste and Water Tubing 6 NA
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List numbers
Accessory list numbers (i-series) Appendix B
Table 52: Additional accessories
Item Quantity List number
Diagnostics Kit 2 per box 01R5940
Maintenance Cleaning Cartridge 2 per box 02R5240
Related information...
List numbers, page 1369
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Glossary
Glossary
AbbottLink A data-sharing software between laboratory instrumentation and Abbott internal
systems that collects and transmits instrument data.
accessories Items that are used repeatedly, such as trays and racks.
Acid Wash (c-series) An acidic wash solution that is used by the cuvette washer to clean the
cuvettes after sample analysis. A dilution of the Acid Wash solution is used to wash
the probes.
active screen The screen that is displayed on the user interface.
Alinity ci-series A multimodule system that includes a clinical chemistry module and an immunoassay
module, each performing all sample-processing activities, and a system control
module to provide a single user-friendly interface.
Alinity c processing A chemistry analyzer that performs sample processing. The Alinity c processing
module module allows random and continuous access as well as priority and automated retest
processing by using photometric and potentiometric detection technologies. The Alinity
c processing module uses photometric detection technology to measure sample
absorbance for the quantification of analyte concentration, uses potentiometric
detection technology to measure the electrical potential in a sample, and uses an
integrated chip technology (ICT) module to measure potentiometric assays
(electrolytes).
Alinity i processing A fully automated immunoassay analyzer that performs sample processing. The Alinity
module i processing module allows random and continuous access as well as priority and
automated retest processing by using chemiluminescent microparticle immunoassay
(CMIA) detection technology. CMIA detection technology is used to determine the
presence of antigens, antibodies, and analytes in samples.
aliquot tube A conical tube (75 mm to 100 mm in height) that contains an aliquot of sample. Aliquot
tubes may be used with sample cups. If only a tube is used, the sample gauge can be
used to verify that the sample volume in the tube is adequate.
Alkaline Wash (c-series) An alkaline wash solution that is used by the cuvette washer to clean the
cuvettes after sample analysis.
bar code label A unique identifier that contains black bars that represent the sample information.
blank adjustment (c-series) A calibration type that uses the absorbance data of the reagent blank to
adjust the calibration curve.
bulk solutions Liquid solutions that are provided in large quantities for use during assay processing.
chemiluminescence (i-series) The emission of light produced by a chemical reaction.
CLSI Clinical and Laboratory Standards Institute. A nonprofit organization that provides a
communication forum for the development, promotion, and use of standards for the
worldwide medical science community.
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Glossary
CMIA (i-series) Chemiluminescent microparticle immunoassay. A detection technology used
to measure analyte concentration.
consumables Replenishable items that are needed for sample processing on the Alinity ci-series.
Examples of consumables include bulk and onboard solutions, calibrators, controls,
reagents, and sample cups.
c-series The name used to refer to all Alinity chemistry processing modules in general.
curve shape method (i-series) An adjustment method that uses the relative light unit (RLU) values that are
stored in a reagent bar code for calibrators A through F to determine the four-
parameter logistic curve fit or four-parameter logistic calibration (4PLC) parameters of
a master calibration.
cuvette washer (c-series) A device with eight nozzles that washes and dries the cuvettes before and
after each use.
diagnostic procedure A procedure that can be used to confirm the status of assemblies and mechanisms to
help identify and resolve operational problems.
FlexRate method (Alinity c) A method used to determine the concentration of samples for an enzymatic
assay that exceeds the linear range. Data points in the flex read time are used for
high-activity and high-concentration samples. Results calculated by using these data
points are identified by the FLEX result flag.
full calibration (c-series) The measurement of a reagent blank and all specified data points. The
absorbance value for each point is plotted against the known concentration and the
system software generates a new calibration curve. Unknown samples are then
evaluated against the calibration curve.
full calibration (i-series) The measurement of six points specified for a quantitative assay plotted
against known concentrations. The system software uses calibration data to generate
a calibration curve that is specific to a processing module.
host An auxiliary computer system or a laboratory information system (LIS) that can
communicate with the Alinity ci-series.
ICT (c-series) Integrated chip technology. The method used to simultaneously measure
sodium, potassium, and chloride. ICT methodology uses solid-state, ion-selective
electrodes that are contained in one chip (ICT module), which reduces the
maintenance that is necessary to perform electrolyte measurements.
ICT aspiration pump (c-series) A syringe-drive pump that uses the syringe on the right side of the pump to
deliver samples or ICT Reference Solution into the ICT module for measurement. After
measurement is completed, the ICT aspiration pump uses the syringe on the left side
of the pump to aspirate waste from the ICT high-concentration waste area to the high-
concentration waste tubing.
ICT module (c-series) An integrated chip that is a component of the ICT unit and contains the
sodium (Na+), potassium (K+), chloride (Cl-), and reference electrodes.
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Glossary
ICT Reference (c-series) A midconcentration standard solution that is aspirated and analyzed by the
Solution ICT module before and after each sample. The solution provides a reference potential
that is used in result calculation.
ICT unit (c-series) A device that has an ICT probe and an ICT module. The ICT unit is used to
perform the indirect potentiometric analysis of sodium (Na+), potassium (K+), and
chloride (Cl-). The ICT probe aspirates the sample. The ICT module simultaneously
measures Na+, K+, and Cl- by using integrated chip technology.
i-series The name used to refer to all Alinity immunoassay processing modules in general.
lamp (c-series) An optical device that provides the light source for photometric assay
measurement. The processing module uses a tungsten-halogen lamp.
load diverter (i-series) A mechanism that directs reaction vessels on the process path from the load
lane to the incubation lane during assay processing.
menu bar The area at the left side of the system software screens that provides navigation
elements that are used to display screens, flyouts, and menus.
message A user interface element that provides information about conditions or errors of
system operation.
message code A numeric identifier for a message.
reagent carousel A rotating mechanism in which racks or cartridges are loaded.
System menu A command on the System menu that represents an available screen. When a
command System menu command is selected, the associated screen is displayed.
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Glossary
NOTES
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Revision history
Document control numbers Revision date Content revised
80000071-101 (Customer) 2016-12-01 Original release
80000256-101 (FSE)
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Revision history
NOTES
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Index
Index
1204 Waste Valve and Pump Test (i-series) (FSE
1 mL syringes (c-series) Logon)
replacing the, 865 diagnostic description, 806
1-point adjustment (c-series) 1206 Pre-Trigger and Trigger Valves and Pumps Test
description of, 688 (i-series)
1000 Optics Background (i-series) diagnostic description, 806
diagnostic description, 793 1208 Wash Zone Valves, Pumps, and Motors Test (i-
1005 Shutter Test (i-series) series)
diagnostic description, 794 diagnostic description, 807
1045 Optics Verification (i-series) (FSE Logon) 1210 Pre-Trigger Precision and Accuracy (i-series)
diagnostic description, 794 diagnostic description, 807
1100 Pipettor Motors Test (i-series) 1211 Trigger Precision and Accuracy (i-series)
diagnostic description, 795 diagnostic description, 808
1105 Pipettor Syringe and Pump Test (i-series) 1221 Wash Zone 1 Precision and Accuracy (i-series)
diagnostic description, 796 diagnostic description, 809
1111 Sample Pipettor Check and Calibration (i-series) 1222 Wash Zone 2 Precision and Accuracy (i-series)
diagnostic description, 796 diagnostic description, 809
1112 R1 Pipettor Check and Calibration (i-series) 1231 Wash Zone 1 Residual Volume (i-series)
diagnostic description, 797 diagnostic description, 810
1113 R2 Pipettor Check and Calibration (i-series) 1232 Wash Zone 2 Residual Volume (i-series)
diagnostic description, 797 diagnostic description, 811
1120 Sample Pipettor Syringe Precision and Accuracy
1241 Particle Capture Wash Zone 1 (i-series) (CSC
(i-series) Logon)
diagnostic description, 798 diagnostic description, 812
1121 R1 Pipettor Syringe Precision and Accuracy (i- 1242 Particle Capture Wash Zone 2 (i-series) (CSC
series) Logon)
diagnostic description, 799 diagnostic description, 812
1122 R2 Pipettor Syringe Precision and Accuracy (i- 1250 Vacuum Diagnostics (i-series) (FSE Logon)
series) diagnostic description, 813
diagnostic description, 800 1261 Wash Zone 1 Wash Monitoring (i-series)
1130 Sample Pipettor Pump Precision and Accuracy diagnostic description, 813
(i-series) 1262 Wash Zone 2 Wash Monitoring (i-series)
diagnostic description, 800 diagnostic description, 814
1131 R1 Pipettor Pump Precision and Accuracy (i- 1270 Bulk Solutions Motors and Sensors Test (i-
series) series)
diagnostic description, 801 diagnostic description, 815
1132 R2 Pipettor Pump Precision and Accuracy (i- 1300 Temperature Status (i-series)
series) diagnostic description, 816
diagnostic description, 802 1400 RV Loader and Sensors Test (i-series)
1160 Liquid Level Sense Test (i-series) diagnostic description, 816
description of, 803 1505 Diverter Test (i-series)
1200 Flush and Prime Fluidics (i-series) diagnostic description, 817
diagnostic description, 804 1510 Vortexer Test (i-series)
1202 Wash Cup Valves Test (i-series) diagnostic description, 818
diagnostic description, 805 1515 Process Path Motors Test (i-series)
1203 Long-Term Shutdown (i-series) (FSE Logon) diagnostic description, 818
diagnostic description, 805 1520 RV Load and Unload Test (i-series)
diagnostic description, 819
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Index
1600 RSM Transport Calibration 4003 Optics Total Test and ICT Data (c-series) (CSC
diagnostic description, 823 Logon)
1610 Reagent and Sample Manager Test diagnostic description, 777
diagnostic description, 824 4004 Beam Height Alignment (c-series) (FSE Logon)
1620 RSM Bar Code Reader Test diagnostic description, 777
diagnostic description, 824 4101 Crash Sensor Alignment (c-series) (FSE Logon)
1630 Sample Positioner Test (i-series) description of, 778
diagnostic description, 819 4102 Sample Pipettor Calibration (c-series)
1631 Sample Positioner Test (c-series) description of, 779
diagnostic description, 785 4103 R1 Pipettor Calibration (c-series)
1635 RSM Transport Test description of, 779
diagnostic description, 825 4104 R2 Pipettor Calibration (c-series)
1690 Reagent and Sample Manager Initialization description of, 779
diagnostic description, 825 4105 Sample Probe and Rack Alignment Test (c-
1703 Reagent Supply Center Test (i-series) series) (CSC Logon)
diagnostic description, 820 diagnostic description, 780
1715 Reagent Carousel and Reagent Transport 4106 Component Move (c-series)
Calibration (i-series) diagnostic description, 780
diagnostic description, 820 4202 Wash Cup Test (c-series) (FSE Logon)
1830 Buffer Run (i-series) diagnostic description, 781
diagnostic description, 821 4205 Flush Water Lines (c-series)
1890 Processing Module Initialization (i-series) diagnostic description, 782
diagnostic description, 822 4206 Flush Bulk Solutions (c-series)
1910 Gravimetric Calculations (i-series) (CSC Logon) diagnostic description, 782
diagnostic description, 822 4207 Move Cuvette Washer (c-series)
1D reagent bar code labels (c-series) diagnostic description, 783
guidelines, 412 4208 Probe and Mixer Wash (c-series)
1D reagent bar code report diagnostic description, 783
printing, 555 4209 Internal Probe Wash Pump Test (c-series) (FSE
2-point adjustment (c-series) Logon)
description of, 689 diagnostic description, 783
2500 Daily Maintenance (i-series) 4301 Temperature Status (c-series)
maintenance description, 768 diagnostic description, 784
2620 Manual Pipettor Probe Cleaning (i-series) 4701 Reagent Carousel Home (c-series)
maintenance description, 769 diagnostic description, 786
2625 Manual Wash Zone Probe Cleaning (i-series) 4703 Reagent Supply Center Test (c-series)
maintenance description, 769 diagnostic description, 786
2630 Manual Wash Cup Cleaning (i-series) 4801 Module Initialization (c-series)
maintenance description, 770 diagnostic description, 787
2900 Internal Decontamination (i-series) (CSC Logon) 4802 Robotics Test Tool (c-series) (FSE Logon)
maintenance description, 770 diagnostic description, 787
2920 Manual RSM Transport Cleaning 4803 Voltage Test (c-series)
maintenance description, 772 diagnostic description, 788
2925 Manual RSM Loading Area and Positioner 4804 Save or Restore DAQ Data (c-series) (FSE
Cleaning (i-series) Logon)
maintenance description, 771 diagnostic description, 788
4001 Optics Trigger Sensor Check (c-series) 4PLC data reduction methods (i-series)
diagnostic description, 776 description of, 693
4002 Absorbance Reads (c-series) x residual minimization (x-weighted), 693
diagnostic description, 776 y residual minimization (y-weighted), 693
5001 Mixer Alignment (c-series) (FSE Logon)
diagnostic description, 789
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Index
5002 Mixer Vibration Test (c-series) printing documentation, 492
diagnostic description, 790 viewing documentation, 492
5003 Clean Cuvettes - Manually (c-series) viewing items, 491
diagnostic description, 790 Abbott Mail Inbox screen
5004 Reaction Carousel Home and Move (c-series) description of, 479
diagnostic description, 791 Abbott Mail Inbox screen, All tab
5005 Exchange Water in Bath (c-series) element descriptions, 480
diagnostic description, 791 Abbott Mail Inbox screen, Assay Files tab
5101 Flush ICT Reference Solution Cup (c-series) element descriptions, 481
diagnostic description, 792 Abbott Mail Inbox screen, Assay Inserts tab
5102 Flush ICT Module (c-series) element descriptions, 482
diagnostic description, 792 Abbott Mail Inbox screen, Calibrator Data tab
5103 ICT Alignment (c-series) (FSE Logon) element descriptions, 484
diagnostic description, 792 Abbott Mail Inbox screen, System Updates tab
5501 Daily Maintenance (c-series) element descriptions, 483
maintenance description, 759 Abbott Mail screen
5601 Clean Cuvettes with Detergent A (c-series) description of, 199
maintenance description, 760 element descriptions, 199
5701 Clean ICT Drain Tip (c-series) AbbottLink
maintenance description, 761 configuring settings (CSC Logon), 224
5801 Sample Syringe Maintenance (c-series) data usage statement, 17
maintenance description, 761 restarting, 478
5802 Wash Solution Syringe Maintenance (c-series) AbbottLink Connection Status flyout
maintenance description, 762 description of, 478
5803 Reagent Syringe Maintenance (c-series) element descriptions, 478
maintenance description, 763 AbbottLink screen
5804 Change 1 mL Syringes (c-series) description of, 222
maintenance description, 763 element descriptions, 222
5805 Check and Change ICT Check Valves (c-series) absorbance data for results
maintenance description, 764 viewing, 634
5806 Change Lamp (c-series) absorbance data reduction method (c-series
maintenance description, 764 photometric)
5807 Check and Clean High-Concentration Waste description of, 681
Sensor (c-series) access levels
maintenance description, 765 descriptions of, 158
5901 Clean Wash Cups (c-series) (FSE Logon) operator, 158
maintenance description, 765 accessing
5905 Internal Decontamination (c-series) (FSE Logon) samples that have tests in process, 575
maintenance description, 766 accessing configuration screens
5910 Wash Cuvettes (c-series) Configure screen, Assay tab, 227
maintenance description, 767 Configure screen, Computer tab, 201
5925 Manual RSM Loading Area and Positioners Configure screen, General tab, 154
Cleaning (c-series) Configure screen, Maintenance & Diagnostics tab,
maintenance description, 767 310
accessories
A list numbers (c-series), 1374
list numbers (i-series), 1377
Abbott Mail racks, 144
accepting items, 492 reagent cartridge with empty bottles (c-series), 145
configuring, 200 required, 144
declining system updates, 495 trays, 145
deleting items, 493
Alinity ci-series Operations Manual 1387
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Index
accessory list numbers Alinity i
description of, 1373 description of, 93
Acid Probe Wash illustration of front view, 93
replacing and updating inventory, 511 illustration of rear view, 93
activating procedure key, 50
users, 163 reagent carousel, 121
Add Printer flyout/Edit Printer flyout reagent supply center, 120
element descriptions, 178 supply center, 115
adding Alinity PRO
comment to an order, 590 configuring, 221
comments to a system update, 338 Alinity PRO Connection Status flyout
comments to Levey-Jennings points, 647 description of, 477
comments to results or exceptions, 612 element descriptions, 477
printer, 180 Alinity PRO screen
test to a specimen order, 600 description of, 221
adjustment calibration (c-series photometric) Alinity system security
1-point adjustment, 687 description of, 13
2-point adjustment, 687 responsibility for, 13
blank adjustment, 688 Alinity system software
description of, 687 description of user interface, 126
adjustment calibration (i-series) descriptions of screen elements, 127
description of, 694 illustration of user interface, 126
adjustment methods (i-series) overview, 126
curve shape, 697 aliquot sample tubes
linear transformation, 696 illustration of, 421
parameter, 696 specifications, 421
ratio technique, 695 verifying sample volume with the sample gauge, 569
agency approvals volumes, 423
description of, 20 animations
Alert Center flyout playing, 39
description of, 927 applying manually
element descriptions, 927 system update (FSE Logon), 340
Alinity c archive
description of, 66 calibrations, 669
illustration of front view, 66 results, 668
illustration of rear view, 66 Archive File Location window
procedure key, 50 element descriptions, 667
reagent carousel, 92 Archive flyout
reagent supply center, 91 description of, 666
supply and pump center, 85 element descriptions, 666
Alinity ci-series assay calibration
hardware overview, 48 guidelines, 674
optional components, 123 mandatory, 674
primary components, 48 optional, 674
RSM, 62 system verification, 701
SCM, 52 types and methods, 675
system characteristics, 392 validity checks, 701
Alinity ci-series Calibrator/Control Replacement Caps viewing status, 709
description of, 136 assay claims
illustration of, 136 verification of, 1311
Alinity ci-series sample cups assay display order
illustrations and measurement, 421 configuring, 282
1388 Alinity ci-series Operations Manual
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Index
Assay Display Order screen ASTM communication
description of, 280 configuring, 217
element descriptions, 281 verifying, 1308
assay file reagent statuses ASTM Communication screen
descriptions of, 272 description of, 215
assay file request statuses element descriptions, 216
descriptions of, 489 audio alert
assay files configuring, 208
deleting, 274 Audio Settings screen
installing, 272 description of, 206
requesting, 493 element descriptions, 207
uninstalling, 274 authentication
assay files (c-series) configuring, 205
exporting, 278 automated calibration ordering
importing, 279 description of, 581
assay insert statuses automated control ordering
descriptions of, 546 description of, 579
assay inserts automated dilution
printing, 561 verifying, 1346
viewing, 561 automated dilution verification
assay parameters c-series worksheet, 1347
editing result settings, 239 i-series worksheet, 1348
assay parameters (c-series photometric) automated ordering
editing calibration settings, 235 by a host, 578
editing general settings, 230 calibrations, 581
assay parameters (c-series potentiometric) capabilities, 578
editing calibration settings, 237 controls, 579
editing general settings, 231 description of, 578
assay parameters (calculated) specimens, 583
editing general settings, 234 automated retest of specimens
assay parameters (i-series) description of, 583
editing calibration settings, 238 automatic backup
editing general settings, 232 configuring, 220
Assay Parameters screen Automatic Backup screen
description of, 228 description of, 219
element descriptions, 229 element descriptions, 219
assay processing automatic processing module activities
description of (c-series), 361 automatic rotation of the reagent carousel (c-series),
description of (i-series), 380 149
assay protocol types (c-series) description of, 147
dilution protocol, 367 processing module wash (c-series), 148
ICT protocol, 369 system flush (c-series), 147
one-reagent protocol, 364 system flush (i-series), 147
pretreatment protocol, 368 system prime (i-series), 148
two-reagent protocol, 366 automatic rotation of the reagent carousel (c-series)
assay protocol types (i-series) description of, 149
One Step 25, 381
pretreatment, 384 B
STAT for One Step 11, 386
STAT for Two Step 4-4, 387 backup
Two Step 18-4, 382 copying to a USB drive, 327
performing manually, 326
Alinity ci-series Operations Manual 1389
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Index
restoring (CSC Logon), 327 bulk solution reservoirs (i-series)
Backup flyout emptying the, 1297
element descriptions, 325 bulk solution storage area (Alinity c)
Backup/Restore screen components, 88
description of, 323 description of, 88
element descriptions, 324 illustration of, 88
bar code label guidelines bulk solution storage area (Alinity i)
1D reagent (c-series), 412 components, 116
1D reagent labels (c-series), bar code print quality description of, 116
of, 412 illustration of, 116
1D reagent labels (c-series), density of, 412 bulk solutions
1D reagent labels (c-series), label stock for, 412 replacing and updating inventory, 508
1D reagent labels (c-series), length of, 412 bulk solutions (c-series)
1D reagent labels (c-series), printer type for, 412 Acid Wash Solution, 137
1D reagent labels (c-series), quiet zone for, 412 Alkaline Wash Solution, 137
1D reagent labels (c-series), symbology for, 412 description of, 137
sample labels, bar code print quality of, 417 ICT Reference Solution, 137
sample labels, density of, 417 illustration of, 137
sample labels, label stock for, 417 bulk solutions (i-series)
sample labels, length of, 417 Concentrated Wash Buffer, 138
sample labels, printer type for, 417 description of, 138
sample labels, quiet zone for, 417 illustration of, 138
sample labels, ratio for, 417 Pre-Trigger Solution, 138
sample labels, symbology for, 417 Trigger Solution, 138
bar code label requirements
1D reagent bar code label data format (c-series), C
414
1D reagent labels (c-series), placement, 415 c-series
sample labels, placement of, 418 electrical specifications and requirements, 404
sample labels, SID length of, 418 optical specifications, 406
bar code scanner processing module capacities, 398
specifications, 409 processing module characteristics, 392
Bar Codes screen processing module specifications, operational, 395
description of, 183 Cal/QC Inventory screen
element descriptions, 184 description of, 518
batteries element descriptions, 519
precautions, 729 Cal/QC Inventory screen, Search flyout
biological hazards element descriptions, 520
description of, 723 Cal/QC Ordering screen
blank adjustment (c-series) description of, 286
description of, 688 element descriptions, 287
bulk solution inventory calculated assays
configuring low alert settings, 195 creating, 251
bulk solution inventory low alert settings calculating
configuring, 195 precision verification value, 1332
bulk solution reservoir area (Alinity c) calibration
components, 89 guidelines, 674
description of, 89 mandatory, 674
illustration of, 89 optional, 674
bulk solution reservoirs (c-series) system verification, 701
emptying the, 1293 types and methods, 675
validity checks, 701
1390 Alinity ci-series Operations Manual
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Index
viewing status, 709 calibrator data (c-series)
calibration expiration editing, 264
overriding, 288 calibrator data (i-series)
calibration methods editing, 266
c-series photometric, 680 calibrator data files
c-series potentiometric, 675 requesting, 494
i-series 4PLC data reduction, 693 calibrator import statuses (c-series)
i-series cutoff assay data reduction, 698 descriptions of, 264
i-series description, 690 calibrator lot
i-series linear regression data reduction, 691 creating from a bar code, 259
i-series point-to-point data reduction, 691 creating manually, 260
i-series reference data reduction, 698 deleting, 263
calibration ordering settings viewing data, 259
configuring, 288 calibrator lot expiration
calibration review overriding, 288
description, 701 calibrator sample processing
calibration sample processing configuring, 193
description of, 564 Calibrator Set screen
Calibration Status Details screen description of, 255
description of, 704 element descriptions, 255
element descriptions, 704 Calibrator Set View/Edit screen
Calibration Status screen element descriptions, 256
description of, 702 calibrator value sheet (c-series)
element descriptions, 702 printing, 267
calibration statuses viewing, 267
descriptions of, 708 calibrator vials
calibration storage onboard storage criteria, 568
active calibrations, 699 calibrators
description, 699 Alinity c, 136
failed calibrations, 700 Alinity c ICT, 136
inactive calibrations, 700 Alinity ci-series Calibrator/Control Replacement
calibration types Caps, 136
c-series 1-point adjustment, 687 Alinity i, 136
c-series 2-point adjustment, 687 description of, 136
c-series blank adjustment, 687 illustration of, 136
c-series description, 680 calibrators troubleshooting
c-series full, 681 c-series, 923
i-series adjustment, 694 i-series, 924
i-series description, 690 cancelling
i-series full, 691 pending transmissions, 474
i-series index, 698 unloading a rack or a cartridge, 558
calibration verification capacities
c-series worksheet, 1338 c-series, 398
i-series worksheet, 1339 i-series, 399
performing, 1337 reagent and sample manager (RSM), 400
calibrations software data storage, 397
archiving, 669 cartridge statuses
automated ordering, 581 descriptions of, 543
failing, 710 cartridges
calibrator data unloading from the reagent carousel, 1290
deleting, 263 changing
importing, 261 sample bar code labels, 185
Alinity ci-series Operations Manual 1391
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Index
status of a TSB that failed to install to a status of Configure screen, General tab
Pending Verification (FSE Logon), 342 description of, 154
status of an installed TSB to a status of Install Failed Configure screen, Maintenance & Diagnostics tab
(FSE Logon), 341 description of, 310
user PINs, 167 configuring
changing default Abbott Mail, 200
printer, 183 AbbottLink settings (CSC Logon), 224
check valves (c-series) Alinity PRO, 221
replacing the, 868 assay display order, 282
checking ASTM communication, 217
system operation after installation, 152 audio alert, 208
chemical hazards authentication, 205
general precautions, 725 automatic backup, 220
overview of, 725 calibration ordering settings, 288
Clear Control Failure flyout control ordering settings, 288
element descriptions, 653 date, 205
clearances distance alert settings, 225
external waste pump, 412 HL7 communication, 214
system, 403 host interface, 211
clearing ICT module (c-series module), 174
control failures, 656 language, 205
CLI Diagnostic screen (FSE Logon) liquid waste container, 174
description of, 347 message alert, 208
CMIA reaction sequence module name (c-series module), 174
description of, 375 module name (i-series), 175
CMIA technology name, 205
description of, 375 number format, 205
codes onboard calibrators and controls (c-series), 174
processing, 602 onboard calibrators and controls (i-series), 175
comment optics values, 175
adding to an order, 590 panels, 285
comments personal display theme, 167
adding to a system update, 338 print screen file output destination, 198
adding to notes, 461 printer, 180
adding to results or exceptions, 612 priority sections, 174
Comments flyout reagent and sample manager, 174
element descriptions, 332 reports, 197
comments, adding retest options, 174
to Levey-Jennings points, 647 retest rules, 241
component replacement sample bar code checksums, 185
c-series processing center, 827 sample bar code labels, 185
c-series supply and pump center, 864 sample bar code length, 185
description of, 827 sample bar code start/stop characters, 185
i-series processing center, 892 sample bar code type, 185
i-series supply and pump center, 904 screen time-out, 205
optional, 912 shortcut icons, 218
computer and interface SmartWash settings (c-series), 243
specifications, 409 speaker volume, 205
Configure screen, Assay tab STAT protocol, 175
description of, 227 system, 154
Configure screen, Computer tab time, 205
description of, 201 Westgard rules, 309
1392 Alinity ci-series Operations Manual
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Index
consumable inventory management control vials
description of, 500 onboard storage criteria, 568
consumable list numbers controls
description of, 1370 Alinity ci-series Calibrator/Control Replacement
consumables Caps, 135
Alinity ci-series Calibrator/Control Replacement automated ordering, 579
Caps, 136 description of, 135
bulk solutions (c-series), 137 illustration of, 135
bulk solutions (i-series), 138 multiconstituent, 135
calibrators, 136 single-constituent, 135
controls, 135 controls troubleshooting
ICT module (c-series), 140 c-series, 923
list numbers (c-series), 1371 i-series, 924
list numbers (i-series), 1372 Copy Backup flyout
maintenance solutions (c-series), 139 element descriptions, 325
onboard solutions (c-series), 139 corrective action procedure, reagent and sample
probe conditioning solution (i-series), 141 manager (RSM)
reaction vessels (i-series), 142 removing racks from the sample positioners, 1305
reagent kits and components, 133 corrective action procedures
required, 133 miscellaneous, 1290
requirements for use, 714 processing module, 1290
sample cups, 142 reagent and sample manager (RSM), 1304
consumables troubleshooting user interface (UI) computer, 1306
c-series, 919 corrective action procedures, processing module
i-series, 921 emptying the bulk solution reservoirs (c-series), 1293
Contents tab emptying the bulk solution reservoirs (i-series), 1297
Help window description, 31 emptying the diluted wash buffer reservoir (i-series),
Help window illustration, 31 1301
procedure for use, operations manual, 38 enabling or disabling the ICT module (c-series),
Control Create/Edit screen 1304
element descriptions, 291 manually unloading a cartridge or rack from the
control failures reagent carousel, 1290
clearing, 656 corrective action procedures, user interface (UI)
control lot computer
manually creating, 295 verifying the ASTM communication, 1308
control lot expiration verifying the HL7 communication, 1307
overriding, 288 Create New User screen
control lot number element descriptions, 159
number of characters, 295 Create Order screen
control name description of, 591
maximum lot numbers, 295 Create Order screen, Calibration tab
control ordering settings element descriptions, 594
configuring, 288 Create Order screen, Control tab
control results element descriptions, 593
releasing, 614 Create Order screen, Specimen tab
control sample processing element descriptions, 591
description of, 563 creating
control summary details calculated assays, 251
viewing, 657 calibration orders, 599
Control Summary Details screen calibrator lot manually, 260
description of, 650 control lot manually, 295
element descriptions, 650 control orders, 597
Alinity ci-series Operations Manual 1393
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Index
Levey-Jennings graphs, 654 calibrator data, 263
new calibrator lot from a bar code, 259 calibrator lot, 263
new users, 160 exceptions, 635
notes, 459 imported quality control data, 305
quality control lot manually, 295 notes, 461
specimen orders, 595 panel, 286
user-defined assays (c-series photometric), 247 print job, 476
user-defined maintenance procedures, 319 quality control lots, 303
Current Firmware screen quality controls, 302
description of, 346 reagent carousel items (CSC Logon), 561
element descriptions, 346 sample results, 635
curve shape adjustment methods (i-series) tests from sample orders, 602
description of, 697 Details for Log flyout
customer service element descriptions, 755
contacting, 14 Detergent A
cutoff assay data reduction method (i-series) replacing and updating inventory, 511
description of, 698 Detergent B
one-point qualitative (index formula) method, 698 configuring modules, 195
two-point qualitative (index formula) method, 698 diagnostics
cuvette dry tip (c-series) overview of, 740
replacing the, 852 diluent (c-series) low alert setting
cuvette segments (Alinity c) configuring, 193
description of, 76 diluted wash buffer reservoir (i-series)
illustration of, 76 emptying the, 1301
cuvette segments (c-series) dimensions
replacing the, 848 external waste pump, 411
cycling power disabling
processing module, 432 reagent cartridge, 559
reagent and sample manager (RSM), 432 sample processing, 205
system, 428 disclaimers
system control module, 428 description of, 17
displaying
D values for Levey-Jennings points, 646
distance alert
data configuring settings, 225
filtering, 664 description of, 60
searching, 664 illustration of, 60
data reduction calculation verifying the function, 226
c-series photometric description, 355 Distance Alert screen
c-series potentiometric description, 360 description of, 225
i-series description, 380 downloading
date system update software, 336
configuring, 205
declining E
system update, 337
decontamination Edit User screen
bar code scanner, 773 element descriptions, 161
external components, 773 editing
monitor, 774 calibration settings of assay parameters (c-series
requirements, 731 photometric), 235
deleting calibration settings of assay parameters (c-series
assay files, 274 potentiometric), 237
1394 Alinity ci-series Operations Manual
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Index
calibration settings of assay parameters (i-series), Cal/QC Inventory screen, Search flyout, 520
238 Cal/QC Ordering screen, 287
calibrator data (c-series, 264 Calibration Status Details screen, 704
calibrator data (i-series), 266 Calibration Status screen, 702
general settings of assay parameters (c-series Calibrator Set screen, 255
photometric), 230 Calibrator Set View/Edit screen, 256
general settings of assay parameters (c-series Clear Control Failure flyout, 653
potentiometric), 231 Comments flyout, 332
general settings of assay parameters (calculated), Control Create/Edit screen, 291
234 Control Summary Details screen, 650
general settings of assay parameters (i-series), 232 Copy Backup flyout, 325
notes, 460 Create New User screen, 159
panel definition, 285 Create Order screen, Calibration tab, 594
printer, 181 Create Order screen, Control tab, 593
quality controls, 298 Create Order screen, Specimen tab, 591
result settings of assay parameters, 239 Current Firmware screen, 346
SmartWash settings (c-series), 245 Details for Log flyout, 755
user-defined maintenance procedures, 319 Edit User screen, 161
users, 162 General Settings screen, 203
electrical hazarads HL7 Communication screen, 213
awareness of, 734 Home screen, 464
electrical safety Host Connection Status flyout, 473
requirements, 734 Host Setup screen, 209
electrical specifications Import Calibrators screen (c-series), 258
system control module (SCM), 404 Import screen, 294
electromotive force measurement data reduction (c- Import/Export Assays screen, Export Files tab (c-
series potentiometric) series), 275
calculation, 675 Import/Export Assays screen, Import Files tab (c-
description of, 675 series), 276
element descriptions Install/Uninstall Assays screen, Available Files tab,
Abbott Mail Inbox screen, All tab, 480 268
Abbott Mail Inbox screen, Assay Files tab, 481 Install/Uninstall Assays screen, Installed Files tab,
Abbott Mail Inbox screen, Assay Inserts tab, 482 270
Abbott Mail Inbox screen, Calibrator Data tab, 484 Install/Uninstall Procedures screen, Available Files
Abbott Mail Inbox screen, System Updates tab, 483 tab, 311
Abbott Mail screen, 199 Install/Uninstall Procedures screen, Installed Files
AbbottLink Connection Status flyout, 478 tab, 312
AbbottLink screen, 222 Levey-Jennings (Graph) screen, 641
Add Printer flyout/Edit Printer flyout, 178 Log On screen, 454
Alert Center flyout, 927 Manual File Request screen, Assay Files tab, 486
Alinity PRO Connection Status flyout, 477 Manual File Request screen, Calibrator Data tab (c-
Archive File Location window, 667 series), 487
Archive flyout, 666 Message Details For flyout, 939
Assay Display Order screen, 281 Modules screen (c-series), 170
Assay Parameters screen, 229 Modules screen (i-series), 172
ASTM Communication screen, 216 Modules screen, reagent and sample manager
Audio Settings screen, 207 (RSM), 168
Automatic Backup screen, 219 Order Details (Specimen, Control, and Calibrator)
Backup flyout, 325 screen, 588
Backup/Restore screen, 324 Orders screen, 584
Bar Codes screen, 184 Orders screen, Search flyout, 586
Cal/QC Inventory screen, 519 Panel Definition screen, 283
Alinity ci-series Operations Manual 1395
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Index
Perform Procedure screen, 745 User-Defined Maintenance screen, Export tab, 317
Point Details screen, 644 Users Import screen, Users Export screen, 157
Print flyout, 659 Users screen, 156
Printer Queue flyout, 180 Version Details for Procedure flyout, 743
Printer Status/Queue flyout, 475 Westgard screen, 308
Printer Verification flyout, 179 emergency shutdown
Printers screen, 177 performing, 449
Procedures Log screen, Diagnostics tab, 754 emptying
Procedures Log screen, Maintenance tab, 753 bulk solution reservoirs (c-series), 1293
Procedures screen, 741 bulk solution reservoirs (i-series), 1297
Quality Control screen, 290 diluted wash buffer reservoir (i-series), 1301
Quality Control Summary screen, 648 high-concentration waste bottle and updating
Reagent Cartridge Details screen, 541 inventory (c-series), 514
Reagents and Supplies screen, Reagents/Diluents enabling
tab, 187 reagent cartridge, 560
Reagents and Supplies screen, Supplies tab, 189 enabling or disabling
Reagents screen, Current tab, 534 ICT module (c-series), 1304
Reagents screen, Historical tab, 538 environmental specifications and requirements
Reagents screen, Search flyout, 539 Alinity ci-series, 408
Report File Location window, 661 evaluating
Reports screen, 196 precision data, 1330
Requested Categories flyout, 488 exceptions
Rerun Options flyout, control order, 628, 629 deleting, 635
Result Details (Specimen and Control) screen, 624 transmitting to the host, 635
Results screen, Control tab, 620 excluding
Results screen, Exception tab, 621 Levey-Jennings points, 646
Results screen, Search flyout, 622 exporting
Results screen, Specimen tab, 618 c-series assay files, 278
Results screen, Unreleased tab, 617 user-defined maintenance procedures, 321
Sample Details (Specimen, Control, and Calibrator) users, 164
screen, 608 exposure
Sample Status screen, 604 to hot objects, 738
Sample Status screen, Search flyout, 606 external waste pump
Select Items window (c-series), 277 clearances, 412
Shortcuts, 218 description of, 123
Status Change flyout (FSE Logon), 333 dimensions, 411
Supplies screen (c-series), 501 electrical specifications and requirements, 411
Supplies screen (i-series), 505 illustration of, 123
System Logs screen, Abbott Mail tab, 938 weight, 411
System Logs screen, All Messages tab, 930 external waste pump (i-series)
System Logs screen, Configuration tab, 936 replacing the, 912
System Logs screen, Host tab, 937
System Logs screen, Informational tab, 933 F
System Logs screen, Inventory tab, 934
System Logs screen, Notifications/Alerts tab, 932 factor data reduction method (c-series photometric)
System Logs screen, User Access tab, 935 description of, 681
System Update Import screen, 334 file update statuses
System Updates screen, 329 descriptions of, 271
Troubleshooting screen, 342 flags
User Profile screen, 166 quality control result, 632
User-Defined Maintenance screen, Create/Edit tab, specimen result, 630
315
1396 Alinity ci-series Operations Manual
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Index
floor loading, typical tripping, 738
Alinity c, 401 heavy objects
Alinity ci-series, 401 lifting techniques, 737
Alinity i, 401 precautions, 737
fluidics subsystems troubleshooting high-concentration waste bottle (c-series)
c-series, 919 emptying bottle and updating inventory, 514
i-series, 921 HL7 communication
flyout configuring, 214
AbbottLink Connection Status, 478 verifying, 1307
Alert Center, 927 HL7 Communication screen
Alinity PRO Connection Status, 477 description of, 212
Archive, 666 element descriptions, 213
Host Connection Status, 472 Home screen
Notepad, 458 AbbottLink Connection Status flyout element
Print, 658 descriptions, 478
Printer Status/Queue, 475 Alert Center flyout element descriptions, 927
Search, 664 description of, 463
full calibration element descriptions, 464
c-series description, 681 Host Connection Status flyout element descriptions,
i-series description, 691 473
illustration of, 463
G host connection
enabling or disabling, 474
general requirements Host Connection Status flyout
description of, 712 description of, 472
general safety information element descriptions, 473
overview, 12 host connection statuses
General Settings screen descriptions of, 473
description of, 202 host interface
element descriptions, 203 configuring, 211
Glossary tab host interface specifications
Help window description, 33 description of, 409
Help window illustration, 33 host orders
procedure for use, operations manual, 42 description of, 578
graphical symbols Host Setup screen
assay technology, 375 description of, 209
guidelines element descriptions, 209
1D reagent bar code labels (c-series), 412 hot objects
sample bar code labels, 417 exposure to, 738
H I
handling consumables i-series
requirements, 714 electrical specifications and requirements, 405
hard drive processing module capacities, 399
specifications, 409 processing module characteristics, 393
hardware troubleshooting processing module specifications, operational, 396
c-series, 919 ICT module
i-series, 921 configuring expiration, 195
hazards ICT module (c-series module)
hot objects, 738 configuring, 174
mechanical, 735
Alinity ci-series Operations Manual 1397
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Index
ICT module (c-series) initiating
description of, 140 sample processing, 574
enabling or disabling, 1304 Install/Uninstall Assays screen
illustration of, 140 description of, 268
illustration of internal components, 359 Install/Uninstall Assays screen, Available Files tab
location of, 81 element descriptions, 268
replacing the, 859 Install/Uninstall Assays screen, Installed Files tab
ICT module expiration element descriptions, 270
configuring, 195 Install/Uninstall Procedures screen
ICT probe (c-series) description of, 310
location of, 81 Install/Uninstall Procedures screen, Available Files tab
replacing the, 859 element descriptions, 311
ICT Reference Solution delivery (c-series) Install/Uninstall Procedures screen, Installed Files tab
description of sequence, 356 element descriptions, 312
illustration of, 356 installation procedures and special requirements
ICT sample delivery (c-series) overview, 151
description of sequence, 356 installing
illustration of, 356 assay files, 272
ICT unit (Alinity c) maintenance and diagnostic procedure files, 314
description of, 81 system, 152
illustration of, 81 system update, 336
location of, 859 instrument statuses
Import Calibrators screen descriptions of, 496
c-series element descriptions, 258 transition of, 498
Import screen integrated chip technology (c-series)
element descriptions, 294 description of, 356
Import/Export Assays screen (c-series) Intellectual Property statement
description of, 275 description of, 21
Import/Export Assays screen, Export Files tab intended use
c-series element descriptions, 275 description of, 15
Import/Export Assays screen, Import Files tab
c-series element descriptions, 276 K
importing
c-series assay files, 279 key to symbols
calibrator data, 261 descriptions of, 22
quality control data, 304 illustrations of, 22
system update, 339
users, 163 L
inactivating
users, 163 labels
including 1D reagent bar code label guidelines (series), 412
Levey-Jennings points, 646 sample bar code label guidelines, 417
index calibration (i-series) lamp (Alinity c)
description of, 698 description of, 77
Index tab illustration of, 77
Help window description, 33 lamp (c-series)
Help window illustration, 33 replacing the, 844
procedure for use, operations manual, 41 lamp plate (c-series)
initializing replacing the, 844
processing module and reagent and sample language
manager (RSM), 447 configuring, 205
1398 Alinity ci-series Operations Manual
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Index
level sensor liquid waste arm probe (i-series)
Concentrated Wash Buffer, replacing the, 906 replacing the, 900
diluted wash buffer, replacing the, 909 liquid waste container
Pre-Trigger Solution, replacing the, 906 configuring, 174
Trigger Solution, replacing the, 906 liquid wastes
Levey-Jennings (Graph) screen waste handling precautions, 728
description of, 641 list numbers
element descriptions, 641 accessories, 1373
Levey-Jennings graphs additional accessories (c-series), 1374
creating, 654 additional accessories (i-series), 1377
Levey-Jennings points Alinity c accessory kit #1, 1374
adding comments to, 647 Alinity c accessory kit #2, 1374
displaying the values for, 646 Alinity i accessory kit, 1377
excluding or including, 646 consumables, 1370
viewing details for, 647 consumables (c-series), 1371
limit of blank (LoB) consumables (i-series), 1372
c-series worksheet, 1313 customer maintenance kit (c-series), 1374
description of, 1312 description of, 1369
i-series worksheet, 1314 load statuses
verifying an LoB claim, 1312 descriptions of, 545
limit of detection (LoD) loading
c-series worksheet, 1316 cartridges on reagent and sample manager (RSM),
description of, 1312 527
i-series worksheet, 1317 floor, typical, 401
verifying an LoD claim, 1315 onboard solutions on reagent and sample manager
limit of quantitation (LoQ) (RSM), 530
assay claim definitions, 1318 racks and reagent cartridges into temporary priority
c-series precision and bias method worksheet, 1325 positions, 531
c-series total allowable error method worksheet, racks on reagent and sample manager (RSM), 526
1320 sample diluents on reagent and sample manager
description of, 1312 (RSM), 530
i-series precision and bias method worksheet, 1326 samples into sample racks, 569
i-series total allowable error method worksheet, 1322 vial racks for immediate use, 572
LoQ claim, precision method, 1328 vial racks for onboard storage, 549
verifying an LoQ claim, precision and bias method, vials for immediate use, 572
1323 vials for onboard storage, 549
verifying an LoQ claim, total allowable error method, loading area
1319 description of, 64
linear data reduction method (c-series photometric) illustration of, 64
description of, 682 locking
linear regression data reduction method (i-series) user interface, 457
description of, 691 Log On screen
illustration of, 691 description of, 454
linear transformation adjustment method (i-series) element descriptions, 454
description of, 696 logit-4 data reduction method (c-series photometric)
linearity description of, 684
c-series worksheet, 1342 long-term shutdown (i-series)
i-series worksheet, 1343 description of, 452
verifying the, 1341
liquid waste arm
illustration of, 100
Alinity ci-series Operations Manual 1399
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Index
M method comparison
description of, 1351
mail statuses qualitative worksheet (c-series), 1359
descriptions of, 491 qualitative worksheet (i-series), 1362
maintenance qualitative, performing, 1358
overview of, 740 quantitative worksheet (c-series), 1353
maintenance and diagnostic procedure files quantitative worksheet (i-series), 1356
installing, 314 quantitative, performing, 1351
uninstalling, 314 minimum sample volume
maintenance solutions (c-series) requirements, 423
description of, 139 mixers (Alinity c)
illustration of, 139 description of, 78
managing illustration of, 78
user PINs, 165 mixers (c-series)
manual backup replacing the, 855
performing, 326 module name (c-series module)
Manual File Request screen configuring, 174
description of, 486 module name (i-series)
Manual File Request screen, Assay Files tab configuring, 175
element descriptions, 486 Modules screen
Manual File Request screen, Calibrator Data tab (c- c-series element descriptions, 170
series) description of, 168
element descriptions, 487 i-series element descriptions, 172
measuring interval Modules screen, reagent and sample manager (RSM)
description of, 1345 element descriptions, 168
mechanical hazards monitor
description of, 735 adjusting the position, 57
menu bar specifications, 409
description of, 130
illustration of, 130
message alert
N
configuring, 208 name
message codes configuring, 205
assay-specific (1000-1999), 941 navigation pane
computer hardware peripheral (8000-8999), 941 Help window description, 30
general (0001-0999), 941 Help window illustration, 30
level sense and fluidics (3000-3999), 941 network connectors
maintenance and diagnostic (2000-2999), 941 description of, 56
optics and bar code reader (4000-4999), 941 illustration of, 56
robotics and sensor (5000-5999), 941 new users
software (9000-9999), 941 creating, 160
support system (6000-6999), 941 Notepad flyout
temperature (7000-7999), 941 description of, 458
Message Details For flyout notes
element descriptions, 939 adding comments, 461
message probable cause and corrective action creating, 459
viewing, 928 deleting, 461
message types deleting all unpinned, 462
descriptions of, 940 display order of comments, 461
messages editing, 460
deleting, 929 maximum number of comments, 461
viewing associated messages, 928 pinning, 459
1400 Alinity ci-series Operations Manual
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Index
unpinning, 459 operations manual glossary
viewing, 458 using, 42
number format operations manual home page
configuring, 205 displaying, 37
operations manual index
O using, 41
operations manual navigation pane
observed problems hiding, 41
c-series processing module, 1264 operations manual related information
c-series sample results, 1270 accessing, 40
general description, 1263 operations manual table of contents
i-series processing module, 1268 hiding, 41
i-series sample results, 1276 scrolling through the, 38
printer, 1288 operations manual terms
user interface (UI) computer, 1287 searching for, 42
onboard calibrator and control sample processing operations manual topic
reagent and sample manager (RSM), 567 printing, 43
onboard calibrators and controls redisplaying, 41
configuring, 174 scrolling through an, 38
onboard calibrators and controls (i-series) using breadcrumbs to access, 40
configuring, 175 operator
onboard sample storage responsibility for using the system, 720
requirements, 425 optical subsystem troubleshooting
onboard solution inventory c-series, 919
configuring low alert settings, 195 i-series, 921
onboard solution inventory low alert settings optical system
configuring, 195 c-series illustration, 353
onboard solutions i-series illustration, 378
preparing, 551 optics (Alinity i)
onboard solutions (c-series) illustration of, 105
Acid Probe Wash, 139 optics values
description of, 139 configuring, 175
Detergent A, 139 optimum sampling sequence feature (c-series)
Detergent B, 139 description of, 371
illustration of, 139 optional components
onboard storage criteria description of, 123
calibrator vials, 568 external waste pump, 123
control vials, 568 Order Details (Specimen, Control, and Calibrator)
operational precautions and limitations screen
impact of failure to comply, 711 element descriptions, 588
operations manual Order Details screen
accessing, 37 description of, 588
changing the position, 42 orders
closing, 42 automated, 578
conventions for, 28 calibration, creating, 599
Help window description, 29 control, creating, 597
Help window illustration, 29 host, 578
organization of, 26 specimen, creating, 595
using the, 37 Orders screen
operations manual content description of, 584
moving through a sequence of topics, 41 element descriptions, 584
paging through, 41
Alinity ci-series Operations Manual 1401
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Index
Orders screen, Search flyout physical specifications
element descriptions, 586 Alinity ci-series, 400
overriding pipetting hardware (Alinity i)
calibration expiration, 288 description of, 111
calibrator lot expiration, 288 illustration of, 111
control lot expiration, 288 processing center, 111
pipettor probes (i-series)
P reagent, replacing the, 894
sample, replacing the, 894
packages pipettors (Alinity c)
troubleshooting, 343 illustration of, 70
panel reagent 1, description, 70
configuring, 285 reagent 2, description, 70
deleting, 286 sample, description, 70
panel definition pipettors (Alinity i)
editing, 285 illustration of, 112
Panel Definition screen reagent 1, description, 112
description of, 283 reagent 2, description, 112
element descriptions, 283 sample, description, 112
parameter adjustment method (i-series) Point Details screen
description of, 696 element descriptions, 644
pausing point-to-point data reduction method (i-series)
processing module, 447 description of, 691
reagent and sample manager (RSM), 448 illustration of, 691
pending transmissions potentiometric calibration method (c-series)
cancelling, 474 description of, 675
Perform Procedure screen potentiometric data reduction method (c-series)
description of, 744 electromotive force measurement, 675
element descriptions, 745 sample measurement, 678
Performance characteristics and specifications slope calculation, 676
overview, 391 potentiometric method (c-series)
performing description of, 355
calibration verification, 1337 powering off
emergency shutdown, 449 processing module, 440
manual backup, 326 reagent and sample manager (RSM), 446
qualitative method comparison, 1358 powering on
quantitative method comparison, 1351 processing module, 436
personal display theme reagent and sample manager (RSM), 444
configuring, 167 Pre-Trigger and Trigger manifold (Alinity i)
photometric calibration methods (c-series) illustration of, 104
description of, 680 precautions
photometric calibration types (c-series) description of, 723
description of, 680 precautions and requirements before operation
photometric data reduction methods (c-series) description of, 713
absorbance, 681 precautions during operation
factor, 681 description of, 713
linear, 682 precision
logit-4, 684 c-series worksheet, 1333
spline, 685 calculating a verification value, 1332
use factor and blank, 687 description of, 1329
physical hazards evaluating the data, 1330
overview, 737 i-series worksheet, 1335
1402 Alinity ci-series Operations Manual
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Index
verifying the, 1329 element descriptions, 177
precision and bias method printing
verifying an LoQ claim, 1323 1D reagent bar code report, 555
precision method Abbott Mail documentation, 492
LoQ claim, 1328 assay inserts, 561
preparing calibrator value sheet (c-series), 267
onboard solutions, 551 quality control inserts, 306
reagent cartridges, 548 reports, 662
sample diluents and user-defined reagents, 552 screen images, 663
vial racks for immediate use, 572 system update documentation, 335
vial racks for onboard storage, 549 priority sections
vials for immediate use, 572 configuring, 174
vials for onboard storage, 549 probe conditioning solution (i-series)
pretreatment path (Alinity i) description of, 141
illustration of, 107 illustration of, 141
pretreatment path motor (Alinity i) probe tubing
illustration of, 109 c-series reagent, replacing the, 840
pretreatment unload diverter (Alinity i) c-series sample, replacing the, 837
illustration of, 108 probes
pretreatment vortexer (Alinity i) c-series reagent, replacing the, 832
illustration of, 110 c-series sample, replacing the, 829
primary components i-series liquid waste arm, replacing the, 900
Alinity ci-series, 48 i-series reagent pipettor, replacing the, 894
primary sample tubes i-series sample pipettor, replacing the, 894
specifications, 421 i-series wash zone, replacing the, 897
volumes, 423 probes and other sharps
Print flyout precautions, 737
description of, 658 procedure key
element descriptions, 659 Alinity c illustration, 50
print job Alinity i illustration, 50
deleting, 476 description of, 50
print jobs SCM illustration, 50
viewing the printer queue, 476 procedure key settings
print screen descriptions of, 746
configuring, 198 procedure map
printer description of, 44
adding, 180 displaying and using, 38
changing default, 183 illustration of, 44
configuring, 180 task lists, 45
editing, 181 Procedures Log screen
observed problems, 1288 description of, 752
removing, 183 Procedures Log screen, Diagnostics tab
verifying, 182 element descriptions, 754
Printer Queue flyout Procedures Log screen, Maintenance tab
element descriptions, 180 element descriptions, 753
Printer Status/Queue flyout Procedures screen
description of, 475 description of, 740
element descriptions, 475 element descriptions, 741
Printer Verification flyout process path (Alinity i)
element descriptions, 179 illustration of, 97
Printers screen process path motor (Alinity i)
description of, 176 illustration of, 103
Alinity ci-series Operations Manual 1403
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Index
processing center Q
Alinity i description, 96
Alinity i illustration, 96 qualitative method comparison
processing codes c-series worksheet, 1359
descriptions of, 602 i-series worksheet, 1362
processing module performing, 1358
Alinity c description, 66 quality control (QC) summary data
Alinity i description, 93 viewing, 656
c-series observed problems, 1264 quality control analysis
general description, 66 description of, 637
general observed problems, 1263 quality control data
i-series observed problems, 1268 importing, 304
optional components, 123 quality control data, imported
pausing, 447 deleting, 305
processing module capacities quality control import statuses
c-series, 398 descriptions of, 307
i-series, 399 quality control inserts
processing module characteristics printing, 306
c-series, 392 viewing, 306
i-series, 393 quality control lot
processing module corrective action procedures manually creating, 295
emptying the bulk solution reservoirs (c-series), 1293 quality control lots
emptying the bulk solution reservoirs (i-series), 1297 deleting, 303
emptying the diluted wash buffer reservoir (i-series), quality control result flags
1301 descriptions of, 632
enabling or disabling the ICT module (c-series), Quality Control screen
1304 description of, 289
manually unloading a cartridge or rack from the element descriptions, 290
reagent carousel, 1290 Quality Control Summary screen
processing module interface specifications description of, 648
description of, 409 element descriptions, 648
processing module specifications, electrical quality controls
c-series, 404 deleting, 302
i-series, 405 editing, 298
processing module specifications, liquid waste output quantitative method comparison
c-series, 407 c-series worksheet, 1353
i-series, 408 i-series worksheet, 1356
processing module specifications, operational performing, 1351
c-series, 395 quiet zone
i-series, 396 1D reagent bar code labels (c-series), 412
processing module wash (c-series) sample bar code labels, 417
description of, 148
processing priorities R
reagent and sample manager (RSM), 565
proprietary statement racks
description of, 16 illustration of, 144
pump center (Alinity c) removing from the sample positioners, 1305
components, 86 unloading from the reagent carousel, 1290
description of, 86 racks and cartridges
illustration of, 86 loading into trays, 523
racks, vial
loading for immediate use, 572
1404 Alinity ci-series Operations Manual
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Index
loading for onboard storage, 549 reagent cartridges
preparing for immediate use, 572 preparing, 548
preparing for onboard storage, 549 reagent inventory
ratio technique adjustment methods (i-series) processing, 569
description of, 695 reagent inventory (individual c-series)
reaction graphs for results configuring, 193
viewing, 634 reagent inventory (individual i-series)
reaction vessels (i-series) configuring, 194
description of, 142 reagent kits and components
illustration of, 142 Alinity c reagent cartridge, 133
replenishing and updating inventory, 517 Alinity i reagent cartridge, 133
reagent and sample manager Alinity Reagent Replacement Cap, 133
configuring, 174 description of, 133
reagent and sample manager (RSM) illustration of, 133
capacities, 400 reagent troubleshooting (c-series), 923
components, 62 reagent troubleshooting (i-series), 924
description of, 62 reagent lot expiration
illustration of, 62 overriding, 192
loading area, 64 reagent low alert setting (individual c-series)
processing priorities, 565 configuring, 193
sample processing, 565 reagent low alert setting (individual i-series)
sample processing for onboard calibrators and configuring, 194
controls, 567 reagent probes (c-series)
status indicators, 65 replacing the, 832
reagent and sample manager (RSM) corrective action replacing the tubing, 840
procedure reagent stability
removing racks from the sample positioners, 1305 overriding, 192
reagent carousel reagent supply center (Alinity c)
manually unloading cartridges, 1290 description of, 91
manually unloading racks, 1290 illustration of, 91
reagent carousel (Alinity c) reagent carousel, 92
components, 92 reagent supply center (Alinity i)
description of, 92 components, 91, 120
illustration of, 92 description of, 120
reagent carousel (Alinity i) illustration of, 120
components, 121 reagent carousel, 121
description of, 121 reagent syringe (c-series)
illustration of, 121 replacing the O-ring and seal tips, 878
reagent carousel inventory reagent syringes (Alinity c)
verifying, 547 description of, 90
reagent carousel inventory management illustration of, 90
description of, 533 Reagents and Supplies screen
reagent cartridge description of, 186
disabling, 559 Reagents and Supplies screen, Reagents/Diluents tab
enabling, 560 element descriptions, 187
Reagent Cartridge Details screen Reagents and Supplies screen, Supplies tab
description of, 540 element descriptions, 189
element descriptions, 541 Reagents screen
reagent cartridge with empty bottles (c-series) description of, 533
description of, 145 Reagents screen, Current tab
illustration of, 145 element descriptions, 534
Alinity ci-series Operations Manual 1405
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Index
Reagents screen, Historical tab restarting
element descriptions, 538 AbbottLink, 478
Reagents screen, Search flyout restoring (CSC Logon)
element descriptions, 539 backup, 327
reference data reduction method (i-series) Result Details (Specimen and Control) screen
description of, 698 element descriptions, 624
reference range (expected values) Result Details screen
c-series worksheet, 1366 description of, 624
i-series worksheet, 1367 result interpretation
verifying the, 1365 limitations of, 718
releasing results
control results, 614 archiving, 668
specimen results, 614 transmitting to the host, 635
relocating viewing absorbance data for, 634
system, 153 viewing reaction graphs for, 634
removing Results screen
printer, 183 description of, 616
racks from the sample positioners, 1305 Results screen, Control tab
RV waste and updating inventory (i-series), 515 element descriptions, 620
replacing Results screen, Exception tab
Acid Probe Wash, 511 element descriptions, 621
bulk solutions and updating inventory, 508 Results screen, Search flyout
Detergent A, 511 element descriptions, 622
sample onboard wash solutions and updating Results screen, Specimen tab
inventory (c-series), 511 element descriptions, 618
replenishing Results screen, Unreleased tab
reaction vessels and updating inventory (i-series), element descriptions, 617
517 results, sample
Report File Location window deleting, 635
element descriptions, 661 resuming
reports sample processing, 574
configuring, 197 retest options
printing, 662 configuring, 174
Reports screen retest rules
description of, 196 configuring, 241
element descriptions, 196 retrieving
Requested Categories flyout troubleshooting package, 345
element descriptions, 488 RV access door (Alinity i)
requirements for illustration of, 102
handling consumables, 714 RV loader system (Alinity i)
Rerun Options flyout, control order illustration of, 114
element descriptions, 629 RV unloader (Alinity i)
Rerun Options flyout, specimen order illustration of, 106
element descriptions, 628 RV waste (i-series)
rerunning removing and updating inventory, 515
tests or exceptions for a specimen or control, 612 RV waste storage area (Alinity i)
reservoir areas (Alinity i) components, 119
bulk solution reservoir area, 117 description of, 119
descriptions of, 117 illustration of, 119
illustrations of, 117
pump drawer, 117
1406 Alinity ci-series Operations Manual
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Index
S description of, 562
disabling, 205
safety icons initiating or resuming, 574
description of, 721 reagent and sample manager (RSM), 565
sample and reagent syringe area (Alinity c) sample processing for onboard calibrators and
components, 90 controls
description of, 90 reagent and sample manager (RSM), 567
illustration of, 90 sample results
sample bar code checksums c-series observed problems, 1270
configuring, 185 deleting, 635
sample bar code labels i-series observed problems, 1276
changing, 185 Sample Status screen
configuring, 185 description of, 603
guidelines, 417 element descriptions, 604
sample bar code length Sample Status screen, Search flyout
configuring, 185 element descriptions, 606
sample bar code start/stop characters sample syringe (Alinity c)
configuring, 185 description of, 90
sample bar code type illustration of, 90
configuring, 185 sample syringe (c-series)
sample cups replacing the O-ring and seal tips, 885
description of, 142 sample tube specifications (aliquot and primary)
illustration of, 142 illustration and measurements, 421
illustrations and measurement, 421 sample volume requirements
volumes, 423 aliquot tube, 423
Sample Details (Specimen, Control, and Calibrator) description of, 423
screen primary tube, 423
element descriptions, 608 sample cup, 423
Sample Details screen samples
description of, 608 loading into sample racks, 569
sample diluents and user-defined reagents SCM hardware components
preparing, 552 bar code scanner, 55
sample gauge description of, 55
verifying sample volume in aliquot sample tubes, 569 Ethernet switch, 55
sample interference indices (c-series) firewall, 55
description of, 372 illustration of, 55
illustration of absorption spectra, 372 network connectors, 55
measurement, 372 RSM embedded computer, 55
protocol, 372 RSM X motor, 55
sample management SCM power supply, 55
description of, 562 UI computer, 55
sample measurement data reduction (c-series UI power strip, 55
potentiometric) uninterrupted power supply (UPS), 55
description of, 678 waste manifold, 55
sample onboard wash solutions (c-series) water inlet, 55
replacing and updating inventory, 511 screen elements
sample probe (c-series) descriptions of, 127
replacing the, 829 screen images
replacing the tubing, 837 printing, 663
sample processing screen time-out
calibration, 564 configuring, 205
control, 563
Alinity ci-series Operations Manual 1407
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Index
Search flyout processing module interface, 409
description of, 664 specifications, external waste pump
Search tab clearances, 412
Help window description, 34 dimensions, 411
Help window illustration, 34 electrical, 411
procedure for use, operations manual, 42 weight, 411
Select Items window specifications, liquid waste output
c-series element descriptions, 277 c-series, 407
sensitizers i-series, 408
precautions, 727 specifications, operational
setting c-series, 395
applied system update as available for installation i-series, 396
(FSE Logon), 340 specifications, optical
declined system update as available for installation, c-series, 406
339 specifications, SCM
settings hard drive, 409
procedure key, 746 monitor, 409
shortcut icons specimen collection
configuring, 218 requirements, 716
Shortcuts specimen handling
element descriptions, 218 requirements, 716
Shortcuts screen specimen preparation and storage
description of, 217 requirements, 716
slope calculation data reduction (c-series specimen result flags
potentiometric) descriptions of, 630
description of, 676 specimen results
SmartWash (c-series) releasing, 614
configuring settings, 243 spills
editing settings, 245 cleanup precautions, 730
SmartWash feature (c-series) spline data reduction method (c-series photometric)
description of, 370 description of, 685
sodium azide stability
precautions, 726 sodium hypochlorite, 732
sodium hydroxide solution starting
preparing, 731 processing module and reagent and sample
sodium hypochlorite manager (RSM), 447
stability, 732 STAT protocol
software data storage configuring, 175
capacities, 397 Status Change flyout (FSE Logon)
software troubleshooting element descriptions, 333
c-series, 919 status indicators
i-series, 921 description of, 65
solutions illustration of, 65
used in daily operations (c-series), 513 status of a TSB that failed to install
speaker volume changing to a status of Pending Verification (FSE
configuring, 205 Logon), 342
specifications status of an installed TSB
electrical (c-series), 404 changing to a status of Install Failed (FSE Logon),
electrical (i-series), 405 341
host interface, 409 statuses
operator interface, 409 assay file reagent, 272
physical, 400 assay file request, 489
1408 Alinity ci-series Operations Manual
80000256-101 - 2016-12-01
Index
assay insert, 546 symbols
calibration, 708 key to, 22
calibrator import (c-series), 264 syringe area (Alinity c)
cartridge, 543 sample and reagent, 90
file update, 271 syringes (c-series)
host connection, 473 1 mL, replacing the, 865
instrument, 496 O-ring and seal tips for reagent, replacing the, 878
load, 545 O-ring and seal tips for sample, replacing the, 885
mail, 491 O-ring and seal tips for wash solution, replacing the,
quality control import, 307 871
test, 601 reagent, description of, 90
transmission, 634 reagent, illustration of, 90
vial, 521 sample, description of, 90
view, 491 sample, illustration of, 90
stopping system
processing module and reagent and sample checking for appropriate operation, 152
manager (RSM), 449 clearances, 403
storage configuring, 154
description of requirements, 714 installing, 152
storage requirements logon, 457
description of, 714 relocating, 153
Supplies screen system characteristics
c-series element descriptions, 501 Alinity ci-series, 392
description of, 500 system control module (SCM)
i-series element descriptions, 505 computer and interface specifications, 409
supply and pump center (Alinity c) description of, 52
bulk solution reservoir area, 89 distance alert, 60
bulk solution storage area, 88 electrical specifications and requirements, 404
components, 85 hardware components, 55
description of, 85 illustration of, 52
illustration of, 85 network connectors, 56
pump center, 86 procedure key, 50
sample and reagent syringe area, 90 processor specifications, 409
supply and waste inventory software data storage capacities, 397
verifying, 508 system documentation
supply center (Alinity i) description of, 25
bulk solution storage area, 116 system flush (c-series)
components, 115 description of, 147
description of, 115 system flush (i-series)
illustration of, 115 description of, 147
reservoir areas, 117 system installation and relocation
RV waste storage area, 119 overview, 152
supply low alerts system level control sample processing
configuring, 195 configuring, 192
supply options system level reagent inventory
overriding lot expiration, 195 configuring, 192
overriding stability, 195 system level reagent low alert setting
suspending configuring, 192
samples that have tests in process, 575 System Logs screen
symbology description of, 930
1D reagent bar code labels (c-series), 412 Message Details For flyout element descriptions, 939
sample bar code labels, 417
Alinity ci-series Operations Manual 1409
80000256-101 - 2016-12-01
Index
System Logs screen, Abbott Mail tab tests or exceptions for a specimen or control
element descriptions, 938 rerunning, 612
System Logs screen, All Messages tab time
element descriptions, 930 configuring, 205
System Logs screen, Configuration tab toolbar
element descriptions, 936 Help window description, 30
System Logs screen, Host tab Help window illustration, 30
element descriptions, 937 topic pane
System Logs screen, Informational tab Help window description, 35
element descriptions, 933 Help window illustration, 35
System Logs screen, Inventory tab total allowable error method
element descriptions, 934 verifying an LoQ claim, 1319
System Logs screen, Notifications/Alerts tab transmission statuses
element descriptions, 932 descriptions of, 634
System Logs screen, User Access tab transmitting
element descriptions, 935 exceptions to the host, 635
system operation precautions and requirements results to the host, 635
impact of failure to comply, 713 trays
system prime (i-series) illustration of, 145
description of, 148 loading on reagent and sample manager (RSM), 524
system security tripping hazards
Alinity systems, 13 description of, 738
description of, 13 troubleshooting
responsibility for, 13 Alert Center flyout element descriptions, 927
system update approach to, 918
adding comments, 338 troubleshooting package
applying manually (FSE Logon), 340 retrieving, 345
declining, 337 troubleshooting packages
downloading software, 336 descriptions of, 343
importing, 339 troubleshooting reagent variables (c-series)
installing, 336 calibrators, 923
printing documentation, 335 controls, 923
setting a declined update as available for description of, 923
installation, 339 reagent kits, 923
setting an applied update as available for installation troubleshooting reagent variables (i-series)
(FSE Logon), 340 calibrators, 924
verifying manually, 338 controls, 924
viewing documentation, 335 description of, 924
System Update Import screen reagent cartridges, 924
element descriptions, 334 Troubleshooting screen
System Updates screen description of, 342
description of, 328 element descriptions, 342
element descriptions, 329 troubleshooting system variables (c-series)
consumables, 919
T description of, 919
fluidics subsystems, 919
temperature hardware, 919
c-series, 395 optical subsystem, 919
environmental requirements, 408 software, 919
i-series, 396 troubleshooting system variables (i-series)
test statuses consumables, 921
descriptions of, 601 description of, 921
1410 Alinity ci-series Operations Manual
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Index
fluidics subsystems, 921 User Profile screen
hardware, 921 description of, 165
optical subsystem, 921 element descriptions, 166
software, 921 user-defined assays (c-series photometric)
types creating, 247
message, 940 user-defined maintenance procedures
creating, 319
U editing, 319
exporting, 321
uninstalling uninstalling, 320
assay files, 274 User-Defined Maintenance screen
maintenance and diagnostic procedure files, 314 description of, 315
user-defined maintenance procedures, 320 User-Defined Maintenance screen, Create/Edit tab
unloading screen
cartridges from the reagent carousel, 1290 element descriptions, 315
racks and cartridges from reagent carousel to RSM, User-Defined Maintenance screen, Export tab
557 element descriptions, 317
racks from the reagent carousel, 1290 users
reagents from reagent and sample manager (RSM), activating, 163
558 editing, 162
samples from reagent and sample manager (RSM), exporting, 164
575 importing, 163
trays from reagent and sample manager (RSM), 533 inactivating, 163
vials from reagent and sample manager (RSM), 576 Users Import screen, Users Export screen
unscheduled cleaning element descriptions, 157
cleaning and decontaminating external components, Users screen
773 description of, 155
cleaning and decontaminating the bar code scanner, element descriptions, 156
773 Utilities screen
cleaning and decontaminating the monitor, 774 description of, 323
description of, 772
USB drive V
copying a backup, 327
USB flash drive verification
inserting and removing, 671 assay claims, 1311
use factor and blank data reduction method (c-series verifying
photometric) ASTM communication, 1308
description of, 687 automated dilution, 1346
user interface distance alert function, 226
description of, 126 HL7 communication, 1307
illustration of, 126 linearity, 1341
locking, 457 LoB claim, 1312
user interface (UI) computer LoD claim, 1315
observed problems, 1287 LoQ claim, precision and bias method, 1323
user interface (UI) computer corrective action LoQ claim, total allowable error method, 1319
procedures precision, 1329
verifying the ASTM communication, 1308 printer, 182
verifying the HL7 communication, 1307 reagent carousel inventory, 547
user PINs reference range (expected values), 1365
changing, 167 supply and waste inventory, 508
managing, 165 vial inventory data, 522
Alinity ci-series Operations Manual 1411
80000256-101 - 2016-12-01
Index
verifying manually reagent 1, 113
system update, 338 reagent 2, 113
Version Details for Procedure flyout sample, 113
element descriptions, 743 wash solution syringe (c-series)
vial inventory data replacing the O-ring and seal tips, 871
verifying, 522 wash zone probe (i-series)
vial racks replacing the, 897
loading for immediate use, 572 waste handling and disposal
loading for onboard storage, 549 overview, 728
preparing for immediate use, 572 water and liquid waste requirements
preparing for onboard storage, 549 Alinity ci-series, 406
vial statuses c-series, 407
descriptions of, 521 i-series, 408
vials Westgard rules
loading for immediate use, 572 application, 637
loading for onboard storage, 549 configuring, 309
preparing for immediate use, 572 descriptions, 638
preparing for onboard storage, 549 run descriptions, 640
vials, calibrator Westgard screen
onboard storage criteria, 568 description of, 308
vials, control element descriptions, 308
onboard storage criteria, 568 worksheets
view statuses c-series automated dilution verification, 1347
descriptions of, 491 c-series calibration verification, 1338
viewing c-series limit of blank (LoB), 1313
Abbott Mail documentation, 492 c-series limit of detection (LoD), 1316
Abbott Mail items, 491 c-series limit of quantitation (LoQ), precision and
absorbance data for results, 634 bias method, 1325
assay calibration status, 709 c-series limit of quantitation (LoQ), total allowable
assay inserts, 561 error method, 1320
calibrator lot data, 259 c-series linearity, 1342
calibrator value sheet (c-series), 267 c-series precision, 1333
control summary details, 657 c-series qualitative method comparison, 1359
details for Levey-Jennings points, 647 c-series quantitative method comparison, 1353
notes, 458 c-series reference range (expected values), 1366
print jobs in the printer queue, 476 i-series automated dilution verification, 1348
quality control (QC) summary data, 656 i-series calibration verification, 1339
quality control inserts, 306 i-series limit of blank (LoB), 1314
reaction graphs for results, 634 i-series limit of detection (LoD), 1317
system update documentation, 335 i-series limit of quantitation (LoQ), precision and bias
vortexers (Alinity i) method, 1326
illustration of, 98 i-series limit of quantitation (LoQ), total allowable
error method, 1322
W i-series linearity, 1343
i-series precision, 1335
warranty i-series qualitative method comparison, 1362
description of, 19 i-series quantitative method comparison, 1356
wash cups (Alinity i) i-series reference range (expected values), 1367
illustration of, 113
1412 Alinity ci-series Operations Manual
80000256-101 - 2016-12-01
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