BS-480

Chemistry Analyzer

Operator’s Manual
Basic Volume
2014-2022 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All
rights Reserved.
For this Operator’s Manual, the issue date is 2022-11.

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Copyright

Publication Information

Publication version Revision date Change description

1.0 2014-05- First version
2.0 2014-08 Added windows 7 operating
system
3.0 2019-04 Safety standard was upgraded
4.0 2021-11 Added contents according to the
requirements of REGULATION (EU)
2017/746 OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL
of 5 April 2017 on in vitro
diagnostic medical devices and
repealing Directive 98/79/EC and
Commission Decision
2010/227/EU, unique device
identifier, and electronic
interfaces.
5.0 2022-11 Modified EMC requirements

ii
 Copyright

Intellectual Property Statement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter
called Mindray) owns the intellectual property rights to this Mindray
product and this manual. This manual may refer to information protected
by copyright or patents and does not convey any license under the patent
rights or copyright of Mindray, or of others.
Mindray intends to maintain the contents of this manual as confidential
information. Disclosure of the information in this manual in any manner
whatsoever without the written permission of Mindray is strictly
forbidden.
Release, amendment, reproduction, distribution, rental, adaptation,
translation or any other derivative work of this manual in any manner
whatsoever without the written permission of Mindray is strictly
forbidden.

, , , , BeneView,
WATO, BeneHeart, are the trademarks, registered or otherwise, of
Mindray in China and other countries. All other trademarks that appear
in this manual are used only for informational or editorial purposes. They
are the property of their respective owners.

iii
Copyright

Responsibility on the Manufacturer Party

Contents of this manual are subject to change without prior notice.

All information contained in this manual is believed to be correct. Mindray

shall not be liable for errors contained herein or for incidental or
consequential damages in connection with the furnishing, performance,
or use of this manual.

Mindray is responsible for the effects on safety, reliability and

performance of this product, only if:
 all installation operations, expansions, changes, modifications and
repairs of this product are conducted by Mindray authorized
personnel;
 the electrical installation of the relevant room complies with the
applicable national and local requirements; and
 the product is used in accordance with the instructions for use.

Warning
It is important for the hospital or organization that employs this equipment to carry
out a reasonable service/maintenance plan. Neglect of this may result in machine
breakdown or personal injury.

Note
This equipment must be operated by skilled/trained clinical professionals.

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 Copyright

Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER
WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

Exemptions
Mindray's obligation or liability under this warranty does not include any
transportation or other charges or liability for direct, indirect or
consequential damages or delay resulting from the improper use or
application of the product or the use of parts or accessories not approved
by Mindray or repairs by people other than Mindray authorized personnel.
This warranty shall not extend to:
 Malfunction or damage caused by improper use or man-made failure.
 Malfunction or damage caused by unstable or out-of-range power
input.
 Malfunction or damage caused by force majeure such as fire and
earthquake.
 Malfunction or damage caused by improper operation or repair by
unqualified or unauthorized service people.
 Malfunction of the instrument or part whose serial number is not
legible enough.
 Others not caused by instrument or part itself.

Customer service department

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address: Mindray Building, Keji 12th Road South, High-tech
industrial park, Nanshan, Shenzhen 518057,P.R.China
Website: www.mindray.com
E-mail Address: service@mindray.com
Tel: +86 755 81888998
Fax: +86 755 26582680

EC - Representative
EC-Representative: Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestraβe 80, 20537 Hamburg, Germany
Tel: 0049-40-2513175
Fax: 0049-40-255726

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 Preface

This manual contains the instructions necessary to operate the product

safely and in accordance with its function and intended use. Please read
this manual thoroughly before using the product. This manual is based on
the maximum configuration and therefore some contents may not apply
to your product. It you have any questions, please contact us.
Observance of this manual is a prerequisite for proper performance and
correct operation, and it ensures patient and operator safety. All graphics
including screens and printouts in this manual are for illustration purpose
only and must not be used for any other purposes. The screens and
printouts on the product should prevail.

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 Safety Information

This chapter provides you with safety symbols used in this manual and
their meanings, summarizes the safety hazards and operating
precautions that should be considered seriously when the instrument is
being operated, and lists the labels and silkscreen that has been applied
to the instrument and their indications.

Safety Information-1
Safety Information

Safety Symbols
Safety symbols are used in this manual in order to remind you of the
instructions necessary to operate the product safely and in accordance
with its function and intended use. A safety symbol and text constitutes a
notice as shown in the table below:
Symbol Text Description
WARNING Read the statement following the symbol. The
statement is alerting you to an operating hazard
that can cause personal injury.
BIOHAZARD Read the statement following the symbol. The
statement is alerting you to a potentially
biohazardous condition.
CAUTION Read the statement following the symbol. The
statement is alerting you to a possibility of system
damage or unreliable results.
NOTE Read the statement following the symbol. The
statement is alerting you to information that
requires your attention.

Safety Information -2
 Safety Information

Summary of Hazards
Introduction
Observe the following safety precautions when using the product.
Ignoring any of these safety precautions may lead to personal injury or
equipment damage.

WARNING
If the product is used in a manner not specified by our company, the protection
provided by the product may be impaired.

Electric Shock Hazards

Observe the following instructions to prevent electric shock.

WARNING
 When the MAIN POWER is turned on, users other than the servicing personnel
authorized by our company must not open the rear cover or side cover.
 Spillage of reagent or sample on the product may cause equipment failure and
even electric shock. Do not place sample and reagent on the product. In case of
spillage, switch off the power immediately, remove the spillage and contact our
Customer Service Department or your local distributor.

Moving Parts Hazards

Observe the following instructions to prevent personal injury caused by
moving parts.

WARNING
 Do not touch such moving parts as sample probe, reagent probe, mixers , cuvette
wash station, sample carousel, reagent carousel and reaction carousel,when the
system is in operation.
 Do not put your fingers or hands into any open part when the system is in
operation.

Photometer Lamp Hazards

Observe the following instructions to prevent personal injury caused by
photometer lamp.

WARNING
 Eye injury could occur from light emission from the photometer lamp. Do not stare
into the lamp when the system is in operation.

Safety Information-3
Safety Information
 If you want to replace the photometer lamp, first switch off the MAIN POWER and
then wait at least 15 minutes for the lamp to cool down before touching it. Do not
touch the lamp before it cools down, or you may get burned.

Laser Beam Hazards

Observe the following instructions to prevent personal injury caused by
laser beam.

WARNING
Light emitted by the bar code reader may cause eye injury. Do not stare into the laser
beam radiated from the bar code reader when the system is in operation.

Sample, Calibrator and Control Hazards

Observe the following instructions to protect against the biohazardous
infection by samples, calibrators and control samples.

BIOHAZARD
 Inappropriately handling samples, controls and calibrators may lead to
biohazardous infection. Do not touch samples, mixtures or waste with your bare
hands. Wear gloves and lab coat and, if necessary, goggles.
 In case your skin contacts the sample, control or calibrator, follow the standard
laboratory safety procedure and consult a doctor.

Reagent and Wash Solution Hazards

Observe the following instructions to protect against the biohazardous
infection by reagents and wash solution.

WARNING
Reagents and concentrated wash solution are corrosive to human skins. Exercise
caution when using reagents and concentrated wash solution. In case your skin or
clothes contact them, wash them off with soap and clean water. If reagents or wash
solution spills into your eyes, rinse them with much water and consult an oculist.

Waste Hazards
Observe the following instructions to prevent environmental pollution and
personal injury caused by waste.

BIOHAZARD
 Some substances contained in reagent, control, concentrated wash solution and
waste are subject to regulations of contamination and disposal. Dispose of the
waste in accordance with your local or national rule for biohazard waste disposal
and consult the manufacturer or distributor of the reagents for details.
 Wear gloves and lab coat and, if necessary, goggles.

System Disposal Hazards

Observe the following instructions to dispose of the waste analyzer.

Safety Information -4
 Safety Information

WARNING
Materials of the analyzer are subject to contamination regulations. Dispose of the
waste analyzer in accordance with your local or national rule for waste disposal.

Fire and Explosion Hazards

Observe the following instructions to prevent fire and explosion.

WARNING
Ethanol is flammable substance. Please exercise caution while using ethanol around
the instrument in order to prevent fire and explosion.

Removal of Analyzer from Use for Repair or Disposal

To minimize or eliminate the hazards involved in repair, transportation,
disposal process, please observe the following instruction.

WARNING
When the analyzer is not in use, for example, in repair, transportation or disposal
process, please clean and sterilize the parts (sample probe, reagent probe, etc.) or
surfaces that may cause biohazdards and remind the person who handles the device
of the related hazards.

Software and Cybersecurity

WARNING
Data should be transmitted in a closed network or virtual isolated network
environment. The laboratory is responsible for the security of the virtual isolated
network environment.
Make sure that the network authorization information (such as user information and
password) is secure and not obtained by unauthorized persons.
Please use Microsoft firewall and kill the virus regularly.

Notification of Adverse Events

NOTE
As a health care provider, you may report the occurrence of certain events to
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD., and possibly to the
competent authority of the Member state in which the user and / or patient is
established.
These events, include device-related death and serious injury or illness. In addition,
as part of our Quality Assurance Program, SHENZHEN MINDRAY BIO-MEDICAL
ELECTRONICS CO., LTD. requests to be notified of device failures or malfunctions.
This information is required to ensure that SHENZHEN MINDRAY BIO-MEDICAL
ELECTRONICS CO., LTD. provides only the highest quality products.

Safety Information-5
Safety Information

Precautions on Use
Introduction
To use the product safely and efficiently, pay attention to the following
operating precautions.

Intended Use

WARNING
The instrument is an automated chemistry analyzer for in vitro diagnostic use in
clinical laboratories and designed for in vitro quantitative determination of clinical
chemistries in serum, plasma, urine and cerebrospinal fluid samples. Please consult
us before you use the instrument for other purposes.
When drawing a clinical conclusion, please also refer to patients’ clinical symptoms
and other test results.

Environment Precautions

CAUTION
Evaluate the electromagnetic environment prior to operating the system.
Please install and operate the system in an environment specified by this manual.
Installing and operating the system in other environment may lead to unreliable
results and even equipment damage.
To relocate the system, please contact our Customer Service Department or your
local distributor.

Installation Precautions

NOTE
The safety of any system incorporating the equipment is the responsibility of the
assembler of the system.

Electromagnetic Noise Precautions

CAUTION
The IVD MEDICAL EQUIPMENT complies with the emission and immunity requirements
described in this part of IEC 61326.
This equipment is not intended for use in residential environments and may not
provide adequate protection to radio reception in such environments.
This equipment is designed for use in a PROFESSIONAL HEALTHCARE FACILITY
ENVIRONMENT. It is likely to perform incorrectly if used in a HOME HEALTHCARE
ENVIRONMENT. If it is suspected that performance is affected by electromagnetic
interference, correct operation may be restored by increasing the distance between
the equipment and the source of the interference.
The electromagnetic environment should be evaluated prior to operation of the
device.

Safety Information -6
 Safety Information
Do not use this device in proximity to sources of strong electromagnetic radiation
(e.g. unshielded intentional RF sources), as these can interfere with proper
operation..

NOTE
 It is the manufacturer’s responsibility to provide equipment electromagnetic
compatibility information to the customer or user.
 It is the user’s responsibility to ensure that a compatible electromagnetic
environment for the equipment can be maintained in order that the device will
perform as intended.
 The calculation formula to determine the separation distance between an IVD
MEDICAL EQUIPMENT and a mobile phone is given by d = 6/E ∙√P, where d is the
minimum separation distance in metres, P is the maximum power in watts, and E
is the immunity test level in V/m.

Operating Precautions

CAUTION
 Take the clinical symptoms or other test results of the patient into considerations
when making a diagnosis based on the measuring results produced by the system.
 Operate the system strictly as instructed by this manual. Inappropriate use of the
system may lead to unreliable test results or even equipment damage or personal
injury.
 When using the system for the first time, first run calibrations, and then QC tests
to make sure the system is in proper state.
 Be sure to run QC tests every time when you use the system, otherwise the result
may be unreliable.
 Do not uncover the reagent carousel when the system is in operation. Keep the
reagent carousel cover closed.
 The RS-232 port on the analyzing unit is used for connection with the operation
unit only. Do not use it for other connections. Use the cables provided by our
company or your local distributor for the connection.
 The operation unit is a personal computer with the operating software installed.
Installing other software or hardware on the computer may interfere with the
system operation. Do not run other software when the system is working.
 Computer virus may destroy the operating software or test data. Do not use the
computer for other purposes or connect it to the Internet. If the computer is
infected by virus, please install anti-virus software to check for and clear virus.
 Do not touch the display, mouse or keyboard with wet hands or hands with
chemicals.
 Do not place the MAIN POWER to ON again within 10 seconds since placing it to OFF;
otherwise the system may enter the protection status. If it does so, place the MAIN
POWER to OFF and place it to ON again.
 Any serious incident that has occurred in relation to the device shall be reported
to the manufacturer and the competent authority of the country in which the user
and/or the patient is established.

Safety Information-7
Safety Information

Maintenance and Servicing Precautions

CAUTION
 Maintain the system strictly as instructed by this manual. Inappropriate
maintenance may lead to unreliable results, equipment damage or personal
injury.
 When the instrument is stored for a long time, dust may accumulate on the
surface. To wipe off dust from the system surface, use a soft, clean and wet (not
too wet) cloth soaked with soap water if necessary. Do not use such organic
solvents as ethanol for cleaning. After cleaning, wipe the surface dry with dry
cloth.
 Switch off all the powers and disconnect the power plug before cleaning and
servicing the instrument (external vacuum pump included). Take necessary
measures to prevent water ingression, otherwise equipment damage or personal
injury may be caused.
 Replacement of such major parts as sample probe, reagent probe and syringe
assembly must be followed by a calibration.
 The tubing of peristaltic pump may fail after a long period of work, which will lead
to dispersion overflow. Replace the pump tubing regularly.
 If the system fails and needs servicing, contact our Customer Service Department
or your local distributor. The system may need to be stopped or transported during
servicing, which will probably cause biohazards, electric shock hazards and
moving part hazards. Exercise caution when prepare the system for servicing.
 To avoid biohazards and chemical risks, wear gloves, lab coat and goggles.

NOTE
Check the safe state of the equipment after repair. Make sure the equipment is safe
and then offer it to the customer.

Chemistry Parameter Configuration Precautions

CAUTION
To define such parameters as sample volume, reagent volume and wavelength, follow
the instructions in this manual and the instructions of reagents.

ISE Module Precautions

CAUTION
To prevent ISE electrodes from being damaged due to water scarcity, if the system,
when equipped with an ISE module, will be powered off for a long time, perform the
electrode storage maintenance.

Sample Precautions

CAUTION
 Use samples that are completely free of insoluble substances like fibrin or
suspended matter; otherwise the sample probe may be clogged.
 Medicines, anticoagulants or preservative in the samples may lead to unreliable
results.

Safety Information -8
 Safety Information
 Hemolysis, icterus or lipemia in the samples may lead to unreliable test results;
running a sample blank, therefore, is recommended.
 Store the samples properly. Improper storage may change the compositions of
samples and lead to unreliable results.
 Sample volatilization may lead to unreliable results. Do not leave the sample open
for a long period.
 The system has a specific requirement on the sample volume. Refer to this manual
for proper sample volume.
 Load samples to correct positions on the sample carousel before the analysis
begins; otherwise reliable results may not be obtained.

Reagent, Calibrator and Control Precautions

CAUTION
 Use proper reagents, calibrators and controls on the system.
 Select appropriate reagents according to the performance characteristics of the
system. Consult the reagent suppliers, our company or our authorized distributor
for details, if you are not sure about your reagent choice.
 Store and use the reagents, calibrators and controls strictly as instructed by the
suppliers; otherwise, reliable results or best performance of the system may not
be obtained. Improper storage of reagents, calibrators and controls may lead to
unreliable results and bad performance of the system even in validity period.
 Perform calibration after changing the reagents, otherwise reliable results may
not be obtained.
 Contamination caused by carryover among reagents may lead to unreliable test
results. Consult the reagent suppliers for details.

Data Archiving Precautions

NOTE
The system automatically stores the data to the built-in hard disk. Data loss, however,
is still possible due to mis-deletion or physical damage of the hard disk. You are
recommended to regularly archive the data to such medium as CDs.
To avoid the data loss caused by unexpected power failure, UPS (uninterrupted power
supply) is recommended.

External Equipment Precautions

WARNING
For operating instructions and precautions of the computer and printer, please refer
to their operation manuals.
External equipment connected to the analogue and digital interfaces must be
authorized and complied with relevant safety and EMC standards (e.g., IEC 60950
Safety of Information Technology Equipment Standard and CISPR 22 EMC of
Information Technology Equipment Standard (CLASS B)). Any person, who connects
additional equipment to the signal input or output ports and configures an IVD system,
is responsible for ensuring that the system works normally and complies with the
safety and EMC requirements. If you have any questions, consult the technical
services department of your local representative.

Safety Information-9
Safety Information

External Vacuum Pump Precautions

WARNING
Make sure the vacuum pump tubing is connected properly without any twists or sharp
angles so that it can work normally.
Tubing and cables connected to the vacuum pump must be protected to prevent
damage and breaks due to human or other causes.
Set the vacuum pump on a solid flat platform or ground.

Tube and Liquid Container Precautions

WARNING
When the tube or the part that contain liquid become aged or damaged, please stop
its use immediately and contact our customer service department or your local
distributor to check and replace it.

Cleaning and Decontamination

CAUTION
Appropriate decontamination should be carried out in accordance with laboratory
safety regulations if reagent, sample or other liquids are spilled onto the equipment.
In case of large-amount liquid ingression, please contact our customer service
department or the local distributor.
No decontamination or cleaning agents can be used which could cause a HAZARD as a
result of a reaction with parts of the equipment or with material contained in it.
Strong acid or alkaline solutions are forbidden to clean the equipment.
If there is any doubt about the compatibility of the decontamination or cleaning
agents with parts of the equipment or with material contained in it, please contact
our customer service department or the local distributor.

CAUTION
Recommended detergent: water and 75% ethanol.
Prohibited detergent: materials that may corrode metals, for example, 3% hydrogen
peroxide.
The user shall perform regular cleaning to the cover of the analyzer. Use the specified
materials to clean the equipment only. For any damage to the instrument or other
accidents caused by using materials other than specified, Mindray will not provide
any warranty.
Mindray does not claim the validity of the listed chemicals in infection control. For
effective control of infection, please consult the Infection Prevention Department of
the hospital or the epidemic professionals.
Disinfection may damage the system to some extent. It is recommended to perform
disinfection only when necessary according to your laboratory protocol.
Do not use any cleaning agents which could cause a HAZARD as a result of a reaction
with parts of the equipment or with material contained in it.
If you accidentally spill hazardous material (for example, samples and reagents) on
the instrument, clean and disinfect the instrument. Recommended detergents and
disinfectants include water and 75% ethanol. Do not use materials that may corrode
metals (for example, 3% hydrogen peroxide). Wear proper personal protective

Safety Information -10

 Safety Information
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when
handling them and the contacted areas in the laboratory.

Safety Information-11
Safety Information

Labels and Silkscreen

Introduction
The following non-warning and warning labels and silkscreen are used on
the product for system identification and operating instruction.

For the label marked with , please consult the related

documentations in order to find out the nature of the potential HAZARDS
and any actions which have to be taken to avoid them.
Check the labels regularly for cleanliness and integrity. If any of the labels
becomes vague or peels off, contact our Customer Service Department or
your local distributor for replacement.
The general meaning assigned to geometric shapes, safety colors and
contrast colors for safety signs are as follows:
Geometric Meaning Safety color Contrast Graphical
shape color symbol color

Prohibition Red White Black

Mandatory Blue White White

Warning Yellow Black Black

Warning Yellow Black Black

Symbol Meaning
Serial number

Date of manufacture

Manufacturer

CE marking

Unique device identifier

Authorized Representative in the European

Community

Safety Information -12

 Safety Information
Symbol Meaning
The following definition of the WEEE label applies to
EU member states only: The use of this symbol
indicates that this product should not be treated as
household waste. By ensuring that this product is
disposed of correctly, you will help prevent bringing
potential negative consequences to the environment
and human health. For more detailed information with
regard to returning and recycling this product, please
consult the distributor from whom you purchased the
product.
In Vitro diagnostic medical device

Biological risks

Caution

Caution: hot surface

Caution: laser radiation

“ON” (power)

“OFF” (power)

“ON” for a part of equipment

“OFF” for a part of equipment

Computer network

Protective conductor terminal

Alternating current

Non-Warning Labels and Silkscreen

Interfaces for fluid connection
This symbol located on the fluid connection interfaces indicates the
connection of fluid tubing.

Safety Information-13
Safety Information

The fluidic interfaces for standard configuration are shown as follows:

HIGH CONC. WASTE HIGH CONC. WASTE SENSOR

LOW CONC. WASTE SENSOR

LOW CONC. WASTE DEIONIZED WATER

The fluidic interfaces for optional configuration are shown as follows:

Safety Information -14

 Safety Information

Warning Labels
Biohazard warning
This label indicating the risk of biohazardous infection is located in the
following positions:
 Sample probe
 Sample carousel
 Waste outlet
 Waste tank

Risk of electrical shock

This label is located on the power supply shielding box and vacuum
pump .Be cautious of electrical shock!

Moving parts warning

This symbol and text indicating the hazardous moving parts is located in
the following positions:
 Reagent probe and sample probe;
 Mixers
 Reagent carousel, reaction carousel and sample carousel
 Wash station

Safety Information-15
Safety Information

Laser warning
This symbol and text located near the sample bar code reader and the
reagent bar code reader reminds you of not staring into the laser beam.

Photometer lamp warning

This symbol and text located on the lamp housing reminds you of not
touching the lamp before it gets cool.

Probe collision warning

This symbol and text located near the sample carousel and reagent
carousel reminds you of not opening the cover to prevent from damaging
the probes.

Vacuum pump connection warning

This symbol and text located near the external vacuum pump and the
built-in vacuum pump reminds you of connecting the inlet and outlet
tubing correctly.

Safety Information -16

 Safety Information

Water supply/drainage/external vacuum module warning

This symbol and text located on the water supply module, drainage
module and external vacuum module reminds you of not pressing or
placing heavy goods on these modules.

Upper cover
This symbol and text located on the transparent upper cover reminds you
of not wipe the upper cover with ethanol or other organic solutions.

ISE module
This symbol and text located in the side cover of the ISE module. Please
turn off the main power before opening the side door.

Safety Information-17
Safety Information

Safety Information -18

 Contents

Publication Information ................................................................................................... ii

Intellectual Property Statement ..................................................................................... iii
Responsibility on the Manufacturer Party .................................................................... iv
Warranty ............................................................................................................................ v
Exemptions ............................................................................................................ v
Customer service department ............................................................................. v
EC - Representative .............................................................................................. v
Preface ··································································································vi
Safety Information ·····················································································1
Safety Symbols ................................................................................................................. 2
Summary of Hazards ....................................................................................................... 3
Introduction ........................................................................................................... 3
Electric Shock Hazards......................................................................................... 3
Moving Parts Hazards .......................................................................................... 3
Photometer Lamp Hazards .................................................................................. 3
Laser Beam Hazards ............................................................................................ 4
Sample, Calibrator and Control Hazards ............................................................ 4
Reagent and Wash Solution Hazards ................................................................. 4
Waste Hazards ...................................................................................................... 4
System Disposal Hazards .................................................................................... 4
Fire and Explosion Hazards ................................................................................. 5
Removal of Analyzer from Use for Repair or Disposal ...................................... 5
Software and Cybersecurity ................................................................................. 5
Notification of Adverse Events ............................................................................ 5
Precautions on Use .......................................................................................................... 6
Introduction ........................................................................................................... 6
Intended Use.......................................................................................................... 6
Environment Precautions ..................................................................................... 6
Installation Precautions ....................................................................................... 6

I
Contents - Basic Volume
Electromagnetic Noise Precautions .................................................................... 6
Operating Precautions .......................................................................................... 7
Maintenance and Servicing Precautions ............................................................ 8
Chemistry Parameter Configuration Precautions.............................................. 8
ISE Module Precautions ....................................................................................... 8
Sample Precautions .............................................................................................. 8
Reagent, Calibrator and Control Precautions ..................................................... 9
Data Archiving Precautions ................................................................................. 9
External Equipment Precautions ......................................................................... 9
External Vacuum Pump Precautions ................................................................ 10
Tube and Liquid Container Precautions ........................................................... 10
Cleaning and Decontamination ......................................................................... 10
Labels and Silkscreen .................................................................................................... 12
Introduction ......................................................................................................... 12
Non-Warning Labels and Silkscreen ................................................................. 13
Warning Labels .................................................................................................... 15
Contents ·································································································· I
1 System Description ···············································································1-1
1.1 Installation Requirements and Procedure ........................................................... 1-2
1.1.1 Installation Requirements ...................................................................... 1-2
1.1.2 Installation Procedure ............................................................................. 1-6
1.2 Hardware Structure ................................................................................................ 1-8
1.2.1 System Overview ..................................................................................... 1-8
1.2.2 Sample Handling System ..................................................................... 1-10
1.2.3 Reagent Handling System .................................................................... 1-13
1.2.4 Reaction System .................................................................................... 1-16
1.2.5 Cuvette Wash Station ............................................................................ 1-17
1.2.6 Photometric System .............................................................................. 1-18
1.2.7 Mixer Assembly ..................................................................................... 1-19
1.2.8 Operation Unit ........................................................................................ 1-20
1.2.9 Output Unit ............................................................................................. 1-20
1.2.10 Accessories and Consumables.......................................................... 1-20
1.3 Optional Modules ................................................................................................. 1-21
1.3.1 Introduction ............................................................................................ 1-21
1.3.2 ISE Module ............................................................................................. 1-21
1.3.3 Built-in Sample Bar Code Reader ........................................................ 1-21
1.3.4 Built-in Reagent Bar Code Reader ....................................................... 1-22
1.3.5 Water Supply Module ............................................................................ 1-23
1.3.6 Drainage Module ................................................................................... 1-24
1.3.7 External Vacuum Pump......................................................................... 1-25
1.3.8 Other Optional Modules ........................................................................ 1-26

II
 Contents - Basic Volume
1.4 Software Description ........................................................................................... 1-28
1.4.1 Main Screen ........................................................................................... 1-28
1.4.2 Using a Mouse ....................................................................................... 1-31
1.4.3 Using Online Help .................................................................................. 1-31
1.5 System Specifications ......................................................................................... 1-35
1.5.1 Technical Parameters ........................................................................... 1-35
1.5.2 Main Performance Indices.................................................................... 1-38
1.5.3 Contraindication .................................................................................... 1-40
1.5.4 Power supply ......................................................................................... 1-40
1.5.5 Environmental Requirements ............................................................... 1-40
1.5.6 Dimensions and Weight ........................................................................ 1-40
1.5.7 Input Device ........................................................................................... 1-40
1.5.8 Output Device......................................................................................... 1-40
1.5.9 Noise and Fuse ...................................................................................... 1-41
1.5.10 Communication Interfaces ................................................................. 1-41
1.5.11 Safety Classification ........................................................................... 1-41
1.5.12 EMC Requirements .............................................................................. 1-42
2 General Operating Procedure ··································································2-1
2.1 General Operating Procedure ................................................................................ 2-2
2.2 Check before Powering On .................................................................................... 2-3
2.2.1 Checking Water Supply ........................................................................... 2-3
2.2.2 Checking Power Supply .......................................................................... 2-3
2.2.3 Checking Printing Paper ......................................................................... 2-3
2.2.4 Checking Waste Tanks and Tubing ........................................................ 2-3
2.2.5 Checking Probes and Mixers .................................................................. 2-4
2.2.6 Checking Concentrated Wash Solution ................................................. 2-4
2.3 Powering On............................................................................................................ 2-6
2.3.1 Turning On Water Supply, Water Supply Module and Drainage Module2-6
2.3.2 Powering On the System ........................................................................ 2-6
2.3.3 Starting the Operating Software ............................................................ 2-7
2.4 Checking System Status ....................................................................................... 2-9
2.4.1 Checking System Status ......................................................................... 2-9
2.4.2 Checking Alarm Status ........................................................................... 2-9
2.4.3 Checking Reagent/Calibration Status ................................................. 2-10
2.4.4 Checking Maintenance Status ............................................................. 2-11
2.4.5 Checking Subsystems........................................................................... 2-12
2.5 Preparing Reagents.............................................................................................. 2-15
2.5.1 Loading Biochemical Reagents ........................................................... 2-15
2.5.2 Loading Concentrated Wash Solution ................................................. 2-19
2.5.3 Loading Reagent Probe Wash Solution ............................................... 2-20
2.5.4 Loading Sample Probe Wash Solution ................................................ 2-22

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Contents - Basic Volume
2.5.5 Loading Physiological Saline ............................................................... 2-22
2.6 Calibration ............................................................................................................. 2-25
2.6.1 Requesting Calibrations........................................................................ 2-25
2.6.2 Loading Calibrators ............................................................................... 2-28
2.6.3 Running Calibrations ............................................................................. 2-29
2.7 Quality Control ...................................................................................................... 2-30
2.7.1 Programming Control Samples ............................................................ 2-30
2.7.2 Loading Control Samples ..................................................................... 2-31
2.7.3 Running Control Samples ..................................................................... 2-32
2.7.4 Auto quality control ............................................................................... 2-32
2.8 Programming Routine Samples .......................................................................... 2-34
2.8.1 Programming Routine Samples ........................................................... 2-34
2.8.2 Loading Routine Samples ..................................................................... 2-40
2.8.3 Running Routine Samples .................................................................... 2-41
2.9 Programming STAT Samples .............................................................................. 2-42
2.9.1 Programming STAT Samples ............................................................... 2-42
2.9.2 Starting Analysis ................................................................................... 2-46
2.10 Test Status and Emergency Stop ..................................................................... 2-47
2.10.1 Checking Reagent Status ................................................................... 2-47
2.10.2 Viewing Test Status ............................................................................ 2-48
2.10.3 Viewing Reagent Carousel Status ..................................................... 2-50
2.10.4 Emergency Stop................................................................................... 2-51
2.11 Daily Maintenance ............................................................................................. 2-52
2.12 Powering Off ....................................................................................................... 2-53
2.13 Check after Powering Off .................................................................................. 2-54
3 System Setup·······················································································3-1
3.1 System Setup Options ........................................................................................... 3-2
3.1.1 Introduction .............................................................................................. 3-2
3.1.2 Sample Options and Reagent Alarm Limits .......................................... 3-2
3.1.3 Auto Rerun Setup ..................................................................................... 3-5
3.1.4 Instrument Setup Options ...................................................................... 3-7
3.1.5 Print Setup.............................................................................................. 3-10
3.1.6 Bar Code Setup ...................................................................................... 3-10
3.1.7 Host Communication Setup ................................................................. 3-10
3.1.8 User Accounts and Permissions .......................................................... 3-10
3.1.9 Customizing Sample Information ........................................................ 3-11
3.1.10 Customizing Patient Demographics.................................................. 3-11
3.1.11 Reagent/Calibration Setup ................................................................. 3-11
3.2 Chemistries Setup ................................................................................................ 3-12
3.2.1 Introduction ............................................................................................ 3-12
3.2.2 User-defined Chemistries Setup .......................................................... 3-12

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 Contents - Basic Volume
3.2.3 Processing Parameters ........................................................................ 3-14
3.2.4 Error Detection Limits ........................................................................... 3-20
3.2.5 Flag Qualitative Result .......................................................................... 3-24
3.2.6 Slope and Offset Adjustment ............................................................... 3-25
3.2.7 Reference/Critical Range Setup ........................................................... 3-26
3.3 Calibration Setup .................................................................................................. 3-30
3.3.1 Introduction ............................................................................................ 3-30
3.3.2 Defining a Calibrator ............................................................................. 3-30
3.3.3 Importing a Calibrator ........................................................................... 3-31
3.3.4 Editing a Calibrator ................................................................................ 3-32
3.3.5 Setting up Calibrator Concentrations .................................................. 3-33
3.3.6 Setting up Calibration Rules ................................................................. 3-34
3.3.7 Calibrator Acceptance Limits ............................................................... 3-36
3.3.8 Deleting a Calibrator.............................................................................. 3-37
3.4 QC Setup ............................................................................................................... 3-38
3.4.1 Introduction ............................................................................................ 3-38
3.4.2 Defining/Editing a Control .................................................................... 3-38
3.4.3 Selection of Chemistries ....................................................................... 3-39
3.4.4 Setting up Control Concentrations ...................................................... 3-40
3.4.5 Setting up QC Rules............................................................................... 3-41
3.4.6 Deleting a Control .................................................................................. 3-42
4 Operation Theories ···············································································4-1
4.1 Overview .................................................................................................................. 4-2
4.2 Principles of Measurement ................................................................................... 4-3
4.2.1 Introduction .............................................................................................. 4-3
4.3 Endpoint Measurements ....................................................................................... 4-4
4.3.1 Introduction .............................................................................................. 4-4
4.3.2 Calculation of Reaction Absorbance ..................................................... 4-4
4.3.3 Calculation of Blank Absorbance ........................................................... 4-4
4.3.4 Calculation of K Factor ............................................................................ 4-4
4.3.5 Calculation of Response ......................................................................... 4-5
4.3.6 Sample Blanked Response ..................................................................... 4-5
4.4 Fixed-time Measurements .................................................................................... 4-7
4.4.1 Introduction .............................................................................................. 4-7
4.4.2 Calculation of Response ......................................................................... 4-7
4.5 Kinetic Measurements ........................................................................................... 4-9
4.5.1 Introduction .............................................................................................. 4-9
4.5.2 Data Calculation in Kinetic Measurements........................................... 4-9
4.5.3 Determination of Linearity Range .......................................................... 4-9
4.5.4 Calculation of Response ....................................................................... 4-10
4.5.5 Evaluation for Linearity ......................................................................... 4-11

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Contents - Basic Volume
4.5.6 Enzyme Linearity Range Extension ...................................................... 4-12
4.6 Calibration Math Model and Factors .................................................................. 4-14
4.6.1 Linear Calibrations ................................................................................ 4-14
4.6.2 Non-Linear Calibrations........................................................................ 4-15
4.7 Prozone Check ...................................................................................................... 4-17
4.7.1 Introduction ............................................................................................ 4-17
4.7.2 Antigen Addition Method ...................................................................... 4-17
4.7.3 Reaction Rate Method ........................................................................... 4-18
Contents ·································································································· I
5 Reagents ····························································································5-1
5.1 Overview .................................................................................................................. 5-2
5.1.1 Introduction .............................................................................................. 5-2
5.1.2 Reagent/Calibration Screen Overview ................................................... 5-2
5.2 Customizing Reagent Display ............................................................................... 5-5
5.2.1 Introduction .............................................................................................. 5-5
5.2.2 Customizing Reagent Display ................................................................ 5-5
5.3 Sort Reagents ......................................................................................................... 5-6
5.3.1 Introduction .............................................................................................. 5-6
5.3.2 Sort Reagents .......................................................................................... 5-6
5.4 Reagent Inventory Alarm Limits Setup ................................................................ 5-7
5.4.1 Introduction .............................................................................................. 5-7
5.4.2 Setting up Reagent Inventory Alarm Limit for Biochemistry Reagent 5-7
5.4.3 Auto refreshing reagent inventory ......................................................... 5-8
5.5 Reagent Inventory Check....................................................................................... 5-9
5.5.1 Introduction .............................................................................................. 5-9
5.5.2 Checking Reagent Inventory .................................................................. 5-9
5.5.3 Canceling Reagent Inventory Check .................................................... 5-10
5.6 Bar-Coded Reagents Load .................................................................................. 5-11
5.6.1 Loading Bar-Coded Reagents .............................................................. 5-11
5.7 On-line Load of Reagents .................................................................................... 5-12
5.7.1 Introduction ............................................................................................ 5-12
5.7.2 On-Line Load of Reagents .................................................................... 5-12
5.8 Off-line Load of Reagents ................................................................................... 5-14
5.8.1 Introduction ............................................................................................ 5-14
5.8.2 Off-line Load of Reagents ..................................................................... 5-14
5.9 On-Line Replacement of Reagents..................................................................... 5-15
5.9.1 Introduction ............................................................................................ 5-15
5.9.2 On-Line Replacement of Reagents ...................................................... 5-15
5.10 Off-Line Replacement of Reagents .................................................................. 5-17
5.10.1 Introduction.......................................................................................... 5-17
5.10.2 Off-Line Replacement of Reagents ................................................... 5-17

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 Contents - Basic Volume
5.11 Unloading Reagents........................................................................................... 5-18
5.11.1 Introduction.......................................................................................... 5-18
5.11.2 Unloading Biochemical Reagents ...................................................... 5-18
6 Calibration ··························································································6-1
6.1 Overview .................................................................................................................. 6-2
6.2 Calibration Status and Alarm ................................................................................ 6-3
6.3 Calibrator Dilution Setup ....................................................................................... 6-4
6.3.1 Introduction .............................................................................................. 6-4
6.3.2 Setting up Calibrator Dilution Factors ................................................... 6-4
6.3.3 Editing Calibrator Dilution Factors ......................................................... 6-5
6.3.4 Deleting Calibrator Dilution Factors ...................................................... 6-6
6.4 Reagent Blank ......................................................................................................... 6-7
6.4.1 Introduction .............................................................................................. 6-7
6.4.2 Mixed Blank Absorbance and Response ............................................... 6-7
6.4.3 Requesting a Reagent Blank .................................................................. 6-8
6.4.4 Recalling Reagent Blank Results ........................................................... 6-8
6.5 Auto Calibration .................................................................................................... 6-12
6.5.1 Introduction ............................................................................................ 6-12
6.5.2 Auto Calibration Setup .......................................................................... 6-12
6.5.3 Auto Calibration Reminding.................................................................. 6-13
6.5.4 Removing Auto Calibration ................................................................... 6-13
6.6 Extending Calibration Time ................................................................................. 6-14
6.6.1 Introduction ............................................................................................ 6-14
6.6.2 Extending Calibration Time .................................................................. 6-14
6.6.3 Removing an Extended Status ............................................................. 6-15
6.7 Calibration Override ............................................................................................. 6-16
6.7.1 Introduction ............................................................................................ 6-16
6.7.2 Overriding a Calibration ........................................................................ 6-16
6.7.3 Removing Cal Overridden Status ......................................................... 6-16
6.8 Reject ..................................................................................................................... 6-17
6.8.1 Introduction ............................................................................................ 6-17
6.8.2 Rejecting a Calibration .......................................................................... 6-17
6.8.3 Removing Reject Status ........................................................................ 6-17
6.9 Recalling Calibration Results .............................................................................. 6-18
6.9.1 Recalling Current Calibration Factors.................................................. 6-18
6.9.2 Recalling History Calibration Factors .................................................. 6-18
6.9.3 Calibration Curve ................................................................................... 6-19
6.9.4 Calibration Reaction Curve ................................................................... 6-21
6.9.5 Editing Calibration Factors ................................................................... 6-24
6.9.6 Archiving Calibration Results ............................................................... 6-24
6.9.7 Calibration Trends ................................................................................. 6-25

VII
Contents - Basic Volume
7 Quality Control ····················································································7-1
7.1 Overview .................................................................................................................. 7-2
7.1.1 Introduction .............................................................................................. 7-2
7.1.2 Quality Control Operating Procedure ..................................................... 7-2
7.1.3 QC Alarms ................................................................................................ 7-2
7.1.4 QC Result Flags ....................................................................................... 7-2
7.1.5 Control Status .......................................................................................... 7-3
7.2 QC Evaluation ......................................................................................................... 7-4
7.2.1 Introduction .............................................................................................. 7-4
7.2.2 Evaluation of Single Controls ................................................................. 7-4
7.2.3 Two-Control Evaluation .......................................................................... 7-5
7.3 Auto Quality Control ............................................................................................... 7-8
7.3.1 Introduction .............................................................................................. 7-8
7.3.2 Auto QC Setup .......................................................................................... 7-8
7.3.3 Auto Quality Control ................................................................................ 7-9
7.3.4 Removing Auto QC Status ...................................................................... 7-9
7.4 Recalling Control Results .................................................................................... 7-10
7.4.1 Control Sample Results ........................................................................ 7-10
7.4.2 Recalling L-J Chart ................................................................................ 7-12
7.4.3 Recalling Twin-Plot Chart ..................................................................... 7-14
7.4.4 Recalling QC Data .................................................................................. 7-15
7.4.5 Recalling QC Summary ......................................................................... 7-20
8 Sample Programming and Processing ·························································8-1
8.1 Overview .................................................................................................................. 8-2
8.2 Sample Programming and Processing ................................................................ 8-3
8.2.1 Introduction .............................................................................................. 8-3
8.2.2 Adding Samples ....................................................................................... 8-3
8.2.3 Adding/Modifying Chemistries .............................................................. 8-4
8.2.4 Rerunning Samples ................................................................................. 8-4
8.2.5 Programming Samples with Increased or Decreased Volume ......... 8-12
8.2.6 Programming Diluted Samples ............................................................ 8-14
8.2.7 Sample Blank ......................................................................................... 8-16
8.2.8 Sample Management ............................................................................ 8-18
8.3 Serum Index .......................................................................................................... 8-21
8.3.1 Introduction ............................................................................................ 8-21
8.3.2 Theory of Serum Index .......................................................................... 8-21
8.3.3 Serum Index Setup ................................................................................ 8-22
8.3.4 Auto Serum Index .................................................................................. 8-23
8.3.5 Running SI Chemistry............................................................................ 8-24
8.4 Clear Samples ....................................................................................................... 8-25
8.4.1 Introduction ............................................................................................ 8-25

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 Contents - Basic Volume
8.4.2 Clearing Samples ................................................................................... 8-25
8.5 Unpositioned Samples ......................................................................................... 8-26
8.5.1 Introduction ............................................................................................ 8-26
8.5.2 Viewing Unpositioned Samples ........................................................... 8-26
8.5.3 Assigning Positions .............................................................................. 8-26
8.6 Release Sample Position ..................................................................................... 8-28
8.6.1 Introduction ............................................................................................ 8-28
8.6.2 Releasing Sample Positions ................................................................. 8-28
8.6.3 Auto Release of Samples ...................................................................... 8-29
8.7 Sample Logs ......................................................................................................... 8-30
8.7.1 Introduction ............................................................................................ 8-30
8.7.2 Viewing Sample Logs ............................................................................ 8-30
8.8 Customizing Sample Information ....................................................................... 8-32
8.8.1 Introduction ............................................................................................ 8-32
8.8.2 Customizing Sample Information ........................................................ 8-32
8.9 Customizing Patient Demographics .................................................................. 8-33
8.10 Sample and Chemistry Lists ............................................................................. 8-34
8.10.1 Introduction.......................................................................................... 8-34
8.10.2 Sample List .......................................................................................... 8-34
8.10.3 Chemistry List ...................................................................................... 8-35
8.11 Optimizing Result Display ................................................................................. 8-37
8.11.1 Introduction.......................................................................................... 8-37
8.11.2 Optimizing Result Display .................................................................. 8-37
8.12 Results Recall ..................................................................................................... 8-39
8.12.1 Introduction.......................................................................................... 8-39
8.12.2 Displaying Current Results ................................................................. 8-39
8.12.3 Recalling Current Results ................................................................... 8-40
8.12.4 Displaying History Results ................................................................. 8-41
8.12.5 Recalling History Results ................................................................... 8-42
8.12.6 Review Sample Results....................................................................... 8-43
8.12.7 Viewing/Editing Patient Demographics ............................................ 8-43
8.12.8 Reaction Curve..................................................................................... 8-44
8.12.9 Transmitting Results to LIS Host....................................................... 8-48
8.12.10 Printing Results ................................................................................. 8-49
8.12.11 Editing Results ................................................................................... 8-51
8.12.12 Deleting Results ................................................................................ 8-53
8.12.13 Customizing Result Display ............................................................. 8-54
8.12.14 Recalculating Results ....................................................................... 8-56
8.12.15 Compensating Results ..................................................................... 8-57
8.12.16 Recalling Result Trend ...................................................................... 8-58
8.12.17 Archiving Results .............................................................................. 8-59
8.13 Workload Statistics ............................................................................................ 8-60

IX
Contents - Basic Volume
8.14 Result Statistics ................................................................................................. 8-62
9 Result Printouts ···················································································9-1
9.1 Data Import and Export ......................................................................................... 9-2
9.1.1 Introduction .............................................................................................. 9-2
9.1.2 Import/Export Chemistries ..................................................................... 9-2
9.1.3 Data Archive ............................................................................................. 9-6
9.1.4 Sending sample results and QC results to LIS ..................................... 9-7
9.2 Print Setup .............................................................................................................. 9-8
9.2.1 Introduction .............................................................................................. 9-8
9.2.2 General Print Setup Options ................................................................... 9-8
9.2.3 Set Up Default Template ......................................................................... 9-9
9.2.4 Delete Template ....................................................................................... 9-9
9.2.5 Edit Print Template .................................................................................. 9-9
9.2.6 Import Print Template ............................................................................. 9-9
9.2.7 Defining Chemistry Print Order ............................................................ 9-10
9.3 Sample Reports .................................................................................................... 9-12
9.3.1 Introduction ............................................................................................ 9-12
9.3.2 Single Sample Report ............................................................................ 9-12
9.3.3 Multi-Sample Report ............................................................................. 9-13
9.3.4 Print Report Collection .......................................................................... 9-14
10 Chemistries ····················································································· 10-1
10.1 Twin Chemistries................................................................................................ 10-2
10.1.1 Introduction.......................................................................................... 10-2
10.1.2 Chemistry Definition ........................................................................... 10-2
10.1.3 Removing Twin Relation ..................................................................... 10-3
10.1.4 Reagent Setup ..................................................................................... 10-3
10.1.5 Setting Up and Requesting Calibration ............................................. 10-4
10.1.6 Setting Up and Requesting Quality Control ...................................... 10-4
10.1.7 Sample Programming and Processing ............................................. 10-4
10.2 Special Calculations .......................................................................................... 10-5
10.2.1 Introduction.......................................................................................... 10-5
10.2.2 Defining/Editing a Calculation ........................................................... 10-5
10.2.3 Enabling/Disabling Calculations........................................................ 10-6
10.2.4 Deleting User-Defined Calculations .................................................. 10-7
10.2.5 Running Calculations .......................................................................... 10-8
10.3 Panels .................................................................................................................. 10-9
10.3.1 Introduction.......................................................................................... 10-9
10.3.2 Defining/Editing a Panel ..................................................................... 10-9
10.3.3 Adjusting Display Order of Panels ................................................... 10-10
10.3.4 Deleting Panels .................................................................................. 10-10

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 Contents - Basic Volume
10.3.5 Running Panels.................................................................................. 10-10
10.4 Off-system Chemistries .................................................................................. 10-11
10.4.1 Introduction........................................................................................ 10-11
10.4.2 Define/Edit Off-System Chemistries ............................................... 10-11
10.4.3 Running the Off-system Chemistries .............................................. 10-12
10.4.4 Deleting Off-system Chemistries .................................................... 10-13
10.5 Serum Index ...................................................................................................... 10-14
10.6 Chemistry Configuration ................................................................................. 10-15
10.6.1 Introduction........................................................................................ 10-15
10.6.2 Enabling Chemistries ........................................................................ 10-15
10.6.3 Disabling Chemistries ....................................................................... 10-16
10.6.4 Customizing Chemistry Display Order ............................................ 10-17
10.6.5 Adjusting Test Order of Chemistries ............................................... 10-17
10.7 Carryover Setup ................................................................................................ 10-19
10.7.1 Introduction........................................................................................ 10-19
10.7.2 Defining/Editing Carryover Pair ....................................................... 10-19
10.7.3 Removing a Carryover Pair ............................................................... 10-20
10.8 Default Panel .................................................................................................... 10-21
10.8.1 Introduction........................................................................................ 10-21
10.8.2 Defining the Default Panel ................................................................ 10-21
10.8.3 Running Default Panel for Routine Samples .................................. 10-21
10.8.4 Running Default Panel for Emergent Samples ............................... 10-22
10.9 Masking/Unmasking Chemistries .................................................................. 10-23
10.9.1 Introduction........................................................................................ 10-23
10.9.2 Masking/Unmasking Chemistries ................................................... 10-23
10.10 Reflex............................................................................................................... 10-25
10.10.1 Introduction ..................................................................................... 10-25
10.10.2 Setting Reflex Relation ................................................................... 10-25
10.10.3 Editing Reflex Relation .................................................................... 10-26
10.10.4 Deleting Reflex Relation.................................................................. 10-26
10.10.5 Measurement and Result Recall .................................................... 10-27
11 System Commands and Setup Options ···················································· 11-1
11.1 Home ................................................................................................................... 11-2
11.1.1 Introduction.......................................................................................... 11-2
11.1.2 Homing System ................................................................................... 11-2
11.2 Stop Print ............................................................................................................ 11-3
11.2.1 Introduction.......................................................................................... 11-3
11.2.2 Stop Print ............................................................................................. 11-3
11.3 Sleep and Wake Up ............................................................................................ 11-4
11.3.1 Introduction.......................................................................................... 11-4
11.3.2 System Hibernation............................................................................. 11-4

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Contents - Basic Volume
11.3.3 Waking up the System ........................................................................ 11-4
11.4 User and Password Setup ................................................................................. 11-5
11.4.1 Introduction.......................................................................................... 11-5
11.4.2 Defining a User .................................................................................... 11-5
11.4.3 Modifying a User ................................................................................. 11-6
11.4.4 Assigning/Modifying Permissions .................................................... 11-6
11.4.5 Deleting a User .................................................................................... 11-7
11.5 Sleep and Awake Setup ..................................................................................... 11-8
11.5.1 Introduction.......................................................................................... 11-8
11.5.2 Auto Sleep Setup ................................................................................. 11-8
11.5.3 Auto Startup Setup .............................................................................. 11-9
11.5.4 Auto Awake Setup ............................................................................. 11-10
11.6 Dictionary Setup ............................................................................................... 11-11
11.6.1 Introduction........................................................................................ 11-11
11.6.2 Defining, Editing and Deleting Data Option ..................................... 11-11
11.7 Software Upgrade ............................................................................................ 11-13
11.7.1 Introduction........................................................................................ 11-13
11.7.2 Software Upgrade .............................................................................. 11-13
11.8 Software Version .............................................................................................. 11-14
11.8.1 Introduction........................................................................................ 11-14
11.8.2 Software Version ............................................................................... 11-14
11.9 Voice Tone Setup ............................................................................................. 11-16
11.9.1 Introduction........................................................................................ 11-16
11.9.2 Importing Audio Files ........................................................................ 11-16
11.9.3 Setting Up Voice Tone ....................................................................... 11-16
12 Use of ISE Module ············································································· 12-1
12.1 Precautions on Use ............................................................................................ 12-2
12.1.1 Introduction.......................................................................................... 12-2
12.1.2 Precautions on Use ............................................................................. 12-2
12.2 Principles of Measurement ............................................................................... 12-4
12.3 ISE Chemistry Parameters ................................................................................ 12-5
12.3.1 Introduction.......................................................................................... 12-5
12.3.2 Viewing ISE Chemistry Parameters ................................................... 12-5
12.3.3 Introduction to ISE Chemistry Parameters ....................................... 12-5
12.3.4 Flag ISE Qualitative Result ................................................................. 12-6
12.4 Preparing ISE Reagents for Measurement ...................................................... 12-8
12.4.1 Introduction.......................................................................................... 12-8
12.4.2 Off-line Load ISE Reagent .................................................................. 12-8
12.4.3 On-line Load ISE Reagent ................................................................. 12-10
12.4.4 Load ISE Wash Solution .................................................................... 12-10
12.4.5 Replacing ISE Wash Solution ........................................................... 12-11

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12.5 Calibration and Results Recall ........................................................................ 12-12
12.5.1 Introduction........................................................................................ 12-12
12.5.2 Calibration Setup ............................................................................... 12-12
12.5.3 Calibration Status and Alarm ........................................................... 12-13
12.5.4 ISE Calibration ................................................................................... 12-14
12.5.5 Results Recall .................................................................................... 12-14
12.5.6 Extending ISE Calibration Time ........................................................ 12-17
12.6 Quality Control and Results Recall ................................................................. 12-18
12.6.1 Quality Control and Results Recall .................................................. 12-18
12.7 Sample Programming and Results Recall ..................................................... 12-19
12.8 Reagent Inventory Alarm Limit ....................................................................... 12-20
12.8.1 Introduction........................................................................................ 12-20
12.8.2 Setting up Reagent Inventory Alarm Limit ...................................... 12-20
12.9 ISE Prime Cycle ................................................................................................ 12-21
12.9.1 Introduction........................................................................................ 12-21
12.9.2 Defining/Modifying ISE Prime Times .............................................. 12-21
12.10 Daily Maintenance ......................................................................................... 12-22
12.10.1 Daily Maintenance .......................................................................... 12-22
12.11 Troubleshooting ISE Module ......................................................................... 12-23
12.11.1 Troubleshooting ISE Module .......................................................... 12-23
13 Use of Bar Code ················································································ 13-1
13.1 Sample Bar Code Reader ................................................................................... 13-2
13.1.1 Introduction.......................................................................................... 13-2
13.1.2 Sample Bar Code Setup ...................................................................... 13-2
13.1.3 Programming Bar-Coded Routine Samples ..................................... 13-4
13.1.4 Programming Bar-Coded STAT Samples.......................................... 13-6
13.1.5 Adding New Samples or Chemistries ................................................ 13-9
13.1.6 Rerunning Bar-Coded Samples ....................................................... 13-10
13.1.7 Results Recall .................................................................................... 13-12
13.1.8 Recalling Current Results ................................................................. 13-13
13.2 Reagent Bar Code Reader ............................................................................... 13-14
13.2.1 Introduction........................................................................................ 13-14
13.2.2 Reagent Bar Code Setup ................................................................... 13-15
13.2.3 Loading Bar-Coded Reagents .......................................................... 13-16
13.3 Bar Code Reader Maintenance ....................................................................... 13-18
13.3.1 Introduction........................................................................................ 13-18
13.3.2 Cleaning Sample and Reagent Bar Code Scanning Windows....... 13-18
13.4 Troubleshooting Bar Code Reader ................................................................. 13-19
14 LIS and RMS ····················································································· 14-1
14.1 Overview .............................................................................................................. 14-2

XIII
Contents - Basic Volume
14.2 Host Communication ......................................................................................... 14-3
14.2.1 Introduction.......................................................................................... 14-3
14.2.2 Connection between PC and LIS Host .............................................. 14-3
14.2.3 Host Communication Parameters ..................................................... 14-4
14.2.4 Defining Chemistry Code .................................................................... 14-6
14.3 Programming Samples with LIS Host .............................................................. 14-7
14.3.1 Introduction.......................................................................................... 14-7
14.3.2 Programming Functions ..................................................................... 14-7
14.4 Result Transmission ........................................................................................ 14-11
14.4.1 Introduction........................................................................................ 14-11
14.4.2 Result Transmission Setup .............................................................. 14-12
14.4.3 Manually Sending Results to LIS Host ............................................ 14-12
14.5 Troubleshooting LIS ......................................................................................... 14-13
14.6 Use of RMS ....................................................................................................... 14-14
14.6.1 Introduction........................................................................................ 14-14
14.6.2 Connection between PC and RMS ................................................... 14-14
14.6.3 Troubleshooting RMS ....................................................................... 14-15
Contents ·································································································· I
15 Diagnostics ······················································································ 15-1
15.1 Overview .............................................................................................................. 15-2
15.2 Diagnosis of Sample System ............................................................................ 15-3
15.2.1 Introduction.......................................................................................... 15-3
15.2.2 Sample Probe Clog Detection ............................................................ 15-3
15.2.3 Sample Probe Level Sense Test ......................................................... 15-5
15.3 Diagnosis of Reagent System ........................................................................... 15-8
15.3.1 Introduction.......................................................................................... 15-8
15.3.2 Reagent Probe Level Sense Test ....................................................... 15-8
15.4 Sensor Diagnosis ............................................................................................. 15-11
15.4.1 Introduction........................................................................................ 15-11
15.4.2 Sensor Diagnosis .............................................................................. 15-11
16 Maintenance ···················································································· 16-1
16.1 Overview .............................................................................................................. 16-2
16.1.1 Introduction.......................................................................................... 16-2
16.1.2 Introduction.......................................................................................... 16-2
16.1.3 Consumables ....................................................................................... 16-3
16.1.4 Tools Required for Maintenance ........................................................ 16-4
16.2 Biochemistry Maintenance ............................................................................... 16-6
16.2.1 Introduction.......................................................................................... 16-6
16.2.2 Biochemistry Maintenance Screen Overview ................................... 16-6
16.3 ISE Maintenance ................................................................................................ 16-8

XIV
 Contents - Basic Volume
16.3.1 Introduction.......................................................................................... 16-8
16.3.2 ISE Maintenance Screen Overview .................................................... 16-8
16.4 Scheduled Maintenance Log .......................................................................... 16-10
16.4.1 Introduction........................................................................................ 16-10
16.4.2 Maintenance Schedule ..................................................................... 16-10
16.4.3 Scheduled Maintenance Procedures............................................... 16-11
16.4.4 Maintenance Log Sheet .................................................................... 16-12
16.4.5 Scheduled Maintenance Screen Overview ...................................... 16-15
16.5 Daily Maintenance ........................................................................................... 16-19
16.5.1 Introduction........................................................................................ 16-19
16.5.2 Check Probes/Mixers/Wash Wells .................................................. 16-19
16.5.3 Check Sample/Reagent Syringes .................................................... 16-21
16.5.4 Check Deionized Water ..................................................................... 16-22
16.5.5 Check Waste ...................................................................................... 16-23
16.5.6 Check Concentrated Wash Solution ................................................ 16-24
16.5.7 Check Sample Probe Wash Solution ............................................... 16-25
16.5.8 Clean Electrode Tubes (For ISE Module) ......................................... 16-26
16.6 Weekly Maintenance ........................................................................................ 16-28
16.6.1 Clean Sample/Reagent Probe Exterior ............................................ 16-28
16.6.2 Clean Mixers ...................................................................................... 16-29
16.6.3 Special Wash...................................................................................... 16-30
16.6.4 Cuvette Check .................................................................................... 16-31
16.6.5 Photometer Check ............................................................................. 16-33
16.7 Monthly Maintenance ...................................................................................... 16-35
16.7.1 Clean Wash Wells .............................................................................. 16-35
16.7.2 Clean Wash Station ........................................................................... 16-36
16.7.3 Clean Filter Core ................................................................................ 16-37
16.7.4 Clean Dust Screens ........................................................................... 16-39
16.7.5 Clean Sample Injection Port (For ISE Module) ............................... 16-40
16.7.6 Pump Calibration (For ISE Module) ................................................. 16-41
16.7.7 Air Bubble Detector Calibration (For ISE Module) .......................... 16-42
16.7.8 Clean the Dust Screen of the External Vacuum Pump................... 16-43
16.8 Three-Month Maintenance ............................................................................. 16-45
16.8.1 Clean DI Water Tank .......................................................................... 16-45
16.8.2 Replace Filter Core ............................................................................ 16-47
16.9 Six-Month Maintenance .................................................................................. 16-49
16.9.1 Replace Lamp .................................................................................... 16-49
16.9.2 Replace Water Inlet Filter .................................................................. 16-50
16.9.3 Replace Reference Electrode(For ISE Module) ............................... 16-51
16.10 As-Needed/As-Required Maintenance ....................................................... 16-54
16.10.1 Clean Analyzer Panels .................................................................... 16-54
16.10.2 Clean Sample Compartment .......................................................... 16-55

XV
Contents - Basic Volume
16.10.3 Clean Reagent Compartment ......................................................... 16-56
16.10.4 Clean Sample Probe Interior .......................................................... 16-57
16.10.5 Clean Reagent Probe Interior ......................................................... 16-61
16.10.6 Replace Sample Probe .................................................................... 16-62
16.10.7 Replace Reagent Probe .................................................................. 16-65
16.10.8 Replace Sample Mixer .................................................................... 16-66
16.10.9 Replace Reagent Mixer ................................................................... 16-67
16.10.10 Remove Air Bubbles in Sample Syringe ...................................... 16-68
16.10.11 Remove Air Bubbles in Reagent Syringe .................................... 16-70
16.10.12 Replace Cuvette ............................................................................ 16-71
16.10.13 Special Wash Probes .................................................................... 16-74
16.10.14 Bar Code Maintenance ................................................................. 16-74
16.10.15 Clean Probes/Mixers Exterior ...................................................... 16-75
16.10.16 Replace ISE Electrode ................................................................... 16-76
16.10.17 Remove Reagent Pack (For ISE Module) .................................... 16-78
16.10.18 Store Electrodes (For ISE Module) ............................................... 16-79
16.10.19 Two-Point Calibration (For ISE Module) ..................................... 16-80
16.10.20 Maintenance (For ISE Module) .................................................... 16-80
16.10.21 Purge A (For ISE Module) ............................................................. 16-81
16.10.22 Purge B (For ISE Module) ............................................................. 16-81
16.10.23 Program Check Instruction (For ISE Module) ............................. 16-81
16.10.24 Read Dallas Chip (For ISE Module).............................................. 16-81
16.10.25 Write Dallas Chip (For ISE Module) ............................................. 16-81
16.10.26 Replace Sample Syringe ............................................................... 16-82
16.10.27 Replace Reagent Syringe ............................................................. 16-84
16.10.28 Clean Rotors .................................................................................. 16-85
16.10.29 Clean ISE Waste Tube ................................................................... 16-86
17 Alarms and Troubleshooting································································· 17-1
17.1 Classification of Logs ........................................................................................ 17-2
17.1.1 Introduction.......................................................................................... 17-2
17.1.2 Error Logs ............................................................................................. 17-2
17.1.3 Edit Logs ............................................................................................... 17-2
17.2 Viewing and Handling Logs .............................................................................. 17-3
17.2.1 Description of Error Log Screen ......................................................... 17-3
17.2.2 Description of Edit Log Screen ........................................................... 17-3
17.2.3 Recalling Logs ..................................................................................... 17-4
17.2.4 Refreshing Logs ................................................................................... 17-5
17.2.5 Clearing Logs ....................................................................................... 17-5
17.2.6 Printing Logs ........................................................................................ 17-6
17.3 Error Troubleshooting ........................................................................................ 17-7
17.3.1 Introduction.......................................................................................... 17-7

XVI
 Contents - Basic Volume
17.3.2 Error Indications .................................................................................. 17-7
17.3.3 Identifying Errors ................................................................................. 17-8
17.4 Data Alarm ........................................................................................................ 17-10
17.4.1 Introduction........................................................................................ 17-10
17.4.2 Result Flags ....................................................................................... 17-11
17.5 Error Messages and Corrective Actions ........................................................ 17-22
18 Template Modifying Software ······························································· 18-1
18.1 Main Screen ........................................................................................................ 18-2
18.1.1 Main Screen ......................................................................................... 18-2
18.1.2 File (F) ................................................................................................... 18-2
18.1.3 Edit (E) .................................................................................................. 18-5
18.1.4 View (V) ................................................................................................ 18-5
18.1.5 Insert (I) ................................................................................................ 18-6
18.1.6 Format (M) ........................................................................................... 18-7
18.1.7 Set(S) .................................................................................................... 18-8
18.1.8 Help (H)................................................................................................. 18-9
18.2 Common Tools ................................................................................................. 18-10
18.3 Draw Tools ........................................................................................................ 18-11
18.4 Property Window .............................................................................................. 18-13
18.4.1 Page .................................................................................................... 18-13
18.4.2 Line ..................................................................................................... 18-13
18.4.3 Rectangle ........................................................................................... 18-14
18.4.4 Label ................................................................................................... 18-15
18.4.5 Text ..................................................................................................... 18-17
18.4.6 Title ..................................................................................................... 18-18
18.4.7 Image .................................................................................................. 18-19
18.5 Report Window ................................................................................................. 18-21
Electronic Interface····················································································1
Vocabulary ·······························································································1
Index ······································································································1
Bibliography ·····························································································1

XVII
Contents - Basic Volume

XVIII
 1 System Description

This chapter describes the system from the installation, hardware,

software and specifications perspectives, including:
 Installation requirements and methods of the instrument
 Hardware components
 Optional modules that can be configured with the instrument
 Introduction and operation of software screens
 Technical specifications

1-1
1 System Description

1.1 Installation Requirements and Procedure

1.1.1 Installation Requirements

CAUTION
Install the instrument in a place meeting the requirements presented in this section;
otherwise, it will not perform as intended.

Installation environment
 The system is for indoor use only.
 The bearing platform (or ground) should be level (with gradient less
than 1/200).
 The bearing platform (or ground) should be able to support at least
300Kg weight.
 The installation site should be well ventilated.
 The installation site should be free of dust.
 The installation side should not be in direct sun.
 The installation site should be kept away from a heat or draft source.
 The installation site should be free of corrosive gas and flammable
gas.
 The bearing platform (of ground) should be free of vibration.
 The installation site should be kept away from large noise and power
supply interference.
 Keep the system away from brush-type motors and electrical contact
device that is frequently switched on and off.
 Do not use such devices as mobile phones and radio transmitter near
the system.
 The system should be installed in a place with altitude height
between -400 to 4000 meters. In places with an altitude height
between 2000m to 4000m, an external vacuum pump should be
employed.

Power supply
 Connect the system to a power supply meeting the requirements
specified in this manual. For more information, refer to 1.5 System
Specifications(page1-35).
 The system is provided with a three-wire power cord, which has good
grounding performance.
 The system should be connected to a properly-grounded power
socket.
 Grounding voltage must be configured.

1-2
 1 System Description

WARNING
Make sure the power socket is grounded correctly. Improper grounding may lead to
electric shock or equipment damage. Check if the power sockets outputs voltage
meeting the specified requirements and has a proper fuse installed.

Temperature and humidity

 Ambient temperature: 15° C-30° C
 Relative humidity: 35%-85%, without condensation.

CAUTION
Operating the system in an environment other than the specified may lead to
unreliable test results. If the temperature or relative humidity does not meet
the above-mentioned requirements, use air-conditioning equipment.

Water supply and drainage

 The supplied water must meet the requirements of CLSI type II.:
Resistance is more than 1MΩ.CM.; Silicate is lower than 0.1 mg/L,

CAUTION
The supplied water must meet the requirements of CLSI type II; otherwise
insufficiently purified water may result in misleading test results.

 Flow: no less than 38L/H for average flow, and 2L/M for transient
peak flow.
 If you use water supply equipment, make sure that the water supply
pressure is within 95kPa-392kPa and the length of the inlet tubing is
no longer than 10m.
 Make sure that the outlet is no less than 50mm wide and no greater
than 100mm high, and the length of the waste tubing does not exceed
5 meters.

BIOHAZARD
Dispose of the waste liquid according to the local regulations.

After installing the instrument, connect it with the fluidic components as

instructed in the figure below.

BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.

CAUTION
When connecting the tubes, exercise caution to avoid folding or pressing them.

1-3
1 System Description
Figure 1.1 Fluidic connection diagram

High Conc.
waste
Sensor

High conc.waste High Conc. WasteTank

Vacuum pump
control
(optional)
Vacuum Pump（ optional（
Vacuum
pump control
(optional)

Low Conc. Drainage

waste module(optional)
sensor
Analyzer

IN1 IN2 OUT

FIL01 Outlet
Low Conc. Waste
Water Supply
Module(optional)

OUT1 OUT2 IN
Water tank
V01

DI water
Water unit

FIL01

Space and accessibility requirements

Install the instrument according to the clearance requirements as shown
in the figure below.
Figure 1.2 System clearances

Wall
Min. 500

Maximum of 3000

Min. 500
Operation Unit
720

Analyzing Unit

Front
1190
Min. 500

Min. 500 Unit: mm

1-4
 1 System Description

Recommended computer configuration

Table 1.1 Recommended computer configuration

Item Description
CPU At least P4 2.6GHz above
Random access At least 2GB for each RAM
memory (RAM)
Network adapter The computer is connected to the chemistry analyzer
through a network adapter. If you are going to connect
the computer with the LIS or Internet, you should
prepare another network adapter (Intel gigabit
network adapter)
Serial port The computer should provide an RS232 serial port,
which is used to connect it with the chemistry analyzer.
Hard disk defragment At least 160GB for hard disk. Install the operating
system in the C drive and the operating software of the
instrument in the D drive. Make sure that the C drive is
over 30G and D drives over 100G, and the disk file
system is of NTFS format. Deselect the two options at
the bottom of the disk properties window: “Compress
drive to save disk space” and “Allow Indexing Service
to index this disk for fast file searching”.
Operating system The operating system installed on the computer must
be an activated or free version Microsoft Windows 8(64
bit) or Windows7(32 bit) .
Application software Except for the operating system, other application
software must not be installed or reserved on the
computer. If an anti-virus application has been
installed, then remove the automatic scheduled
scanning and add the operating software and BSLOG to
the trust list.
Screen saver and Turn off the screen saver and BS Special Power Policy
system standby power scheme, and then disable the hibernation
option.
Screen display Set the screen resolution as 1280*1024 pixels and color
properties quality as Highest (32 bit).
Automatic Disable the Automatically synchronize with an Internet
synchronization with time server option.
Internet time server
Automatic updates Turn off the automatic updates.
Auto awake and If you are going to use the auto awake/shutdown
shutdown setup function, perform necessary settings for BIOS and
network adapters while referring to their operation
manuals.
Sound card and speaker The system must be configured with sound card and
speaker.

Recommended printer configuration

You are suggested to choose one of the following printers for use with the
computer:
 Ink jet printer

1-5
1 System Description

 Laser printer
 Stylus printer

1.1.2 Installation Procedure

WARNING
The system should be installed only by technicians of or authorized by our company.

The system should be installed by technicians of or authorized by our

company. Before the technicians arrive, prepare a proper site to install the
system.

Before installation
When you receive the package, check it carefully. If you find any signs of
mishandling or damage, file a claim immediately with our Customer
Service Department or your local distributor.

1-6
 1 System Description

After opening the package, check the delivered goods against the packing
list, and then visually check the system appearance. If you find anything
missing or damaged, alert our Customer Service Department or your local
distributor immediately.

System relocation
If you want to relocate your system, contact our Customer Service
Department or your local distributor.

1-7
1 System Description

1.2 Hardware Structure

1.2.1 System Overview
The chemistry analyzer consists of the analyzing unit (analyzer),
operation unit (computer), output unit (printer), accessories and
consumables.
The analyzing unit, the analyzer, determines various clinical chemistries
in samples and displays the test results. It is composed of the following
components:
 Sample handling system
 Reagent handling system
 Reaction system
 Cuvette wash station
 Photometric system
 Mixer assembly

The operation unit, a computer configured with the operating software,

controls the analyzing unit to finish tests and produce test results.

The output unit is a printer used to print out test results and other data.

Accessories and consumables are components that are required for

sample processing and should be replenished regularly.

1-8
 1 System Description
Figure 1.3 Front view
(3) (4)

(6) (5)
(2)
(1)
(
1
)

1. Reagent carousel 4. Auto wash station

2. Sample Carousel 5. Sample probe
3. Reaction carousel 6. Reagent probe

Figure 1.4 Rear view

（1） ( （1）
1
（4） ) （5）

（2） （2）
(
2
（1） )
（6）

（3）

1. Radiating fan 4. Network port

2. handle 5. Serial port
3. Fluidic interfaces 6. Power jack

1-9
1 System Description

1.2.2 Sample Handling System

The sample handling system is used to hold samples and provides them
for analysis. It consists of the following assemblies:
 Sample carousel assembly
 Sample bar code reader
 Sample dispenser assembly
 Sample containers

Sample carousel assembly

The sample carousel is a turntable located on right side of the analyzer
panel. It holds sample tubes and carries each of them to the sample
aspirate position for aspirating.
Figure 1.5 Sample carousel
（1） （2） （3）

1. First ring 3. Third ring

2. Second ring

The sample loading indicator tells you when you should load samples and
when you must not. Do not operate on the movement path of sample
probe, or collision might happen.
The sample loading indicator has the following states:
 Flash: indicates that the corresponding carousel is rotating or is
going to rotate.
 ON: indicates that the corresponding carousel is stopped for sample
aspirating or that the sample probe is aspirating on the reaction
carousel during test for the diluted samples
 OFF: indicates that the corresponding carousel has no sample being
aspirated and will not rotate in the next period.
The sample carousel includes three circles: inner, middle and outer, each
of which provides 30 tube positions. 90 positions in total are available on
the sample carousel and assigned as follows:
 Routine samples: 1-60
 Calibrators:S1-S10
 Controls:C1-C7

1-10
 1 System Description

 STAT samples:E1-E10
Others:
 D1 (No.88) for ISE cleaning solution
 D2 (No.89) for wash solution
 W (No.90): for physiological saline
To remove the sample carousel,
 Loosen the two retaining screws on the sample carousel.
 Grab the handle and pull the sample carousel upward to remove it
from the rotor.
To install the sample carousel,
 Align the positioning pins on the sample carousel to the counterparts
on base.
 Set the sample carousel and tighten the two retaining screws on the
carousel.

Sample bar code reader

The sample bar code reader is an optional module and used to obtain
sample information through reading a sample bar code. For more
information, refer to 1.3.3 Built-in Sample Bar Code Reader (page 1-21).

Sample dispenser assembly

The sample dispenser assembly located above the sample carousel is
composed of the sample probe, probe arm, probe rotor, syringe and
related tubing. It aspirates the specified amount of sample from a sample
tube and then dispenses it into a cuvette for reaction and analysis.
Figure 1.6 Sample dispenser assembly

（1） （2） （3）

1. Sample probe 2. Sample probe arm

3. Sample probe rotor

Sample probe
The system has one sample probe, which aspirates the specified amount

1-11
1 System Description

of sample for different type of chemistries:

 Biochemical chemistries: 1.5μl-45μL, with increment of 0.1μL.
 ISE chemistries: plasma/serum: 70μL; diluted urine: 140μL.
The sample probe is capable not only of aspirating sample but also of the
following functions:
 Clog detection: checks the sample probe for blockage. When
detecting blockage, the system produces a warning and prompts you
with the next step.
 Horizontal obstruct detection: detects obstacles in the horizontal
direction. When the sample probe collides with an obstacle in the
horizontal direction, the auto guard system is started to prevent the
sample probe from being damaged.
 Vertical obstruct detection: detects obstacles in the vertical direction.
When the sample probe collides with an obstacle in the vertical
direction, the auto guard system is started to prevent the sample
probe from being damaged.
 Level detection and tracking: detects the sample level and determines
the depth of lowering down into the sample based on the specified
aspirate volume.

WARNING
When the system is in operation, do not place any part of your body or any obstacle
in the route where the sample probe arm moves; otherwise, personal injury or
equipment damage may be caused.

Sample probe washing

The sample probe is cleaned in its wash well with water spraying its
interior and exterior from two opposite directions.
Sample syringe
When the front left door of the analyzer is opened, you will see the sample
syringe as shown below.
Figure 1.7 Sample syringe

（1）

1. Sample syringe

1-12
 1 System Description

Sample containers
 Microtube: Mindray sample cup Φ14× 25mm, Φ12× 37mm
 Primary tube or plastic tube: Φ12×68.5mm, Φ12×99mm, Φ12.7×75mm,
Φ12.7×100mm, Φ13×75mm, Φ13×95mm, Φ13×100mm,
Sample tubes varying in specification requires different minimum sample
volumes. Each sample tube must contain the minimum amount of sample;
otherwise, correct aspirating cannot be ensured. The minimum sample
volume is the sum of the minimum sample volume for analysis and the
dead volume of the sample container.
The table below shows the dead volume of each type of sample container.

Table 1.2 Specification and dead volume of sample containers

Sample Container Specification Dead Volume
Sample tube Φ14×25mm, 0.5ml 70μl
Φ14×25mm, 2ml 150μl
Φ12×37mm, 2ml 100μl
Primary tube or Φ12×68.5 mm 8mm more over the
plastic tube Φ12×99 mm unacceptable sample level
height
Φ12.7×75 mm
Φ12.7×100 mm
Φ13×75 mm
Φ13×95 mm
Φ13×100 mm

1.2.3 Reagent Handling System

The reagent handling system is used to hold reagents and provides them
for reacting with samples. It consists of the following assemblies:
 Reagent carousel assembly
 Reagent bar code reader
 Reagent dispenser assembly

Reagent carousel assembly

The reagent carousel assembly consists of a reagent carousel (including
a cover) and a refrigeration unit.
The reagent carousel holds reagent bottles and carries the defined
reagent bottle to the aspirate position for aspirating reagent.

The refrigeration unit keeps reagents in a low-temperature environment

to keep them stable and minimize volatilization.
The reagent carousel provides a refrigerating environment which is
constant within 2° C-10° C for 24 hours a day. The reagents stored in such
environment can be kept stable with little volatilization.

1-13
1 System Description

Reagent positions: There are 80 bottle positions on the reagent carousel.

D is for wash solution and W is for deionized water or physiological
saline.

NOTE
The refrigeration unit has a power supply independent of that of the analyzing unit.
The refrigeration unit is operational once the MAIN POWER is turned to the ON
position.

Figure 1.8 Reagent carousel

（1）

1. Reagent carousel cover

CAUTION
Note: Every day before analysis, remove the plug on the reagent carousel in order to
prevent mechanical reset failure and bending reagent probe.
Ensure that the reagent carousel is closed while the system is analyzing. Opening the
reagent carousel cover during analyzing will abort the analysis and invalidate the
tests that are running.

One virtual reagent carousel (80 positions) is allowed. You’ll be reminded

to change the reagent carousel on which all reagent aspiration is finished.
To remove the reagent carousel,
 Loosen the two retaining screws on the reagent carousel.
 Grab the handle and pull the reagent carousel upward to remove it
from the rotor.
To install the reagent carousel,
 Align the positioning pins on the reagent carousel to the counterparts
on base.
 Set the reagent carousel and tighten the two retaining screws on the
carousel.

Reagent bar code reader

The reagent bar code reader is an optional module and used to obtain

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 1 System Description

reagent information through reading a reagent bar code. For more

information, refer to 1.3.4 Built-in Reagent Bar Code Reader (page 1-22).

Reagent dispenser assembly

The sample dispenser assembly located on the upper right of the reagent
carousel consists of the reagent probe, probe arm, probe rotor, syringes
and related tubing. It aspirates the specified amount of reagent from a
reagent bottle and then dispenses it into a cuvette for reaction and
analysis.
Figure 1.9 Reagent dispenser assembly

（1）

（2）

（3）

1. Probe arm 3. Reagent Probe

2. Probe rotor

Reagent probe
 The system has one probe. Reagent volume: 10μL ~350μL with 1μL
increment.
The reagent probe is capable not only of aspirating reagent but also of
the following functions:
 Horizontal obstruct detection: detects obstacles in the horizontal
direction. When the reagent probe collides with an obstacle in the
horizontal direction, the auto guard system is started to prevent the
reagent probe from being damaged.
 Vertical obstruct detection: detects obstacles in the vertical direction.
When the reagent probe collides with an obstacle in the vertical
direction, the auto guard system is started to prevent the reagent
probe from being damaged.
 Level detection and tracking: detects the reagent level and determines
the depth of lowering down into the reagent based on the specified
aspirate volume.
 Empty aspiration alarm: When the reagent probe cannot aspirate or
aspirate insufficient reagent due to reagent insufficiency or air bubble,
the system will give an alarm.

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1 System Description

WARNING
When the system is in operation, do not place any part of your body or any obstacle
in the route where the reagent probe arm moves; otherwise, personal injury or
equipment damage may be caused.

Reagent probe washing

The reagent probe is cleaned in its wash well with water spraying its
interior and exterior from two opposite directions.
Reagent syringe
When the left door of the analyzer is opened, you will see the reagent
syringes as shown below.
Figure 1.10 Reagent syringe

（1）

1. Reagent syringe

Reagent bottle
The reagent carousel is compatible with the following reagent bottles:
Mindray outer ring reagent bottle 40ml or 20ml; Mindray inner ring
reagent bottle 40 ml or 62 ml. Only 40 ml or 62 ml. Reagent bottle can be
placed on the inner ring and only 40ml or 20ml reagent bottle can be
placed on the outer ring.

1.2.4 Reaction System

The reaction carousel assembly consists of a reaction carousel, cuvettes
and heater. See Figure below.

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 1 System Description
Figure 1.11 Reaction carousel

（1）

(1) Reaction carousel

The reaction carousel holds the cuvettes, in which the sample reacts with
the reagent(s) and colorimetric readings are taken.
The semi-permanent plastic cuvettes are designed for reaction of sample
and reagents, and also colorimetric measurement.
The heater provides a constant-temperature environment for reaction.
Cuvettes on the reaction carousel are carried to the reagent dispensing
position, sample dispensing position, mixing position and then washing
position successively.

Reaction carousel
The reaction carousel rotates counter-clockwise, carrying the specified
cuvette to reagent dispensing position, sample dispensing position,
mixing position and then washing position successively.
The reaction carousel is circular and can hold 90 semi-permanent plastic
cuvettes.
Reaction volume: 120μl-360μl.
The reaction carousel is capable of temperature control and provides a
constant environment at 37± 0.3° C with fluctuation of ± 0.1° C.

Reaction cuvette
The plastic cuvette is provided by the factory The light pathlength of the
cuvette is 5mm±0.03mm, and its inside dimension is 5mm (length)*5mm
(depth)*29mm (height).
When finishing a test, the system washes and dries the cuvette
automatically for later use.

1.2.5 Cuvette Wash Station

The system provides an eight-phase auto wash function, through which
the cuvettes are washed via eight wash probes when a test is finished.
The cuvette wash station consists of the wash probes, elevating motor
and related tubing. The wash probes driven by the elevating motor to go

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1 System Description

up and down during each wash phase dispenses and aspirates wash
solution in the cuvette to finish washing.
Figure 1.12 Cuvette wash station

（3）

（2）

（1）

1. Wash probe 3. Cuvette wash station

2. Wipe block

The cuvette wash station cleans the cuvettes with wash solution and
Deionized water in eight phases, which are divided as follows:
 Phase 1 and 2: the cuvette is washed with diluted wash solution
 Phase 3 to 6: the cuvette is rinsed with deionized water
 Phase 7 and 8: the cuvette is dried and wiped
The cuvette is washed and rinsed with preheated diluted wash solution
and deionized water in phase 1 to 6. After the washing, the waste fluid is
discharged in two flows: high-concentration waste and
low-concentration waste. The system is capable of detecting the waste
fluid level and produces an alarm when detecting excessive waste.

1.2.6 Photometric System

The photometric system located inside of the analyzing unit measures
the absorbance of the reaction mixture in the cuvette. The photometric
system, composed of the photometer assembly and the signal detection
assembly, measures the light transmitted through the reaction mixture
and then converts the light change signal into electrical signal, which
reflects the change of the light intensity.
The photometer assembly, which consists of the light source, colorimetric
component and optical component, provides sufficient monochromatic
light and reliable colorimetric structure.
The signal detection assembly consists of the AD conversion component
and the AD signal collection component. It converts the monochromatic
light transmitted through the reaction mixture into an electrical signal,
which is amplified and output as photometric data and then sent to the
corresponding control unit for absorbance calculating.
The table below shows the main technical parameters of the photometric

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 1 System Description

system.

Table 1.3 Specifications of photometric system

Name Value
Light source Tungsten-halogen lamp, 12V/20W
Colorimetric Reaction cuvette
component
Light transmission Holographic concave flat-field gratings
component
Light transmission Reversed optics
mode
Signal detector Photodiode array
Measuring 12 wavelengths: 340nm, 380nm, 412nm,
wavelength 450nm, 505nm, 546nm, 570nm, 605nm,
660nm, 700nm, 740nm and 800nm
Wavelength accuracy ±2nm
Measurement range 0-3.3A
Full width at half <10nm
maximum (FWHM)

1.2.7 Mixer Assembly

The mixer assembly, consisting of the sample mixer assembly and the
reagent mixer assembly, is used to stir the reaction mixture when
sample/R3 and R2/R4 are dispensed into the cuvette. There are two
mixers: one is sample mixer, the other reagent probe.

Sample mixer assembly

Sample mixer assembly, located on the upper left side of the reaction
carousel, mixes the sample in cuvette once it is dispensed and after R3 is
dispensed.
Figure 1.13 Sample mixer assembly

（1） （3） （2）

1. Sample mixer 3. Mixer arm

2. Mixer rotor

When stirring is finished, the mixer moves automatically to its wash well
for cleaning.

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1 System Description

Reagent mixer assembly

Reagent mixer assembly, located on the upper right side of the reaction
carousel, mixes the sample in cuvette after R2 and R4 is dispensed.
Figure 1.14 Reagent mixer assembly

（2） （1） （3）

1. Reagent mixer 3. Mixer arm

2. Mixer rotor

1.2.8 Operation Unit

The operation unit is a computer configured with the operating software.
It consists of the monitor, computer, keyboard and mouse.

1.2.9 Output Unit

The output unit is a printer used to print out test results and other data.
The system supports three types of printer, which include inkjet printer,
laser printer and stylus printer.

1.2.10 Accessories and Consumables

Accessories and consumables are replenishable components required to
run tests and should be checked regularly for refilling and replacement.

CAUTION
Use the accessories, power cords and consumables manufactured or recommended
by our company in order to achieve the promised system performance and safety. If
needed, contact our customer service department or your local distributor.

For more information about accessories and consumables, refer to 16.1.3

Consumables (page 16-3).

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 1 System Description

1.3 Optional Modules

1.3.1 Introduction
Optional modules are not provided as standard configuration
accompanying the instrument when it is delivered. They can be
configured according to your requirements. The following modules are
supplied:
 ISE module
 Built-in sample bar code reader
 Built-in reagent bar code reader
 Water supply module
 Drainage module
 External vacuum pump

1.3.2 ISE Module

ISE (Ion-Selective Electrode) module consists of pump, tubes and
connectors used in combination with Na+ electrode, K+ electrode, Cl-
electrode, reference electrode to measure the concentration of Na, K and
Cl in serum, plasma and diluted urine.
The sample volume for measuring serum and plasma is 70μl; the sample
volume for measuring diluted urine is 140μl. The theory of measurement
is direct ion-selective electrode method.
Figure 1.15 ISE Module

1.3.3 Built-in Sample Bar Code Reader

The sample bar code reader is located on the left inside the sample
carousel. The outer ring and middle ring of the sample carousel support
bar code scanning. The sample bar code reader assembly consists of the
following components:
 Sample bar code reader
 Bar code label

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1 System Description

 Hardware and software to control bar code scanning

When sample tubes are loaded to the sample carousel, the system scans
the bar code label on the sample tubes to read the sample information
and then display it on the screen.
Figure 1.16 Sample bar code scanning window
（1）

（
1
）

1. Sample bar code scanning window

WARNING
The light radiated from the sample bar code reader may hurt your eyes. Do not stare
into the laser beam coming from the sample bar code reader.

1.3.4 Built-in Reagent Bar Code Reader

The reagent bar code reader located on the right inside the reagent
carousel consists of the following components:
 Reagent bar code reader
 Bar code label
 Hardware and software to control bar code scanning
When the reagent carousel cover is closed after reagent bottles are
loaded, select End Load F2, the system scans all reagents positions to
reader reagent information and then displays it on the screen.
Figure 1.17 Reagent bar code scanning window
（1）

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 1 System Description
1. Reagent bar code scanning window

WARNING
The light emitted by the reagent bar code reader may cause eye injury. Do not stare
into the laser beam coming from the reagent bar code reader.

1.3.5 Water Supply Module

The water supply module provides deionized water for the chemistry
analyzer. When water is required during the measuring process, the water
supply module turns on the internal inlet valve and transmits water while
driven by the pneumatic pump; when water is not needed, the water
supply module turns off the internal inlet valve and cuts off the power
supply of the pneumatic pressure pump to stop supplying water.

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1 System Description
Figure 1.18 Water supply module

（1） （2） （3） （4）

1. Air vent 3. Inlet

2. Hand operated Valve 4. Outlet

Figure 1.19 Connecting instrument with water supply module

Chemistry Analyzer
DI water tank

6 7

4 5

1 2 8——Air vent

DI water inlet 8 9 10 9——Water inlet

Inlet filter
10——Water outlet

Water supply module

Make sure that there is sufficient space between the water supply module
and the wall so that it is convenient to connect or disconnect the power
cord. Sufficient deionized water should be prepared in the water tank
when using the water supply module. Make sure the water supply module
is powered on before running. The module should be powered off if not
used for a long time.
If there is something wrong with the water supply module, please consult
our customer service department or your local distributor

1.3.6 Drainage Module

The drainage module increases the pressure of waste liquids, which will
be discharged more easily. When the outlet tubing of the analyzer
exceeds 5m or the sewer is higher than 1.2m, a drainage module is
required. Make sure that there is sufficient space between the drainage
module and the wall so that it is convenient to connect or disconnect the

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 1 System Description

power cord.
The drainage module collects and discharges to the waste buffer the
low-concentration waste liquids from the outlet on rear panel of the
analyzer. When the liquid level sensor detects that specified amount of
waste liquids have been collected in the waste buffer, the waste pump of
the drainage module starts running, discharging the waste to the sewer.
If there is something wrong with the drainage module, please consult our
customer service department or your local distributor.

Figure 1.20 Drainage module

（3）
（1）

（4）

（2）

(1) Low conc. Waste 1 (3) Low conc. waste sensor

(2) Outlet (4) Low conc. Waste 2

1.3.7 External Vacuum Pump

When operated in a place with the altitude above 2,000m, the system may
be degraded in its liquid aspirating performance due to the decreased
atmospheric pressure. In this situation, an external vacuum pump is
required to assist the system with liquid aspiration.

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1 System Description
Figure 1.21 Front view of the external vacuum pump

（1）

（2）

1. Pressure gauge
2. Dust screen

Figure 1.22 Rear view of the external vacuum pump

(1)
(3)
(2)

(4)

(5)

1. Gas connector 4. Power switch

2. Control interface 5. Power jack
3. Cooling fans

Make sure that there is sufficient space between the external vacuum
pump and the wall so that it is convenient to connect or disconnect the
power cord. Before using the vacuum pump, connect the gas connector
and control interface with the counterpart connectors on the rear panel of
the analyzer; connect the vacuum pump to the power supply with the
three-wire power cord. The external vacuum pump will be controlled by
the analyzer when powered on and requires no manual operations. When
finishing all tests every day, you are recommended to power off the
external vacuum pump. Before starting the tests every day, please make
sure the external vacuum pump is powered on.
The pointer of the pressure gauge is deviated from the 0 point when the
vacuum pump works normally. If the pointer stops at the 0 point while the
vacuum pump is running, there must be something wrong with the
external vacuum pump. Consult our customer service department or your
local distributor.
The external vacuum pump should be installed and adjusted only by the
technicians of or authorized by our company.

1.3.8 Other Optional Modules

For more information about other optional modules, contact our customer

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 1 System Description

service department or your local distributor.

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1 System Description

1.4 Software Description

1.4.1 Main Screen
Figure 1.23 Main screen
（5）

（1）

（2） （4）

（3）

1. Status display area 4. Function window

2. Function buttons area 5. Shortcut icons area
3. Prompt message area

Status display area

The status display area shows the status of analysis, LIS connection,
printer and system date/time.
“None-test status” in this manual refers to Incubation, Standby, Stopped
and Sleep; while “test status” refers to other status.

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 1 System Description

Table 1.4 Status display area

Status Indicator Description
Biochemistry/ISE This indicator appears on the left of the status display
area. If Biochemistry/ISE appears intact, the
biochemistry module and ISE module are enabled.
The status of the biochemistry system includes:
Initializing, Incubation, Standby, Running, Sample
Load, Reagent Load, Inventory Check, Stop, Restoring,
Sleep, Wake Up, Alignment, Maintenance, Diagnostics,
SPT (System Performance Test) and Shutdown.
The status of the ISE module includes: Standby,
Running, Sample Load, Reagent Load, Pause,
Maintenance, Stop, Restoring, Sleep, Wake Up and
Alignment.
Analyzing time left This indicator appears in the middle of the status
display area. The time indicates how many minutes left
the analysis will be finished.
Sample Stop/Reagent This indicator appears on the right of the status display
Stop area. The time indicates how many minutes left the
dispensing of sample or reagent will be stopped.
LIS status
This indicator appears on the left of the status display
area. The following information is indicated:

 If appears in blue, the LIS host is connected

and online.

 If appears in grey, the LIS host is offline.

Printer status
This indicator appears on the left of the status display
area. It indicates the status of the printer: not printing
and printing.
 If the icon appears in grey, the printer is not printing
or unconnected.
 If the icon appears in blue, the printer is printing.
Operator This indicator appears in the middle of the status
display area. It indicates the user who logs in the
system.
Date and time This indicator appears on the right of the status display
area. It indicates the system date and time.

Function buttons area

The function buttons area contains the following buttons used to access
various function windows of the system:

 : used to program patient samples and control samples, and

view sample carousel status.

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1 System Description

 : used to recall test results of patient samples and controls and

view the result statistics and test statistics.

 : used to load reagents, define/edit calibrators, request

calibrations, recall calibration results and view reagent carousel
status.

 : used to define/edit controls and rules, recall QC results and

summary.

 : used to execute instrument commands, set up chemistry and

system parameters, perform system maintenance and diagnostics,
and view component status.

 : used to recall and handle error logs and deleting/editing logs.

 : used to exit the system by sleeping, logging off or shutting

down.

Prompt message area

The prompt message area contains two lines, the upper line displaying
operation prompts for screen controls and the lower line displaying error
messages.

Function window
The function window contains options, buttons and other controls used
to perform various functions of the system.

Shortcut icons area

The shortcut icons area contains the following icons used to quickly
access certain function window or perform an operation:

 : Start icon. Select it to display the Start Conditions window, on

which you are allowed to start new analysis or resume early testing.
 : Sample Stop icon. Select it to stop sample dispensing. And then
you are allowed to load new samples or replenish samples.

 : Emergency stop icon. Select it to stop all tests. All tests that are
running will be invalidated.
 : STAT icon. Select it to display the STAT Sample Program window,
on which you are enabled to program emergency samples quickly.

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 1 System Description

 : Online help icon. Select it to display the online help of the current
window, where you will find description of parameters and operations.

1.4.2 Using a Mouse

Move
The mouse is presented on the screen in the form of pointer. Place the
mouse on a flat platform, and then move it to the make the pointer lap
over the object that you want to select or edit.

Select
Move the mouse to make the pointer lap over the object that you want to
select or edit, and then press the left mouse button and release it quickly.

Double-click
Move the mouse to make the pointer lap over the object that you want to
select or edit, and then quickly press the left mouse button twice and
release it.

Drag
Dragging is used to move the slider on a screen in order to choose a scale.
Move the mouse to make it stop over the slider, press and hold the left
mouse button, move the mouse left and right to adjust the slider to the
desired scale.

Using a mouse in conjunction with a keyboard

Some lists on the screen allow you to select more than one object at one
time, and you can achieve this by using a mouse in conjunction with a
keyboard. When selected, the objects will be highlighted for easy
identification.
Perform the following operations to select more than one object:
 To select discontinuous objects, press the left mouse button to select
the first object, press and hold the Ctrl key, use the mouse to select
other desired objects, and then release the Ctrl key.
 To select continuous objects, press the left mouse button to select
the first object, press and hold the Shift key, use the mouse to select
the last object, and then release the Shift key.

1.4.3 Using Online Help

The system provides you with help information about the screens. If you
do not understand a parameter or an operation on a screen, you can go to
the online help for relevant information.

Accessing the online help

Access the online help from the following screens:

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1 System Description

 Select the icon on the upper right corner to display the help topic
related to the current screen.
Figure 1.24 Accessing the online help from the main screen

 Select the icon in front of each maintenance instruction or item

to display the relevant operating instructions.
Figure 1.25 Accessing the online help from the Maintenance window

 Select the icon in front of each diagnostic test to display the

corresponding topic.

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 1 System Description
Figure 1.26 Accessing the online help from the Diagnostics screen

 Select the icon in front of each error log to display the

corresponding topic.
Figure 1.27 Accessing the online help from the Error Log screen

 Select the icon on a warning message window to display the

corresponding descriptions and solutions.
 Select the icon on an error message window to display the
corresponding descriptions and solutions.
 Press the shortcut combination key Alt+F1 to display the topics
related to the current screen or window.

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1 System Description

Viewing screen information

The online help document contains descriptions of parameters,
operations, maintenance and troubleshooting of the operating software.
To view the information related to the current screen or window, perform
the following steps.
1 Access the online help in the following ways:

 Select the button on the upper right corner of the main screen,
or press the shortcut combination key Alt+F1.
 To perform maintenance operations, select the icon in front
of the desired maintenance procedure.
 To view details of an error log, select the icon in front of the
error log.
 To view details of an alarm message, select the icon on a
warning or error message window.
2 Read the help topics. Move the scroll bar on the right side of the help
window to view more information.

3 Select to close the help window.

Viewing other information

To view other information in the online help,

1 Select the icon on the upper right corner of the main screen, or
press the shortcut combination key Alt+F1.

2 Select the following tabs to view relevant information:

 Contents: to navigate through all topics of the online help.

 Index: to view topics related to the input keywords.
 Search: to view topics containing the input keywords.
 Favourites: to view your favorite topics.
3 Read the help topics. Move the scroll bar on the right side of the help
window to view more information.

4 Select to close the help window.

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 1 System Description

1.5 System Specifications

1.5.1 Technical Parameters
Throughput and reaction type

Table 1.5 Throughput and reaction type

Parameter Description
Throughput for 400 tests/hour for single-/double-reagent
biochemistries chemistries.
Throughput for ISE Serum/plasma:240 samples/hour, and urine:171
chemistries tests/hour (including K, Na, Cl)
Biochemistries and ISE 560 tests/hour
chemistries
Maximum number of tests 84 tests, which include 78 biochemistries, 3 ISE
run simultaneously chemistries and 3 serum index chemistries.
Principles of analysis Colorimetry, turbidity, and ISE method
Reaction types Endpoint, fixed-time, and Kinetic
Reagent mode Supporting
single-/double-/triple-/quadruple-reagent tests
Wavelength Supporting single/double-wavelength mode

Sample handling system

Table 1.6 Specifications of the sample handling system

Parameter Description
Sample carousel One carousel, including three rings. Each provides
30 positions, 90 positions in total.
Sample volume for routine 1.5μl-45μl, with increment of 0.1μl
chemistry
Sample volume for ISE Serum/plasma 70μL;diluted urine:140μl
chemistry
Sample probe One sample probe available, featuring level
detection, horizontal/vertical obstruct detection,
clog detection and level tracking.
Sample probe washing The sample probe is cleaned in its wash well with
water spraying its interior and exterior
Emergent samples Emergent samples can be analyzed at any time
with highest priority.
Rerunning mode Supporting auto dilution, standard volume,
increment, decrement, decrement dilution,
increment dilution.

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1 System Description

Reagent handling system

Table 1.7 Specifications of the reagent handling system

Parameter Description
Reagent carousel Reagent carousel provides 80 positions of which D is
used for wash solution and W for physiological saline
water.
Reagent volume 10μl~350μl with increment of 1μl.
Reagent probe One reagent probe, featuring level detection,
horizontal/vertical obstruct detection, empty
aspiration alarm and level tracking.
Reagent probe washing The reagent probe is cleaned in its wash well with
water spraying its interior and exterior.

Mixer assembly

Table 1.8 Specifications of the mixer assembly

Parameter Description
Mixer assembly Composed of mixer, probe arm and probe rotor
Mixer Two mixers available, one sample mixer and one
reagent mixer

Reaction system

Table 1.9 Specifications of the reaction system

Parameter Description
Reaction carousel 90 positions available
Reaction temperature 37°C
Reaction cuvette Plastic cuvette 5mm×5mm×29mm (length × depth ×
height), light pathlength of 5mm±0.03mm
Reaction mixture volume 120μl-360μl

Photometric system

Table 1.10 Specifications of the photometric system

Parameter Description
Light transmission mode Holographic concave flat-field gratings
Light source 12V/20W tungsten-halogen lamp
Measuring wavelength 12 wavelengths: 340nm, 380nm, 412nm, 450nm,
505nm, 546nm, 570nm, 605nm, 660nm, 700nm,
740nm and 800nm
Measuring period 9 seconds

Water consumption
Less than 20L/H

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 1 System Description

Water supply module

Table 1.11 Specifications of water supply module

Parameter Description
Power supply 100V-240V~, 50Hz/60Hz
Voltage fluctuation ±10%
Rated input power 50VA
Flux 0.6LPM
Tube length and 4*6mm PU tubes
connecting method Connecting the water tank and the analyzer,<10m
IN and the water tank ,<5m
OUT2 and the waste outlet,<10m
Weight 9.7Kg(±1)
Size(length*width* 321.8mm×303.5mm×241.2mm(±5mm)
height)
Maintenance No need to perform the maintenance procedure
requirement

Drainage module

Table 1.12 Specifications of the drainage module

Parameter Description
Power supply 100V-240V~, 50Hz/60Hz
Voltage fluctuation ±10%
Rated input power 50VA
Flux 1LPM
Tube length and 12*18 mm braided tubes
connecting method Connecting the analyzer and IN1/IN2,<5m
OUT and the discharge outlet,<10m
Weight 12.5Kg(±1)
Size(length*width* 436.5mm×312.8mm×287.7mm(±5mm)
height)
Maintenance requirement No need to perform the maintenance procedure

External vacuum pump

Table 1.13 Specifications of the external vacuum pump

Parameter Description
Power supply 110V:
110V/115V~, 60Hz
220V:
220V-240V~, 50Hz
220V/230V~, 60Hz
Voltage fluctuation ±10%
Rated input power 500VA

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1 System Description

Parameter Description
Vacuum flux >10SLPM under the atmospheric pressure of -33KPa
Tube PU tube,7*10mm,<3m
Weight 29.7±1.2kg
Size 478mm×425mm×466mm
Maintenance requirement Clean the dust screen monthly according to the
operation guide

1.5.2 Main Performance Indices

Stray Light
Absorbance shall be no less than 4.6.

Absorbance Linearity Range

The maximum absorbance with relative bias within ± 5% should be no less
than 3.3.

Absorbance Accuracy
The absorbance accuracy shall meet the requirements in Table 1.14 .

Table 1.14 Absorbance Accuracy

Absorbance Value Absorbance Accuracy
0.5 ±0.025
1. 0 ±0.07

Absorbance Stability
Absorbance change should not be greater than 0.01.

Absorbance Repeatability
Expressed by coefficient of variation (CV value), which should not be
greater than 1%.

Sample Carryover
Sample carryover rate of should not be greater than 0.05%

Dispensing Accuracy and Repeatability

The dispensing accuracy and repeatability shall meet the requirements of
Table 1.15 , where the dispensing repeatability is expressed by coefficient
of variation.

Table 1.15 Dispensing Accuracy and Repeatability

Category Volume Allowable Error Coefficient of
μL Variation
Sample probe 1.5 ±5% ≤2%

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 1 System Description

Category Volume Allowable Error Coefficient of

μL Variation
5 ±5% ≤2%
45 ±3% ≤1%
Reagent probe 10 ±5% ≤2%
350 ±2% ≤1%

Carryover Rate of ISE Module

The carryover rate of ISE module should meet the requirements in Table
1.16 .

Stability of ISE Module

The stability of the ISE module should meet the requirements in Table
1.16 .

Accuracy of ISE Module

The accuracy of the ISE module should meet the requirements in Table
1.16 .

Precision of ISE Module

The precision of the ISE module should meet the requirements in Table
1.16 .

Linearity of ISE Module

The linearity of the ISE module should meet the requirements in Table
1.16 .

Table 1.16 Performance Requirements Of ISE Module

Parameter Carryover Stability Accuracy Precision Linearity
(△§) (△D) (Deviation ) (CV) （D）
(B)
K+ ≤1.5% ≤2.0% ≤3.0% ≤1.5% ≤3.0%
Na+ ≤1.5% ≤2.0% ≤3.0% ≤1.0% ≤3.0%
Cl- ≤1.5% ≤2.0% ≤3.0% ≤1.5% ≤3.0%

Limitations

Table 1.17 Table 1.1 interferences may affect the measurement results
Interferent
Limitations ascorbic acid
hemoglobin
lipemia
bilirubin

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1 System Description

1.5.3 Contraindication
None.

1.5.4 Power supply

Table 1.18 Power supply
Parameter Description
Power supply 110V:
110V/115V~, 60Hz
220V:
220V-240V~, 50Hz
220V/230V~, 60Hz

Rated power consumption 1500VA

Voltage fluctuation ±10%

Frequency fluctuation ±1Hz

1.5.5 Environmental Requirements

Operating environment
 Temperature: 15° C-30° C
 Relative humidity: 35%-85%, without condensation
 Altitude height: -400m-2000m (An external vacuum pump is required
for areas with altitude height between 2000-4000m.)

Storage environment
 Temperature: 0° C-40° C
 Relative humidity: 30%-85%, without condensation
 Altitude height: 50kPa-106kPa

1.5.6 Dimensions and Weight

 Dimension: ≤1190mm(length)× 720mm(depth)× 1155mm(height)
 Weight: ≤300Kg

1.5.7 Input Device

 Keyboard (prepared by user)
 Mouse (prepared by user)
 Display monitor (prepared by user)
 Bar code reader
 LIS: HL7 and ASTM1394 (communicating through serial port or net
port of the TCP/IP interface of static IP address)

1.5.8 Output Device

 Printer (prepared by user)

1-40
 1 System Description

 Display monitor (prepared by user)

 LIS: HL7 and ASTM1394 (communicating through serial port or net
port of the TCP/IP interface of static IP address)

1.5.9 Noise and Fuse

Table 1.19 Noise and fuse
Parameter Description
Noise ≤ 65dBA
Fuse For 110V: 250V 16A
For 220V: 250V 13A

1.5.10 Communication Interfaces

Table 1.20 Communication interfaces
Communication Description
Interfaces
RS232 serial port  Used for communication between the analyzing
unit and the operation unit
 Used for communication between the LIS and
the operation unit
 Used for connecting the operation unit with a
printer
Network interface  Used for communication between the analyzing
unit and the operation unit
 Used for communication between the LIS and
the operation unit
USB interface  Used for connecting the operation unit with a
printer
 Used for connecting the operation unit with an
external storage device

1.5.11 Safety Classification

Table 1.21 Safety classification
Parameter Description
Overvoltage type Class II
Pollution degree 2
Device type Fixed device
Work type Continuous
Degree of IP(Ingress Common device ,IPX0 (no protection against
Protection) liquids)

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1 System Description

1.5.12 EMC Requirements

The IVD device complies with the EMC standard IEC 61326-1/EN 61326-1
and IEC 61326-2-6/EN 61326-2-6. For EMISSIONS and IMMUNITY
specific requirements, see the two tables below..
Table 1.22 GUIDANCE AND MINDRAY DECLARATION—ELECTROMAGNETIC EMISSIONS
GUIDANCE AND MINDRAY DECLARATION—ELECTROMAGNETIC EMISSIONS
The system is intended for use in the electromagnetic environment specified below. The
customer or the user of system should assure that it is used in such an environment.
EMISSIONS TEST COMPLIANCE
RF emissions
CISPR 11
RF emissions Group 1 Class A
CISPR 11
Harmonic Emissions
IEC 61000-3-2
Voltage Fluctuations/ Flicker Emissions N/A
IEC 61000-3-3
Table 1.23 GUIDANCE AND MINDRAY DECLARATION—ELECTROMAGNETIC IMMUNITY
GUIDANCE AND MINDRAY DECLARATION—ELECTROMAGNETIC IMMUNITY
The system is intended for use in the electromagnetic environment specified below. The
customer or the user of system should assure that it is used in such an environment.
BASIC TEST VALUE PERFORMANCE
IMMUNITY TEST
STANDARD CRETERION
Electrostatic ± 4 kV contact B
IEC 61000-4-2
Discharge (ESD) ± 2 kV, ± 4 kV, ± 8 kV air B
Electromagnetic
IEC 61000-4-3 3 V/m (80 MHz to 6 GHz) A
field
Electrical fast
IEC 61000-4-4 ± 1 kV (5 kHz or 100 kHz) B
Transient / burst
± 0,5 kV line-to-line B
Surge IEC 61000-4-5
± 1 kV line-to-ground B
Conducted RF IEC 61000-4-6 3 V (150 kHz to 80 MHz) A
Voltage dips,
Short 0 % during 0,5 cycles B
interruptions and 0 % during 1 cycle B
IEC 61000-4-11
voltage variation 70 % during 25/30 cycles C
on power supply 0 % during 250/300 cycles C
input voltage
Power frequency
IEC 61000-4-8 3 A/m (50 Hz, 60 Hz) A
magnetic field
NOTE: “25/30 cycles" means "25 cycles for 50 Hz test" or "30 cycles for 60 Hz test”.
Performance criterion:
A. The equipment shall continue to operate as intended during and after the test.
B. The equipment shall continue to operate as intended after the test.
C. LOSS OF FUNCTION is allowed, provided the function is self-recoverable or can be
restored by the operation of the controls.

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 2 General Operating Procedure

This chapter illustrates the methods of using the instrument and the
routine

 Check before powering on

 Powering on
 Checking system status
 Loading reagents
 Calibration
 Quality control
 Programming routine samples
 Programming STAT samples
 Test status and emergency stop
 Daily maintenance
 Powering off
 Check after powering off

2-1
2 General Operating Procedure

2.1 General Operating Procedure

Table 2.1 General operating procedure
Procedures Description Page
1. Check before powering Check if the following components are ready Page 2-3
on for analysis: water supply, power supply,
printing paper, low-/high-concentration waste
connection, probes/mixers, concentrated wash
solution inventory.
2. Powering on Turn on the water inlet valve, switch on the Page 2-6
water supply module, drainage module and
analyzing unit, and open the operating
software.
3. Checking system status Check the status of the system, alarms, Page 2-9
reagent/calibration, maintenance and
subsystems.
4. Preparing reagents Prepare the biochemical reagents, ISE reagents Page 2-15
and wash solutions.
5. Calibration Request calibrations, prepare calibrators and Page 2-25
run calibration tests.
6. Quality Control Program, prepare and run control samples. Page 2-30
7. Programming routine Program, prepare and run routine samples. Page 2-34
samples
8. Programming STAT Run emergent and STAT samples Page 2-42
samples
9. Test status and analysis View reagent status and reagent carousel Page 2-47
control status as well as the running status of
calibrators, control samples, routine samples
and STAT samples, pause and stop the analysis.
10. Daily maintenance Clean the ISE electrodes, sample and reagent Page 2-52
compartments, analyzer panel, etc.
11. Powering off Switch off the water supply and power supply Page 2-52
12. Check after powering Restore the reagent carousel cover, take out Page 2-54
off the calibrators, controls and samples from the
sample carousel and store them properly, clean
the analyzer panels, and empty the waste tank.

2-2
 2 General Operating Procedure

2.2 Check before Powering On

2.2.1 Checking Water Supply
1 Check the deionized water tank or other water reservoirs, and make
sure that water can be supplied continuously.

2 Check if the connections between the water supply, water supply

module and analyzer are correct and tight.

3 Check if the water tubes are free of twists and leaks.

2.2.2 Checking Power Supply

1 Check if the power supply is available and can provide correct
voltage:

2 Check the connections among the analyzing unit, operation unit and
printer. Make sure the connections are correct and secure. Check the
power cords of the analyzing unit, operation unit and printer and
make sure they are well connected to the power sockets.

2.2.3 Checking Printing Paper

Check if sufficient printing paper is prepared in the printer. If not, refill the
printing paper.

2.2.4 Checking Waste Tanks and Tubing

The waste fluid of the system is discharged in two flows:
high-concentration waste and low-concentration waste. The former is
drained through the waste tank and then disposed according to relevant
regulations, or drained to the sewer; the latter is directly drained to the
sewer.

BIOHAZARD
While checking the waste tanks and tubing, wear gloves and lab coat, if necessary,
goggles.
1 Check if the high-concentration waste tank has been emptied. If not,
empty it.

High-concentration waste output: 1.5L/H (including ISE waste).

2 Check if the low-concentration waste tubing is not bent and the
sewer opening is lower than the waste outlet of the system.

2-3
2 General Operating Procedure
Figure 2.1 Connecting instrument with waste drainage facilities

Maximum of 1200mm
Chemistry Analyzer
High-conc waste

Maximum of 100mm
High-conc waste sensor 6 7

Water purifying
equipment
4 5

3
Low-conc waste sensor DI water
1 2
Drainage module
Low-conc waste
Inlet filter
IN1 IN2 OUT

High-conc wate tank

Drain outlet

2.2.5 Checking Probes and Mixers

The sample probe, reagent probe and mixers are easy to be polluted or
damaged. Check them carefully for dirt and bend before powering on the
system.
1 Check the sample probe for dirt and bend.

 If it is polluted, clean it.

 If it is bent, replace it.
2 Check the reagent probe for dirt and bend.

 If it is polluted, clean it.

 If it is bent, replace it.
3 Check the sample mixer for dirt and bend.

 If it is polluted, clean it.

 If it is bent, replace it.
4 Check the reagent mixer for dirt and bend.

 If it is polluted, clean it.

 If it is bent, replace it.

2.2.6 Checking Concentrated Wash Solution

Insufficient concentrated wash solution may terminate the
measurements. A tank of
concentrated wash solution is 2L and can be used for analysis for 6 days
on condition
that plastic cuvettes are used and 2000 tests are done every day. Please
check and refill the concentrated wash solution according to the
consumption and tank volume.
1 Check the wash solution placed on sample and reagent carousels. If

2-4
 2 General Operating Procedure

necessary, fill more or replace the wash solution.

2 Open the front door of the analyzer and check the concentrated wash
solution. If necessary, fill more or replace the wash solution.

2-5
2 General Operating Procedure

2.3 Powering On
2.3.1 Turning On Water Supply, Water Supply Module and
Drainage Module
Turn on the water supply and power on the water supply module and
drainage module and make sure the water entering the system is within
95kPa-392kPa.
The water supply module and drainage module are optional equipments.
For instructions of operating and maintaining these equipments, refer to
their operation manual.

2.3.2 Powering On the System

After connecting correctly the system to the power sockets, switch on the
power in the sequence presented below:
1 Turn on the main power switch of the analyzer.
Figure 2.2 Main power switch of the analyzer

(2)

(1)

(1) Main power switch of analyzer (2) Analyzing unit power switch

 Place the switch to the position to turn it on.

 Place the switch to the position to turn it off.

2 Turn on the analyzing unit power switch (see the above figure).

3 Press the power button on the monitor of the operation unit.

4 Press the power button on the computer of the operation unit.

5 Press the power button of the printer.

2-6
 2 General Operating Procedure

2.3.3 Starting the Operating Software

Note
If virtual reagent carousel is used, please make sure that the loaded one is the
NO.1 reagent carousel before starting the operating software each time.
1 When the operation unit (computer) is turned on, the operating
software will run automatically.

If the system detects that the hardware and software environments of

the computer do not meet the requirements, a prompt message will
appear to ask for your confirmation to convert the screen resolution.
If you cancel the conversion or the conversion is failed, you are
allowed to abort the startup or reboot the system.
2 Enter the username and password in the Login window, and then
select OK.

NOTE
The default username and password for administrator is Admin. Please note that
the password is case sensitive. You are recommended to change the password
when logging on the system for the first time in order to prevent others from
abusing the privileges of the administrator.
If an operator forgets his password, he may ask the administrator to log on the
system and delete the username and then redefine a username; or he may
contact our customer service department or your local distributor. If the
administrator forgets his password, contact our customer service department or
your local distributor.
3 When the startup check is passed, the main screen shows. The
startup procedure is finished.

The system will display prompt message when detecting unsatisfied

environment during the startup process. Please take actions
according to the instructions in the message box.

2-7
2 General Operating Procedure

CAUTION
To ensure accurate test results, do not start measurement until the system
status turns to Standby and the system has been turned on for about 20 minutes,
so that the light source and reaction temperature gets steady.

2-8
 2 General Operating Procedure

2.4 Checking System Status

After the startup procedure is finished, check the system status, such as
system status, alarm status, reagent/calibration status, maintenance
status and sub system status. If the status is not satisfied for
measurement, troubleshoot and maintain the system as instructed by 17
Alarms and Troubleshooting (page 17-1) and 16 Maintenance (page
16-1).

2.4.1 Checking System Status

Printer status
Check the printer status indication in the system status area of the main
screen:

 If the icon appears in blue, the printer is printing.

 If the icon appears in grey, the printer is not printing.

ISE module status

Check the ISE module status indication in the system status area of the
main screen:
 If Initializing is displayed, it indicates that the ISE module is
performing the startup procedure. Do no start measurements until the
initialization is finished.
 If Standby is displayed, it indicates that an ISE module is steady and
ready for measurement.
 If Running is displayed, it indicates that the ISE module is performing
measurements.
 If Stop is displayed, it indicates that the ISE module goes wrong or is
stopped. Troubleshoot the ISE module and take relevant corrective
solutions.

LIS status
Check the LIS status indication in the system status area of the main
screen:

 If appears in blue, the LIS host is connected and online.

 If appears in grey, the LIS host is offline.

2.4.2 Checking Alarm Status

1 Check the Alarm button on the left of the main screen.

 If it appears in yellow, it indicates that a warning occurs. Proceed

to the next step.

2-9
2 General Operating Procedure

 If it appears in red, it indicates that an error occurs, or both

warning and error occur. Proceed to the next step.
2 Select the Alarm button. The Error Log screen is displayed.
Figure 2.3 Error Log screen

3 New alarm messages are indicated by corresponding colors. Select

the help button in front of a new alarm message to view relevant
description and solutions.

4 Take actions according to the recommended solutions.

2.4.3 Checking Reagent/Calibration Status

1 Check the Reagent button on the left of the main screen.

 If it appears in yellow, it indicates that a warning occurs. Proceed

to the next step.
 If it appears in red, it indicates that an error occurs, or both
warning and error occur. Proceed to the next step.
2 Select the Reagent button. The Reagent/Calibration screen is
displayed.

2-10
 2 General Operating Procedure
Figure 2.4 Reagent/Calibration screen

3 View the reagent status. When a reagent is insufficient or exhausted,

the corresponding chemistry name and chemistries left will be
indicated as follows:

 Yellow: indicates that the reagent is insufficient or expired, and

the analysis will continue. Refill or replace the reagent.
 Red: indicates that the reagent is exhausted or at least one
reagent type is not loaded, and the analysis is stopped. Refill or
replace the reagent.
4 View the calibration status. When the calibration is succeeded or
failed, the Cal Status column of the chemistry shows the calibration
status in corresponding color.

 Yellow: indicates that the calibration factors of the chemistry have

been calculated, or extended, edited or overridden.
 Red: indicates that the calibration of the chemistry is failed or
expired, or the chemistry needs to be calibrated.
5 Check the calibration time left.

6 Take actions according to the calibration status.

For more information about calibration, refer to 2.6 Calibration(page

2-25).

2.4.4 Checking Maintenance Status

When the system is started up, it is necessary to check the maintenance

2-11
2 General Operating Procedure

status. If a maintenance procedure is expired, perform it immediately to

make sure that the system will run normally. When a maintenance
procedure is expired, the following buttons and options will be indicated
by corresponding color:
 Utility button on the left of the main screen
 Maintenance tab
 Maintenance button
 Scheduled Maintenance tab
 Maintenance frequency tab
 Maintenance procedure
1 Check the Utility button on the left of the main screen. If it appears in
yellow, it indicates that a maintenance procedure is expired.

2 Select Utility-Maintenance-Maintenance.

3 Check if the Scheduled Maintenance tab and maintenance frequency

tabs appear in yellow. If they do, it indicates that at least one
maintenance procedure is expired.

4 Select the maintenance frequency tab appearing in yellow, find the

expired maintenance procedure, and then perform the maintenance.

5 Repeat steps 3 and 4 until the maintenance frequency tabs and

maintenance procedures are displayed in normal color.

2.4.5 Checking Subsystems

The subsystem status indicates the current working status of each
subsystem and hardware component, which includes the status summary,
cycle count, temperature, fans, Hydropneumatic subsystem, and control
modules.

Checking subsystems
1 Select Utility-Status.

2 Choose a subsystem tab;

3 Check the subsystem status. When abnormity occurs, troubleshoot

errors with the following methods:

 If the cycle count of a component reaches certain limit and an

alarm occurs, replace the component or contact out customer
service department or your local distributor for replacement of the
component.
 If a component’s temperature is beyond the valid range or
abnormal and an alarm occurs, exit the operating software and

2-12
 2 General Operating Procedure

switch off the analyzing unit power. After that, switch on the
analyzing unit power again and run the operating software. If the
error remains, contact out customer service department or your
local distributor for replacement of the component.
 If the status of the fans is abnormal, exit the operating software
and switch off the analyzing unit power. After that, switch on the
analyzing unit power again and run the operating software. If the
error remains, contact out customer service department or your
local distributor for replacement of the fan.
 If a Hydropneumatic component is beyond the valid range or
abnormal and an alarm occurs, exit the operating software and
switch off the analyzing unit power. After that, switch on the
analyzing unit power again and run the operating software. If the
error remains, contact out customer service department or your
local distributor for replacement of the component.
 If a smart module is abnormal and an alarm occurs, exit the
operating software and switch off the analyzing unit power. After
that, switch on the analyzing unit power again and run the
operating software. If the error remains, contact out customer
service department or your local distributor for replacement of the
component.
 If the control unit is abnormal and an alarm occurs, exit the
operating software and switch off the analyzing unit power. After
that, switch on the analyzing unit power again and run the
operating software. If the error remains, contact out customer
service department or your local distributor for replacement of the
component.

Description of subsystem status

Status summary
The status summary provides a high-level summary of the status of the
system temperatures, fans, Hydropneumatic, and control modules.
Cycle count
The cycle count provides an approximation of a component’s usage,
which can be useful for estimating the maintenance frequencies or
anticipating component failure.
Temperatures
The actual temperature and valid range of the deionized water, reagent
carousel, reaction carousel, and wash station are displayed.
Fans
The actual status of the reagent refrigeration fans, lamp housing fan,
vacuum pump cooling fan is displayed
Hydropneumatic subsystem
Status for the Hydropneumatic subsystem shows: working status of
various tanks.

2-13
2 General Operating Procedure

The actual air pressure and valid range for air pressure equipment
Smart modules
Smart module status monitors the working status of each smart module,
which includes probes, mixers, carousels, cuvette wash station, ISE unit,
etc.

2-14
 2 General Operating Procedure

2.5 Preparing Reagents

After confirming the system status and performing the daily checks,
prepare the reagents for measurement. Chemistries without reagents
loaded can be requested but will not be included in measurements.
Loading reagents is allowed when the system status is Standby and
Incubation. In the case of Running, you must request Reagent stop before
you load the reagents. In the case of Sleep, reagents cannot be loaded
until the instrument is woken up. After assigning reagent positions, print
out the reagent list and then manually load reagents according to it.
When all reagents are loaded, the system will check the reagent inventory
during measurement and then display it on the Reagent/Calibration
screen. You are recommended to perform inventory check manually after
loading reagents; otherwise, the tests left will not be displayed on the
Reagent/Calibration screen.

WARNING
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise
caution when working around the probes.

BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.
Do not touch the reagent directly with your body; otherwise, skin wound or
inflammation may be caused.

2.5.1 Loading Biochemical Reagents

The system supports manual and auto load of biochemical reagents.
Each chemistry can have more than one bottle of reagent loaded;
however the reagent of same chemistry must be loaded on the same
reagent carousel. If your system is not equipped with a reagent bar code
reader, you need to enter the reagent information manually when loading
reagents; if a reagent bar code reader is configured, the system will scan
all reagents automatically and read reagent information from the bar
code.
If no bar code is scanned on automatically loaded reagents, they will be
unloaded automatically. To reload these reagents, input the bar code
manually. No matter if reagents are loaded manually or automatically, the
newly scanned bar code will substitute for the previous one if they are not
the same.
When one or more reagents of a multi-reagent chemistry are not loaded,
the “!” sign will appear near the chemistry’s reagent types that have been
loaded.
Reagents can be loaded manually or via bar code scanning. For more
information about loading bar-coded reagents, refer to 13.2.3 Loading
Bar-Coded Reagents (page 13-16).

2-15
2 General Operating Procedure

NOTE
Before loading biochemistry reagent, ensure that there are no air bubbles inside the
reagent bottle so as to avoid inaccurate test results.

Manual load
When loading reagents manually, you need to enter the reagent
information, which is the only information source of the loaded reagents.
You are allowed to input reagent information before, during or after
loading reagents to the reagent carousel. If loaded reagents are
bar-coded, the reagent information cannot be edited; otherwise, all
reagent information except for position, chemistry and reagent type can
be edited. Manually loaded reagents have the letter “M” (Manual)
appearing near them.
Figure 2.5 Flag for manually loaded reagents
（1）

(1) Flag “M” for manually loaded reagents

1 Check the system status and operate accordingly.

 Standby: Proceed to the next step.

 Running: Select Reagent-Reagent/Calibration. Select Load F1 to
stop reagent aspirating and dispensing. Meanwhile Load F1
becomes No load F1.If you want to abort load, select No load F1.
When the countdown for reagent stop becomes 0 and the system
status is Reagent Load, a message box pops up. Select OK, and
then proceed to the next step.
 Incubation: Proceed to the next step.

2-16
 2 General Operating Procedure

 Sleep: Select Utility-Commands-Wake up, and then proceed to

step 2.
2 Select Reagent-Reagent/Calibration.

3 Select a reagent carousel from the dropdown box of reagent

carousel.

4 Select the down-arrow button on the right side of the screen to

display the biochemical reagents.

5 Choose a position to which you want to load a reagent.

6 Select Load F1. The Load Reagent window is displayed.

Figure 2.6 Load reagent window

7 Enter the following reagent information:

 Bar code
 Chemistry name (required)
 Reagent type (required)
 Lot number
 Serial number
 Bottle type (required)
 Expiration date
8 Select Load F3 to save the input information.

9 Select Prev F1 and Next F2 to load reagents for other chemistries.

10 Select Print F7 to print out the biochemical reagent list.

2-17
2 General Operating Procedure

11 Remove the reagent carousel cover.

CAUTION
If the system is running tests, after requesting reagent stop, do not remove the
reagent carousel cover until the countdown for reagent stop is 0, the system
status is Reagent Load, and the popup message is confirmed; otherwise, probe
collision or other error may occur.
12 Load reagents according to the reagent load list. Place the reagents
in position 1-78 on the reagent carousel, and then uncap the reagent
bottles.

13 Restore the reagent carousel cover.

14 Select End Load F2.

Auto load
Auto load is to load bar-coded reagents to the reagent carousel, which
are identified by bar code scanning.
1 Check the system status and operate accordingly.

 Standby: Proceed to the next step.

 Running: Select Reagent-Reagent/Calibration. Select Load F1 to
stop reagent aspirating and dispensing. Meanwhile Load F1
becomes No load F1.If you want to abort load, select No load F1.
When the countdown for reagent stop becomes 0 and the system
status is Reagent Load, a message box pops up. Select OK, and
then proceed to the next step.
 Incubation: Proceed to the next step.
 Sleep: Select Utility-Commands-Wake Up to awake the system,
and then start loading reagents.
2 Select a reagent carousel from the dropdown box of reagent
carousel.

3 Remove the reagent carousel cover.

CAUTION
If the system is running tests, after requesting reagent stop, do not remove the
reagent carousel cover until the countdown for reagent stop is 0, the system
status is Reagent Load, and the popup message is confirmed; reagent probe
collision or other error may occur.
4 Place the reagents in position 1-78 of the reagent carousel and then
uncap the reagent bottles.

5 Restore the reagent carousel cover.

2-18
 2 General Operating Procedure

6 Select End Load F2.

If reagent barcode reader has been configured, the system scans all
reagent positions and read the following reagent information from the
bar code:
 Chemistry name
 Reagent type
 Days left
 Lot number
 Serial number and bottle type

2.5.2 Loading Concentrated Wash Solution

Concentrated wash solution is used to clean reaction cuvettes and can
only be loaded manually. The lot number, serial number, expiration date,
volume, reagent alarm limit and other information of the loaded wash
solution must be entered. Before loading concentrated wash solution,
ensure that the diluted wash solution is enough for the tests in progress.
1 Select Reagent-Reagent/Calibration.

2 Select Conc Wash in the lower reagent list.

3 Select Load F1. The Load Reagent window is displayed.

Figure 2.7 Load reagent window(Concentrated wash solution)

4 Open the front door of the analyzer.

5 Load the concentrated wash solution.

2-19
2 General Operating Procedure
Figure 2.8 Positions for concentrated wash solution

（1）

(1) Concentrated wash solution

6 Close the front door of the analyzer.

7 Enter the following information:

 Volume % (required)
 Serial number
 Expiration date
 Lot number
 Reagent alarm limit
8 Select Load F3.

9 Select Exit F5 to close the window.

2.5.3 Loading Reagent Probe Wash Solution

Reagent probe wash solution can only be loaded manually. The volume,
lot number, serial number, expiration date, bottle type and other
information of the loaded wash solution must be entered.
You are recommended to check the reagent probe wash solution every
day to ensure its sufficiency.

NOTE
Before loading wash solution, ensure that there are no air bubbles inside the reagent
bottle so as to avoid affecting washing effects.
1 Check the system status and operate accordingly.

 Standby: Proceed to the next step.

 Running: Select Reagent-Reagent/Calibration. Select Load F1 to
stop reagent aspirating and dispensing. Meanwhile Load F1
becomes No load F2. If you want to abort load, select No load F2.
When the countdown for reagent stop becomes 0 and the system
status is Reagent Load, a message box pops up. Select OK, and
then proceed to the next step. Incubation: Proceed to the next
step.

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 2 General Operating Procedure

 Sleep: Select Utility-Commands-Wake up, and then proceed to

step 2.
2 Select Reagent-Reagent/Calibration.

3 Select Wash D in the lower reagent list.

4 Select Load F1. The Load Reagent window is displayed.

Figure 2.9 Load reagent window(Reagent probe wash solution)

5 Remove the reagent carousel cover.

6 Place the wash in position D (No.79) of the reagent carousel.

7 Restore the reagent carousel cover.

8 Enter the following information:

 Volume (%)
 Serial number
 Expiration date
 Lot number
 Bottle type (required)
 Reagent alarm limit
9 Select Load F3.

10 Select Exit F5 to close the window.

11 If a reagent bar code reader has been configured, select End Load F2,
the system will scan the reagent carousel.

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2 General Operating Procedure

2.5.4 Loading Sample Probe Wash Solution

Sample probe wash solution is used to clean the sample probe, and can
only be loaded manually. When the sample probe wash solution is expired
or exhausted, fill more sample probe wash solution.
Three special washes will be conducted for the sample probe when every
batch of tests is finished, and about 90μl wash solution is consumed for
each wash. The amount of concentrated wash solution for weekly
cleaning of reaction cuvettes is 1ml. You are recommended to check and
replace the sample probe wash solution every day to ensure its
sufficiency.

NOTE
Before loading wash solution, ensure that there are no air bubbles inside the test
tube so as to avoid affecting washing effects.
1 Check the system status and operate accordingly.

 Standby: Proceed to the next step.

 Running: Select the button on the upper-right corner of the

main screen to stop sample aspirating and dispensing. When the
countdown for sample stop becomes 0 and the system status is
Sample Load, proceed to the next step.
 Incubation: Proceed to the next step.
 Sleep: Proceed to the next step.
2 Remove the sample carousel cover;

3 Place sample probe wash in position D2 of the sample carousel.

4 Restore the sample carousel cover;

2.5.5 Loading Physiological Saline

Physiological saline is used to run sample blanks, reagent blanks and
calibrations, and dilute samples, and it can only be loaded manually. The
bottle type and volume of the loaded saline must be entered.
Physiological saline used for running sample blanks and diluting samples
should be loaded to the position W on the reagent carousel; and that for
running reagent blanks and calibrations should be loaded manually to the
position W on the sample carousel.

Loading physiological saline on the sample carousel

1 Check the system status and operate accordingly.

 Standby: Proceed to the next step.

 Running: Select the button on the upper-right corner of the

main screen to stop sample aspirating and dispensing. When the
countdown for sample stop becomes 0 and the system status is
Sample Load, proceed to the next step.

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 2 General Operating Procedure

 Incubation: Proceed to the next step.

 Sleep: Proceed to the next step.
2 Remove the sample carousel cover.

3 Place physiological saline in position W of the sample carousel.

4 Restore the sample carousel cover;

Loading physiological saline on the reagent carousel

1 Check the system status and operate accordingly.

 Standby: Proceed to the next step.

 Running: Select Reagent-Reagent/Calibration. Select Load F1 to
stop reagent aspirating and dispensing. Meanwhile Load F1
becomes No load F1. If you want to abort load, select No load F1.
When the countdown for reagent stop becomes 0 and the system
status is Reagent Load, a message box pops up. Select OK, and
then proceed to the next step.
 Incubation: Proceed to the next step.
 Sleep: Select Utility-Commands-Wake Up to awake the system,
and then proceed to step 2.
2 Select Reagent-Reagent/Calibration.

3 Select Saline W in the lower reagent list.

4 Select Load F1. The Load Reagent window is displayed.

Figure 2.10 Load reagent window(Physiological saline)

5 Remove the reagent carousel cover.

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2 General Operating Procedure

CAUTION
If the system is running tests, after requesting reagent stop, do not remove the
reagent carousel cover until the countdown for reagent stop is 0, the system
status is Reagent Load, and the popup message is confirmed; otherwise, Probe
collision or other error may occur.
6 Place the physiological saline for sample blanks and sample dilution
in position W (No.80) of the outer ring of the reagent carousel.

7 Restore the reagent carousel cover.

8 Enter the following information of physiological saline for sample

blanks and sample dilution:

 Volume %
 Bottle type
 Reagent alarm limit
9 Select Load F3.

10 Select Exit F5 to close the window.

11 Select End Load F2.

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 2 General Operating Procedure

2.6 Calibration
Running calibration is to calculate calibration factors for sample result
calculation. Generally, calibration is required when one of the following
conditions occurs:
 A new chemistry is configured.
 QC alarms are given while the reagent, calibrator and control sample
are within the expiration date.
 Reagent lot or bottle is changed.
 The calibration factors of a chemistry are expired.
 The ISE electrodes are adjusted or the ISE module is maintained.
 The calibration rules are changed, such as calibration method,
replicates, concentration and calibrator.
 The chemistry parameters are changed, such as primary wavelength,
secondary wavelength, blank time, reaction time, reagent volume
(R1/R2/R3/R4), sample volume, sample dilution parameters, reaction
type, reaction direction, sample blank and result unit.
 The lamp, syringe or sample probe is replaced.
If any of the following chemistry parameters are changed, a calibration is
required:
 Primary wavelength
 Secondary wavelength
 Blank time
 Reaction time
 Reagent volume(R1/R2/R3/R4)
 Sample volume
 Reaction type
 Reaction direction
 Sample blank and result unit
 Twin chemistries
For more information about calibration setup, refer to 3.3 Calibration
Setup (page 3-30).

2.6.1 Requesting Calibrations

General calibration request
When one of the above-mentioned conditions is happened, request a
calibration according to the steps stated below.
Before requesting a calibration, make sure that the calibrator has been
loaded to correct position.
1 Select Reagent-Reagent/Calibration.

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2 General Operating Procedure

2 Select a reagent carousel from the dropdown box of reagent

carousel.

3 Select the down-arrow button on the right side of the screen to

display the biochemical reagents.
Figure 2.11 Reagent/Calibration screen

4 Select chemistries you want to calibrate.

Select the up-/down-arrow buttons to select more chemistries.

5 Select Cal F5.

6 Select Calibration.

7 Select OK.

Reagent lot calibration

After selecting the Manage Reagents by Lot option on the System Setup
screen, you are allowed to calibrate each reagent lot of a chemistry and
view all calibration results on the Biochemistry Calibration screen.
1 Select Reagent-Reagent/Calibration.

2 Select a reagent carousel from the dropdown box of reagent

carousel.

3 Select the down-arrow button on the right side of the screen to

display the biochemical reagents.

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 2 General Operating Procedure
Figure 2.12 Reagent/Calibration screen

4 Select reagent lots you want to calibrate.

Select the up-/down-arrow buttons to select more chemistries.

5 Select Cal F5.

6 Select Calibration.

7 Select OK.

8 Select the Biochemistry Calibration tab to view calibration results.

Requesting a calibration based on calibration status

When a chemistry has the calibration status of Cal Required, Cal Failed or
Cal Time Out, the system will give an alarm. Perform the following steps
to request a calibration based on the calibration status:
1 Check the Reagent button on the left of the main screen.

 Yellow: indicates that a warning occurs.

 Red: indicates that a serious error occurs.
2 If the Reagent button is highlighted, select
Reagent-Reagent/Calibration.

3 Select a reagent carousel from the dropdown box of reagent

carousel.

4 Select the down-arrow button on the right side of the screen to

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2 General Operating Procedure

display the biochemical reagents.

5 Check the biochemical chemistries of which the calibration status is

highlighted.

6 Select chemistries that you want to calibrate.

7 Select Cal F5.

8 Select Calibration.

9 Select OK.

Auto calibration
The system provides the auto calibration option. When the conditions are
satisfied, the system displays a message indicating calibration required
and then stops running the corresponding chemistry. The conditions for
auto calibration include:
 Calibration factors are expired
 Reagent lot is changed
 Reagent bottle is changed
For more information about auto calibration, refer to 6.5 Auto Calibration
(page 6-12).

2.6.2 Loading Calibrators

BIOHAZARD
Inappropriate handling of calibrators may lead to biohazardous infection. Do not
touch the calibrators directly with your hands. Wear gloves and lab coat, if necessary,
goggles. In case your skin contacts the calibrators, follow standard laboratory safety
procedure and consult a doctor.

CAUTION
Do not use expired calibrators; otherwise, unreliable test results may be caused.
1 Select Reagent-Reagent/Calibration.

2 Select a reagent carousel from the dropdown box of reagent

carousel.

3 Select the down-arrow button on the right side of the screen to

display the biochemical reagents.

4 Select Load List F4.

The calibrator list shows all requested chemistries as well as

calibrators, positions, concentration, lot number and expiration date.
5 Select Print F7.

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 2 General Operating Procedure

6 Select Close F8.

7 Load calibrators to the sample carousel according to the calibrator

list.

NOTE
Calibrators of a chemistry must be placed and analyzed on the same sample
carousel.

2.6.3 Running Calibrations

After requesting calibrations and load calibrators to the sample carousel,
you can start the calibration test.

1 Select on upper right corner of the main screen. The Start

Conditions window is displayed.
Figure 2.13 Start Conditions window

2 Select a sample carousel to which the calibrators are loaded.

3 Select a reagent carousel to which the reagents are loaded.

4 Select OK to start analysis.

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2 General Operating Procedure

2.7 Quality Control

QC results are tools used to monitor the system performance. To check if
the system is running normally and steadily, you are recommended to run
control samples every day. The system provides two modes to run control
samples, auto and manual. New chemistries can be added no matter in
which status the control samples are. The control programs can be edited
when the control status is Programmed rather than In Progress.

2.7.1 Programming Control Samples

QC runs are requested by programming control samples. You are allowed
to choose a control, control position and sample cup type as well as
chemistries and panels for measurement. At least one chemistry must be
selected for control programming. If Manage reagent by lot is selected on
the System setup screen, the system also allows you to run QC samples
by reagent lot. If a chemistry has no QC parameters set up, such as mean
concentration and standard deviation, the chemistry cannot be used to
programming controls.
1 Select Program-Quality Control.
Figure 2.14 Quality Control screen

2 Select a control from the Control pull-down list.

The chemistries assigned for the control are selected automatically.

 If the control has never been programmed, all chemistries
assigned for it will be selected.

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 2 General Operating Procedure

 If the control has been programmed, the chemistries in recent

programming will be selected automatically.
3 Select a position from the Pos pull-down list.

The options include all positions defined for the control. The default is
the position on the first defined sample carousel in ascending
numerical order. For more information about control position
assignment, refer to 3.4.2 Defining/Editing a Control (page 3-38).
4 Choose a sample cup type to be used by the selected control.

The options include Standard and Microtube.

5 Choose desired chemistries and panels in the chemistry list.

If the chemistries included in a panel are set up for QC parameters,

they will be selected automatically; otherwise, the panel can be
selected but will not be programmed for quality control.
If you want to run the QC test by the reagent lot number of the
chemistry:
 First select Options F2.
 Then select reagent lot number for the chemistry.
 Select Save.
6 Select Save F8

7 To program other controls, select Prev F4 or Next F5, and then repeat
steps 3 and 6.

2.7.2 Loading Control Samples

BIOHAZARD
Inappropriate handling of control samples may lead to biohazardous infection. Do
not touch the control samples directly with your hands. Wear gloves and lab coat, if
necessary, goggles. In case your skin contacts the control samples, follow standard
laboratory safety procedure and consult a doctor.

CAUTION
Do not use expired control samples; otherwise, unreliable test results may be
caused.
1 Select Program-Sample.

2 Select List F5.

The sample list shows all programmed patient samples, control

samples and chemistries, including the following information:
 Program date and time

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2 General Operating Procedure

 Sample ID or control name

 Position
 Patient name (of patient samples)
 Chemistry
 Sample status
3 Select Print F7.

Samples and controls are printed out respectively.

4 Select Exit F8.

5 Load control samples to the sample carousel according to the printed

list.

2.7.3 Running Control Samples

After programming and load the control samples, you can start the QC
test.

1 Select on upper right corner of the main screen. The Start

Conditions window is displayed.
Figure 2.15 Start Conditions window

2 Select a sample carousel to which the control samples are loaded.

3 Select a reagent carousel to which the reagents are loaded.

4 Select OK to start analysis.

2.7.4 Auto quality control

Controls can be run automatically based on specified samples and
calibration. When auto QC is enabled, the system will automatically run all
chemistries of the selected controls once the conditions are met.
1 Select Utility-System Setup, and then select Instrument F1.

2 Select 9 QC Evaluation.

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 2 General Operating Procedure

3 Select Auto QC on Carousel, and then select controls for auto QC in

the control list.

4 Set up the conditions for auto quality control:

 Number of samples
 When calibrated
For more information about auto QC setup, refer to 7.3 Auto Quality
Control (page 7-8).

5 Select on upper right corner of the main screen. The Start

Conditions window is displayed.

6 Select OK.

When conditions for auto quality control on sample carousel are

satisfied, the system will run controls automatically for relevant
chemistries through the sample carousel.

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2 General Operating Procedure

2.8 Programming Routine Samples

After running quality controls, if the test results indicate that the system
is in control, you can start programming patient samples. This section
describes how to program and run routine samples. For information
about bar-coded samples, refer to 13.1.3 Programming Bar-Coded
Routine Samples (page 13-4).

2.8.1 Programming Routine Samples

You are allowed to program samples one by one or in batch. Batch
program is not allowed when the sample status is In Progress,
Incomplete, Rerun or Complete. If the sample status is Programmed, the
new program information will overwrite the previous program
information.

Programming a sample
1 Select Program-Sample.
Figure 2.16 Sample screen

2 Enter the sample ID in the ID field.

Sample ID is composed of numbers, or letters and numbers. Up to 10

digits can be entered. The default sample ID ranges from 1 to 9000.
The first sample on each day is numbered as 1. Duplicate sample IDs
are not allowed before the next time the samples are released.
3 Enter the sample position.

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 2 General Operating Procedure

A sample position consists of Crsl and Pos. Routine samples can be

programmed with virtual sample carousel. Up to 10 virtual sample
carousels are provided, and the programming on each day starts from
position No.1 of sample carousel 1. Occupied positions must not be
used for programming before being released.
4 Select a sample type from the Sample Type pull-down list.

The options include serum, plasma, urine, CSF and other.

5 Enter sample barcode in Barcode field or scan the barcode with a
handheld barcode reader

6 Enter the number of the panel or numbers of the panels or the number
range of the panels in the Panels field. Its or their corresponding
chemistries are selected automatically. Or Choose desired panels.
When selected, the panels will appear in a blue frame.

7 Choose desired chemistries.

Chemistries in various statuses are indicated by symbols and color.

Table 2.2 Description of chemistry statuses

Symbol or Chemistry Description
Color
▲ Chemistry for The chemistry will be run with
increment test sample volume increased.
▼ Chemistry for The chemistry will be run with
decrement test sample volume decreased.
Masked chemistry The chemistry is masked. It can
be requested but cannot be run.
Chemistry name Available chemistry The chemistry can be requested
in black for analysis.
Chemistry name Unavailable The chemistry can be requested
in red chemistry but not allowed for analysis due
to the following reasons:
The reagent is not loaded or
inventory is 0.
The calibration status of the
chemistry is Cal Required, Cal
Failed or Cal Time Out.
Chemistry frame Available chemistry The chemistry can be requested
active for analysis.
Chemistry frame Unavailable The chemistry cannot be
inactive and chemistry requested for analysis due to the
appearing in following reasons:
grey Serum index is not applicable to
samples other than serum and
plasma.
Requested chemistries cannot be

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2 General Operating Procedure

Symbol or Chemistry Description

Color
chosen again for samples that are
in progress, rerun, complete or
incomplete.
Chemistry frame Unselected The chemistry is not selected.
in normal color chemistry
Chemistry frame Selected chemistry The chemistry is selected.
in blue
Chemistry frame Auto selected serum The serum index chemistry is
in dark blue index chemistry automatically selected for serum
and plasma samples. When
deselected and requested again,
the chemistry appears in a blue
frame.
8 According to your actual needs, select Options F2 to set up the
following parameters:

 Sample volume
 Sample tube
 Off-line dilution factor
 Number of replicates.
 Predilution factor
Figure 2.17 Options window

9 Enable or disable sample blank for the sample.

Only when the Set Sample Blank Individually checkbox is selected on

the Factory Settings screen, the Sample Blank option will appear. If
you need the settings, contact our customer service department or
your local distributor.
10 If you want to run a chemistry with different parameter, enter the

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 2 General Operating Procedure

values in the chemistry option area:

 Sample Vol
 Replicates
 Predilution
 Sample blank
11 Select OK.

12 Select Save F8.

Batch programming
For batch-programmed samples, all program information such as sample
information, chemistries and patient demographics other than position, ID
and bar code are the same.
1 Select Program-Sample.

2 Enter the sample ID of the first sample.

3 Enter the start position to place the samples.

4 Select a sample type from the Sample Type pull-down list.

5 Enter the number of the panel or numbers of the panels or the number
range of the panels in the Panels field. Its or their corresponding
chemistries are selected automatically. Or Choose desired panels.
When selected, the panels will appear in a blue frame.

6 Choose desired chemistries.

7 According to your actual needs, select Options F2 to set up the

following parameters:

 Sample volume
 Sample tube
 Off-line dilution factor
 Number of replicates.
 Predilution factor
 Sample blank

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2 General Operating Procedure
Figure 2.18 Options window

8 If you want to run a chemistry with different parameter, enter the

values in the chemistry option area:

 Sample Vol
 Replicates
 Predilution
 Sample blank
9 Select OK.

10 Select Batch F3.

Figure 2.19 Program Batch window

11 Enter the sample ID of the last sample.

12 Select OK.

Editing patient information

You can enter the patient information at any time. Patient information can
be customized through System setup screen. For more details, please
refer to 8.9 Customizing Patient Demographics.When sample analysis is
finished, you can view and edit the sample information on the Current

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 2 General Operating Procedure

Results and History Results screens.

1 Select Program-Sample.

2 Enter the sample ID in the ID field.

3 Select Demog F1.

Figure 2.20 Demographics window

4 To change the priority of the sample, select or deselect the STAT

checkbox.

5 Enter the relevant patient information.

6 Select Save F7 to save your input.

7 To edit demographics of other patients, select Prev F4 or Next F5.

8 Select Exit F8 to close the window.

Editing and confirming program information

If the programmed sample is not in progress, you are allowed to edit the
program information and add more chemistries. Samples that are being
analyzed, rerun, incomplete or complete must not be edited. New
chemistries can be added to samples of any status. All program
information of samples in Programmed status can be edited.
1 Select Program-Sample.

2 Enter the sample ID in the Sample ID field, or enter the sample

position in the Crsl and Pos fields.

The program information of the sample is displayed.

3 Edit the following information:

 STAT property
 Sample type
 Comment

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2 General Operating Procedure

 Chemistries
 Panels
 Patient demographics
 Sample options and chemistry options
4 Confirm the program information.

5 Select Save F8.

6 Select Prev F6 or Next F7 to view other samples.

2.8.2 Loading Routine Samples

BIOHAZARD
Inappropriate handling of samples may lead to biohazardous infection. Do not touch
the samples directly with your hands. Wear gloves and lab coat, if necessary, goggles.
In case your skin contacts the samples, follow standard laboratory safety procedure
and consult a doctor.

CAUTION
Do not use expired samples; otherwise, unreliable test results may be caused.

NOTE
Before loading sample, ensure that there are no air bubbles inside the sample cup so
as to avoid inaccurate test results.
1 Select Program-Sample.

2 Select List F5.

The sample list shows all programmed samples, controls and

chemistries, including the following information:
 Program date and time
 Sample ID or control name
 Position
 Patient name of patient samples
 Chemistry
 Sample status
3 Select Print F7.

Samples and controls are printed out respectively.

4 Select Exit F8.

5 Load samples to the sample carousel according to the printed list.

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 2 General Operating Procedure

2.8.3 Running Routine Samples

After programming and loading the samples, you can start the analysis.
To view sample results, refer to 8.12 Results Recall (8-39).

1 Select on upper right corner of the main screen. The Start

Conditions window is displayed.
Figure 2.21 Start Conditions window

2 Select a sample carousel to which the samples are loaded.

3 Select a reagent carousel to which the reagents are loaded.

4 Select a patient sample range: All or Partial. When you select Partial,
you should specify a sample position range for analysis.

5 Select OK.

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2 General Operating Procedure

2.9 Programming STAT Samples

STAT sample program allows emergent samples to be programmed and
analyzed with high priority. The system provides common STAT and quick
STAT program. Common STAT program is used in daytime to run
emergent samples with higher priority than routine samples. Quick STAT
program is mainly used in nighttime and at weekends to program
emergent samples quickly with higher priority than routine and common
STAT samples.

2.9.1 Programming STAT Samples

Programming single STAT Sample
1 Select Program-Sample.

2 Enter the sample ID in the Sample ID field.

Sample ID is composed of numbers, or letters and numbers. Up to 10

digits can be entered. The first sample on each day is numbered as 1.
Duplicate sample IDs are not allowed before the next time the
samples are released.
3 Mark the STAT checkbox.

When the STAT checkbox is marked, the default sample position is the
STAT position available on the sample carousel.
4 If you do not want to use the default position, then enter the sample
position.

5 Select a sample type from the Sample Type pull-down list.

6 Enter barcode in barcode field or scan the barcode with a handheld

barcode reader.

7 Enter the number of the panel or numbers of the panels or the number
range of the panels in the Panels field. Its or their corresponding
chemistries are selected automatically. Or Choose desired panels.
When selected, the panels will appear in a blue frame.

8 Choose desired chemistries.

9 According to your actual needs, select Options F2 to set up the

following parameters:

 Sample volume
 Sample tube

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 2 General Operating Procedure

 Off-line dilution factor

 Number of replicates.
 Predilution factor
 Sample blank
Only when the Set Sample Blank Individually checkbox is selected on
the Factory Settings screen, the Sample Blank option will appear. If
you need the settings, contact our customer service department or
your local distributor.
10 If you want to run a chemistry with different parameter, enter the
values in the chemistry option area:

 Sample Vol
 Replicates
 Predilution
 Sample blank
11 Select OK.

12 Select Save F8.

Batch programming STAT Samples

For batch-programmed samples, all program information such as sample
information, chemistries and patient demographics other than position, ID
and bar code are the same.
1 Select Program-Sample.

2 Enter the sample ID of the first sample.

3 Mark the STAT checkbox.

When the STAT checkbox is marked, the default sample position is the
STAT position available on the sample carousel.
4 If you do not want to use the default position, then enter the sample
position.

5 Select a sample type from the Sample Type pull-down list.

6 Enter the number of the panel or numbers of the panels or the number
range of the panels in the Panels field. Its or their corresponding
chemistries are selected automatically. Or Choose desired panels.
When selected, the panels will appear in a blue frame.

7 Choose desired chemistries.

8 According to your actual needs, select Options F2 to set up the

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2 General Operating Procedure

following parameters:

 Sample volume
 Sample tube
 Off-line dilution factor
 Number of replicates.
 Predilution factor
 Sample blank
9 If you want to run a chemistry with different parameter, enter the
values in the chemistry option area:

 Sample Vol
 Replicates
 Predilution
 Sample blank
10 Select OK.

11 Select Batch F3.

Figure 2.22 Program Batch window

12 Enter the sample ID of the last sample.

13 Select OK.

Quickly programming STAT Samples

1 Select on upper right corner of the main screen. The STAT

Sample Program window is displayed.

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 2 General Operating Procedure
Figure 2.23 STAT Sample Program window

2 Enter the sample ID. The first emergent sample on each day is
numbered as 9001.

Sample ID is composed of numbers, or letters and numbers. Up to 10

digits can be entered. Duplicate sample IDs are not allowed before the
next time the samples are released.
3 If you do not want to use the default position, then enter the sample
position.

4 Select a sample type from the Sample Type pull-down list.

5 Select a sample tube type. The options include micro and standard.

6 Confirm the default chemistries.

7 To select more chemistries, perform the following steps:

 Select Chems F3.

 Choose chemistries and panels to be run for emergent samples.
 Select Save F7.
8 Select Demog F1 to enter patient demographics.

9 According to your actual needs, select Options F2 to set up the

following parameters:

 Sample volume
 Sample blank
 Sample tube
 Off-line dilution factor
 Number of replicates.
 Predilution factor
10 If you want to run a chemistry with different parameter, enter the
values in the chemistry option area:

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2 General Operating Procedure

 Sample Vol
 Replicates
 Predilution
 Sample blank
11 Select OK.

12 Select Save F7;

13 Select Close F8 to close the window.

2.9.2 Starting Analysis

BIOHAZARD
Inappropriate handling of samples may lead to biohazardous infection. Do not touch
the samples directly with your hands. Wear gloves and lab coat, if necessary, goggles.
In case your skin contacts the samples, follow standard laboratory safety procedure
and consult a doctor.

CAUTION
Do not use expired samples; otherwise, unreliable test results may be caused.
1 Load emergent samples to the sample carousel.

2 Select on upper right corner of the main screen. The Start

Conditions window is displayed.
Figure 2.24 Start Conditions window

3 Select a sample carousel to which the samples are loaded.

4 Select a reagent carousel to which the reagents are loaded.

5 Select a patient sample range:

All or Partial. When you select Partial, you should specify a sample
position range for analysis.
6 Select OK.

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 2 General Operating Procedure

2.10 Test Status and Emergency Stop

During the analysis, you can check reagent inventory on the
Reagent/Calibration screen, and view test status of calibrators, controls,
routine and emergent samples on the Program-Status screen. View the
reagent carousel status through Reagent-Status screen. To pause or
stop analysis, select icons on upper right corner of the main screen.

2.10.1 Checking Reagent Status

1 Select Reagent-Reagent/Calibration.

The screen displays by default the inventory of ISE reagent and ISE
calibration status, as well as inventory and days left of wash
solutions and physiological saline. When the inventory is less than
the alarm limit, the system will give an alarm and mark the chemistry
or wash solution name with different colors.
 Yellow: Warning. The reagent is insufficient or has been expired.
 Red: Serious. The reagent is exhausted.
Figure 2.25 ISE reagent/calibration screen

2 Select a reagent carousel from the dropdown box of reagent

carousel.

3 Select the up-/down-arrow buttons to show the biochemistry screen.

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Figure 2.26 Biochemistry reagent/calibration screen

The screen displays the inventory and calibration status of the

biochemistry reagents. When the reagent inventory is less than the
alarm limit, the system will give an alarm and mark the chemistry
name and chemistries left with different colors.
 Yellow: Warning. The number of chemistries left is lower than the
alarm limit, or the calibration status of the reagent is Cal Time
Extended, Calculated, Edited or Cal Overridden.
 Red: Serious. The number of chemistries left is 0, or the
calibration status of the reagent is Cal Failed, Cal Timed Out, or
Cal Required. The chemistry can still be requested but will not be
run. The ongoing tests containing the chemistry will be
invalidated.

2.10.2 Viewing Test Status

1 Select Program-Status.

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 2 General Operating Procedure
Figure 2.27 Status screen

2 View the status of calibrators, controls and samples on the sample

carousel graph.

 White: The position is not being used for analysis or has been
released manually.
 Grey: The sample is programmed but not started for analysis.
 Dark green: The sample is dispensed into a reaction cuvette.
 Red: All chemistries of the sample are run, but one or more of
them have no results.
 Green: All chemistries of the sample are run and have test results.
 Blue: The sample is being analyzed.
 : Indicate invalid sample.
 The sigh appears when sample bar code conflicts, or positions
of controls and calibrators are occupied by patient samples, or
invalid bar code is detected. The conflicting positions of
samples rather than controls and calibrators can be released
manually.
 A bar code is deemed invalid if it contains invalid characters or
exceeds the length limit, or is detected in an idle position but
has no corresponding sample information or default panel for
analysis.
 Select Log F2 to find the specific causes.

 : The sample does not have programmed chemistries.

3 Choose a sample on the sample carousel graph.

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The detailed information of the selected sample is displayed on the

right side of the screen:
 Sample position
 Sample status
 Program date and time
 Sample ID (patient sample)
 Bar code (patient sample)
 Calibrator name and lot number (calibrator)
 Name and lot number (control sample)
4 Choose the following buttons as needed:

 Search F1: used to search for desired calibrator, control or patient

sample.
 Log F2: used to recall controls and patient samples which are not
complete due to some reasons within the recent 24 hours.
 Release F3: used to release the specified or all positions on the
current sample carousel.
 Result F4: used to display the Current Results screen, on which
you can recall all controls and patient samples that are
programmed and analyzed since the system is started up.
 Scan F5: used to scan the specified position or all positions on the
selected sample carousel.

2.10.3 Viewing Reagent Carousel Status

1 Select Reagent-Reagent Carousel Status.
The Reagent Carousel screen is displayed. You can view the status of
the reagent carousel, each reagent and configured reagents.
2 Select a reagent carousel from the dropdown box of reagent
carousel.

The simulated reagent carousel graph is shown in the middle of the

screen. Reagent carousel status includes vacant, sufficient reagent,
insufficient reagent, expired, and invalid reagent, marked by different
colors.

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 2 General Operating Procedure
Figure 2.28 Reagent carousel status

3 Select a position to display its reagent information on the right.

4 Select the following buttons to perform respective operations:

 Load F1: select this button to load the reagent.
 End Load F2: If reagent bar code reader is configured and the
reagents have been loaded, select this button to scan the reagent
carousel; if Auto Refresh Reagent Inventory is selected in system
setup, the reagents whose inventory is 0 can be refreshed as
available when End Load F2 is selected.
 InventoryF3: select this button to check reagent inventory.

2.10.4 Emergency Stop

Emergency stop will terminate all measurements on the instrument, and
all tests that are not finished yet will be invalidated. Do not use emergent
stop unless it is really needed, for example, system failure. Emergency
stop can be performed in any system status.

Select the icon on upper right corner of the screen, and then select
OK. All unfinished actions of the system are cancelled, all pumps and
valves are turned off, and the system enters the failure status.
To restore system failure, select Utility-Commands, and then select
Home. To resume the analysis, select the icon.

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2.11 Daily Maintenance

After finishing all tests every day, you are required to perform the daily
maintenance procedures and those maintenance procedures indicated in
yellow.
Daily maintenance procedures include:
 Check probes/mixers/wash wells
 Check sample/reagent syringes
 Check deionized water connection
 Check waste tube connection
 Check concentrated wash solution
 Check sample probe wash solution
 Clean electrode tubes

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2.12 Powering Off

1 Make sure that the system is in Standby status.

2 Select Exit-Shut Down on the left of the main screen. The Windows
operating system will quit automatically.

3 Switch off the power in the following order:

 Printer
 Monitor display of the operation unit
 Analyzing unit power switch
 Water supply module (optional)
 Drainage module(optional)
When the analyzing unit power is switched off, the refrigeration
system is still running. If you are going to store the system for over 7
days, switch off the main power.

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2.13 Check after Powering Off

1 Remove the sample carousel cover, and then remove the calibrators,
controls and patient samples.

2 Check the analyzer panel for stains and wipe them off with clean
gauze if any.

3 Check the high-concentration waste tank. Clear it if necessary.

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 System options
 Chemistries
 Calibration
 Quality control

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3.1 System Setup Options

3.1.1 Introduction
This section summarizes the setup options on the System Setup screen
as shown in the figure below.
Figure 3.1 System Setup screen

3.1.2 Sample Options and Reagent Alarm Limits

The sample options and reagent alarm limits allow you to:
 Set up default sample type, default sample tube and expiration date of
samples
 Set up the interval of sample probe cleaning
 Enable/Disable auto serum index
 Set up alarm for exhaustion of reagent
 Manage reagents by lot
 Enable/Disable reaction temperature monitoring before analysis
 Result display settings
 Define result flags for reference range
 Set up inventory alarm limit for ISE reagent
 Set up the alarm volume and beep volume
 Set up ISE startup primes

Default sample type

The system supports a couple of sample types, which include serum,

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plasma, urine, cerebrospinal fluid samples (CSF) and other. The default is
serum. When the default sample type is set up, it will be selected by
default for programmed samples on the Sample screen.

Default sample cup type

The system supports the standard sample cup and Microtube. The
default is the standard sample cup. When the default sample cup type is
set up, it will be selected by default for programmed samples on the
Sample screen.

Valid period of samples

Valid period of samples refers to the time interval that a patient sample is
first loaded to the sample carousel and then expired. When the valid
period of samples is set up, only samples within this period are allowed
for analysis. If the valid period is not set up, the samples are valid all the
time.
The valid period ranges from 1 to 99 in hour or day. The default is day.
Valid period is applicable to patient samples rather than calibrators and
controls. Once the collection time is entered, the system will calculate the
valid period from the time when the sample is collected; otherwise, the
time when the sample is programmed will be used for calculating the
valid period.

Special wash sample probe

The sample probe special wash function is used to execute additional
cleaning procedure for the sample probe during measurement in order to
avoid clogging. Enter the number of tests in the Number of Tests field.
The input range is 100-10,000, and the default is 400. When the number
of tests is finished, the system will clean the sample probe with wash
solution in an additional cleaning procedure.

Auto serum index

When the auto serum index function is enabled, the SI chemistry on the
Sample screen will be selected by default for programmed serum or
plasma samples, and the system will measure the degree of Hemolysis,
icterus and lipemia contained in these samples. If the Qualitative
Analysis checkbox on the Auto Serum Index window is marked, the
system will display qualitative flags of serum index on patient reports.
Serum index is only used to evaluate the integrity of samples rather than
making a diagnosis for patients.

Reaction temperature monitoring

The reaction temperature can be monitored before analysis begins.
 When the Start Analysis When Temperature is Steady checkbox is
selected, the system will check before analysis begins if the reaction
temperature is normal. If the temperature is normal, you are allowed

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to select to start analysis; otherwise, a message will appear

indicating analysis is forbidden in current condition.
 When the Start Analysis When Temperature is Steady checkbox is
not selected, the system will still check before analysis begins if the
reaction temperature is normal and within 37± 2.0° C. If the
temperature is normal, you are allowed to select to start analysis;
otherwise, the system will remind you that the results may be
influenced if you continue to start analysis. You may continue or
abort the analysis.

Alarm when reagent exhausted

Each chemistry can have more than one bottle of reagent loaded. You can
set up alarms for the case that the reagent is running out.
Select the Alarm when reagent exhausted option. When the reagent is
exhausted, the system will give an alarm. If the option is not selected, the
system will not give an alarm.

Manage reagents by lot

This option is used to monitor the calibration status and time of each
reagent lot, supports reagent lot calibration, and displays calibration
results of each reagent lot.
When this option is enabled, special attentions should be paid for the
following operations:
 Loading reagents: You are required to input the lot number when
loading reagents manually. The lot number of bar-coded reagents
cannot be left blank; otherwise, reagent load will fail.
 Viewing calibration status and requesting calibration: You can view
calibration status and time of each reagent lot, and request
calibration accordingly. For more information of reagent lot
calibration, refer to Reagent lot calibration (Page 2-26).
 Recalling calibration results: You can recall calibration results of each
reagent lot on the Biochemistry Calibration screen.
 Auto calibration: Auto calibration by reagent bottle or lot is forbidden.
When a different reagent lot is used, the system will request and run
calibration automatically. Reagent lots with valid calibration factors
will not be calibrated again when used for measurement.

Result display settings

This option is used to set up flags and color for results less than or
greater than the reference range, as well as color for results less than or
greater than the critical range.
Click the relevant color setup button, choose desired color, and then
select OK. The system will display flags in the Flag column of the Current
Results and History Results screens and on patient reports if the test
result is less than or greater than the reference range. The flags can be
composed of numbers, letters and symbols for no more than 10 digits.

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 3 System Setup

The default flags for reference range are ∧ and ∨. If a result is greater
than the high limit, ∧ will appear near the result; if a result is less than
the low limit, ∨.will appear near the result.
If test results are beyond the critical range, they will appear in the set
color.

Reagent alarm limit

Reagent alarm limit is only applicable to ISE reagent. If the inventory
alarm limit is set up, the system will give an alarm and mark the reagent
with colors when the reagent inventory is less than the alarm limit.
For more information about reagent inventory alarm limit, refer to 5.4
Reagent Inventory Alarm Limits Setup (page 5-7).

Alarm Sound volume

This option is to adjust the volume of alarm tone and beep. Alarm tone is
the sound of a system alarm and beep is given when mis-input or
mis-operation occurs. Volume of both sounds can be adjusted manually
according to the practical conditions of the environment. Drag the slider
in the Alarm Volume and Beep Volume fields horizontally. The scale is
ascending from left to right. When the slider is moved to the leftmost
position, the alarm buzzer is silenced.
Since the Windows 8 does not support alarming through buzzer, you
should install an audio card on your computer in order to ensure the
alarm and beep sound can be adjusted and given.

ISE prime cycle

For details of ISE primes setup, refer to 12.9 ISE Prime (page 12-21).

3.1.3 Auto Rerun Setup

The system provides a couple of conditions for auto rerun. When selected
conditions are satisfied, chemistries for which auto rerun has been
enabled will be rerun automatically with the specified sample volume
type.
Select the checkbox to the left of a condition, and then select a sample
volume type from the pull-down list to the right of the condition. The
sample volume type options include: increased, standard, decreased, and
last volume. When the condition is satisfied, chemistries with auto rerun
enabled will be rerun automatically with the selected sample volume type.
Only users who have the permissions of system setup are allowed to set
up auto rerun conditions.

Above Critical High

Select a rerun mode from the pull-down list box. It means that the system
will rerun the tests with the selected mode when the test result exceeds
the critical range high limit.
Unselection means this item will not be checked.

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3 System Setup

Below Critical Low

Select a rerun mode from the pull-down list box. It means that the system
will rerun the tests with the selected mode when the test result is lower
than the critical range low limit.
Unselection means this item will not be checked.

Above Linearity High

Select a rerun mode from the pull-down list box. It means that the system
will rerun the tests with the selected mode when the test result exceeds
the linearity high limit.
Unselection means this item will not be checked.

Below Linearity Low

Select a rerun mode from the pull-down list box. It means that the system
will rerun the tests with the selected mode when the test result is lower
than the linearity low limit.
Unselection means this item will not be checked.

Above Highest Calib.

Select a rerun mode from the pull-down list box. When selected, it means
the analyzer will rerun the sample with the selected mode automatically if
its response is beyond that of the highest-concentration calibrator.
Unselection means this item will not be checked.

Below Lowest Calib.

Select a rerun mode from the pull-down list box. When selected, it means
the analyzer will rerun the sample with the selected mode automatically if
its response is beyond that of the lowest-concentration calibrator.
Unselection means this item will not be checked.

Substrate Depletion
Select a rerun mode from the pull-down list box. When selected, it means
the analyzer will rerun the tests with the selected mode automatically if
the substrate ran out during running.
Unselection means this item will not be checked.

Prozone Check Error

Select a rerun mode from the pull-down list box. It means that the system
will rerun the tests with the selected mode when prozone occurs during
reaction process.
Unselection means this item will not be checked.

Nonlinear
Select a rerun mode from the pull-down list box. If the calculated linearity
is greater than the defined linearity limit, the system will rerun the tests

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 3 System Setup

with the selected mode.

Unselection means this item will not be checked.

No Linear Interval
Select a rerun mode from the pull-down list box. It means that the system
will rerun the tests with the selected mode when the number of
measuring points within substrate limit is less than or equal to 3. This
option applies to Kinetic method only.
Unselection means this item will not be checked.

No Calculation Interval
Select a rerun mode from the pull-down list box. If the number of
measuring points within linearity range is less than 2 during high-activity
enzyme measurement, the linearity range will be expanded. If the number
of measuring points is less than 2 even when the lag time is included, the
system will rerun the tests with the selected mode. This option applies to
Kinetic method only.
Unselection means this item will not be checked.

3.1.4 Instrument Setup Options

In the Instrument Setup window, you are allowed to:
 Set up time for system auto sleep and auto startup
 Mask/Unmask chemistries
 Dictionary setup
 Set up system communication options
 Select language for the operating software
 Upgrade the operating software, control software and ISE module
software
 View software versions
 System date and time
 Set up control run length and auto QC
 Voice tone setup
 Set up auto release time of samples
 Optimizing result display
 Customize sample information
 Customize patient demographics
 Reagent/calibration setup

Sleep and awake setup

The Sleep/Awake setup option is used to set up the auto sleep time
interval, and the auto awake time of the system.
If the auto sleep time interval is set up, the counter will start counting
down once the system enters Standby status and begins to sleep when

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3 System Setup

the countdown is finished.

The system allows you to choose a weekday and specific time that the
system will be started up automatically. When the awake time is reached,
the system will be woken up automatically no matter if it is off or sleeping.
For more information, refer to 11.5 Sleep and Awake Setup (page 11-8).

Masking/Unmasking Chemistries
The Masking/Unmasking Chemistries option is used to disable
chemistries, which will still be displayed on the Sample, Quality Control
and Reagent/Calibration screens. Masked chemistries can be requested
but will not be run for sample analysis.
For details of chemistry masking/unmasking, refer to 10.9
Masking/Unmasking Chemistries (page 10-23).

Dictionary setup
The Dictionary option is provided for setting up and managing frequent
data information, including: result unit, sample type, sample comment,
and QC comment.
For more information, refer to 11.6 Dictionary Setup (page 11-11).

System communication options

The Com Setup option is used to set up the IP address for connections
between the PC and LIS. For more details, please refer to 14.2.2
Connection between PC and LIS Host.

Select language
The operating software is displayed by default in the same language as
the current operating software. You are allowed to change the language
of the operating software.
Select System Setup-Instrument F1-5 Language, and then choose a
language from the following options: Chinese, English, Turkish, Russian,
French, Portuguese, Italian, Spanish, and Polish. Select OK to save the
settings. The language you select will take effect only when you reboot
the operating software.

Software upgrading
By running the upgrade program, you are allowed to upgrade the
operating software, control software and ISE module software. For more
information, refer to 11.7 Software Upgrade (page 11-13).

Viewing software versions

The Version Info window shows the versions of the operating software,
control software, ISE software and database. For more information, refer
to 11.8 Software Version (page 11-14).

Date and time

The Date and Time option allows you to set the current date and time,

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 3 System Setup

select the date/time formats to be displayed on software screens and

printed reports, and restore default date and time formats.
When adjusted, the date and time will influence the time left of reagents
and calibration, shelf life of samples, and run length of two-control
evaluation. The date and time cannot be edited when the system status is
Running. Modification of the date and time will not affect samples on the
Current Results screen or QC evaluation and Twin-Plot chart.
Follow this procedure to change system date and time:
1 Select Utility-System Setup.

2 Select Instrument F1.

3 Select 8 Date/Time.
Figure 3.2 Date/Time window

4 Select date in the Date area.

5 Set the time in the Time area.

Manually enter the hour, minute and second, or move the cursor to
hour, minute and second, and then click the up/down arrows to adjust
the time.
6 Choose a date format from the Order pull-down list.

 yyyy-mm-dd: e.g. 2010-07-28

 dd-mm-yyyy: e.g. 28-07-2010
 mm-dd-yyyy: e.g. 07-28-2010
7 Choose a time format from the Time Format pull-down list.

 24-hour: e.g. 14:33:27

 12-hour: e.g. 02:33:27
8 Select OK to save your input information.

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9 To restore the date and time defaults, select Restore Defaults.

10 Select Exit to close the window.

QC run length and auto QC

By choosing the QC Evaluation, you are allowed to set up the QC run
length and auto QC conditions.
For more information, refer to 7 Quality Control (page 7-1).

Auto release of samples

The system allows setting of daily release time of samples. When the set
time is reached, samples that are currently in Complete status will be
released automatically.
For more information, refer to 8.6.3 Auto Release of Samples (page 8-29).

Voice tone setup

This option is used to customize the alarm sound and beep sound.
For more information refer to “11.9 Voice Tone Setup” (Page 11-16).

Customize reagent display

This option is used to set up reagent information displayed on the
biochemistry reagent/calibration screen.
For more information, refer to 5.2 Customizing Reagent Display(Page5-5).

3.1.5 Print Setup

The Print Setup window allows you to set up paper size and default
printer. For more information, refer to 9.2 Print Setup (page 9-8).

3.1.6 Bar Code Setup

The Bar Code option is used to set up sample and reagent bar code
options. You are allowed to set up the bar code options only when you
equip your system with the bar code module. For more information, refer
to 13 Use of Bar Code (page 13-1).

3.1.7 Host Communication Setup

The Host option allows you to set up the host communication options
and the transmission methods of test results. For more information, refer
to 14.2 Host Communication.

3.1.8 User Accounts and Permissions

The User option allows you to define and edit user accounts, passwords
and permissions. For more information, refer to 11.4 User and Password
Setup (page 11-5).

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3.1.9 Customizing Sample Information

Customizing sample information allows you to specify sample
information to be displayed on the Sample screen. For more information,
refer to 8.8.2 Customizing Sample Information.

3.1.10 Customizing Patient Demographics

You can specify patient demographics to be displayed, its default and its
display order on the Patient Demographics screen. For more information,
refer to 8.9 Customizing Patient Demographics.

3.1.11 Reagent/Calibration Setup

Via Reagent/Calibration option on instrument setup screen, you can
configure whether to automatically refresh the reagent with 0 inventory
as available for test, when reagent has been loaded and End Load F2
button is selected. For more information, refer to 5.4.3 Auto refreshing
reagent inventory.

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3.2 Chemistries Setup

3.2.1 Introduction
Up to 200 chemistries can be defined and configured. The Chemistries
screen is as shown below:
Figure 3.3 Chemistries screen

Definition and setup of user-defined chemistries will be described in

detail in the following sections.

3.2.2 User-defined Chemistries Setup

Defining a chemistry
1 Select Utility-Chemistries.

2 Choose a blank frame in the chemistry list.

3 Select Define F1.

4 Enter the processing parameters and error detection limits of the

chemistry.

5 Select Next F5 to save your input information and define more

chemistries. Or

 Select Discard F6 to restore the default parameter settings.

 Select Save F7 to save your input information.
 Select Print F1 to print out the chemistry parameters.

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6 Select Close F8 to exit the window.

Editing user-defined chemistries

You are allowed to edit user-defined chemistries if:
 You have sufficient permissions, and
For user permission setup, refer to 11.4 User and Password Setup
(page 11-5).
 The system is not running tests.
Editing user-defined chemistries is similar to defining a chemistry. Refer
to other sections in this chapter for details.

Viewing user-defined chemistries

You are allowed to view the following information in any system status:
 Processing parameters
 Error detection limits
 Slope and offset
 Reference/Critical range
Perform the following steps to view chemistries you have defined:

1 Select Utility-Chemistries.

2 Choose a chemistry from the chemistry list.

3 Select Define F1 to view the processing parameters, error detection

limits and dilution factors.

4 Select Close F8 to close the Define/Edit Chemistries window.

5 Select Ref Range F4 to view the reference range and critical range.

6 Select Slope/Offset F5 to view the slope and offset values.

Deleting a user-defined chemistry

Make sure that you have sufficient permission to delete a chemistry you
have defined. For user permission setup, refer to 11.4 User and Password
Setup (page 11-5). SI and ISE chemistries are not allowed to be deleted.
1 Remove the reagent from the reagent carousel.

2 Select Utility-Chemistries.

3 Select the chemistry in the chemistry list.

4 Check if the following conditions are satisfied:

 The system is not running tests.

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 The selected chemistry is not requested or run for samples,

calibrators and controls.
 The selected chemistry is disabled.
 The corresponding reagent has been unloaded from the reagent
carousel.
5 Select Delete F2.

All test results, data and parameters related to the chemistry are
cleared.

3.2.3 Processing Parameters

This section introduces the processing parameters for user-defined
chemistries.
The processing parameters setup window is as shown below:
Figure 3.4 Processing parameters setup window

Chem
Chemistry name is the only identity of a chemistry and must not be
duplicate. A chemistry name can be composed of up to 10 characters.

No.
No. is a unique number for chemistry. It can be left blank but must not be
duplicate. Chemistry number is composed of numbers and ranges from
0-9999.

Sample type
Sample type refers to the samples to which the chemistry is applicable.
The options include serum, plasma, urine, CSF and other. The options
available in the Sample Type pull-down list are those supported by the
chemistry, and the default is the default sample type.
The system allows definition of chemistry parameters for more than one

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sample type, including the processing parameters and error detection

limits. During definition of chemistries, the parameters should be firstly
defined for serum sample, and then other sample types. Such chemistries
will be calibrated with serum sample parameters by default.

Chemistry
Chemistry is the complete form of chemistry name. It can be composed
of up to 36 characters. The input is not case sensitive. The Chemistry
field can be left blank or duplicate.
A chemistry is only represented by its print name on patient reports and
appears on other reports in the form of short name.

Print Name
Print name is displayed on patient reports representing a chemistry. It
can be composed of up to 15 characters. The print name can be edited
and duplicate. When this field is left blank, the short form of the chemistry
name will appear on reports. A chemistry is represented by its short name
on all reports other than patient reports.

Reaction Type
Reaction type is a measurement theory based on which chemistries are
run for samples and then calculated. The system supports three reaction
types, which are Endpoint, Fixed-time and Kinetic.

Table 3.1 Reaction types

Reaction Type Description
Endpoint Qualitative analysis is performed based on the absorption
spectrum and absorbed light intensity of the reactant when
the reaction becomes equilibrious.
Fixed-time For this reaction type, the reaction velocity is directly
proportional to the substrate concentration. As the substrate is
consumed continuously, the reaction velocity is decreasing
gradually, and so is the absorbance change rate. It will take a
long time for such reaction to become equilibrium, and the
reaction can get steady only after a delay.
Kinetic Kinetic, also called continuous monitoring method, is used to
continuously measure the multiple change points of a reactant
or substrate’s concentration which varies with the enzymatic
reaction, thus calculating the initial velocity of the enzymatic
reaction and then the enzyme activity. This reaction type is
mainly used for measurement of enzyme activity.

Reaction Direction
Reaction direction refers to the change trend of absorbance during the
reaction process, and includes two options:
 Positive: indicates increasing absorbance with time.
 Negative: indicates decreasing absorbance with time.

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Primary Wavelength
The primary wavelength is chosen based on the light absorption features
of the reactant and used to measure the absorbed light intensity.
Options for primary wavelength include: 340nm, 380nm, 412nm, 450nm,
505nm, 546nm, 570nm, 605nm, 660nm, 700nm, 740nm and 800nm

Secondary Wavelength
The secondary wavelength is used to correct the absorbance measured
at the primary wavelength and eliminate the influence of noise, such as
light flash and drift, and scratches on cuvettes, etc. The two wavelengths
cannot be equal.
Options for secondary wavelength include: blank, 340nm, 380nm, 412nm,
450nm, 505nm, 546nm, 570nm, 605nm, 660nm, 700nm, 740nm and
800nm

Unit
Changing the result units of the chemistries are allowed.
The result unit is blank by default. After changing the unit, you are
required to update calibrator concentrations, control concentrations and
standard deviations (SDs), reference ranges and offsets. Those test
results calculated with the old unit will remain unchanged.
The following table summarizes the result units available for chemistries.

Table 3.2 Result units

Unit Full name
1.mg/dl Milligrams per decilitre
2. mg/L Milligrams per litter
3. g/dl Grams per decilitre
4. g/L Grams per litre
5. mmol/L Micromole per litre
6. μmol/L Millimole per litre
7. IU/L International unit per litre
8. μg/ml Microgram per millilitre
9. μg/dl Microgram per decilitre
10. μg/L Microgram per litter
11. U/L Unit per litter
12. % Percent
13. IU/ml International unit per millilitre
14. U/ml Unit per millilitre
15. mg/ml Milligram per millilitre
16. %GHB Glycohemoglobin
17. %Alc Hemoglobin A1C
18. nkat/L Nanokatal per liter
19. μkat/L Microkatal per liter

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 3 System Setup

Unit Full name

20. ng/L Nanograms per liter
21. nmol/L Nanomoles per liter
22. KU/L Kilo units per liter
23. N/A /

Decimal
Decimal specifies the number of decimal places for test results. The
decimal is allowed to be edited. Up to 3 decimal places can be set up and
respectively correspond to 0, 0.1, 0.01 and 0.001.

Blank Time and Reaction Time

Blank time refers to the period between dispensing of the second reactant
(reagent or sample) in reversed order and of the last reactant (reagent or
sample).
For endpoint analysis, the reaction time refers to the time span from the
start point of the reaction to the end point; for fixed-time and Kinetic
analysis, it refers to the period from reaction equilibrium to the end of
monitoring.
The blank time and reaction time are counted in measuring points.
Suppose the blank time range is N-P and the reaction time range is L-M.
The start point is the first measuring point after dispensing of R1.

Table 3.3 Blank time and reaction time input ranges for endpoint analysis
Endpoint Blank Time Reaction Time
When the blank absorbance is read before the reaction begins,
Single-reagent 5≤N≤P≤12 14≤L≤M≤82
Double-reagent 14≤N≤P≤49 51≤L≤M≤82
Triple-reagent 51≤N≤P≤90 104≤L≤M≤172
Quadruple-reagent 104≤N≤P≤139 141≤L≤M≤172
When the blank absorbance is read after the reaction begins,
Single-reagent 14≤N≤P P<L≤M≤82
Double-reagent 51≤N≤P P<L≤M≤82
Triple-reagent 104≤N≤P P<L≤M≤172
Quadruple-reagent 141≤N≤P P<L≤M≤172
When the blank absorbance is not subtracted,
Single-reagent N=P=0 14≤L≤M≤82
Double-reagent N=P=0 51≤L≤M≤82
Triple-reagent N=P=0 104≤L≤M≤172
Quadruple-reagent N=P=0 141≤L≤M≤172

Table 3.4 Blank time and reaction time input ranges for fixed-time and Kinetic
analysis
Fixed-time and Kinetic Blank Time Reaction Time

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Fixed-time and Kinetic Blank Time Reaction Time

When the blank absorbance is read before the reaction begins,
Single-reagent 5≤N<P≤12 14≤L<M≤82
Double-reagent 14≤N<P≤49 51≤L<M≤82
Triple-reagent 51≤N<P≤90 104≤L<M≤172
Quadruple-reagent 104≤N<P≤139 141≤L<M≤172
When the blank absorbance is not subtracted,
Single-reagent N=P=0 14≤L<M≤82
Double-reagent N=P=0 51≤L<M≤82
Triple-reagent N=P=0 104≤L<M≤172
Quadruple-reagent N=P=0 141≤L<M≤172

The blank time and reaction time are almost the same for both fixed-time
and Kinetic analysis, except that M-L≥2 is required for Kinetic analysis,
that is, the reaction time should include at least 3 measuring points.

Sample Volume, Standard, Aspirated, Diluent, Increased, and

Decreased
Sample volume is the standard sample amount, which should be
dispensed in a normal test. It ranges from 1.5μl to 45μl with an increment
of 0.1μl. The default is 1.5μl. A maximum of one decimal is allowed.
Aspirated volume refers to the amount of sample used for dilution at the
specified ratio. It ranges from 2μl to 45μl with an increment of 0.1μl. The
default is blank. A maximum of one decimal is allowed.
Diluent volume refers to the amount of diluent used for sample dilution. It
ranges from 120μl to 350μl with an increment of1μl. The default is blank.
A maximum of one decimal is allowed.

NOTE
If aspirated volume for dilution and diluent volume are defined, ensure the total sum
of them is within 120μl~360μl; otherwise, the settings cannot be saved.
The diluent volume for standard, increased and decreased analysis can be defined in
the same way.

Decreased sample volume indicates the sample amount required for a

decrement test. It ranges from 1.5μl to 45μl with an increment of 0.1μl.
The default is blank. A maximum of one decimal is allowed.
Increased sample volume indicates the sample amount required for an
increment test. It ranges from 1.5μl to 45μl with an increment of 0.1μl.
The default is blank. A maximum of one decimal is allowed.

NOTE
If aspirated volume for dilution and diluent volume are defined, standard, decreased
and increased analysis will be performed with diluted sampled; otherwise, it will be
done based on standard, decreased or increased sample volume.

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Sample Blank
Sample blank is similar to sample analysis except for use of equivalent
amount of physiological saline. Sample blank is used for removal of
non-chromogenesis reaction, such as influence of sample interference
(Hemolysis, icterus and lipemia) on absorbance readings.
The sample blank reaction curve is almost a straight line with slope of 0
during the reaction period, and therefore means nothing for fixed-time
and Kinetic analysis. For double, triple and quadruple reagent endpoint
analysis, the sample blank absorbance can be subtracted through
parameter settings. Therefore, sample blank is only effective for
single-reagent endpoint chemistries.
Mark the Sample Blank checkbox with a tick. The chemistry will be
sample blanked before the reaction begins.

Auto Rerun
The Auto Rerun option is used to rerun the chemistries when the auto
rerun conditions are satisfied.
Mark the Auto Rerun checkbox means enabling the auto rerun option.
For more information about auto rerun, refer to 8.2.4 Rerunning Samples
(page 8-4).

Reagent Volume and Diluent

Reagent volume specifies the reagent amount, which should be
dispensed for measurement. The system allows the dispensing of four
reagents: R1,R2,R3 and R4.
Reagent Reagent volume Diluent volume Reagent volume+
Diluent volume
Non-concentrated reagent
R1 120μl~350μl, with an 120μl~350μl
increment of 1μl none
R2 10μl~350μl, with an 10μl~350μl
increment of 1μl none
R3 10μl~350μl, with an 10μl~350μl
increment of 1μl none
R4 10μl~350μl, with an 10μl~350μl
increment of 1μl none
Concentrated reagent
R1 10μl~340μl, with an 10μl~340μl,with an 120μl~350μl
increment of 1μl increment of 1μl
R2 10μl~340μl, with an 10μl~340μl,with an 10μl~350μl
increment of 1μl increment of 1μl
R3 10μl~340μl, with an 10μl~340μl,with an 10μl~350μl
increment of 1μl increment of 1μl
R4 10μl~340μl, with an 10μl~340μl,with an 10μl~350μl
increment of 1μl increment of 1μl

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3 System Setup

The second, third and fourth reagents are allowed only when the
reagent(s) prior to them are configured. For example, R2 can be set up
with the prerequisite of R1; R3 with R1and R2; R4 with R1, R2 and R3. If
one of R2, R3 and R4 is removed, the remaining reagents behind it will
also be removed and appear in grey.
Diluent volume refers to the amount of diluent used for reagent dilution.
The combined volume of all reagents, reagent diluent and sample must
be within 120μl and 360μl. If your input does not satisfy the requirements
of reaction mixture volume, the system will display an error message.
Check the sample volume, reagent diluent and reagent volumes you have
entered, and change them if necessary.

3.2.4 Error Detection Limits

This section introduces the error detection limits for user-defined
chemistries. For more information about error detection limits, refer to 4
Operation Theories (4-1).
The error detection limits setup window is as shown below:
Figure 3.5 Error detection limits setup window

Linearity Range
The linearity range indicates the measurable range of the system, during
which the test result is linear to the response R. Determine the linearity
range according to the reagent package insert.
Linearity range(standard):-99999 to 999999. The lower limit less than or
equal to the higher limit. The default is blank.
Linearity range(increased):-99999 to 999999. The lower limit less than or
equal to the higher limit. The default is blank.

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Linearity range(decreased):-99999 to 999999. The lower limit less than or

equal to the higher limit. The default is blank.
The system compares the calculated sample concentration with the
linearity range. When the high limit is exceeded, the > sign will appear
near the result; when the low limit is exceeded, the < sign will appear. For
more information of result flags, refer to 17.4 Data Alarm (page 17-10).
The default is blank, which means not performing this check.

Linearity Limit
Linearity limit is only applicable to Kinetic analysis, in which the
absorbance change is linear to the reaction time. If the reagent undergoes
substrate depletion, or the photometer fluctuates, or the reaction mixture
is not stirred evenly, the test results may be unreliable. Therefore, the
linearity of the measuring period is calculated and then compared with
the set linearity limit.
If the reaction data within the linearity range does not satisfy the linearity
limit, the system will flag the test result with “LIN” on the patient report.
For more information of result flags, refer to 17.4 Data Alarm (page
17-10).
The linearity limit can be any number between 0 and 1 with a maximum of
2 decimals. The default is blank, which means not performing this check.

Substrate Depletion
The Substrate Depletion option is only applicable to Kinetic and
fixed-time analysis. It can be obtained through the following formula:
Substrate depletion limit = Input substrate depletion limit + K(L1-Lb)
Where,
 L1: refers to the absorbance of primary wavelength measured at the
first measuring point when sample is dispensed and stirred in sample
analysis.
 Lb: refers to the absorbance of primary wavelength measured at the
first measuring point when sample is dispensed and stirred in a
reagent blank test or calibration with 0-concentration calibrator.
 K: correction factor of liquid volume
Results will not be adjusted when L1-Lb≤0 or the measurement is not a
reagent blank or 0-concentration calibration. Substrate depletion is not
applicable for calibrations.
We deem that substrate depletion occurs if the primary wavelength
absorbance of the first measuring point is greater than the substrate
depletion limit in ascending reactions or lower than the substrate
depletion limit in descending reactions. When substrate depletion occurs,
the system will flag the test result with “BOE” in the patient report. For
more information of result flags, refer to 17.4 Data Alarm (page 17-10).
The substrate depletion limit can be any number within -33,000-33,000.
The default is blank, which means not performing this check.

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R1 Blank Absorbance Range

The R1 Blank Abs indicates the allowable range of the maximum
absorbance in the previous period prior to sample dispensing. The input
range must be within -33,000-33,000, and the low limit lower than the
high limit.
If the maximum absorbance in the previous period prior to sample
dispensing is beyond the set range, the system will flag the test result
with “RBK”.
The default is -33,000-33,000; the field can be left blank.

Mixed Blank Absorbance Range

The Mixed Blank Abs indicates the allowable range of the absorbance
measured at the end point of a zero-concentration calibrator reaction or a
reagent blank reaction. The input range must be within -33,000-33,000,
and the low limit lower than the high limit.
If the absorbance measured at the reaction end point is beyond the set
range, the system will flag the test result with “MBK”.
The default is -33,000-33,000; the field can be left blank.

Blank Response
The Blank Response specifies the allowable range of the response in a
zero-concentration calibrator analysis or a reagent blank test. The input
range can be any number within -33,000-33,000, and the low limit lower
than the high limit.
If the response is beyond the set range, the system will flag the test result
with “BLK”.
The default is -33,000-33,000; the field can be left blank.

Uncapping Time
The Uncapping Time refers to the number of days that the reagent can be
kept valid since uncapped at the first time.
The input range must be within 1-999 days. The default is blank.

Twin Chemistry
Twin Chemistry is associated with the current chemistry, and the two
chemistries are run with the same reagent. Results of two twin
chemistries are calculated in the same test.
The chemistry whose result will be firstly calculated should be defined
prior to the associated chemistry. Volume of the shared reagent and
sample volume must be the same for the two chemistries. Only the two
chemistries that have had no reagents loaded can be configured as twins.
For more information about twin chemistries, refer to “10.1 Twin
Chemistries” (Page 10-2).

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Reagent Alarm Limit

Set up the reagent alarm limit for the chemistry. The input range is 1-100,
and the default is 10. It can be left blank. When the number of chemistries
left is lower than the limit, an alarm will occur; if no alarm limit is defined,
the system will not give an alarm.
Only when sample type is Serum can reagent alarm limit be defined.

Enzyme Linear Extension

Linearity limit is only applicable to Kinetic analysis. Only when the
substrate depletion has been set up properly, this option is activated.
Select this option to enable enzyme linear extension function. For more
details, please refer to 4.5.6 Enzyme Linearity Range Extension.

Prozone Check
In the reaction of antigen and antibody, the amount of generated insoluble
compound is closely related to the proportion of antigen and antibody.
The maximum amount of compound will be generated at a proper
proportion of antigen and antibody, at this point least light is passed and
the greatest absorbance is obtained. For other proportions, the amount of
insoluble compound will decrease with more light passed and lower
absorbance calculated. Therefore, samples with quite different
concentrations may generate the equivalent amount of insoluble
antigen/antibody compound, and can have the same test results without
a Prozone check.
The Prozone check can be performed in two ways: rate check and antigen
addition.
 The rate check is based on the condition that the antibody excess
reaction rather than the antigen excess reaction can reach equilibrium
within the same specified period. This method is used for all
chemistries.
 With the antigen addition method, more antigens are added to the
finished reaction, and if the reaction does not continue, it indicates
antigen excess. This method is only applicable to single and double
reagent chemistries.
Rate check:
You are required to set up the following six parameters for the rate check
method, which are Q1, Q2, Q3, Q4, PC and ABS. The unit is the same as
the reaction time and blank time.
Enter the six parameters as follows:
 Single-reagent chemistries: 14≤q1 <q2< q3< q4≤82, “14” is the first
measuring point after the sample is dispensed and stirred.
 Double-reagent chemistries: 51≤q1 <q2< q3< q4≤82 “51” is the first
measuring point after R2 is dispensed and stirred.
 Triple-reagent chemistries: 104≤q1 <q2< q3< q4≤172,. “104” is the
first measuring point after R3 is dispensed and stirred.

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3 System Setup

 Quadruple-reagent chemistries: 141≤q1 <q2< q3< q4≤172,. “141” is

the first measuring point after R4 is dispensed and stirred.
 PC: a number between -99999999 and 99999999, with four decimals.
 ABS: any integer between -99999999 and 99999999.
Antigen addition:
For the antigen addition method, you need to enter the parameters, which
are PCM, Q1, Q2,Q3 and Q4.
When Q3=Q4=0, abslowlimit can not be entered.
 172≥q2≥104, 102≥q1≥reaction end point.
 If one parameter among PCM,Q1 and Q2 is not entered, the antigen
addition method is not applied.

3.2.5 Flag Qualitative Result

When the analyzer is in the status of standby, incubation, hibernation or
stop, you can flag the result of the chemistries qualitatively and the
results will be represented by a qualitative flag.
1 Select Utility-Chemistries.

2 Select a chemistry.
3 Select Define F1.
Figure 3.6 Define/edit chemistries

4 Select Qualitative F3.

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 3 System Setup
Figure 3.7 Qualitative result window

5 Select Use Qualitative Result.

6 Enter the qualitative range and flag.

For instance, type in “10” in the first edit box of the Range field, and
then enter “+” in the Flag field of the same row. If the chemistry result
(L1) contained in a sample is lower than 10, the “+” sign will be added
to the result in the patient report. Type in “20” in the second edit box
below the Range icon and “+-” in the second edit box below the Flag
icon. If the chemistry result (L2) is greater than 10 and lower than 20,
the result will be flagged with the “+-” sign. The cycle continues. If the
result is greater than L5, the six flag will appear on the patient report.
7 Select OK to save the setup.
Refer to these steps to flag the qualitative result of ISE chemistries
and calculations.

3.2.6 Slope and Offset Adjustment

The slope and offset are calculation factors that are used to compensate
the test results of a chemistry when the QC result of the chemistry is
slightly deviating.
When the measurement is finished, the system adjusts the test result
with the following equation:
y=kx+b
Where, x is the test result before adjustment, y is the result after
adjustment, k is the slope, and b is the offset.
Before setting up the calculating factors, make sure that you have
sufficient permissions and the system is not running tests.
1 Select Utility-Chemistries.

2 Select Slope/Offset F5.

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3 System Setup
Figure 3.8 Slope/Offset Adjustment window

3 Choose a chemistry.

4 Double click the Slope field and then input the slope.

Positive, negative and decimal numbers (-99999999~999999999) can

be entered. The maximum input length is 8 digits.
5 Double click the Offset field and then input the offset.

Positive, negative and decimal numbers (-99999999~999999999) can

be entered. The maximum input length is 8 digits.
6 Repeat step 3 to 5 to set up the slope and offset for other chemistries.

7 Select Save to save your input information.

8 To restore the factory settings of slope and offset, select Restore

Defaults.

9 Select Close the exit the window.

3.2.7 Reference/Critical Range Setup

The system allows the setup of reference/critical ranges for each
chemistry.
 Reference range indicates the allowable concentration range of a
normal sample.
 Critical range is the allowable result range from the perspective of
clinical diagnosis.
If a result is greater than the high limit of the reference range, ↑ will
appear near the result; if a result is less than the low limit of the reference

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 3 System Setup

range, ↓ will appear near the result. If a result is greater than the high
limit of the critical range, ↑! will appear near the result; if a result is less
than the low limit of the critical range, ↓! will appear near the result. You
may enable the auto rerun function for a chemistry, which will be rerun
automatically once the test result is beyond the critical range.
Prior to defining the reference/critical range, ensure that you have
sufficient permissions and the system status is not Running.

Defining/Editing reference/critical range

1 Select Utility-Chemistries.

2 Select Ref Range F4.

Figure 3.9 Reference/Critical Range Setup window

3 Choose a chemistry from the Chemistry pull-down list.

4 Choose a sample type for the reference and critical range.

5 Choose patient gender for the reference and critical range.

6 Enter the age range in the Age Range field.

 Enter the age low limit in the first edit box.

 Enter the age high limit in the second edit box.
 Choose an age unit from year, month, day and hour.
7 Enter the reference range.

 Enter the reference range low limit in the first edit box.
 Enter the reference range high limit in the second edit box.
 The maximum input length is 8 digits.
8 Enter the critical range.

 Enter the critical range low limit in the first edit box.

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3 System Setup

 Enter the critical range high limit in the second edit box.
 The maximum input length is 8 digits.
9 To rerun the ISE chemistry when its test result is beyond the critical
range, mark the Auto Rerun checkbox with a tick.

Biochemistries and user-defined calculations cannot be rerun. The

Auto Rerun checkbox will not appear if the current chemistry is a
biochemistry or a calculation.
For more information about auto rerun, refer to 8.2.4 Rerunning
Samples (page 8-4).
10 Select Save F7. The reference/critical range are displayed in the
middle list.

 Select Discard F6 to abort the input information, or

 Select Set Defaults F1 to set the reference/critical range as the
default for the chemistry.
11 Select Prev F4 or Next F5 to set up reference/critical range for more
chemistries.

12 Select Exit F8 to close the window.

Setting up default reference/critical range

You are allowed to select a default reference/critical range for a sample
type and gender. The default range appears in red. Only one default
reference/critical range is allowed for the same sample type and gender
of each chemistry.
1 Select Utility-Chemistries.

2 Select Ref Range F4.

3 Choose the chemistry name, sample type, gender and age range.

4 Choose a reference/critical range in the middle list.

5 Select Set Defaults F1.

The selected reference/critical range is set as the default of the

chemistry. The system will check the test result, and if necessary, flag
and rerun the chemistry. For details of reference range flags, refer to
Result display settings (page 3-4).
6 Select Exit F8 to close the window.

Deleting a reference/critical range

1 Select Utility-Chemistries.

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 3 System Setup

2 Select Ref Range F4.

3 Choose the chemistry name, sample type, gender and age range.

4 Choose a reference/critical range you want to remove.

5 Select Delete F2.

6 Select OK.

7 To clear all ranges of the chemistry, select Del All F3.

NOTE
The reference/critical range cannot be recovered once deleted. Think twice
before the deletion.
8 Select OK.

9 Select Exit F8 to close the window.

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3.3 Calibration Setup

3.3.1 Introduction
Perform calibration settings in the following order:
 Define a calibrator
 Set up calibrator concentrations
 Set up calibration rules
 Set up calibrator acceptance limits
You are allowed to add, edit and delete calibrators only when the system
status is not Running.

3.3.2 Defining a Calibrator

The system allows the definition of up to 99 calibrators. You are required
to input the name and position for each defined calibrator.
1 Select Reagent-Setup.

2 Select Define F1.

Figure 3.10 Calibrator Definition window

3 Enter the calibrator name with 1-10 characters.

4 Enter the expiration date of the calibrator. The default is the current
day in the next year.

Calibrators beyond the expiration date cannot be used.

5 Enter the lot number.

The input range is 0-18 and accepts numbers and letters. Calibrators
with the same name must not have the same lot number.
6 Assign positions for the calibrator.

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 3 System Setup

You are allowed to assign one position of each sample carousel for
the calibrator. The fourth ring (center) of the sample carousel is used
to carry calibrators and controls. You may also place the calibrator on
other idle positions of the sample carousel.
7 Select Save to save your input information.

8 To define more calibrators, repeat step 3 to 7.

9 Select Close to exit the window.

3.3.3 Importing a Calibrator

Calibrator parameters such as calibrator name, lot number, expiration
date, concentration of each chemistry and dilution parameter can be
imported.
1 Select Reagent-Setup.

2 Select Define F1.

Figure 3.11 Calibrator Definition window

3 Select Import and insert USB drive.

4 Select the path of .cif file.

Only .cif file can be imported; each .cif file stores information for one
calibrator and each time only one calibrator can be imported. When
the system reads the cabibrator information, the following window is
displayed:

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3 System Setup
Figure 3.12 Calibrator Definition window

5 Enter Lot No.

6 Select OK.

7 Assign positions for the calibrator.

8 Select Save to save your input information

9 Select Close to exit the window.

3.3.4 Editing a Calibrator

You are allowed to edit calibrators only when the system is not running
any tests. The default calibrator WATER (physiological saline) is placed in
position W (No.90) of the sample carousel. It is used for reagent blank
measurement and cannot be edited or deleted.
1 Select Reagent-Setup.

2 Choose a calibrator to edit and select Edit F2.

Figure 3.13 Calibrator Definition window

3 Edit the following calibrator information:

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 3 System Setup

 Calibrator name
 Expiration date
 Lot number
 Position
4 Select Save to save your input information.

5 Select Close to exit the window.

3.3.5 Setting up Calibrator Concentrations

You are required to set up calibrator concentrations for each chemistry
after defining the calibrator. Only the calibrator with positions assigned
and concentrations determined can be used for programming. You are
allowed to change the calibrator concentrations when the system is not
running any tests.
The default calibrator WATER has concentration of 0 for all chemistries. It
has no lot number and expiration date and must not be edited or
removed.
1 Select Reagent-Setup.
Figure 3.14 Calibrator concentration setup window

2 Choose a calibrator in the left list.

The chemistries configured for the calibrator are displayed in the right
list.
3 Choose chemistries to which the calibrator is applicable, and then
select the corresponding Conc column and type in the calibrator

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3 System Setup

concentration for it.

The concentration must be above 0.

4 Select the Unit from the dropdown box.

5 Select Save F8 to save your input information.

A message box pops up indicating that parameters are changed and

calibration is required.

3.3.6 Setting up Calibration Rules

You should set up the calibration rules after defining a calibrator and
determining concentrations for it. You are allowed to set up or edit the
calibration rules, replicates, K factor and auto calibration only when the
system is not running any tests.
1 Select Reagent-Setup.

2 Select Rules F4.

Figure 3.15 Calibration Setup window

3 Choose a chemistry from the Chem pull-down list.

4 Choose a calibration method in the Math Model field.

The options include:

 K factor
 Two-point linear
 Multi-point linear
 Logit-Log 4P
 Logit-Log 5P
 Exponential 5P

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 3 System Setup

 Polynomial 5P
 Parabola
 Spline
5 If you choose K Factor, type in the K factor in the Factor field.

This field is activated only when the one-point linear math model is
chosen. When the K factor is determined, the calibration results will
be calculated with the equation Y=K*X. Where, Y is the calibration
result, K is the factor, and X is the response. The K factor can be used
to calculate sample results without running a calibration.
6 Choose the number of replicates.

The input range is 1-5, and the default is 1.

7 If you want to run auto calibration, choose the conditions.

 When reagent bottle is changed;

 When reagent lot is change; or
 When the calibration time is exceeded.
For more information about auto calibration, refer to 6.5 Auto
Calibration (page 6-12).
8 Choose calibrators in the right list for the chemistry.

Up to 10 calibrators, including WATER, are allowed for each chemistry.

The correspondence between the number of calibrators and
calibration math model is shown in the table below.

Table 3.5 Correspondence between number of calibrators and calibration math

model
Calibration Math Model Number of Calibrators
K Factor N=0 or 1
Two-point linear N=2
Multi-point linear 2< N≤10
Logit-Log 4P 4≤N≤10
Logit-Log 5P 5≤N≤10
Exponential 5P 5≤N≤10
Polynomial 5P 5≤N≤10
Parabola 3≤N≤10
Spline 3≤N≤10
9 Select Save F7 to save your input information.

10 Select Prev F4 or Next F5 to set up the QC rules for other

chemistries.

11 Select Close F8 to close the window.

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3.3.7 Calibrator Acceptance Limits

The calibration results are compared with the determined acceptance
limits. If the calibration results exceed the acceptance limits, the system
will give an alarm and flag the results on calibration reports.
1 Select Reagent-Setup.

2 Select Rules F4.

3 Enter the following acceptance limits in the Acceptance Limits area.

Table 3.6 Calibration acceptance limits

Acceptance Limits Description
Calibration time The validity period indicates the number of days
that the calibration factors can be used. If the
validity period is exceeded, the system will give an
alarm.
The input range must be within 1-9999 hours. The
default is blank, which means the calibration factors
of the chemistry can be used all the time.
Slope difference The slope difference is applicable to linear
calibration only. It is the K factor (slope) difference
between two adjacent calibrations. The system will
give the flag “FAC” and an alarm when the slope
difference is exceeded.
Type in the percentage within 0-100. The default is
blank, which means not performing this check.
The slope difference is not applicable to K factor
calibration.
Standard deviation The standard deviation is used for multi-point linear
(SD) and non-linear calibrations. The system will give the
flag “CSD” and an alarm when the SD value is
exceeded.
The input range must be within 0-999. The default is
blank, which means not performing this check.
Sensitivity The sensitivity is the absolute response difference
between two calibrators with the maximum and
minimum concentration. The system will give the
flag “SEN” and an alarm when the sensitivity is
exceeded.
The input range must be within 0-33,000. The
default is blank, which means not performing this
check.
Repeatability The repeatability is the difference of the maximum
and minimum response of each calibrator. If the
calculated calibrator response difference is lower
than the set limit, the system will give the flag
“DUP” and an alarm.
The input range must be within 0-33,000. The
default is blank, which means not performing this
check.
Determination The determination coefficient is the fit degree of
coefficient the calibration curve. The system will give the flag

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 3 System Setup

Acceptance Limits Description

“DET” and an alarm when the calibration fit degree
is exceeded.
The input range must be within 0-1. The default is
blank, which means not performing this check.
4 Select Save F7 to save your input information.

5 Select Close F8 to close the window.

3.3.8 Deleting a Calibrator

You are allowed to remove the calibrators other than WATER. When a
calibrator is deleted, all calibration settings and its position are cleared,
and it cannot be used for programming. The stored test results of the
calibrator can be recalled according to the chemistry name. only
calibrators that are not requested or run can be deleted.
1 Select Reagent-Setup.

2 Choose a calibrator you want to remove.

3 Select Delete F6.

4 Select OK. The selected calibrator is deleted.

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3 System Setup

3.4 QC Setup
3.4.1 Introduction
Perform QC settings in the following order:
 Define a control
 Select chemistries
 Set up control concentrations
 Set up QC rules

3.4.2 Defining/Editing a Control

The system allows the definition of up to 99 controls. You are required to
enter the control name and sample type. The combination of control
name and lot number must not be duplicate and should be unique. If a
control has no lot number, you are not allowed to define another control
with the same name.
1 Select QC-Setup.

2 Select Define F1.

Figure 3.16 Define/Edit Controls window

3 Type in the control name.

4 Enter the control number.

The input range is 1-99.

5 Enter the lot number.

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 3 System Setup

The lot number can be composed of characters or numbers. The

combination of control name and lot number must not be duplicate.
6 Select a sample type from the Sample Type pull-down list.

The options include serum, plasma, urine, CSF and other. The default
is serum.
7 Select expiration date for the control.

When the expiration date is exceeded, the control can still be

programmed and analyzed, while the system flags the test result in
the Flag column to remind you of replacing the expired control.
8 Assign positions for the control.

You are allowed to assign one position of each sample carousel for
the control. The fourth ring (center) of the sample carousel is used to
carry calibrators and controls. You may also place the control on
other idle positions of the sample carousel.
9 Select OK to save your input information.

10 To define more controls, select New and repeat step 3 to 9.

11 Select Exit to exit the window.

3.4.3 Selection of Chemistries

After defining a control, you need to select chemistries for which the
control will be used. When selecting chemistries, make sure that the
system status is Incubation, Standby, Stop or Sleep, and the control
status is not Programmed or Incomplete.
1 Select QC-Setup.

2 Choose a control in the left list.

3 Select Chems F2.

Figure 3.17 Chemistries window

3-39
3 System Setup

4 Choose chemistries for the control. Use the right-arrow button to

display more chemistries.

5 To choose all chemistries in the list, select Select All.

6 To deselect the chemistries, select Clear.

7 Select OK.

3.4.4 Setting up Control Concentrations

You are required to set up the average concentrations and SDs of a
control for each chemistry after defining the control and choosing
chemistries. Only the control with positions assigned and concentrations
determined can be used for programming.
To run quality control for special calibrations, you must define the mean
value and SD; otherwise, no control results will be calculated. If the sub
chemistries of a special calculation have no mean value and SD, QC
evaluation will not be done and QC plot cannot be recalled.
1 Select QC-Setup.
Figure 3.18 Setup screen

2 Choose a control in the left list.

The chemistries configured for the control are displayed in the right
list.
3 Select the Mean column of a chemistry and type in the average
concentration for it.

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 3 System Setup

The concentration must be above 0 with no more than 8 digits.

4 Select the SD column of a chemistry and type in the standard
deviation for it.

The SD must be above 0 with no more than 8 digits.

5 Select Unit from the dropdown box.

6 Select Save F8 to save your input information.

3.4.5 Setting up QC Rules

You should set up the control rules after defining a control and
determining concentrations for it. The controls without QC rule can still
be programmed and analyzed but will not be monitored for error detection.
You are allowed to change the QC rules when the system is not running
any tests.
1 Select QC-Setup.

2 Select Rules F3. The QC Rules Setup window is displayed.

Figure 3.19 QC Rules Setup window

3 Choose a chemistry from the Chem list.

4 Choose QC rules in the Westgard Rules area.

5 If you assign a couple of controls for the chemistry, you are allowed to
enable the Two-Control Evaluation option.

Those controls not contained in the two-control evaluation will be

monitored according the Westgard rules.
6 Select the first control in the Control(X) field.

7 Select the second control in the Control(Y) field.

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3 System Setup

8 Select OK to save your input information.

9 Repeat step 3 to 8 to set up quality control rules for other chemistries.

10 Select Exit to exit the window.

3.4.6 Deleting a Control

You are allowed to change the control concentrations when the system is
not running any tests. When a control is deleted, the control information,
concentration parameters and QC results as well as the control position
are cleared. If the deleted control is included in the two-control evaluation,
the relevant two-control evaluation will be disabled. Those controls
programmed for analysis cannot be deleted.
1 Select QC-Setup.

2 Choose a control in the left list.

3 Select Delete F6.

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 4 Operation Theories

This chapter gives brief introduction of the operation theories of the

instrument, which include:
 Principles of measurement
 Calibration math model and calculation of factors
 Prozone check

4-1
4 Operation Theories

4.1 Overview
The system is a fully automated computer-controlled clinical chemistry
analyzer allowing the random selection of chemistries. It is capable of
running a variety of chemistries based on the operation theories and
measurement principles.
The system performs measurement and generates the test results in the
following procedure:
Figure 4.1 Measurement workflow

AD value

Absorbance

Response

Calibration factors

Sample QC result
result
QC conclusion

The system measures the light intensity through photoelectric conversion,

linear amplification and AD conversion, and then calculates the reaction
mixture’s absorbance and the absorbance change rate, that is, the
response, based on which the calibration factors are obtained. The
system performance is evaluated according to the test results of the
control samples. If the system is working normally, you may start the
analysis of patient samples and the system will calculate the sample
results with the calibration factors.

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 4 Operation Theories

4.2 Principles of Measurement

4.2.1 Introduction
The system performs measurement with the following principles:
 Endpoint
 Fixed-time
 Kinetic
In the description of the following sections, N and P indicate the blank
read time range, L and M indicate the reaction read time range. In
double-wavelength measurements, absorbance A is the absorbance
difference between the primary and secondary wavelengths; in
single-wavelength measurements, absorbance A is the absorbance
measured at the primary wavelength.

4-3
4 Operation Theories

4.3 Endpoint Measurements

4.3.1 Introduction
In endpoint measurements, the reaction reaches equilibrium after a
period of time. Since the equilibrium constant is quite high, it can be
considered that all substrates (analytes) have changed into products, and
the absorbance of the reactant will not change any more. The absorbance
change is directly proportional to the analytes’ concentration. The
endpoint method, also called equilibrium method, is most ideal for
measurements.
The endpoint reaction is insensitive to minor changes in such conditions
as the enzyme volume, pH value and temperature, provided the changes
are not significant enough to affect the reaction time.

4.3.2 Calculation of Reaction Absorbance

Set up the reaction time range by understanding the following
instructions:
 If L=M, that is, [M] and [M] are entered for the reaction time range, one
measuring point will be used for absorbance calculation, and the
reaction absorbance will be the absorbance measured at point M, i.e.
Ai=AM.
 If L=M-1, that is, [M-1] and [M] are entered for the reaction time range,
two measuring points will be used for absorbance calculation, and the
reaction absorbance will be the average of the absorbance measured
A  AM 1
at the two points, i.e. Ai= M .
2
 If L=M-2, that is, [M-2] and [M] are entered for the reaction time range,
three measuring points will be used for absorbance calculation, and
the reaction absorbance will be the mediate absorbance measured at
the three points, while the maximum and minimum absorbance is
removed.
 If M>L+2, the reaction absorbance will be the average of the
remaining absorbance when the maximum and minimum absorbance
is removed.

4.3.3 Calculation of Blank Absorbance

The blank absorbance Ab is calculated in the same way as the reaction
absorbance Ai.
When N=P=0, the blank absorbance Ab will not be calculated.

4.3.4 Calculation of K Factor

The system provides four K factors for result calculation, which are
expressed through the following equations:

4-4
 4 Operation Theories

VR1
 k1 
VR1  VS
VR1  VS
 k2 
VR1  VS  VR 2
VR1  VS  VR 2
 k3 
VR1  VS  VR 2  VR 3
VR1  VS  VR 2  VR 3
 k4 
VR1  VS  VR 2  VR 3  VR 4
Where, VR1, VR2, VR3 and VR4 are the volumes of R1, R2, R3 and R4; V s is the
actual volume of sample dispensed for reaction.

4.3.5 Calculation of Response

The response in endpoint measurements is calculated as follows:
R  Ai  k  Ab
k is the calculation factor and varies with the chemistry parameters.

Table 4.1 Calculation of response for endpoint measurements

Endpoint Blank Time Reaction Time K Factor
When the blank absorbance is read before the reaction begins,
Single-reagent 5≤N≤P≤12 14≤L≤M≤82 K1
Double-reagent 14≤N≤P≤49 51≤L≤M≤82 K2
Triple-reagent 51≤N≤P≤90 104≤L≤M≤172 K3
Quadruple-reagent 104≤N≤P≤139 141≤L≤M≤172 K4
When the blank absorbance is read after the reaction begins,
Single-reagent 14≤N≤P P<L≤M≤82 1
Double-reagent 51≤N≤P P<L≤M≤82 1
Triple-reagent 104≤N≤P P<L≤M≤172 1
Quadruple-reagent 141≤N≤P P<L≤M≤172 1
When the blank absorbance is not subtracted,
Single-reagent N=P=0 14≤L≤M≤82 0
Double-reagent N=P=0 51≤L≤M≤82 0
Triple-reagent N=P=0 104≤L≤M≤172 0
Quadruple-reagent N=P=0 141≤L≤M≤172 0

4.3.6 Sample Blanked Response

Sample blank is used for removal of non-chromogenesis reaction, such
as influence of sample interference (Hemolysis, icterus and lipemia) on
absorbance readings. The sample blank reaction curve is almost a
straight line with slope of 0 during the reaction period, and therefore
means nothing for fixed-time and Kinetic analysis.
In single-reagent endpoint measurements, the response of the sample
Rsb  Ai  k  Ab
blank test is , and the sample blanked response is

4-5
4 Operation Theories

R '  R  RSb
.

4-6
 4 Operation Theories

4.4 Fixed-time Measurements

4.4.1 Introduction
In fixed-time measurements, namely, rate measurements, the reaction
velocity (v) is directly proportional to the substrate concentration [S]
within a specific period, that is, v=k[S]. As the substrate is consumed
continuously, the reaction velocity is decreasing gradually, and so is the
absorbance change rate. It takes a long time for the reaction to reach
equilibrium. Theoretically, the absorbance reading can be taken at any
time. The reaction can, however, become steady only after a lag because
it is complicated at the beginning and there are miscellaneous reactions
due to complex serum compositions.
For any rate measurements, the substrate concentration [S] at a given
point t since the reaction begins is obtained through the following
formula:
S   S 0  e  kt
Where,
 S0: the initial substrate concentration
 e: base of the natural log
 k: velocity constant
The change of substrate concentration Δ[S] over a fixed time interval, t1
to t 2 , is related to [S0] by the following equation:

 [ S ]
[ S 0]   kt1  kt 2
e e

That is, the change in substrate concentration is directly proportional to

its initial concentration within a fixed time interval. This is the common
feature of rate measurements. Within this interval, the absorbance
change is directly proportional to the analytes concentration. The
fixed-time reaction is also called, rate reaction, first-order Kinetic reaction
and two-point Kinetic reaction.
It is available in single-interval and double-interval according to the input
mode of measuring points. In the double-interval reaction, the sample
blank, which is the absorbance change at two points within the
incubation time, is subtracted from the reaction absorbance.
The fixed-time measurements allow the check of substrate depletion at
the two measuring points. When detecting substrate depletion, the
system will flag the test result with “BOE” and give an alarm.

4.4.2 Calculation of Response

The response in fixed-time measurements is calculated as follows:

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4 Operation Theories

AM  AL A  AN
R  60*( k P )
tM  t L tP  tN
k is the calculation factor and varies with the chemistry parameters.

Table 4.2 Calculation of response for fixed-time measurements

Fixed-time Blank Time Reaction Time K Factor
When the blank absorbance is read before the reaction begins,
Single-reagent 5≤N<P≤12 14≤L<M≤82 K1
Double-reagent 14≤N<P≤49 51≤L<M≤82 K2
Triple-reagent 51≤N<P≤90 104≤L<M≤172 K3
Quadruple-reag 104≤N<P≤139 141≤L<M≤172 K4
ent
When the blank absorbance is not subtracted,
Single-reagent N=P=0 14≤L<M≤82 0
Double-reagent N=P=0 51≤L<M≤82 0
Triple-reagent N=P=0 104≤L<M≤172 0
Quadruple-reag N=P=0 141≤L<M≤172 0
ent

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 4 Operation Theories

4.5 Kinetic Measurements

4.5.1 Introduction
In Kinetic measurements, namely, zero-order Kinetic measurements or
continuous-monitoring measurements, the reaction velocity is not related
to substrate concentration and remains constant during the reaction
process. As a result, the analytes absorbance changes evenly at a given
wavelength, and the change rate (A/min) is directly proportional to the
activity or concentration of the analytes. The Kinetic method is usually
used to measure enzyme activity.
In fact, it is impossible for the substrate concentration to be absolutely
high, and the reaction will be no longer a zero-order reaction when the
substrate is consumed to certain degree. Therefore, the reaction type only
stands within certain reaction period. In addition, the reaction can
become steady only after a period of time, because the reaction is
complicated at the beginning and there are miscellaneous reactions due
to complex serum compositions.
In Kinetic reaction, the concentration or activity is obtained according to
the absorbance change among specified measuring points.

4.5.2 Data Calculation in Kinetic Measurements

Figure 4.2 Data calculation flow of Kinetic measurements

Determination of linearity
range

Calculate response with the

least square method

Evaluation for linearity

4.5.3 Determination of Linearity Range

The absorbance linearity range is determined based on the substrate
depletion limit, and checked within the reaction time rather than the blank
time.

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4 Operation Theories
Figure 4.3 Determination of linearity range for Kinetic measurements

Enter L and M

Enter substrate
depletion limit?
No

Yes

Yes
Substrate depleted Alarm of "NLN"
at L+2

No

Find M′ without substrate depletion

Yes
Substrate depleted at within M and the reaction start
M reading point

No

Linearity range is L-M Linearity range is L-M′

The number (N) of measuring points within the substrate depletion limit
is monitored for different operations:
 If N≥3, the linearity range includes all measuring points from the
reaction start point to the substrate depletion limit;
 If N=2, the system will give the flag “NLN” while using two measuring
points for calculating the response.
 If N=0 or 1, when Enzyme Linear Extension option is selected on the
chemistry parameter screen, enzyme linear extension will be enabled
and the system gives the flag “NLN”; when Enzyme Linear Extension
option is not selected on the chemistry parameter screen, enzyme
linear extension will not be enabled and the system gives the flag
“NLN” too.

4.5.4 Calculation of Response

Absorbance change rate ⊿ALM’ within the reaction time
The response ⊿ALM’ within L-M’ is calculated with the least square
method.
M'

 (T  T )  ( A  A)
i i
A LM'  60 * i  L M'

 (T  T )
iL
i
2

Where,
 L: start point of the linearity range
 M’: end point of the linearity range

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 4 Operation Theories

 Ai: absorbance measured at measuring point i

 A : average absorbance within L-M’
 Ti: actual measuring time (second) at measuring point i
 T : average measuring time within L-M
If there are less than two measuring points without substrate depletion
within the reaction time, the system will calculate the absorbance change
rate by extending the enzyme linearity range.

Absorbance change rate ⊿ANP within the blank time

The absorbance change rate ⊿ANP within the blank time is calculated
with the same equation as ⊿ALM’.
If N=P=0, the absorbance change rate within the blank time is 0.

Calculation of Response
The response in Kinetic measurements is calculated as follows:
R  ALM'  K  A NP
k is the calculation factor and varies with the chemistry parameters.

Table 4.3 Calculation of response for Kinetic measurements

Kinetic Blank Time Reaction Time K
When the blank absorbance is read before the reaction begins,
Single-reagent 5≤N<P≤12 14≤L<M≤82 K1
Double-reagent 14≤N<P≤49 51≤L<M≤82 K2
Triple-reagent 51≤N<P≤90 104≤L<M≤172 K3
Quadruple-reagent 104≤N<P≤139 141≤L<M≤172 K4
When the blank absorbance is not subtracted,
Single-reagent N=P=0 14≤L<M≤82 0
Double-reagent N=P=0 51≤L<M≤82 0
Triple-reagent N=P=0 104≤L<M≤172 0
Quadruple-reagent N=P=0 141≤L<M≤172 0

Note: M-L≥2 indicates that at least 3 measuring points should be

included within the reaction time.

4.5.5 Evaluation for Linearity

Af  Ab
Linearity= 100  Linearity Limit
Au ,v

Where, A f , Ab and Au ,v are the absorbance change rates in the
front part, back part and at all measuring points of the reaction. These
three values are calculated based on the number of measuring points
within the linearity range.

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4 Operation Theories

 When N>8, A f is the absorbance change rate of the first 6

measuring points, Ab of the last 6 measuring points, and Au ,v of
all measuring points.
 When 4  N  8 , A f is the absorbance change rate of the first 3
measuring points, Ab of the last 3 measuring points, and Au ,v of
all measuring points.
 When N  3, the system will not check the test results for linearity.
A f  Ab Au ,v
 When  60 or  60 (unit: A/10000/minute), the
system will not check the test results for linearity.
The system will compare the calculated linearity with that defined for the
chemistry, and will flag the test result with “LIN” and given an alarm if the
configured linearity is exceeded.

4.5.6 Enzyme Linearity Range Extension

Figure 4.4 Reaction curve with extended enzyme linearity range

Lag time
Reaction Time

Absorbance

Substrate depletion mark

Substrate depleted

Absorbance read time

4-12
 4 Operation Theories

In high-activity enzyme measurements, the substrate may be depleted

quickly and the reaction curve will appear obviously nonlinear (as a
smooth curve). If the measurement is performed based on the general
procedure, the system will flag the test result with “NLN” (no linearity
interval), reminding the user to rerun the test after diluting the sample.
This will more or less bring troubles to the user.
Extending enzyme linearity range:
Suppose the reaction start time is t1 and the reaction time is tL-tM, then
t1-tL is the lag time.
If the number (N) of valid measuring points within tL-tM is less than 2
and too few to calculate the response, the sample response can be
obtained by extending the enzyme linearity range.
Calculation of ⊿Amax:
The linearity range t1-tL’ without substrate depletion is found within the
lag time t1-tL.
If the number (N) of valid measuring points within tL-tM is less than 2, the
system will not calculate the response but flag the test result with “ENC”
(no calculation interval) and give an alarm;
or the system calculates the reaction rate ⊿A=60*(Ai+1-Ai)/(ti+1-ti), i=1,
2…L’ with the lag time t1-tL’. The maximum ⊿A is taken as the response
of the sample. Therefore, the enzyme linearity range is extended via the
lag time. The results calculated by extending the enzyme linearity range
will be flagged with “EXP” and “NLN”.

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4 Operation Theories

4.6 Calibration Math Model and Factors

The system provides linear and non-linear math models. The former is
used for Colorimetry chemistries and the later for turbidity chemistries.
In this section,
 R: calibrator response
 C: calibrator concentration (or internal converting concentration in
non-linear calibrations)
 K, R0, a, b, c and d: calibration factors

4.6.1 Linear Calibrations

Single-point linear calibration
The single-point linear calibration is also called the K factor method.
Calculation formula: C  K  ( R  R0 )
Where, K is the user-defined K factor, R0 is the reagent blank response of
the first calibrator. If the chemistry is not reagent blanked, R 0=0.
Please note that the R and R0 must be divided by 10,000.

Two-point linear calibration

Calculation formula: C  K  ( R  R 0 )
C 2  C1
The formula contains two factors, K and R 0, where K  , and
R2  R1
C1
R0  R1  .
K
The calibration math model requires two calibrators. C1 and C2 are the
concentrations of calibrator 1 and 2; R 1 and R2 are the responses of
calibrator 1 and 2.

Multi-point linear calibration

C  K  (R R 0 )
Calculation formula:
The formula contains two factors, K and R0. The calibration math model
requires n(n≥3) calibrators. Ci is the concentration of calibrator i. Ri is the
response of calibrator i. K and R0 can be calculated with the least square
method:
n n n

 CiRi  ( Ci)( Ri ) / n
K i 1
n
i 1
n
i 1

 Ri
i 1
2
 ( Ri ) 2 / n
i 1

4-14
 4 Operation Theories
n

n
( Ci) / n
R0  ( Ri ) / n  i 1

i 1 K

4.6.2 Non-Linear Calibrations

Logit–Log 4P
1
Calculation formula: R  R0  K
1  exp[ (a  b ln C )]
The formula contains four factors, which are R 0, K, a and b.
The calibration math model requires at least four calibrators. The four
factors can be calculated with the L-M method.
This calibration type is applied to the chemistries which have a
calibration curve with the response reversely proportional to the
concentration.

Logit–Log 5P
1
R  R0  K
Calculation formula: 1  exp[ (a  b ln C  cC )]

The formula contains five factors, which are R 0, K, a, b and c. The

calibration math model requires at least five calibrators, and calculates
the five factors with the L-M method.
This math model has the same application with the Logit-Log 4P except
for a higher fitting.

Exponential 5P
R  R0  K exp[ a ln C  b(ln C ) 2  c(ln C ) 3 ]
Calculation formula:
The formula contains five factors, which are R 0, K, a, b and c. The
calibration math model requires at least five calibrators, and calculates
the five factors with the L-M method.
This calibration type is applied to the chemistries which have a
calibration curve with the response directly proportional to the
concentration.

Polynomial 5P
R  R0 R  R0 2 R  R0 3
ln C  a  b( )  c( )  d( )
Calculation formula: 100 100 100
The formula contains five factors, which are R0, a, b, c and d. The
calibration math model requires at least five calibrators. The response (R)
of the first calibrator (with internal converting concentration of 0) is R0,
which is given.
R  R0
x
Suppose, y  ln C and 100 .

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4 Operation Theories

Then, y  a  bx  cx  dx can be calculated with the least square

2 3

method for polynomial expressions.

Parabola
R  aC 2  bC  R0
Calculation formula:
The formula contains three factors, which are a, b and R 0. The calibration
math model requires at least three calibrators. The three factors can be
calculated with the least square method.

Spline
R  R0i  ai (C  Ci )  bi (C  Ci ) 2  ci (C  Ci ) 3
Calculation formula:
The calibration math model requires 2-9 calibrators. Suppose the number
of calibrators is n, then the calculation formula contains 4(n-1) factors,
which are R0 i , ai , bi , and c i . Due to the subsection fitting, this math
model has be best fit curves than other math models.

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 4 Operation Theories

4.7 Prozone Check

4.7.1 Introduction
Figure 4.5 Reaction curve of antigen and antibody
Prozone Equivalent Postzone
Response R

(antibody excess) zone (antigen excess)

Concentration C

In the reaction of antigen and antibody, the amount of generated insoluble

compound is closely related to the proportion of antigen and antibody.
The maximum amount of compound will be generated at a proper
proportion of antigen and antibody, at this point least light is passed and
the greatest absorbance is obtained. For other proportions, the amount of
insoluble compound will decrease with more light passed and lower
absorbance calculated. Therefore, samples with quite different
concentrations may generate the equivalent amount of insoluble
antigen/antibody compound, and can have the same test results without
a Prozone check. The Prozone check, therefore, is necessary for
antigen-antibody reactions.
The Prozone limit is the allowable maximum or minimum PC when
antigen excess does not happen.
The Prozone check factors include:
 PCM (Prozone check limit), q1, q2, q3 and q4.
 Absorbance low limit: ABS
The Prozone check can be performed in two ways: rate check and antigen
addition, which are described in detail in the following sections.

4.7.2 Antigen Addition Method

Antigen excess can be detected by further addition of antigen. When
enough antibodies are provided, the antigen reacts with them in reaction
medium and forms into stable compound particles, thus producing
dispersed light, which increases dynamically with compound amount

4-17
4 Operation Theories

increased and reaction time extended (antibody excess). If the antibody

keeps excess in specified period, it will continue to react with further
added antigen, and the reaction will increase accordingly. If the antigen is
excessive before further addition, the reaction will decrease. The antigen
addition method is applicable to both single-/double-reagent
chemistries.
Enter the Prozone check factors as follows:
 PCM (Prozone check limit), q1 and q2.
 If the absorbance low limit ABS appears in grey, that is q3=q4=0, it
cannot be set up.
 172≥q2≥104, 102≥q1≥Reaction end point.
If one of PCM, q1 and q2 is not input, the system will not check the
antigen.
 Sample PC=Aq2-k× Aq1.
 k is the calculation factor.
 For single-reagent chemistries: k=(VR1+VS)/(VR1+2VS).
 For double-reagent chemistries:
k=(VR1+VS+VR2)/(VR1+2VS+VR2).
The system will flag the test result with “PRO” (Prozone check abnormal)
and give an alarm if PC<PCM in positive reactions or PC>PCM in negative
reactions.

4.7.3 Reaction Rate Method

The rate check is based on the condition that the antibody excess
reaction rather than the antigen excess reaction can reach equilibrium
within the same specified period. Enter the Prozone check factors as
follows:
 PCM (Prozone check limit), q1, q2, q3 and q4.
 Absorbance low limit: ABS
Aq 4  Aq 3
q 4  q3
 Sample PC: PC  . If PC>PCM, the system will flag the test
Aq 2  Aq1
q 2  q1
result with “PRO” and give an alarm.
Enter the measuring points as follows:
 Single-reagent chemistries: 14≤q1<q2<q3<q4≤82, “14” is the first
measuring point after the sample is dispensed and stirred.
 Double-reagent chemistries: 51≤q1<q2<q3<q4≤82. “51” is the first
measuring point after R2 is dispensed and stirred.
 Triple-reagent chemistries: 104≤q1<q2<q3<q4≤172. “104” is the first
measuring point after R3 is dispensed and stirred.

4-18
 4 Operation Theories

 Quadruple-reagent chemistries: 141≤q1<q2<q3<q4≤172. “141” is the

first measuring point after R4 is dispensed and stirred.
If one of PCM, q1, q2, q3 and q4 is not input, the system will not check the
reaction rate.
Prozone check will be disabled if:
 (Reaction end point absorbance – Reaction start point absorbance)
<ABS
 The sample response is not within the calibrator response range for
sample and control analysis of non-linear chemistries.

4-19
4 Operation Theories

4-20
BS-480

Chemistry Analyzer

Operator’s Manual
Advanced Volume
 Contents

Publication Information ................................................................................................... ii

Intellectual Property Statement ..................................................................................... iii
Responsibility on the Manufacturer Party .................................................................... iv
Warranty ............................................................................................................................ v
Exemptions ............................................................................................................ v
Customer service department ............................................................................. v
EC - Representative .............................................................................................. v
Preface ··································································································vi
Safety Information ·····················································································1
Safety Symbols ................................................................................................................. 2
Summary of Hazards ....................................................................................................... 3
Introduction ........................................................................................................... 3
Electric Shock Hazards......................................................................................... 3
Moving Parts Hazards .......................................................................................... 3
Photometer Lamp Hazards .................................................................................. 3
Laser Beam Hazards ............................................................................................ 4
Sample, Calibrator and Control Hazards ............................................................ 4
Reagent and Wash Solution Hazards ................................................................. 4
Waste Hazards ...................................................................................................... 4
System Disposal Hazards .................................................................................... 4
Fire and Explosion Hazards ................................................................................. 5
Removal of Analyzer from Use for Repair or Disposal ...................................... 5
Software and Cybersecurity ................................................................................. 5
Notification of Adverse Events ............................................................................ 5
Precautions on Use .......................................................................................................... 6
Introduction ........................................................................................................... 6
Intended Use.......................................................................................................... 6
Environment Precautions ..................................................................................... 6
Installation Precautions ....................................................................................... 6

I
Contents – Advanced Volume
Electromagnetic Noise Precautions .................................................................... 6
Operating Precautions .......................................................................................... 7
Maintenance and Servicing Precautions ............................................................ 8
Chemistry Parameter Configuration Precautions.............................................. 8
ISE Module Precautions ....................................................................................... 8
Sample Precautions .............................................................................................. 8
Reagent, Calibrator and Control Precautions ..................................................... 9
Data Archiving Precautions ................................................................................. 9
External Equipment Precautions ......................................................................... 9
External Vacuum Pump Precautions ................................................................ 10
Tube and Liquid Container Precautions ........................................................... 10
Cleaning and Decontamination ......................................................................... 10
Labels and Silkscreen .................................................................................................... 12
Introduction ......................................................................................................... 12
Non-Warning Labels and Silkscreen ................................................................. 13
Warning Labels .................................................................................................... 15
Contents ·································································································· I
1 System Description ···············································································1-1
1.1 Installation Requirements and Procedure ........................................................... 1-2
1.1.1 Installation Requirements ...................................................................... 1-2
1.1.2 Installation Procedure ............................................................................. 1-6
1.2 Hardware Structure ................................................................................................ 1-8
1.2.1 System Overview ..................................................................................... 1-8
1.2.2 Sample Handling System ..................................................................... 1-10
1.2.3 Reagent Handling System .................................................................... 1-13
1.2.4 Reaction System .................................................................................... 1-16
1.2.5 Cuvette Wash Station ............................................................................ 1-17
1.2.6 Photometric System .............................................................................. 1-18
1.2.7 Mixer Assembly ..................................................................................... 1-19
1.2.8 Operation Unit ........................................................................................ 1-20
1.2.9 Output Unit ............................................................................................. 1-20
1.2.10 Accessories and Consumables.......................................................... 1-20
1.3 Optional Modules ................................................................................................. 1-21
1.3.1 Introduction ............................................................................................ 1-21
1.3.2 ISE Module ............................................................................................. 1-21
1.3.3 Built-in Sample Bar Code Reader ........................................................ 1-21
1.3.4 Built-in Reagent Bar Code Reader ....................................................... 1-22
1.3.5 Water Supply Module ............................................................................ 1-23
1.3.6 Drainage Module ................................................................................... 1-24
1.3.7 External Vacuum Pump......................................................................... 1-25
1.3.8 Other Optional Modules ........................................................................ 1-26

II
 Contents – Advanced Volume

1.4 Software Description ........................................................................................... 1-28

1.4.1 Main Screen ........................................................................................... 1-28
1.4.2 Using a Mouse ....................................................................................... 1-31
1.4.3 Using Online Help .................................................................................. 1-31
1.5 System Specifications ......................................................................................... 1-35
1.5.1 Technical Parameters ........................................................................... 1-35
1.5.2 Main Performance Indices.................................................................... 1-38
1.5.3 Contraindication .................................................................................... 1-40
1.5.4 Power supply ......................................................................................... 1-40
1.5.5 Environmental Requirements ............................................................... 1-40
1.5.6 Dimensions and Weight ........................................................................ 1-40
1.5.7 Input Device ........................................................................................... 1-40
1.5.8 Output Device......................................................................................... 1-40
1.5.9 Noise and Fuse ...................................................................................... 1-41
1.5.10 Communication Interfaces ................................................................. 1-41
1.5.11 Safety Classification ........................................................................... 1-41
1.5.12 EMC Requirements .............................................................................. 1-42
2 General Operating Procedure ··································································2-1
2.1 General Operating Procedure ................................................................................ 2-2
2.2 Check before Powering On .................................................................................... 2-3
2.2.1 Checking Water Supply ........................................................................... 2-3
2.2.2 Checking Power Supply .......................................................................... 2-3
2.2.3 Checking Printing Paper ......................................................................... 2-3
2.2.4 Checking Waste Tanks and Tubing ........................................................ 2-3
2.2.5 Checking Probes and Mixers .................................................................. 2-4
2.2.6 Checking Concentrated Wash Solution ................................................. 2-4
2.3 Powering On............................................................................................................ 2-6
2.3.1 Turning On Water Supply, Water Supply Module and Drainage Module2-6
2.3.2 Powering On the System ........................................................................ 2-6
2.3.3 Starting the Operating Software ............................................................ 2-7
2.4 Checking System Status ....................................................................................... 2-9
2.4.1 Checking System Status ......................................................................... 2-9
2.4.2 Checking Alarm Status ........................................................................... 2-9
2.4.3 Checking Reagent/Calibration Status ................................................. 2-10
2.4.4 Checking Maintenance Status ............................................................. 2-11
2.4.5 Checking Subsystems........................................................................... 2-12
2.5 Preparing Reagents.............................................................................................. 2-15
2.5.1 Loading Biochemical Reagents ........................................................... 2-15
2.5.2 Loading Concentrated Wash Solution ................................................. 2-19
2.5.3 Loading Reagent Probe Wash Solution ............................................... 2-20
2.5.4 Loading Sample Probe Wash Solution ................................................ 2-22

III
Contents – Advanced Volume
2.5.5 Loading Physiological Saline ............................................................... 2-22
2.6 Calibration ............................................................................................................. 2-25
2.6.1 Requesting Calibrations........................................................................ 2-25
2.6.2 Loading Calibrators ............................................................................... 2-28
2.6.3 Running Calibrations ............................................................................. 2-29
2.7 Quality Control ...................................................................................................... 2-30
2.7.1 Programming Control Samples ............................................................ 2-30
2.7.2 Loading Control Samples ..................................................................... 2-31
2.7.3 Running Control Samples ..................................................................... 2-32
2.7.4 Auto quality control ............................................................................... 2-32
2.8 Programming Routine Samples .......................................................................... 2-34
2.8.1 Programming Routine Samples ........................................................... 2-34
2.8.2 Loading Routine Samples ..................................................................... 2-40
2.8.3 Running Routine Samples .................................................................... 2-41
2.9 Programming STAT Samples .............................................................................. 2-42
2.9.1 Programming STAT Samples ............................................................... 2-42
2.9.2 Starting Analysis ................................................................................... 2-46
2.10 Test Status and Emergency Stop ..................................................................... 2-47
2.10.1 Checking Reagent Status ................................................................... 2-47
2.10.2 Viewing Test Status ............................................................................ 2-48
2.10.3 Viewing Reagent Carousel Status ..................................................... 2-50
2.10.4 Emergency Stop................................................................................... 2-51
2.11 Daily Maintenance ............................................................................................. 2-52
2.12 Powering Off ....................................................................................................... 2-53
2.13 Check after Powering Off .................................................................................. 2-54
3 System Setup·······················································································3-1
3.1 System Setup Options ........................................................................................... 3-2
3.1.1 Introduction .............................................................................................. 3-2
3.1.2 Sample Options and Reagent Alarm Limits .......................................... 3-2
3.1.3 Auto Rerun Setup ..................................................................................... 3-5
3.1.4 Instrument Setup Options ...................................................................... 3-7
3.1.5 Print Setup.............................................................................................. 3-10
3.1.6 Bar Code Setup ...................................................................................... 3-10
3.1.7 Host Communication Setup ................................................................. 3-10
3.1.8 User Accounts and Permissions .......................................................... 3-10
3.1.9 Customizing Sample Information ........................................................ 3-11
3.1.10 Customizing Patient Demographics.................................................. 3-11
3.1.11 Reagent/Calibration Setup ................................................................. 3-11
3.2 Chemistries Setup ................................................................................................ 3-12
3.2.1 Introduction ............................................................................................ 3-12
3.2.2 User-defined Chemistries Setup .......................................................... 3-12

IV
 Contents – Advanced Volume

3.2.3 Processing Parameters ........................................................................ 3-14

3.2.4 Error Detection Limits ........................................................................... 3-20
3.2.5 Flag Qualitative Result .......................................................................... 3-24
3.2.6 Slope and Offset Adjustment ............................................................... 3-25
3.2.7 Reference/Critical Range Setup ........................................................... 3-26
3.3 Calibration Setup .................................................................................................. 3-30
3.3.1 Introduction ............................................................................................ 3-30
3.3.2 Defining a Calibrator ............................................................................. 3-30
3.3.3 Importing a Calibrator ........................................................................... 3-31
3.3.4 Editing a Calibrator ................................................................................ 3-32
3.3.5 Setting up Calibrator Concentrations .................................................. 3-33
3.3.6 Setting up Calibration Rules ................................................................. 3-34
3.3.7 Calibrator Acceptance Limits ............................................................... 3-36
3.3.8 Deleting a Calibrator.............................................................................. 3-37
3.4 QC Setup ............................................................................................................... 3-38
3.4.1 Introduction ............................................................................................ 3-38
3.4.2 Defining/Editing a Control .................................................................... 3-38
3.4.3 Selection of Chemistries ....................................................................... 3-39
3.4.4 Setting up Control Concentrations ...................................................... 3-40
3.4.5 Setting up QC Rules............................................................................... 3-41
3.4.6 Deleting a Control .................................................................................. 3-42
4 Operation Theories ···············································································4-1
4.1 Overview .................................................................................................................. 4-2
4.2 Principles of Measurement ................................................................................... 4-3
4.2.1 Introduction .............................................................................................. 4-3
4.3 Endpoint Measurements ....................................................................................... 4-4
4.3.1 Introduction .............................................................................................. 4-4
4.3.2 Calculation of Reaction Absorbance ..................................................... 4-4
4.3.3 Calculation of Blank Absorbance ........................................................... 4-4
4.3.4 Calculation of K Factor ............................................................................ 4-4
4.3.5 Calculation of Response ......................................................................... 4-5
4.3.6 Sample Blanked Response ..................................................................... 4-5
4.4 Fixed-time Measurements .................................................................................... 4-7
4.4.1 Introduction .............................................................................................. 4-7
4.4.2 Calculation of Response ......................................................................... 4-7
4.5 Kinetic Measurements ........................................................................................... 4-9
4.5.1 Introduction .............................................................................................. 4-9
4.5.2 Data Calculation in Kinetic Measurements........................................... 4-9
4.5.3 Determination of Linearity Range .......................................................... 4-9
4.5.4 Calculation of Response ....................................................................... 4-10
4.5.5 Evaluation for Linearity ......................................................................... 4-11

V
Contents – Advanced Volume
4.5.6 Enzyme Linearity Range Extension ...................................................... 4-12
4.6 Calibration Math Model and Factors .................................................................. 4-14
4.6.1 Linear Calibrations ................................................................................ 4-14
4.6.2 Non-Linear Calibrations........................................................................ 4-15
4.7 Prozone Check ...................................................................................................... 4-17
4.7.1 Introduction ............................................................................................ 4-17
4.7.2 Antigen Addition Method ...................................................................... 4-17
4.7.3 Reaction Rate Method ........................................................................... 4-18
Contents ·································································································· I
5 Reagents ····························································································5-1
5.1 Overview .................................................................................................................. 5-2
5.1.1 Introduction .............................................................................................. 5-2
5.1.2 Reagent/Calibration Screen Overview ................................................... 5-2
5.2 Customizing Reagent Display ............................................................................... 5-5
5.2.1 Introduction .............................................................................................. 5-5
5.2.2 Customizing Reagent Display ................................................................ 5-5
5.3 Sort Reagents ......................................................................................................... 5-6
5.3.1 Introduction .............................................................................................. 5-6
5.3.2 Sort Reagents .......................................................................................... 5-6
5.4 Reagent Inventory Alarm Limits Setup ................................................................ 5-7
5.4.1 Introduction .............................................................................................. 5-7
5.4.2 Setting up Reagent Inventory Alarm Limit for Biochemistry Reagent 5-7
5.4.3 Auto refreshing reagent inventory ......................................................... 5-8
5.5 Reagent Inventory Check....................................................................................... 5-9
5.5.1 Introduction .............................................................................................. 5-9
5.5.2 Checking Reagent Inventory .................................................................. 5-9
5.5.3 Canceling Reagent Inventory Check .................................................... 5-10
5.6 Bar-Coded Reagents Load .................................................................................. 5-11
5.6.1 Loading Bar-Coded Reagents .............................................................. 5-11
5.7 On-line Load of Reagents .................................................................................... 5-12
5.7.1 Introduction ............................................................................................ 5-12
5.7.2 On-Line Load of Reagents .................................................................... 5-12
5.8 Off-line Load of Reagents ................................................................................... 5-14
5.8.1 Introduction ............................................................................................ 5-14
5.8.2 Off-line Load of Reagents ..................................................................... 5-14
5.9 On-Line Replacement of Reagents..................................................................... 5-15
5.9.1 Introduction ............................................................................................ 5-15
5.9.2 On-Line Replacement of Reagents ...................................................... 5-15
5.10 Off-Line Replacement of Reagents .................................................................. 5-17
5.10.1 Introduction.......................................................................................... 5-17
5.10.2 Off-Line Replacement of Reagents ................................................... 5-17

VI
 Contents – Advanced Volume

5.11 Unloading Reagents........................................................................................... 5-18

5.11.1 Introduction.......................................................................................... 5-18
5.11.2 Unloading Biochemical Reagents ...................................................... 5-18
6 Calibration ··························································································6-1
6.1 Overview .................................................................................................................. 6-2
6.2 Calibration Status and Alarm ................................................................................ 6-3
6.3 Calibrator Dilution Setup ....................................................................................... 6-4
6.3.1 Introduction .............................................................................................. 6-4
6.3.2 Setting up Calibrator Dilution Factors ................................................... 6-4
6.3.3 Editing Calibrator Dilution Factors ......................................................... 6-5
6.3.4 Deleting Calibrator Dilution Factors ...................................................... 6-6
6.4 Reagent Blank ......................................................................................................... 6-7
6.4.1 Introduction .............................................................................................. 6-7
6.4.2 Mixed Blank Absorbance and Response ............................................... 6-7
6.4.3 Requesting a Reagent Blank .................................................................. 6-8
6.4.4 Recalling Reagent Blank Results ........................................................... 6-8
6.5 Auto Calibration .................................................................................................... 6-12
6.5.1 Introduction ............................................................................................ 6-12
6.5.2 Auto Calibration Setup .......................................................................... 6-12
6.5.3 Auto Calibration Reminding.................................................................. 6-13
6.5.4 Removing Auto Calibration ................................................................... 6-13
6.6 Extending Calibration Time ................................................................................. 6-14
6.6.1 Introduction ............................................................................................ 6-14
6.6.2 Extending Calibration Time .................................................................. 6-14
6.6.3 Removing an Extended Status ............................................................. 6-15
6.7 Calibration Override ............................................................................................. 6-16
6.7.1 Introduction ............................................................................................ 6-16
6.7.2 Overriding a Calibration ........................................................................ 6-16
6.7.3 Removing Cal Overridden Status ......................................................... 6-16
6.8 Reject ..................................................................................................................... 6-17
6.8.1 Introduction ............................................................................................ 6-17
6.8.2 Rejecting a Calibration .......................................................................... 6-17
6.8.3 Removing Reject Status ........................................................................ 6-17
6.9 Recalling Calibration Results .............................................................................. 6-18
6.9.1 Recalling Current Calibration Factors.................................................. 6-18
6.9.2 Recalling History Calibration Factors .................................................. 6-18
6.9.3 Calibration Curve ................................................................................... 6-19
6.9.4 Calibration Reaction Curve ................................................................... 6-21
6.9.5 Editing Calibration Factors ................................................................... 6-24
6.9.6 Archiving Calibration Results ............................................................... 6-24
6.9.7 Calibration Trends ................................................................................. 6-25

VII
Contents – Advanced Volume
7 Quality Control ····················································································7-1
7.1 Overview .................................................................................................................. 7-2
7.1.1 Introduction .............................................................................................. 7-2
7.1.2 Quality Control Operating Procedure ..................................................... 7-2
7.1.3 QC Alarms ................................................................................................ 7-2
7.1.4 QC Result Flags ....................................................................................... 7-2
7.1.5 Control Status .......................................................................................... 7-3
7.2 QC Evaluation ......................................................................................................... 7-4
7.2.1 Introduction .............................................................................................. 7-4
7.2.2 Evaluation of Single Controls ................................................................. 7-4
7.2.3 Two-Control Evaluation .......................................................................... 7-5
7.3 Auto Quality Control ............................................................................................... 7-8
7.3.1 Introduction .............................................................................................. 7-8
7.3.2 Auto QC Setup .......................................................................................... 7-8
7.3.3 Auto Quality Control ................................................................................ 7-9
7.3.4 Removing Auto QC Status ...................................................................... 7-9
7.4 Recalling Control Results .................................................................................... 7-10
7.4.1 Control Sample Results ........................................................................ 7-10
7.4.2 Recalling L-J Chart ................................................................................ 7-12
7.4.3 Recalling Twin-Plot Chart ..................................................................... 7-14
7.4.4 Recalling QC Data .................................................................................. 7-15
7.4.5 Recalling QC Summary ......................................................................... 7-20
8 Sample Programming and Processing ·························································8-1
8.1 Overview .................................................................................................................. 8-2
8.2 Sample Programming and Processing ................................................................ 8-3
8.2.1 Introduction .............................................................................................. 8-3
8.2.2 Adding Samples ....................................................................................... 8-3
8.2.3 Adding/Modifying Chemistries .............................................................. 8-4
8.2.4 Rerunning Samples ................................................................................. 8-4
8.2.5 Programming Samples with Increased or Decreased Volume ......... 8-12
8.2.6 Programming Diluted Samples ............................................................ 8-14
8.2.7 Sample Blank ......................................................................................... 8-16
8.2.8 Sample Management ............................................................................ 8-18
8.3 Serum Index .......................................................................................................... 8-21
8.3.1 Introduction ............................................................................................ 8-21
8.3.2 Theory of Serum Index .......................................................................... 8-21
8.3.3 Serum Index Setup ................................................................................ 8-22
8.3.4 Auto Serum Index .................................................................................. 8-23
8.3.5 Running SI Chemistry............................................................................ 8-24
8.4 Clear Samples ....................................................................................................... 8-25
8.4.1 Introduction ............................................................................................ 8-25

VIII
 Contents – Advanced Volume

8.4.2 Clearing Samples ................................................................................... 8-25

8.5 Unpositioned Samples ......................................................................................... 8-26
8.5.1 Introduction ............................................................................................ 8-26
8.5.2 Viewing Unpositioned Samples ........................................................... 8-26
8.5.3 Assigning Positions .............................................................................. 8-26
8.6 Release Sample Position ..................................................................................... 8-28
8.6.1 Introduction ............................................................................................ 8-28
8.6.2 Releasing Sample Positions ................................................................. 8-28
8.6.3 Auto Release of Samples ...................................................................... 8-29
8.7 Sample Logs ......................................................................................................... 8-30
8.7.1 Introduction ............................................................................................ 8-30
8.7.2 Viewing Sample Logs ............................................................................ 8-30
8.8 Customizing Sample Information ....................................................................... 8-32
8.8.1 Introduction ............................................................................................ 8-32
8.8.2 Customizing Sample Information ........................................................ 8-32
8.9 Customizing Patient Demographics .................................................................. 8-33
8.10 Sample and Chemistry Lists ............................................................................. 8-34
8.10.1 Introduction.......................................................................................... 8-34
8.10.2 Sample List .......................................................................................... 8-34
8.10.3 Chemistry List ...................................................................................... 8-35
8.11 Optimizing Result Display ................................................................................. 8-37
8.11.1 Introduction.......................................................................................... 8-37
8.11.2 Optimizing Result Display .................................................................. 8-37
8.12 Results Recall ..................................................................................................... 8-39
8.12.1 Introduction.......................................................................................... 8-39
8.12.2 Displaying Current Results ................................................................. 8-39
8.12.3 Recalling Current Results ................................................................... 8-40
8.12.4 Displaying History Results ................................................................. 8-41
8.12.5 Recalling History Results ................................................................... 8-42
8.12.6 Review Sample Results....................................................................... 8-43
8.12.7 Viewing/Editing Patient Demographics ............................................ 8-43
8.12.8 Reaction Curve..................................................................................... 8-44
8.12.9 Transmitting Results to LIS Host....................................................... 8-48
8.12.10 Printing Results ................................................................................. 8-49
8.12.11 Editing Results ................................................................................... 8-51
8.12.12 Deleting Results ................................................................................ 8-53
8.12.13 Customizing Result Display ............................................................. 8-54
8.12.14 Recalculating Results ....................................................................... 8-56
8.12.15 Compensating Results ..................................................................... 8-57
8.12.16 Recalling Result Trend ...................................................................... 8-58
8.12.17 Archiving Results .............................................................................. 8-59

IX
Contents – Advanced Volume
8.13 Workload Statistics ............................................................................................ 8-60
8.14 Result Statistics ................................................................................................. 8-62
9 Result Printouts ···················································································9-1
9.1 Data Import and Export ......................................................................................... 9-2
9.1.1 Introduction .............................................................................................. 9-2
9.1.2 Import/Export Chemistries ..................................................................... 9-2
9.1.3 Data Archive ............................................................................................. 9-6
9.1.4 Sending sample results and QC results to LIS ..................................... 9-7
9.2 Print Setup .............................................................................................................. 9-8
9.2.1 Introduction .............................................................................................. 9-8
9.2.2 General Print Setup Options ................................................................... 9-8
9.2.3 Set Up Default Template ......................................................................... 9-9
9.2.4 Delete Template ....................................................................................... 9-9
9.2.5 Edit Print Template .................................................................................. 9-9
9.2.6 Import Print Template ............................................................................. 9-9
9.2.7 Defining Chemistry Print Order ............................................................ 9-10
9.3 Sample Reports .................................................................................................... 9-12
9.3.1 Introduction ............................................................................................ 9-12
9.3.2 Single Sample Report ............................................................................ 9-12
9.3.3 Multi-Sample Report ............................................................................. 9-13
9.3.4 Print Report Collection .......................................................................... 9-14
10 Chemistries ····················································································· 10-1
10.1 Twin Chemistries................................................................................................ 10-2
10.1.1 Introduction.......................................................................................... 10-2
10.1.2 Chemistry Definition ........................................................................... 10-2
10.1.3 Removing Twin Relation ..................................................................... 10-3
10.1.4 Reagent Setup ..................................................................................... 10-3
10.1.5 Setting Up and Requesting Calibration ............................................. 10-4
10.1.6 Setting Up and Requesting Quality Control ...................................... 10-4
10.1.7 Sample Programming and Processing ............................................. 10-4
10.2 Special Calculations .......................................................................................... 10-5
10.2.1 Introduction.......................................................................................... 10-5
10.2.2 Defining/Editing a Calculation ........................................................... 10-5
10.2.3 Enabling/Disabling Calculations........................................................ 10-6
10.2.4 Deleting User-Defined Calculations .................................................. 10-7
10.2.5 Running Calculations .......................................................................... 10-8
10.3 Panels .................................................................................................................. 10-9
10.3.1 Introduction.......................................................................................... 10-9
10.3.2 Defining/Editing a Panel ..................................................................... 10-9
10.3.3 Adjusting Display Order of Panels ................................................... 10-10

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 Contents – Advanced Volume

10.3.4 Deleting Panels .................................................................................. 10-10

10.3.5 Running Panels.................................................................................. 10-10
10.4 Off-system Chemistries .................................................................................. 10-11
10.4.1 Introduction........................................................................................ 10-11
10.4.2 Define/Edit Off-System Chemistries ............................................... 10-11
10.4.3 Running the Off-system Chemistries .............................................. 10-12
10.4.4 Deleting Off-system Chemistries .................................................... 10-13
10.5 Serum Index ...................................................................................................... 10-14
10.6 Chemistry Configuration ................................................................................. 10-15
10.6.1 Introduction........................................................................................ 10-15
10.6.2 Enabling Chemistries ........................................................................ 10-15
10.6.3 Disabling Chemistries ....................................................................... 10-16
10.6.4 Customizing Chemistry Display Order ............................................ 10-17
10.6.5 Adjusting Test Order of Chemistries ............................................... 10-17
10.7 Carryover Setup ................................................................................................ 10-19
10.7.1 Introduction........................................................................................ 10-19
10.7.2 Defining/Editing Carryover Pair ....................................................... 10-19
10.7.3 Removing a Carryover Pair ............................................................... 10-20
10.8 Default Panel .................................................................................................... 10-21
10.8.1 Introduction........................................................................................ 10-21
10.8.2 Defining the Default Panel ................................................................ 10-21
10.8.3 Running Default Panel for Routine Samples .................................. 10-21
10.8.4 Running Default Panel for Emergent Samples ............................... 10-22
10.9 Masking/Unmasking Chemistries .................................................................. 10-23
10.9.1 Introduction........................................................................................ 10-23
10.9.2 Masking/Unmasking Chemistries ................................................... 10-23
10.10 Reflex............................................................................................................... 10-25
10.10.1 Introduction ..................................................................................... 10-25
10.10.2 Setting Reflex Relation ................................................................... 10-25
10.10.3 Editing Reflex Relation .................................................................... 10-26
10.10.4 Deleting Reflex Relation.................................................................. 10-26
10.10.5 Measurement and Result Recall .................................................... 10-27
11 System Commands and Setup Options ···················································· 11-1
11.1 Home ................................................................................................................... 11-2
11.1.1 Introduction.......................................................................................... 11-2
11.1.2 Homing System ................................................................................... 11-2
11.2 Stop Print ............................................................................................................ 11-3
11.2.1 Introduction.......................................................................................... 11-3
11.2.2 Stop Print ............................................................................................. 11-3
11.3 Sleep and Wake Up ............................................................................................ 11-4
11.3.1 Introduction.......................................................................................... 11-4

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Contents – Advanced Volume
11.3.2 System Hibernation............................................................................. 11-4
11.3.3 Waking up the System ........................................................................ 11-4
11.4 User and Password Setup ................................................................................. 11-5
11.4.1 Introduction.......................................................................................... 11-5
11.4.2 Defining a User .................................................................................... 11-5
11.4.3 Modifying a User ................................................................................. 11-6
11.4.4 Assigning/Modifying Permissions .................................................... 11-6
11.4.5 Deleting a User .................................................................................... 11-7
11.5 Sleep and Awake Setup ..................................................................................... 11-8
11.5.1 Introduction.......................................................................................... 11-8
11.5.2 Auto Sleep Setup ................................................................................. 11-8
11.5.3 Auto Startup Setup .............................................................................. 11-9
11.5.4 Auto Awake Setup ............................................................................. 11-10
11.6 Dictionary Setup ............................................................................................... 11-11
11.6.1 Introduction........................................................................................ 11-11
11.6.2 Defining, Editing and Deleting Data Option ..................................... 11-11
11.7 Software Upgrade ............................................................................................ 11-13
11.7.1 Introduction........................................................................................ 11-13
11.7.2 Software Upgrade .............................................................................. 11-13
11.8 Software Version .............................................................................................. 11-14
11.8.1 Introduction........................................................................................ 11-14
11.8.2 Software Version ............................................................................... 11-14
11.9 Voice Tone Setup ............................................................................................. 11-16
11.9.1 Introduction........................................................................................ 11-16
11.9.2 Importing Audio Files ........................................................................ 11-16
11.9.3 Setting Up Voice Tone ....................................................................... 11-16
12 Use of ISE Module ············································································· 12-1
12.1 Precautions on Use ............................................................................................ 12-2
12.1.1 Introduction.......................................................................................... 12-2
12.1.2 Precautions on Use ............................................................................. 12-2
12.2 Principles of Measurement ............................................................................... 12-4
12.3 ISE Chemistry Parameters ................................................................................ 12-5
12.3.1 Introduction.......................................................................................... 12-5
12.3.2 Viewing ISE Chemistry Parameters ................................................... 12-5
12.3.3 Introduction to ISE Chemistry Parameters ....................................... 12-5
12.3.4 Flag ISE Qualitative Result ................................................................. 12-6
12.4 Preparing ISE Reagents for Measurement ...................................................... 12-8
12.4.1 Introduction.......................................................................................... 12-8
12.4.2 Off-line Load ISE Reagent .................................................................. 12-8
12.4.3 On-line Load ISE Reagent ................................................................. 12-10
12.4.4 Load ISE Wash Solution .................................................................... 12-10

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 Contents – Advanced Volume

12.4.5 Replacing ISE Wash Solution ........................................................... 12-11

12.5 Calibration and Results Recall ........................................................................ 12-12
12.5.1 Introduction........................................................................................ 12-12
12.5.2 Calibration Setup ............................................................................... 12-12
12.5.3 Calibration Status and Alarm ........................................................... 12-13
12.5.4 ISE Calibration ................................................................................... 12-14
12.5.5 Results Recall .................................................................................... 12-14
12.5.6 Extending ISE Calibration Time ........................................................ 12-17
12.6 Quality Control and Results Recall ................................................................. 12-18
12.6.1 Quality Control and Results Recall .................................................. 12-18
12.7 Sample Programming and Results Recall ..................................................... 12-19
12.8 Reagent Inventory Alarm Limit ....................................................................... 12-20
12.8.1 Introduction........................................................................................ 12-20
12.8.2 Setting up Reagent Inventory Alarm Limit ...................................... 12-20
12.9 ISE Prime Cycle ................................................................................................ 12-21
12.9.1 Introduction........................................................................................ 12-21
12.9.2 Defining/Modifying ISE Prime Times .............................................. 12-21
12.10 Daily Maintenance ......................................................................................... 12-22
12.10.1 Daily Maintenance .......................................................................... 12-22
12.11 Troubleshooting ISE Module ......................................................................... 12-23
12.11.1 Troubleshooting ISE Module .......................................................... 12-23
13 Use of Bar Code ················································································ 13-1
13.1 Sample Bar Code Reader ................................................................................... 13-2
13.1.1 Introduction.......................................................................................... 13-2
13.1.2 Sample Bar Code Setup ...................................................................... 13-2
13.1.3 Programming Bar-Coded Routine Samples ..................................... 13-4
13.1.4 Programming Bar-Coded STAT Samples.......................................... 13-6
13.1.5 Adding New Samples or Chemistries ................................................ 13-9
13.1.6 Rerunning Bar-Coded Samples ....................................................... 13-10
13.1.7 Results Recall .................................................................................... 13-12
13.1.8 Recalling Current Results ................................................................. 13-13
13.2 Reagent Bar Code Reader ............................................................................... 13-14
13.2.1 Introduction........................................................................................ 13-14
13.2.2 Reagent Bar Code Setup ................................................................... 13-15
13.2.3 Loading Bar-Coded Reagents .......................................................... 13-16
13.3 Bar Code Reader Maintenance ....................................................................... 13-18
13.3.1 Introduction........................................................................................ 13-18
13.3.2 Cleaning Sample and Reagent Bar Code Scanning Windows....... 13-18
13.4 Troubleshooting Bar Code Reader ................................................................. 13-19
14 LIS and RMS ····················································································· 14-1

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Contents – Advanced Volume
14.1 Overview .............................................................................................................. 14-2
14.2 Host Communication ......................................................................................... 14-3
14.2.1 Introduction.......................................................................................... 14-3
14.2.2 Connection between PC and LIS Host .............................................. 14-3
14.2.3 Host Communication Parameters ..................................................... 14-4
14.2.4 Defining Chemistry Code .................................................................... 14-6
14.3 Programming Samples with LIS Host .............................................................. 14-7
14.3.1 Introduction.......................................................................................... 14-7
14.3.2 Programming Functions ..................................................................... 14-7
14.4 Result Transmission ........................................................................................ 14-11
14.4.1 Introduction........................................................................................ 14-11
14.4.2 Result Transmission Setup .............................................................. 14-12
14.4.3 Manually Sending Results to LIS Host ............................................ 14-12
14.5 Troubleshooting LIS ......................................................................................... 14-13
14.6 Use of RMS ....................................................................................................... 14-14
14.6.1 Introduction........................................................................................ 14-14
14.6.2 Connection between PC and RMS ................................................... 14-14
14.6.3 Troubleshooting RMS ....................................................................... 14-15
Contents ·································································································· I
15 Diagnostics ······················································································ 15-1
15.1 Overview .............................................................................................................. 15-2
15.2 Diagnosis of Sample System ............................................................................ 15-3
15.2.1 Introduction.......................................................................................... 15-3
15.2.2 Sample Probe Clog Detection ............................................................ 15-3
15.2.3 Sample Probe Level Sense Test ......................................................... 15-5
15.3 Diagnosis of Reagent System ........................................................................... 15-8
15.3.1 Introduction.......................................................................................... 15-8
15.3.2 Reagent Probe Level Sense Test ....................................................... 15-8
15.4 Sensor Diagnosis ............................................................................................. 15-11
15.4.1 Introduction........................................................................................ 15-11
15.4.2 Sensor Diagnosis .............................................................................. 15-11
16 Maintenance ···················································································· 16-1
16.1 Overview .............................................................................................................. 16-2
16.1.1 Introduction.......................................................................................... 16-2
16.1.2 Introduction.......................................................................................... 16-2
16.1.3 Consumables ....................................................................................... 16-3
16.1.4 Tools Required for Maintenance ........................................................ 16-4
16.2 Biochemistry Maintenance ............................................................................... 16-6
16.2.1 Introduction.......................................................................................... 16-6
16.2.2 Biochemistry Maintenance Screen Overview ................................... 16-6

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 Contents – Advanced Volume

16.3 ISE Maintenance ................................................................................................ 16-8

16.3.1 Introduction.......................................................................................... 16-8
16.3.2 ISE Maintenance Screen Overview .................................................... 16-8
16.4 Scheduled Maintenance Log .......................................................................... 16-10
16.4.1 Introduction........................................................................................ 16-10
16.4.2 Maintenance Schedule ..................................................................... 16-10
16.4.3 Scheduled Maintenance Procedures............................................... 16-11
16.4.4 Maintenance Log Sheet .................................................................... 16-12
16.4.5 Scheduled Maintenance Screen Overview ...................................... 16-15
16.5 Daily Maintenance ........................................................................................... 16-19
16.5.1 Introduction........................................................................................ 16-19
16.5.2 Check Probes/Mixers/Wash Wells .................................................. 16-19
16.5.3 Check Sample/Reagent Syringes .................................................... 16-21
16.5.4 Check Deionized Water ..................................................................... 16-22
16.5.5 Check Waste ...................................................................................... 16-23
16.5.6 Check Concentrated Wash Solution ................................................ 16-24
16.5.7 Check Sample Probe Wash Solution ............................................... 16-25
16.5.8 Clean Electrode Tubes (For ISE Module) ......................................... 16-26
16.6 Weekly Maintenance ........................................................................................ 16-28
16.6.1 Clean Sample/Reagent Probe Exterior ............................................ 16-28
16.6.2 Clean Mixers ...................................................................................... 16-29
16.6.3 Special Wash...................................................................................... 16-30
16.6.4 Cuvette Check .................................................................................... 16-31
16.6.5 Photometer Check ............................................................................. 16-33
16.7 Monthly Maintenance ...................................................................................... 16-35
16.7.1 Clean Wash Wells .............................................................................. 16-35
16.7.2 Clean Wash Station ........................................................................... 16-36
16.7.3 Clean Filter Core ................................................................................ 16-37
16.7.4 Clean Dust Screens ........................................................................... 16-39
16.7.5 Clean Sample Injection Port (For ISE Module) ............................... 16-40
16.7.6 Pump Calibration (For ISE Module) ................................................. 16-41
16.7.7 Air Bubble Detector Calibration (For ISE Module) .......................... 16-42
16.7.8 Clean the Dust Screen of the External Vacuum Pump................... 16-43
16.8 Three-Month Maintenance ............................................................................. 16-45
16.8.1 Clean DI Water Tank .......................................................................... 16-45
16.8.2 Replace Filter Core ............................................................................ 16-47
16.9 Six-Month Maintenance .................................................................................. 16-49
16.9.1 Replace Lamp .................................................................................... 16-49
16.9.2 Replace Water Inlet Filter .................................................................. 16-50
16.9.3 Replace Reference Electrode(For ISE Module) ............................... 16-51
16.10 As-Needed/As-Required Maintenance ....................................................... 16-54

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Contents – Advanced Volume
16.10.1 Clean Analyzer Panels .................................................................... 16-54
16.10.2 Clean Sample Compartment .......................................................... 16-55
16.10.3 Clean Reagent Compartment ......................................................... 16-56
16.10.4 Clean Sample Probe Interior .......................................................... 16-57
16.10.5 Clean Reagent Probe Interior ......................................................... 16-61
16.10.6 Replace Sample Probe .................................................................... 16-62
16.10.7 Replace Reagent Probe .................................................................. 16-65
16.10.8 Replace Sample Mixer .................................................................... 16-66
16.10.9 Replace Reagent Mixer ................................................................... 16-67
16.10.10 Remove Air Bubbles in Sample Syringe ...................................... 16-68
16.10.11 Remove Air Bubbles in Reagent Syringe .................................... 16-70
16.10.12 Replace Cuvette ............................................................................ 16-71
16.10.13 Special Wash Probes .................................................................... 16-74
16.10.14 Bar Code Maintenance ................................................................. 16-74
16.10.15 Clean Probes/Mixers Exterior ...................................................... 16-75
16.10.16 Replace ISE Electrode ................................................................... 16-76
16.10.17 Remove Reagent Pack (For ISE Module) .................................... 16-78
16.10.18 Store Electrodes (For ISE Module) ............................................... 16-79
16.10.19 Two-Point Calibration (For ISE Module) ..................................... 16-80
16.10.20 Maintenance (For ISE Module) .................................................... 16-80
16.10.21 Purge A (For ISE Module) ............................................................. 16-81
16.10.22 Purge B (For ISE Module) ............................................................. 16-81
16.10.23 Program Check Instruction (For ISE Module) ............................. 16-81
16.10.24 Read Dallas Chip (For ISE Module) .............................................. 16-81
16.10.25 Write Dallas Chip (For ISE Module) ............................................. 16-81
16.10.26 Replace Sample Syringe ............................................................... 16-82
16.10.27 Replace Reagent Syringe ............................................................. 16-84
16.10.28 Clean Rotors .................................................................................. 16-85
16.10.29 Clean ISE Waste Tube ................................................................... 16-86
17 Alarms and Troubleshooting································································· 17-1
17.1 Classification of Logs ........................................................................................ 17-2
17.1.1 Introduction.......................................................................................... 17-2
17.1.2 Error Logs ............................................................................................. 17-2
17.1.3 Edit Logs ............................................................................................... 17-2
17.2 Viewing and Handling Logs .............................................................................. 17-3
17.2.1 Description of Error Log Screen ......................................................... 17-3
17.2.2 Description of Edit Log Screen ........................................................... 17-3
17.2.3 Recalling Logs ..................................................................................... 17-4
17.2.4 Refreshing Logs ................................................................................... 17-5
17.2.5 Clearing Logs ....................................................................................... 17-5
17.2.6 Printing Logs ........................................................................................ 17-6

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 Contents – Advanced Volume

17.3 Error Troubleshooting ........................................................................................ 17-7

17.3.1 Introduction.......................................................................................... 17-7
17.3.2 Error Indications .................................................................................. 17-7
17.3.3 Identifying Errors ................................................................................. 17-8
17.4 Data Alarm ........................................................................................................ 17-10
17.4.1 Introduction........................................................................................ 17-10
17.4.2 Result Flags ....................................................................................... 17-11
17.5 Error Messages and Corrective Actions ........................................................ 17-22
18 Template Modifying Software ······························································· 18-1
18.1 Main Screen ........................................................................................................ 18-2
18.1.1 Main Screen ......................................................................................... 18-2
18.1.2 File (F) ................................................................................................... 18-2
18.1.3 Edit (E) .................................................................................................. 18-5
18.1.4 View (V) ................................................................................................ 18-5
18.1.5 Insert (I) ................................................................................................ 18-6
18.1.6 Format (M) ........................................................................................... 18-7
18.1.7 Set(S) .................................................................................................... 18-8
18.1.8 Help (H)................................................................................................. 18-9
18.2 Common Tools ................................................................................................. 18-10
18.3 Draw Tools ........................................................................................................ 18-11
18.4 Property Window .............................................................................................. 18-13
18.4.1 Page .................................................................................................... 18-13
18.4.2 Line ..................................................................................................... 18-13
18.4.3 Rectangle ........................................................................................... 18-14
18.4.4 Label ................................................................................................... 18-15
18.4.5 Text ..................................................................................................... 18-17
18.4.6 Title ..................................................................................................... 18-18
18.4.7 Image .................................................................................................. 18-19
18.5 Report Window ................................................................................................. 18-21
Electronic Interface····················································································1
Vocabulary ·······························································································1
Index ······································································································1
Bibliography ·····························································································1

XVII
Contents – Advanced Volume

XVIII
 5 Reagents

This chapter provides you with functions and operating instructions

associated with reagent.

5-1
5 Reagents

5.1 Overview
5.1.1 Introduction
This chapter introduces the advanced application of the reagent module.
Perform the following operations according to the practical conditions in
your laboratory:
 Sorting reagents
 Setting up reagent inventory alarm limits
 Checking reagent inventory
 Loading bar-coded reagents
 On-line load of reagents
 Off-line load of reagents
 On-line replacement of reagents
 Off-line replacement of reagents
 Unloading reagents

5.1.2 Reagent/Calibration Screen Overview

Select Reagent in the function button area of the main screen. The
Reagent/Calibration screen is displayed. The screen is composed of the
biochemistry reagent/calibration page and ISE reagent/calibration page.
The latter is displayed by default.
Figure 5.1 ISE reagent/calibration screen

The ISE reagent/calibration screen is divided into three areas. The upper
list shows the ISE chemistries, calibration status, calibration date and
calibration time left; the lower list shows the volume, load date, expiration

5-2
 5 Reagents

date, lot number and serial number of all wash solutions and
physiological saline; the function buttons at the bottom are used to
access relevant functions.
Select the down-arrow button on the right side of the screen to display
the biochemical reagents.
Figure 5.2 Biochemistry reagent/calibration screen

The screen shows all configured biochemistry reagents, including the

following information:
 Position: position of the reagent on the reagent carousel.
 Chemistry: name of the chemistry.
 Chemistries left: It refers to the minimum tests left of R1, R2, R3 and
R4. When the number of chemistries left is 0, the chemistry is still
allowed for programming and measurement.
 Reagent type: reagent type of a multi-reagent chemistry. It includes
R1, R2, R3 and R4.
 Tests left: It refers to the remaining tests of each reagent bottle.
 Days left: the difference of reagent expiration date and current date
and the uncapping time, whichever the less. When a negative value is
displayed, it indicates that the reagent is expired and should be
replaced immediately.
 Lot number: lot number of the reagent. It can be input manually during
reagent load.
 Calibration status: calibration status of the chemistry, including, Cal
Required, Requested, Calibrated, Cal Failed, Cal Time Out, Cal Time
Extended, Calculated, Edited, Cal Overridden and N/A.
 Time left: the time left when the calibration factors are expired. It will
be displayed only when the calibration status is Calibrated, Cal Time

5-3
5 Reagents

Out or Cal Time Extended. When the time left is less than 30 minutes,
the system displays a message indicating calibration time out; when
the calibration time is exceeded, the calibration factors can no longer
be used, and you are allowed to recalibrate the chemistry or extend
the calibration time.

5-4
 5 Reagents

5.2 Customizing Reagent Display

5.2.1 Introduction
The reagent information on the biochemistry reagent/calibration screen
can be tailored and displayed in desired order.

5.2.2 Customizing Reagent Display

1 Select Utility-System Setup.

2 Select Instrument F1.

3 Select 16 Customize Reagent Display.

Figure 5.3 Customize Reagent Display window

4 Select checkbox of reagent information to display it on the

reagent/calibration screen, deselect checkbox to cancel the display.

5 Select Up and Down to adjust the display order of reagent

information.
6 Select Save to save the settings.

7 Select Exit to close the window.

5-5
5 Reagents

5.3 Sort Reagents

5.3.1 Introduction
Reagents on the biochemistry reagent/calibration screen can be sorted
by name, position, chemistries left, days left and calibration time left, and
a V-type symbol appears to the right of the sort criteria. Prior to loading
reagents or running calibrations, sort the reagents to display the desired
ones in the front.

5.3.2 Sort Reagents

1 Select Reagent-Reagent/Calibration.

2 Select a reagent carousel from the dropdown box of reagent

carousel.

3 Select the down-arrow button on the right side of the screen to

display the biochemical reagents.

4 Choose a sorting criterion, and then click on the corresponding list

head to rearrange the reagents.

To view or load reagents, choose the following standards:

 Reagent position
 Chemistry name
 Chemistries left
 Days left
To view calibration status or run calibrations, choose the following
standard:
 Calibration time left
 Calibration status

5-6
 5 Reagents

5.4 Reagent Inventory Alarm Limits Setup

5.4.1 Introduction
When the reagent inventory is lower than the alarm limit during or before
the analysis, the system will give an alarm and display the reagents or
wash solution name in yellow on the Reagent/Calibration screen, and the
volume of ISE reagent and wash solutions become 0.
For Concentrated wash solution, reagent probe wash solution and
physiological saline, please set up the reagent alarm limit on the Load
Reagent window. Please refer to 2.5.2 Loading Concentrated Wash
Solution, 2.5.3 Loading Reagent Probe Wash Solution2.5.3 and 2.5.5
Loading Physiological Saline for details.

5.4.2 Setting up Reagent Inventory Alarm Limit for Biochemistry

Reagent
1 Select Utility-Chemistries.

2 Select a Chemistry.

3 Select Define F1.

4 Select down arrow to get to the second page.

Figure 5.4 Define/Edit Chemistries screen

5 Type in the reagent alarm limit.

Enter an integer between 1 and 100. The default is 10.

6 Select Save F7.

5-7
5 Reagents

5.4.3 Auto refreshing reagent inventory

Via Reagent/Calibration option on instrument setup screen, you can
configure whether to automatically refresh the reagent with 0 inventory
as available for test, when reagent has been loaded and End Load button
is selected.
1 Select Utility-System Setup.

2 Select Instrument F1.

3 Select 15 Reagent/Calibration Setup

Figure 5.5 Reagent/calibration window

4 Select or deselect the option Auto refresh reagent inventory which

is unselected by default.

5 Click Save.

5-8
 5 Reagents

5.5 Reagent Inventory Check

5.5.1 Introduction
The system provides the manual and auto check of inventory of
biochemical reagents. During the test, the system automatically checks
the reagent inventory and displays it on the Reagent/Calibration screen.
After the reagents are loaded, it is necessary to perform the inventory
check in order to ensure that sufficient reagents are available for analysis.
Reagent inventory check is allowed only when the system status is
Incubation or Standby. While the system is checking reagent inventory,
loading or unloading reagents on the current module is not permitted, and
the Utility button is disabled.

5.5.2 Checking Reagent Inventory

1 Select Reagent- Reagent/Calibration.

2 Select Inventory F3.

Figure 5.6 Check window

3 Choose reagent positions:

 Following position(s): check the reagents on specified positions.

Enter reagent positions and separate them with a comma. Enter
single reagent positions like 1, 2, 3, or position range like 2-15,
20-25.
 All positions: check all reagent positions of the reagent carousel.
 All reagents of selected chemistry: check the inventory of all
reagent types of the selected chemistry.
4 Select Check.

 The Inventory F3 button on the Reagent/Calibration screen

changes to No Invent. F3.

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5 Reagents

 The reagent carousel graph refreshes the reagent status

automatically.
 The Reagent/Calibration screen refreshes the Tests Left of the
selected chemistry, Chems Left, and the Volume of the selected
wash solution.

5.5.3 Canceling Reagent Inventory Check

To cancel reagent inventory check,
 Select Close on the Check window, and then select No Invent. F3 on
the Reagent/Calibration screen. Or

 Select the icon on the upper-right corner of the main screen, and
then select OK to start analysis.

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 5 Reagents

5.6 Bar-Coded Reagents Load

5.6.1 Loading Bar-Coded Reagents
If your system is equipped with a reagent bar code reader, you may put
the bar-coded reagents on the reagent carousel, and the system will scan
all reagent positions automatically and obtain reagent information from
the bar code label.
The bar code scanning is only applied to biochemical reagents. The
reagent probe wash solution and physiological saline can only be loaded
manually rather than bar code scanning. If a bar code is scanned in the
fixed positions (D and W), the wash solution or physiological saline in the
positions will be unloaded automatically, but the scanned reagents will
not be loaded.
For details of loading bar-coded reagents, refer to 13.2.3 Loading
Bar-Coded Reagents (page 13-16).

WARNING
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise
caution when working around the probes.

BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.
Do not touch the reagent directly with your body; otherwise, skin wound or
inflammation may be caused.

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5 Reagents

5.7 On-line Load of Reagents

5.7.1 Introduction
The on-line load of reagents is performed while the system is running
tests. Before starting an on-line load, request for reagent stop, do not
load reagents until all started tests are finished for reagent dispensing. If
the system is running calibrations, STAT samples or diluted samples, you
are not allowed to start loading reagents unless all tests finish reagents
dispensing.

WARNING
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise
caution when working around the probes.

BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.
Do not touch the reagent directly with your body; otherwise, skin wound or
inflammation may be caused.

5.7.2 On-Line Load of Reagents

1 Select Reagent-Reagent/Calibration.

2 Select a reagent carousel from the dropdown box of reagent

carousel.

3 Select Load F1 to request for reagent stop. Meanwhile Load F1

becomes No load F1.If you want to abort load, select No load F1.

The system status area shows a countdown for reagent stop, and a
message box will be displayed when the countdown is finished.

CAUTION
Do not open the reagent carousel cover before the countdown is finished;
otherwise, probe collision or other error may occur.
4 To load non-bar-coded reagents, select OK and then Load F1, and
remove the reagent carousel cover; to load bar-coded reagents, just
remove the reagent carousel cover.

5 Place the reagents in correct positions:

Place the reagents in positions 1-78 of the reagent carousel.

6 Restore the reagent carousel cover.

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 5 Reagents

 For load of non-bar-coded reagents, enter the reagent information

on the Load Reagent window and then select End Load F2.
 For load of bar-coded reagents, the system scans all reagents
positions automatically and read reagent information from the bar
code, when End Load F2 button is selected.

The system will resume the tests or select the icon to start new
test.

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5.8 Off-line Load of Reagents

5.8.1 Introduction
The off-line load of reagents is performed while the system is not running
any tests. You are allowed to directly place the reagents on the reagent
carousel, sample carousel or other positions.

WARNING
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise
caution when working around the probes.

BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.
Do not touch the reagent directly with your body; otherwise, skin wound or
inflammation may be caused.

5.8.2 Off-line Load of Reagents

1 Remove the reagent carousel cover.

2 Place the reagents in correct positions:

Place the reagents in positions 1-78 of the reagent carousel.

3 Restore the reagent carousel cover.
 For load of non-bar-coded reagents, enter the reagent information
on the Load Reagent window.
 For load of bar-coded reagents, when the reagents have been
loaded and the reagent carousel cover has been restored, select
End Load F2 button, the system scans all reagent positions
automatically and read reagent information from the bar code.

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5.9 On-Line Replacement of Reagents

5.9.1 Introduction
When a reagent is insufficient or exhausted or going to be expired while
the system is running tests, you should request for reagent stop and
replace the reagent immediately to ensure that the following
measurements will be done smoothly.

5.9.2 On-Line Replacement of Reagents

1 Select Reagent-Reagent/Calibration.

2 Select a reagent carousel from the dropdown box of reagent

carousel.

3 Confirm the reagent to be replaced and select the reagent position.

4 Select Load F1 to request for reagent stop.

The system status area shows a countdown for reagent stop, and a
message box will be displayed when the countdown is finished.

CAUTION
Do not open the reagent carousel cover before the countdown is finished;
otherwise, probe collision or other error may occur.
5 To load non-bar-coded reagents, select OK and then Load F1, and
remove the reagent carousel cover; to load bar-coded reagents, just
remove the reagent carousel cover.

6 Remove the reagent.

7 Place the new reagent.

8 Restore the reagent carousel cover.

If Auto Refresh Reagent Inventory is enabled on the System
Setup-Reagent/Calibration window(refer to 5.4.3 Auto refreshing
reagent inventory), please follow the steps below:
 For load of non-bar-coded reagents, select the reagent position
and enter the reagent information on the Load Reagent window
and then select End Load F2.
 For load of bar-coded reagents, select End Load F2 and the
system scans all reagent positions automatically and read
reagent information from the bar code.

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5 Reagents

If Auto Refresh Reagent Inventory is not enabled on the System

Setup-Reagent/Calibration window(refer to 5.4.3 Auto refreshing
reagent inventory), please follow the steps below:
 For load of non-bar-coded reagents, select the reagent position
and select Load F1 and then select Unload F4.Enter the reagent
information again on the Load Reagent window and then select
End Load F2.
 For load of bar-coded reagents, select End Load F2 and the
system scans all reagent positions automatically and read
reagent information from the bar code.

The system will resume the tests or select the icon to start new
test.

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 5 Reagents

5.10 Off-Line Replacement of Reagents

5.10.1 Introduction
When a reagent is insufficient or exhausted or going to be expired while
the system is not running any tests, you should replace the reagent
immediately to ensure that the following measurements will be done
smoothly.

5.10.2 Off-Line Replacement of Reagents

1 Remove the reagent carousel cover.

2 Remove the reagent.

3 Place the new reagent.

4 Restore the reagent carousel cover.

 For load of non-bar-coded reagents, enter the reagent information
on the Load Reagent window.
 For load of bar-coded reagents, when the reagents have been
loaded and the reagent carousel cover has been restored, select
End Load F2 button, the system scans all reagent positions
automatically and read reagent information from the bar code.
If Auto Refresh Reagent Inventory is not enabled on the System
Setup-Reagent/Calibration window(refer to 5.4.3 Auto refreshing reagent
inventory), Before running the tests, please use the Inventory Check
function to refresh the reagent inventory of the newly loaded reagent,
otherwise they cannot be used. For more details about inventory check,
refer to 5.5 Reagent Inventory Check(Page 5-9).

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5 Reagents

5.11 Unloading Reagents

5.11.1 Introduction
If some chemistries will not be used, you are allowed to clear the
chemistry parameters and unload the relevant reagents. The Unload
option is also used to remove reagents that are going to be exchanged.
All reagents other than ISE reagent, sample wash solution, reagent wash
solution, physiological saline and concentrated wash solution can be
removed through the Unload function. When a chemistry is requested for
quality control, sample analysis or calibration, all reagents of the
chemistry still can be unloaded.
When a reagent is unloaded, all relevant information and its position are
cleared. The reagents that are being used for analysis cannot be
unloaded.

5.11.2 Unloading Biochemical Reagents

The following procedures are only applicable to unloading the reagents
without bar code; for those reagents with barcode, when the reagents are
taken away from the reagent carousel, they are unloaded automatically.
1 Make sure that the reagent to be unloaded is not being used for
analysis.

2 Select Reagent-Reagent/Calibration.

3 Select the up and down arrow buttons to display the biochemical

regent/calibration screen.

4 Select the reagent position to unload reagent.

5 Select Load F1.

6 Select Unload F4.

7 Remove the reagent carousel cover.

8 Take out the reagent from the reagent carousel.

9 Restore the reagent carousel cover.

10 Select Exit F5 to close the window.

11 Select End Load F2.

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 6 Calibration

 Calibration status and alarm indication

 Calibrator dilution setup
 Reagent blank
 Auto calibration
 Extending calibration time
 Overriding a calibration
 Calibration results recall

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6 Calibration

6.1 Overview
In a calibration, the system measures the response of the calibrator with
given concentration, and then calculates the factors in the
concentration-response equation. In this way, a math equation about
concentration and response is determined. The concentration of a patient
sample can be calculated based on the math equation and the measured
sample response.
When the calibration status is abnormal, the system will give an alarm
and display the calibration status with specific color. The system allows
multiple concentrations of a calibrator for multi-point calibration. The
calibration factors can be adjusted through a reagent blank test. When
you set up the auto calibration conditions, the system will automatically
remind you of calibrating chemistries. Expired calibration factors can be
used again by extending the calibration time. You are allowed to override
a failed calibration and obtain results based on the failed calibration
factors.

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 6 Calibration

6.2 Calibration Status and Alarm

On the Reagent/Calibration screen, the chemistries are indicated with
various texts and colors for different calibration status. Chemistries in Cal
Required, Cal Failed or Cal Time Out status can be requested but will not
be run.
Check the chemistries’ calibration status frequently and take relevant
actions according to the following table.

Table 6.1 Calibration status

Calibration Description Severity Color
Status
Cal Required Indicates that the chemistry needs to be Serious Red
calibrated.
This status appears when the chemistry
is not calibrated or has no calibration
factors calculated due to un-monotonic
or in-convergent calibration curve.
Requested Indicates that the chemistry has been Normal No color
requested for calibration but the test indication
has not begun.
Calibrated Indicates that the chemistry has been Normal No color
calibrated and has not exceeded the indication
calibration period.
Cal Failed Indicates that the test has finished but Serious Red
cannot calculate the final result, or the
calculated result exceeds the
acceptance limits.
Cal Time Out Appears when the chemistry exceeds Serious Red
the calibration period or the reagent of
different serial number and lot number
is used.
Cal Time Indicates that the calibration period has Warning Yellow
Extended been extended and the current
calibration factors can be used without
time limit.
Calculated Indicates that the calibration factors of Warning Yellow
the chemistry have been calculated and
can be used without time limit.
Edited Indicates that the calibration factors of Warning Yellow
the chemistry have been edited and can
be used without time limit.
Cal Indicates that the test results of the Warning Yellow
Overridden chemistry are based on a failed
calibration, and flagged accordingly.
N/A Indicates the reagent has no calibration Normal No color
status. indication

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6 Calibration

6.3 Calibrator Dilution Setup

6.3.1 Introduction
The system supports diluted calibrator(s) and allows one calibrator to
have 9 concentrations for the same chemistry. You are only required to
enter the final concentration of the diluted calibrator and the diluted
calibrator volume aspirated by the sample probe during calibration. The
system will automatically calculate the diluent volume and the sample
volume for diluting. When you set up the dilution factors for a chemistry,
its original calibrator concentration will be removed.
Diluted calibrator is only applied to biochemical chemistries rather than
ISE chemistries.
You are allowed to edit or delete the calibrator dilution factors when the
system is not running any tests.

6.3.2 Setting up Calibrator Dilution Factors

1 Select Reagent-Setup.

2 Choose a calibrator in the left list.

3 Choose a chemistry in the right list.

4 Select Dilute F5.

Figure 6.1 Calibrator Dilution Setup window

5 Select the unit from the Unit dropdown box for the calibrator.

If the selected unit is different from the result unit of the chemistry,
the configured parameters will be converted automatically to the
values corresponding to the current result unit.

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 6 Calibration

6 Enter the final concentration of the diluted calibrator in the Conc field.

7 Enter the calibrator volume dispensed by the sample probe during

calibration in the Aspirated Vol field.

The input must be an integer multiple of 0.1 within 1.5μl-45μl. This

field is required.
8 Enter the calibrator volume used for diluting in the Neat Vol field.

The input must be an integer multiple of 0.1 within 2μl-45μl. This field
can be left blank.
9 Enter the diluent volume used for diluting in the Diluent Vol field.

The input must be an integer multiple of 1 within 120μl-350μl. This

field can be left blank.

NOTE
If the neat sample volume and diluent volume are defined, ensure that the sum
of the two volumes is within 120μl-360μl.
The two volumes must be defined or left blank simultaneously.
10 Select Save.

11 To define more concentrations for the calibrator, repeat step 5 to 9.

12 To set up dilution factors for other calibrators, repeat step 5 to 10.

13 Select Close to exit the window.

6.3.3 Editing Calibrator Dilution Factors

1 Select Reagent-Setup.

2 Choose a calibrator in the left list.

3 Choose the chemistries.

4 Select Dilute F5.

5 Choose a concentration line to edit.

6 Select Edit.

The selected concentration line is editable.

7 Change the concentration, sample volume, neat sample volume and
diluent volume.

NOTE

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6 Calibration
If the neat sample volume and diluent volume are defined, ensure that the sum
of the two volumes is within 120μl-360μl.
The two volumes must be defined or left blank simultaneously.
8 Select Save.

9 Select Close to exit the window.

6.3.4 Deleting Calibrator Dilution Factors

1 Select Reagent-Setup.

2 Choose a calibrator in the left list.

3 Choose a chemistry in the concentration list.

4 Select Dilute F5.

5 Choose a concentration line to delete.

6 Select Delete.

7 Select Close to exit the window.

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 6 Calibration

6.4 Reagent Blank

6.4.1 Introduction
In a reagent blank test, the reagents react with the physiological saline or
a calibrator with concentration of 0, and then the blank absorbance is
calculated. When a reagent is uncapped for a long period, the reagent
absorbance may be changed. At this time, you are allowed to run a
reagent blank instead of calibration to calculate the reagent blank
absorbance, which will be used to adjust the calibration factors of the
reagent in order to ensure reliable sample results.
The reagent blank is allowed only in the following calibration status:
Calibrated which means the calibration is successfully performed.
If the reagent blank results, including the mixed blank absorbance and
blank response, are within the acceptance range, the system will update
the calibration factors and the remaining calibration time based on the
results. If the results exceed the acceptant limits, the system will give an
alarm and remind you to rerun the reagent blank. The Biochemistry
Calibration screen shows the calculated reagent blank response,
absorbance and run date.
Reagent blank is applied to biochemical chemistries only.

6.4.2 Mixed Blank Absorbance and Response

When defining a chemistry, you need to set up the mixed blank
absorbance and blank response to check the reagent blank results.
The mixed blank absorbance indicates the allowable range of the
absorbance measured at the end point of a zero-concentration calibrator
reaction or a reagent blank reaction. If the absorbance measured at the
reaction end point is beyond the set range, the system will flag the test
result.
The blank response specifies the allowable range of the response in a
zero-concentration calibrator analysis or a reagent blank test. If the
response is beyond the set range, the system will flag the test result.
1 Select Utility-Chemistries.

2 Choose a biochemical chemistry, or enter the chemistry name in the

Chemistry Name field.

3 Select Define F1.

4 Select the down-arrow button to show the error detection parameters

setup page.

5 Enter the mixed blank absorbance range in the Mixed Blank Abs field.

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6 Calibration

Both the low and high limits must be an integer within -33,000-33,000.
The default is -33,000-33, 000, and it can be left blank.
6 Enter the blank response range in the Blank Response field.

Both the low and high limits must be an integer within

-33,000-33,000.The default is -33,000-33, 000, and can be left blank.
7 Select Save F7.

6.4.3 Requesting a Reagent Blank

Please note that reagent blank can only be run in following conditions:
 Chemistries with all calibration math models rather than two-point
linear and K factor must have the 0-concentration calibrator set up.
 K factor chemistries must have calibrators set up.
 Chemistries of all calibration math models rather than K factor must
have been successfully calibrated.
1 Select Reagent-Reagent/Calibration,

2 Select a reagent carousel from the dropdown box of reagent

carousel.

3 Select the up and down arrow buttons to display the biochemical

reagent/calibration screen.

4 Choose the chemistries.

5 Check if the desired chemistries’ calibration status is Calibrated, Cal

Time Out or Cal Required.

6 Select Cal F5.

7 Choose Rgt Blk.

8 Select OK.

9 Select the icon to start the analysis.

6.4.4 Recalling Reagent Blank Results

If the reagent blank results are within the acceptance limit range, they will
be used to update the current calibration parameters. You are allowed to
recall the reagent blank response, absorbance and run date on the
Biochemistry Calibration screen. Calibration curve of reagent blank
cannot be recalled.

Recalling reagent blank response

1 Select Reagent-Biochemistry Calibration.

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 6 Calibration

2 Choose a chemistry in the Chem pull-down list.

3 Select Search F1.

The calibration results and reagent blank results of the chemistry are
displayed in the result list.
4 Choose a calibration result.

5 Select Reac Curve F3.

Figure 6.2 Reagent blank reaction curve

The response value current displayed is the updated reagent blank

response.
6 Select the reaction data table to view the reagent blank reaction data.
Figure 6.3 Reagent blank reaction data

7 Choose the following buttons as needed:

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6 Calibration

 Prev F4: to view reaction curve and data of the previous calibrator
of the chemistry.
 Next F5: to view reaction curve and data of the next calibrator of
the chemistry.
 Print F7: to print the current reaction curve or data.
8 Select Close F8.

Recalling reagent blank trends

1 Select Reagent-Biochemistry Calibration.

2 Choose a chemistry in the Chem pull-down list.

3 Select Search F1.

The calibration results and reagent blank results of the chemistry are
displayed in the result list.
4 Choose a calibration result.

5 Select Trend F6.

Figure 6.4 Graphic Trend tab page

6 Choose a trend type you want to recall.

The options include:

 R1 blank absorbance
 Mixed blank absorbance
 Calibrator response
 K factor (for linear calibrations only)
7 Select the calibration time range.

8 Select Search F1.

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 6 Calibration

The graphical trend of the selected chemistry within the specific

period is displayed.
9 Select the Tabular Trend tab to view the trend data.
Figure 6.5 Tabular Trend tab page

10 Choose the following buttons as needed:

 Prev F4: to view the calibration trends and data of the previous
chemistry.
 Next F5: to view the calibration trends and data of the next
chemistry.
 Print F7: to print the current graphic trend or data.
11 Select Close F8 to close the window.

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6 Calibration

6.5 Auto Calibration

6.5.1 Introduction
Based on the auto calibration conditions, the system can determine
chemistries that need to be calibrated and remind you through calibration
status and color indication. Auto calibration conditions include:
 Calibration factors’ validity period
 Reagent lot changed
 Reagent bottle changed
When the lot number or serial number of R1, R2, R3 or R4 is changed,
calibration is required. If no lot number or serial number is set for the
reagents, the chemistries will not be calibrated automatically even though
the conditions are met. When the calibration time is exceeded, the system
will remind you of running calibrations.

6.5.2 Auto Calibration Setup

1 Select Reagent-Setup.

2 Select Rules F4.

3 Choose a chemistry from the Chem pull-down list.

Figure 6.6 Calibration Setup window

4 Choose auto calibration conditions:

 Bottle changed: The system will remind you to run calibration

when you use a different bottle of reagents.
 Lot changed: The system will remind you to run calibration when
you use reagents of a different lot. If the reagents have no lot

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 6 Calibration

number, they will be considered as the same lot and different from
other lots.
 Calibration time: The system will remind you in 30 minutes before
the calibration is timed out and display the chemistry’s calibration
status with yellow.

NOTE
If the Manage Reagents by Lot option on the System Setup screen is enabled,
Bottle Changed and Lot Changed will not appear. When a different reagent lot
is used, the system will request and run calibration automatically.
5 Select Save F7.

6 Select Prev F4 or Next F5 to set up the calibration rules for other

chemistries.

7 Select Close F8 to close the window.

6.5.3 Auto Calibration Reminding

When the auto calibration conditions are satisfied, the system will remind
you through the calibration status, prompt message and color indication.
 If you choose the Bottle Changed option, the system will display the
calibration status as Cal Required and shows a message indicating
calibration is required when you use a different bottle of reagents.
 If you choose the Lot Changed option, the system will display the
calibration status as Cal Required and shows a message indicating
calibration is required when you use reagents of a different lot.
 If you choose the Cal Time option, the system will remind you in 30
minutes before the calibration is timed out and display the chemistry
name and calibration status with yellow.

6.5.4 Removing Auto Calibration

To disable the auto calibration, perform the following steps:
1 Select Reagent-Setup.

2 Select Rules F4.

3 Choose a chemistry from the Chem pull-down list.

4 Deselect all auto calibration conditions.

5 Select Save F7.

6 Select Close F8 to close the window.

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6.6 Extending Calibration Time

6.6.1 Introduction
Calibration factors that exceed the calibration period cannot be used for
result calculation. The calibration status becomes Cal Required and the
chemistry can no longer be run. The system will display a warning
message in 30 minutes before the calibration is timed out, and you are
allowed to recalibrate the chemistry or extend its calibration time. If you
are certain that the calibration factors are correct and valid, you may
prolong their validity period by using the calibration time extension
function. A calibration time can be extended only if the current calibration
of the chemistry is timed out. The results calculated based on extended
calibration factors will be flagged.

6.6.2 Extending Calibration Time

1 Select Reagent-Reagent/Calibration.

2 Select a reagent carousel from the dropdown box of reagent

carousel;

3 Select the up and down arrow buttons to display the biochemical

reagent/calibration screen.

4 Choose a chemistry you want to extend.

5 Select Cal Options F8.

6 Select Extend Calibration Time from the Calibration Options

window.
Figure 6.7 Calibration Options window

7 Select OK. The calibration factors of the selected chemistry can be

used without time limit.

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 6 Calibration

6.6.3 Removing an Extended Status

Calibration extension is not absolutely definite. Recalibrate the chemistry
to remove the extended status.

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6 Calibration

6.7 Calibration Override

6.7.1 Introduction
The Calibration Override option allows the system to override a failed
calibration and calculate results based on the failed calibration factors.
Calibration override is only applied to failed calibrations. Results that are
obtained based on failed calibration factors will be flagged.

CAUTION
Before overriding a calibration, make sure that the calibration factors are within the
acceptance limits of your laboratory. The magnitude of the error should be totally
under the control of your laboratory. Use of overridden calibration factors may lead
to unreliable results and influence the doctor’s diagnosis. Think twice before
overriding a failed calibration.

6.7.2 Overriding a Calibration

1 Select Reagent-Reagent/Calibration.

2 Choose a chemistry you want to override.

3 Select Cal Options F8.

4 Select Calibration Override from the Calibration Options window.

Figure 6.8 Calibration Options window

5 Select OK. The failed calibration factors of the selected chemistry can
be used for result calculation.

6.7.3 Removing Cal Overridden Status

Recalibrate the chemistry to remove its Cal Overridden status.

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6.8 Reject
6.8.1 Introduction
If the current calibration fails but sample analysis needs to be performed
immediately, you may use the Reject function to reject the current
calibration factors, and use the latest valid ones for calculating sample
results. Calibration factors of status other than Requested and Cal
Required can be rejected. Rejected calibration factors cannot be rejected
again.

6.8.2 Rejecting a Calibration

1 Select Reagent-Reagent/Calibration.

2 Choose a chemistry you want to reject.

3 Select Cal Options F8.

4 Select Reject from the Calibration Options window.

Figure 6.9 Calibration Options window

5 Select OK. Calibration factors of the selected chemistry are rejected.

6.8.3 Removing Reject Status

Recalibrate the chemistry to remove its Reject status.

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6.9 Recalling Calibration Results

On the Biochemistry Calibration screen you are enabled to recall the
current and stored calibration factors of a chemistry. If the Manage
Reagents by Lot option on the System Setup screen is enabled, you can
recall calibration results of each reagent lot. The Current calibration
factors are obtained in the recent calibration and are being used for result
calculation. You are allowed to recall the calibration curve, calibration
reaction curve and calibration trends during the specified period, and edit
or recalculate the calibration factors.

6.9.1 Recalling Current Calibration Factors

1 Select Reagent-Biochemistry Calibration.

The screen shows all the calibrations requested on the day, including
the following information:
 Chemistry name
 Lot number
 Result flag
 Calibration status
 R0: reagent blank response
 K: K factor
 A, B, C and D: factors a, b, c and d in nonlinear calibration
equations
 Run date and time
2 Choose a chemistry from the Chem pull-down list.

3 Select Search F1.

The current calibration factors of the chemistry are displayed in the

result list.
4 To print the calibration report, select Print F7.

6.9.2 Recalling History Calibration Factors

1 Select Reagent-Biochemistry Calibration.

2 Choose the History option button.

3 Choose a chemistry from the Chem pull-down list.

4 Select the date range in the Cal Date field.

5 Select Search F1.

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 6 Calibration

The calibration factors used within the specified period are displayed
on the screen.
6 Choose the following buttons as needed:

 Cal Curve F2
 Reac Curve F3
 Edit F4
 Archive F5
 Trend F6
 Print F7

6.9.3 Calibration Curve

A calibration curve reflects the mathematical relation between calibrator
concentration and response. It is drawn based on the obtained response
and the multiple values between the minimum and maximum
concentrations of the calibrator. The calibration curve is a straight line in
linear calibrations and a curve in nonlinear calibrations.
1 Search for desired calibration results on the Biochemistry Calibration
screen.

2 Choose a chemistry in the result list.

3 Select Cal Curve F2. The Calibration Curve window is displayed.

Figure 6.10 Calibration Curve window

4 Choose the following buttons as needed:

 Prev F4: to view the calibration curve of the previous chemistry.

 Next F5: to view the calibration curve of the next chemistry.

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6 Calibration

 Recalculate F6: to recalculate the calibration factors based on the

specified math model.
 Print F7: to print the current calibration curve.
5 Select Close F8 to close the window.

Recalculating calibration factors

When a calibration is finished, the system allows recalculating of the
calibration factors based on the new math model. A flag indicating that
the calibration result is recalculated will appear on the Biochemistry
Calibration screen.
Recalculating calibration factors is not applicable to K factor calibrations.
Calibration factors that have been recalculated cannot be calculated
again.
1 Select Reagent-Biochemistry Calibration.

2 Search for desired calibration results to recalculate.

3 Choose a chemistry in the result list.

4 Select Cal Curve F2.

5 Select Recalculate F6. The Recalculate window shows.

Figure 6.11 Recalculate window

6 Choose a math model from the Math Model pull-down list.

The corresponding calculation formula is displayed in the text box to

the right of the Math Model field.
7 Choose calibrators to recalculate in the left list. Move the scroll bar to
view more calibrators.

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 6 Calibration

Choose the correct number of calibrators corresponding to the math

model. For more information, refer to 3.3.6 Setting up Calibration
Rules (page 3-34).
8 Select Save F7.

The system will recalculate the calibration factors with the selected
math model and calibrators.
 If the recalculation is succeeded, the new calibration factors will
be displayed on the Biochemistry Calibration screen with the
calibration status shown as Recalculated, and “CALR” will appear
in the corresponding Flag column.
 If the recalculation is failed, the system will show a message box
indicating the old calibration factors will remain to be used.
9 To view the reaction curve of the selected calibrator, select Reac
Curve F1.

10 Select Close F8 to close the window.

6.9.4 Calibration Reaction Curve

A calibration reaction curve reflects the relationship of the absorbance
measured at the primary wavelength, secondary wavelength and
primary-secondary wavelength. It is drawn based on the absorbance of
the calibrator-reagent mixture measured within the reaction period.
Observing reaction curve:
1 Search for desired calibration results on the Biochemistry Calibration
screen.

2 Choose a chemistry in the result list.

3 Select Reac Curve F3. The Reaction Curve window is displayed.

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6 Calibration
Figure 6.12 Reaction Curve window

4 Select a point on the curve. Relevant measuring period and

absorbance are displayed on the right of the window.

5 Select a filter condition from the following options:

 None: observe reaction curve and data in the default mode.

 Chemistry: observe reaction curve of the results for the selected
test.
 Calibrator: observe reaction curve of the results for the selected
calibrator.
6 Choose the Reaction Data tab to view the reaction data.
Figure 6.13 Reaction Data tab page

7 Choose the following buttons as needed:

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 6 Calibration

 Reagent F1: to view the calibrators and reagents used in

calibration, and reagents for reagent blank test.
 Sample Blank F2: to view the sample blank reaction curve and
reaction data of the calibrator.
 Adjust F3: to adjust the absorbance display range of current
reaction curve. Refer to 8.12.8 Reaction Curve (Page 8-44) for
details.
 Prev F4: to view reaction curve and data of the previous calibrator
of the chemistry.
 Next F5: to view reaction curve and data of the next calibrator of
the chemistry.
 Print F7: to print the current reaction curve or data.
8 Select Close F8 to close the window.

Viewing reagent information:

On the calibration reaction curve window, you are allowed to view the
calibrators and reagents used in calibration, and reagents for reagent
blank test.
1 Search for desired calibration results on the Biochemistry Calibration
screen.

2 Choose a chemistry in the result list.

3 Select Reac Curve F3. The Reaction Curve window is displayed.

4 Select Reagent F1.

Figure 6.14 Reagent window

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6 Calibration

The window shows the calibrators and reagents used in calibration,

and reagents for reagent blank test.
5 Select Close to exit the window.

6.9.5 Editing Calibration Factors

If the calibration factors of linear calibration are higher or lower than the
expected values or than those obtained on other instruments, you are
allowed to edit them to keep them consistent with the expected ones or
those on other instruments. A flag will appear for results calculated based
on edited calibration factors, and the calibration curve and reaction curve
of edited calibration factors cannot be recalled.
Prior to editing calibration factors, ensure that you have sufficient
permissions and the system status is not Running.
1 Select Reagent-Biochemistry Calibration.

2 Search for desired calibration results to edit.

3 Choose a desired chemistry.

4 Select Edit F4. The Edit window shows.

Figure 6.15 Edit window

5 Type in slope K and offset R0.

6 Select Save.

The system will refresh the calibration results and curves with the
input slope and offset, and take the edited calibration factors as the
defaults.
7 Select Close to exit the window.

6.9.6 Archiving Calibration Results

The system allows you to archive all searched calibration results to a
designated hard disk directory or to a storage device, such as U disk.
Archived calibration results are displayed in the same format as on the

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 6 Calibration

software screen. The archived content includes: chemistry name, flag,

calibration status, R0, K factor, calibration coefficients A/B/C/D, and
calibration time. The archiving file is of .csv format and named by date
and time.
1 Select Reagent-Biochemistry Calibration.

2 Search for desired calibration results.

3 Select Archive F5.

4 Specify archiving path and file name.

5 Select Save.

6.9.7 Calibration Trends

Calibration graphical trends summarize a chemistry’s calibrations during
a period of time and reflect the trends of the calibrations. The calibration
graphical trends show the chemistry’s R1 blank absorbance, mixed blank
absorbance and calibrator response.
R1 blank absorbance and mixed blank absorbance are available only for
chemistries with 0-concentration calibrators. The K factor trends can be
recalled for linear chemistries.
The following results can be recalled in a trend:
 R1 blank absorbance: displays calculated and valid calibration results
with the calibration status of Calibrated, Cal Failed, Cal Time Out, Cal
Time Extended and Cal Overridden.
 Mixed blank absorbance: displays calculated and valid calibration
results with the calibration status of Calibrated, Cal Failed, Cal Time
Out and Cal Time Extended.
 Calibrator response: displays calculated and valid calibration results
with the calibration status of Calibrated, Cal Failed, Cal Time Out and
Cal Time Extended.
 K factor: displays calculated and valid calibration results with the
calibration status of Calibrated, Cal Failed, Cal Time Out and Cal Time
Extended.

Follow this procedure to observe calibration trends:

1 Search for desired calibration results on the Biochemistry Calibration
screen.

2 Choose a chemistry in the result list.

3 Select Trend F6. The Calibration Trends window is displayed.

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6 Calibration
Figure 6.16 Calibration Trends window

4 Choose a trend type you want to recall.

The options include:

 R1 blank absorbance
 Mixed blank absorbance
 Calibrator response
 K factor (for linear calibrations only)
5 Select the date range in the Cal Date field.

6 Select Search F1.

The trend within the specified period is displayed on the screen.

7 Choose the Tabular Trend tab to view the trend data.
Figure 6.17 Tabular Trend window

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 6 Calibration

8 Choose the following buttons as needed:

 Reac Curve F3: to view the reaction curve and data of the current
calibration test.
 Prev F4: to view the calibration trends and data of the previous
chemistry.
 Next F5: to view the calibration trends and data of the next
chemistry.
 Print F7: to print the current graphic trend or data.
9 Select Close F8 to close the window.

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 7 Quality Control

This chapter describes applications of quality control, which include:

 Daily and monthly QC procedure
 QC alarm indications
 QC result flags
 Control status
 QC evaluation
 Auto QC
 Control results recall

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7 Quality Control

7.1 Overview
7.1.1 Introduction
A QC run may require more than one control samples. You are
recommended to use two control samples, one with normal values (within
the reference range) and the other with abnormal values (beyond the
reference range).
To ensure the system performance, run control samples every time after
you perform a calibration, or change the reagent lot, or maintain and
troubleshoot the instrument.

7.1.2 Quality Control Operating Procedure

After you define a control, chemistry and QC rules, there is no need to edit
them frequently, and you are only required to run control samples every
day to make sure that the system works well. Run control samples
according to the following procedure:
Figure 7.1 Quality control operating procedure

Define Set up two- Print monthly

Set up QC Choose QC Enable auto
Monthly control
parameters rules
control
QC QC plot and
operations samples evaluation QC summary

Program Running
Load control Recall QC Print real-time
control control
Daily operations samples results QC results
samples samples

7.1.3 QC Alarms
The system provides the real-time monitoring of quality controls, and
check if the QC results are under control when a QC run is finished. If the
results exceed the reference range, the system will give an audible alarm
and shows an alarm message indicating the chemistry name, control
name and control rules. For instance, “Chemistry ALT control C1 1-3s out
of control!”. In this situation, you should stop the analysis and find the
causes of the failure, and resume the analysis after solving the problem.
For QC alarms and corrective actions, refer to 17.5 Error Messages and
Corrective Actions (page 17-22).

7.1.4 QC Result Flags

When a QC result is failed, the system will give an audible alarm and show
alarm message to remind you of the failure. Moreover, the following flags
will appear for failed results in the Flag column of the QC reports.
 1-3s
 2-2s
 R-4s
 2-2s

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 7 Quality Control
 4-1s
 10-x
The system checks the failed QC results for system error or random error
and then flag them accordingly. A “#” sign indicates a systematic error,
and an asterisk “*” indicates a random error. For more information about
QC result flags, refer to 17.4 Data Alarm(page 17-10).

7.1.5 Control Status

When you choose a control on the Quality Control screen, the current
status of the control is displayed in the Sample Status field. It is
necessary to understand the control statuses. The table below shows the
various statuses of control samples.

Table 7.1 Descriptions of control status

Control Status Description
N/A Indicates that the control is not programmed for analysis.
Requested Indicates that the control sample has been programmed but
not analyzed yet.
In Progress Indicates that the control sample is being analyzed.
Incomplete Indicates that all chemistries of the control sample have been
finished but one or more of them have no results.
Complete Indicates that all chemistries of the control sample have been
finished with results.

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7 Quality Control

7.2 QC Evaluation
7.2.1 Introduction
The system provides the Westgard rules for evaluating QC results of the
chemistries, and give alarms and flags when the obtained QC results are
beyond the reference range. Since every chemistry may have one or more
control samples, the QC results can be evaluated with different rules
accordingly. Those controls that are not included in any lots will be
evaluated as single controls.

7.2.2 Evaluation of Single Controls

The Westgard rules for evaluation of single controls are listed in the table
below:

Table 7.2 Westgard rules for single controls

Rules Description Flag Error Type
12s One result is between ±2 and ±3 N/A N/A
standard deviations from the
assigned mean concentration.
13s One result is greater than ±3 1-3s *(1)
standard deviations from the
assigned mean concentration.
22s Two continuous results are 2-2s #(2)
greater than +2 or -2 standard
deviations from the assigned
mean concentration, e.g. (Xn,
Xn-1)
41s Four continuous results are 4-1s #
greater than +1 or -1 standard
deviation from the assigned mean
concentration, e.g. (Xn, Xn-1,
Xn-2, Xn-3)
10x Ten results being compared are on 10-x #
the same side, e.g. (Xn, Xn-1,
Xn-2, Xn-3..Xn-9)

(1) An asterisk “*” indicates a random error, which requires no special

action but must not be ignored.
(2) A “#” symbol indicates a systematic error, which requires special
consideration.

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 7 Quality Control
The evaluation procedure of single controls is shown in the figure below:
Figure 7.2 Evaluation procedure of single controls

Control data

No
>2S In-control
Yes No
Yes
12S Warning
No
No No No
13S 22S 41S 10X
Yes Yes Yes Yes

Out of control

7.2.3 Two-Control Evaluation

What is a run
A QC run is based on two control samples: C1 and C2, and at most one
QC run is performed for each chemistry. The system allows the definition
of QC run interval on the System Setup screen. The maximum QC run
interval is 24 hours.
1 Select Utility-System Setup.

2 Select Instrument F1.

3 Choose 9 QC Evaluation.

4 Type in the QC run length in the Run Length field.

Enter an integer between 1 and 24. The default is 24.
5 Select OK.

Two-control evaluation rules

In every QC run, two results are obtained: Xn and Yn, which are used to
define a point on the Twin-plot chart. In this way, a complete twin-plot
chart is drawn based on all the QC results and used for detecting
systematic errors and random errors.

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7 Quality Control
The Westgard rules for two-control evaluation are listed in the table
below:

Table 7.3 Two-control evaluation rules

Rules Description Flag Error Type
12s One result is between ±2 and ±3 N/A N/A
standard deviations from the assigned
mean concentration.
13s One result is greater than ±3 standard 1-3s *(1)
deviations from the assigned mean
concentration.
22SA Two results (Xn, Yn) of a run are 2-2s #(2)
simultaneously greater than +2 or -2
standard deviations from the assigned
mean.
R4s One result of a run is greater than +2 R-4s *
standard deviations from the assigned
mean and the other greater than
-2SDs.
22SW Two continuous results of a control are 2-2s #
greater than +2 or -2 standard
deviations from the assigned mean
concentration, e.g. (Xn, Xn-1), (Yn,
Yn-1).
41SA Results of two continuous runs are 4-1s #
greater than +1 or -1 standard
deviation from the assigned mean, e.g.
(Xn, Yn, Xn-1, Yn-1).
41SW Four continuous results of a control are 4-1s #
greater than +1 or -1 standard
deviations from the assigned mean
concentration, e.g. (Xn, Xn-1, Xn-2,
Xn-3), (Yn, Yn-1, Yn-2, Yn-3).
10XA Results of five continuous runs (10 10-x #
results) compared are on the same
side, e.g. (Xn, Yn, Xn-1, Yn-1, Xn-2,
Yn-2, Xn-3, Yn-3, Xn-4, Yn-4).
10XW Ten continuous results (10 results) of a 10-x #
control are on the same side, e.g. (Xn,
Xn-1, Xn-2, Xn-3..Xn-9), (Yn, Yn-1,
Yn-2, Yn-3..Yn-9).

(1) An asterisk “*” indicates a random error, which requires no special

action but must not be ignored.
(2) A “#” symbol indicates a systematic error, which requires special
consideration.
The random errors in two-control evaluation correspond to those in
single-control evaluation as follows:
 22SA\22SW corresponding to 22s.
 41SA\41SW corresponding to 41s.
 10XA\10XW corresponding to 10x.

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 7 Quality Control
The procedure of two-control evaluation is shown in the figure below:
Figure 7.3 Two-control evaluation workflow
Measured values of X
and Y controls

No
12S In control
Yes
No
No No No
22SA R4S 41SA 10XA
Yes Yes Yes Yes

Out of control (occurrence of alarm)

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7 Quality Control

7.3 Auto Quality Control

7.3.1 Introduction
The system provides the auto quality control function. When the
conditions for a QC run are satisfied, the system will request and run the
specified controls automatically. The control samples automatically run
can be selected on the QC Parameters window.
The conditions for auto quality control include:
 Number of samples: indicates the number of patient samples. After
the given number of samples is finished, the system will run the
selected control(s) automatically.
 When calibrated: The system will automatically run the chemistry for
the selected control(s) every time when the chemistry is calibrated.
Auto QC is not applicable to non-measurement calibrations, such as
recalculation and editing.
When the control samples automatically run are selected, all chemistries
configured for the control samples will be run.

7.3.2 Auto QC Setup

1 Select Utility-System Setup.
2 Select Instrument F1.

3 Choose 9 QC Evaluation.
Figure 7.4 QC Parameters window

4 Select Auto QC on carousel.

5 Set up the conditions for auto quality control:

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 7 Quality Control
 Number of Samples: enter the number of samples for auto QC run.
The input range is 10-500, 0 means auto QC is disabled.
 When Calibrated: select the checkbox to allow the system to run
controls when a chemistry is calibrated.
6 Choose controls to be run automatically.

One or more controls can be selected.

7 Select OK.

7.3.3 Auto Quality Control

After setting up auto QC conditions and selecting the Auto QC checkbox
on the Start Conditions window, the system will insert QC runs
automatically once the conditions are met.
1 After setting up auto QC, place controls on the sample carousel.

2 Select on upper right corner of the main screen. The Start

Conditions window is displayed.

3 Select OK. The system will insert a QC run in the current test queue.

7.3.4 Removing Auto QC Status

To remove an auto QC status, clear the auto QC settings on the QC
Parameters window.

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7 Quality Control

7.4 Recalling Control Results

The Recalling Control Results option allows you to view control sample
results, L-J chart, twin-plot chart, analysis data and data summary.
Patient demographics and rerunning are not applicable to controls.

7.4.1 Control Sample Results

1 Select Result-Current Results or History Results.

 The Current Results screen displays all incomplete patient

samples and control samples, as well as those programmed on
the current day.
 The History Results screen displays all patient samples and
control samples programmed before the current day.
2 Choose a result recall mode:

 By sample
 By chemistry
3 When recalling results by sample, choose a control in the left list. The
right list displays all results of the control. When recalling results by
chemistry, choose a chemistry in the left list. The right list displays all
results of the chemistry.

4 Choose the following buttons as needed:

 Search F1: to recall control results.

 Options F2: to delete, edit, rerun or print control samples.
 Reac Curve F4: to view the reaction curve of the selected control.
 Print F7: to print control results.
 Host F8: to transmit the selected control results to the LIS host.

Viewing control reaction curve

1 Search for desired control results on the Current Results or History
Results screen.

2 Choose a chemistry in the result list.

3 Select Reac Curve F4. The Reaction Curve window is displayed.

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 7 Quality Control
Figure 7.5 Reaction Curve screen

4 Choose the Reaction Data tab to view the reaction data.

Figure 7.6 Reaction Data screen

5 Choose the following buttons as needed:

 Sample Blank F2: to view the sample blank reaction curve and
reaction data of the selected control.
 Prev F4: to view the reaction curve and data of the previous
chemistry.
 Next F5: to view the reaction curve and data of the next
chemistry.
 Print F7: to print the current reaction curve or data.
6 Select Close F8 to close the window.

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7 Quality Control
Printing control results
You are allowed to print the selected or all control results on the Current
Results or History Results screen.
1 Search for desired control results on the Current Results or History
Results screen.

2 To print the selected controls, select them in the sample list.

3 Select Print F7.

4 Select Print Sample Report.

5 Choose the print range:

 Selected Sample(s)
 All Sample(s)
6 If you print all samples, you are allowed to skip those that are already
printed out. Mark the Bypass Printed Sample(s) checkbox.

7 Select OK.

7.4.2 Recalling L-J Chart

A Levey-Jennings (L-J) chart, drawn based on the QC date (X) and test
results (Y), shows the QC result trend of a chemistry during the specified
period. The graphical trends of up to 3 controls can be displayed on one
L-J chart and distinguished with different colors. Each page can display
31 QC points. The query date must not be longer than 1 year.

Recalling L-J chart

1 Select QC-Levey-Jennings.

2 Choose a chemistry to recall in the Chem pull-down list box, or select

Chems F2 and then choose a chemistry.

3 Select the date range in the QC Date field.

4 Choose controls you desire to view. Up to 3 controls can be selected.

5 Select Search F1. The L-J chart area shows the QC result trends of
the selected chemistry during the specified period.

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 7 Quality Control
Figure 7.7 Levey-Jennings screen

6 Choose the following buttons as needed:

 Prev F4: to view the L-J chart of the previous chemistry.

 Next F5: to view the L-J chart of the next chemistry.
 Delete F6: to delete the selected point on the L-J chart. If you
want to display the removed points on the L-J chart, mark the
Show Deleted Points checkbox.
 Print F7: to print the current L-J chart.
 Comment F8: to add, modify and delete comments of a QC point.

Adding/Modifying comments
1 Select QC-Levey-Jennings.

2 Select a chemistry, QC date and controls, and then select Search F1

to query the corresponding L-J chart.

3 Choose a QC point on the chart.

4 Select Comment F8, and then input comments for the QC point.
5 Select OK.
Select the QC point on the chart. The comments of this QC point are
displayed in the Comment area at the upper-right corner of the
screen.
To delete the comments of a QC point, select the QC point on the
chart, clear the comments, and then select OK.

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7 Quality Control
Selecting chart option
The L-J chart can be drawn by QC date or QC time. Either of the two
options can be selected to display the L-J chart. The default standard is
QC time.
1 Select QC-Levey-Jennings.

2 Select Chart F3.

Figure 7.8 Chart Options window

3 Choose an option to draw the L-J chart:

 QC Time: The X coordinate of the L-J chart is displayed in the

format of “YYMMDDHHMMSS”.
 QC Date: The X coordinate of the L-J chart is displayed in the
format of “MMDD”.
4 Select OK. The L-J chart is refreshed automatically and displayed in
the selected format.

7.4.3 Recalling Twin-Plot Chart

A twin-plot chart, drawn based on the results of control X and control Y in
the same run, is used to detect systematic errors and random errors. It
shows the recent 10 QC results of a chemistry and excludes those that
have been deleted.
1 Select QC-Twin-Plot.

2 Choose a chemistry to recall in the Chem pull-down list box, or select

Chems F2 and then choose a chemistry.

3 Select Search F1. The twin-plot chart area displays the recent 10
results of control X and control Y for the chemistry.

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 7 Quality Control
Figure 7.9 Twin-Plot screen

4 Choose the following buttons as needed:

 Prev F4: to view the twin-plot chart of the previous chemistry.

 Next F5: to view the twin-plot chart of the next chemistry.
 Print F7: to print the current twin-plot chart.

7.4.4 Recalling QC Data

QC data includes QC results, and the set mean and standard deviation,
and can be recalled based on control name, chemistry name and run date.
1 Select QC-Results.

2 Select Chems F2.

3 Choose a chemistry to recall, and then select OK.

4 Select the date range in the QC Date field.

5 Choose a control in the Control pull-down list.

6 Select Search F1.

The result list shows all results of the control for the chemistry during
the specified period, as well as the set means and standard
deviations.

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7 Quality Control
Figure 7.10 Results screen

7 Choose the following buttons as needed:

 Sort F3: to sequence the QC results by control or chemistry.

 Reac Curve F4: to view the reaction curve and data of the
selected QC result.
 Comment F5: to add comments to the selected QC result.
 Archive F6: to archive the currently displayed QC results to an
external storage device.
 Print F7: to print the QC results currently displayed in the result
list.

Sort QC results
The searched QC results can be rearranged by control or chemistry.
1 Search for desired QC results on the Results screen.

2 Select Sort F3.

Figure 7.11 Sort window

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 7 Quality Control
3 Select a sorting criterion.

 Control: control number + chemistry + run date/time

 Chemistry: chemistry order + control + run date/time
4 Select OK.

The QC results on the Results screen are rearranged ascending based

on the selected criterion.

Viewing control reaction curve

1 Search for desired QC results on the Results screen.

2 Choose a QC result to recall.

3 Select Reac Curve F4. The Reaction Curve window is displayed.

Figure 7.12 Control reaction curve

4 Select a point on the curve. Relevant measuring period and

absorbance are displayed on the right of the window.

5 Select a filter condition from the following options:

 None: observe reaction curve and data in the default mode.

 Chemistry: observe reaction curve of the results for the selected
test.
 Control: observe reaction curve of the results for the selected
control.
6 Select the Reaction Data tab to view the reaction data.

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7 Quality Control
Figure 7.13 Control reaction data

7 Choose the following buttons as needed:

 Reagent F1: to view the reagents used for quality control,

calibrators and reagents used in calibration, and reagents for
reagent blank test. Refer to 8.12.8 Reaction Curve (Page 8-44) for
details.
 Sample Blank F2: to view the sample blank reaction curve and
reaction data of the selected control.
 Adjust F3: to adjust the absorbance display range of current
reaction curve. Refer to 8.12.8 Reaction Curve (Page 8-44) for
details.
 Prev F5: to view the reaction curve and data of the previous
control.
 Next F6: to view the reaction curve and data of the next control.
 Print F7: to print the current reaction curve or data.
8 Select Close F8 to close the window.

Add QC comments
Comments can be added to specific QC result for special notice.
1 Search for desired QC results on the Results screen.

2 Choose a QC result in the result list.

3 Select Comment F5.

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 7 Quality Control
Figure 7.14 Comment window

4 Type in comments for the selected QC result.

Up to 100 characters can be entered.

5 Select OK.

Archive QC data
The system allows archiving of QC results to a storage device. The file
format is CSV and the default file name is QCData.csv. which cannot be
edited. QC results must not be archived to the hard disk.
The archived QC results and data include the following information:

Table 7.4 Archived QC data types

ID Control Result Information
1 Chemistry type
2 Chemistry number
3 Chemistry name
4 Control number
5 Control name
6 Lot number
7 Control concentration
8 Standard deviation
9 Measured results
10 Flag
11 Run date

Perform the following steps to archive QC results and data:

1 Search for desired QC results on the Results screen.

2 Select Archive F6.

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7 Quality Control
Figure 7.15 Archive window

3 Select OK.

7.4.5 Recalling QC Summary

The QC summary reports the measurements of a control for the selected
chemistry during the specified period. It presents you the means,
standard deviations and coefficients of variation in this period, and
compares them with the set mean and SD, enabling you to check if the
system is working normally.
1 Select QC-Summary.

2 Select Chems F2.

3 Choose a chemistry to recall, and then select OK.

4 Select the date range in the QC Date field.

5 Choose a control in the Control pull-down list.

6 Select Search F1.

The result summary of the control for the chemistry is displayed on

the screen.

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 7 Quality Control
Figure 7.16 Summary screen

7 To print the QC summary report, select Print F7.

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7 Quality Control

7-22
8 Sample Programming and Processing

This chapter provides description of functions and operating instructions

about sample analysis, which include:
 Modifying/Adding samples and chemistries
 Rerunning samples
 Programming samples with increased or decreased volume
 Programming diluted samples
 Sample blank
 Loading/Unloading samples
 Viewing unpositioned samples and assign positions for them
 Releasing finished samples
 Viewing sample logs
 Customizing sample information
 Viewing sample and chemistry lists
 Optimizing result display
 Sample results recall
 Workload statistics and result statistics
 Customizing patient demographics

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8 Sample Programming and Processing

8.1 Overview
Sample programming can be performed in manual and auto modes, in
batch or by single, by rerunning or adding chemistry and samples, in
common or quick STAT mode, and via virtual sample carousels.
Chemistries selected for samples include biochemical chemistries, ISE
chemistries, serum index, calculations, off-system chemistries and
panels. If a chemistry will not be used in your laboratory, you are allowed
to mask it and remove it from the chemistry list. Samples can be
programmed and analyzed based on the running options. Patient
demographics should be entered before or during the measurements. You
may view the sample analyzing status through the Status screen. The
system allows the deletion of programmed and complete samples.
These functions and operations will be described in detail in the following
sections.

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8.2 Sample Programming and Processing

8.2.1 Introduction
Except for analysis of routine samples, you often need to add samples or
chemistries to the programming or rerun an abnormal sample. Samples
can be diluted manually or prediluted automatically before being
analyzed.

8.2.2 Adding Samples

BIOHAZARD
Inappropriate handling of samples may lead to biohazardous infection. Do not touch
the samples directly with your hands. Wear gloves and lab coat, if necessary, goggles.
In case your skin contacts the samples, follow standard laboratory safety procedure
and consult a doctor.

CAUTION
Do not use expired samples; otherwise, unreliable test results may be caused.
1 Add samples to the existing programming according to 2.8.1
Programming Routine Samples (page 2-34).

2 Confirm the program information.

3 Select the icon on the upper-right corner of the main screen to

request for sample stop.

4 Check the sample stop countdown in the system status area and wait
until it comes to 0.

5 Check the sample carousel indicators, and proceed to the next step
when the indicators are extinguished.

 Flash: indicates that the corresponding carousel is rotating or is

going to rotate.
 ON: indicates that the corresponding carousel is stopped for
sample aspirating or that the sample probe is aspirating on the
reaction carousel during test for the diluted samples
 OFF: indicates that the corresponding carousel has no sample
being aspirated and will not rotate in the next period.
6 Place the added samples on the assigned positions of the sample

carousel, and then select to start the analysis.

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 If the sample is within the specified position range of the selected

sample carousel, it is analyzed automatically.
 Otherwise, you should specify the sample carousel and position to
start the analysis.

8.2.3 Adding/Modifying Chemistries

No matter in which status a sample is, new chemistries can be added,
and dilution factors and replicates can be defined for them. For samples
that are programmed but not analyzed yet, editing the sample information
(except for STAT feature), patient demographics and chemistries is
allowed; for samples in the status of In Progress, Rerun, Incomplete or
Complete, the sample information and chemistries must not be edited,
while patient demographics can be edited and new chemistries can be
added.
1 Select Program-Sample.

2 Type in the sample ID.

The programming information of the sample is displayed on the

screen.
3 Deselect chemistries you won’t run, and then select chemistries you
desire to run.

4 Deselect panels you won’t run, and then select panels you desire to
run.

5 Choose chemistries and panels to add to the sample.

6 Select Save F8.

 If the system is running tests, it will analyze the added

chemistries and panels automatically.

 If the system is in Standby status, select the icon on the

upper-right corner of the main screen.

8.2.4 Rerunning Samples

Finished samples can be rerun in manual or auto mode. Only chemistries
that have been finished can be rerun. If a chemistry is run for more than
one replicate, it cannot be rerun only when all replicates are finished.
Manual rerun is performed on the List screen, Current Results screen and
History Results screen; auto rerun is performed when a result is beyond
the set critical range or linearity range. Samples in all status are allowed
for rerunning.

Manual rerun on List screen

The Rerun window of the List screen allows you to manually rerun single
or multiple samples that are in Complete, Incomplete, Rerun or In

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Progress status. When rerunning samples, you are allowed to edit the
sample cup type, sample position, STAT feature and chemistries. If a
chemistry is finished, it can be rerun with edited sample volume,
replicates and predilution factor. Sample ID, bar code, sample type and
collection time of rerunning samples must not be edited. If certain
chemistries of a sample are not finished yet before the sample is rerun,
the chemistries for rerunning cannot be modified.
Rerunning single sample:
A single sample can be rerun by specifying the bar code or sample ID.
1 Select Program-Sample.

2 Select List F5.

3 Select Rerun F4.

Figure 8.1 Rerun window

4 Type in the ID or bar code of the sample you desire to rerun or enter
the barcode of the sample.

5 To edit sample information, select Select.

Figure 8.2 Rerun Samples window

6 Edit the following information:

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 Position: change the carousel number and position of the sample.

 STAT: select or deselect the STAT checkbox.
 Comment: choose or enter a sample comment.
 Chemistry and panel: change chemistries and panels.
 Options: edit the number of replicates and predilution factors for
the sample or for a chemistry, and then modify the sample cup
type.
7 Select Save F8.

8 Select Exit F7.

9 After confirming all rerun information, load samples to the assigned

positions, and select to start the analysis.

 If the sample is within the specified position range of the selected

sample carousel, it is analyzed automatically.
 Otherwise, you should specify the sample carousel and position to
start the analysis.
Rerunning batch samples:
Batch samples can be rerun by specifying the sample ID range and with
same chemistries.
1 Select Program-Sample.

2 Select List F5.

3 Select Rerun F4.

Figure 8.3 Rerun window

4 Type in the sample ID or range you desire to rerun.

Separate single samples with comma, e.g. 5, 7, 9; and connect

multiple continuous samples with a dash, e.g. 1-3.
5 To edit sample information, select Select.

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Figure 8.4 Rerun Samples window

6 Edit the following information:

 Position: change the carousel number and position of the sample.

 STAT: select or deselect the STAT checkbox.
 Comment: choose or enter a sample comment.
 Options: edit the number of replicates and predilution factors for
the sample or for a chemistry, and then modify the sample cup
type.
7 Select Save F8.

8 Select Exit F7.

9 Select Batch.
Figure 8.5 Rerun Batch window

10 Choose chemistries for rerunning the samples.

The list includes all chemistries that have been enabled and
configured. The selected chemistries will be requested for rerunning
the samples.

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11 Select OK.

12 After confirming all rerun information, load samples to the assigned

positions, and select to start the analysis.

 If the samples are within the specified position range of the

selected sample carousel, they are analyzed automatically.
 Otherwise, you should specify the sample carousel and position to
start the analysis.

Manual rerun on Current Results or History Results screen

1 Select Result-Current Results or History Results.

2 Choose the By Sample option.

3 Search for desired sample results.

4 Check the Flag column for flags indicating abnormities.

5 Choose results you desire to rerun.

6 Select Rerun F5.

Figure 8.6 Rerun window

7 Change the carousel number and position of the sample.

8 Select a sample volume type to rerun the sample.

The sample volume is the same as that defined for the chemistry. If
increased and decreased volumes are defined for the chemistry,
Increased and Decreased are available here for selection.
9 Enable or disable sample blank for the sample.

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Only when the Set Sample Blank Individually checkbox is selected on

the Factory Settings screen, the Sample Blank option will appear. If
you need the settings, contact our customer service department or
your local distributor.
10 Choose a sample tube type. The options include micro and standard.

11 Enter the off-line dilution factor.

The input range is 2-9999, and the default is blank.

12 Enter the predilution factor.

The input range is 4-176, and the default is blank. When dilution
factors for both normal run and rerun are defined, the product of the
two factors and the auto dilution factor must not be greater than 176.
13 If you want to run a chemistry with different sample volume,
replicates and predilution factor, enter the values in the chemistry
option area:

 Sample Vol: sample volume required to run the chemistry. The

sample volume is the same as that defined for the chemistry. If
increased and decreased volumes are defined for the chemistry,
Increased and Decreased are available here for selection.
 Predilution: ratio at which samples containing the chemistry will
be prediluted before being analyzed. When dilution factors for
both normal run and rerun are defined, the product between the
two factors and the auto dilution factor must not be greater than
176.
 Sample blank: set up sample blank for chemistries.
14 Select Save.

15 Load samples to the assigned positions, and select to start the

analysis.

 If the sample is within the specified position range of the selected

sample carousel, it is analyzed automatically.
 Otherwise, you should specify the sample carousel and position to
start the analysis.

Batch rerun on Current Results or History Results screen

When recalling results by chemistry on the Current Results or History
Results screen, you are allowed to rerun multiple samples of a chemistry
that are Complete or Incomplete.
1 Select Result-Current Results or History Results.

2 Choose the By Chemistry option.

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3 Search for desired sample results.

4 Choose a chemistry and samples you desire to rerun.

5 Select Rerun F5.

Figure 8.7 Rerun window

The window shows the selected chemistry and samples, as well as

sample ID, bar code, sample volume in previous test, predilution factor,
sample blank and off-line dilution factor.
6 Enable or disable sample blank for the sample.

7 Modify the sample volume, predilution factor, and off-line dilution

factor.

 Predilution factor: The input range is 4-176, and the default is

blank.
 Off-line dilution factor: The input range is 2-9999, and the default
is blank.
 Sample blank: set up sample blank for chemistries.
8 Select OK.

9 Load samples to the original positions, and select to start the

analysis.

Auto rerun based on critical range

The auto rerun function can be enabled on the Reference/Critical Range
window. Once the auto rerun is enabled, the system will check if the result
is beyond the critical range, and if it is, will rerun the sample.
1 Select Utility-Chemistries.

2 Select Ref Range F4.

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 8 Sample Programming and Processing

3 Choose a chemistry from the Chemistry pull-down list.

4 Set up the reference range and critical range.

5 Mark the Auto Rerun checkbox with a tick.

The system will rerun the sample if the chemistry result is beyond the
critical range.
6 Select Save F7 to save the settings.

7 Select Exit F8 to close the window.

Rerun when meeting auto rerun conditions

The auto rerun function can be also enabled on the Define/Edit
Chemistries window. Once the auto rerun is enabled, the system will
check if the rerun conditions are met, and if they are, will rerun the
sample.
For more information about auto rerun setup, refer to 3.1.3 Auto Rerun
Setup. (Page 3-5).
1 Select Utility-Chemistries.

2 Choose a chemistry.

3 Select Define F1.

4 Select the down-arrow button to show the error detection parameters

setup page.

5 Mark the Auto Rerun checkbox with a tick.

6 Select Utility-System Setup.

7 Set up auto rerun conditions.

The system will rerun the sample if the rerun conditions are met.
8 Select Save F7 to save the settings.

9 Select Close F8 to close the window.

Recalling rerun results

The rerun results of a sample are presented on the Recall Rerun Results
window, through which you are allowed to recall all rerun results. Users
with sufficient permissions are allowed to delete the rerun results of a
sample.
1 Select Result-Current Results or History Results.

2 Search for desired sample results.

3 Choose a sample and then a chemistry you desire to recall.

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4 Select Cal Options F2.

5 Select Recall Rerun Results. The Recall Rerun Results window is

displayed.

The screen shows the sample information and all reruns results of the
chemistry.
Figure 8.8 Recall Rerun Results window

6 The latest rerun result is the default one. To change the default result,
choose a result, and then select Set Defaults.

The Default column of the result shows Y, which stands for Yes.
7 Select Exit to exit the window.

8.2.5 Programming Samples with Increased or Decreased Volume

In common tests, chemistries are run with standard sample volume.
Owing to the specificity of certain sample, the result may be high or low.
To ensure accurate results, the system allows the processing of samples
with increased or decreased volume. When a sample is analyzed with
standard volume and a result is beyond the reference range or deemed
abnormal, you are allowed to rerun the corresponding chemistry manually
with the increased or decreased sample volume.
1 Select Utility-Chemistries.

2 Choose a chemistry.

3 Select Define F1.

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Figure 8.9 Define/Edit Chemistries window

4 Type in the decreased and increased sample volume.

5 Type in the aspirated volume and diluent volume for decreased

sample volume analysis.

6 Type in the aspirated volume and diluent volume for increased

sample volume analysis.

7 Select Save F7.

8 Select Close F8.

9 Select Program-Sample.

10 Enter the following information:

 ID
 Sample position
 STAT status
 Sample type
 Comment
 Chemistries and panels
11 Set the chemistry options:

 Select Options F2.

 Choose a sample volume type and sample cup type.
 Enter the replicates, off-line dilution factor and predilution factor
for the sample.
 Choose a sample volume for the chemistry.
 Enter the replicates and predilution factor for the chemistry.

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 Set up sample blank.

 Select OK.
12 Select OK F8.

13 Select the icon to start the analysis.

8.2.6 Programming Diluted Samples

Due to patient specificity, certain results of a sample may be relatively
high. In this condition, you are allowed to rerun the corresponding
chemistries by manually or automatically diluting the sample at certain
ratio for part or all of the chemistries. When a sample is analyzed and a
result is beyond the reference range or deemed abnormal, you are allowed
to rerun the corresponding chemistry manually with the sample diluted.
You are allowed to set the sample dilution factors when defining a
chemistry or requesting the chemistry for sample analysis. When you set
both the off-line dilution factor and predilution factor when requesting a
chemistry, the result will be multiplied automatically by the two dilution
factors. For chemistries with dilution factors,
 If the dilution factors are not set, the result will be directly multiplied
by the predilution factor.
 If the dilution factors are set, the result will be directly multiplied by
the product between the predilution factor and the ratio calculated
based on the set dilution factors.
If the sample volume, replicates and predilution factor are set for both the
sample and the chemistry, the chemistry will be run based on its own
settings instead of those of the sample.
Perform the following steps to run diluted samples.
1 Select Utility-Chemistries.

2 Choose a chemistry.

3 Select Define F1.

4 Type in the aspirated sample volume and diluent volume for standard
sample volume analysis.

5 Type in the aspirated sample volume and diluent volume for

decreased and increased sample volume analysis.

6 Select Save.

7 Select Close.

8 Select Program-Sample.

9 Enter the following information:

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 ID
 Sample position
 STAT status
 Sample type
 Comment
 Chemistries and panels
10 Select OK F8.

11 Select Options F2.

Figure 8.10 Options window

12 Select a sample volume type to run the sample.

The options include:

 Standard
 Increased
 Decreased
13 Enable or disable sample blank for the sample.

14 Select a sample tube type from the Sample Cup pull-down list.

The options include:

 Microtube
 Standard
15 Enter the off-line dilution factor.

The input range is 2-9999, and the default is blank.

16 Enter the number of replicates.

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The input range is 1-90, and the default is 1.

17 Enter the predilution factor.

The input range is 4-176, and the default is blank.

18 Choose a chemistry.

19 Select a sample volume type in the Sample Vol column for the
chemistry.

20 Enter the number of replicates.

21 Enter the predilution factor.

When dilution factors for both normal run and rerun are defined, the
product between the two factors and the predilution factor must not
be greater than 176.
22 Move the scroll bar to view more chemistries.

23 Select Save.

24 Select the icon to start the analysis.

8.2.7 Sample Blank

Sample blank is similar to sample analysis except for use of equivalent
amount of physiological saline. Sample blank is used for removal of
non-chromogenesis reaction, such as influence of sample interference
(Hemolysis, icterus and lipemia) on absorbance readings.
The sample blank reaction curve is almost a straight line with slope of 0
during the reaction period, and therefore means nothing for fixed-time
and Kinetic analysis. For double, triple and quadruple reagent endpoint
analysis, the sample blank absorbance can be subtracted through
parameter settings. Therefore, sample blank is only effective for
single-reagent endpoint chemistries.

Running a sample blank

1 Select Utility-Chemistries.

2 Choose a chemistry.

3 Select Define F1.

4 Mark the Sample Blank checkbox with a tick.

5 Select Save F7.

6 Select Close F8.

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The system will run a sample blank when running calibrators,

controls and samples for the chemistry.

Recalling sample blank results

1 Select Result-Current Results or History Results.

2 Search for desired sample results.

3 Choose a sample and then a chemistry you desire to recall.

4 Select Reac Curve F4.

5 Select Sample Blank F2.

Figure 8.11 Sample blank reaction curve

6 Choose the Reaction Data tab to view the reaction data.

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8 Sample Programming and Processing
Figure 8.12 Sample blank reaction data

7 To print the reaction curve or reaction data, select Print F7.

8 Select Close F8 to close the window.

8.2.8 Sample Management

Before programming samples, it is necessary to understand the sample
cups, and sample volume of the system, as well as how to load and
unload samples.

CAUTION
Prepare the sample according to the procedure recommended by the tube
manufacturer. For collection and preparation of samples, please see the reagent
Instructions for Use. Use clean tubes, microcups and other disposable materials
specified by the manufacturer. Do not reuse disposables.
When using vacuum collection tube for sample collection, make sure that the cap of
the vacuum collection tube is clean.

Sample cup types

The sample carousel supports blood collecting tube, centrifugal tube,
plastic tube and Microtube, which are available in the following
specifications:
 Microtube: Mindray sample cup, Φ14×25mm, Φ12×37mm
 Blood collecting tube or plastic tube: Φ12×68.5 mm, Φ12×99 mm,
Φ12.7×75 mm, Φ12.7×100 mm, Φ13×75 mm, Φ13×95 mm, Φ13×100
mm.

Sample volume
The amount of sample required for a common measurement is 1.5-45μl,
with an increment of 0.1μl. Analysis with insufficient samples may lead to

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inaccurate results.
If a sample is exhausted during the analysis, the system will
automatically invalidate all incomplete chemistry of the sample. Before
running samples, make sure that they are sufficient in volume for
analysis.

Loading samples

BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.
1 Check if the sample inside the sample tube is sufficient for analysis
and the bar code label is applied correctly.

2 Check the system status.

 If the system status is Running, select to request for sample

stop.
 If the system status is Standby, proceed to the next step.
 If the system status is Incubation, wait until the system gets
steady, and then proceed to the next step.
3 Check if the sample carousel and the sample probe have stopped
moving.

4 To load samples, remove the sample carousel cover.

5 Insert the sample tube into the tube holder until the tube bottom
contacts the groove of the tube rack.

6 Restore the sample carousel.

Unloading samples

BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.

Caution
When unloading Φ16.5×92mm sample cups, remove the sample carousel, or press
the sample carousel with one hand and take out the sample cups with the other
hand.
1 Check if the sample carousel and the sample probe have stopped
moving.

2 If the system status is Running, select to request for sample

stop.

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3 Remove the sample carousel cover.

4 Grab the sample tube and pull it upward to remove it from the tube
holder.

5 Repeat step 4 and 5 to unload more samples.

6 Restore the sample carousel.

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8.3 Serum Index

8.3.1 Introduction
Serum index is the degree of hemolysis, icterus and lipemia contained in
serum sample. They are usually seen in serums and can influence the
test results in physical or chemical way.
The serum index function is used to analyze the interferents in samples,
helping clinical professionals to evaluate the test results.

8.3.2 Theory of Serum Index

Figure 8.13 Absorption spectrum of interferents in serum samples

(1)

(2)

(3)

The figure above shows the absorption spectrum of interferents in serum

samples. (1) refers to lipemia, (2) refers to hemolysis, and (3) refers to
icterus.
The three interferents are selective to wavelength and have complex
absorption spectrums. They cannot be removed completely by means of
double-wavelength measurements. The serum index option can be used
to analyze the interferents contained in samples, helping clinical
professionals to evaluate the test results.
Six wavelengths are chosen to determine the serum index. The equations
of serum index are as follows:
 Lipemia: primary wavelength of 660, secondary wavelength of 700.
AL  A660  A700 , lipemia index: L  1 / C  AL

 Hemolysis: primary wavelength of 570, secondary wavelength of 605.

AH  A570  A605 , hemolysis index: H  1/ A  ( AH  B  AL )

 Icterus: primary wavelength of 450, secondary wavelength of 505.

AI  A450  A505 , icterus index:
I  1/ D  [ AI  E  ( AH  B  AL )  F  AL ]
Where,

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 B and F: determined by the absorption spectrum of lipemia and not

adjustable.
 E: determined by the absorption spectrum of hemolysis and not
adjustable.
 C: determined by single lipemia, and can be user-defined.
 A: determined by single hemolysis, and can be user-defined.
 D: determined by single icterus, and can be user-defined.

8.3.3 Serum Index Setup

The serum index includes lipemia (L), hemolysis (H) and icterus (I), and
has the common name of SI. The chemistry name, sample volume and
reagent volume of SI are defined by the manufacturer and cannot be
modified by users. The SI chemistry cannot be deleted. You are allowed
to define the print names and qualitative result flags for the chemistry.

Defining print name

1 Select Utility-Chemistries.

2 Choose the SI chemistry.

3 Select Define F1.

Figure 8.14 Serum Index window

4 Type in the print name of lipemia in the Print Name of the Lipemia
area. Up to 15 characters can be entered.

The lipemia index will appear as the print name on patient reports and
as “SI” on other reports.
5 Repeat step 4 to define print names for hemolysis and icterus.

6 Select Save F7.

7 Select Close F8.

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Defining qualitative result flags

The Qualitative Analysis option, when enabled, analyzes every sample for
the detection of lipemia, hemolysis and icterus and calculates the
numeric values of the index. If the volume of the interferents contained in
a sample is beyond the set range, a flag will be added to the patient
report.
The system allows 6 ranges and flags for each interferent.
1 Select Utility-Chemistries.

2 Choose the SI chemistry.

3 Select Define F1.

4 Mark the Use Qualitative Result checkbox in the Lipemia area.

The Range and Flag fields below are activated for editing.
5 Type in the detection range in the first edit box of the Range field, and
then enter a flag in the first edit box of the Flag field.

For instance, type in “10” in the first edit box of the Range field in the
Lipemia area, and then enter “+” in the Flag field of the same row. If
the lipemia volume (L1) contained in a sample is lower than 10, the
“+” sign will be added to the result in the patient report. Type in “20” in
the second edit box below the Range icon and “+-” in the second edit
box below the Flag icon. If the lipemia volume (L2) is greater than 10
and lower than 20, the result will be flagged with the “+-” sign. The
cycle continues. If the result is greater than L5, the six flag will appear
on the patient report.
6 Repeat step 4-5 to define ranges and flags for hemolysis and icterus.

7 Select Save F7.

8 Select Close F8.

8.3.4 Auto Serum Index

When the Auto Serum Index function is enabled, the system will select the
SI chemistry automatically for serum or plasma samples. The SI
chemistry will also be requested automatically when you program routine
samples manually or by using the LIS host, or program STAT samples, or
program routine samples with the default panels.
When programming samples with auto serum index, you are required to
select at least one chemistry other than SI.
1 Select Utility-System Setup.

2 Mark the Auto Serum Index checkbox with a tick.

3 Select Save F8.

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8.3.5 Running SI Chemistry

The SI chemistry is only applicable to serum and plasma samples
(routine and STAT) rather than controls and calibrators.
To run the SI chemistry, choose the SI chemistry while programming
samples. It will be analyzed along with other chemistries.

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8.4 Clear Samples

8.4.1 Introduction
The Clear Samples function is used to delete programmed samples that
have not been analyzed. One or more samples can be cleared at one time.
When samples are cleared, the sample information will be removed
completely; the sample ID, position and bar code can be used for
programming other samples. The action of clearing samples will be
recorded in the edit logs.

8.4.2 Clearing Samples

1 Select Program-Sample.

2 Select Clear F4. The Clear Samples window appears.

Figure 8.15 Clear Samples window

3 Select samples you desire to clear.

 Current sample: type in the sample ID on the Sample screen.

 Sample(s) with following ID(s): type in the sample ID range in the
Sample ID field. Single sample ID and sample range are
acceptable.
4 Select OK.

The selected samples are cleared along with their programming

information.

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8.5 Unpositioned Samples

8.5.1 Introduction
Unpositioned samples are those:
 downloaded from the LIS host and not positioned yet. Such samples
cannot be programmed for analysis until they have positions
assigned. If your system is equipped with a sample bar code reader,
the samples can be analyzed immediately without assigning
positions for them.
 that are in Incomplete status when their positions are used for
programming new samples.
 that are incomplete when their positions are released.
Once positioned, the samples will be removed from the unpositioned
samples list.

8.5.2 Viewing Unpositioned Samples

1 Select Program-Sample.

2 Select List F5.

3 Select Unpositioned F2.

Figure 8.16 Unpositioned Samples window

4 Move the scroll bar to view more samples.

5 Select Exit to exit the window.

8.5.3 Assigning Positions

1 Select Program-Sample.

2 Select List F5.

3 Select Unpositioned F2.

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4 Select Assign.
Figure 8.17 Assign positions

5 Select the program date of sample(s) to assign position.

6 Type in the sample ID or range in the ID field.

7 Choose a sample carousel on which you will place the sample.

8 Enter the positions in the Pos field.

 To assign position for single sample, input the position number in

the first edit box.
 To assign positions for multiple samples, enter the start position
number in the first edit box, and then the end position number in
the second edit box. The system will assign positions for the
samples ascending according to the sample ID.
 If the available positions among the specified range are more than
or equal to the number of samples, the extra positions will be
neglected.
 If the available positions among the specified range are less than
the number of samples, the system will display a message
indicating insufficient positions. Assign the positions again.
9 Select OK.

10 To run the samples, select the icon on the upper-right corner of

the main screen.

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8.6 Release Sample Position

8.6.1 Introduction
When a sample is analyzed, the position cannot be used for programming
new sample until it is released. The Status screen provides the Release
Sample Position function, which allows you to release the selected
position or all positions on the current sample carousel that are not
running any tests. When a sample is released, its results and
programming information can be still recalled.
Sample positions can be released automatically at specified time every
day. When the set time is reached,
 If the system is shut down, the sample positions in the status of
Complete will be released next time when the system is started up.
 If the system is not running any tests, the sample positions in the
status of Complete will be released.
 If the system status is Running, the sample positions in the status of
Complete will be released when the system status becomes Standby
or Failure at the first time.
When a sample is released, its results and programming information can
be still recalled.

8.6.2 Releasing Sample Positions

Only patient samples rather than controls, calibrators, ISE wash solution
and physiological saline can be released.
1 Select Program-Status.

2 Choose a sample carousel to release samples.

3 Select Release F3.

Figure 8.18 Release Positions window

4 Choose the sample range:

 Following position(s): type in the sample ID or range to release in
the edit box.

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 All positions: to release all positions of the selected sample

carousel.
5 Select OK.

8.6.3 Auto Release of Samples

1 Select Utility-System Setup.

2 Select Instrument F1.

3 Select 10 Auto Release Sample.

4 Select the auto release time of patient samples in the Auto Release
Time field.

Select an integer between 00 and 23. The default is 00.

5 Select OK.

When the time is reached, the system will release automatically all
sample positions in the status of Complete.

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8.7 Sample Logs

8.7.1 Introduction
The Sample Logs screen provides the controls and patient samples that
are not complete within the recent 24 hours due to certain reasons. You
are to rerun the samples or take other actions for the controls and
samples. The sample logs refresh automatically as the analysis is
performed, and can be printed out for archiving.

8.7.2 Viewing Sample Logs

1 Select Program-Status.

2 Select Log F2.

Figure 8.19 Sample Logs window

3 The screen shows the controls and patient samples that are not
complete within the recent 24 hours due to certain reasons.

The table below summaries the sample status and relevant

descriptions.

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Table 8.1 Description and probable causes to sample statuses

Sample status Description Probable Causes
Incomplete The sample is being analyzed
and still has some tests which
have no results.
Programmed The position is assigned to a
sample but now occupied by
another sample.
Unprogrammed The sample is identified, but Inquiring the LIS host is
no corresponding program is timed out.
obtained from the LIS host. The sample has no
program information on
the LIS host and is
programmed with the
default panel.

Rerun The sample is programmed The result is beyond the

automatically for rerun but critical range.
cannot be run due to The Status column will
scanning error; or the sample display Rerun, and the
is rerun automatically for a Causes column will show
result is beyond the critical the rerun results.
range.

Removed The sample has been Samples that are being

unloaded but some tests are analyzed are unloaded.
still being processed.
Duplicate The sample bar code has The positions for control
been assigned to a sample and calibrator are
that already exists. occupied by patient
samples.
A sample is detected in an
idle position but has no
corresponding
programming information
or default panel.
4 To print the sample logs, select Print F7.

5 Select Exit F8 to close the window.

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8.8 Customizing Sample Information

8.8.1 Introduction
The system provides the Cust. Sample Info. option for specifying sample
information to be displayed on the Sample screen. It includes: bar code,
sample comment, patient ID, panels, sample status, and all editable
information on the Demographics window like date of birth, gender,
collection time, diagnosis, etc.

8.8.2 Customizing Sample Information

1 Select Utility-System Setup.

2 Select Instrument F1.

3 Select 13 Cust. Sample Info.

Figure 8.20 “Customize Sample Information” window

4 Find desired sample information and mark the corresponding

Customize checkbox.

Click the checkbox again to deselect it.

5 Select Save.

6 Select Cancel to close the window.

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8.9 Customizing Patient Demographics

You can specify patient demographics to be displayed, its default and its
display order on the Patient Demographics screen.
1 Select Utility-System Setup.

2 Select Instrument F1.

3 Select 14 Patient Demographics

Figure 8.21 Patient Demographics

4 Select the desired information and the default value and then click
Add.

5 Select the desired information and click Delete to delete it from the
demographics list.

6 Select Up, Down, Home and End button to adjust the displayed order
of patient demographics.

7 Select OK to save the setup.

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8.10 Sample and Chemistry Lists

8.10.1 Introduction
The List option allows you to view, inquire and print all unfinished
samples, and assign positions for unpositioned samples. You are also
allowed to view the requested chemistries’ calibration status, reagent
status, tests left, and number of requests.

8.10.2 Sample List

Viewing programmed samples
The sample list shows all samples that have been programmed but not
analyzed yet. Samples can be inquired by program date, sample status, ID,
or bar code.
1 Select Program-Sample.

2 Select List F5.

Figure 8.22 Sample List tab page

3 Move the scroll bar to view more samples.

4 To print the sample list, select Print F7.

5 Select Exit F8 to close the window.

Inquiring samples by program date, sample status or ID

1 Select Search F1 on the Sample List tab page.

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Figure 8.23 Search window

2 Enter the conditions:

 Select the program date of samples you desire to inquire; and/or

 Select a sample status, which is available in All, Programmed, In
Progress, Incomplete, Complete, and Rerun; and/or
 Type in the single sample ID or ID range in the Sample ID field.
3 Select OK. All samples that satisfy the conditions are displayed on the
screen.

Inquiring a bar-coded sample

1 Select Search F1 on the Sample List tab page.

2 Type in the sample bar code you desire to inquire.

3 Select OK. The corresponding sample is displayed on the screen.

8.10.3 Chemistry List

To view the summary of chemistries that are requested on the current day
or requested before but not finished yet, perform the following steps:
1 Select Program-Sample.

2 Select List F5.

3 Select the Chemistry List tab.

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Figure 8.24 Chemistry List tab page

The screen shows all requested chemistries, including the name,

calibration status, number of requests, and tests left.
4 Move the scroll bar to view more chemistries.

5 To print the chemistry list, select Print F7.

6 Select Exit F8 to close the window.

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8.11 Optimizing Result Display

8.11.1 Introduction
Due to low sensitivity of certain reagents, samples with low concentration
may have 0 or negative results, or cannot be represented accurately by
results out of linearity range. To express sample concentration accurately,
the system provides the Optimize Result Display option to customize
such results. When less than the low limit of linearity range, results will
show as “< Low limit of linearity range”; when greater than the high limit
of linearity range, they will show as “> High limit of linearity range”; when
less than both the low limit of linearity range and concentration of the
lowest-concentration calibrator, they will show as “< Maximum of the two
values”; when greater than the high limit of linearity range and
concentration of the highest-concentration calibrator, they will show as
“> Minimum of the two values”.
Result optimizing will not affect storage, transmission and archiving of
results. The calculations will be calculated with the actual results of
relevant chemistries.
Only users who have the permissions of system setup are allowed to
optimize result display.

8.11.2 Optimizing Result Display

1 Select Utility-System Setup.

2 Select Instrument F1.

3 Select 12 Optimize Result Display.

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Figure 8.25 “Optimize Result Display” window

4 Find desired chemistry, and mark the corresponding Low and High
checkboxes.

Click the checkboxes again to deselect them.

 Select Low. When a result is less than the low limit of linearity
range or concentration of the lowest-concentration calibrator, it
will show as “< Low limit of linearity range”, “< Concentration of
the lowest-concentration calibrator”, or “< Maximum of the two
values”.
 Select High. When a result is greater than the high limit of linearity
range or concentration of the highest-concentration calibrator, it
will show as “> High limit of linearity range”, “> Concentration of
the highest-concentration calibrator”, or “> Minimum of the two
values”.
5 Select Save.

6 Select Cancel to close the window.

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8.12 Results Recall

8.12.1 Introduction
The Results Recall option allows routine samples, STAT samples and
controls to be recalled and handled on the Current Results or History
Results screen. The Current Results include those that are programmed
and analyzed on the current day; the History Results are those
programmed and analyzed before the current day. All results can be
recalled by sample or by chemistry.

8.12.2 Displaying Current Results

1 Select Result-Current Results.

The screen shows all samples and controls that are programmed and
analyzed on the current day. When certain test of a control sample or
patient sample triggers a data alarm, the sample will appear in yellow.
Figure 8.26 Current Results screen

The sample type includes R, E and C. R stands for routine sample, E

for STAT sample, and C for control.
The Host column indicates the transmission status of the sample. Y
means that the sample has been sent to the LIS host, and N means
the opposite.
The Print column indicates the print status of the sample. Y means
that the sample has been printed, and N means the opposite.

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Samples displayed in the sample list can be sorted by the type, ID,
status, position, completion time, program date/time, host and print
fields.
2 Choose a result recall mode:
 By sample
 By chemistry
3 When recalling results by sample, choose a sample in the left list. The
right list displays all results of the sample. When recalling results by
chemistry, choose a chemistry in the left list. The right list displays all
results of the chemistry.

4 Choose the following buttons as needed:

 Search F1: to inquire sample results.

 Options F2: to delete, edit, rerun and print samples, recall rerun
results, customize result display options, recalculate results,
compensate results, and observe result trend.
 Demog F3: to view patient demographics of the sample.
 Reac Curve F4: to view the reaction curve of the sample.
 Rerun F5: to rerun a finished sample.
 Review F6 to review the sample result.
 Print F7: to print sample results.
 Host F8: to transmit the selected sample results to the LIS host.

8.12.3 Recalling Current Results

Current results can be inquired by sample type, patient name, patient ID,
sample ID or sample bar code,etc., along with the current date. Whichever
status the system is, only one condition is required for inquiring desired
results.
1 Select Result-Current Results.

2 Select Search F1.

3 Enter one or more search conditions.

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Figure 8.27 Recall results window

4 Select OK. The samples matching the condition are displayed on the
screen.

5 Select a function button to perform relevant operations.

8.12.4 Displaying History Results

1 Select Result-History Results.

The screen shows all samples and controls that are programmed and
analyzed before the current day.
Figure 8.28 History Results screen

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8 Sample Programming and Processing

The sample type includes R, E and C. R stands for routine sample, E

for STAT sample, and C for control.
The Host column indicates the transmission status of the sample. Y
means that the sample has been sent to the LIS host, and N means
the opposite.
The Print column indicates the print status of the sample. Y means
that the sample has been printed, and N means the opposite.
2 Choose a result recall mode:
 By sample
 By chemistry
3 Select Search F1 to search for desired results.

4 When recalling results by sample, choose a sample in the left list. The
right list displays all results of the sample. When recalling results by
chemistry, choose a chemistry in the left list. The right list displays all
results of the chemistry.

5 Choose the following buttons as needed:

 Options F2: to delete, edit, rerun and print samples, recall rerun
results, customize result display options, recalculate results,
compensate results, and observe result trend.
 Demog F3: to view patient demographics of the sample.
 Reac Curve F4: to view the reaction curve of the sample.
 Rerun F5: to rerun a finished sample.
 Review F6 to review the sample results.
 Print F7: to print sample results.
 Host F8: to transmit the selected sample results to the LIS host.

8.12.5 Recalling History Results

Stored results can be inquired by sample type, patient name, patient ID,
sample ID or sample bar code, along with the program date. Whichever
status the system is, only one condition is required for inquiring desired
results, while the Program Date field can be left blank. To quickly search
for desired results from the tremendous amount of data, you are
recommended to enter both the program date and any of the conditions.
1 Select Result-History Results.
2 Select Search F1.
3 Select the program date range you want to recall. Select the start date
in the first box and the end date in the second box.

4 Enter one or more search conditions.

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 8 Sample Programming and Processing
Figure 8.29 Recall Results window

5 Select OK. The samples matching the condition are displayed on the
screen.
6 Select a function button to perform relevant operations.

8.12.6 Review Sample Results

Only when the sample status is complete, can the sample results be
reviewed.
1 Select Result-Current Results or History Results.

2 Choose the By Sample option.

3 Choose a sample or more samples in the sample list.

4 Select Review F6.

The review status in the sample list turns from N to Y.

5 Select No Review to cancel the review operation.

8.12.7 Viewing/Editing Patient Demographics

Patient demographics can be viewed or edited in any system status.
1 Select Result-Current Results or History Results.

2 Choose the By Sample option.

3 Choose a sample in the sample list. Move the scroll bar to view more
samples.

4 Select Demog F3.

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8 Sample Programming and Processing
Figure 8.30 Demographics window

Patient demographics can be customized. For more information,

please refer to customize patient demographics
5 Edit the related patient information:

6 Select Save F7 to save your input.

7 Select Prev F4 or Next F5 to view demographics of the previous or

next sample.

8 Select Exit F8 to close the window.

8.12.8 Reaction Curve

A reaction curve reflects the relationship of the absorbance measured at
the primary wavelength, secondary wavelength and primary-secondary
wavelength. It is drawn based on the absorbance of the sample-reagent
mixture measured within the reaction period.
Observing reaction curve:
1 Search for desired samples on the Current Results or History Results
screen.

2 Choose a result recall mode:

 By sample
 By chemistry
3 Choose a chemistry or sample in the result list.

4 Select Reac Curve F4. The Reaction Curve window is displayed.

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 8 Sample Programming and Processing
Figure 8.31 Sample reaction curve

5 Select a point on the curve. Relevant measuring period and

absorbance are displayed on the right of the window.

6 Select a filter condition from the following options:

 None: observe reaction curve and data in the default mode.
 Chemistry: observe reaction curve of the results for the selected
test.
 Sample: observe reaction curve of the results for the selected
sample.
7 Choose the Reaction Data tab to view the reaction data.

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8 Sample Programming and Processing
Figure 8.32 Sample reaction data

8 Choose the following buttons as needed:

 Reagent F1: to view the reagents used for sample analysis,

calibrators and reagents used in calibration, and reagents for
reagent blank test.
 Sample Blank F2: to view the sample blank reaction curve and
reaction data of the selected sample.
 Adjust F3: to adjust the absorbance display range of current
reaction curve. Refer to the following page for details.
 Prev F4: to view the reaction curve and data of the previous
chemistry.
 Next F5: to view the reaction curve and data of the next
chemistry.
 Print F7: to print the current reaction curve or data.
9 Select Close F8 to close the window.

Viewing reagent information:

On the reaction curve window, you are allowed to view the reagents in
sample measurement, the calibrators and reagents used in calibration,
and reagents for reagent blank test.
1 Search for desired samples on the Current Results or History Results
screen.

2 Choose a result recall mode:

 By sample
 By chemistry

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 8 Sample Programming and Processing

3 Choose a chemistry or sample in the result list.

4 Select Reac Curve F3. The Reaction Curve window is displayed.

5 Select Reagent F1.

Figure 8.33 Reagent window

The window shows the calibration date and time, sample

measurement date and time, calibrators, reagents for reagent blank
test, and reagents for sample analysis.
6 Select Close to exit the window.
Adjusting display range:
The maximum absorbance display range of reaction curve can be
adjusted automatically or manually. The adjustment is only applicable to
the currently-displayed curve, which will restore the default display when
opened next time.
1 Search for desired samples on the Current Results or History Results
screen.

2 Choose a result recall mode:

 By sample
 By chemistry
3 Choose a chemistry or sample in the result list.

4 Select Reac Curve F4. The Reaction Curve window is displayed.

5 Select Adjust F3.

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8 Sample Programming and Processing
Figure 8.34 Adjust window

6 Choose an adjustment mode:

 Auto: The system automatically determines the display range of X

axis (measuring period) and Y axis (absorbance) according to the
reaction data.
 Manual: The system displays the reaction curve according to the
specified absorbance range. Input the absorbance range
(-40000~40000).
7 Select OK. The current reaction curve is refreshed accordingly.

8.12.9 Transmitting Results to LIS Host

Sample results and QC results can be sent to the LIS host in any system
status if the LIS host is connected correctly. The Host option allows the
transmission of single or multiple samples, or all samples to the LIS host.
The results to be transmitted include:
 Patient demographics
 Sample results
 QC results
1 Search for desired samples on the Current Results or History Results
screen.

2 Choose the By Sample option.

3 To transmit single or multiple samples, select them in the sample list.

4 Select Host F8.

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 8 Sample Programming and Processing
Figure 8.35 Transmit Results window

5 Select the sample range you want to transmit:

 Selected sample(s)
 All samples
6 If you transmit all samples, you are allowed to skip those results that
are already transmitted to the LIS host. Mark the Bypass Transmitted
Results checkbox.

7 Select OK.

8.12.10 Printing Results

Samples can be printed manually on the Current Results and History
Results screens. The system allows multiple samples to be printed on
one report or one sample on one report. Before printing the recalled
results, you should select a report template on the System Setup screen.
The Print option allows single or multiple samples, or all samples to be
printed out.

Print by Sample
Print by sample option allows you to print the test results of one or more
samples when they are recalled by sample.
1 Search for desired samples on the Current Results or History Results
screen.

2 Choose the By Sample option.

3 To print single or multiple samples, select them in the sample list.
 To select current results, select the first sample, press and hold
the Shift key, and then select the last sample; or select the first
sample, press and hold the Ctrl key, and then select other
samples; or press Ctrl + A to select all samples displayed on the
current page. To display the first or last row in the current sample
list, press Ctrl + Home or End.
 To select history samples, directly click the type button of the
samples to select them.

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8 Sample Programming and Processing

4 Select Print F7.

Figure 8.36 Print window

5 Select Print Sample Report.

6 Choose the print range:

 Selected Sample(s)
 All Sample(s)
7 If you print all samples, you are allowed to skip those that are already
printed out. Mark the Bypass Printed Sample(s) checkbox.

8 Select OK.

Print by Chemistry
Print by chemistry option allows you to print the test results of one or
more chemistries when they are recalled by chemistries.
Laboratory Version
1 Search for desired samples on the Current Results or History Results
screen.

2 Choose the By Chemistry option.

3 To print single chemistry in the chemistry list, select it; to print all
chemistries, there is no need to select them.

4 Select Print F7.

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Figure 8.37 Print window

5 Choose the print range:

 Selected chemistry
 All chemistries
6 Select OK.

Only the sample results that have been reviewed can be printed out.

8.12.11 Editing Results

The Edit Results option allows editing of results that slightly exceed the
reference range or the linearity range but will not lead to mis-diagnosis of
patients, or of results that are all on the high side or low side. This option
is used for sample results only, exclusive of control results. Results of
special calculations cannot be edited while results of off-system
chemistry can be edited. Edited results will be flagged for distinguishing
from others.
Only the samples that have been analyzed and have results can be edited.
For those tests that are run for over one time, result of each run can be
edited. For rerun tests, only the default result can be edited.

CAUTION
Edit Results function gives doctors with freedom to modify the results, and therefore,
must be used with cautions. Only users that have sufficient permissions are allowed
to edit results.
1 Select Result-Current Results or History Results.

2 Choose a result recall mode:

 By sample
 By chemistry
3 Select Search F1 to search for desired results.

4 Choose a sample or chemistry in the sample list which includes the

off-system chemistries as well.

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5 Select Options F2.

6 Select Edit Results.
The screen shows the samples or chemistry and all measured results.
Figure 8.38 Edit Results window – By sample(History results)

Figure 8.39 Edit Results window – By sample(Current results)

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 8 Sample Programming and Processing
Figure 8.40 Edit Results window – By chemistry

Choose a chemistry to edit, and then input result in the Final Result
column.

 On the Edit Results window- By sample (Current results), select

Prev or Next to locate the results that require editing.
 For normal runs, only Complete chemistries can be edited.
 For reruns, only the default result can be edited.
 For off-system chemistries, the results can be edited at anytime.
8 Repeat step 7 to edit other results.

9 Select Save to save your editing.

10 Select Cancel.

8.12.12 Deleting Results

The system has a limited storage capacity and can store a maximum of
50,000 samples. The results with the earliest date will be overridden when
the capacity is exceeded. The system allows deleting of routine samples,
emergent samples and controls, while they are sent to the LIS host or
printed out. When the system status is Running, samples in the status of
Running cannot be deleted; when the system status is but Running,
samples in any status can be removed. Deleted results cannot be
restored. Make sure that you have archived them by sending them to the
LIS host or printed out or in other ways.
Before deleting a result, check if you have sufficient permissions. Only
users that have sufficient permissions are allowed to delete results. The
deleting operation will be automatically recorded in event logs.
1 Select Result-Current Results or History Results.
2 Choose a result recall mode:

 By sample

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 By chemistry
3 Select Search F1 to search for desired results.

4 When recalling results by sample, choose samples in the sample list.

When recalling results by chemistry, choose a chemistry in the left
list.

All results of the selected sample or chemistry are displayed on the

screen.
5 Select Options F2.

6 Select Delete Results.

All results of the samples are displayed on the screen.

Figure 8.41 Delete Results window

7 Choose the sample range:

 Selected result(s): to delete the results of the selected samples or

chemistries.
 All results: to delete all results on the screen.
8 Select OK.

8.12.13 Customizing Result Display

The Customize Result Display option allows tailoring of sample and result
display options on the Current Results and History Results screens.
When recalling results by sample, the sample list and result list can be
customized. When recalling results by chemistry, only the result list can
be tailored.
1 Select Result-Current Results or History Results.

2 Choose a result recall mode:

 By sample
 By chemistry
3 Select Options F2.

4 Select Customize Result Display.

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Figure 8.42 Customize Result Display window – By sample

Figure 8.43 Customize Result Display window – By chemistry

5 If recalling results by sample,

 Choose desired header names in the Sample List Setup area and
screens where they are going to be displayed. Use the Up and
Down buttons to adjust the display order of the header names.
To forbid display of a header name in the sample list, deselect the
corresponding checkbox. Please note that the Type option for the
History Results screen cannot be forbidden.
 Choose desired header names in the Result List Setup area. Use
the Up and Down buttons to adjust the display order of the header
names.
To forbid display of a header name in the result list, deselect the
corresponding checkbox.
6 If recalling results by chemistry,

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Choose desired header names in the Result List Setup area. Use the
Up and Down buttons to adjust the display order of the header
names.
To forbid display of a header name in the result list, deselect the
corresponding checkbox.
7 Select Save to save the settings and close the window.

8.12.14 Recalculating Results

The Recalculate Results option is used to recalculate current sample
results with the latest valid calibration factors of relevant chemistry. This
option is often used when test result cannot be calculated due to
incomplete or failed calibration.
Recalculate Results is only applicable to biochemistries. Result of
samples in In Progress status cannot be recalculated. The recalculation
will be automatically recorded in event logs.
1 Select Result-Current Results.

2 Select Options F2.

3 Select Recalculate Results.

Figure 8.44 Recalculate Results window

4 Choose a chemistry from the Chem pull-down list.

5 Input single sample ID or ID range you desire to recalculate results.

6 Select Calculate.

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Results of the selected chemistry for the specified samples are

recalculated automatically with the latest calibration factors and then
displayed in the list at the bottom.
7 Select Close to exit the window.

8.12.15 Compensating Results

The Compensate Results option is used to recalculate multiple results of
certain biochemistry through the linear formula Y=K*X+B with specified
slope K and offset B.
Compensate Results is invalid for special calculations and off-system
chemistries. A calculation will be recalculated automatically once its
constituent chemistries are compensated. Only users that have sufficient
permissions are allowed to compensate results. The compensation will
be automatically recorded in event logs.
1 Select Result - Current or History.

2 Choose the By Chemistry option.

3 Choose the chemistry that you want to compensate in the left list.

4 Select Options F2.

5 Select Compensate Results.

Figure 8.45 “Compensate” window

All results of the chemistry are displayed in the list at the bottom.
6 Input the slope K and offset B.

7 Select Save.

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The system recalculates all results of the chemistry with the specified
slope and offset. The final results are displayed in the list of the
window.

8.12.16 Recalling Result Trend

Result trend allows you to observe the result trend of the selected
chemistry.
1 Select Result-Current Results or History Results.

2 Choose the result recall mode – By chemistry.

3 Select Search F1 to search for desired results.

4 Choose a chemistry in the left list.

5 Select Options F2.

6 Select Recall Result Trend.

Figure 8.46 “Result Trend” window

The result trend curve of the selected chemistry is displayed on the

window.
7 Move the cursor to certain point on the graphic trend. The actual
result, final result, completion time, reagent lot number, serial number,
and calibration time are displayed on the right of the window.

8 To show all results of repeated analysis or rerun tests, select the

Include Replicate Results checkbox.

9 To observe result trend of other sample types, select Prev F1 or Next

F2.

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10 Select Print F7 to print the current trend curve.

11 Select Exit F8 to close the window.

8.12.17 Archiving Results

The system allows archiving of sample results to a storage device. The
file format is CSV and the default file name is
SampleResultYYYYMMDD.csv. which cannot be edited. Sample results
must not be archived to the hard disk.
The archived sample results include the following information:

Table 8.2 Archived sample result types

ID Sample Result Information
1 Sample type (routine, STAT, control)
2 Sample ID
3 Sample bar code
4 Sample type (serum, plasma, etc)
5 Collecting date
6 Chemistry
7 Result
8 Response
9 Number of replicates
10 Unit
11 Result flag
12 Reference range
13 Run date and time
14 Module

Perform the following steps to archive sample results and data:

1 Search for desired sample results on the Current Results or History
Results screen.

NOTE
It may take a long time to archive a large amount of results. You are
recommended not to archive results over one week each time.
2 Select Options F2.

3 Select Archive.

4 Select OK.

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8.13 Workload Statistics

On the Workload screen, you can view test requests and reagent
application for each chemistry during a period, and you can sample
requests and the quantity of its chemistries as well. Calibration test and
QC test are not included in the statistics.
1 Select Result-Statistics-Workload.

2 Select By Sample or By Chemistry.

Figure 8.47 Workload screen-by sample

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Figure 8.48 Workload screen-by chemistry

 By Sample: To view all requested samples and the quantity of its

requested chemistries.
 By Test: To view test requisitions and reagent volume for the
chemistries.
3 Select or enter the start date and end date in the Date field. the start
date cannot be later than the end date.

4 Select Search F1.

All samples or tests requested during the period are displayed in the
middle list of the Workload screen.
5 Select Print to print out the currently-displayed statistic information
of measurements.

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8.14 Result Statistics

Result statistics option can summarize the total chemistries and the
distribution trend of its results and provide the test data and graph.
Calibration and control tests are not included in the statistics.
1 Select Result-Statistics.

2 Select the Results.

3 Select Statistic Graph or Statistic Data.

Figure 8.49 Result statistics screen -statistic graph

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Figure 8.50 Result statistics screen -statistic data

4 Click Search F1 and Recall results box pops up.

5 Input one or more search conditions such as:

 Date
 Chemistry
 Sample type
 Gender
 Age

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 Medical Record
 Patient ID
 Sample ID
 Bar code
6 Click OK.

The chemistry, number of tests, mean, standard deviation, maximum

value, minimum value are displayed in the statistic results
column .The statistic data include test time, result, sample ID, bar
code, patient ID, medical number, sample type, reference range, sex
and age.
7 Select Print F7 to print out the statistic graph and statistic data.

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This chapter describes data archiving, print setup, auto print and manual
print methods, and result printouts.

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9.1 Data Import and Export

9.1.1 Introduction
The Data Import and Export function allows various data to be imported
from or exported to an external storage device. Exporting data is allowed
only when the system status is Standby, Incubation and Failure.
The following data can be imported:
 Open-/Closed-reagent chemistries, including biochemistries,
Off-system chemistries, ISE chemistries, SI and calculations
The following data can be exported:
 Sample results (including results of all replicates): transmitted to LIS
host
 Control results: transmitted to LIS host
 QC data: archived to external storage device
 Calibration results: archived to external storage device
 Open-reagent chemistries: exported to a .text file

9.1.2 Import/Export Chemistries

The system supports specified and default chemistries to be imported
from an external file.
If an imported closed-reagent chemistry is no longer needed, it can be
deleted with the Delete F2 button on the Chemistries screen. Ensure the
following conditions are met prior to deleting a closed-reagent chemistry:
 The system is not running tests.
 The selected chemistry is not requested or run for samples,
calibrators and controls.
 The selected chemistry is disabled.
 The corresponding reagent has been unloaded from the reagent
carousel.

Import default chemistry list

Those chemistries imported from the default parameter form can be run
only based on reagents manufactured by our company. Only the print
name, result unit, decimal places, error detection limits, auto rerun
dilution factor and slope/offset can be modified and deleted, while the
others can only be browsed.
1 Select Utility-Chemistries.

2 Select Config F3.

3 Select Options.

4 Select Import.

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5 Select Load Default.

All chemistries contained in the default parameter form are displayed

in the Available Chemistries list.
6 Use the following buttons to import desired chemistries:

 Add All>>: add all chemistries in the Available Chemistries list to

the Imported Chemistries list.
 Add ->: add the selected chemistries in the Available Chemistries
list to the Imported Chemistries list.
 <-Remove: remove the selected chemistries from the Imported
Chemistries list.
 <<Remove All: remove all chemistries from the Imported
Chemistries list.
7 Select Import.

All imported chemistries are enabled by default and can be used for
measurement. If the result unit is changed, the corresponding
chemistry must be recalibrated.
8 Select Exit.

Import specified chemistry list

Open-reagent chemistries can be imported from a .csv file, while
closed-reagent chemistries can only be imported from an .item file. A
maximum of 300 open-/closed-reagent chemistries can be imported, and
the number of newly-imported chemistries must not exceed 200. The
open-reagent chemistries include biochemistries, as well as the
processing parameters, error detection limits, slop and offset, dilution
factors, and sample type. The closed-reagent chemistries include
biochemistries, ISE chemistries, SI and special calculations, as well as
carryover pairs, reagent type, biochemistry calibration settings, ISE
calibration settings, unit conversion rules, processing parameters, error
detection limits, carryover settings and slop and offset.
When chemistries are imported, they are enabled by default if set up
correctly. If the number of open-reagent chemistries imported exceeds
the maximum limit, the excessive open-reagent chemistries will be
disabled.
Only users with sufficient permission are allowed to import chemistries.
Importing chemistries can be performed only when the system status is
Standby, Incubation, Stop and Sleep.

CAUTION
While importing chemistries, do not switch off the analyzing unit main power or exit
the operating software.
1 Select Utility-Chemistries.

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2 Select Config F3.

3 Select Options.

4 Select Import.
Figure 9.1 Import window

5 Select Load.

6 Locate the path of the parameter form, and then select it.

 To import open-reagent chemistries, choose a .csv file.

 To import closed-reagent chemistries, choose an .item file.
7 Select Open.

All chemistries contained in the parameter form are displayed in the

Available Chemistries list.
8 Use the following buttons to import desired chemistries:

 Add All>>: add all chemistries in the Available Chemistries list to

the Imported Chemistries list.
 Add ->: add the selected chemistries in the Available Chemistries
list to the Imported Chemistries list.
 <-Remove: remove the selected chemistries from the Imported
Chemistries list.
 <<Remove All: remove all chemistries from the Imported
Chemistries list.
9 Select Import.

All imported chemistries with correct parameters are enabled by

default and can be used for measurement. If you change any of the

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following parameters of an imported chemistry, recalibrate the
chemistry:
 Reaction type
 Primary wavelength
 Secondary wavelength
 Reaction direction
 Reaction time
 Blank time
 Result unit
 Sample volume
 Reagent volume (R1, R2, R3 and R4)
 Sample dilution factors
 Sample blank
10 Select Exit.

Export chemistries
Open-reagent chemistries rather than closed-reagent chemistries can be
exported, as well as the processing parameters, error detection limits and
slop and offset. Only the open-reagent biochemistries can be exported
from the system.
Only users with sufficient permission are allowed to export chemistries.
Exporting chemistries can be performed when the system status is
Standby, Incubation and Failure.
1 Select Utility-Chemistries.

2 Select Config F3.

3 Select Options.

4 Select Export.

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Figure 9.2 Export window

The Available Chemistries list shows all open-reagent chemistries

other than those that have been masked or disabled.
5 Use the following buttons to export desired chemistries:

 Add All>>: add all chemistries in the Available Chemistries list to

the Exported Chemistries list.
 Add ->: add the selected chemistries in the Available Chemistries
list to the Exported Chemistries list.
 <-Remove: remove the selected chemistries from the Exported
Chemistries list.
 <<Remove All: remove all chemistries from the Exported
Chemistries list.
6 Select Export.

7 Select the path to export and input the file name.

The default file name is composed of the current date and time, such
as 20100527_0951. The file format is .csv.
8 Select Save.

9 Select Exit.

9.1.3 Data Archive

You are recommended to regularly archive the ISE and biochemistry
calibration results to the hard disk or a storage device, and archive QC
data to an external storage device, such as U disk and floppy disk.

Archiving biochemistry calibration results

When archived, the biochemistry calibration results are displayed in the

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same format as those on software screens. The archived content
includes: chemistry name, flag, calibration status, R0, K factor, calibration
coefficients A/B/C/D and run date/time. The archiving file is of .csv
format and named by date and time the results are archived.
For more information of archiving biochemistry calibration results, refer
to 6.9.6 Archiving Calibration Results (page 6-24).

Archiving ISE calibration results

Both the current and early calibration factors of ISE chemistries can be
archived. The archiving file is of .csv format and named by date and time
the results are archived.
For more information of archiving ISE calibration results, refer to
Archiving ISE calibration results (page 12-16).

Archiving QC data
The QC results and data can be archived to a storage device with the file
name of QCData.csv, which cannot be edited.
For more information of archiving QC data, refer to Archive QC data (page
7-19).

9.1.4 Sending sample results and QC results to LIS

Sample results and QC results can be sent manually or in real-time mode
to the LIS host for reviewing and storage. When a sample is analyzed with
its all tests finished, the system can automatically send the test results to
the LIS host; also you are allowed to search for desired results and then
manually send them to LIS.
For more information about sending sample/QC results to LIS, refer to
14.4 Result Transmission (page 14-11).

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9.2 Print Setup

9.2.1 Introduction
Results and data can be printed out with the specified template through
the default printer. You are allowed not only to set up the printer type,
default printer and printed hospital name, import print report but also
define the print order of chemistries, edit print template and preview print
template.

9.2.2 General Print Setup Options

1 Select Utility-System Setup.

2 Select Print F3.

Figure 9.3 Print setup screen

3 Select a report type from the report list on the left of the window.

4 Select a template from the template list.

 The template list includes all the report templates of the selected
report type.
 The template list has four columns. Only one template can be
selected at the same time.
5 Select one option from the check box:

 Auto print patient report

 Print after reviewal
 Auto print QC report.
 Auto print calibration report

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6 Choose a printer type.

The system supports three types of printer, which include laser printer,
inkjet printer and stylus printer.
7 Choose a default printer to print reports.

8 Choose a print mode between Paginal and Serial.

9 Select OK.

9.2.3 Set Up Default Template

1 Select Utility-System Setup.

2 Select Print F3.

3 Select a report type from the Report list on the left of the window.

4 Select a template from the template list.

5 Click Set Defaults to set the selected template in the template list as
the default one.

9.2.4 Delete Template

1 Select Utility-System Setup.

2 Select Print F3.

3 Select a report type from the Report list on the left of the window.

4 Select a template from the template list.

5 Click Delete to delete the selected template.

If it is the default one or it has the print duty, it cannot be deleted.

9.2.5 Edit Print Template

1 Select Utility-System Setup.

2 Select Print F3.

3 Select a report type from the Report list on the left of the window.

4 Select a template from the template list.

5 Click Edit to open the template modifying software

You can edit the report templates as needed. Refer to 18 Template
Modifying Software for details.

9.2.6 Import Print Template

1 Select Utility-System Setup.

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2 Select Print F3.

3 Click Import to import the print template.

Figure 9.4 Import print template window

4 Select a report type from the factory template dropdown box.

5 Select one or more templates in the template list to be imported.
6 Click Import.
The selected template(s) can be imported
7 Click Customize to import the template you edited from a tmplt file.

The legal directory should be a portable storage device. The

templates can be imported in batch.
8 Click Import

The imported templates will be displayed in the template list.

9 Click Exit to exit the window.

9.2.7 Defining Chemistry Print Order

1 Select Utility-System Setup.

2 Select Print F3.

3 Select Print Order.

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Figure 9.5 Print Order window

4 Use the following buttons to adjust the chemistry print order:

 Home: to move the chemistry to the first position.

 Up: to move the chemistry to the previous position.
 Down: to move the chemistry to the next position.
 End: to move the chemistry to the last position.
5 Set up result print mode.

 To print results on patient report, select the corresponding Print

checkbox.
 To forbid printing results on patient report, deselect the
corresponding Print checkbox or leave it unselected.
6 Select OK to save your settings.

7 To restore the factory settings, select Restore Defaults.

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9.3 Sample Reports

9.3.1 Introduction
Sample reports are used to print sample results, sample list, reaction
curve and data, as well as sample blank reaction curve and data.
The result reports include:
 Single sample report
 Multi-sample report
 Report collection
 Chemistry summary
The list reports include:
 Sample list report
 Control list report
 Chemistry list report
The above-mentioned reports and printing methods are described in
detail in the following sections.

9.3.2 Single Sample Report

A single sample report contains all results of a sample, including
emergent sample, routine sample and control sample. It can be printed
out on:
 Current Results screen
 History Results screen
Print a single sample report by performing the following steps:
1 Select Result-Current Results or History Results.

2 Choose the By Sample option.

3 Search for desired results to print.

4 Choose a sample.

5 Select Print F7.

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 9 Result Printouts
Figure 9.6 Print sample results window

6 Select Print Sample Report.

7 Select the Selected Sample(s) option button.

8 Select OK.
Figure 9.7 Single sample report example

9.3.3 Multi-Sample Report

A multi-sample report can print two or more samples of a patient on a
report. If the patient demographics of the samples are not consistent, the
demographics of the first will be printed by default. A multi-sample report
can be printed out on:

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 Current Results screen
 History Results screen
Print a multi-sample report by performing the following steps:
1 Select Result-Current Results or History Results.

2 Choose the By Sample option.

3 Search for desired results to print.

4 Choose results to print.

5 Select Options F2.

6 Select Print Multi-Sample Report.

Figure 9.8 Multi-sample report example

9.3.4 Print Report Collection

Report collection contains the test results of all samples and QC samples
for the purpose of archiving and internal audit of the clinical laboratories.
1 Select Result-Current Results or History Results.

2 Choose the By Sample option.

3 Search for desired results to print.

4 Select Print F7.

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Figure 9.9 Print window

5 Select Print Report Collection.

6 Select OK.

All inquired sample results and the results of the QC samples will be
printed out; however, only valid results can be printed. If a sample has
been tested for a same chemistry for several times, the results of
each time will be printed out.

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Figure 9.10 Sample summary report

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This chapter introduces applications of chemistries, including:

 Definition and application of twin chemistries
 Definition and application of calculations
 Definition and application of panels
 Definition and application of off-system chemistries
 Configuration and application of serum index
 Masking and unmasking of chemistries
 Chemistry configuration
 Definition and application of default panels
 Carryover setup
 Reflex

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10.1 Twin Chemistries

10.1.1 Introduction
Twin chemistries are run and calculated based on the same reagent.
Results of the two twin chemistries are calculated through the same test.
Take the reagent HBA1C as an example. It can be used for running two
chemistries in the same test. The chemistry HB is measured during the
former reaction period, while the chemistry HbA1c measured during the
latter one. Finally, HbA1C (%) can be calculated based on results of the
two chemistries.
Similar to normal chemistries, twin chemistries can be run only when the
following settings are finished:
 defining chemistries
 assigning reagent position
 setting up calibrator and calibration rule
 setting up control and QC rule
Twin chemistries are run in the test order of the “latter chemistry” for
which the twin is specified.

10.1.2 Chemistry Definition

Twin chemistries can be defined in the same way as normal chemistries.
The following parameters, however, must be set up differently for two twin
chemistries:
 Sample type
 Normal sample volume, increased sample volume, and decreased
sample volume
 Volume of the same reagent type
 Prozone check
A chemistry that has been set as the twin of another chemistry must not
have another twin. When twin chemistries are defined, both chemistries
must be calibrated.

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Figure 10.1 Chemistry definition window

For defining methods of chemistries, refer to “3.2 Chemistries Setup”

(Page 3-12).

10.1.3 Removing Twin Relation

To remove the twin relation between two chemistries, cancel the selection
of a twin chemistry. Only when reagents of the two chemistries are
unloaded can the twin relation between them be removed.

10.1.4 Reagent Setup

Twin chemistries are run with the same reagent in the same position. The
reagent can be loaded manually or through bar code scanning.
Manual load:
You are only required to manually set up reagents for one of the twin
chemistries. The reagent of the same type for the other twin chemistry
will be automatically set up with the same position.
Automatic load:
Place the bar-coded reagents of twin chemistries on the reagent carousel,
the system will scan the reagent bar code and automatically assign the
same position for the same reagent of the twin chemistries.
If reagent loading is failed for either of the twin chemistries, both
chemistries cannot be run.

For details of reagent loading, refer to “2.5.1 Loading Biochemical

Reagents” (Page 2-15).

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10.1.5 Setting Up and Requesting Calibration

Calibration setup
The calibrator, number of replicates and auto calibration conditions must
be the same for two twin chemistries.
For calibration settings, refer to “3.3 Calibration Setup” (Page 3-30).

Requesting calibration
Twin chemistries can be requested for calibration in the same way as
normal chemistries. When either of the twin chemistries is requested, the
other twin will be requested automatically, and finally both chemistries
will be calibrated. You are allowed to recall the calibration results,
calibration curves and reaction curves of the two chemistries.

10.1.6 Setting Up and Requesting Quality Control

QC setup
Twin chemistries must be defined with the same control, and the QC
setup of twin chemistries is the same as that of normal chemistries. Refer
to “3.4 QC Setup” (Page 3-38) for details.

Programming controls
Twin chemistries can be requested for quality control in the same way as
normal chemistries. When either of the twin chemistries is requested, the
other twin will be requested automatically, and finally both chemistries
will be run for quality control. You are allowed to recall the QC results and
QC reaction curves of the two chemistries.

10.1.7 Sample Programming and Processing

Twin chemistries can be requested for sample analysis in the same way
as normal chemistries. When either of the twin chemistries is requested,
the other twin will be requested automatically, and finally both
chemistries will be run for sample analysis. You are allowed to recall the
sample results and sample reaction curves of the two chemistries.

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10.2 Special Calculations

10.2.1 Introduction
Calculation of certain chemistries can derive new chemistries of clinical
purposes, such as A/G (ALB/ (TP-ALB)), I-BIL (T-Bil - D-Bil), etc.
A calculation is composed of chemistries, calculation operators and
algorithm. Only users with sufficient permissions are allowed to define,
modify and delete calculations. The system allows a maximum of 50
calculations to be defined.
For the print order of calculations, refer to 9.2.7 Defining Chemistry Print
Order (Page 9-10).

10.2.2 Defining/Editing a Calculation

1 Select Utility-Chemistries.

2 Select Calculations F6.

3 Select Define F1.

Figure 10.2 Special Calculations window

4 Type in the calculation’s short name in the Chem field.

5 If you are going to use the calculation for analysis, mark the Enable
checkbox.

6 Choose a sample type to which the calculation will be applied.

The options include:

 Serum

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 Plasma
 Urine
 CSF
 Other
7 Type in the calculation’s full name in the Chemistry field.

8 Type in the print name of the calculation to appear on patient reports.

9 Choose a result unit from the Unit pull-down list.

10 Choose a result precision, that is, the number of decimal places.

The options include:

 0
 0.1
 0.01
 0.001
11 Edit the calculation formula:

 Choose chemistries in the Chemistries list. The chemistries are

then displayed in the Formula field.
 Choose numbers and operators in the Mathematical Symbols area
to constitute the calculation formula along with the chemistries.
 To remove a chemistry, number or operator, move the cursor
behind them and select BS.
 To clear the entire formula, select AC.
12 Select Flag qualitative results if you want to flag the qualitative
results.

For more information, please refer to 3.2.5 Flag Qualitative Result

13 Select OK to save the settings.

14 Select Exit to exit the window.

10.2.3 Enabling/Disabling Calculations

When a special calculation is defined, it is enabled by default and will be
calculated for sample analysis. If a calculation is disabled, it will not be
calculated for sample measurements. Before enabling or disabling a
calculation, make sure that the system status is not Running.
Perform the following steps to enable or disable calculations:
1 Select Utility-Chemistries.

2 Select Calculations F6.

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 The calculation list shows all calculations and formulas.
 When the Enable checkbox is marked, it indicates that the
calculation will be included for result calculating.
 When the Enable checkbox is not marked, it indicates that the
calculation will not be included for result calculating.
Figure 10.3 Special Calculations window

3 To activate a calculation, mark the Enable checkbox.

4 To inactivate a calculation, deselect the Enable checkbox.

10.2.4 Deleting User-Defined Calculations

Calculations can be deleted by users with sufficient permissions while
the system status is not Running. Only user-defined calculations rather
than closed calculations can be deleted.
1 Select Utility-Chemistries.

2 Select Calculations F6.

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Figure 10.4 Special Calculations window

3 Choose calculations to delete.

4 Select Delete F2.

10.2.5 Running Calculations

Calculations will not be run for calibration, but for quality control and
sample analysis along with other chemistries.
If a chemistry contained in a calculation is run for more than one
replicates, the final result of the chemistry will be used to calculate the
result of the special calculation.

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10.3 Panels
10.3.1 Introduction
A couple of chemistries combined together for certain clinical purposes
can constitute a panel, such as liver function, kidney function, etc. Panels
can help fast programming of samples.
Panels can be composed of biochemistries and ISE chemistries except
for SI and calculations. The system allows a maximum of 100 panels to
be defined. Only users with sufficient permissions are allowed to define,
modify and delete panels.

10.3.2 Defining/Editing a Panel

1 Select Utility-Chemistries.

2 Select Panels F7.

3 Select Define F1.

Figure 10.5 Define/Edit Panels window

4 Type in the panel name.

5 Choose panel types.

 Sample: indicates that the panel can be used for sample analysis.
 QC: indicates that the panel can be used for quality control.
At least one panel type must be selected. A panel can be applied to
both sample and control analysis.
6 Choose chemistries for the panel.

At least one biochemistry should be selected. The three ISE

chemistries (Na, K and Cl) can be selected alone.

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7 To remove a chemistry, click it again.

8 Select Save F7.

9 Select Close F8 to close the window.

10.3.3 Adjusting Display Order of Panels

Display order of panels on the Sample and Quality Control screens can
be adjusted manually for convenient test requisition.
1 Select Utility-Chemistries.

2 Select Panels F7.

3 Select Up F3 to move the current panel to the previous position, or

select Down F4 to move it to the next position.

4 Select Save F7 to save the settings.

10.3.4 Deleting Panels

Panels can be deleted by users with sufficient permissions while the
system status is not Running. When a panel is removed, the chemistries
contained in it will still remain and can constitute panels with other
chemistries.
1 Select Utility-Chemistries.

2 Select Panels F7.

3 Choose panels to delete.

4 Select Delete F2.

10.3.5 Running Panels

Panels will not be run for calibration, but for sample and control analysis
along with other chemistries.

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10.4 Off-system Chemistries

10.4.1 Introduction
All the chemistries that are not run by the analyzer are referred to as the
off-system chemistries. You can manually enter the off-system
chemistry results into the system to print out them in the patient report.
There are two types of off-system test: qualitative and quantitative.
 Qualitative chemistries: No numeric results are obtained but the flags
you defined on the system. Reference value can be set for the
qualitative chemistries
 Quantitative chemistries: Numeric results and defined flags are
displayed and printed. Reference range can be set for the quantitative
chemistries

10.4.2 Define/Edit Off-System Chemistries

1 Select Utility-Chemistries.

2 Select a blank chemistry box.

3 Select Define F1.

Figure 10.6 Chemistry type

4 Select Off-system.

5 Select OK

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Figure 10.7 Define/Edit chemistries

6 Enter the chemistry parameters

7 Select Use Qualitative Result to flag the result of a quantitative
off-system chemistry.

8 Enter Range and Flag.

9 Select OK.

10.4.3 Running the Off-system Chemistries

Off-system chemistries can participate in the panel setup and
quantitative off-system chemistries can join the special calculations
setup. You can program the off-system chemistries on the Program-
Sample screen and the STAT Sample Program screen. The off-system
chemistry can be added singly or in batch to the sample which needs
rerun on the Rerun Sample window and Rerun Batch window. For details,
please refer to 8.2.4 Rerunning Samples. After the off-system chemistries
are programmed, you can edit their results on the Result screen. The
results of the off-system chemistries can be edited in any status of the
sample.
1 Program the off-system chemistries on the Program- Sample screen.
Refer to 2.8.1 Programming Routine Samples

2 Select Result-Current Results/History Results.

3 Choose a result recall mode:
 By sample
 By chemistry
4 Select Search F1 to search for desired results.
5 Select the sample or chemistry whose results you want to edit.

6 Select Option F2.

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7 Select Edit Results.

8 Edit the results.

9 Click Save.

10.4.4 Deleting Off-system Chemistries

When the system status is not running, the off-system chemistries can be
deleted.
1 Select Utility-Chemistries.

2 Select the off-system chemistry you want to delete.

3 Select Delete F2.

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10.5 Serum Index

Serum index is the degree of lipemia, hemolysis and icterus contained in
samples, and used to check if these interferents will influence the sample
results.
For more information about serum index, refer to 8.3 Serum Index (page
8-21).

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10.6 Chemistry Configuration

10.6.1 Introduction
The Chemistry Configuration function is used to enable/disable
chemistries that have been defined correctly and customize their display
order on the Sample, STAT Sample Program and Quality Control screens.
When disabled, chemistries will no longer appear on the Sample,
Reagent/Calibration, Quality Control, Define/Edit Panels, Special
Calculations, Current Results and History Results screens. Only the
enabled chemistries can be requested for measurements and recalled on
results screens.
The system allows up to 200 chemistries to be enabled. The number of
open-reagent chemistries can be adjusted according to the practical
situations in your laboratory.
The Chemistry Configuration screen is as shown below:
Figure 10.8 Chemistry Configuration screen

10.6.2 Enabling Chemistries

All chemistries other than ISE chemistries and SI can be enabled or
disabled. The closed-reagent chemistries are enabled by default after
being imported from a chemistry file; while the open-reagent chemistries
will be enabled only if the parameters are set up correctly. The SI is
always enabled and cannot be disabled. If an ISE module is configured,
the ISE chemistries will always be enabled.
To enable chemistries, perform the following steps:
1 Select Utility-Chemistries.

2 Select Config F3.

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10 Chemistries
3 Choose one or more chemistries in the Available Chemistries list.

4 Select Add->.

The selected chemistries are enabled and appear in the Configured

Chemistries list.
5 To enable all available chemistries, select Add All>>.

All chemistries in the Available Chemistries list are enabled and

displayed in the Configured Chemistries list.
6 Select OK.

10.6.3 Disabling Chemistries

Some chemistries that will not be used for the moment can be disabled,
and will no longer appear on request screens. ISE chemistries and SI are
always available and cannot be disabled. Results of disabled chemistries
cannot be recalled until the chemistries are enabled again.
A chemistry can be disabled only if:
 It is not an ISE chemistry.
 It is not SI.
 It has no reagent position.
 It has no calibrator position and has not been requested for
calibration.
 It has no control position.
 It is not contained in samples and controls that are in Programmed,
Incomplete or Rerun status.
Perform the following procedure to disable chemistries:
1 Select Utility-Chemistries.

2 Select Config F3.

3 Choose a chemistry in the Configured Chemistries list.

ISE chemistries and SI cannot be disabled.

4 Select <-Remove.

The selected chemistry is disabled and removed from the Configured

Chemistries list.
5 To disable all chemistries, select <<Remove All.

All chemistries in the Configured Chemistries list that meet the

requirements are disabled. The disabled open-reagent chemistries
are indicated in red.

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 10 Chemistries
If one of the chemistries does not satisfy the requirements, the
operation will be aborted and all the chemistries cannot be disabled.
6 Select OK.

10.6.4 Customizing Chemistry Display Order

Chemistries can be customized to match the test order of your laboratory
and will be refreshed on the request screens. Chemistries on the
Chemistry Configuration window are displayed alphabetically. In case an
ISE module is configured, Na, K and Cl will appear on the first three
positions after SI in the Configured Chemistries list. In the Available
Chemistries and Configured Chemistries lists, click the Chemistry or
Module header line to sort the chemistries by name or by module.
To adjust chemistry display order, perform the following steps:
1 Select Utility-Chemistries.

2 Select Config F3.

3 Choose a chemistry in the Configured Chemistries list.

4 Use the following buttons to adjust the chemistry’s display order:

 Home: to move the chemistry to the first position.

 Up: to move the chemistry to the previous position.
 Down: to move the chemistry to the next position.
 End: to move the chemistry to the last position.
5 Select OK.

The chemistry list on the request screens are refreshed automatically.

10.6.5 Adjusting Test Order of Chemistries

Test order of configured biochemistries can be adjusted manually. During
sample analysis, the chemistries are run in the order of ISE chemistries, SI,
and then biochemistries. If multiple biochemistries are requested, they
will be run in the default order. If the test order is adjusted manually, the
biochemistries will be run in the updated order.
Only users with corresponding permission are allowed to adjust the test
order of biochemistries.
1 Select Utility-Chemistries.

2 Select Config F3.

3 Select Options.
4 Select Test Order.

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10 Chemistries
Figure 10.9 Test Order window

5 Choose a chemistry in the Configured Chemistries list.

6 Use the following buttons to adjust the chemistry’s test order:

 Home: to move the chemistry to the first position.

 Up: to move the chemistry to the previous position.
 Down: to move the chemistry to the next position.
 End: to move the chemistry to the last position.
7 Select OK.

8 To restore the default test order, select Restore Defaults.

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 10 Chemistries

10.7 Carryover Setup

10.7.1 Introduction
The Carryover Setup option is used to set up the carryover relations
between open-reagent chemistries and between cuvettes. The system
will insert a cleaning to reagent probe and cuvettes based on the
carryover settings. The closed-reagent chemistries have been set up by
the manufacturer and cannot be viewed or edited, while the open-reagent
chemistries need to be set up on the Carryover window.
Note: When there exists carryover between the twin chemistries and a
third chemistry, you should set up the carryover relationship of both the
chemistries in the twin chemistries pair with the third chemistry. For
example, HBA1C and HB are twin chemistries, if there exists the carryover
between the twin chemistries and a third chemistry, then you should set
up the carryover between HBA1C and the third chemistry and the
carryover between HB and the third chemistry at the same time.
If carryover of one chemistry in the twin chemistries pair has been set up,
edited or deleted, the carryover of the other chemistry should be set up,
edited or deleted too.
Carryover setup can only be performed by users with sufficient
permissions when the system status is not Running.
Figure 10.10 Carryover window

10.7.2 Defining/Editing Carryover Pair

1 Select Utility-Chemistries.

2 Select Carryover F8.

3 Mark the Reagent checkbox of the contaminated, if the contaminator

may cause reagent cross-contamination with the contaminated. If

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10 Chemistries
the contaminator may cause cuvette cross-contamination, mark the
Cuvette checkbox of the contaminated.

 Only when the reagent checkbox of the contaminated is selected,

all enabled chemistries are displayed in the Contaminators and
Contaminated lists.
 Once the reagent checkbox of the contaminated is selected, the
special wash check box is selected as well and cannot be edited.
 When the Cuvette checkbox of the contaminated is selected, the
special wash check box is not selected by default and can be
edited. When special wash check box is not selected, the system
performs DI water wash.
4 Choose one or all contaminator chemistries that may contaminate
other chemistries.

5 Choose one or all contaminated chemistries in the Contaminated list.

Note: All (the entire contaminator) to All (the contaminated) is not

permitted to set up.
6 If different reagent type may cause reagent carryover, choose a
reagent type in the contaminator reagent list and choose a reagent
type in the contaminated reagent list.

7 Select Save F7.

The defined carryover pair appears in the Carryover Pairs list.

8 Select Define F1 and follow the above steps to set up other carryover
pairs.
9 Select Close F8 to close the window.

10.7.3 Removing a Carryover Pair

1 Select Utility-Chemistries.

2 Select Carryover F8.

3 Choose desired carryover pair.

4 Select Delete F5.

5 Select OK to confirm the deletion.

6 Select Close F8 to close the window.

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 10 Chemistries

10.8 Default Panel

10.8.1 Introduction
The system allows a maximum of one default panel to be defined. When a
bar-coded sample has no relevant programming information on the LIS
host or has not been programmed manually, it can be analyzed with the
default panel. The default panel is only applicable to routine and
emergent samples, and often used for a tremendous amount of samples
that are analyzed with the same chemistries.
Only a sample panel rather than control panel can be set as the default.

10.8.2 Defining the Default Panel

1 Select Utility-Chemistries.

2 Select Panels F7.

3 Select Define F1.

4 Type in the number of the panel.

5 Type in the panel name.

6 Choose panel types.

 Sample: indicates that the panel can be used for sample analysis.
 QC: indicates that the panel can be used for quality control.
At least one panel type must be selected. A panel can be applied to
both sample and control analysis.
7 Choose chemistries for the panel.

At least one biochemistry should be selected. The three ISE

chemistries (Na, K and Cl) can be selected alone.
8 Select Save F7.

9 Select Close F8.

10 Select the defined panel in the panel list.

11 Mark the Default checkbox in the same row as the selected panel.

12 Select Close F8 to close the window.

10.8.3 Running Default Panel for Routine Samples

BIOHAZARD
Inappropriate handling of samples may lead to biohazardous infection. Do not touch
the samples directly with your hands. Wear gloves and lab coat, if necessary, goggles.

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10 Chemistries
In case your skin contacts the samples, follow standard laboratory safety procedure
and consult a doctor.

CAUTION
Do not use expired samples; otherwise, unreliable test results may be caused.
1 Load samples to the sample carousel.

2 Select the icon on the upper-right corner of the main screen.

3 Select a sample carousel to which the samples are loaded.

4 Select OK.

10.8.4 Running Default Panel for Emergent Samples

BIOHAZARD
Inappropriate handling of samples may lead to biohazardous infection. Do not touch
the samples directly with your hands. Wear gloves and lab coat, if necessary, goggles.
In case your skin contacts the samples, follow standard laboratory safety procedure
and consult a doctor.

CAUTION
Do not use expired samples; otherwise, unreliable test results may be caused.
1 Load emergent samples to the sample carousel.

2 Select the icon on the upper-right corner of the main screen.

3 Select a sample carousel to which the samples are loaded.

4 Select OK.

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 10 Chemistries

10.9 Masking/Unmasking Chemistries

10.9.1 Introduction
The chemistry masking function is used when a chemistry needs to be
disabled temporarily due to abnormal result or reagent exhaustion. The
marked chemistry will have a symbol appearing on its upper-left
corner, and will still be displayed on the Sample, Quality Control and
Reagent/Calibration screens. Masked chemistries can be requested but
cannot be run until they are unmasked.
In any system status chemistries can be masked or unmasked. Any users
are allowed to mask or unmask chemistries.
If a sample contains masked chemistries, it will enter the Incomplete
status when finished; if chemistries are unmasked while the sample
status is Programmed, the they will be run along with other chemistries; if
chemistries are unmasked while the sample is being analyzed, they will
be added automatically to the analysis; if chemistries are unmasked after
the sample is analyzed, they will be run automatically when analysis
begins next time.

10.9.2 Masking/Unmasking Chemistries

1 Select Utility-System Setup.

2 Select Instrument F1.

3 Select 2 Mask/Unmask Chem.

Figure 10.11 Mask/Unmask Chemistries window

4 Choose chemistries to mask, select OK.

5 To unmask chemistries, select them and then select OK.

6 Select Exit to close the window.

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10 Chemistries

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 10 Chemistries

10.10 Reflex
10.10.1 Introduction
The Reflex option allows related chemistries to be requested and run
automatically when the deciding biochemistry’s result is within specified
range. Each biochemistry may embrace multiple reflex conditions, and
each condition may contain a maximum of 20 related chemistries.
Reflex conditions and related chemistries are open for observation, but
only users with corresponding permission are allowed to set, modify or
delete reflex relation.

10.10.2 Setting Reflex Relation

Before using the reflex function, it must be enabled with reflex conditions
and related chemistries configured. Please note that the chemistries in a
reflex condition must have existed. When the system status is running,
the reflex function cannot be set up.
1 Select Utility-Chemistries.

2 Choose a chemistry for which you desire to configure reflex settings.

3 Select Define F1.

4 Select Reflex F2.

Figure 10.12 Reflex window

5 Mark the Enable Reflex Function checkbox to activate this option.

6 Set up reflex conditions.

Two conditions are available: “or” and “and”:

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10 Chemistries
 or: When the test result (concentration) is greater than certain
value OR less than certain value, the related chemistries will be
requested and run automatically.
 and: When the test result (concentration) is greater than certain
value AND less than certain value, the related chemistries will be
requested and run automatically.
Select an option and input the concentration range (0~9999.999).
7 Choose related chemistries in the chemistry list.

The options include all configured biochemistries.

8 Select OK.

The defined reflex relation is shown in the left list.

9 To define more relations for the current chemistry, repeat steps 6~8.

10 Select Exit to close the window.

11 To define reflex relations for other chemistries, repeat steps 1~8.

10.10.3 Editing Reflex Relation

Only users with corresponding permission are allowed to edit reflex
relation.
1 Select Utility-Chemistries.

2 Choose a chemistry for which you desire to edit reflex settings.

3 Select Define F1.

4 Select Reflex F2.

5 Select a reflex relation in the left list.

6 Modify the condition and related chemistries.
7 Select OK.
8 Select Exit to close the window.

10.10.4 Deleting Reflex Relation

Only users with corresponding permission are allowed to delete reflex
relation. If a chemistry is deleted, the corresponding reflex relation to
which it is related will be removed automatically.
1 Select Utility-Chemistries.

2 Choose a chemistry for which you desire to delete reflex settings.

3 Select Define F1.

4 Select Reflex F2.

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 10 Chemistries
5 Select a reflex relation in the left list.

6 Select Delete.

7 Select OK.

8 Select Exit to close the window.

10.10.5 Measurement and Result Recall

Chemistries with reflex settings are run in the same way as routine
biochemistries. When the test result meets the set condition, the related
chemistries will be requested and run automatically while those that have
been requested for the sample will be excluded. To view the results, select
Result-Current Results or History Results.

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10 Chemistries

10-28
11 System Commands and Setup
Options

The system commands include:

 Home
 Stop print
 Wake up
The advanced setup options include:
 User and password setup
 System timers for auto sleep and auto startup
 Dictionary setup
 Software version upgrading
 Software version
 Voice tone setup

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11 System Commands and Setup Options

11.1 Home
11.1.1 Introduction
The Home command is used to initialize the biochemistry system and the
ISE module, and to recover them from failures, making all components
return to the home positions. When the Home command is executed, the
system status becomes Standby.

11.1.2 Homing System

1 Select Utility-Commands.

2 Select Home.

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 11 System Commands and Setup Options

11.2 Stop Print

11.2.1 Introduction
The Stop Print command will stop all print requests in the print queue and
prevent them from being sent to the printer. This feature is used for
stopping print requests of many pages, such as error logs, QC reports,
multi-sample reports, etc. The print tasks that are Printing, Deleted,
Canceling or Canceled in the print task window will not be deleted.

11.2.2 Stop Print

1 Select Utility-Commands.

2 Select Stop Print. All print requests in the print queue will be
removed.

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11 System Commands and Setup Options

11.3 Sleep and Wake Up

11.3.1 Introduction
When hibernating manually through the sleep option, the system can be
activated by the Wake Up command. Except for Wake Up, the system can
also be activated based on the set auto awake time.
For more information about auto sleep and wake up, refer to 11.5 Sleep
and Awake Setup (page 11-8).

11.3.2 System Hibernation

1 Select Exit.

2 Select Sleep.

The system starts hibernating and the system status changes into
Sleep.

11.3.3 Waking up the System

1 Select Utility-Commands.

2 Select Wake Up.

3 The system is waking up, and the system status becomes Standby.

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 11 System Commands and Setup Options

11.4 User and Password Setup

11.4.1 Introduction
Users can be defined, deleted or modified on the User and Password
window. The system allows up to 100 users to be defined and belonged to
two user groups: administrator and operator. Administrators are allowed
to assign permissions for operators.
Figure 11.1 User and Password window

NOTE
The default username and password for administrator is Admin. Please note that the
password is case sensitive. You are recommended to change the password when
logging on the system for the first time in order to prevent others from abusing the
privileges of the administrator.
If an operator forgets his password, he may ask the administrator to log on the
system and delete the username and then redefine a username; or he may contact
our customer service department or your local distributor. If the administrator
forgets his password, contact our customer service department or your local
distributor.

11.4.2 Defining a User

Only administrators are allowed to define users. Up to 100 users are
allowed, including administrators. You should enter the username,
password, confirm password and user group when defining a user.
1 Select Utility-System Setup.

2 Select User F6.

3 Enter the username.

4 Enter the password.

A maximum of 20 characters can be entered.

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11 System Commands and Setup Options
5 Enter the password again in the Confirm field.

6 Choose a user group in the User Group pull-down list.

The options include:

 Administrator
 Operator
7 Select a doctor from Associated Doctor dropdown box.

When the user and the associated doctor have been set up, the
default tester in the patient demographics is the associated doctor of
the current login user.
8 Select New. The defined user appears in the user list.

9 Select Exit to close the window.

11.4.3 Modifying a User

Only administrators are allowed to edit the user group of themselves and
other users. Username and password can only be modified by the user
himself rather than anyone else.
1 Select Utility-System Setup.

2 Select User F6.

3 Choose a user to edit in the user list.

4 Enter the new username.

5 Enter the new password.

6 Enter the new password again in the Confirm Password field.

7 Choose a user group in the User Group pull-down list.

The options include:

 Administrator
 Operator
8 Select Modify.

9 Select Exit to close the window.

11.4.4 Assigning/Modifying Permissions

Permissions are assigned to user groups, which include administrator
and operator. Administrators are allowed to use, assign and modify all
permissions that are assigned for operators; while operators are only
allowed to use common functions, such as assigning reagent position;
programming samples, controls and calibrators; recalling

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 11 System Commands and Setup Options
sample/QC/calibration results; and those assigned by the administrators.
1 Select Utility-System Setup.

2 Select User F6.

3 Choose a user you desire to setup permissions in the user list, and
then select Permission.
Figure 11.2 Permission assignment

4 Assign permissions for the selected user.

 To assign new permissions, select the box in front of the relevant

operation. The select button changes to Yes.
 To cancel permissions, deselect the box in front of the relevant
operation. The select button changes to No.
5 Select Save to save the settings.

6 Select Exit to close the window.

11.4.5 Deleting a User

The username that has been used to log on the system currently cannot
be deleted. Only the administrators are allowed to delete users.
1 Select Utility-System Setup.

2 Select User F6.

3 Choose a username in the user list.

4 Select Delete.

5 Select OK.

6 Select Exit to close the window.

11-7
11 System Commands and Setup Options

11.5 Sleep and Awake Setup

11.5.1 Introduction
The Sleep/Awake feature includes the Auto Sleep Setup and Auto Awake
Setup options.
The Auto Sleep Setup option is used to set up the time interval of auto
sleep time of the system. After the sleep time interval is set up, a
countdown will begin from the moment that the system status becomes
Standby. When the time interval is elapsed, the system will begin sleeping.
Except for the auto sleep setting, the system can be woken up by means
of the wake up command.
The Auto Awake Setup option allows to define date and time of starting
up the system. When the time is reached, the system will be started up or
woken automatically no matter if it is off or sleeping.

11.5.2 Auto Sleep Setup

1 Select Utility-System Setup.

2 Select Instrument F1.

3 Select 1 Sleep/Awake.

4 Select 1 Auto Sleep Setup.

Figure 11.3 Auto Sleep Setup window

5 Type in the time interval for auto sleep.

The options include N/A, 30, 60, 90, 120, 150, 180,210,240,270 and
300 and the default is 60 minutes. N/A means the auto sleep timer is
disabled

NOTE

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 11 System Commands and Setup Options
If auto sleep is not enabled, some components, such as lamp, may get aged
quickly and degraded in performance. You are recommended to enable this
option.
6 Select Save.

When the interval is elapsed, the system will starts to sleep and the
system status becomes Sleep.
7 Select Exit.

11.5.3 Auto Startup Setup

NOTE
After setting up the auto startup time, ensure that the operation unit and the
analyzer are connected to power supply; otherwise, they cannot be started up
automatically.
1 Select Utility-System Setup.

2 Select Instrument F1.

3 Select 1 Sleep/Awake.

4 Select 2 Auto Startup Setup.

Figure 11.4 Auto Startup Setup

5 Choose the weekday for auto startup, and then set up the specific
time.

Any time within a week(from Monday to Sunday) can be defined for

the system to start up automatically.
6 Select Save.

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11 System Commands and Setup Options
When the date and time is reached, the system will be started up
automatically no matter if it is off.
7 Select Close.

11.5.4 Auto Awake Setup

NOTE
After setting up the auto awake time, ensure that the operation unit and the
analyzing unit are connected to power supply; otherwise, they cannot be woken up
automatically.
1 Select Utility-System Setup.

2 Select Instrument F1.

3 Select 1 Sleep/Awake.

4 Select 2 Auto Awake Setup.

Figure 11.5 Auto Awake Setup

5 Choose the weekday for auto startup, and then set up the specific
time.

Any time within a week (from Monday to Sunday) can be defined for
the system to start up automatically.
6 Select Save.

When the date and time is reached, the system will be started up or
woken automatically no matter if it is off or sleeping.
7 Select Exit.

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 11 System Commands and Setup Options

11.6 Dictionary Setup

11.6.1 Introduction
The Dictionary option is provided for setting up and managing frequent
data information, including: result unit, sample type, sample comment,
and QC comment. A maximum of 30 data options can be defined for each
dictionary, and each dictionary must not contain duplicate data. Sample
comment can be entered manually or selected from the Comment
pull-down list on the Sample screen, Levey-Jennings screen, and (QC)
Results screen.
Data options can be defined, edited or deleted in any system status. The
default data options cannot be deleted or edited.

11.6.2 Defining, Editing and Deleting Data Option

1 Select Utility-System Setup.

2 Select Instrument F1.

3 Select 3 Dictionary.
Figure 11.6 Dictionary window

4 Choose desired dictionary in the Data list.

To add a data option:

 Select New.
 Input the data description in the Data field.
 Select Save.

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11 System Commands and Setup Options
To modify a data option:
 Select desired data option in the data list.
 Modify the data description in the Data field.
 Select Save.
To delete a data option:
 Select desired data option in the data list.
 Select Delete.
5 Select Close.

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 11 System Commands and Setup Options

11.7 Software Upgrade

11.7.1 Introduction
Software Upgrade is used to upgrade the operating software and ISE
module software. When software versions is upgraded, the original data,
including those in the database and saved in files, will not be destroyed
and can be compatible with the new versions.

11.7.2 Software Upgrade

1 Select Utility-System Setup.

2 Select Instrument F1.

3 Select 6 Version Upgrade.

4 Insert the U disk containing the software into the USB interface of the
computer.

5 Select OK, and then operate according to the screen prompts.

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11 System Commands and Setup Options

11.8 Software Version

11.8.1 Introduction
You are allowed to view the version number of the operating software and
control software in any system status.

11.8.2 Software Version

1 Select Utility-System Setup.

2 Select Instrument F1.

3 Select 7 Version Info.

Figure 11.7 Software Version window

4 View the version number of the operating software, control software,

database, and ISE module software.

If a new version is released, upgrade the operating software while

referring to 11.7 Software Upgrade (page 11-13). If no ISE module is
configured, the ISE Software Version area will be blank.
5 To view the version numbers of the smart module software, select
Details.

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 11 System Commands and Setup Options
Figure 11.8 Smart module software version window

6 Move the scroll bar to view more versions.

7 Select OK.

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11 System Commands and Setup Options

11.9 Voice Tone Setup

11.9.1 Introduction
The Voice Tone Setup option provides voice tone choices for system
failures or user’s mis-input or mis-operation. You are allowed to import
audio files from an external storage device and set them as voice tone.

11.9.2 Importing Audio Files

1 Select Utility-System Setup.

2 Select Instrument F1.

3 Select 11 Voice Tone Setup.

4 Select Import.

5 Select the path and one or more favorite audio files.

6 Select Open.

The imported audio files are displayed in the Alarm and Message Tip
pull-down lists.

11.9.3 Setting Up Voice Tone

1 Select Utility-System Setup.

2 Select Instrument F1.

3 Select 11 Voice Tone Setup.

Figure 11.9 Voice Tone Setup window

4 Choose a voice tone from the pull-down list box, and then select the
corresponding Test button to test the voice effect until the proper one
is found.

5 Select Save to save the settings.

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 12 Use of ISE Module

This chapter introduces the ISE module in the following aspects:

 Precautions on use
 Principles of measurement
 Chemistry parameters setup
 Preparing reagents for analysis
 Running ISE chemistries
 Results recall
 ISE primes and calibration factor expiration date

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12 Use of ISE Module

12.1 Precautions on Use

12.1.1 Introduction
Read the following precautions thoroughly prior to using the ISE module.

12.1.2 Precautions on Use

Operator Precautions

Warning
The ISE module must be operated by skilled/trained doctors, nurses or clinical
professionals.

Driver parts precautions

Warning
Exercise caution while using the ISE module. Prevent your hair, legs or other parts of
your body from being hurt by the driver parts.

Serum sample biohazards

BIOHAZARD
The serum samples remaining in the electrodes may contain a great number of
viruses. Wear gloves to prevent infection while operating around the electrodes.

Calibration precautions

CAUTION
Calibrate the ISE chemistries for serum and urine before starting the measurement.
If the result of a chemistry is based on the calibration factors of another chemistry, it
may not be accurate enough.
After changing electrodes or other consumables, perform a calibration. You are
recommended to perform calibration at least once every day to ensure accurate
results.

Calibrator biohazards

BIOHAZARD
The calibrators contain preservatives. In case your skin contacts calibrators, wash
them off with soap and water. In case the calibrators spill into your eyes, rinse them
with water and consult an oculist. If you swallow them by mistake, see a doctor.

CAUTION
Use the calibrators specified by our company. Use of other reagents or calibrators
may result in unreliable results, or damage the Hydropneumatic system, or even
shorten the electrodes life span.

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 12 Use of ISE Module
Prior to using the calibrators, check if they are within the expiration date.
Place them correctly; otherwise, it may cause unreliable results, or leak, or module
damage.

ISE wash solution biohazards

BIOHAZARD
The ISE wash solution is sodium hypochlorite. Use the ISE wash solution carefully to
prevent it from contacting your skins or eyes. If your skins or eyes contact the ISE
wash solution, rinse them off with fresh water and consult a doctor.

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12 Use of ISE Module

12.2 Principles of Measurement

The ISE unit measures the concentration of Na+, K+ and Cl- ions
contained in serum and urine samples with the ion-selective electrode
method. The relation between the electromotive force of ion-selective
electrodes and the ion concentration is expressed in a Nernst formula.
Serum is tested without dilution while urine should be diluted manually
before test with buffer solution at the ratio of 1:9.
A single measurement of the ISE unit is conducted in the following order:
 Drainage: The calibrator in the ISE pipe is drained
 Sample analysis: The sample probe dispenses the sample (70μL for
serum sample,140μL for diluted urine) into the sample injection port
of the ISE module and then the sample is absorbed into the flow cell
for measurement. When the measurement is finished, the waste is
drained from it.
 Cleaning pipework: 100μL calibrator A is dispensed into the ISE
module for cleaning the ISE flow cell
 Single point calibration: 80μL calibrator is dispensed into the ISE
module to perform single point calibration.
The table below lists the measurement range of the ISE module:

Table 12.1 Measurement range of ISE module

Chemistry Serum Urine
Na+ 100～200mmol/L 10～500mmol/L
K+ 1～8mmol/L 5～200mmol/L
Cl- 50～150mmol/L 15～400mmol/L

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 12 Use of ISE Module

12.3 ISE Chemistry Parameters

12.3.1 Introduction
The ISE module measures the concentration of K+, Na+ and Cl- ions
contained in human body fluid by means of electrodes, helping diagnosis
of electrolyte disturbance, body fluid equilibrium, and other relevant
diseases.
The ISE chemistries are applicable to serum and urine, and the default
sample type is serum. If the sample is of a type other than serum and
urine, it will be analyzed with the chemistry parameters for serum.
ISE chemistry parameters can be viewed but cannot be modified and
reconfigured.
Figure 12.1 Define/Edit ISE Chemistries window

12.3.2 Viewing ISE Chemistry Parameters

The ISE chemistry parameters are opened to all users for viewing in any
system status.
1 Select Utility-Chemistries.

2 Choose the ISE box.

3 Select Define F1.

4 View the parameters.

5 Click Exit to close the window.

12.3.3 Introduction to ISE Chemistry Parameters

ISE chemistry parameters and reference range are displayed on the

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Define/Edit ISE chemistries screen. ISE chemistry has two test mode:
serum and urine. For urine, it has to be diluted manually before test.
In the following table, U stands for urine and S for serum.

Table 12.2 ISE chemistry parameters(cannot be edited)

Parameter/Chemistry K+ Na+ Cl-
Unit (S) mmol/L mmol/L mmol/L
Unit (U) mmol/L mmol/L mmol/L
Decimal (S) 0.01 0.1 0.1
Decimal (U) 1 1 1
Measurement Range (S) 1.00–8.00 100.0–200.0 50.0–150.0
Measurement Range 5–200 10–500 15–400
(U)

Unit
The unit of K,Na and Cl is mmol/L which can be viewed but cannot be
edited.

Decimal
The decimal of the result can be viewed but cannot be edited.

Measurement Range
The measurement range can be viewed but cannot be edited.

12.3.4 Flag ISE Qualitative Result

1 Select Utility-Chemistries.

2 Choose the ISE box.

3 Select Define F1.

4 Click the Down button.

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 12 Use of ISE Module
Figure 12.2 Define/Edit ISE Chemistries window

5 Select Use Qualitative Result under Na.

6 Enter Range and Flag.

7 Repeat 5-6 to flag the qualitative result for Na and Cl.

8 Click OK to save the setup.
9 Select Exit to close the window.

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12.4 Preparing ISE Reagents for Measurement

12.4.1 Introduction
The ISE wash solution is placed on the sample carousel. When you cancel
the configuration of the ISE module, the loaded reagents are deleted.
Please follow the steps below to load the ISE reagents:

12.4.2 Off-line Load ISE Reagent

Off-line load ISE reagent is performed when ISE is not running its tests.
1 Make sure the ISE module is not running its tests.
2 Select Reagent-Reagent/Calibration-ISE Reagent.

3 Select Load F1.

If it is the first time to load the ISE reagent, please enter Step 7; if not,
unload the reagent first.
Figure 12.3 Unload Reagent

4 Select Unload to unload the reagent pack.

5 Disconnect the wand from the top of the Reagent Pack by pushing
down the yellow button in the wand, which disconnects the wand
from and Reagent Pack. Set the wand on the table surface, which
should not leak. Carefully remove the used Reagent Pack from the
Chemistry Analyzer and dispose of it properly.

6 Click OK to load the reagent pack.

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 12 Use of ISE Module
7 Remove the red caps from Reagent Pack first and push the wand just
above the top of Reagent Pack. Make sure that the three pipe
adapters at the bottom of the wand are opposite to those on the top
of Reagent Package, then push down the wand to Reagent Package.
The wand will only fit one way. Once the wand is connected to the
reagent pack, place the reagent pack on the sliding tray
Figure 12.4 Installing Reagent Pack 1

Figure 12.5 Installing Reagent Pack 2

NOTE
When installing ISE reagent pack, do not twist, press and squeeze the pipes of
the ISE Module otherwise the ISE pipes may be clogged.
Wear gloves and lab coat and, if necessary, goggles.

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12 Use of ISE Module
Figure 12.6 Load Reagent

8 Enter the number in Purge A/B field which can be any integer within
1-50 and the default is 30.

9 Click Prime.

10 Select OK to calibrate ISE chemistry when Purge A/B is complete.

12.4.3 On-line Load ISE Reagent

On-line loading ISE reagent is performed when ISE module is running its
tests.
1 Select Reagent-Reagent/Calibration-ISE Reagent.

2 Select Load F1 to stop reagent aspirating and dispensing. Meanwhile

Load F1 becomes No load F1.

3 If you want to cancel the reagent stop, select No Load F1.

4 Click OK and then select Load F1. Here, the load steps are the same
as off-system load ISE reagent.

12.4.4 Load ISE Wash Solution

ISE wash solution is used to wash the electrodes and can only be loaded
manually.
1 Check the system status and operate accordingly.

 Standby: Proceed to the next step.

 Running: Select the button on the upper-right corner of the

main screen to stop sample aspirating and dispensing. When the
countdown for sample stop becomes 0 and the system status is
Sample Load, proceed to the next step.

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 12 Use of ISE Module
 Incubation: Proceed to the next step.
 Sleep: Proceed to the next step.
2 Remove the sample carousel cover;

3 Place ISE wash solution in position D1 (No.88) of the sample

carousel.

4 Restore the sample carousel cover;

5 Select the icon to resume the test or start new test.

12.4.5 Replacing ISE Wash Solution

Replacing the wash solution can be performed when the ISE module
status is Standby or Running. If the system status is Standby, you are
allowed to directly replace the wash solution in the same way as it is
loaded; if the system status is Running, the wash solution can only be
replaced after the current tests are finished; if the ISE module is running a
calibration, you are not allowed to replace the wash solution until all tests
of the calibration are finished.
1 Check the system status and operate accordingly.

 Standby: proceed to the next step.

 Running: Select the button on the upper-right corner of the

main screen to stop sample aspirating and dispensing. When the
countdown for sample stop becomes 0 and the system status is
Sample Load, proceed to the next step.
 Incubation: proceed to the next step.
 Sleep: Start replacing reagents.
2 Remove the sample carousel cover.

3 Remove the ISE wash solution from position D1 (No.88) of the sample
carousel.

4 Place the new wash solution.

5 Restore the sample carousel cover.

6 Select the icon to resume the test or start new test.

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12.5 Calibration and Results Recall

12.5.1 Introduction
Current calibration factors and all intermediate data are provided on the
ISE Calibration screen. Calibration results can be printed out or archived
to an external storage device. The Trend option is provided to enable you
to view the calibration trends of ISE chemistries during a period of time.
When the calibration factors are expired, the Extend Calibration Time can
help prolonging their validity period for measurement.

12.5.2 Calibration Setup

Set up ISE calibrators and the calibration time. When a calibrator is
expired, it will be indicated in yellow and cannot be used for calibration.

Setting up ISE calibration time

1 Select Reagent-Setup.

2 Select Rules F4.

3 Choose a chemistry from the Chemistry pull-down list.

Figure 12.7 ISE calibration setup window

4 Enter the calibration time in the Cal Time field.

The input range is 1-9999, and the default is 8 hours. If the field is left
blank, it indicates that the calibration factors can be always used.
5 Select Auto Calibration if you want to set up ISE auto calibration.

6 Enter the auto calibration time.

The range is 1-24 hour; the default is blank.

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 12 Use of ISE Module
7 Select Save F7 to save the setup.

8 Select Prev F4 or Next F5 to set up calibration rules for other

chemistries.

9 Select Close F8 to close the window.

12.5.3 Calibration Status and Alarm

On the Reagent/Calibration screen, the chemistries are indicated with
various texts and colors for different calibration status. Chemistries in Cal
Required, Cal Failed or Cal Time Out status can be requested but will not
be run.
Check the chemistries’ calibration status frequently and take relevant
actions according to the following table.

Table 12.3 ISE calibration status

Calibration Description Severity Color
Status
Cal Required Indicates that the chemistry Serious Red
needs to be calibrated.
This status appears when the
chemistry is not calibrated or the
ISE reagent/electrode is
replaced.
Requested Indicates that the chemistry has Normal No color
been requested for calibration indication
but not finished yet.
Calibrated Indicates that the chemistry has Normal No color
been calibrated successfully and indication
has not exceeded the calibration
time.
Cal Failed Indicates that the chemistry has Serious Red
calibration factors calculated but
they exceed the acceptance
limits, or has no calibration
factors calculated.
Cal Time Out Appears when the chemistry Serious Red
exceeds the calibration period or
the reagent of different serial
number and lot number is used.
Appears when the chemistry
exceeds the calibration time.
Cal Time Indicates that the calibration Warning Yellow
Extended period has been extended and the
current calibration factors can be
used without time limit.
Default Appears when the result is Warning Yellow
calculated with the default
calibration factors defined by the
user rather than the factory.

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Calibration Description Severity Color

Status
N/A Indicates that the reagent is not Normal No color
loaded. indication

12.5.4 ISE Calibration

ISE chemistries, which include Na, K and Cl, are calibrated without being
divided into ISE serum and ISE urine
1 Select Reagent-Reagent/Calibration.
Figure 12.8 Reagent/Calibration screen

2 Choose ISE Chemistry.

3 Select Calibrate F5.

4 Select OK to start calibration.

12.5.5 Results Recall

The calibration data and trends of ISE chemistries are provided on the ISE
Calibration screen. The system allows you to recall the current ISE
calibration factors and results of recent 540 calibrations. If a calibration
result is abnormal, a flag will be added on patient reports and on the ISE
Calibration screen.
For more information about result flags, refer to 17.4 Data Alarm (page
17-10).

Recalling calibration results

1 Select Reagent-ISE Calibration.

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 12 Use of ISE Module
Figure 12.9 ISE Calibration screen

The screen shows the calibration factors that are being used for
calculating results.
2 Select the History option button, and then select date range that the
chemistry is calibrated.

3 Select Search F1.

The calibration results of the chemistry are displayed in the result list.
4 To print the calibration report, select Print F7.

Recalling calibration trends

1 Search for desired calibration results on the ISE Calibration screen.

2 Select Trend F6. The Calibration Trends window is displayed.

3 Choose desired trend type and calibration date range, and then select
Search F1.

The trend of the chemistry within the specified time period is

displayed on the screen. The trend type options will not include
Reference Electrode when trends of ISE Urine are being recalled.

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12 Use of ISE Module
Figure 12.10 Calibration Trends window

4 Choose the Tabular Trend tab to view the trend data.

Figure 12.11 Tabular Trend window

5 Choose the following buttons as needed:

 Prev F4: to view the calibration trends and data of the previous
chemistry.
 Next F5: to view the calibration trends and data of the next
chemistry.
 Print F7: to print the current graphic trend or data.
6 Select Close F8 to close the window.

Archiving ISE calibration results

Both the current and early calibration factors of ISE chemistries can be

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 12 Use of ISE Module
archived. The archiving file is of .csv format and named by the date and
time the results are archived.
1 Select Reagent-ISE Calibration.

2 Search for desired calibration results.

3 Select Archive F5.

4 Specify archiving path and file name.

5 Select Save.

12.5.6 Extending ISE Calibration Time

When ISE calibration factors exceed the validity period, they cannot be
used for measurement, and the calibration status changes to Cal
Required. If you are certain that the calibration factors are correct and
valid, you may prolong their validity period by using the calibration time
extension function. A calibration time can be extended only if the current
calibration of the chemistry is timed out or succeeded. The results
calculated based on extended calibration factors will be flagged.
1 Select Reagent-Reagent/Calibration.

2 Choose a chemistry you want to extend.

3 Select Cal Options F8.

4 Select Extend Calibration Time from the Calibration Options

window.

5 Select OK. The calibration factors of the selected chemistry can be

used without time limit.

6 To remove the extended status, recalibrate the chemistry.

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12 Use of ISE Module

12.6 Quality Control and Results Recall

12.6.1 Quality Control and Results Recall
Control samples can be defined, run and recalled for the ISE chemistries
in the same way as for biochemistries. The ISE chemistries are divided
into the following based on the sample types:
 Na (serum)
 K (serum)
 Cl (serum)
 Na (urine)
 K (urine)
 Cl (urine)
For the operating procedure of quality control, refer to 2.7 Quality Control
(page 2-30).
For details of QC evaluation and results recall, refer to 7 Quality Control
(page 7-1).

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12.7 Sample Programming and Results Recall

The ISE chemistries, like biochemistries, can be also used for analyzing
routine samples, emergent samples, added samples and reruns, and
requested along with the biochemistries. They are requested in the form
of Na, K and Cl, and applicable to serum, plasma, urine, CSF and other
sample types. The four sample types other than urine are programmed
with the serum parameters, while urine sample is with the urine
parameters.
Nevertheless, the ISE chemistries are slightly different from
biochemistries for that they do not support the measurement with
increased or decreased or prediluted samples.
For the operating procedure of sample analysis, refer to 2.8 Programming
Routine Samples (page 2-34).
ISE test results have no reaction curves and can be recalled in the same
way as other chemistries. Refer to 8 Sample Programming and
Processing (page 8-1) for details.

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12.8 Reagent Inventory Alarm Limit

12.8.1 Introduction
When the reagent inventory is lower than the alarm limit during or before
the analysis, the system will give an alarm and display the volume of ISE
reagent and wash solution as <x on the Reagent/Calibration screen and
the ISE reagent is marked by yellow ;(“x” stands for the defined alarm limit)
When the ISE reagent inventory is 0, it is marked by red.

12.8.2 Setting up Reagent Inventory Alarm Limit

1 Select Utility-System Setup.
Figure 12.12 System Setup screen

2 Type in the inventory alarm limit of ISE reagent.

Enter an integer between 1 and 50. The default is 5.

3 Select Save F8.

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12.9 ISE Prime Cycle

12.9.1 Introduction
While the analyzer is started up and new reagent pack is identified, the
ISE module will prime automatically to replace the reagents inside of it
with fresh reagents. The number of primes can be defined on the System
Setup screen.
Only administrators are allowed to define or modify the startup prime
times.

12.9.2 Defining/Modifying ISE Prime Times

1 Select Utility-System Setup.

2 Type in the number of primes in the ISE Prime Cycle field.

The input range is 1-50, and the default is 30.

3 Select Save F8.

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12.10 Daily Maintenance

12.10.1 Daily Maintenance
To ensure the ISE module’s life span and measurement performance,
maintain it regularly as instructed in this manual. The system provides
scheduled maintenance and maintenance instructions, in which the latter
contains all of the scheduled maintenance procedures and some
maintenance instructions that can be performed independently.
The table below is a summary of the scheduled maintenance procedures
and maintenance instructions for the ISE module.

Table 12.4 Scheduled maintenance and instructions for ISE module

Schedule Maintenance Procedures
Daily Clean ISE electrode tubes
Monthly Clean sample injection port
Pump calibration
Air bubble Detector calibration
Six month Replace reference electrode
Other Replace ISE electrode
Store electrodes
Remove reagent pack
Two-point calibration
Clean waste tube of ISE module
Maintenance Clean electrode tubes
Instructions Maintenance
A purge
B purge
Pump calibration
Air bubble Detector calibration
Replace electrode
Remove reagent pack
Program check instruction
Air bubble Detector calibration result
Pump calibration result
Reading and writing Dallas

For more information about ISE module maintenance, refer to 16

Maintenance (page 16-1).

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12.11 Troubleshooting ISE Module

12.11.1 Troubleshooting ISE Module
The failures occurring on the ISE module may be related to the sample
probe unit, sample carousel unit, Hydropneumatic unit, ISE module,
reagent inventory, reference electrode and communication. The system
provides the following processing methods for the failures:
 Alarm: displaying alarm messages and recording them in error logs
without influencing the tests.
 Invalidating current ISE tests: invalidating the tests that are currently
being run.
 ISE measurement stop: stopping the measurement after finishing the
tests that have been started.
 ISE emergent stop: terminating all ISE tests immediately.
For troubleshooting of the ISE module, refer to 17 Alarms and
Troubleshooting (page 17-1).

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12-24
 13 Use of Bar Code

The setup and operation instructions of the sample bar code reader and
the reagent bar code reader are depicted in this chapter. The sample bar
code reader is used to identify samples and obtain sample information by
scanning the bar code label applied on sample tubes. The reagent bar
code reader scans the bar code labels automatically when the reagents
are loaded.

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13 Use of Bar Code

13.1 Sample Bar Code Reader

13.1.1 Introduction
The sample bar code reader obtains sample information from the bar
code label. When bar-coded samples are loaded to the sample carousel,
the system will make a full scan and locate samples through the bar
code.

Sample bar code specifications

The sample bar code reader is in compliance with the Clinical and
Laboratory Standards Institute (CLSI) and compatible with various
application environments.

Table 13.1 Sample bar code specifications

Name Description
Symbology Codabar, ITF, Code128, Code39, UPC/EAN, and Code93
Minimum bar code 0.19mm~0.5mm
density
Length 3-27 digits
Format and content User-defined
Maximum width 55mm
Minimum height 10mm
Maximum inclination ±5º
angle
Print quality No less than Class C according to the ANSI MH10.8M
Print Quality Specification.
Width and narrowness 2.5-3.0:1
Print paper Coated paper or matte paper. Printing bar code on
common paper may result in vague bar code or
degraded bar code label. You are not suggested to print
bar code on common print paper.
Characters Meaningful characters, such as numbers (0~9) and
upper-case letters (A~Z). You are recommended to
print the check digit in order to check that a bar code
is read accurately.

Information contained in a sample bar code

The system will obtain the following information from the LIS host based
on sample bar code:
 Sample ID
 Sample type
 Requested chemistries

13.1.2 Sample Bar Code Setup

Before performing the setup procedure, check if your system is equipped

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 13 Use of Bar Code
with a sample bar code reader. If needed, contact our customer service
department or your local distributor.
Perform the following steps to set up sample bar code:
1 Select Utility-System Setup.
2 Select Bar Code F4.
3 Choose Sample Bar Code.
4 Choose a bar code symbology and set up the check digit status.
The following symbologies are provided:
 Codabar
 Interleaved 2 of 5
 Code128
 Code39
 UPC/EAN
 Code93
Code 128, Code 93 and UPC/EAN requires a check digit by default,
and other symbologies are not compulsive. The Code 128 is selected
by default and cannot be modified.

CAUTION
You are recommended to enable the check function for all symbologies in order
to prevent misreading of bar code.
5 Set up sample bar code applications according to actual demands.

The following three options are available:

 Enable/Disable sample carousel bar code
 Mark the Enable/Disable Sample Bar Code checkbox to enable
the sample bar code reader. Bar Code will appear on the
Current Results and History Results screen in the place of
Sample ID.
 To disable the sample bar code reader, deselect the checkbox.
 Enable or disable auto numbering of bar-coded samples
 When this option is enabled, the system will automatically
number the bar-coded samples during bar code scanning. The
start number will be the next available one since the last
sample is programmed. The default start number for every day
is 1. Sample barcode
 Extract sample information: if it is selected, the system will
automatically extract the sample information according to the
barcode. For example, if the barcode only contains the sample ID
and Date, when being analyzed, the sample ID and Date are added

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13 Use of Bar Code
to the information of the sample. Only when LIS communication
mode is unidirectional, can the option be enabled.
 Define STAT sample positions on sample carousel
 Samples placed in the specified STAT positions will be taken
automatically as emergent samples. Input the start and end
positions within the range of 1~115. The set positions will be
indicated by E (Emergent) on the sample carousel status
screen.
The Sample Crsl Bar Code and Auto Number Scanned Samples
options are selected by default.
6 Select OK to save the setup.
7 Select Format
8 Define the bar code digits.
The system can scan a sample bar code of fixed length or within 3-27
digits. The Interleaved 2 of 5 only supports bar code of even number
length and the digits of the barcode must be defined.
 To use a fixed-length bar code,
 Mark the Fixed Digits checkbox of relevant symbology.
 Type in the number of digits in the edit box to the right of the
Fixed Digits field.
 To use a sample bar code within 3-27 digits, you have no need to
define the fixed digits.
9 Select OK to save the setup.

13.1.3 Programming Bar-Coded Routine Samples

Program bar-coded routine samples by choosing an operating procedure
according to the facilities in your laboratory.

BIOHAZARD
Inappropriate handling of samples may lead to biohazardous infection. Do not touch
the samples directly with your hands. Wear gloves and lab coat, if necessary, goggles.
In case your skin contacts the samples, follow standard laboratory safety procedure
and consult a doctor.

CAUTION
Do not use expired samples; otherwise, unreliable test results may be caused.

NOTE
When manually entering sample program information in bar code mode, ensure that
the input program information is consistent with the samples loaded to the sample
carousel. After the manually programmed samples are analyzed, they must be
released manually to leave space for other samples.

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 13 Use of Bar Code
When a LIS is provided
1 Place the bar-coded samples in idle positions of the sample carousel.

2 Select the icon on the upper-right corner of the main screen.

3 Select a sample carousel to which the samples are loaded, and mark
the Sample Crsl Bar Code checkbox.

4 Select a patient sample range: All or Partial. When you select Partial,
you should specify a sample position range for analysis.

5 Select OK.

The system starts scanning the samples on the sample carousel and
then analyzes them according to the program information
downloaded from the LIS host.

When no LIS is provided

If your system is not equipped with a LIS host, you are allowed to
program bar-coded samples with the default panel or to program them
manually one by one or by batch. For more information, refer to 10.8
Default Panel (page 10-21).
1 Place bar-coded samples sequentially on the sample carousel.

If the auto numbering feature is enabled, the system will

automatically number the samples according to the order in which
they have been placed. The start number will be the next available
one since the last sample is programmed.
2 Select Program-Status.

3 Select Scan F5. The Scan window is displayed.

Figure 13.1 Scan window

Prior to selecting the Scan F5 button, ensure the following conditions

have been satisfied:
 A sample bar code reader has been configured.

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13 Use of Bar Code
 Sample bar code scanning is activated on the Sample Bar Code
window.
 The system status is Standby or Sample Stop.
4 Choose the scanning range.

 All positions: to scan all positions on the sample carousel.

 Specified positions: to scan the specified positions on the sample
carousel. Input the start and end scanning positions.
5 Select OK.

If a default panel has been defined, the scanned samples will be

programmed with the default panel; otherwise, chemistries should be
requested for the samples.
6 Select Program-Sample.

7 Enter the sample programming information.

To program a single sample,

 Input the sample ID, press Enter, and then choose chemistries for
analysis.
 Select Save F8.
To batch-program samples,
 Input the start sample ID, press Enter, and then choose
chemistries for analysis.
 Select Batch F3, input the end sample ID, and then select OK.

8 Select the icon on the upper-right corner of the main screen.

9 Select a sample carousel to which the samples are loaded.

10 Select a patient sample range: All or Partial. When you select Partial,
you should specify a sample position range for analysis.

11 Select OK.

13.1.4 Programming Bar-Coded STAT Samples

STAT sample program allows emergent samples to be programmed and
analyzed with high priority. The system provides common STAT and quick
STAT program. Common STAT program is of higher priority than routine
samples. Quick STAT program is mainly used to program emergent
samples quickly with higher priority than routine and common STAT
samples.
Common STAT samples can be analyzed automatically by means of the
sample bar code system and the LIS. Quick STAT samples, however, can
only be analyzed by selecting the icon at the upper-right corner of

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 13 Use of Bar Code
the main screen. Refer to Quickly programming STAT Samples (Page 2-44)
for details.

BIOHAZARD
Inappropriate handling of samples may lead to biohazardous infection. Do not touch
the samples directly with your hands. Wear gloves and lab coat, if necessary, goggles.
In case your skin contacts the samples, follow standard laboratory safety procedure
and consult a doctor.

CAUTION
Do not use expired samples; otherwise, unreliable test results may be caused.

NOTE
When manually entering sample program information in bar code mode, ensure that
the input program information is consistent with the samples loaded to the sample
carousel. After the manually programmed samples are analyzed, they must be
released manually to leave space for other samples.

When a LIS is provided

1 Place the bar-coded samples in idle positions of the sample carousel.

2 Select the icon on the upper-right corner of the main screen.

3 Select a sample carousel to which the samples are loaded, and mark
the Sample Crsl Bar Code checkbox.

4 Select a patient sample range: All or Partial. When you select Partial,
you should specify a sample position range for analysis.

5 Select OK.
The system starts scanning samples on the sample carousel and
analyzes them automatically according to the program information
obtained from the LIS host.

When no LIS is provided

If your system is not equipped with a LIS host, you are allowed to
program bar-coded samples by using the default panel, or to program
them one by one or by batch. For more information about analysis with
default panel, refer to 10.8 Default Panel (page 10-21).
After locating a sample by entering the bar code, you are allowed to
manually program the sample for analysis.
1 Place bar-coded STAT samples sequentially on the sample carousel.

If the auto numbering feature is enabled, the system will

automatically number the samples according to the order in which
they have been placed. The start number will be the next available
one since the last sample is programmed.

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13 Use of Bar Code
2 Select Program-Status.

3 Select Scan F5. The Scan window is displayed.

Figure 13.2 Scan window

Prior to selecting the Scan F5 button, ensure the following conditions

have been satisfied:
 A sample bar code reader has been configured.
 Sample bar code scanning is activated on the Sample Bar Code
window.
 The system status is Standby or Sample Stop.
4 Choose the scanning range.

 All positions: to scan all positions on the sample carousel.

 Specified positions: to scan the specified positions on the sample
carousel. Input the start and end scanning positions.
5 Select OK.

If a default panel has been defined, the scanned samples will be

programmed with the default panel; otherwise, chemistries should be
requested for the samples.
6 Select Program-Sample.

7 Enter the sample programming information.

To program a single sample,

 Input the sample ID, press Enter or Tab, mark the STAT checkbox,
and then choose chemistries for analysis.
 Select Save F8.
To batch-program samples,
 Input the start sample ID, press Enter, and then choose
chemistries for analysis.
 Select Batch F3, input the end sample ID, and then select OK.

8 Select the icon on the upper-right corner of the main screen.

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 13 Use of Bar Code
9 Select a sample carousel to which the samples are loaded.
10 Select a patient sample range: All or Partial. When you select Partial,
you should specify a sample position range for analysis.

11 Select OK.

13.1.5 Adding New Samples or Chemistries

BIOHAZARD
Inappropriate handling of samples may lead to biohazardous infection. Do not touch
the samples directly with your hands. Wear gloves and lab coat, if necessary, goggles.
In case your skin contacts the samples, follow standard laboratory safety procedure
and consult a doctor.

CAUTION
Do not use expired samples; otherwise, unreliable test results may be caused.
1 Select Program-Sample.

2 Select List F5.

3 Select Download F7.

4 Choose one of the following options:

 All programmed samples: to download all samples programmed

on the current day.
 Latest samples: to download samples which are programmed on
the current day but have not been downloaded.
 Sample with the following IDs: to download samples with the
specified program date and ID. Type in the single sample ID or ID
range in the edit box.
 Sample with the following bar code: to download the sample with
the specified bar code. Enter the bar code of the desired sample.
5 Select OK.

6 Select List F5, and then select Unpositioned F2 to view samples

downloaded from the LIS host.

7 Select Assign and set positions for the downloaded samples.

 Select the program date.

 Input single sample ID or sample ID range.
 Choose a sample carousel on which the sample(s) will be placed.
 Input the start and end positions.
8 Type in the sample ID or bar code on the Sample screen, and then
confirm the program information.

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13 Use of Bar Code

9 Select the icon on the upper-right corner of the main screen to

request for sample stop.

10 Check the sample stop countdown in the system status area and wait
until it comes to 0.

11 Check the sample carousel indicators, and proceed to the next step
when the indicators are extinguished.

 Flash: indicates that the corresponding carousel is rotating or will

start to rotate after 2 periods.
 ON: indicates that the corresponding carousel is stopped for
sample aspirating or that the sample probe is aspirating on the
reaction carousel during test for the diluted samples
 Off: indicates that the corresponding carousel has no sample
being aspirated and will not rotate in the next period.
12 Place the bar-coded samples on the idle positions of the sample
carousel.

 If the system is running tests, it will analyze the added samples

automatically.
 If the system is not running any tests,

 Select the icon on the upper-right corner of the main

screen.
 Select a sample carousel to which the samples are loaded, and
mark the Sample Crsl Bar Code checkbox.
 Select a patient sample range: All or Partial. When you select
Partial, you should specify a sample position range for
analysis.
 Select OK.

13.1.6 Rerunning Bar-Coded Samples

BIOHAZARD
Inappropriate handling of samples may lead to biohazardous infection. Do not touch
the samples directly with your hands. Wear gloves and lab coat, if necessary, goggles.
In case your skin contacts the samples, follow standard laboratory safety procedure
and consult a doctor.

CAUTION
Do not use expired samples; otherwise, unreliable test results may be caused.

Programming rerun samples

1 Select Result-Current Results.

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 13 Use of Bar Code
2 Choose results you desire to rerun.

3 Select Rerun F5.

Figure 13.3 Rerun window

4 Enter the sample position.

5 Select a sample volume type to rerun the sample.

The sample volume is the same as that defined for the chemistry. If
increased and decreased volumes are defined for the chemistry,
Increased and Decreased are available here for selection.
6 Type in the predilution factor for the sample.

The input range must be within 4-176. The default is blank, which
indicates that the sample needs not to be prediluted before being
analyzed.
7 Select OK.

Modifying and adding chemistries

1 Select Program-Sample.

2 Enter the sample ID in the Sample ID field.

Sample ID is composed of numbers, or letters and numbers. Up to 10

digits can be entered. The ID range for routine samples and common
STAT samples is 1-9000; while quick STAT samples start from 9001
by default.
3 Modify the requested chemistries, or add new chemistries.

4 To change the sample volume and dilution factor, select Options F2,
and then do necessary settings.

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13 Use of Bar Code
5 Select Save F8.

Starting analysis
1 Check that the rerun samples have been loaded to the sample
carousel.

2 If the system is running tests, it will automatically scan all sample

positions and then start the analysis.

3 If the system status is Standby, select the icon on the

upper-right corner of the main screen.

4 Select the sample carousel on which the samples are located.

5 Select a patient sample range: All or Partial. When you select Partial,
you should specify a sample position range for analysis.

6 Select OK.

The system starts scanning the samples on the sample carousel and
then analyzes them according to the program information
downloaded from the LIS host.

Recalling rerun results and determining default result

Recalling rerun results and setting default results are the same with
non-bar-coded samples. For more information refer to 8.2.4 Rerunning
Samples (page 8-4).

13.1.7 Results Recall

Displaying current results
1 Select Result-Current Results.

The screen shows all incomplete samples and controls, as well as

those programmed and analyzed on the current day.

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 13 Use of Bar Code
Figure 13.4 Current Results screen

2 Choose a sample in the left list. The right list displays all results of
the sample.

3 Choose the following buttons as needed:

 Search F1: to inquire sample results.

 Options F2: to delete, edit, rerun or print samples.
 Demog F3: to view patient demographics of the sample.
 Reac Curve F4: to view the reaction curve of the sample.
 Rerun F5: to rerun a finished sample.
 Print F7: to print sample results.
 Host F8: to transmit the selected sample results to the LIS host.

13.1.8 Recalling Current Results

Current results can be inquired by sample type, patient name, patient ID,
sample ID or sample bar code, etc. along with the program date.
Whichever status the system is, only one condition is required for
inquiring desired results.
You are allowed to view patient demographics, reaction curve and data, to
delete or edit results, to send results to the LIS host, and to print the
results. For more information, refer to 8.12 Results Recall (page 8-39).

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13 Use of Bar Code

13.2 Reagent Bar Code Reader

13.2.1 Introduction
The reagent bar code reader obtains reagent information from the bar
code label. When bar-coded reagents are loaded to the reagent carousel,
the system will make a full scan and obtain reagent information from the
bar code labels.

Reagent bar code specifications

The reagent bar code reader is compatible with various application
environments. The code128 is selected by default with total bar code
length of 13 digits. Users are allowed to set up the symbology and bar
code compositions for open reagents. Open reagents are identified based
on the symbology and bar code compositions defined by the user; while
closed reagents are identified based on those defined by the
manufacturer.

Table 13.2 Reagent bar code specifications

Name Description
Symbology Codabar, ITF, Code128, Code39, UPC/EAN, and
Code93
Minimum bar code density 0.25mm-0.5mm
Length 13-30 digits
Format and content User-defined
Maximum width 44mm
Minimum height 12mm
Maximum inclination angle Less than 5°
Print quality No less than Class C according to the ANSI MH10.8M
Print Quality Specification.
Width and narrowness 2.5:1
Print paper Coated paper or matte paper. Printing bar code on
common paper may result in vague bar code or
degraded bar code label. You are not suggested to
print bar code on common print paper.
Characters Meaningful characters, such as numbers (0~9) and
upper-case letters (A~Z). You are recommended to
print the check digit in order to check that a bar
code is read accurately.

Information contained in a reagent bar code

The system will obtain the following information from a reagent bar code:
 Chemistry number
 Chemistry name
 Reagent type

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 13 Use of Bar Code
 Bottle type
 Lot number
 Serial number
 Expiration date (YYMM)
The reagent information obtained from a bar code label cannot be
modified.

13.2.2 Reagent Bar Code Setup

It is necessary to set up the reagent bar code symbologies, check digit
and bar code information before using the reagent bar code scanning.
Only open-reagent bar code rather than close-reagent bar code needs to
be set up.
1 Select Utility-System Setup.

2 Select Bar Code F4.

3 Choose Reagent Bar Code.

4 Select or deselect Analyze barcode of open reagent.

 If Reagent barcode system is configured , the option Analyze

barcode of open reagent is not selected by default
 When Analyze barcode of open reagent is selected, once the
barcode of the open reagent is identified, its information is
analyzed according to its setup.
 While loading the reagent manually, you can enter the barcode of
the open reagent on the condition that Analyze barcode of open
reagent is not selected.
5 Choose a bar code symbology and set up the check digit status.

The following symbologies are provided:

 Codabar
 Interleaved 2 of 5
 Code128
 Code39
 UPC/EAN
 Code93
Code 128, Code 93 and UPC/EAN requires a check digit by default,
and other symbologies are not compulsive. The Code 128 is selected
by default and cannot be modified.

CAUTION
You are recommended to enable the check function for all symbologies in order
to prevent misreading of bar code.

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13 Use of Bar Code
6 Define the total length of reagent bar code.

 Type in the total length of the reagent bar code in the T field. The
input range is 13-30 digits. The Interleaved 2 of 5 only supports
bar code of even number length.
 Type in the start digit of the reagent bar code in the S field.
 Type in the end digit of the reagent bar code in the E field.
7 Determine reagent bar code compositions.

 Type in the number of digits for reagent information in the Digits

field.
 Type in the start digit of the reagent information in the S field.
 Type in the end digit of the reagent information in the E field.

Table 13.3 Reagent bar code compositions

Reagent Information Number of Digits
Chemistry number 0-4 digits
Chemistry name 1-10 digits
Reagent type 1 digit (“1” stands for R1, “2” for R2, “3” for
R3, and “4” for R4)
Serial number 0-5 digits
Bottle type 1-3 digits(one digit is recommended; “1”
stands for Mindray 20ml outer ring reagent
bottle; “2” for 40ml outer ring bottle; “3” for
40ml inner ring bottle; “4” for 62ml inner ring
bottle.)
Lot number 0-18 digits
Expiration date 0, 4, 6 or 8 digits (4digits:yymm;
6digits:yyyymm; 8digits:yyyymmdd)

8 Select OK.

13.2.3 Loading Bar-Coded Reagents

Both open reagents and closed reagents can be loaded through bar code
scanning.
If the system is equipped with a reagent bar code reader, you may put the
bar-coded reagents on the reagent carousel, and the system will scan all
reagent positions automatically and obtain reagent information from the
bar code label. The information obtained from a reagent bar code include
chemistry name, reagent type, expiration date, lot number, serial number
and bottle type, which cannot be modified except for the reagent position.
The reagent bar code is enabled by default. Reagents are identified
through bar code scanning with reagent information obtained, all of which
but bar code can only be viewed and cannot be edited.
The bar code scanning is only applied to biochemical reagents. The

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 13 Use of Bar Code
sample probe wash solution, reagent probe wash solution, physiological
saline ISE wash solution can only be loaded manually rather than bar
code scanning.

Warning
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise
caution when working around the probe.

BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.
Do not touch the reagent directly with your body; otherwise, skin wound or
inflammation may be caused.

Perform the following steps to load bar-coded reagents:

1 Check the system status and operate accordingly.

 Standby: proceed to the next step.

 Running: Select Reagent-Reagent/Calibration. Select Load F1 to
stop reagent aspirating and dispensing. Meanwhile Load F1
becomes No load F1.If you want to abort load, select No load F1.
When the countdown for reagent stop becomes 0 and the system
status is Reagent Load, a message box pops up. Select OK, and
then proceed to the next step.
 Incubation: proceed to the next step.
 Sleep: Select Utility-Commands-Wake Up to awake the system,
and then proceed to step 2.
2 Select a reagent carousel from the dropdown box of reagent
carousel.

3 Remove the reagent carousel cover.

CAUTION
If the system is running tests, after requesting reagent stop do not remove the
reagent carousel cover until the countdown for reagent stop is 0; otherwise, the
tests currently run will be invalidated.
4 Place the bar-coded reagents on correct positions and then uncap
the reagent bottles.

5 Restore the reagent carousel cover.

6 Select End Load F2.

The system scans all reagent positions automatically and read

reagent information from the bar code.

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13 Use of Bar Code

13.3 Bar Code Reader Maintenance

13.3.1 Introduction
The sample and reagent bar code readers are located inside the analyzing
unit and need not to be maintained. You are only required to regularly
check the bar code scanning window, and clean them if dust or other
stains, such as sample and reagent, accumulate.

13.3.2 Cleaning Sample and Reagent Bar Code Scanning Windows

For details about cleaning the sample and reagent bar code scanning
windows, refer to 16.10.14 Bar Code Maintenance (Page 16-74).

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 13 Use of Bar Code

13.4 Troubleshooting Bar Code Reader

For troubleshooting methods of the bar code reader, refer to 17 Alarms
and Troubleshooting (page 17-1).

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 14 LIS and RMS

This chapter contains communication parameter setup of LIS and RMS,

as well as sample analysis and result transmission when an LIS is
connected.

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14 LIS and RMS

14.1 Overview
The chapter provides detailed description of the LIS and RMS.
Laboratory Information System (LIS) is an external host computer
connected with the chemistry analyzer through a fixed interface. The LIS
is used to download sample program information to the analyzer and
receives results sent from the analyzer.
You should set up the communication parameters and results
transmission methods prior to using the LIS host.
Check that your analyzer is equipped with a LIS. If needed, contact our
customer service department or your local distributor.
Remote Management System (RMS) provides a platform of remote
diagnosis and maintenance based on the internet. The RMS allows
transfer of data and files with the chemistry analyzers in hospitals, and
helps the service engineers to find, collect, analyze, locate and solve the
failures happening at the user end.

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 14 LIS and RMS

14.2 Host Communication

14.2.1 Introduction
The host communication parameters, such as transmission mode, IP
address and port, should be set up prior to use of the LIS host. To
download sample program information from or sent results to the host,
you need to set up the chemistry code used for identification of
chemistries on both the LIS host and the analyzer, which, otherwise,
cannot identify the chemistries simultaneously.

14.2.2 Connection between PC and LIS Host

Follow the procedure below to set up the connection between the
operation unit PC with the LIS host.
1 Select Utility-System Setup.

2 Select Instrument F1.

3 Select 4 Com Setup. The System Communication window is

displayed.
Figure 14.1 System communication setup

4 Select PC and LIS (selected by default).

5 Choose a network connection in the Network Adaptor area.

6 Set up the connection between operation unit and LIS.

 Auto Obtain IP Address(selected by default)

 Or set using Following IP Address: type in the IP Address, Subnet
Mask and Default Gateway for connecting the operation unit PC
with the LIS host.
7 Select Apply.

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14 LIS and RMS
A dialog box pops up: Check the network cable connection prior to
applying new settings. Please check the connection of the network
cable and then click OK to save the settings.
8 Select Exit to close the window.

14.2.3 Host Communication Parameters

1 Select Utility-System Setup.

2 Select Host F5. The Host Communication Parameters window shows.

Figure 14.2 Host communication Parameters window

3 Set up the following parameters:

Table 14.1 Host communication parameters

Parameter Description
Transport Choose a transport mode from the Transport Mode
pull-down list. The options include Serial and TCP/IP.
The default is Serial.
IP address Enter the IP address of the LIS host. The connection
between the analyzer and the LIS host is based on the
network, i.e. TCP/IP protocol.
Port Enter the interface number of the LIS host.
Serial If you choose Serial as the transport mode, set up the
communication following parameters:
parameters  Serial port: The default is COM1.
 Data bits: 7 or 8. The default is 8.
 Stop bits: 1 or 2. The default is 1.
 Parity: None, Odd, or Even. The default is None.
 Baud rate: 300, 1200, 2400, 4800, 9600, or 19200.
The default is 9600.

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 14 LIS and RMS
Parameter Description
Protocol Choose a protocol for connection between the
analyzer and the LIS host from the Protocol pull-down
list. The options include HL7 and ASTM 1394.
Mode Choose a data transmission mode for the analyzer and
LIS host. The available options are Unidirectional and
Bidirectional.
 Unidirectional: You are only allowed to send results
and patient demographics to the host rather than
downloading sample programs from it.
 Bidirectional: You are allowed to send results and
patient demographics to the host and downloading
sample programs from it.
Timeout Enter the time out limit for querying the LIS host. The
input range is 30s-60s, and the default is 30s.
If the time out limit is exceeded when you attempt to
download sample programs from, or send results to,
or connect the analyzer with the LIS host, the system
will give an alarm indicating communication timed
out.
Auto Connect to LIS When the checkbox is selected, the system will
connect to the LIS host automatically when started
up.
Retry after When the checkbox is selected, the system will try to
Disconnection reconnect the LIS host for every set interval once the
connection is interrupted.
Interval Input the time interval for which the system will try to
reconnect the LIS host for every set interval once the
connection is interrupted. The default is 30 seconds.
Send Complete When the checkbox is selected, the system will
Samples automatically send results to the LIS host after a
sample changes from In Progress to Complete. This
function is only applicable to samples analyzed on the
current day rather than those analyzed before.
Send Incomplete When the checkbox is selected, the system will
Samples automatically send results to the LIS host after a
sample changes from In Progress to Incomplete. This
function is only applicable to samples analyzed on the
current day rather than those analyzed before.

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14 LIS and RMS
Parameter Description
Advanced options Select Advanced. The Advanced window appears,
providing the following options:
 Send Programmed Samples: When the checkbox is
selected, the system will automatically send the
program information to the LIS host once a single
or batch routine and STAT samples are
programmed.
 Rerun Finished Chemistries When Downloaded:
When the checkbox is selected, chemistries that
have been finished will be rerun if downloaded
again. If this option is not selected, they will be
neglected.
 Send Actual Results and Rerun Results: When the
checkbox is selected, all actual results and rerun
results of each chemistry will be sent to the LIS. If
this option is not selected, only the default result
will be sent.
 Bypass Results Beyond Linearity Range: When the
checkbox is selected, those results that are beyond
the linearity range will not be sent to the LIS. If
this option is not selected, they will be sent.
 Ignore Alarms for Unknown Chemistries: When
the checkbox is selected, the system will not give
an alarm if the samples downloaded from the LIS
host contain unknown chemistries without
identification code. If this option is not selected,
an alarm will be given indicating sample
programming failure.

4 Select Save to save your input information.

5 Select Connect to connect the analyzer with the LIS host.

14.2.4 Defining Chemistry Code

1 Select Utility-System Setup.

2 Select Host F5. The Host Communication Parameters window shows.

3 View the chemistry channel number list on the right of the window.

The screen shows the chemistries and code in two columns. The left
column provides all chemistries that have been defined and set up
correctly; the right column shows the code for identifying a chemistry
on the LIS host.
4 Click on the Channel No. column of a chemistry, and then type in a
code for it.

5 Repeat step 4 to define a code for other chemistries.

6 Select Save.

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 14 LIS and RMS

14.3 Programming Samples with LIS Host

14.3.1 Introduction
Sample programming information can be sent by or downloaded from the
LIS host, and then the measured results are sent to it manually or in
real-time mode.
Both bar-coded and non-bar-coded samples can be programmed with
the LIS host. When a sample bar code module is configured, the system
will automatically identify samples and match them with the
programming information downloaded from the host. If there is no
sample bar code module, you should manually assign positions for the
downloaded samples.

14.3.2 Programming Functions

Samples can be downloaded manually or automatically from the LIS host.
If the system status is Standby, you are allowed to download samples
manually from LIS.
Sample programs downloaded from the LIS host can be edited. When
programs are downloaded for samples that are in Programmed status,
the requested chemistries in the programs will be used to overwrite the
original chemistries; if the samples are in a status other than
Programmed, the requested chemistries will be added to the original
ones.

Sending sample programs from LIS

Sending bar-coded samples:
1 When samples are sent from the LIS host to the analyzer, select
Program-Sample.

2 Select List F5 to view downloaded samples.

3 On the Sample screen, type in the sample bar code, and then confirm
the program information.

4 Select Save F8.

5 Load the samples to idle positions of the sample carousel.

6 Select the icon on the upper-right corner of the main screen.

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14 LIS and RMS
Sending non-bar-coded samples:
1 After program samples on the LIS host, send them to the analyzer,
and then select Program-Sample on the analyzer.

2 Select List F5 to view downloaded samples.

3 Select Unpositioned F2.

4 Select Assign.

5 Select the date the desired samples are programmed.

6 Type in the single sample ID or ID range in the ID field.

7 Choose a sample carousel on which you will place the sample.

8 Enter the sample position.

The options include all available positions of the selected sample

carousel.
 To assign position for single sample, input the position number in
the first edit box.
 To assign positions for multiple samples, enter the start position
number in the first edit box, and then the end position number in
the second edit box. The system will assign positions for the
samples ascending according to the sample ID.
 If the available positions among the specified range are more than
or equal to the number of samples, the extra positions will be
neglected.
 If the available positions among the specified range are less than
the number of samples, the system will display a message
indicating insufficient positions. Assign the positions again.
9 Select OK.

10 Enter the sample ID on the Sample screen and edit the following
information:

 Position
 STAT status
 Sample type
 Comment
 Chemistries and panels
 Sample options and chemistry options
11 Select Save F8.

12 Load the samples to the assigned positions on the sample carousel.

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 14 LIS and RMS

13 Select the icon on the upper-right corner of the main screen.

Obtaining samples automatically

When the system status is Standby or Sample Stop, load the samples to
the sample carousel, and then select . The system will automatically
scan the samples and then query the LIS host to download relevant
program information. After matching the downloaded program
information with the samples, the system will start the analysis.
The obtained sample program information includes:
 Patient demographics: patient name, gender, date of birth, etc.
 Requested chemistries: sample bar code, sample ID, sample type and
chemistry code.

Downloading samples manually

Downloading bar-coded samples:
1 Select Program-Sample.

2 Select Download F7.

3 Choose one of the following options:

 All programmed samples: to download all samples programmed

on the current day.
 Latest samples: to download samples that are programmed on
the current day but have not been downloaded.
 Samples with the following IDs: to download samples with the
specified program date and ID. Enter the sample IDs or ID range to
download.
 Sample with the following bar code: to download the sample with
the specified bar code. Enter the bar code of the desired sample.
4 Select OK.

5 Confirm the sample information and selected chemistries/panels.

6 Load the samples to idle positions of the sample carousel.

7 Select the icon on the upper-right corner of the main screen.

8 Select OK to start analysis.

Downloading non-bar-coded samples:

1 Select Program-Sample.

2 Select Download F7.

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14 LIS and RMS
3 Choose one of the following options:

 All programmed samples: to download all samples programmed

on the current day.
 Latest samples: to download samples that are programmed on
the current day but have not been downloaded.
 Sample with the following IDs: to download samples with the
specified program date and ID. Enter the sample IDs or ID range to
download.
4 Select OK.

5 Select List F5 to view downloaded samples.

6 Select Unpositioned F2.

7 Select Assign.

8 Select the date the desired samples are programmed.

9 Type in the single sample ID or ID range in the ID field.

10 Choose a sample carousel on which you will place the sample.

11 Enter the sample position.

The options include all available positions of the selected sample

carousel.
 To assign position for single sample, input the position number in
the first edit box.
 To assign positions for multiple samples, enter the start position
number in the first edit box, and then the end position number in
the second edit box. The system will assign positions for the
samples ascending according to the sample ID.
 If the available positions among the specified range are more than
or equal to the number of samples, the extra positions will be
neglected.
 If the available positions among the specified range are less than
the number of samples, the system will display a message
indicating insufficient positions. Assign the positions again.
12 Select OK.

13 Load the samples to the assigned positions on the sample carousel.

14 Select the icon on the upper-right corner of the main screen.

15 Select OK to start analysis.

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 14 LIS and RMS

14.4 Result Transmission

14.4.1 Introduction
Sample results and QC results can be sent manually or in real-time mode
to the LIS host for reviewing and storage. When a sample is analyzed with
its all tests finished, the system can automatically send the test results to
the LIS host; also you are allowed to search for desired results and then
manually send them to LIS.
Patient demographics, sample results and QC results can be sent to the
LIS host.
Patient demographics:
 Patient name
 Gender
 Age
 Patient ID
 Clinical diagnosis
 Ordering physician
 Ordering date
 Test date
 Tester
 Ordering department
Sample results:
 Sample type
 Sample bar code
 Sample ID
 Program date
 Completion date
 Sample status
 Chemistry name
 Result
 Unit
 Original result
Control results:
 Chemistry name
 Run date
 Control name
 Lot number
 Expiration date

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14 LIS and RMS
 Concentration level
 Standard deviation
 Result

14.4.2 Result Transmission Setup

When all tests of a sample are finished and at least one of them has
calculated a result, the result can be sent to the LIS host automatically.
Duplicate results on the LIS host can be handled by means of adding,
overwriting or ignoring. For rerun results, only the default result (that is
currently displayed on the Current Results screen) is sent to the LIS host.
The results of all replicates of a sample or chemistry will sent to the LIS
host.
1 Select Utility-System Setup.

2 Select Host F5. The Host Communication Parameters window shows.

3 Mark the Send Complete Samples or Send Incomplete Samples

checkbox with a tick.

A sample will be sent to the LIS host automatically when it changes

from In Progress to Complete or Incomplete.
If you won’t send results, deselect the checkbox.
4 Select Save.

14.4.3 Manually Sending Results to LIS Host

1 Select Result-Current Results or History Results.

2 Search for control results or sample results to transmit.

3 Select desired samples in the sample list.

4 Select Host F8.

5 Select the sample range you want to transmit:

 Selected sample(s)
 All samples

6 If you transmit all results, you are allowed to skip those that are
already transmitted to the LIS host. Mark the Bypass Transmitted
Results checkbox.

7 Select OK.

14-12
 14 LIS and RMS

14.5 Troubleshooting LIS

For troubleshooting methods of the LIS host, refer to 17 Alarms and
Troubleshooting (page 17-1).

14-13
14 LIS and RMS

14.6 Use of RMS

14.6.1 Introduction
The RMS provides a platform of remote diagnosis and maintenance
based on the internet. The RMS allows transfer of data and files with the
chemistry analyzers in hospitals, and helps the service engineers to find,
collect, analyze, locate and solve the failures happening at the user end.
Before connecting the analyzer with the RMS, you should set up the IP
address of the operation unit PC.

14.6.2 Connection between PC and RMS

Follow the procedure below to set up the IP address for connecting the
operation unit PC with the RMS.
1 Select Utility-System Setup.

2 Select Instrument F1.

3 Select 4 Com Setup. The System Communication window is

displayed.
Figure 14.3 System communication setup

4 Select PC and RMS.

5 Choose a network connection in the Network Adaptor area.

6 Set up the connection between operation unit and RMS.

 Auto Obtain IP Address(selected by default)

 Or set using Following IP Address: type in the IP Address, Subnet
Mask and Default Gateway for connecting the operation unit PC
with the RMS.
7 Select Apply.

14-14
 14 LIS and RMS
A dialog box pops up: Check the network cable connection prior to
applying new settings. Please check the connection of the network
cable and then click OK to save the settings.
8 Select Exit to close the window.

14.6.3 Troubleshooting RMS

For troubleshooting methods of the RMS, refer to 17 Alarms and
Troubleshooting (page 17-1).

14-15
BS-480

Chemistry Analyzer

Operator’s Manual
Maintenance Volume
 Contents

Publication Information ................................................................................................... ii

Intellectual Property Statement ..................................................................................... iii
Responsibility on the Manufacturer Party .................................................................... iv
Warranty ............................................................................................................................ v
Exemptions ............................................................................................................ v
Customer service department ............................................................................. v
EC - Representative .............................................................................................. v
Preface ··································································································vi
Safety Information ·····················································································1
Safety Symbols ................................................................................................................. 2
Summary of Hazards ....................................................................................................... 3
Introduction ........................................................................................................... 3
Electric Shock Hazards......................................................................................... 3
Moving Parts Hazards .......................................................................................... 3
Photometer Lamp Hazards .................................................................................. 3
Laser Beam Hazards ............................................................................................ 4
Sample, Calibrator and Control Hazards ............................................................ 4
Reagent and Wash Solution Hazards ................................................................. 4
Waste Hazards ...................................................................................................... 4
System Disposal Hazards .................................................................................... 4
Fire and Explosion Hazards ................................................................................. 5
Removal of Analyzer from Use for Repair or Disposal ...................................... 5
Software and Cybersecurity ................................................................................. 5
Notification of Adverse Events ............................................................................ 5
Precautions on Use .......................................................................................................... 6
Introduction ........................................................................................................... 6
Intended Use.......................................................................................................... 6
Environment Precautions ..................................................................................... 6
Installation Precautions ....................................................................................... 6

I
Contents – Maintenance Volume
Electromagnetic Noise Precautions .................................................................... 6
Operating Precautions .......................................................................................... 7
Maintenance and Servicing Precautions ............................................................ 8
Chemistry Parameter Configuration Precautions.............................................. 8
ISE Module Precautions ....................................................................................... 8
Sample Precautions .............................................................................................. 8
Reagent, Calibrator and Control Precautions ..................................................... 9
Data Archiving Precautions ................................................................................. 9
External Equipment Precautions ......................................................................... 9
External Vacuum Pump Precautions ................................................................ 10
Tube and Liquid Container Precautions ........................................................... 10
Cleaning and Decontamination ......................................................................... 10
Labels and Silkscreen .................................................................................................... 12
Introduction ......................................................................................................... 12
Non-Warning Labels and Silkscreen ................................................................. 13
Warning Labels .................................................................................................... 15
Contents ·································································································· I
1 System Description ···············································································1-1
1.1 Installation Requirements and Procedure ........................................................... 1-2
1.1.1 Installation Requirements ...................................................................... 1-2
1.1.2 Installation Procedure ............................................................................. 1-6
1.2 Hardware Structure ................................................................................................ 1-8
1.2.1 System Overview ..................................................................................... 1-8
1.2.2 Sample Handling System ..................................................................... 1-10
1.2.3 Reagent Handling System .................................................................... 1-13
1.2.4 Reaction System .................................................................................... 1-16
1.2.5 Cuvette Wash Station ............................................................................ 1-17
1.2.6 Photometric System .............................................................................. 1-18
1.2.7 Mixer Assembly ..................................................................................... 1-19
1.2.8 Operation Unit ........................................................................................ 1-20
1.2.9 Output Unit ............................................................................................. 1-20
1.2.10 Accessories and Consumables.......................................................... 1-20
1.3 Optional Modules ................................................................................................. 1-21
1.3.1 Introduction ............................................................................................ 1-21
1.3.2 ISE Module ............................................................................................. 1-21
1.3.3 Built-in Sample Bar Code Reader ........................................................ 1-21
1.3.4 Built-in Reagent Bar Code Reader ....................................................... 1-22
1.3.5 Water Supply Module ............................................................................ 1-23
1.3.6 Drainage Module ................................................................................... 1-24
1.3.7 External Vacuum Pump......................................................................... 1-25
1.3.8 Other Optional Modules ........................................................................ 1-26

II
 Contents – Maintenance Volume

1.4 Software Description ........................................................................................... 1-28

1.4.1 Main Screen ........................................................................................... 1-28
1.4.2 Using a Mouse ....................................................................................... 1-31
1.4.3 Using Online Help .................................................................................. 1-31
1.5 System Specifications ......................................................................................... 1-35
1.5.1 Technical Parameters ........................................................................... 1-35
1.5.2 Main Performance Indices.................................................................... 1-38
1.5.3 Contraindication .................................................................................... 1-40
1.5.4 Power supply ......................................................................................... 1-40
1.5.5 Environmental Requirements ............................................................... 1-40
1.5.6 Dimensions and Weight ........................................................................ 1-40
1.5.7 Input Device ........................................................................................... 1-40
1.5.8 Output Device......................................................................................... 1-40
1.5.9 Noise and Fuse ...................................................................................... 1-41
1.5.10 Communication Interfaces ................................................................. 1-41
1.5.11 Safety Classification ........................................................................... 1-41
1.5.12 EMC Requirements .............................................................................. 1-42
2 General Operating Procedure ··································································2-1
2.1 General Operating Procedure ................................................................................ 2-2
2.2 Check before Powering On .................................................................................... 2-3
2.2.1 Checking Water Supply ........................................................................... 2-3
2.2.2 Checking Power Supply .......................................................................... 2-3
2.2.3 Checking Printing Paper ......................................................................... 2-3
2.2.4 Checking Waste Tanks and Tubing ........................................................ 2-3
2.2.5 Checking Probes and Mixers .................................................................. 2-4
2.2.6 Checking Concentrated Wash Solution ................................................. 2-4
2.3 Powering On............................................................................................................ 2-6
2.3.1 Turning On Water Supply, Water Supply Module and Drainage Module2-6
2.3.2 Powering On the System ........................................................................ 2-6
2.3.3 Starting the Operating Software ............................................................ 2-7
2.4 Checking System Status ....................................................................................... 2-9
2.4.1 Checking System Status ......................................................................... 2-9
2.4.2 Checking Alarm Status ........................................................................... 2-9
2.4.3 Checking Reagent/Calibration Status ................................................. 2-10
2.4.4 Checking Maintenance Status ............................................................. 2-11
2.4.5 Checking Subsystems........................................................................... 2-12
2.5 Preparing Reagents.............................................................................................. 2-15
2.5.1 Loading Biochemical Reagents ........................................................... 2-15
2.5.2 Loading Concentrated Wash Solution ................................................. 2-19
2.5.3 Loading Reagent Probe Wash Solution ............................................... 2-20
2.5.4 Loading Sample Probe Wash Solution ................................................ 2-22

III
Contents – Maintenance Volume
2.5.5 Loading Physiological Saline ............................................................... 2-22
2.6 Calibration ............................................................................................................. 2-25
2.6.1 Requesting Calibrations........................................................................ 2-25
2.6.2 Loading Calibrators ............................................................................... 2-28
2.6.3 Running Calibrations ............................................................................. 2-29
2.7 Quality Control ...................................................................................................... 2-30
2.7.1 Programming Control Samples ............................................................ 2-30
2.7.2 Loading Control Samples ..................................................................... 2-31
2.7.3 Running Control Samples ..................................................................... 2-32
2.7.4 Auto quality control ............................................................................... 2-32
2.8 Programming Routine Samples .......................................................................... 2-34
2.8.1 Programming Routine Samples ........................................................... 2-34
2.8.2 Loading Routine Samples ..................................................................... 2-40
2.8.3 Running Routine Samples .................................................................... 2-41
2.9 Programming STAT Samples .............................................................................. 2-42
2.9.1 Programming STAT Samples ............................................................... 2-42
2.9.2 Starting Analysis ................................................................................... 2-46
2.10 Test Status and Emergency Stop ..................................................................... 2-47
2.10.1 Checking Reagent Status ................................................................... 2-47
2.10.2 Viewing Test Status ............................................................................ 2-48
2.10.3 Viewing Reagent Carousel Status ..................................................... 2-50
2.10.4 Emergency Stop................................................................................... 2-51
2.11 Daily Maintenance ............................................................................................. 2-52
2.12 Powering Off ....................................................................................................... 2-53
2.13 Check after Powering Off .................................................................................. 2-54
3 System Setup·······················································································3-1
3.1 System Setup Options ........................................................................................... 3-2
3.1.1 Introduction .............................................................................................. 3-2
3.1.2 Sample Options and Reagent Alarm Limits .......................................... 3-2
3.1.3 Auto Rerun Setup ..................................................................................... 3-5
3.1.4 Instrument Setup Options ...................................................................... 3-7
3.1.5 Print Setup.............................................................................................. 3-10
3.1.6 Bar Code Setup ...................................................................................... 3-10
3.1.7 Host Communication Setup ................................................................. 3-10
3.1.8 User Accounts and Permissions .......................................................... 3-10
3.1.9 Customizing Sample Information ........................................................ 3-11
3.1.10 Customizing Patient Demographics.................................................. 3-11
3.1.11 Reagent/Calibration Setup ................................................................. 3-11
3.2 Chemistries Setup ................................................................................................ 3-12
3.2.1 Introduction ............................................................................................ 3-12
3.2.2 User-defined Chemistries Setup .......................................................... 3-12

IV
 Contents – Maintenance Volume

3.2.3 Processing Parameters ........................................................................ 3-14

3.2.4 Error Detection Limits ........................................................................... 3-20
3.2.5 Flag Qualitative Result .......................................................................... 3-24
3.2.6 Slope and Offset Adjustment ............................................................... 3-25
3.2.7 Reference/Critical Range Setup ........................................................... 3-26
3.3 Calibration Setup .................................................................................................. 3-30
3.3.1 Introduction ............................................................................................ 3-30
3.3.2 Defining a Calibrator ............................................................................. 3-30
3.3.3 Importing a Calibrator ........................................................................... 3-31
3.3.4 Editing a Calibrator ................................................................................ 3-32
3.3.5 Setting up Calibrator Concentrations .................................................. 3-33
3.3.6 Setting up Calibration Rules ................................................................. 3-34
3.3.7 Calibrator Acceptance Limits ............................................................... 3-36
3.3.8 Deleting a Calibrator.............................................................................. 3-37
3.4 QC Setup ............................................................................................................... 3-38
3.4.1 Introduction ............................................................................................ 3-38
3.4.2 Defining/Editing a Control .................................................................... 3-38
3.4.3 Selection of Chemistries ....................................................................... 3-39
3.4.4 Setting up Control Concentrations ...................................................... 3-40
3.4.5 Setting up QC Rules............................................................................... 3-41
3.4.6 Deleting a Control .................................................................................. 3-42
4 Operation Theories ···············································································4-1
4.1 Overview .................................................................................................................. 4-2
4.2 Principles of Measurement ................................................................................... 4-3
4.2.1 Introduction .............................................................................................. 4-3
4.3 Endpoint Measurements ....................................................................................... 4-4
4.3.1 Introduction .............................................................................................. 4-4
4.3.2 Calculation of Reaction Absorbance ..................................................... 4-4
4.3.3 Calculation of Blank Absorbance ........................................................... 4-4
4.3.4 Calculation of K Factor ............................................................................ 4-4
4.3.5 Calculation of Response ......................................................................... 4-5
4.3.6 Sample Blanked Response ..................................................................... 4-5
4.4 Fixed-time Measurements .................................................................................... 4-7
4.4.1 Introduction .............................................................................................. 4-7
4.4.2 Calculation of Response ......................................................................... 4-7
4.5 Kinetic Measurements ........................................................................................... 4-9
4.5.1 Introduction .............................................................................................. 4-9
4.5.2 Data Calculation in Kinetic Measurements........................................... 4-9
4.5.3 Determination of Linearity Range .......................................................... 4-9
4.5.4 Calculation of Response ....................................................................... 4-10
4.5.5 Evaluation for Linearity ......................................................................... 4-11

V
Contents – Maintenance Volume
4.5.6 Enzyme Linearity Range Extension ...................................................... 4-12
4.6 Calibration Math Model and Factors .................................................................. 4-14
4.6.1 Linear Calibrations ................................................................................ 4-14
4.6.2 Non-Linear Calibrations........................................................................ 4-15
4.7 Prozone Check ...................................................................................................... 4-17
4.7.1 Introduction ............................................................................................ 4-17
4.7.2 Antigen Addition Method ...................................................................... 4-17
4.7.3 Reaction Rate Method ........................................................................... 4-18
Contents ·································································································· I
5 Reagents ····························································································5-1
5.1 Overview .................................................................................................................. 5-2
5.1.1 Introduction .............................................................................................. 5-2
5.1.2 Reagent/Calibration Screen Overview ................................................... 5-2
5.2 Customizing Reagent Display ............................................................................... 5-5
5.2.1 Introduction .............................................................................................. 5-5
5.2.2 Customizing Reagent Display ................................................................ 5-5
5.3 Sort Reagents ......................................................................................................... 5-6
5.3.1 Introduction .............................................................................................. 5-6
5.3.2 Sort Reagents .......................................................................................... 5-6
5.4 Reagent Inventory Alarm Limits Setup ................................................................ 5-7
5.4.1 Introduction .............................................................................................. 5-7
5.4.2 Setting up Reagent Inventory Alarm Limit for Biochemistry Reagent 5-7
5.4.3 Auto refreshing reagent inventory ......................................................... 5-8
5.5 Reagent Inventory Check....................................................................................... 5-9
5.5.1 Introduction .............................................................................................. 5-9
5.5.2 Checking Reagent Inventory .................................................................. 5-9
5.5.3 Canceling Reagent Inventory Check .................................................... 5-10
5.6 Bar-Coded Reagents Load .................................................................................. 5-11
5.6.1 Loading Bar-Coded Reagents .............................................................. 5-11
5.7 On-line Load of Reagents .................................................................................... 5-12
5.7.1 Introduction ............................................................................................ 5-12
5.7.2 On-Line Load of Reagents .................................................................... 5-12
5.8 Off-line Load of Reagents ................................................................................... 5-14
5.8.1 Introduction ............................................................................................ 5-14
5.8.2 Off-line Load of Reagents ..................................................................... 5-14
5.9 On-Line Replacement of Reagents..................................................................... 5-15
5.9.1 Introduction ............................................................................................ 5-15
5.9.2 On-Line Replacement of Reagents ...................................................... 5-15
5.10 Off-Line Replacement of Reagents .................................................................. 5-17
5.10.1 Introduction.......................................................................................... 5-17
5.10.2 Off-Line Replacement of Reagents ................................................... 5-17

VI
 Contents – Maintenance Volume

5.11 Unloading Reagents........................................................................................... 5-18

5.11.1 Introduction.......................................................................................... 5-18
5.11.2 Unloading Biochemical Reagents ...................................................... 5-18
6 Calibration ··························································································6-1
6.1 Overview .................................................................................................................. 6-2
6.2 Calibration Status and Alarm ................................................................................ 6-3
6.3 Calibrator Dilution Setup ....................................................................................... 6-4
6.3.1 Introduction .............................................................................................. 6-4
6.3.2 Setting up Calibrator Dilution Factors ................................................... 6-4
6.3.3 Editing Calibrator Dilution Factors ......................................................... 6-5
6.3.4 Deleting Calibrator Dilution Factors ...................................................... 6-6
6.4 Reagent Blank ......................................................................................................... 6-7
6.4.1 Introduction .............................................................................................. 6-7
6.4.2 Mixed Blank Absorbance and Response ............................................... 6-7
6.4.3 Requesting a Reagent Blank .................................................................. 6-8
6.4.4 Recalling Reagent Blank Results ........................................................... 6-8
6.5 Auto Calibration .................................................................................................... 6-12
6.5.1 Introduction ............................................................................................ 6-12
6.5.2 Auto Calibration Setup .......................................................................... 6-12
6.5.3 Auto Calibration Reminding.................................................................. 6-13
6.5.4 Removing Auto Calibration ................................................................... 6-13
6.6 Extending Calibration Time ................................................................................. 6-14
6.6.1 Introduction ............................................................................................ 6-14
6.6.2 Extending Calibration Time .................................................................. 6-14
6.6.3 Removing an Extended Status ............................................................. 6-15
6.7 Calibration Override ............................................................................................. 6-16
6.7.1 Introduction ............................................................................................ 6-16
6.7.2 Overriding a Calibration ........................................................................ 6-16
6.7.3 Removing Cal Overridden Status ......................................................... 6-16
6.8 Reject ..................................................................................................................... 6-17
6.8.1 Introduction ............................................................................................ 6-17
6.8.2 Rejecting a Calibration .......................................................................... 6-17
6.8.3 Removing Reject Status ........................................................................ 6-17
6.9 Recalling Calibration Results .............................................................................. 6-18
6.9.1 Recalling Current Calibration Factors.................................................. 6-18
6.9.2 Recalling History Calibration Factors .................................................. 6-18
6.9.3 Calibration Curve ................................................................................... 6-19
6.9.4 Calibration Reaction Curve ................................................................... 6-21
6.9.5 Editing Calibration Factors ................................................................... 6-24
6.9.6 Archiving Calibration Results ............................................................... 6-24
6.9.7 Calibration Trends ................................................................................. 6-25

VII
Contents – Maintenance Volume
7 Quality Control ····················································································7-1
7.1 Overview .................................................................................................................. 7-2
7.1.1 Introduction .............................................................................................. 7-2
7.1.2 Quality Control Operating Procedure ..................................................... 7-2
7.1.3 QC Alarms ................................................................................................ 7-2
7.1.4 QC Result Flags ....................................................................................... 7-2
7.1.5 Control Status .......................................................................................... 7-3
7.2 QC Evaluation ......................................................................................................... 7-4
7.2.1 Introduction .............................................................................................. 7-4
7.2.2 Evaluation of Single Controls ................................................................. 7-4
7.2.3 Two-Control Evaluation .......................................................................... 7-5
7.3 Auto Quality Control ............................................................................................... 7-8
7.3.1 Introduction .............................................................................................. 7-8
7.3.2 Auto QC Setup .......................................................................................... 7-8
7.3.3 Auto Quality Control ................................................................................ 7-9
7.3.4 Removing Auto QC Status ...................................................................... 7-9
7.4 Recalling Control Results .................................................................................... 7-10
7.4.1 Control Sample Results ........................................................................ 7-10
7.4.2 Recalling L-J Chart ................................................................................ 7-12
7.4.3 Recalling Twin-Plot Chart ..................................................................... 7-14
7.4.4 Recalling QC Data .................................................................................. 7-15
7.4.5 Recalling QC Summary ......................................................................... 7-20
8 Sample Programming and Processing ·························································8-1
8.1 Overview .................................................................................................................. 8-2
8.2 Sample Programming and Processing ................................................................ 8-3
8.2.1 Introduction .............................................................................................. 8-3
8.2.2 Adding Samples ....................................................................................... 8-3
8.2.3 Adding/Modifying Chemistries .............................................................. 8-4
8.2.4 Rerunning Samples ................................................................................. 8-4
8.2.5 Programming Samples with Increased or Decreased Volume ......... 8-12
8.2.6 Programming Diluted Samples ............................................................ 8-14
8.2.7 Sample Blank ......................................................................................... 8-16
8.2.8 Sample Management ............................................................................ 8-18
8.3 Serum Index .......................................................................................................... 8-21
8.3.1 Introduction ............................................................................................ 8-21
8.3.2 Theory of Serum Index .......................................................................... 8-21
8.3.3 Serum Index Setup ................................................................................ 8-22
8.3.4 Auto Serum Index .................................................................................. 8-23
8.3.5 Running SI Chemistry............................................................................ 8-24
8.4 Clear Samples ....................................................................................................... 8-25
8.4.1 Introduction ............................................................................................ 8-25

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 Contents – Maintenance Volume

8.4.2 Clearing Samples ................................................................................... 8-25

8.5 Unpositioned Samples ......................................................................................... 8-26
8.5.1 Introduction ............................................................................................ 8-26
8.5.2 Viewing Unpositioned Samples ........................................................... 8-26
8.5.3 Assigning Positions .............................................................................. 8-26
8.6 Release Sample Position ..................................................................................... 8-28
8.6.1 Introduction ............................................................................................ 8-28
8.6.2 Releasing Sample Positions ................................................................. 8-28
8.6.3 Auto Release of Samples ...................................................................... 8-29
8.7 Sample Logs ......................................................................................................... 8-30
8.7.1 Introduction ............................................................................................ 8-30
8.7.2 Viewing Sample Logs ............................................................................ 8-30
8.8 Customizing Sample Information ....................................................................... 8-32
8.8.1 Introduction ............................................................................................ 8-32
8.8.2 Customizing Sample Information ........................................................ 8-32
8.9 Customizing Patient Demographics .................................................................. 8-33
8.10 Sample and Chemistry Lists ............................................................................. 8-34
8.10.1 Introduction.......................................................................................... 8-34
8.10.2 Sample List .......................................................................................... 8-34
8.10.3 Chemistry List ...................................................................................... 8-35
8.11 Optimizing Result Display ................................................................................. 8-37
8.11.1 Introduction.......................................................................................... 8-37
8.11.2 Optimizing Result Display .................................................................. 8-37
8.12 Results Recall ..................................................................................................... 8-39
8.12.1 Introduction.......................................................................................... 8-39
8.12.2 Displaying Current Results ................................................................. 8-39
8.12.3 Recalling Current Results ................................................................... 8-40
8.12.4 Displaying History Results ................................................................. 8-41
8.12.5 Recalling History Results ................................................................... 8-42
8.12.6 Review Sample Results....................................................................... 8-43
8.12.7 Viewing/Editing Patient Demographics ............................................ 8-43
8.12.8 Reaction Curve..................................................................................... 8-44
8.12.9 Transmitting Results to LIS Host....................................................... 8-48
8.12.10 Printing Results ................................................................................. 8-49
8.12.11 Editing Results ................................................................................... 8-51
8.12.12 Deleting Results ................................................................................ 8-53
8.12.13 Customizing Result Display ............................................................. 8-54
8.12.14 Recalculating Results ....................................................................... 8-56
8.12.15 Compensating Results ..................................................................... 8-57
8.12.16 Recalling Result Trend ...................................................................... 8-58
8.12.17 Archiving Results .............................................................................. 8-59

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Contents – Maintenance Volume
8.13 Workload Statistics ............................................................................................ 8-60
8.14 Result Statistics ................................................................................................. 8-62
9 Result Printouts ···················································································9-1
9.1 Data Import and Export ......................................................................................... 9-2
9.1.1 Introduction .............................................................................................. 9-2
9.1.2 Import/Export Chemistries ..................................................................... 9-2
9.1.3 Data Archive ............................................................................................. 9-6
9.1.4 Sending sample results and QC results to LIS ..................................... 9-7
9.2 Print Setup .............................................................................................................. 9-8
9.2.1 Introduction .............................................................................................. 9-8
9.2.2 General Print Setup Options ................................................................... 9-8
9.2.3 Set Up Default Template ......................................................................... 9-9
9.2.4 Delete Template ....................................................................................... 9-9
9.2.5 Edit Print Template .................................................................................. 9-9
9.2.6 Import Print Template ............................................................................. 9-9
9.2.7 Defining Chemistry Print Order ............................................................ 9-10
9.3 Sample Reports .................................................................................................... 9-12
9.3.1 Introduction ............................................................................................ 9-12
9.3.2 Single Sample Report ............................................................................ 9-12
9.3.3 Multi-Sample Report ............................................................................. 9-13
9.3.4 Print Report Collection .......................................................................... 9-14
10 Chemistries ····················································································· 10-1
10.1 Twin Chemistries................................................................................................ 10-2
10.1.1 Introduction.......................................................................................... 10-2
10.1.2 Chemistry Definition ........................................................................... 10-2
10.1.3 Removing Twin Relation ..................................................................... 10-3
10.1.4 Reagent Setup ..................................................................................... 10-3
10.1.5 Setting Up and Requesting Calibration ............................................. 10-4
10.1.6 Setting Up and Requesting Quality Control ...................................... 10-4
10.1.7 Sample Programming and Processing ............................................. 10-4
10.2 Special Calculations .......................................................................................... 10-5
10.2.1 Introduction.......................................................................................... 10-5
10.2.2 Defining/Editing a Calculation ........................................................... 10-5
10.2.3 Enabling/Disabling Calculations........................................................ 10-6
10.2.4 Deleting User-Defined Calculations .................................................. 10-7
10.2.5 Running Calculations .......................................................................... 10-8
10.3 Panels .................................................................................................................. 10-9
10.3.1 Introduction.......................................................................................... 10-9
10.3.2 Defining/Editing a Panel ..................................................................... 10-9
10.3.3 Adjusting Display Order of Panels ................................................... 10-10

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 Contents – Maintenance Volume

10.3.4 Deleting Panels .................................................................................. 10-10

10.3.5 Running Panels.................................................................................. 10-10
10.4 Off-system Chemistries .................................................................................. 10-11
10.4.1 Introduction........................................................................................ 10-11
10.4.2 Define/Edit Off-System Chemistries ............................................... 10-11
10.4.3 Running the Off-system Chemistries .............................................. 10-12
10.4.4 Deleting Off-system Chemistries .................................................... 10-13
10.5 Serum Index ...................................................................................................... 10-14
10.6 Chemistry Configuration ................................................................................. 10-15
10.6.1 Introduction........................................................................................ 10-15
10.6.2 Enabling Chemistries ........................................................................ 10-15
10.6.3 Disabling Chemistries ....................................................................... 10-16
10.6.4 Customizing Chemistry Display Order ............................................ 10-17
10.6.5 Adjusting Test Order of Chemistries ............................................... 10-17
10.7 Carryover Setup ................................................................................................ 10-19
10.7.1 Introduction........................................................................................ 10-19
10.7.2 Defining/Editing Carryover Pair ....................................................... 10-19
10.7.3 Removing a Carryover Pair ............................................................... 10-20
10.8 Default Panel .................................................................................................... 10-21
10.8.1 Introduction........................................................................................ 10-21
10.8.2 Defining the Default Panel ................................................................ 10-21
10.8.3 Running Default Panel for Routine Samples .................................. 10-21
10.8.4 Running Default Panel for Emergent Samples ............................... 10-22
10.9 Masking/Unmasking Chemistries .................................................................. 10-23
10.9.1 Introduction........................................................................................ 10-23
10.9.2 Masking/Unmasking Chemistries ................................................... 10-23
10.10 Reflex............................................................................................................... 10-25
10.10.1 Introduction ..................................................................................... 10-25
10.10.2 Setting Reflex Relation ................................................................... 10-25
10.10.3 Editing Reflex Relation .................................................................... 10-26
10.10.4 Deleting Reflex Relation.................................................................. 10-26
10.10.5 Measurement and Result Recall .................................................... 10-27
11 System Commands and Setup Options ···················································· 11-1
11.1 Home ................................................................................................................... 11-2
11.1.1 Introduction.......................................................................................... 11-2
11.1.2 Homing System ................................................................................... 11-2
11.2 Stop Print ............................................................................................................ 11-3
11.2.1 Introduction.......................................................................................... 11-3
11.2.2 Stop Print ............................................................................................. 11-3
11.3 Sleep and Wake Up ............................................................................................ 11-4
11.3.1 Introduction.......................................................................................... 11-4

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Contents – Maintenance Volume
11.3.2 System Hibernation............................................................................. 11-4
11.3.3 Waking up the System ........................................................................ 11-4
11.4 User and Password Setup ................................................................................. 11-5
11.4.1 Introduction.......................................................................................... 11-5
11.4.2 Defining a User .................................................................................... 11-5
11.4.3 Modifying a User ................................................................................. 11-6
11.4.4 Assigning/Modifying Permissions .................................................... 11-6
11.4.5 Deleting a User .................................................................................... 11-7
11.5 Sleep and Awake Setup ..................................................................................... 11-8
11.5.1 Introduction.......................................................................................... 11-8
11.5.2 Auto Sleep Setup ................................................................................. 11-8
11.5.3 Auto Startup Setup .............................................................................. 11-9
11.5.4 Auto Awake Setup ............................................................................. 11-10
11.6 Dictionary Setup ............................................................................................... 11-11
11.6.1 Introduction........................................................................................ 11-11
11.6.2 Defining, Editing and Deleting Data Option ..................................... 11-11
11.7 Software Upgrade ............................................................................................ 11-13
11.7.1 Introduction........................................................................................ 11-13
11.7.2 Software Upgrade .............................................................................. 11-13
11.8 Software Version .............................................................................................. 11-14
11.8.1 Introduction........................................................................................ 11-14
11.8.2 Software Version ............................................................................... 11-14
11.9 Voice Tone Setup ............................................................................................. 11-16
11.9.1 Introduction........................................................................................ 11-16
11.9.2 Importing Audio Files ........................................................................ 11-16
11.9.3 Setting Up Voice Tone ....................................................................... 11-16
12 Use of ISE Module ············································································· 12-1
12.1 Precautions on Use ............................................................................................ 12-2
12.1.1 Introduction.......................................................................................... 12-2
12.1.2 Precautions on Use ............................................................................. 12-2
12.2 Principles of Measurement ............................................................................... 12-4
12.3 ISE Chemistry Parameters ................................................................................ 12-5
12.3.1 Introduction.......................................................................................... 12-5
12.3.2 Viewing ISE Chemistry Parameters ................................................... 12-5
12.3.3 Introduction to ISE Chemistry Parameters ....................................... 12-5
12.3.4 Flag ISE Qualitative Result ................................................................. 12-6
12.4 Preparing ISE Reagents for Measurement ...................................................... 12-8
12.4.1 Introduction.......................................................................................... 12-8
12.4.2 Off-line Load ISE Reagent .................................................................. 12-8
12.4.3 On-line Load ISE Reagent ................................................................. 12-10
12.4.4 Load ISE Wash Solution .................................................................... 12-10

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 Contents – Maintenance Volume

12.4.5 Replacing ISE Wash Solution ........................................................... 12-11

12.5 Calibration and Results Recall ........................................................................ 12-12
12.5.1 Introduction........................................................................................ 12-12
12.5.2 Calibration Setup ............................................................................... 12-12
12.5.3 Calibration Status and Alarm ........................................................... 12-13
12.5.4 ISE Calibration ................................................................................... 12-14
12.5.5 Results Recall .................................................................................... 12-14
12.5.6 Extending ISE Calibration Time ........................................................ 12-17
12.6 Quality Control and Results Recall ................................................................. 12-18
12.6.1 Quality Control and Results Recall .................................................. 12-18
12.7 Sample Programming and Results Recall ..................................................... 12-19
12.8 Reagent Inventory Alarm Limit ....................................................................... 12-20
12.8.1 Introduction........................................................................................ 12-20
12.8.2 Setting up Reagent Inventory Alarm Limit ...................................... 12-20
12.9 ISE Prime Cycle ................................................................................................ 12-21
12.9.1 Introduction........................................................................................ 12-21
12.9.2 Defining/Modifying ISE Prime Times .............................................. 12-21
12.10 Daily Maintenance ......................................................................................... 12-22
12.10.1 Daily Maintenance .......................................................................... 12-22
12.11 Troubleshooting ISE Module ......................................................................... 12-23
12.11.1 Troubleshooting ISE Module .......................................................... 12-23
13 Use of Bar Code ················································································ 13-1
13.1 Sample Bar Code Reader ................................................................................... 13-2
13.1.1 Introduction.......................................................................................... 13-2
13.1.2 Sample Bar Code Setup ...................................................................... 13-2
13.1.3 Programming Bar-Coded Routine Samples ..................................... 13-4
13.1.4 Programming Bar-Coded STAT Samples.......................................... 13-6
13.1.5 Adding New Samples or Chemistries ................................................ 13-9
13.1.6 Rerunning Bar-Coded Samples ....................................................... 13-10
13.1.7 Results Recall .................................................................................... 13-12
13.1.8 Recalling Current Results ................................................................. 13-13
13.2 Reagent Bar Code Reader ............................................................................... 13-14
13.2.1 Introduction........................................................................................ 13-14
13.2.2 Reagent Bar Code Setup ................................................................... 13-15
13.2.3 Loading Bar-Coded Reagents .......................................................... 13-16
13.3 Bar Code Reader Maintenance ....................................................................... 13-18
13.3.1 Introduction........................................................................................ 13-18
13.3.2 Cleaning Sample and Reagent Bar Code Scanning Windows....... 13-18
13.4 Troubleshooting Bar Code Reader ................................................................. 13-19
14 LIS and RMS ····················································································· 14-1

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Contents – Maintenance Volume
14.1 Overview .............................................................................................................. 14-2
14.2 Host Communication ......................................................................................... 14-3
14.2.1 Introduction.......................................................................................... 14-3
14.2.2 Connection between PC and LIS Host .............................................. 14-3
14.2.3 Host Communication Parameters ..................................................... 14-4
14.2.4 Defining Chemistry Code .................................................................... 14-6
14.3 Programming Samples with LIS Host .............................................................. 14-7
14.3.1 Introduction.......................................................................................... 14-7
14.3.2 Programming Functions ..................................................................... 14-7
14.4 Result Transmission ........................................................................................ 14-11
14.4.1 Introduction........................................................................................ 14-11
14.4.2 Result Transmission Setup .............................................................. 14-12
14.4.3 Manually Sending Results to LIS Host ............................................ 14-12
14.5 Troubleshooting LIS ......................................................................................... 14-13
14.6 Use of RMS ....................................................................................................... 14-14
14.6.1 Introduction........................................................................................ 14-14
14.6.2 Connection between PC and RMS ................................................... 14-14
14.6.3 Troubleshooting RMS ....................................................................... 14-15
Contents ·································································································· I
15 Diagnostics ······················································································ 15-1
15.1 Overview .............................................................................................................. 15-2
15.2 Diagnosis of Sample System ............................................................................ 15-3
15.2.1 Introduction.......................................................................................... 15-3
15.2.2 Sample Probe Clog Detection ............................................................ 15-3
15.2.3 Sample Probe Level Sense Test ......................................................... 15-5
15.3 Diagnosis of Reagent System........................................................................... 15-8
15.3.1 Introduction.......................................................................................... 15-8
15.3.2 Reagent Probe Level Sense Test ....................................................... 15-8
15.4 Sensor Diagnosis ............................................................................................. 15-11
15.4.1 Introduction........................................................................................ 15-11
15.4.2 Sensor Diagnosis .............................................................................. 15-11
16 Maintenance ···················································································· 16-1
16.1 Overview .............................................................................................................. 16-2
16.1.1 Introduction.......................................................................................... 16-2
16.1.2 Introduction.......................................................................................... 16-2
16.1.3 Consumables ....................................................................................... 16-3
16.1.4 Tools Required for Maintenance ........................................................ 16-4
16.2 Biochemistry Maintenance ............................................................................... 16-6
16.2.1 Introduction.......................................................................................... 16-6
16.2.2 Biochemistry Maintenance Screen Overview ................................... 16-6

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 Contents – Maintenance Volume

16.3 ISE Maintenance ................................................................................................ 16-8

16.3.1 Introduction.......................................................................................... 16-8
16.3.2 ISE Maintenance Screen Overview .................................................... 16-8
16.4 Scheduled Maintenance Log .......................................................................... 16-10
16.4.1 Introduction........................................................................................ 16-10
16.4.2 Maintenance Schedule ..................................................................... 16-10
16.4.3 Scheduled Maintenance Procedures............................................... 16-11
16.4.4 Maintenance Log Sheet .................................................................... 16-12
16.4.5 Scheduled Maintenance Screen Overview ...................................... 16-15
16.5 Daily Maintenance ........................................................................................... 16-19
16.5.1 Introduction........................................................................................ 16-19
16.5.2 Check Probes/Mixers/Wash Wells .................................................. 16-19
16.5.3 Check Sample/Reagent Syringes .................................................... 16-21
16.5.4 Check Deionized Water ..................................................................... 16-22
16.5.5 Check Waste ...................................................................................... 16-23
16.5.6 Check Concentrated Wash Solution ................................................ 16-24
16.5.7 Check Sample Probe Wash Solution ............................................... 16-25
16.5.8 Clean Electrode Tubes (For ISE Module) ......................................... 16-26
16.6 Weekly Maintenance ........................................................................................ 16-28
16.6.1 Clean Sample/Reagent Probe Exterior ............................................ 16-28
16.6.2 Clean Mixers ...................................................................................... 16-29
16.6.3 Special Wash...................................................................................... 16-30
16.6.4 Cuvette Check .................................................................................... 16-31
16.6.5 Photometer Check ............................................................................. 16-33
16.7 Monthly Maintenance ...................................................................................... 16-35
16.7.1 Clean Wash Wells .............................................................................. 16-35
16.7.2 Clean Wash Station ........................................................................... 16-36
16.7.3 Clean Filter Core ................................................................................ 16-37
16.7.4 Clean Dust Screens ........................................................................... 16-39
16.7.5 Clean Sample Injection Port (For ISE Module) ............................... 16-40
16.7.6 Pump Calibration (For ISE Module) ................................................. 16-41
16.7.7 Air Bubble Detector Calibration (For ISE Module) .......................... 16-42
16.7.8 Clean the Dust Screen of the External Vacuum Pump................... 16-43
16.8 Three-Month Maintenance ............................................................................. 16-45
16.8.1 Clean DI Water Tank .......................................................................... 16-45
16.8.2 Replace Filter Core ............................................................................ 16-47
16.9 Six-Month Maintenance .................................................................................. 16-49
16.9.1 Replace Lamp .................................................................................... 16-49
16.9.2 Replace Water Inlet Filter .................................................................. 16-50
16.9.3 Replace Reference Electrode(For ISE Module) ............................... 16-51
16.10 As-Needed/As-Required Maintenance ....................................................... 16-54

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Contents – Maintenance Volume
16.10.1 Clean Analyzer Panels .................................................................... 16-54
16.10.2 Clean Sample Compartment .......................................................... 16-55
16.10.3 Clean Reagent Compartment ......................................................... 16-56
16.10.4 Clean Sample Probe Interior .......................................................... 16-57
16.10.5 Clean Reagent Probe Interior ......................................................... 16-61
16.10.6 Replace Sample Probe .................................................................... 16-62
16.10.7 Replace Reagent Probe .................................................................. 16-65
16.10.8 Replace Sample Mixer .................................................................... 16-66
16.10.9 Replace Reagent Mixer ................................................................... 16-67
16.10.10 Remove Air Bubbles in Sample Syringe ...................................... 16-68
16.10.11 Remove Air Bubbles in Reagent Syringe .................................... 16-70
16.10.12 Replace Cuvette ............................................................................ 16-71
16.10.13 Special Wash Probes .................................................................... 16-74
16.10.14 Bar Code Maintenance ................................................................. 16-74
16.10.15 Clean Probes/Mixers Exterior ...................................................... 16-75
16.10.16 Replace ISE Electrode ................................................................... 16-76
16.10.17 Remove Reagent Pack (For ISE Module) .................................... 16-78
16.10.18 Store Electrodes (For ISE Module) ............................................... 16-79
16.10.19 Two-Point Calibration (For ISE Module) ..................................... 16-80
16.10.20 Maintenance (For ISE Module) .................................................... 16-80
16.10.21 Purge A (For ISE Module) ............................................................. 16-81
16.10.22 Purge B (For ISE Module) ............................................................. 16-81
16.10.23 Program Check Instruction (For ISE Module) ............................. 16-81
16.10.24 Read Dallas Chip (For ISE Module) .............................................. 16-81
16.10.25 Write Dallas Chip (For ISE Module) ............................................. 16-81
16.10.26 Replace Sample Syringe ............................................................... 16-82
16.10.27 Replace Reagent Syringe ............................................................. 16-84
16.10.28 Clean Rotors .................................................................................. 16-85
16.10.29 Clean ISE Waste Tube ................................................................... 16-86
17 Alarms and Troubleshooting································································· 17-1
17.1 Classification of Logs ........................................................................................ 17-2
17.1.1 Introduction.......................................................................................... 17-2
17.1.2 Error Logs ............................................................................................. 17-2
17.1.3 Edit Logs ............................................................................................... 17-2
17.2 Viewing and Handling Logs .............................................................................. 17-3
17.2.1 Description of Error Log Screen ......................................................... 17-3
17.2.2 Description of Edit Log Screen ........................................................... 17-3
17.2.3 Recalling Logs ..................................................................................... 17-4
17.2.4 Refreshing Logs ................................................................................... 17-5
17.2.5 Clearing Logs ....................................................................................... 17-5
17.2.6 Printing Logs ........................................................................................ 17-6

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 Contents – Maintenance Volume

17.3 Error Troubleshooting ........................................................................................ 17-7

17.3.1 Introduction.......................................................................................... 17-7
17.3.2 Error Indications .................................................................................. 17-7
17.3.3 Identifying Errors ................................................................................. 17-8
17.4 Data Alarm ........................................................................................................ 17-10
17.4.1 Introduction........................................................................................ 17-10
17.4.2 Result Flags ....................................................................................... 17-11
17.5 Error Messages and Corrective Actions ........................................................ 17-22
18 Template Modifying Software ······························································· 18-1
18.1 Main Screen ........................................................................................................ 18-2
18.1.1 Main Screen ......................................................................................... 18-2
18.1.2 File (F) ................................................................................................... 18-2
18.1.3 Edit (E) .................................................................................................. 18-5
18.1.4 View (V) ................................................................................................ 18-5
18.1.5 Insert (I) ................................................................................................ 18-6
18.1.6 Format (M) ........................................................................................... 18-7
18.1.7 Set(S) .................................................................................................... 18-8
18.1.8 Help (H)................................................................................................. 18-9
18.2 Common Tools ................................................................................................. 18-10
18.3 Draw Tools ........................................................................................................ 18-11
18.4 Property Window .............................................................................................. 18-13
18.4.1 Page .................................................................................................... 18-13
18.4.2 Line ..................................................................................................... 18-13
18.4.3 Rectangle ........................................................................................... 18-14
18.4.4 Label ................................................................................................... 18-15
18.4.5 Text ..................................................................................................... 18-17
18.4.6 Title ..................................................................................................... 18-18
18.4.7 Image .................................................................................................. 18-19
18.5 Report Window ................................................................................................. 18-21
Electronic Interface····················································································1
Vocabulary ·······························································································1
Index ······································································································1
Bibliography ·····························································································1

XVII
Contents – Maintenance Volume

XVIII
 15 Diagnostics

This chapter provides test descriptions, test procedures, test results and
corrective actions for diagnosis in Sample and Reagent systems.

15-1
15 Diagnostics

15.1 Overview
Diagnostics consist of a series of tests and actions, which are used for
troubleshooting errors. These tests and actions are made to detect
failures, but cannot be used to confirm one specific failure. Users should
make a judgment by integrating the information of diagnosis and
warnings with the failure characteristics. Diagnostic tests available in two
function modules are described in the table below.

Table 15.1 Categories of diagnostics

Function Module Description
Sample System Diagnostic tests here are used to detect failures of
components in Sample system.
Reagent System Diagnostic tests here are used to detect failures of
components in Reagent system.
Sensor Diagnosis Diagnostic tests here are used to detect failures of
the sensors.

15-2
 15 Diagnostics

15.2 Diagnosis of Sample System

15.2.1 Introduction
The Sample System is responsible for delivering samples to the system
for analysis. Tests include:
 Sample Probe Clog Detection
 Sample Probe Level Sense Test

15.2.2 Sample Probe Clog Detection

Test description
This test can help you find if the Sample Probe Clog Detection function
works normally. Related data or text will be displayed after testing, which
can be used to confirm the results.
Use this test when one of the following alarms is given:
 Clog detection board communication error.
 The sample probe is clogged while the sample is deemed OK.
 The sample probe is clogged during cleaning.
 Clog detection board working mode setting error.

Test procedure
1 Select Utility -> Maintenance -> Diagnostics.

2 Select Sample System tab.

3 Select Sample Probe Clog Detection.

4 Load one cuvette of water onto Position 1 on sample carousel, and

click Next to open the Sample Probe Clog Detection Diagnosis
window.

15-3
15 Diagnostics
Figure 15.1 Sample Probe Clog Detection Diagnosis window

5 Click Start.

The system starts to run each test for sample probe clog detection.
Tests include:
 Basic Check
 Wash Check
 Clog Check
 Sample Aspiration Check (1.5μL)
 Sample Aspiration Check (45μL)
6 When tests are complete, the tested voltage and the level sense test
data are displayed on the screen.

7 Click Exit to close the window.

Test results
The testing result of each subitem is displayed on the screen. Judge if the
result meets the requirements by comparing with the corresponding
reference value. “PASS” in the PASS/FAIL column indicates the test is
normal, while “FAIL” indicates the test is failed and it should be corrected
based on the suggestions provided.

Corrective action

Table 15.2 Sample system obstruction detection reference range and corrective
action
Test Type Test Item Reference Range Corrective Action
Basic Check Version of Clog Contact our
Detection Board customer service
12V 10.8V-13.2V department or your

15-4
 15 Diagnostics
Test Type Test Item Reference Range Corrective Action
5V 4.5V-5.5.V local distributor.
Pressure of Clog 9.0psia-16.0psia
Detection Board
Clog Signal OK/Error/”/”
Wash Check Wash Pressure 30.0psia-60.0psia
Clog Check Final Result OK/Error/”/”
Sample P0p <7psi
Aspiration Check Final Result OK/Error/”/”
(1.5μL)
Sample P0p <7psi
Aspiration Check Final Result OK/Error/”/”
(45μL)

15.2.3 Sample Probe Level Sense Test

Test description
The Level Sense Test is used to diagnose the level detection performance
of the sample system and gives related data that helps you locate the
causes of an error.
Use this test when one of the following conditions happens:
 An alarm message appears indicating that the sample probe contacts
no liquid in the aspiration positions (include sample carousel,
reaction carousel and concentrated wash position) and the analysis
is stopped.
 An alarm message appears indicating that the sample probe
aspirates nothing in the aspiration positions and the analysis is
stopped, and has confirmed that the failure is not caused by probe
clog.
 An alarm message appears indicating that the sample probe contacts
no liquid during dispensing samples into reaction carousel and the
analysis is stopped, and has confirmed that the failure is not caused
by neither reagent bubbles nor reagent probe level sensing.
 An alarm message appears indicating that problems related with level
sensing occur during dispensing samples in ISE module, and has
confirmed it is not the problems of ISE module itself.
 An alarm message appears indicating that the sample probe contacts
no liquid during liquid dispensing (also called water testing), and the
analysis is stopped.
 An alarm message appears indicating that the sample probe contacts
no liquid in the wash well and the analysis is stopped, and has
confirmed that it is not a hydropneumatic failure.

Test procedure
1 Select Utility -> Maintenance -> Diagnostics.

2 Select Sample System tab.

15-5
15 Diagnostics
3 Select Sample Probe Level Sense Test.

4 Place a tube with its 2/3 full of water in test position, and click Next
to open the Sample Probe Level Sense Test Results window.
Figure 15.2 Sample Probe Level Sense Test Results window

The default test position is position 1 on the sample carousel. To

change the test position, click Change Pos and enter a new number
within the range from 1 to 90, and then click OK.
5 Click Start.

The system will start to check the level sense board voltage of the
sample probe, and continuously detect level in the test position for 20
times.
6 When tests complete, the tested voltage and the level sense test data
will be displayed on the screen.

7 Click Exit to close the window.

Test results
The results shown are described below:
Level Sense Board Voltage Check Results
If the Actual value falls in the Reference range, the result is PASS,
indicating the voltage of the level detection board is normal; otherwise,
the result is FAIL, indicating the voltage is abnormal. You should correct it
based on the suggestions provided.
Level Sense Test Data
The system will continuously check the lowering height of the sample
probe for 20 times, to judge if the lowering position is the vertical extreme

15-6
 15 Diagnostics
position. If it is, abnormity exists. If the extreme difference of 20 lowering
heights is greater than 1mm, then the result should be considered as
abnormal, indicating that there are problems with connections of sample
probe and Printed Circuit Board Assembly (PCBA), PCBA power, output
voltage for level sense detection, or connections of level sense board and
probe/mixer conversion board, and vice versa. You should correct it
based on the suggestions provided.

Corrective action
If the operating voltage of the level detection board is beyond the
reference range, contact our customer service department or your local
distributor.
If the result of the level detection performance is abnormal, contact our
customer service department or your local distributor.

15-7
15 Diagnostics

15.3 Diagnosis of Reagent System

15.3.1 Introduction
The Reagent System is responsible for delivering reagents to the system
for analysis. Test includes:
 Reagent Probe Level Sense Test

15.3.2 Reagent Probe Level Sense Test

Test description
The Level Sense Test is used to diagnose the level detection performance
of the reagent probe and gives related data that helps you locate the
causes of an error.
Use this test when one of the following conditions happens:
 An alarm message appears indicating that the reagent probe contacts
no liquid on the reagent carousel, and the analysis is stopped. An
alarm message appears indicating that probe aspirates nothing in the
aspiration position and the analysis is stopped.
 An alarm message appears indicating that the reagent probe contacts
no liquid during dispensing reagents and the analysis is stopped, and
has confirmed that it is not caused by reagent bubbles.
 An alarm message appears indicating that the reagent probe contacts
no liquid in the wash well and the analysis is stopped, and has
confirmed that it is not a hydropneumatic failure.

Test procedure
1 Select Utility -> Maintenance -> Diagnostics.

2 Select Reagent System tab.

3 Select Reagent Probe Level Sense Test.

4 Place a tube with its 2/3 full of water in position 1 of reagent carousel,
and click Next to open Reagent Probe Level Sense Test Results
window.

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 15 Diagnostics
Figure 15.3 Reagent Probe Level Sense Test Results window

The default test position is position 1 on reagent carousel. To change

the test position, click Change Pos and enter a new number within the
range from 1 to 80, and then click OK.
5 Click Start.

The system starts to check the level sense board voltage for reagent
probe, and continuously detects level in the test position for 20 times.
6 When tests complete, the tested voltage and the level sense test data
are displayed on the screen.

7 Click Exit to close the window.

Test results
The results shown are described below:
Level Sense Board Voltage Check Results
If the Actual value falls in the Reference range, the result is PASS,
indicating the voltage of the level detection board is normal; otherwise,
the result is FAIL, indicating the voltage is abnormal. You should correct it
based on the suggestions provided.

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15 Diagnostics
Level Sense Test Data
The system will continuously check the lowering height of reagent probe
for 20 times, to judge if the lowering position is the vertical extreme
position. If it is, abnormity exists. If the difference of 20 lowering heights
is greater than 1mm, then the result should be considered as abnormal,
indicating that there are problems with connections of reagent probe and
PCBA, PCBA power, output voltage for level sense detection, or
connections of level sense board and probe/mixer conversion board, and
vice versa. You should correct it based on the suggestions provided.

Corrective action
If the operating voltage of the level detection board is beyond the
reference range of 2.8V-4.8V, contact our customer service department or
your local distributor.
If the result of the level detection performance is abnormal, contact our
customer service department or your local distributor.

15-10
 15 Diagnostics

15.4 Sensor Diagnosis

15.4.1 Introduction
Sensor diagnosis provides diagnosis results of the sensors of the
analyzer to help locate the failure cause of the related parts.

15.4.2 Sensor Diagnosis

Use this test when one of the following conditions happens:
 Reaction carousel loses steps or positioning failed.
 Wash station loses steps or fails to find the mechanical zero position.
 Sample carousel loses steps or positioning failed.
 Sample probe loses steps in horizontal or vertical movement or fails
to find the mechanical zero position.
 Sample syringe loses steps or fails to find the mechanical zero
position.
 Reagent carousel loses steps or positioning failed.
 Reagent probe loses steps in horizontal or vertical movement or fails
to find the mechanical zero position.
 Reagent syringe loses steps or fails to find the mechanical zero
position.
 Sample mixer, reagent mixer fails to find the mechanical zero
position.
 Interior wash syringe fails to find the mechanical zero position.
 Phase 1-2 wash syringe fails to find the mechanical zero position.

Test procedure
1 Select Utility -> Maintenance -> Diagnostics.

2 Select Sensor Diagnosis tab.

3 Select the optical coupler to be diagnosed.

Click Select All or Cancel All to select the sensors.

4 Select Start to inquire the status of the sensors.

To stop the test, select Stop.

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15 Diagnostics
Figure 15.4 Sensor diagnosis window

5 Click Exit to close the window.

Test result
Sensor high level signal is indicated by “unblocked “while low level signal
is indicated by “blocked”.

Corrective action
Perform the operations:block or unblock the sensors and perform the
diagnosis test. observe if the sensor signal is changed accordingly with
your operations. If the displayed status is changed accordingly, it means
the sensor works normally; If the displayed status is not changed with
your operations, it means the sensor is abnormal and please contact our
customer service department.

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 16 Maintenance

This chapter provides you with maintenance of the instrument, including

frequently-used maintenance commands and scheduled maintenance
procedures. The purpose, time, system status, precautions and steps of
each maintenance procedure are described here.

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16 Maintenance

16.1 Overview
16.1.1 Introduction
16.1.2 Introduction
Maintenance of the system should be performed regularly by trained
personnel to ensure reliable performance and reduce unnecessary service
calls. Even you are only an operator, it is important for you to read this
chapter. Your thorough understanding will help you obtain the best
performance of the system.
The Biochemistry Maintenance, ISE Maintenance and Scheduled
Maintenance Log are provided. The Biochemistry Maintenance and ISE
Maintenance features provide a list of the maintenance procedures that
can be performed to optimize the system performance. The Scheduled
Maintenance Log feature allows you to understand what maintenance is
needed, when it is performed and who performed the procedure. It is
capable of reminding you of the maintenance that is due and keeping
track of what is happened during a maintenance procedure.
In the case of maintenance that is beyond your capability or not covered
in this chapter, contact our customer service department or your local
distributor.
The maintenance frequencies stated in this manual are based on working
for 5 hours a day, that is 5*400=2,000 tests/day, and 5*400*25=50,000
tests/month.

Warning
Do not perform any maintenance procedures that are not described in this chapter;
otherwise, equipment damage or personal injury may be caused.
Do not touch the components other than those specified in this chapter.
Performing unauthorized maintenance procedures can damage the instrument and
cause personal injury, or invalidate the applicable warranty provisions in the service
contract.
After performing maintenance, make a verification to ensure that the system runs
normally.
Do not spill water or reagent on mechanical or electrical components of the system.
If the system is to be stored for a long time (over 1 week) or transported, contact our
customer service department or your local distributor to perform necessary
maintenance in order to ensure the system’s optimal performance in following use.

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.

16-2
 16 Maintenance
16.1.3 Consumables
Please use the consumables manufactured or recommended by our
company in order to achieve the promised system performance. If needed,
contact our customer service department or your local distributor.

Table 16.1 Consumables

Item Location Description
20W Lamp housing Regularly-replaced part. Replace it
tungsten-halogen when it serves for over 2000 hours or
lamp the system shows a prompt message
indicating light intensity too weak.
You are recommended to replace the
lamp when is it is used for no longer
than 6 months.
Kloehn 100μl Sample syringe Regularly-replaced part. Replace it
syringe plunger when:
assembly it serves for 3 months; or
it works for 100,000 tests; or
it is obviously damaged.
Kloehn 1ml Reagent syringe Regularly-replaced part. Replace it
syringe plunger when:
assembly it serves for 3 months; or
it works for 300,000 tests; or
it is obviously damaged.
Sample syringe Connection joint Regularly-replaced part. Replace it
washer between the sample when the sample syringe is
syringe and the T piece reinstalled for 2 to 3 times.
Reagent syringe Connection joint Regularly-replaced part. Replace it
washer between the reagent when the reagent syringe is
syringe and the T piece reinstalled for 2 to 3 times.
Reagent probe Reagent probe arm Irregularly-replaced part. Replace it
assembly when it is damaged or bent.
Sample probe Sample probe arm Irregularly-replaced part. Replace it
assembly when it is damaged or bent.
Sample probe Nut on the sample Regularly-replaced part. Replace it
washer probe when,
the sample probe is reinstalled for 2
to 3 times; or
the sample probe is replaced with a
new one.
Reagent probe Nut on the reagent Regularly-replaced part. Replace it
washer probe when,
the reagent probe is reinstalled for 2
to 3 times; or
the reagent probe is replaced with a
new one.
Mixer Mixer arm Irregularly-replaced part. Replace it
when it is damaged.
A4 paper Printer Consumable
Reaction cuvette Reaction carousel Replace it as needed.
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16 Maintenance
Item Location Description
Deionized water Water supply Replace it in every 6 months.
filter assembly
Filter core Water inlet filter Replace it in every 3 months.
Water inlet filter Water supply module Replace it in every 6 months.
or water unit
Wash solution Water tank bracket Consumable
Reagent bottle Reagent carousel Consumable
for reagent
carousel inner
ring
(40ml)
Reagent bottle Reagent carousel Consumable
for reagent
carousel inner
ring
(62ml)
Reagent bottle Reagent carousel Consumable
for reagent
carousel outer
ring
(20ml)
Reagent bottle Reagent carousel Consumable
for reagent
carousel outer
ring
(40ml)
Na electrode ISE module (optional) Consumable
K electrode ISE module (optional) Consumable
Cl electrode ISE module (optional) Consumable
Reference ISE module (optional) Consumable
electrode
Spacer ISE module (optional) Consumable
Wash solution ISE module (optional) Consumable
package
Reagent module ISE module (optional) Consumable
Urine diluent ISE module (optional) Consumable
ISE control ISE module (optional) Consumable

16.1.4 Tools Required for Maintenance

The following tools will be used for maintenance of the system.

Accompanying Tools

Table 16.2 Accompanying Tools

Item Applicable Maintenance
Philips-head screwdriver φ3.3×100 Removing the system enclosure and the
cooling fans

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 16 Maintenance
Item Applicable Maintenance
Philips-head screwdriver φ4.7×100 Installing the probes and lamp
Slot-head screwdriver φ4.7×100 Installing/removing the probes, and
installing the tube hoop.
Wash solution Enhanced cleaning
Round-head needle, Unclogging the probes
0.25+/-0.01mm*125mm
Unclogging device for reagent probe Unclogging the reagent probe
Unclogging device for sample probe Unclogging the sample probe

Tools to be Prepared by User

Table 16.3 Tools to be Prepared by User

Item Applicable Maintenance
Tube brush, ultrasound cleaner Cleaning the filter core
Clean gauze Cleaning the syringes, rotors,
probes/mixers
Cotton swabs Cleaning the wash well, sample
compartment, etc.
Suction cleaner Cleaning the fans and dust screens
Hair brush Cleaning the dust screen
Tweezers Removing/Installing probes and syringe
washers
Thread syringe Unclogging the sample probe and reagent
probe
Tube brush or ultrasound cleaner Cleaning the filter core
Beaker Cleaning the needle and unclogging device
Ethanol Cleaning the photometer lens, probes,
mixers and wash station
NaClO (0.5% sodium hypochlorite Cleaning the wash wells
solution)
Fiber-free gloves Cleaning and replacing reaction cuvettes
etc.
Large water container Cleaning the deionized water tank
Screen and keyboard wash solution Cleaning the screen and keyboard

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16 Maintenance

16.2 Biochemistry Maintenance

16.2.1 Introduction
The Biochemistry Maintenance feature provides maintenance
instructions for the biochemistry system. The following three types of
maintenance are available.
Photometric system:
 Cuvette check
 Photometer check
 Replace lamp
 Replace cuvette
Hydropneumatics:
 Clean probes/mixers exterior
 Clean probes interior
 Prime wash station
 Clean filter and DI water tank
 Circulate wash cuvettes
Sample/Reagent handling system and mixer assembly:
 Home
 Clean probes/mixers/wash wells
 Special wash
 Special wash probes
The biochemistry maintenance is described in detail in the following
pages.

16.2.2 Biochemistry Maintenance Screen Overview

Select Utility-Maintenance-Maintenance-Biochemistry Maintenance.
The screen shows the biochemistry maintenance commands that are
frequently used.

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 16 Maintenance
Figure 16.1 Biochemistry Maintenance screen

Maintenance procedures
Provides frequently-used maintenance commands of the biochemistry
system. Select a maintenance command button to start the maintenance
procedure.
Online help
Online help information is provided for each biochemistry maintenance
command. Select the icon to the left of a maintenance command to
show relevant instructions.
Exit
Select this button to close the Maintenance window.

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16 Maintenance

16.3 ISE Maintenance

16.3.1 Introduction
The ISE Maintenance feature provides maintenance commands for the
ISE module. The following maintenance procedures are included:
 Two-point calibration
 Clean electrode tubes
 Pump calibration
 Maintenance
 Air bubble detector calibration
 Purge A
 Purge B
 Replace electrode
 Remove reagent pack
 Program check instruction
 Air bubble detector calibration result
 Pump calibration result
 Read Dallas chip
 Write Dallas chip
 Store electrodes
 Clean sample injection port
The ISE maintenance is described in detail in the following pages.

16.3.2 ISE Maintenance Screen Overview

Select Utility-Maintenance-Maintenance-ISE Maintenance. The screen
shows the ISE maintenance commands that are frequently used. Operate
according to the screen prompts.

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 16 Maintenance
Figure 16.2 ISE Maintenance screen

Maintenance procedures
Provides frequently-used maintenance commands of the ISE module.
Select a maintenance command button to start the maintenance
procedure.
Online help
Online help information is provided for each ISE maintenance command.
Select the icon to the left of a maintenance command to show
relevant instructions.
Exit
Select this button to close the Maintenance window.

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16 Maintenance

16.4 Scheduled Maintenance Log

16.4.1 Introduction
Scheduled maintenance procedures are determined by use of the
components and frequency of performance, and should be performed
regularly by trained personnel to ensure reliable performance and reduce
unnecessary service calls. Read this section carefully prior to doing the
maintenance.
The Customize feature allows definition of maintenance procedures and
configuration of manufacturer-/user-defined maintenance procedures for
each maintenance frequency. The Electronic Maintenance Log is provided
enabling you to record comments and other important information of
maintenance.
Most of the scheduled maintenance procedures are performed by
executing maintenance instructions, while the remaining part by manual
operations. Perform the maintenance strictly as instructed in this manual.

16.4.2 Maintenance Schedule

The scheduled maintenance procedures are divided into the following
periods:
 Daily: 1 day
 Weekly: 8 days
 Two-week: 15 days（No maintenance item for this model）
 Monthly: 31 days
 Three-month: 91 days
 Six-month: 181 days
 Other (As-needed/As-required)
The maintenance frequency is counted down from the date of performing.
When the countdown becomes 0, the corresponding maintenance
procedure is highlighted in yellow. To determine that a due maintenance
procedure is due, check if the following items are displayed in yellow
background:
 Utility button on the main screen
 Maintenance tab
 Maintenance button
 Scheduled Maintenance tab
 Maintenance frequency tab
 Maintenance procedure

The maintenance information will not be lost when the operating software
version is upgraded. When new version software is installed to remove
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 16 Maintenance
the system failure or fix the system, the maintenance counter returns to 0
and restarts a countdown.

16.4.3 Scheduled Maintenance Procedures

Maintenance procedures vary from different maintenance frequencies.
The maintenance procedures described in this chapter are based on a
complete configuration of the system. If some modules are not equipped
on your system, you have no need to perform relevant maintenance.
Daily maintenance:
 Check probes/mixers/wash wells
 Check sample/reagent syringes
 Check deionized water connection
 Check waste tube connection
 Check concentrated wash solution
 Check sample probe wash solution
 Clean electrode tubes
Weekly maintenance:
 Clean sample/reagent probe exterior/ mixers
 Special wash
 Clean mixers
 Cuvette check
 Photometer check
Monthly maintenance:
 Clean wash wells
 Clean cuvette wash station
 Clean filter core
 Clean dust screens
 Clean sample injection port
 Pump calibration
 Air bubble detector calibration
Three-month maintenance:
 Clean DI water tank
 Replace filter core
Six-month maintenance:
 Replace lamp
 Replace water inlet filter
 Replace reference electrode
Other (As-needed/As-required):
 Clean analyzer panels
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16 Maintenance
 Bar code maintenance
 Clean sample compartment
 Clean reagent compartment
 Clean sample probe interior
 Clean reagent probe interior
 Replace sample probe
 Replace reagent probe
 Replace sample mixer
 Replace reagent mixer
 Remove air bubbles in sample syringe
 Remove air bubbles in reagent syringe
 Special wash probes
 Replace cuvettes
 Replace ISE electrode
 Store electrodes
 Remove reagent pack
 Replace sample syringe
 Replace reagent syringe
 Clean rotors
Perform the scheduled maintenance according to the instruction in this
chapter. Run calibration or quality control after performing the
maintenance.

16.4.4 Maintenance Log Sheet

Refer to the following table for scheduled maintenance procedures you
are supposed to perform. Please copy it every month and place a check
mark in relevant day column every time after you performing
maintenance.

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 16 Maintenance

Table 16.4 Maintenance Log Sheet

Maintenance Log Sheet
Year Month Page 1 of 2
Daily Maintenance 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 27 28 29 30 31
Check Probes/Mixers/Wash
1
Wells
2 Check Sample/Reagent Syringes
Check Deionized Water
3
Connection
4 Check Waste Tube Connection
Check Concentrated Wash
5
Solution
Check Sample Probe Wash
6
Solution
7 Clean ISE Electrodes
Weekly Maintenance 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 27 28 29 30 31
Clean Sample/Reagent probe
1
Exterior
2 Clean Mixers
3 Special Wash
4 Cuvette Check
5 Photometer Check
Monthly Maintenance 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 27 28 29 30 31
1 Clean Wash Wells
2 Clean Cuvette Wash Station
3 Clean Filter Core
4 Clean Dust Screens
5 Clean Sample Injection Port
6 Pump Calibration
7 Air Bubble Detector Calibration
Clean the Dust Screen of the
8
External Vacuum Pump
Three-Month Maintenance 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 27 28 29 30 31
1 Clean DI Water Tank
2 Replace Filter Core
Six-Month Maintenance 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 27 28 29 30 31
1 Replace Lamp
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16 Maintenance
2 Replace Water Supply Filter
3 Replace Reference Electrode
As-Required/As-Needed
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 27 28 29 30 31
Maintenance
1 Clean Analyzer Panels
2 Bar Code Maintenance
3 Clean Sample Compartment
4 Clean Reagent Compartment
5 Clean Sample Probe Interior
6 Clean Reagent Probe Interior
7 Replace Sample Probe
8 Replace Reagent Probe
9 Replace sample mixer
10 Replace reagent mixer
Remove Air Bubbles In Sample
11
Syringe
Remove Air Bubbles In Reagent
12
Syringe
13 Special Wash Probes
14 Replace Cuvettes
15 Replace ISE Electrodes
16 Store Electrodes
17 Remove Reagent Pack
18 Replace sample syringe
19 Replace reagent syringe
20 Clean rotors
21 Clean waste tube of ISE module

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 16 Maintenance

16.4.5 Scheduled Maintenance Screen Overview

The Scheduled Maintenance screen contains maintenance frequency
tabs, maintenance procedures, scroll bar, and function buttons. Select a
tab to view the maintenance procedures to be performed in the period.
Choose a maintenance procedure, and then select function buttons to
access windows to execute an operation.
Figure 16.3 Scheduled Maintenance screen

Fields and buttons on the screen are introduced as follows.

Maintenance procedures
Shows the preset and user-defined maintenance procedures for the
current maintenance frequency.
Select field
Choose a maintenance procedure and click on the corresponding Select
checkbox. A tick appears in the middle of the checkbox, which indicates
the maintenance procedure is chosen. Select the function buttons at the
bottom of the screen to access a window or execute an operation. To
deselect a maintenance procedure, click on the Select checkbox again.
The tick inside the checkbox disappears, which indicates the
maintenance procedure is deselected.
Property field
Shows how the maintenance procedure is defined. The Property includes
two options: System and User. System indicates that the maintenance
procedure is defined by the manufacturer and cannot be configured; User
indicates that the maintenance is defined by user and can be configured
for each maintenance frequency.
Operator field
Shows who performs the maintenance procedure, that is, the user ID

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16 Maintenance
currently logging on the system.
Date Performed field
Shows the date confirmed by the operator on which the maintenance was
performed. After performing a maintenance procedure, mark the Select
checkbox and select OK. The date is refreshed and displayed as the
current date. The system will restart the countdown of the maintenance
frequency from the current date.
Scroll bar
If all maintenance procedures of a period are not shown on the current
screen, move the scroll bar view more maintenance procedures.
Select All button
This function allows selection of all maintenance procedures currently
available on the screen. When the Select All button is selected, a tick
appears in all Select checkboxes to the right of the maintenance
procedures. Choose the following buttons as needed:
 OK: allows the reviewal of the selected maintenance procedure and
entering of the date performed.
 Log: allows recording of comments and other important information
of maintenance.
 History: provides a stored history record of maintenance performance
with date and operator for the procedure selected.
OK button
This function allows the reviewal of the selected maintenance procedure
and entering of the date performed. When the approving a maintenance
procedure, the date of performance will be displayed as the current date.
Log button
The electronic maintenance log function allows the recording of
comments and other important information of maintenance. Choose one
or more maintenance procedures, and then select the Log button. The
Maintenance Log window shows. Input logs for the procedure selected,
and then select OK. Your input information will be applied to the selected
maintenance procedure.

History button
This feature provides a stored history record of maintenance performance
with date and operator for the procedure selected. You are allowed to edit
or delete a maintenance record. Please note that only one maintenance
procedure can be recalled for history performance at one time.
1 Choose a maintenance procedure on the Scheduled Maintenance
screen.

2 Select History. The Maintenance Log window is displayed.

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 16 Maintenance
3 View all performance records of the selected maintenance procedure.

4 To edit a maintenance record:

 Mark the checkbox of the desired maintenance record.

 Select Edit.
 Modify the maintenance record.
 Select OK.
Only one maintenance record can be edited at one time.
5 To delete maintenance records:

 Mark the checkbox of one or more desired maintenance records.

 Select Delete.
 Select OK. The selected maintenance records are removed.
6 To print maintenance log:

 Mark the checkbox of one or more desired maintenance records.

 Select Print.
7 Select Close to exit the window.

Customize button
The Customize function allows definition of new maintenance procedures
and configuration of manufactured-/user-defined maintenance
procedures. User-defined maintenance procedures can be deleted.
Select Customize on the Scheduled Maintenance screen. The Customize
Maintenance Procedure window is displayed.
To define a maintenance procedure:
 Select New.
 Enter the name of the new maintenance procedure.
 Select OK. The maintenance procedure is displayed in the Available
Procedures list.
 Use >> and << to configure or cancel user-defined maintenance
procedures. The property of a user-defined maintenance procedure is
User.
 Select OK to save the configuration, or select Cancel to abort it.
To configure a maintenance procedure:
 Choose a maintenance frequency in the Frequency pull-down list.
 Choose a maintenance procedure in the Available Procedures list.
Move the vertical scroll bar to view more maintenance procedures.
 Select >>. The selected maintenance procedure appears in the
Enabled Procedures list, and the relevant maintenance schedule
screen will be refreshed automatically.
To remove a maintenance procedure:

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16 Maintenance
 Choose a maintenance procedure in the Enabled Procedures list.
 Select <<. The selected maintenance procedure is removed from the
Enabled Procedures list and appears in the Available Procedures list.
The relevant maintenance schedule screen will be refreshed
automatically.
 Select OK to save the configuration, or select Cancel to abort it.
Delete button
The system allows deleting of maintenance procedures that will no longer
be used. Only user-defined rather than manufacturer-defined
maintenance procedures can be deleted.
1 Choose a maintenance procedure on the Scheduled Maintenance
screen.

2 Select Delete.

3 Select OK. The selected maintenance procedure is deleted. The

Available Procedures list on the Customize Maintenance Procedure
window is refreshed automatically.

Close
Select this button to close the Maintenance window.

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 16 Maintenance

16.5 Daily Maintenance

16.5.1 Introduction
The daily maintenance procedures should be performed every day prior to
measurements. The maintenance for the biochemistry system is to check
the sample probe, reagent probe, mixers, wash wells, syringes, deionized
water connection, waste connection, and concentrated wash solution
volume. The maintenance for the ISE module is to clean the electrodes in
order to remove the proteins and lipid remaining on their surfaces.

16.5.2 Check Probes/Mixers/Wash Wells

Abnormal sample probe, reagent probe, wash wells or mixers may
influence the measurement performance and result in inaccurate results.
Prior to measurements every day, check the sample probe and reagent
probe for stains and crystals, and check if the mixers cannot rotate
normally or are lifted and the water flow in the wash wells is abnormal. If
the above-mentioned abnormities exist, clean or adjust the probes and
mixers immediately.
Purpose
To check the sample probe and reagent probe for water dripping, stains
and liquid flow abnormities, and check if the mixers can rotate normally
and the water flow in the wash wells is abnormal.
When to do
You are recommended to do this maintenance procedure every day before
starting the analysis.
System status
Make sure that the system status is Standby.
Precautions

Warning
The probes and mixers are sharp and vulnerable. To prevent injury and equipment
damage, exercise caution when working around the probes and mixers. Keep away
from the probes and mixers to avoid collision with them.

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles.

How to do
1 Open the upper and rear protective shields of the analyzer.

2 Select Utility-Maintenance-Maintenance- Biochemistry

Maintenance.

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16 Maintenance
3 Select Clean Probes/Mixers/Wash Wells.

4 Check the exterior of the probes/mixers for stains. If stains exist,

perform the Clean Sample/Reagent Probe Exterior or Clean Mixers
procedure.

5 Select Continue to clean the reagent probe and sample probe

interiors.

6 Check the liquid flow of the sample probe and reagent probe. If the
liquid flow is sprayed out or does not come out vertically, the probe
may be clogged. Perform the Concentrated Wash Probes/Mixers
procedure,, and then check them again. If the abnormity remains,
perform the Clean Sample Probe Interior or Clean Reagent Probe
Interior procedure. If the abnormity still remains, perform the Replace
Sample Probe or Replace Reagent Probe procedure, or contact a
service engineer.
Figure 16.4 Normal and abnormal liquid flows of sample probe and reagent probe

OK Error

7 Select Second Wash. The probe interior wash can be performed again.

8 Select Continue.

9 Observe the water flow of the probe/mixer wash wells, and check if
the water reaches to about 5mm of the probe/mixer from the tip. If it
does, proceed to the next step; otherwise, contact a service engineer.

10 Select Continue.

11 Select Done.

12 Select Scheduled Maintenance-Daily.

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 16 Maintenance
13 Mark the Select checkbox to the right of Check Probes/Mixers/Wash
Wells.

14 Select OK to refresh the current date as the performance date.

15 Select Log, and then record comments and other important

information for the procedure.

16 Select OK to save your input information.

17 Restore the protective shields.

16.5.3 Check Sample/Reagent Syringes

The sample syringe and reagent syringes are precise devices used to
aspirate/dispense small amount of sample and reagent. If the syringes
leak, they cannot aspirate/dispense the correct amount of sample or
reagent, and may even be damaged. Prior to measurements every day,
check the sample/reagent syringes for leak.
Purpose
To check the sample/reagent syringes for leak and air bubbles.
When to do
You are recommended to do this maintenance procedure every day before
starting the analysis.
Materials required
Clean gauze
System status
Make sure that the system status is Incubation or Standby.
Precautions

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles.

How to do
1 Open the front door of the analyzer. You will see two syringes on the
two side of the water tank.

2 Check the T piece assembly and plunger guide cap for leak.

3 Use dry gauze to wipe the T piece, and then check if the gauze is
moistened.

 If it is not, proceed to the next step.

 If it is, tighten the T piece.

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16 Maintenance
 Check the T piece and plunger guide cap again. If the leak remains,
check if the washer inside the syringe connector is intact.
 If the washer is damaged, replace it with a new one; otherwise,
replace the syringe.
4 Check the syringe interior for air bubbles. If yes, remove the air
bubbles.

5 Check if the retaining screws at the bottom of the syringe are

tightened.

 If not, tighten them and proceed to the next step.

 If yes, proceed to the next step.
6 Close the front door of the analyzer.

7 Select Utility-Maintenance-Maintenance, and then select Scheduled

Maintenance-Daily.

8 Mark the Select checkbox to the right of Check Sample/Reagent

Syringes.

9 Select OK to refresh the current date as the performance date.

10 Select Log, and then record comments and other important

information for the procedure.

11 Select OK to save your input information.

16.5.4 Check Deionized Water

If the deionized water tubes are not connected properly, deionized water
cannot be supplied normally or leak may be caused, influencing the
measurements.
Purpose
To check the DI water connection to ensure normal supply of DI water.
When to do
You are recommended to do this maintenance procedure every day before
starting the analysis.
System status
Make sure that the system is powered off, or the system status is
Incubation or Standby.
How to do
1 Check that the water tank or other water containers have sufficient
deionized water.

2 Check that the tubes are not bent or folded or leaking.

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 16 Maintenance
3 Check that the water supply module is powered on.

4 Select Utility-Maintenance-Maintenance, and then select Scheduled

Maintenance-Daily.

5 Mark the Select checkbox to the right of Check DI Water Connection.

6 Select OK to refresh the current date as the performance date.

7 Select Log, and then record comments and other important

information for the procedure.

8 Select OK to save your input information.

16.5.5 Check Waste

If the waste tube is not connected properly or the high-concentration
waste tank is full, overflow may be caused, resulted in environmental
contamination or cross contamination, or even damaging the equipment.
It is necessary to regularly check the waste tube connection and the
high-concentration waste tank.
Purpose
To check the waste tube connection and the high-concentration waste
tank to prevent overflow.
When to do
You are recommended to do this maintenance procedure every day before
starting the analysis.
System status
Make sure that the system is powered off, or the system status is
Incubation or Standby.
Precautions

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
Dispose of the waste in accordance with your local or national guidelines for
biohazard waste disposal.

How to do
1 Check if the waste drainage system works well, and make sure that
the waste tube is not bent or folded and the high-/low-concentration
waste is drained properly.

2 Check if the high-concentration waste tank has been emptied. If not,

empty it.

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16 Maintenance
High-concentration waste output: 1.5L/H, low-concentration waste
output: no more than 18.5L/H, and water consumption: no more than
20L/H.
3 If leak remains after performing the above-stated steps, contact our
customer service department or your local distributor.

4 Select Utility-Maintenance-Maintenance, and then select Scheduled

Maintenance-Daily.

5 Mark the Select checkbox to the right of Check Waste Tank

Connection.

6 Select OK to refresh the current date as the performance date.

7 Select Log, and then record comments and other important

information for the procedure.

8 Select OK to save your input information.

16.5.6 Check Concentrated Wash Solution

Insufficient concentrated wash solution may terminate the
measurements. Prior to measurements every day, check the concentrated
wash solution volume, and fill more, if necessary.
A tank of concentrated wash solution is 2L and can be used for 6 days for
plastic cuvettes on condition that 2000 tests are done every day. Please
check and refill the concentrated wash solution according to the
consumption and tank volume.
Purpose
To check the concentrated wash solution volume to prevent
measurements from being terminated.
When to do
You are recommended to do this maintenance procedure everyday before
starting the analysis.
System status
Make sure that the system is powered off, or the system status is
Incubation or Standby.
Precautions

Warning
Concentrated wash solution is corrosive to human skins. Wear gloves and goggles
while checking the concentrated wash solution. In case your hand or clothes contact
the wash solution, wash them off with soap and water. If the wash solution spills into
your eyes, rinse them with water and consult an oculist.

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 16 Maintenance

CAUTION
When the system is Initializing, it may be diluting the concentrated wash solution.
Do not try to fill concentrated wash solution until the system status becomes
Standby.

How to do
1 Open the front door of the analyzer and check the concentration wash
solution. If necessary, fill more or replace the wash solution.

2 Close the front door of the analyzer.

3 Power on the analyzer and run the operating software.

4 Make sure that the system status is Incubation or Standby.

5 Select Utility-Maintenance-Maintenance, and then select Scheduled

Maintenance-Daily.

6 Mark the Select checkbox in the same row as Check Concentrated

Wash Solution.

7 Select OK to refresh the current date as the performance date.

8 Select Log, and then record comments and other important

information for the procedure.

9 Select OK to save your input information.

16.5.7 Check Sample Probe Wash Solution

Insufficient sample probe wash solution may cause probe clogging and
cross contamination.
Three special washes will be conducted for the sample probe when every
batch of tests is finished, and about 90μl wash solution is consumed for
each wash. You are recommended to check and replace the sample probe
wash solution every day to ensure its sufficiency.
Purpose
To check the sample probe wash solution volume to prevent
measurements from being terminated.
When to do
You are recommended to do this maintenance procedure every day before
starting the analysis.
System status
Make sure that the system is powered off, or the system status is
Incubation or Standby.
Precautions

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16 Maintenance

CAUTION
You are recommended to replace the sample probe wash solution every day in order
to prevent probe clogging and cross contamination.
While the system is running tests, do not try to fill sample probe wash solution until
the system status becomes Standby.

How to do
1 Check the volume of the sample probe wash solution on the sample
carousel position D2.

2 If necessary, fill more or replace the wash solution.

3 Select Utility-Maintenance-Maintenance, and then select Scheduled

Maintenance-Daily.

4 Mark the Select checkbox in the same row as Check Sample Probe
Wash Solution.

5 Select OK to refresh the current date as the performance date.

6 Select Log, and then record comments and other important

information for the procedure.

7 Select OK to save your input information.

16.5.8 Clean Electrode Tubes (For ISE Module)

When the ISE module finishes a great number of measurements, the
proteins and lipid contained in samples may remain on surfaces of the
electrodes, influencing their measurement performance. You should clean
the electrodes regularly to ensure system performance. It will take about
2 minutes to perform this procedure.
Purpose
To remove the proteins and lipid remaining on the electrode surfaces.
When to do
You are recommended to perform this procedure after finishing all ISE
tests of the day, or before shutting down the system, or 50 samples are
analyzed.
Materials required
ISE wash solution, 2ml sample tube
System status
Make sure that the status of both the biochemistry system and ISE
module is Standby.

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 16 Maintenance
Precautions

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles.
The wash solution may hurt your eyes and skins. Exercise caution while using the
wash solution. If your eyes contact the wash solution, rinse them off with fresh
water and consult a doctor.

CAUTION
Please use consumables recommended by our company. Use of other consumables
may degrade the system performance.

NOTE
After performing this procedure, recalibrate the ISE electrodes prior to starting
analysis.

How to do
1 Select Utility-Maintenance-Maintenance- ISE Maintenance.

2 Choose Clean Electrode Tubes. The maintenance guide window

shows.

3 Open the upper protective shield of the analyzer.

4 Fill a 2ml sample tube with 300μl ISE wash solution, and then load it
to position D1 on the sample carousel.

5 Select Continue. The system starts cleaning the ISE electrodes.

6 Select Done.

7 Select Scheduled Maintenance-Daily.

8 Mark the Select checkbox in the same row as Clean Electrode Tubes.

9 Select OK to refresh the current date as the performance date.

10 Select Log, and then record comments and other important

information for the procedure.

11 Select OK to save your input information.

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16 Maintenance

16.6 Weekly Maintenance

16.6.1 Clean Sample/Reagent Probe Exterior
The sample probe and reagent probe are often dirty on their surfaces,
causing carryover between samples or reagents and resulting in
inaccurate results. You are recommended to perform this procedure every
week.
Purpose
To clean the exterior of the sample probe and reagent probe to prevent
cross contamination.
When to do
This procedure should be performed on weekly basis.
Materials required
2 pieces of clean gauze, ethanol, deionized water, tweezers
System status
Make sure that the system status is not Running.
Precautions

Warning
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise
caution when working around the probes. If the probe is bent or damaged, replace it
immediately; otherwise, unreliable results may be obtained.

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.

How to do
1 Switch off the analyzing unit power.

2 Rotate the probe arm to move the probe to a position convenient for
cleaning, and then use gauze soaked with ethanol to gently wipe the
probe exterior. Clean the probe tip until it becomes clear without
stain.

Do not pull the probe horizontally to prevent probe damage.

3 Use gauze moistened with deionized water to clear the ethanol on the
probe.

4 After finishing the cleaning, turn on the analyzing unit power switch.

5 Select Utility-Commands-Home to reset the probe.

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 16 Maintenance
6 Select Utility-Maintenance-Maintenance, and then select Scheduled
Maintenance-Weekly.

7 Mark the Select checkbox to the right of Clean Sample/Reagent

Probe Exterior.

8 Select OK to refresh the current date as the performance date.

9 Select Log, and then record comments and other important

information for the procedure.

10 Select OK to save your input information.

16.6.2 Clean Mixers

The mixers are often dirty on their surfaces, causing carryover between
samples or reagents and resulting in inaccurate results. You are
recommended to perform this procedure every week.
Purpose
To clean the sample mixer and reagent mixer to prevent cross
contamination.
When to do
This procedure should be performed on weekly bases.
Materials required
2 pieces of clean gauze, ethanol, deionized water, tweezers
System status
Make sure that the system status is not Running.
Precautions

Warning
Exercise caution while working around the mixer. If it is bent or damaged, replace it
immediately; otherwise, unreliable results may be obtained.

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.

How to do
1 Switch off the analyzing unit power.

2 Rotate the mixer arm to move the mixer to a position convenient for
cleaning, and then use gauze soaked with ethanol to gently wipe the
mixer exterior until it becomes clear without stain.

Do not pull the mixer horizontally to prevent damage.

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16 Maintenance
3 Use gauze moistened with deionized water to clear the ethanol on the
mixer.

4 After finishing the cleaning, turn on the analyzing unit power switch.

5 Select Utility-Commands-Home to reset the mixer.

6 Select Utility-Maintenance-Maintenance, and then select Scheduled

Maintenance-Weekly.

7 Mark the Select checkbox in the same row as Clean Mixers.

8 Select OK to refresh the current date as the performance date.

9 Select Log, and then record comments and other important

information for the procedure.

10 Select OK to save your input information.

16.6.3 Special Wash

Special wash is to clean the sample probe, reagent probe, mixers, reaction
cuvettes and wash station by using the concentrated wash solution, with
the aim of eliminating carryover and preventing waste from leaving in the
waste tubes. It will take about 30 minutes to perform this procedure.
Purpose
To eliminate cross contamination among the sample probe, reagent
probe, mixers, cuvettes and wash station, and prevent waste from leaving
in the waste tubes.
When to do
You are recommended to perform this procedure on weekly basis or when
the equipment is to be stored for a long time.
Materials required
Concentrated wash solution manufactured by our company
System status
Make sure that the system status is Standby.
How to do
1 Open the upper protective shield of the analyzer.

2 Place more than 40ml concentrated wash solution in position D of the

reagent carousel, and place more than 1ml concentrated wash
solution in position D2 on the sample carousel.

3 Select Utility-Maintenance-Maintenance- Biochemistry

Maintenance.

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 16 Maintenance
4 Choose Special Wash.

5 Confirm if cuvette check is needed after the special wash. If it is, mark
the checkbox in front of Perform Cuvette Check.

6 Select Continue to continue, or select Exit to abort the special wash.

7 The system starts cleaning the sample probe, reagent probe, mixers,
cuvettes and wash station. To terminate the clean process, select
Stop.

8 Perform the cuvette check procedure. Refer to 16.6.4 Cuvette Check

(page 16-31) for details.

9 Select Done.

10 Restore the upper protective shield of the analyzer.

11 Select Scheduled Maintenance-Weekly.

12 Mark the Select checkbox in the same row as Special Wash.

13 Select OK to refresh the current date as the performance date.

14 Select Log, and then record comments and other important

information for the procedure.

15 Select OK to save your input information.

16.6.4 Cuvette Check

After being used for a long time, the reaction cuvettes may have proteins
or other stains left inside of them that are difficult to remove and will
influence the light transmittance of the cuvettes. If the cuvettes are
polluted or scratched or damaged, the light transmittance will be affected,
threatening the accuracy and stability of the results. Check the reaction
cuvettes regularly to avoid unwanted results. It will take about 15~20
minutes to perform this procedure.
Purpose
To check if the reaction cuvettes are polluted and the light transmittance
is decreased in order to prevent unreliable test results.
When to do
You are recommended to perform this procedure on weekly basis or after
replacing the reaction cuvettes.
System status
Prior to performing the maintenance, make sure that the system has been
power on for over 10 minutes and the system status is Standby. Check if
the reaction carousel has a cuvette for each position. If not, load cuvettes.

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16 Maintenance
Precautions

NOTE
When a cuvette is deemed dirty, clean or replace it immediately, and then perform
the cuvette check again.
Stains inside cuvettes will influence the photometric measurement. You are
recommended to perform the Cuvette Check after finishing the Concentrated Wash
procedure.

How to do
1 Select Utility-Maintenance-Maintenance- Biochemistry
Maintenance.

2 Choose Cuvette Check.

3 Make sure that the lamp has been turned on for over 10 minutes.
Select Continue and then select Start. When finishing the check, the
system refreshes the cuvette status based on the check results.
Record the cuvettes highlighted in yellow and please replace the
cuvettes highlighted in yellow. To abort the cuvette check, select
Stop.

The screen shows all cuvettes and highlights the dirty cuvettes with
special color:
 No color indication: normal cuvette
 Yellow: dirty cuvette
4 Select Result. The Cuvette Check Results window appears and
shows the latest check result of the 90 cuvettes at all wavelengths.

5 Choose a cuvette in the result list. The Cuvette Status window pops
up.

Choose the following buttons as needed:

 |<: to view the first cuvette.
 <: to view the previous cuvette.
 >: to view the next cuvette.
 >|: to view the last cuvette.
 Print: to print the results currently displayed on the screen.
 Exit: to close the Cuvette Status window.
6 Select Exit to close the Cuvette Check window.

7 Select Scheduled Maintenance-Weekly.

8 Mark the Select checkbox in the same row as Cuvette Check.

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 16 Maintenance
9 Select OK to refresh the current date as the performance date.

10 Select Log, and then record comments and other important

information for the procedure.

11 Select OK to save your input information.

16.6.5 Photometer Check

Decreased light intensity and stability of the lamp will directly influence
the accuracy and repeatability of the results. Check the lamp regularly, or
if necessary, replace it. The Photometer Check procedure provides
detection of too strong or too weak light intensity. The photometer status
will be provided through an alarm message or prompt message.
Purpose
To check the light intensity by measuring absorbance of 5 cuvettes and
help you determine whether to replace the lamp.
When to do
You are recommended to perform this procedure on weekly basis or after
replacing the lamp.
System status
Prior to performing the maintenance, make sure that the system has been
power on for over 10 minutes and the system status is Standby.
Precautions

NOTE
Before checking the lamp, perform the Cuvette Check procedure and replace or
clean the dirty cuvettes; otherwise, the photometer check results are unreliable.
To ensure the photometer’s measurement performance, replace the lamp in the case
of weak light intensity.

How to do
1 Select Utility-Maintenance-Maintenance- Biochemistry
Maintenance.

2 Choose Photometer Check. The following window appears.

3 Make sure that the lamp has been turned on for over 10 minutes.
Select Continue and then select Start. When finishing the check, the
system displays the results and refreshes the photometer status. To
abort the photometer check, select Stop.

On the left of the screen shows the absorbance at each wavelength in

the current photometer check; on the right of the screen shows that
of the previous photometer check. By checking the results of the

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16 Maintenance
previous and current photometer check, you may understand the
status of the lamp.
4 If the Current Status field shows Normal, it indicates that the lamp’s
light intensity satisfies the requirements of measurement; if it shows
“Light intensity is weak” in red, it indicates that the lamp has
insufficient light intensity.

5 If an alarm occurs during the check, operate as follows:

 If the alarm indicates the lamp is off, check if the lamp has been
turn on. If not, manually turn on the lamp; if yes, contact our
customer service department or your local distributor.
 If the alarm indicates light intensity too strong, contact our
customer service department or your local distributor.
 If the alarm indicates light intensity weak, select Replace to
replace the lamp. For more information, refer to 16.9.1 Replace
Lamp (page 16-49).
6 Choose the following buttons as needed:

 Print: to print the photometer check results currently available on

the screen.
 Exit: to close the window.
7 Select Done to close the Photometer Check window.

8 Select Scheduled Maintenance-Weekly.

9 Mark the Select checkbox in the same row as Photometer Check.

10 Select OK to refresh the current date as the performance date.

11 Select Log, and then record comments and other important

information for the procedure.

12 Select OK to save your input information.

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 16 Maintenance

16.7 Monthly Maintenance

16.7.1 Clean Wash Wells
When the system is used for a long time, waste and dust may accumulate
in the wash wells and block them. Clean the wash wells every month to
keep them clean and smooth.
Purpose
To remove the waste and dust from the wash wells (of reagent probe,
sample probe, sample mixer and reagent mixer).
When to do
This procedure should be performed on monthly basis.
Materials required
Cotton swabs and sodium hypochlorite solution (NaClO)
System status
Make sure that the system status is not Running.
Precautions

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.

How to do
1 Switch off the analyzing unit power.

2 Open the upper protective shield of the analyzer.

3 Rotate the same probe, reagent probe and mixers to keep them away
from the wash wells.

4 Use clean cotton swabs moistened with NaClO to clean the wash
wells.

5 After finishing the cleaning, turn on the analyzing unit power switch.

6 Select Utility-Commands-Home to reset the probes and mixers,

check if the wash wells have a normal water flow.

7 Select Utility-Maintenance-Maintenance, and then select Scheduled

Maintenance-Monthly.

8 Mark the Select checkbox in the same row as Clean Wash Wells.

9 Select OK to refresh the current date as the performance date.

10 Select Log, and then record comments and other important

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16 Maintenance
information for the procedure.

11 Select OK to save your input information.

16.7.2 Clean Wash Station

Clean the wash station regularly to prevent waste from accumulating on
it.
Purpose
To clean the cuvette wash station in order to avoid waste buildup and
cross contamination.
When to do
This procedure should be performed on monthly basis.
Materials required
Gauze, ethanol, deionized water, waste container (large beaker)
System status
Make sure that the system status is Standby.
Precautions

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
Dispose of the used gauze in accordance with your local or national guidelines for
biohazard waste disposal.

How to do
1 Open the upper protective shield of the analyzer.

2 Remove the cuvette wash station and use ethanol-moistened gauze

to wipe the wash probes and wipe blocks.

3 Use gauze moistened with deionized water to clear the ethanol on the
wash probes.

4 Restore the wash station.

5 Select Utility-Maintenance-Maintenance- Biochemistry

Maintenance.

6 Choose Prime Wash Station. The maintenance guide window shows.

Select Continue.

7 Enter the wash cycle (1~100).

8 Select Continue.

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 16 Maintenance
9 When the cleaning and priming are finished, select Done.

10 Restore the upper protective shield of the analyzer.

11 Select Scheduled Maintenance-Monthly.

12 Mark the Select checkbox in the same row as Clean Cuvette Wash
Station.

13 Select OK to refresh the current date as the performance date.

14 Select Log, and then record comments and other important

information for the procedure.

15 Select OK to save your input information.

16 Select Utility-Commands, and then select Home to put the

instrument into the Standby status.

16.7.3 Clean Filter Core

Clean the filter core every month to prevent accumulation of foreign
matters and improve the water quality.
Purpose
To clean the filter core in order to prevent accumulation of foreign matters
and improve the water quality.
When to do
This procedure should be performed on monthly basis.
Materials required
Tube brush or ultrasound cleaner
System status
Make sure that the system status is Standby.
How to do
1 Select Utility-Maintenance-Maintenance- Biochemistry
Maintenance.

2 Choose Clean Filter/Water Tank, and then select Continue.

3 Open the front door of the analyzer, unscrew the cap of the
concentrated wash solution tank, and then remove the tank. The DI
water filter appears in front of you.

4 Put a water container below the filter.

5 Remove the connectors from the DI water tank and the filter.

6 Tilt the filter assembly, loosen the filter cap and remove the filter core.

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16 Maintenance
Use a tube brush to clean the filter core’s surface, or put it in an
ultrasound cleaner for 10 minutes.
Figure 16.5 Remove deionized water filter core

Press
the filter Loosen the
filter cap

Filter core

Remove
the filter
core

7 Restore the filter core and filter cap according to the

above-mentioned steps in reversed order.

8 Select Continue. The system starts priming the tubes with deionized
water.

9 When the priming is complete, select Done.

10 Close the front door of the analyzer.

11 Select Scheduled Maintenance-Monthly.

12 Mark the Select checkbox in the same row as Clean Filter Core.

13 Select OK to refresh the current date as the performance date.

14 Select Log, and then record comments and other important

information for the procedure.

15 Select OK to save your input information.

16 Select Utility-Commands, and then select Home to put the

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 16 Maintenance
instrument into the Standby status.

16.7.4 Clean Dust Screens

Dust may accumulate on the dust screens when the instrument is used
for a long time, influencing the ventilation and heat elimination effects. It
is necessary to clean the dust screens regularly.
Purpose
To clean the dust screens to ensure good ventilation.
When to do
This procedure should be performed on monthly basis.
Materials required
Suction cleaner, hair brush and fresh water
System status
Make sure that the analyzer main power is off.
Precautions

NOTE
Use a suction cleaner to clean the dust screens while keeping them uninstalled, or
use a hair brush and fresh water to clean the dust screens after removing them from
the analyzer.
Do not reinstall the dust screens until they are dry completely.
Install the dust screens correctly to avoid gaps.
To clean the dust screens by knocking them at solid ground, find an appropriate
place, and then carefully knock them at the ground.

How to do
1 Switch off the analyzer’s main power.

2 Open the front door of the analyzer and remove the dust screens.
Figure 16.6 Dust screens

Dust screen Dust screen

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16 Maintenance
3 Use the suction cleaner, or hair brush and fresh water to clean the
dust screens, and then dry them in air.

4 Reinstall the dust screens when they are dry.

5 Close the front door of the analyzer.

6 Power on the analyzer and run the operating software.

7 Make sure that the system status is Incubation or Standby.

8 Select Utility-Maintenance-Maintenance, and then select Scheduled

Maintenance-Monthly.

9 Mark the Select checkbox in the same row as Clean Dust Screens.

10 Select OK to refresh the current date as the performance date.

11 Select Log, and then record comments and other important

information for the procedure.

12 Select OK to save your input information.

16.7.5 Clean Sample Injection Port (For ISE Module)

When the ISE module is used for a period, stains may build up in the
sample injection port and influence the measurement performance. Clean
the sample injection port regularly to keep it clear.
Purpose
To remove the stains accumulating in the sample injection port.
When to do
You are recommended to perform this procedure every month.
Materials required
Deionized water, cotton swabs, and ethanol
System status
Make sure that the status of the ISE module is Standby or Failure.
How to do
1 Make sure that the system status is Incubation or Standby.

2 Select Utility-Maintenance-Maintenance- ISE Maintenance.

3 Choose the Clean Sample Injection Port option.

4 Open the upper protective shield of the analyzer.

5 Open the cover of the ISE module.

6 Use clean cotton swab soaked with ethanol to wipe the sample

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 16 Maintenance
injection port (interior of the sample injection cup of the ISE module )
until it is clean; then use a clean cotton swab soaked with DI water to
wipe the interior and periphery of the sample injection port.

7 Select Done.

8 Select Purge A and Purge B to prime the ISE module.

9 Select Scheduled Maintenance-Monthly.

10 Mark the Select checkbox in the same row as Clean Sample Injection
Port.

11 Select OK to refresh the current date as the performance date.

12 Select Log, and then record comments and other important

information for the procedure.

13 Select OK to save your input information.

14 Restore the cover of the ISE module.

15 Restore the upper protective shield of the analyzer.

16.7.6 Pump Calibration (For ISE Module)

The peristaltic pump may get aging when used for a long time. It is
necessary to calibrate it regularly.
Purpose
To calibrate the peristaltic pump to ensure accurate test result.
When to do
This procedure should be performed on monthly basis.
System status
Make sure that the status of the ISE module is Standby .
How to do
1 Make sure that the system status is Incubation or Standby.

2 Select Utility-Maintenance-Maintenance- ISE Maintenance.

3 Choose Pump Calibration.

4 Select Start. Place 500ul DI water in the place designated by the

software.

When the calibration is complete, the calibration results are displayed

on the screen.
5 Select Done.

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16 Maintenance
6 To view the detailed results, select Pump Calibration Result. The
detailed results are displayed in the data list.

7 Select Scheduled Maintenance-Monthly.

8 Mark the Select checkbox in the same row as Pump Calibration.

9 Select OK to refresh the current date as the performance date.

10 Select Log, and then record comments and other important

information for the procedure.

11 Select OK to save your input information.

16.7.7 Air Bubble Detector Calibration (For ISE Module)

The air bubble detector may get aging when used for a long time. It is
necessary to calibrate it regularly.
Purpose
To calibrate the air bubble detector to ensure accurate test result.
When to do
This procedure should be performed on monthly basis.
System status
Make sure that the status of the ISE module is Standby .
Precautions

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.

How to do
1 Select Utility-Maintenance-Maintenance- ISE Maintenance.

2 Choose Air Bubble Detector Calibration.

3 Select Start.

When the calibration is complete, the calibration results are displayed

on the screen.
4 Select Done.

5 To view the detailed results, select Air Bubble Detector Calibration

Result. The detailed results are displayed in the data list.

6 Select Scheduled Maintenance-Monthly.

7 Mark the Select checkbox in the same row as Air Bubble Detector
Calibration.

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 16 Maintenance
8 Select OK to refresh the current date as the performance date.

9 Select Log, and then record comments and other important

information for the procedure.

10 Select OK to save your input information.

16.7.8 Clean the Dust Screen of the External Vacuum Pump

Dust may accumulate on the dust screens when the vacuum pump is
used for a long time, influencing the ventilation and heat elimination
effects. It is necessary to clean the dust screen monthly.
1 Remove the front dust screen of the external vacuum pump.

 Push the dust screen upward gently along the groove and make
its lower end leave the groove.

 Pull the dust screen out of the groove.

2 Replace it with a clean one.

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16 Maintenance
 Insert the upper end of the dust screen into the groove and push it
upward.

 Press the dust screen and make it contact tightly with the groove.
 Push it downward gently and make the lower end inserted into the
groove as well.

3 Wash the removed dust screen with water and dry it.

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 16 Maintenance

16.8 Three-Month Maintenance

16.8.1 Clean DI Water Tank
Stains will remain in the deionized water tank when it is used for a long
time and may influence the cleaning effects of the system.
Purpose
To clean the deionized water tank to ensure good cleaning performance
of the system.
When to do
You are recommended to perform this procedure every 3 months.
Materials required
Water container
System status
Make sure that the system status is Standby.
How to do
1 Select Utility-Maintenance-Maintenance- Biochemistry
Maintenance.

2 Choose Clean Filter/Water Tank, and then select Continue.

3 Open the front door of the analyzer. You will see the deionized water
tank as shown in the figure below.
Figure 16.7 Deionized water tank

DI water tank

4 Remove the quick connector from the outlet of the water tank, and
then pull the water tank outwards for a little to expose its opening.

5 Put a water container below the outlet of the DI water tank; insert
another normally open quick connector into the outlet to drain water
into the water container. When the DI water tank is emptied, proceed
to the next step. Or you may close the outlet with a solid plug, take

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out the water tank completely, and then empty it by inclining it.
Choose this method if there is little water inside the DI water tank.

6 Remove the tubes from the tank inlet, disconnect the liquid level
floater signal cable from the right panel of the water tank, take out the
water tank completely, and then remove the liquid level floater.
Perform this step according to the figure below.
Figure 16.8 Remove deionized water tank

Floater signal cable

Outlet connector.
Press to drain water

7 Clean the water tank repeatedly with deionized water.

8 Insert the floater into the connector on rear panel of the water tank,
connect the backflow tube to the water tank, connect the floater
signal cable and water supply tube to the water tank according to the
labels on it, and then place the water tank in the cabinet of the
analyzer.

9 Select Continue. The system automatically primes the deionized

water tubes.

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10 Take away the water container and close the front door of the
analyzer.

11 Select Scheduled Maintenance-Three-Month.

12 Mark the Select checkbox in the same row as Clean DI Water Tank.

13 Select OK to refresh the current date as the performance date.

14 Select Log, and then record comments and other important

information for the procedure.

15 Select OK to save your input information.

16 Select Utility-Commands, and then select Home to put the

instrument into the Standby status.

16.8.2 Replace Filter Core

The filter may be blocked after being used for a long time. Replace the
filter core every 3 months to ensure good filtering effects.
Purpose
To replace the filter core and ensure good filtering effects.
When to do
You are recommended to perform this procedure every 3 months.
Materials required
New filter core
System status
Make sure that the system status is Standby.
How to do
1 Select Utility-Maintenance-Maintenance- Biochemistry
Maintenance.

2 Choose Clean Filter/Water Tank, and then select Continue.

3 Remove the deionized water filter core according to the Clean Filter
Core procedure.

4 Put the new filter core in the filter and reinstall the filter.

5 Select Continue. The system starts priming the deionized water

tubes.

6 When the replacement is complete, select Done.

7 Select Scheduled Maintenance-Three-Month.

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8 Mark the Select checkbox in the same row as Replace Filter Core.

9 Select OK to refresh the current date as the performance date.

10 Select Log, and then record comments and other important

information for the procedure.

11 Select OK to save your input information.

12 Select Utility-Commands, and then select Home to put the

instrument into the Standby status.

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 16 Maintenance

16.9 Six-Month Maintenance

16.9.1 Replace Lamp
An aged lamp will has its energy decreased and influence the
measurement accuracy. Failed lamp will make measurements impossible.
To ensure the optimal performance of the system, replace the lamp
regularly. Every time after you replacing the lamp, if the light intensity is
insufficient, replace the lamp immediately. It will take about 10 minutes to
perform this procedure.
Purpose
To ensure that the lamp works normally.
When to do
You are recommended to perform this procedure every 6 months or when
you find that the lamp does not satisfy the requirements after performing
the Photometer Check.
Materials required
New lamp, Philips-head screwdriver, cotton or antistatic gloves
System status
Make sure that the system status is Standby or Failure.
Precautions

NOTE
Too hot lamp may burn you. Do not replace the lamp until it gets cool.
Do not touch the light entrance on the lamp housing or the lens in front of the lamp.
In case the light entrance is dirty, use cotton swabs moistened with absolute ethanol
to clean it.

CAUTION
Please use consumables recommended by our company. Use of other consumables
may degrade the system performance.

How to do
1 Select Utility-Maintenance-Maintenance- Biochemistry
Maintenance.

2 Choose Replace Lamp. The maintenance guide window pops up.

Select Continue.

3 Make sure that the lamp has cooled down for 5 minutes, and then
select Continue.

4 Remove the cover plate of the lamp.

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16 Maintenance
5 Wear a pair of cotton or antistatic gloves, loosen the nuts on the cable
terminals, and then remove the O-ring connectors from the terminals.

6 Loosen the retaining screw on the left side of the lamp.

7 Remove the lamp from the lamp housing.

CAUTION
Do not hold the lamp by its bulb to prevent contamination and damage.
8 Install the retaining screw, O-ring connectors, cable terminal nuts and
lamp cover plate in the reversed order.

9 Select Continue.

10 When the lamp is incubated, select Done.

Perform the Photometer Check procedure to ensure the system power

is normal. For more information, refer to 16.6.5 Photometer Check
(page 16-33).
11 Select Scheduled Maintenance-Six-Month.

12 Mark the Select checkbox in the same row as Replace Lamp.

13 Select OK to refresh the current date as the performance date.

14 Select Log, and then record comments and other important

information for the procedure.

15 Select OK to save your input information.

16.9.2 Replace Water Inlet Filter

When the water inlet filter is used for a long period, it may be blocked,
influencing the filtering effects. Replace the water inlet filter every 6
months.
Purpose
To replace the water inlet filter to ensure the good filtering effects.

When to do
You are recommended to perform this procedure every 6 months.
Materials required
New water inlet filter
System status
Make sure that the system is powered off, or the system status is
Incubation or Standby.

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 16 Maintenance
How to do
1 Check that the system is powered off, or the system status is
Incubation or Standby.

2 Turn off the power switch of the water unit or other water supply
equipment.

3 Prepare a new water inlet filter with connectors on its two ends.

4 Turn on the ball valve on the water supply module to release the
remaining pressure. When the pressure gauge indicates 0, turn off the
ball value.

5 Press the tubing release button to remove the tubing from two ends
of the old filter assembly.

6 Wash the tubing and insert them into the new filter. Make sure that
the filter is installed in the same direction as the water flow.

7 Power on the water supply module, turn on the ball valve on it and
wait for 5 minutes. When you see the water supply module is
supplying water continuously which signifies the normal working of
the module, turn off its ball valve. Ensure that the pressure gauge on
the water supply module is about 0.25MPa.

8 Select Utility-Maintenance-Maintenance, and then select Scheduled

Maintenance-Six-Month.

9 Mark the Select checkbox in the same row as Replace Water Inlet
Filter.

10 Select OK to refresh the current date as the performance date.

11 Select Log, and then record comments and other important

information for the procedure.

12 Select OK to save your input information.

16.9.3 Replace Reference Electrode(For ISE Module)

The reference electrode is a consumable and has a limited life span.
When used for a long period or after measuring a large number of
samples, it may have its performance degraded and should be replaced
immediately. It will take about 5 minutes to perform this procedure.
Purpose
To replace the reference electrode to ensure the optimal measurement

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performance.
When to do
Replace the electrodes in the following conditions:
 when 10,000 ISE tests are performed, or the instrument is used for 6
months.
 when calibration is failed or quality control is abnormal as the result
of degraded electrode performance.
Materials required
Reference electrode
System status
Make sure that the status of the ISE module is Standby or Failure.
Precautions

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles.

How to do
1 Select Utility-Maintenance-Maintenance- ISE Maintenance.

2 Choose Replace Electrode.

3 Select reference electrode, and enter the lot number and expiration
date. Select Add and then select OK.

4 Take out the insert from the reference electrode, and ensure no
crystallized salt exists in and around it. If needed, clean the electrode
with warm water. Meanwhile make sure the red ball of the reference
electrode floats on the internal fluid. Make sure the O rings of all
electrodes remain intact.

5 Select Continue.

6 Open the ISE side door and remove the cover of the shielding box.

7 Open the electrode case, take out the electrode, remove the tapes
around its inside, and then use clean tissue to wipe it.

8 Remove all electrodes from the ISE module.

9 Replace the old electrode and then press the compressor; place the
reference electrode at the bottom of the ISE module and make the
rear part of the electrode contact closely with the internal wall of the
ISE module. Loosen the compressor and ensure the electrodes are

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fixed tightly.

10 Restore other electrodes in the order of Cl, K, Na and spacer from

bottom to top.

11 Select Continue.

NOTE
The new electrode can be calibrated successfully only after certain time period
(at least 30 minutes).
12 Select Done.

13 Restore the cover of the shielding box and close the side door of the
ISE module.

14 Run ISE calibration.

15 Select Scheduled Maintenance-Other.

16 Mark the Select checkbox in the same row as Replace Reference

Electrode.

17 Select OK to refresh the current date as the performance date.

18 Select Log, and then record comments and other important

information for the procedure.

19 Select OK to save your input information.

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16.10 As-Needed/As-Required Maintenance

16.10.1 Clean Analyzer Panels
The analyzer and computer are often accessed and easily get dirty. To
keep a good operating environment and minimize the biohazards, clean
the components that are often accessed, such as analyzer panel,
carousel cover, screen, keyboard, etc.
Purpose
To clean the analyzer panels, carousel covers, screen and keyboard.
When to do
Perform this procedure when dust or other stains are found on the
components.
Materials required
Clean gauze, screen wash solution, and deionized water
System status
Make sure that the system status is not Running.
Precautions

Warning
Do not spill liquid on the analyzer. Liquid ingression may cause equipment damage.

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
Dispose of the used gauze in accordance with your local or national guidelines for
biohazard waste disposal.

How to do
1 Make sure that the system is not running tests, and then open the
protective shield.

2 Use clean gauze moistened with ethanol to clean the analyzer panels
and carousel covers.

3 Use wash solution to clean the screen and keyboard.

4 Restore the protective shield.

5 Select Scheduled Maintenance-Other.

6 Mark the Select checkbox in the same row as Clean Analyzer Panels.

7 Select OK to refresh the current date as the performance date.

8 Select Log, and then record comments and other important

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information for the procedure.

9 Select OK to save your input information.

16.10.2 Clean Sample Compartment

When samples are sprayed into the sample compartment, or dusts
accumulate inside the compartment, clean them immediately in order to
minimize the risks of cross contamination.
Purpose
To clean the sample carousel assembly to ensure clear operating
environment and eliminate the risks of cross contamination.
When to do
Perform this procedure when samples are spilled into the sample
compartment or dust is found inside of it.
Materials required
Clean gauze, deionized water, ethanol, and cotton swabs
System status
Make sure that the system status is Stopped or Standby.
Precautions

Warning
Do not spill water or ethanol into the sample compartment to prevent equipment
damage.

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
Dispose of the used gauze in accordance with your local or national guidelines for
biohazard waste disposal.

How to do
1 Make sure that the system is in Stopped or Standby status.
2 Remove the sample carousel cover and sample carousel, and then
store them properly.

3 Use clean gauze soaked with deionized water or ethanol to clean the
interior of the sample compartment. If necessary, you can use gauze
moistened with neutral wash solution.

4 Use clean gauze soaked with deionized water or ethanol to clean the
sample carousel, and then use cotton swabs dipped with ethanol to
clean the sample positions.

5 Install the sample carousel and the carousel cover.

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16 Maintenance
6 Select Scheduled Maintenance-Other.

7 Mark the Select checkbox in the same row as Clean Sample

Compartment.

8 Select OK to refresh the current date as the performance date.

9 Select Log, and then record comments and other important

information for the procedure.

10 Select OK to save your input information.

16.10.3 Clean Reagent Compartment

When reagents are sprayed into the reagent compartment, or dusts
accumulate inside the compartment, clean them immediately in order to
minimize the risks of cross contamination.
Purpose
To clean the reagent carousel assembly to ensure clear operating
environment and eliminate the risks of cross contamination.
When to do
Perform this procedure when reagents are spilled into the reagent
compartment or dust is found inside of it.
Materials required
Clean gauze, deionized water, ethanol, and cotton swabs
System status
Make sure that the system status is Stopped or Standby.

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 16 Maintenance
Precautions

Warning
Do not spill water or ethanol into the reagent compartment to prevent equipment
damage.

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
Dispose of the used gauze in accordance with your local or national guidelines for
biohazard waste disposal.

How to do
1 Make sure that the system is in Stopped or Standby status.
2 Remove the reagent carousel cover and reagent carousel, and then
store them properly.

3 Use clean gauze soaked with deionized water or ethanol to clean the
interior of the reagent compartment. If necessary, you can use gauze
moistened with neutral wash solution.

4 Use clean gauze soaked with deionized water or ethanol to clean the
reagent carousel, and then use cotton swabs dipped with ethanol to
clean the reagent positions.

5 Install the reagent carousel and the carousel cover.

6 Select Scheduled Maintenance-Other.

7 Mark the Select checkbox in the same row as Clean Reagent

Compartment.

8 Select OK to refresh the current date as the performance date.

9 Select Log, and then record comments and other important

information for the procedure.

10 Select OK to save your input information.

16.10.4 Clean Sample Probe Interior

The sample probe, once blocked, cannot aspirate or dispense sample
correctly. When you find that the sample probe is clogged and cannot
aspirate or dispense sample, or when the sample probe is detected with
abnormal liquid flow through the Check
Probes/Mixers maintenance, perform this procedure to solve the
problems.
Purpose

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16 Maintenance
To clean the interior of the sample probe and avoid clogging.
When to do
Perform this procedure when you find that the sample probe is clogged
and cannot aspirate or dispense sample, or when the sample probe is
detected with abnormal liquid flow through the Check Probes/Mixers
maintenance.
Materials required
Unclogging device, small slot-head screwdriver, small Philips-head
screwdriver, beaker, deionized water, and thread syringe
System status
Make sure that the system status is Standby or Failure.
Precautions

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.

How to do
1 Recall the maintenance logs and check if the sample probe has been
removed and reinstalled for 3 times. If it has, prepare a new washer
and moisten it with deionized water. Store the washer properly to
avoid being lost.

2 Switch off the analyzing unit power.

3 Grab the lower parts of the arm cover and pull them slightly from the
opposite directions; remove the cover from the arm base.

4 Press the circuit board with one hand and unplug the tube connector
with the other hand, and then use a small slot-head screwdriver to
loosen the earthing wire on the sample probe.

5 Use a small screwdriver to remove the retaining screw from the

sample probe and take out the spring.

6 While holding the connector on the sample probe with one hand,
unscrew the tube connector counterclockwise with the other hand
until the tube connector is disconnected. Remove the tube from the
sample probe.

Exercise caution to prevent the washer from dropping out. If the

washer drops out, store it in a clear place for later installation. To
replace the washer, take it out from the tube connector.

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 16 Maintenance
7 Remove the sample probe. See the figure below.
Figure 16.9 Remove sample probe

Liquid level
detection board
connector

Retaining
Earthing wire screw and
spring

Keep the
washer
steady Washer

8 Connect the unclogging device to the sample probe, fill the syringe
with deionized water and then connect it to the unclogging device.
Put the sample probe inside the beaker while keeping the probe tip
not contacting the beaker. Push the syringe to rinse the interior of the
sample probe. Repeat this step for 10 times.

If the syringe plunger leaks and the sample probe cannot be

unclogged due to serious blockage, replace the sample probe.
9 When continuous water flow comes out of the sample probe in the
same direction with the probe, it indicates the cleaning procedure is
finished successfully. Remove the unclogging device.

10 Insert the sample probe downwards into the hole on the probe arm
while aligning the screw hole on the probe plate to the rod inside the
arm.

11 To replace the washer, remove the old one from the tube connector
and install the new one. Connect the tube connector to the sample

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probe and then tighten it.

12 Fix the earthing wire of the sample probe to the earthing terminal
inside the arm; connect the probe connector to the liquid level
detection board.

13 Sleeve the spring on the rod and tighten the retaining screw. Pay
attention to the spring direction and make the thread opening face
downwards.

14 Pinch the sample probe by the part near the probe arm. Push the
sample probe upwards and then release it to check if the spring
works well.

 If it does, proceed to the next step.

 If not, check if the spring is clamped or fixed too tightly.
15 Switch on the analyzing unit power, and then check if the No.D2 LED
indicator on the circuit board inside the probe arm is lit.

 If it is, the liquid level detection system is normal.

 If not, contact our customer service department or your local
distributor.
16 Install the probe arm cover properly until you hear a click.

17 Pinch the sample probe by the part near the probe arm. Push the
sample probe upwards and then release it to check if the spring
works well.

 If it does, proceed to the next step.

 It not, it indicates that the arm cover is not installed correctly.
Reinstall the arm cover and check the spring until it can move
freely.
18 Execute the Home maintenance command. Check if the water flow
coming out of the sample probe is continuous and in the same
direction as the probe. If it is not, perform the Check Probes/Mixers
procedure to troubleshoot the problems.

19 Select Utility-Maintenance-Maintenance, and then select Scheduled

Maintenance-Other.

20 Mark the Select checkbox to the right of Clean Sample Probe

Interior.

21 Select OK to refresh the current date as the performance date.

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 16 Maintenance
22 Select Log, and then record comments and other important
information for the procedure.

23 Select OK to save your input information.

24 Select Utility-Commands, and then select Home to put the

instrument into the Standby status.

16.10.5 Clean Reagent Probe Interior

The reagent probe, once blocked, cannot aspirate or dispense reagent
correctly. It is necessary to clean the reagent probe interior at times.
Purpose
To clean the interior of the reagent probe and avoid clogging.
When to do
Perform this procedure when you find that a reagent probe is clogged and
cannot aspirate or dispense sample, or when a reagent probe is detected
with abnormal liquid flow through the Check Probes/Mixers maintenance.
Materials required
Unclogging device, small slot-head screwdriver, small Philips-head
screwdriver, beaker, deionized water, and thread syringe
System status
Make sure that the system status is Standby or Failure.
Precautions

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.

How to do
1 Recall the maintenance logs and check if the reagent probe has been
removed and reinstalled for 3 times. If it has, prepare a new washer
and moisten it with deionized water. Store the washer properly to
avoid being lost.

2 Switch off the analyzing unit power.

3 Clean the reagent probe by referring to step 3 to 18 in 16.10.4 Clean

Sample Probe Interior.

4 Select Utility-Maintenance-Maintenance, and then select Scheduled

Maintenance-Other.

5 Mark the Select checkbox to the right of Clean Reagent Probe

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16 Maintenance
Interior.

6 Select OK to refresh the current date as the performance date.

7 Select Log, and then record comments and other important

information for the procedure.

8 Select OK to save your input information.

9 Select Utility-Commands, and then select Home to put the

instrument into the Standby status.

16.10.6 Replace Sample Probe

Replace the sample probe when it is damaged and cannot be repaired, or
blocked seriously, or bent.
Purpose
To replace the sample probe.
When to do
Perform this procedure when the sample probe is damaged and cannot
be repaired due to the following causes, such as serious blockage, or
bending.
Materials required
Small slot-head screwdriver, small Philips-head screwdriver, and new
sample probe
System status
Make sure that the system status is Standby or Failure.

Precautions

Warning
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise
caution when working around the probes.

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.

How to do
1 Prepare the new sample probe. Recall the maintenance logs and
check if the sample probe has been removed and reinstalled for 3
times. If it has, prepare a new washer and moisten it with deionized
water. Store the washer properly to avoid being lost.

2 Switch off the analyzing unit power.

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 16 Maintenance
3 Grab the lower parts of the arm cover and pull them slightly from the
opposite directions; remove the cover from the arm base.

4 Press the circuit board with one hand and unplug the tube connector
with the other hand, and then use a small slot-head screwdriver to
loosen the earthing wire on the sample probe.

5 Use a small screwdriver to remove the retaining screw from the

sample probe and take out the spring.

6 While holding the connector on the sample probe with one hand,
unscrew the tube connector counterclockwise with the other hand
until the tube connector is disconnected. Remove the tube from the
sample probe.

Exercise caution to prevent the washer from dropping out. If the

washer drops out, store it in a clear place for later installation. To
replace the washer, take it out from the tube connector.
7 Remove the sample probe. See the figure below.
Figure 16.10 Remove sample probe

Liquid level
detection board
connector

Retaining
Earthing wire screw and
spring

Keep the
washer
steady Washer

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16 Maintenance
8 Insert the sample probe downwards into the hole on the probe arm
while aligning the screw hole on the probe plate to the rod inside the
arm.

9 To replace the washer, remove the old one from the tube connector
and install the new one. Connect the tube connector to the sample
probe and then tighten it.

10 Fix the earthing wire of the sample probe to the earthing terminal
inside the arm; connect the probe connector to the liquid level
detection board.

11 Sleeve the spring on the rod and tighten the retaining screw. Pay
attention to the spring direction and make the thread opening face
downwards.

12 Pinch the sample probe by the part near the probe arm. Push the
sample probe upwards and then release it to check if the spring
works well.

 If it does, proceed to the next step.

 If not, check if the spring is clamped or fixed too tightly.
13 Switch on the analyzing unit power, and then check if the No.D2 LED
indicator on the circuit board inside the probe arm is lit.

 If it is, the liquid level detection system is normal.

 If not, contact our customer service department or your local
distributor.
14 Install the probe arm cover properly until you hear a click.

15 Execute the Home maintenance command. Check if the water flow

coming out of the sample probe is continuous and in the same
direction as the probe. If it is not, perform the Check Probes/Mixers
procedure to troubleshoot the problems.

16 Select Utility-Maintenance-Maintenance, and then select Scheduled

Maintenance-Other.

17 Mark the Select checkbox in the same row as Replace Sample Probe.

18 Select OK to refresh the current date as the performance date.

19 Select Log, and then record comments and other important

information for the procedure.

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 16 Maintenance
20 Select OK to save your input information.

21 Select Utility-Commands, and then select Home to put the

instrument into the Standby status.

16.10.7 Replace Reagent Probe

Replace the reagent probe when they are damaged and cannot be
repaired, or blocked seriously, or bent.
Purpose
To replace the reagent probe.
Materials required
Small slot-head screwdriver, small Philips-head screwdriver, and new
reagent probe

System status
Make sure that the system status is Standby or Failure.
Precautions

Warning
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise
caution when working around the probes.

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.

How to do
1 Prepare the new reagent probe. Recall the maintenance logs and
check if the reagent probe has been removed and reinstalled for 3
times. If it has, prepare a new washer and moisten it with deionized
water. Store the washer properly to avoid being lost.

2 Switch off the analyzing unit power.

3 Replace the reagent probe by referring to step 3 to 15 in 16.10.6

Replace Sample Probe (page 16-62).

4 Select Utility-Maintenance-Maintenance, and then select Scheduled

Maintenance-Other.

5 Mark the Select checkbox to the right of Replace Reagent Probe.

6 Select OK to refresh the current date as the performance date.

7 Select Log, and then record comments and other important

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16 Maintenance
information for the procedure.

8 Select OK to save your input information.

9 Select Utility-Commands, and then select Home to put the

instrument into the Standby status.

16.10.8 Replace Sample Mixer

Replace the sample mixer when they are bent or damaged and cannot be
repaired.
Purpose
Replace the sample mixer.
When to do
Perform this procedure when the sample mixer are damaged and cannot
be repaired.
Materials required
Ethanol, clean gauze, new sample mixer
System status
Make sure that the system status is Standby or Failure.
Precautions

Warning
The mixer tips are sharp and may cause puncture wounds. To prevent injury, exercise
caution when working around the mixers.

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.

How to do
1 Switch off the analyzing unit power.

2 Gently pull the mixer to its highest point and rotate it to a position
convenient to operate.

3 Pinch the mixer by the knurled part with one hand and unscrew
(counter-clockwise) the retaining nut with the other hand until the
mixer gets loose. Pull the mixer downward to remove it and remove
the nut.

CAUTION

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 16 Maintenance
When trying to pull out the mixer, concentrate your force in the direction of the
axis on the mixer arm. Biased force may damage the mixer and/or the axis.
4 Align the new mixer to the bigger hole of the retaining nut and gently
screw it into the nut until the end of the mixer is in line with the
smaller hole of the nut.

5 Pinch the mixer by the knurled part and align the hole of the nut to the
axis on the mixer and push the nut onto the mixer until it reaches the
end of the mixer. Tighten the nut by screwing clockwise with the other
hand.

CAUTION
When trying to push the mixer into the arm, concentrate your force in the
direction of the axis on the mixer arm. Biased force may damage the mixer
and/or the axis.
Ensure the mixer is all the way pushed to the end.
6 After replacing the bar, visually check whether the mixer is vertical to
the bar arm.

 If not, remove the mixer and reinstall it.

 If so, proceed to the next step.
7 Pull the mixer arm to its highest point and rotate it back to a position
above its wash well.

8 Turn on the analyzing unit power switch.

9 Select Utility- Command; Perform the Home maintenance procedure.

10 Select Utility-Maintenance-Maintenance, and then select Scheduled

Maintenance-Other.

11 Mark the Select checkbox in the same row as Replace Sample mixer.

12 Select OK to refresh the current date as the performance date.

13 Select Log, and then record comments and other important

information for the procedure.

14 Select OK to save your input information.

16.10.9 Replace Reagent Mixer

Replace the reagent mixer when they are bent or damaged and cannot be
repaired.
Purpose

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16 Maintenance
Replace the reagent mixer.
When to do
Perform this procedure when the reagent mixer are damaged and cannot
be repaired.
Materials required
Ethanol, clean gauze, new reagent mixer
System status
Make sure that the system status is Standby or Failure.
Precautions

Warning
The mixer tips are sharp and may cause puncture wounds. To prevent injury, exercise
caution when working around the mixers.

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.

How to do
1 Switch off the analyzing unit power.

2 Replace the reagent mixer by referring to step 2 to 9 in 16.10.9

Replace Reagent Mixer (page 16-67).

3 Select Utility-Command-Home.

4 Select Utility-Maintenance-Maintenance, and then select Scheduled

Maintenance-Other.

5 Mark the Select checkbox in the same row as Replace Reagent

mixer.

6 Select OK to refresh the current date as the performance date.

7 Select Log, and then record comments and other important

information for the procedure.

8 Select OK to save your input information.

16.10.10 Remove Air Bubbles in Sample Syringe

Purpose
To remove the air bubbles possibly existing inside the tubes and
clean/prime the probes, mixers and wash wells. It will take about 20
seconds to perform this procedure.
When to do

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 16 Maintenance
Perform this procedure when you find air bubbles inside the sample
syringe.
Materials required
Concentrated wash solution
System status
Make sure that the system status is Standby.
Precautions

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.

How to do
1 Switch off the analyzing unit power, and open the front door of the
analyzer.

2 Loosen counterclockwise the four retaining screws on top of the

syringe, and then remove the screws and the fixing blocks.

3 Loosen counterclockwise the retaining screw at the bottom of the

syringe and then remove it.

4 Hold the T piece with one hand and the syringe connector with the
other hand. Loosen the syringe counterclockwise and then remove
the washer.

5 Soak the syringe connector in the deionized water beaker, pull the
plunger head to aspirate half syringe of deionized water, and then
push the plunger head to remove the air. Repeat this pull-push
operation until the air bubbles are removed from the syringe. Fill the
syringe with half cylinder of deionized water to prevent new bubbles.

6 Put the washer in the T piece. Hold the T piece with one hand and the
syringe connector with the other hand, and then screw the T piece
clockwise.

7 Install the syringe on the bracket.

8 Install the fixing blocks and 4 retaining screws while having the
retaining screws not tightened.

9 Align the plunger head to the retaining screw at the bottom of the
syringe, and then tighten clockwise the retaining screw.

10 Pinch the plunger guide cap to adjust the syringe height. For the

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sample syringe, make the syringe head over the upper fixing block for
7.5 scales; for the reagent syringes, make the syringe head over the
upper fixing block for 15 scales.

11 Tighten the four retaining screws on the fixing blocks.

12 Turn on the analyzing unit power switch.

13 Perform the Home maintenance procedure. Check the new syringe for
leak and bubbles, and if there is, perform the Check Sample/Reagent
Syringes procedure.

14 Close the front door of the analyzer.

15 Select Utility-Maintenance-Maintenance, and then select Scheduled

Maintenance-Other.

16 Mark the Select checkbox in the same row as Remove Air Bubbles in
Sample Syringe.

17 Select OK to refresh the current date as the performance date.

18 Select Log, and then record comments and other important

information for the procedure.

19 Select OK to save your input information.

16.10.11 Remove Air Bubbles in Reagent Syringe

Purpose
To remove the air bubbles possibly existing inside the tubes and
clean/prime the probes, mixers and wash wells. It will take about 20
seconds to perform this procedure.
When to do
Perform this procedure when you find air bubbles inside the reagent
syringe.
Materials required
Concentrated wash solution
System status
Make sure that the system status is Standby.
Precautions

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.

How to do

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 16 Maintenance
1 Switch off the analyzing unit power, and open the front door of the
analyzer.

2 Remove the air bubbles in reagent syringe by referring to step 2 to 14

in 16.10.10 Remove Air Bubbles in Sample Syringe (page 16-68).

3 Select Utility-Maintenance-Maintenance, and then select Scheduled

Maintenance-Other.

4 Mark the Select checkbox in the same row as Remove Air Bubbles in
Reagent Syringe.

5 Select OK to refresh the current date as the performance date.

6 Select Log, and then record comments and other important

information for the procedure.

7 Select OK to save your input information.

16.10.12 Replace Cuvette

The reaction cuvettes, if contaminated by serum or other stains, or
scratched or damaged, will result in inaccurate photometric
measurement. Check the reaction cuvettes regularly, and if necessary,
replace them immediately. It will take about half a minute to replace a
cuvette.
Purpose
To ensure that the cuvettes are normal and not contaminated, scratched
or damaged.
When to do
Replacing cuvettes is performed as needed or as required. Replace a
cuvette if,
 it is detected abnormal through the Cuvette Check procedure; or
 scratches or cracks are found on the optical surface of the cuvette.
Materials required
Fiber-free gloves, dry cloth or gauze, reaction cuvettes, and concentrated
wash solution manufactured by our company
System status
Make sure that the system status is Standby.
Precautions

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16 Maintenance

Warning
While installing the reaction cuvettes, exercise caution to avoid scratching them. Do
not touch the optical surface of the reaction cuvettes. If the optical surface is
polluted, the obtained absorbance may be inaccurate.
While installing the reaction cuvettes, make sure that the optical surface is
confronted with the outside of the reaction carousel.
Wear gloves free of fibre and powder to avoid polluting the optical surface of the
reaction cuvettes.

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.

CAUTION
Please use consumables recommended by our company. Use of other consumables
may degrade the system performance.

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 16 Maintenance

NOTE
If a cuvette cannot be removed from the reaction carousel, remove 1 or 2 cuvettes
to the right of the cuvette, use a knife to remove the metal plate next to it, and then
use your hands or tweezers to take out the cuvette.
When serious problems occur such as overflow and require the reaction cuvettes to
be maintained, contact our customer service department or your local distributor.

How to do
1 Select Utility-Maintenance-Maintenance- Biochemistry
Maintenance.

2 Choose Replace Cuvette.

3 Select Continue.

4 Remove the reaction carousel cover.

5 Type in the position number of the cuvette you want to replace.

The input range is 1-90. Only one position number can be entered
each time.
6 Select Replace.

7 Wear a pair of gloves and remove the specified cuvette by pulling it

outwards.

8 Install the provided or cleaned cuvette to the reaction carousel and

make sure that the cuvette bottom can no longer proceed.

9 Restore the reaction carousel cover.

10 Select Done. The system resets mechanically.

11 Perform the Cuvette Check procedure to check if the new cuvettes

meet the requirements.

For more information, refer to 16.6.4 Cuvette Check (page 16-31).

12 Select Utility-Maintenance-Maintenance, and then select Scheduled
Maintenance-Other.

13 Mark the Select checkbox in the same row as Replace Cuvette.

14 Select OK to refresh the current date as the performance date.

15 Select Log, and then record comments and other important

information for the procedure.

16 Select OK to save your input information.

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16.10.13 Special Wash Probes
Purpose
To eliminate cross contamination among the sample probe and reagent
probe, and prevent waste from leaving in the waste tubes.
When to do
Perform this procedure when the probes are clogged or the carryover
result exceeds the limit.
Materials required
Concentrated wash solution
System status
Make sure that the system status is Standby.
How to do
1 Open the upper protective shield of the analyzer.

2 Place more than 20ml concentrated wash solution in position D of the

reagent carousel, and place more than 3ml concentrated wash
solution in position D2 on the sample carousel.

3 Select Utility-Maintenance-Maintenance- Biochemistry

Maintenance.

4 Choose Special Wash Probes.

5 Select Special Wash Reagent Probe and Special Wash Sample Probe,
and then select Continue.

The system resets and then clean the two probes.

6 When the cleaning is finished, select Done.

7 Restore the upper protective shield of the analyzer.

8 Select Scheduled Maintenance-Other.

9 Mark the Select checkbox in the same row as Special Wash Probes.

10 Select OK to refresh the current date as the performance date.

11 Select Log, and then record comments and other important

information for the procedure.

12 Select OK to save your input information.

16.10.14 Bar Code Maintenance

This maintenance procedure is used to clean the sample and reagent bar
code scanning windows in order to avoid influencing bar code scanning.

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 16 Maintenance
Purpose
To clean the glass of the sample and reagent bar code scanning windows
in order to avoid influencing bar code scanning.
When to do
This maintenance should be performed if the glass of the sample or
reagent bar code scanning window is contaminated and causes bar code
scanning failure.
Materials required
Clean gauze, deionized water, ethanol, and cotton swabs
System status
Make sure that the system is not running any tests.
Precautions

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.

CAUTION
Exercise caution not to spray water or ethanol or other liquids on the glass of the bar
code scanning window.

How to do
1 Remove the sample/reagent carousel covers and the carousels.

2 Use clean gauze to clean the bar code reader window inside the
sample compartment and reagent compartment. If necessary, you
can use gauze soaked with ethanol or deionized water. Make sure
that there is no trace or dust left on the glass.

3 Install the carousels and carousel covers.

4 Select Utility-Maintenance-Maintenance, and then select Scheduled

Maintenance-Other.

5 Mark the Select checkbox in the same row as Bar Code Maint.

6 Select OK to refresh the current date as the performance date.

7 Select Log, and then record comments and other important

information for the procedure.

8 Select OK to save your input information.

16.10.15 Clean Probes/Mixers Exterior

It is necessary to clean the probes and mixers exterior after maintaining

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16 Maintenance
them as well as the wash wells, to remove air bubbles from the tubes.
Purpose
To clean the exterior of the probes and mixers to remove air bubbles.
When to do
This procedure should be performed after maintenance of probes, mixers
and wash wells.
System status
Make sure that the system status is not Running.
Precautions

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.

How to do
1 Select Utility-Maintenance-Maintenance- Biochemistry
Maintenance.

2 Choose Clean Probes/Mixers Exterior.

3 Input the wash cycle (1~100).

4 Select Continue.

5 Select Done.

16.10.16 Replace ISE Electrode

ISE electrodes are consumables and have a limited life span. When used
for a long period or after measuring a large number of samples, the ISE
electrodes may have their performance degraded and should be replaced
immediately. It will take about 10 minutes to perform this procedure.
Purpose
To replace the ISE electrodes to ensure the optimal measurement
performance.
When to do
Replace the electrodes in the following conditions:
 when 10,000 ISE tests are performed, or the instrument is used for 6
months.
 when calibration is failed or quality control is abnormal as the result
of degraded electrode performance.
Materials required
ISE electrode
System status

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 16 Maintenance
Make sure that the status of the ISE module is Standby or Failure.
Precautions

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles.

NOTE
After performing this procedure, recalibrate the ISE electrodes prior to starting
analysis.

How to do
1 Select Utility-Maintenance-Maintenance- ISE Maintenance.

2 Choose Replace Electrode.

3 Select desired electrodes, and enter the lot number and expiration
date. Select Add and then select OK.

4 Select Continue.

5 Open the ISE side door and remove the cover of the shielding box.

6 Open the electrode case, take out the electrode, remove the tapes
around its inside, and then use clean tissue to wipe it.

NOTE
Take out the insert from the reference electrode, and ensure no crystallized salt
exists in and around it. If needed, clean the electrode with warm water.
Meanwhile make sure the red ball of the reference electrode floats on the
internal fluid. Make sure the O rings of all electrodes remain intact.
7 Remove all electrodes from the ISE module.

8 Replace the old electrode and then press the compressor; place the
reference electrode at the bottom of the ISE module and make the
rear part of the electrode contact closely with the internal wall of the
ISE module. Loosen the compressor and ensure the electrodes are
fixed tightly.

9 Restore other electrodes in the order of Cl, K, Na and spacer from

bottom to top.

10 Select Continue.

NOTE

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16 Maintenance
The new electrode can be calibrated successfully only after certain time period
(at least 30 minutes). Some electrodes need to be activated by serum before
calibration.
11 Select Done.

NOTE
The Na, K and Cl electrodes are of the same size and shape. Ensure that the
electrodes are inserted in the correct order. If one of the electrodes cannot be
easily pushed into the housing, check the electrode first and then repeat the
installation process.
12 Restore the cover of the shielding box and close the side door of the
ISE module.

13 Run ISE calibration.

14 Select Scheduled Maintenance-Other.

15 Mark the Select checkbox in the same row as Replace ISE Electrode.

16 Select OK to refresh the current date as the performance date.

17 Select Log, and then record comments and other important

information for the procedure.

18 Select OK to save your input information.

16.10.17 Remove Reagent Pack (For ISE Module)

When powering off the analyzer for a long time, or storing the electrodes,
or replacing the electrode tubes, remove the reagent pack first.
When to do
Perform this maintenance procedure when powering off the analyzer for a
long time, or storing the electrodes, or replacing the electrode tubes.
System status
Make sure that the status of the ISE module is Standby or Failure.
How to do
1 Select Utility-Maintenance-Maintenance- ISE Maintenance.

2 Choose Remove Reagent Pack.

3 Remove the tube of pump A and then reinstall the tube by switching
the connectors of the tube. Handle pump B in the same way.

4 Select Continue.

5 Install the tubes of pump A and B in the reverse direction and then
select Continue.

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 16 Maintenance
The system executes purge A and B each for 30 times.
6 Select Continue.

7 Select Done.

8 Select Scheduled Maintenance-Other.

9 Mark the Select checkbox in the same row as Remove Reagent Pack.

10 Select OK to refresh the current date as the performance date.

11 Select Log, and then record comments and other important

information for the procedure.

12 Select OK to save your input information.

16.10.18 Store Electrodes (For ISE Module)

While the analyzer is powered off for a long time, the ISE electrodes
cannot be moistened by regular prime, and may be damaged due to lack
of water. It is necessary to store the electrodes properly before powering
off the analyzer for a long period.
Purpose
To store the electrodes separately to prevent them from being damaged
due to lack of water while the analyzer is powered off.
Materials required
Electrode cases and tapes
When to do
Perform this procedure when the analyzer is going to be powered off for
over 3 days. If it will be powered off for no more than 3 days, prime the ISE
electrodes to protect them from being damaged.
System status
Make sure that the status of the ISE module is Standby or Failure.
Precautions

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.

How to do
1 Remove the reagent pack according to 16.10.17 Remove Reagent
Pack (Page 16-78).

2 Select Utility-Maintenance-Maintenance- ISE Maintenance.

3 Choose Store Electrodes.

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16 Maintenance
4 Select Continue.

5 Open the ISE side door and remove the cover of the shielding box.

6 Remove all electrodes from the ISE module.

NOTE
Reference electrode: Put back the insert to the cell of the reference electrode
and prevent the crystallized salt from clogging the cell. And then store the
electrode in an electrode case at the room temperature in a sun-shielding
place.
Na, K, Cl electrode: Take out a little calibrator A from the reagent pack, inject
it into the cell of the electrode and seal it with tape. Make sure proper amount
of calibrator is injected into the cell of the electrode. Store the capped
electrodes in an electrode case at the room temperature in a sun-shielding
place.
Note the storage temperature should be below 40℃.
7 Select Continue.

8 Restore the cover of the shielding box and close the side door of the
ISE module.

9 Select Done.

10 Select Scheduled Maintenance-Other.

11 Mark the Select checkbox in the same row as Store Electrodes.

12 Select OK to refresh the current date as the performance date.

13 Select Log, and then record comments and other important

information for the procedure.

14 Select OK to save your input information.

16.10.19 Two-Point Calibration (For ISE Module)

The Two-point Calibration option is used to calibrate the ISE module with
calibrator A and B.
1 Select Utility-Maintenance-Maintenance- ISE Maintenance.

2 Choose Two-point Calibration.

When the calibration is finished, the progress box is closed

automatically, and the calibration results are displayed in the data list.

16.10.20 Maintenance (For ISE Module)

The Maintenance option is used during electrode replacement to

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 16 Maintenance
discharge the calibrator from the inside of the electrodes. The auto prime
for every 30 minutes will stop.
1 Select Utility-Maintenance-Maintenance- ISE Maintenance.

2 Choose Maintenance.

The maintenance results are displayed in the data list.

16.10.21 Purge A (For ISE Module)

The Purge A option makes the peristaltic pump dispense 100μl calibrator
A to the sample injection port and then to the inside of the electrodes.
1 Select Utility-Maintenance-Maintenance- ISE Maintenance.

2 Choose Purge A.

The purge results are displayed in the data list.

16.10.22 Purge B (For ISE Module)

The Purge B option makes the peristaltic pump dispense 100μl calibrator
B to the sample injection port and then to the inside of the electrodes.
1 Select Utility-Maintenance-Maintenance- ISE Maintenance.

2 Choose Purge B.

The purge results are displayed in the data list.

16.10.23 Program Check Instruction (For ISE Module)

The Program Check Instruction option is used to query the software
version of the ISE module.
1 Select Utility-Maintenance-Maintenance- ISE Maintenance.

2 Choose Program Check Instruction.

The query results are displayed in the data list.

16.10.24 Read Dallas Chip (For ISE Module)

The Read Dallas Chip option is used to read information from the reagent
pack chip.
1 Select Utility-Maintenance-Maintenance- ISE Maintenance.

2 Choose Read Dallas Chip.

The read information is displayed in the data list.

16.10.25 Write Dallas Chip (For ISE Module)

The Read Dallas Chip option is used to write information to the reagent
pack chip.

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16 Maintenance
1 Select Utility-Maintenance-Maintenance- ISE Maintenance.

2 Choose Write Dallas Chip.

The written information is displayed in the data list.

16.10.26 Replace Sample Syringe

The sample syringe has a limited life span, and when due, may have leak
or other phenomena causing inaccurate aspirating/dispensing and
resulting in unreliable results.
Purpose
To replace the syringe plunger assembly to ensure optimal measuring
performance.
When to do
Perform this procedure when the syringe is used for 100,000 times.
Materials required
Deionized water, beaker, and syringe plunger assembly
System status
Make sure that the system status is Standby.
Precautions

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.

How to do
1 Prepare a new syringe plunger assembly and washer, put the plunger
head in the deionized water beaker to remove air from the syringe,
and then moisten the washer in the deionized water.

2 Switch off the analyzing unit power.

3 Open the front door of the analyzer. You will see two syringes, reagent
syringe to the left of the water tank and sample syringe to the right.

4 Loosen counterclockwise the four retaining screws on top of the

syringe, and then remove the screws and the fixing blocks.

5 Loosen counterclockwise the retaining screw at the bottom of the

syringe and then remove it.

6 Hold the T piece with one hand and the syringe connector with the
other hand. Loosen the syringe counterclockwise and then remove
the washer.

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 16 Maintenance
7 Loosen the plunger guide cap counterclockwise, hold the plunger
head and pull it slightly to remove the plunger assembly from the
syringe.

8 Insert the plunger head of the new plunger assembly into the bottom
of the syringe, and then tighten the retaining screw to fix the plunger
head.

9 Soak the new syringe connector in the deionized water beaker, pull
the plunger head to aspirate half syringe of deionized water, and then
push the plunger head to remove the air.

10 If there is no washer inside the T piece, put the new washer in the T
piece. Hold the T piece with one hand and the syringe connector with
the other hand, and then screw the T piece clockwise.

11 Install the syringe on the bracket.

12 Install the fixing blocks and 4 retaining screws while having the
retaining screws not tightened.

13 Align the plunger head to the retaining screw at the bottom of the
syringe, and then tighten clockwise the retaining screw.

14 Pinch the plunger guide cap to adjust the syringe height. For the
sample syringe, make the syringe head over the upper fixing block for
7.5 scales; for the reagent syringes, make the syringe head over the
upper fixing block for 15 scales.

15 Tighten the four retaining screws on the fixing blocks.

16 Turn on the analyzing unit power switch.

17 Perform the Home maintenance procedure. Check if the new syringe

has leak. If it does, perform the Check Sample/Reagent Syringes
procedure to check the syringe.

18 Close the front door of the analyzer.

19 Select Utility-Maintenance-Maintenance, and then select Scheduled

Maintenance-Other.

20 Mark the Select checkbox to the right of Replace Sample Syringe.

21 Select OK to refresh the current date as the performance date.

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16 Maintenance
22 Select Log, and then record comments and other important
information for the procedure.

23 Select OK to save your input information.

16.10.27 Replace Reagent Syringe

The reagent syringe has a limited life span, and when due, may have leak
or other phenomena causing inaccurate aspirating/dispensing and
resulting in unreliable results.
Purpose
To replace the syringe plunger assembly to ensure optimal measuring
performance.
When to do
Perform this procedure when the syringe is used for 300,000 times.
Materials required
Deionized water, beaker, and syringe plunger assembly
System status
Make sure that the system status is Standby.
Precautions

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.

How to do
1 Prepare a new syringe plunger assembly and washer, put the plunger
head in the deionized water beaker to remove air from the syringe,
and then moisten the washer in the deionized water.

2 Switch off the analyzing unit power.

3 Replace the reagent syringe by referring to step 3 to 18 in 16.10.26

Replace Sample Syringe(page 16-82).

4 Select Utility-Maintenance-Maintenance, and then select Scheduled

Maintenance-Other.

5 Mark the Select checkbox to the right of Replace Reagent Syringe.

6 Select OK to refresh the current date as the performance date.

7 Select Log, and then record comments and other important

information for the procedure.

8 Select OK to save your input information.

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 16 Maintenance
16.10.28 Clean Rotors
Clean the rotors of the sample probe, reagent probe and mixers to
eliminate noise and fraying.
Purpose
Clean the rotors of the probes and mixers to minimize noise and fraying
due to movement in order to extend the service life.
When to do
This procedure should be performed when there are dirty substances or
dust on the rotors.
Materials required
Clean gauze
System status
Make sure that the system status is Standby.
Precautions

Warning
The probe and mixer tip are sharp and may cause puncture wounds. To prevent injury,
exercise caution when working around the probes and mixers.

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
Dispose of the used gauze in accordance with your local or national guidelines for
biohazard waste disposal.

How to do
1 Switch off the analyzing unit power.

2 Pull the probe/mixer arm to the highest point, and then rotate the arm
to move the probe/mixer to a position convenient to operate.

3 Wipe the rotor with clean gauze.

4 After finishing the cleaning, turn on the analyzing unit power switch.

5 Select Utility-Commands-Home to reset the probes and mixers.

6 Select Utility-Maintenance-Maintenance, and then select Scheduled

Maintenance-Other.

7 Mark the Select checkbox in the same row as Clean Rotors.

8 Select OK to refresh the current date as the performance date.

9 Select Log, and then record comments and other important

information for the procedure.

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16 Maintenance
10 Select OK to save your input information.

16.10.29 Clean ISE Waste Tube

Samples containing insoluble substance like fibrin may accumulate in the
ISE wand waste outlet after extended usage and clog the waste tube.
Purpose
Clean the waste tube of ISE module to prevent the sediment inside from
clogging the tube.
When to do
When the alarm “No fluid in tube” or “Air in calibrator A” or “Air in
calibrator B” occurs and the waste tube is clogged.
Materials required
Unclogging tool for the ISE waste tube, bleaching agent(Dilution Ratio 1:1)
or 50% sodium hypochlorite and DI water
System status
Make sure that the system is not running test.
Precautions

Warning
Do not spill liquid on the analyzer. Liquid ingression may cause equipment damage.

BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.

Note
Excessive bleach and DI water flushed into the ISE reagent pack waste bag may cause
waste bag over expansion and clog the Cal A & Cal B reagent flow.
To prevent this problem, connect to an old used-up reagent pack and follow the
procedures below.

How to do
1 Ensure the analyzer is on idle (standby) condition. Open the ISE cover
on the right side analyzer panel.

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 16 Maintenance

2 Remove the electrode housing cover. Remove the waste tube fitting
from the bottom of the right angle adaptor. Remove waste peri-pump
tube from the pump bracket. Refer to pictures below.

Right angle
Waste adaptor
Peri-pump

3 Connect the waste tube fitting to a syringe and unclogging tool with
5 mL of undiluted household bleach. Refer to pictures below.

Tube fitting form right angle adaptor

Unclogging Tool

4 Press the wand release button to remove the wand from the current in
use ISE reagent pack and keep it in a save place. Engage the wand to

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16 Maintenance
an old used-up reagent pack.

5 Inject bleach into the ISE waste tube and soak the tube for 5 minutes.
Discharge the waste into the reagent pack.

Note: When the bleach cannot be injected into the ISE pack, remove
the wand and push down to open the waste valve manually with a
sharp object, and then inject again. If bleach can go through this time,
the waste bag was clogged and cannot be used. If bleach still cannot
be injected, replacing the ISE wand is recommended.

Waste valve

6 Repeat this step with 5 mL of DI water without the 5 minutes of

soaking time.

7 Remove the wand from the old use-up pack and re-install it back to
the current in use ISE pack. Re-install the waste tube fitting back to
the ISE electrode housing right angle adaptor and waste peri-pump
tube back to the pump bracket. Re-install the housing cover.

8 Calibrate ISE pump to ensure it passes, all reagents and waste flow
are normal. Calibrate all electrodes and run QC to ensure they all pass
within their given range.

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 17 Alarms and Troubleshooting

The following pages describe how to view and edit error logs and edit
logs, and how to locate failure and determine relevant corrective actions.
Read this chapter thoroughly to achieve the best performance of the
instrument.

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17 Alarms and Troubleshooting

17.1 Classification of Logs

17.1.1 Introduction
The logs provided by the system are divided into:
 Error log
 Edit log

17.1.2 Error Logs

Error logs record all types of failures occurring on the components. The
system stores the failures that occur within the latest 180 days and
deletes those occurring beyond the latest 180 days.

Error code
Each error has a unit code used for identification and locating probable
causes and solutions. An error code consists of 6 letters and numbers,
such as “C01001”, in which “C” indicates that the error occurs on the
operation unit, “01” is the error description of instrument connection, and
“001” is the serial number of the error. Therefore, “C01001” is described
as “the first error of instrument connection on the operation unit”.

Help
Every error log is provided with online help information. Select the
icon in front of an error log. The descriptions, possible causes and
solutions of the error are displayed.

17.1.3 Edit Logs

Edit logs record all deletions and part of editing actions performed by the
user. The system stores the edit operations that are performed within the
latest 1 year, and archives those occurring beyond the latest 1 year to an
external file.
The delete logs record all deleting actions other than the error deletion.
The edit logs include editing of sample results and calibration factors.

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 17 Alarms and Troubleshooting

17.2 Viewing and Handling Logs

All event logs are stored in folders named by the date when the logs are
produced. The system automatically compresses the event logs on the
previous day and then removes the relevant folder.

17.2.1 Description of Error Log Screen

Select Alarm in the function buttons area of the main screen. The Error
Log screen is displayed by default and shows all errors occurring on the
current day. On the Error Log screen you are allowed to view and handle
all errors that occur within the latest 6 months.
Figure 17.1 Error Log screen

Every error log contains the event ID, date/time, error description (by
processing method), event class (by subsystem) and symptom.
Choose the following buttons as needed:
 Search F1: to search for error logs by date, event ID, symptom, or
event class.
 Refresh F2: to refresh the error logs based on the current search
conditions.
 Delete F3: to remove specified error logs on the screen.
 Print F7: to print all error logs currently displayed on the screen.

17.2.2 Description of Edit Log Screen

Select Alarm-Edit Log. The Edit Log screen is displayed and shows all
editing actions occurring on the current day. On the Edit Log screen you
are allowed to view and handle all deleting/editing actions that occur

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17 Alarms and Troubleshooting

within the latest 1 year.

Figure 17.2 Edit Log screen

Every edit log contains the serial number, date/time, operator, event type
and description.
Choose the following buttons as needed:
 Search F1: to search for edit logs based on the occurring date.
 Refresh F2: to refresh the edit logs based on the current search
conditions.
 Delete F3: to remove specified edit logs on the screen.
 Print F7: to print all edit logs currently displayed on the screen.

17.2.3 Recalling Logs

Error logs and edit logs can be recalled by all users in any system status.
Error logs can be recalled by date, event ID, symptom and event class,
while edit logs can only be recalled by occurring date.
Perform the following steps to recall desired event logs:
1 Select Alarm-Error Log or Edit Log.

2 Select Search F1.

3 Enter one or more of the following conditions:

 Date
 Event ID (available for error logs only)
 Symptom (available for error logs only)
 Event class (available for error logs only)

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 17 Alarms and Troubleshooting

4 Select OK. The event logs satisfying the conditions are displayed on
the screen.

5 Choose the following buttons as needed:

 Refresh F2: to refresh the logs based on the current search

conditions.
 Delete F3: to remove specified logs on the screen.
 Print F7: to print all logs currently displayed on the screen.

17.2.4 Refreshing Logs

To refresh the event logs, perform the following procedure:
1 Select Alarm-Error Log or Edit Log.

2 Select Refresh F2.

3 The system refreshes the logs based on the previous search

conditions.

 New error logs are displayed chronologically and highlighted by

different colors. Yellow indicates a warning, and red indicates a
serious error.
 New edit logs are displayed chronologically on the front-most of
the log list.
4 Choose the following buttons as needed:

 Delete F3: to remove specified logs on the screen.

 Archive F4: to archive all event logs occurring within a period of
time.
 Print F7: to print all logs currently displayed on the screen.

17.2.5 Clearing Logs

Since the system has a limited storage capacity, you should clear and
manage the event logs regularly to ensure that the most-recent and
important logs are kept.
Only users with sufficient permissions are allowed to delete event logs.
For more information about user permissions, refer to 11.4.4
Assigning/Modifying Permissions (page 11-6).
Perform the following steps to clear event logs:
1 Select Alarm-Error Log or Edit Log.

2 Select event logs you desire to delete.

3 Select Delete F3.

4 Select OK. To abort the deleting, select Cancel.

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17 Alarms and Troubleshooting

When you confirm the deleting, the system removes the selected
event logs from the screen.

17.2.6 Printing Logs

After searching for desired logs on the Error Log or Edit Log screen,
select Print F7. The event logs currently displayed are printed out in the
same format as shown on the screen.
Printing logs will take a long time and requires a great number of papers.
Think twice before printing logs.
To terminate the printing, select Utility-Commands-Stop Print.

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 17 Alarms and Troubleshooting

17.3 Error Troubleshooting

17.3.1 Introduction
When an error occurs, it will be indicated in many ways. The following
pages describe how to troubleshoot errors and help you determine
solutions to such errors.
Generally, troubleshooting is divided into the following steps:
 An error occurs and is indicated in various ways.
 Check the error logs and component status.
 Identify the error and determine relevant solutions.
 Implement the solutions.
 Check and evaluate the implementation of the solutions.

17.3.2 Error Indications

Errors may occur on hardware, software and the entire system. When an
error occurs, it will be indicated in many ways to help identify it and
determine the possible causes and solutions. Errors can be indicated by
alarm tone, alarm message, color, alarm message box, result flag and
error log, through which you will obtain detailed information about errors
and find the relevant solutions.

Alarm tone
When an error occurs, the buzzer gives alarm tone reminding you to
notice the error and take corrective actions. Alarm tone can be adjusted
manually or silenced.
Perform the following steps to adjust the alarm tone:
1 Select Utility-System Setup.

2 Adjust the alarm tone in the Alarm Volume field.

3 Test the alarm tone until it is satisfied.

4 To silence the alarm tone, drag the slider to the leftmost position of
the scale.

5 Select Save F8 to save the adjustment.

Alarm message
When an error occurs, the system gives an alarm and displays the alarm
message in the second line of the prompt message area. For details of
troubleshooting, refer to 17.5 Error Messages and Corrective Actions
(page 17-22).

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17 Alarms and Troubleshooting

Color highlight
An error will be indicated by highlighting relevant buttons and screen
texts with different colors. Yellow indicates a warning, and red indicates a
serious warning or error.
 Reagent button
 Utility button
 Alarm button
Select a button to access relevant function page, check for abnormities
and take corrective actions. When the problem is solved, the alarm
indication disappears.

Alarm message box

An error can also be shown in an alarm message box, which contains the
date/time, event ID, time(s) and help icon.
Errors that are indicated through an alarm message box are divided into
the following types:
 Common error: including those that are indicated by warning the user,
and by invalidating tests, reagents and samples. When such error
occurs, the alarm message box shows with the title bar highlighted in
yellow.
 Serious error: including those except for the common error. When
such error occurs, the alarm message box shows with the title bar
highlighted in red, and you are only allowed to reboot or exit the
system.
When an alarm message box appears, select the Alarm button to view the
new error logs, analyze the possible causes and determine relevant
corrective actions.

Flag
Flag is also called data alarm. When calibration error or failure, or sample
result error occurs due to the sample, reagent or system failure, a flag will
appear near the corresponding calibration result or sample results.

Error log
All alarms are recorded in the error logs. By recalling the error logs you
are enabled to master the current status of the system and troubleshoot
errors.

17.3.3 Identifying Errors

To identify errors, understand the error indication thoroughly, check the
error logs and system status, and then determine relevant solutions.
The table below shows the error types that may occur on the system.
Find relevant corrective actions according to the description.

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 17 Alarms and Troubleshooting
Table 17.1 Error types
Error Type Description
Instrument failure and Instrument failure and error may be detected on all
error subsystems and processed in different ways. Such
errors are shown in the Error messages and corrective
actions table, and can be identified through the event
ID.
Data alarm Data alarm is a flag indicating biochemistry or ISE
chemistry result error. The flags are included in the
Result flags table, and can be identified through the
flag symbol.

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17 Alarms and Troubleshooting

17.4 Data Alarm

17.4.1 Introduction
Data alarm is a result flag indicating that an error or abnormity occurs to
a result. By identifying results flags can evaluate if the results are reliable
and acceptable. Data alarm is not necessarily an error but will definitely
influence the result and should be considered carefully.
The system provides monitoring of biochemistry results and ISE
chemistry results. When calibration error or failure, or sample result error
occurs due to the sample, reagent or system failure, a flag will appear
near the corresponding calibration result or sample results. The following
pages summary the result flags of the system.

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 17 Alarms and Troubleshooting

17.4.2 Result Flags

Table 17.2 Result flags and corrective actions
Flag Alarm Type Description Probable Causes Corrective Actions
< Result related Exceeds linearity range The result exceeds the low limit of the Take no actions, or rerun the test for
low linearity range. confirmation.
> Result related Exceeds linearity range The result exceeds the high limit of the Rerun the test with sample diluted or
high linearity range. decreased.
Result related Sample volume is Sample volume is Increased one No actions are required.
Increased one
Result related Sample volume is Sample volume is decreased one No actions are required.
decreased one
∧ Result related Exceeds reference range The result exceeds the high limit of the No actions are required.
high reference range.
∧! Result related Exceeds critical range The result exceeds the high limit of the No actions are required.
high critical range.
∨ Result related Exceeds reference range The result exceeds the low limit of the No actions are required.
low reference range.
∨! Result related Exceeds critical range The result exceeds the low limit of the No actions are required.
low critical range.
10-x Result related 10-x Results of five runs (10 results), or 10 Check if the reagent is qualified, control
continuous results of a control are on the sample is normal, and the instrument is
same side. working correctly.
1-2s Result related 1-2s The current QC result is between ±2 and ±3 No actions are required.
standard deviations from the assigned mean
concentration.
1-3s Result related 1-3s The current QC result is greater than ±3 Check if the reagent is qualified, control
standard deviations from the assigned mean sample is normal, and the instrument is
concentration. working correctly.
2-2s Result related 2-2s Results of two controls in the same run or Check if the reagent is qualified, control
two continuous results of a control are on sample is normal, and the instrument is
the same side and greater than ±2 standard working correctly.
deviations from the assigned mean

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17 Alarms and Troubleshooting

Flag Alarm Type Description Probable Causes Corrective Actions

concentration.
4-1s Result related 4-1s Results of two runs (4 results), or 4 Check if the reagent is qualified, control
continuous results of a control are on the sample is normal, and the instrument is
same side and greater than ±1 standard working correctly.
deviation from the assigned mean
concentration.
ABS Result related Absorbance out of range The absorbance of primary or secondary Check the sample for foreign matters or
wavelength used for calculating results is interferents; check if the reagent is qualified
greater than 3.4A. and placed in the correct position; check the
cuvette is clean; check if the photometric
system is working normally.
BLK Calibration Blank response out of The reagent goes wrong; insufficient Check if the cuvette is not overflowed, the
related range reagent is dispensed; the cuvette contains reagent is sufficient without air bubbles, the
air bubbles; the light drifts; or the cuvette light does not drift and the chemistry
is overflowed. parameters are reasonable. If yes, replace the
reagent and then rerun the test.
BOE Result related Substrate depletion The sample concentration is too high, and Check the reaction curve and the substrate
substrate depletion occurs during depletion limit. Rerun the test with diluted
fixed-time measurements. sample.
CALE Result related Edited calibration factor The calibration factors are edited. No actions are required.
CALF Result related Calibration failed.(for The calibration is failed. Recalibrate.
biochemistries)
CALF Result related No fluid in tubing 1. Waste pump tube is aging, blocked, or 1. Replace the reagent pack with a new one
broken； 2. Perform purge B to remove bubbles
2. Sample injection port and fluidic path are 3. /4. Replace the pump tube
blocked or leaking. 5. Clean the sample injection port and reinstall
3. Air bubble detector failed. electrodes.
6. Replace the bubble detector.

1. Place sufficient ISE wash solution.

2. Replace the pump tube
3. Clean the sample injection port and reinstall
electrodes.

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 17 Alarms and Troubleshooting

Flag Alarm Type Description Probable Causes Corrective Actions

4. Replace the bubble detector.
CALF Calibration No fluid in tubing 1. Waste pump tube is aging, blocked, or 1. Replace the reagent pack with a new one
related broken； 2. Perform purge B to remove bubbles
2. Sample injection port and fluidic path are 3. /4. Replace the pump tube
blocked or leaking. 5. Clean the sample injection port and reinstall
3. Air bubble detector failed. electrodes.
6. Replace the bubble detector.

1. Place sufficient ISE wash solution.

2. Replace the pump tube
3. Clean the sample injection port and reinstall
electrodes.
4. Replace the bubble detector.
CALJ Calibration Rejected calibration The calibration factors are rejected No actions are required.
related factor
CALM Result related Air in segment 1. Waste pump tube is aging, blocked, or 1. Replace the pump tube
broken； 2. Clean the sample injection port and reinstall
2. Sample injection port and fluidic path are electrodes.
blocked or leaking. 3. Replace the bubble detector.
3. Air bubble detector failed.
CALM Calibration Air in segment 1. Waste pump tube is aging, blocked, or 1. Replace the pump tube
related broken； 2. Clean the sample injection port and reinstall
2. Sample injection port and fluidic path are electrodes.
blocked or leaking. 3. Replace the bubble detector.
3. Air bubble detector failed.
CALR Result related Recalculated calibration The calibration factors are recalculated. No actions are required.
factor
COV Calibration Calibration curve not For nonlinear calibration, a satisfying base Check that the reagent and calibrator are
related convergent cannot be calculated and no calibration normal, and then recalibrate. If the error
curve is drawn. remains, contact our customer service
department.
CSD Calibration Calibration curve The calculated standard deviation of the Check if the acceptance limit is reasonable and

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17 Alarms and Troubleshooting

Flag Alarm Type Description Probable Causes Corrective Actions

related standard deviation out calibration curve exceeds the specified the reagent and calibrator are normal, and
of range limit. then recalibrate.
DEL Calibration Deleted QC result The QC result has been deleted. No actions are required.
related
DET Calibration Calibration The calculated determination coefficient of Check if the acceptance limit is reasonable and
related determination the calibration curve exceeds the specified the reagent and calibrator are normal, and
coefficient out of range limit. then recalibrate.
DEP Calibration Saving calibration result 1. ISE communication cable failure. 1. Replace the ISE communication cable.
related error 2. Communication interface or pins failure 2. Replace the interface or pins.
3. Main control board of the ISE module goes 3. Replace the main control board of the ISE
wrong. module.
4. Software error. 4. Upgrade the operating software or reinstall
it.
DTGL Result related Insufficient The concentrated wash solution is Fill more concentrated wash solution.
concentrated wash insufficient during measurement.
solution
DUP Calibration Calibration repeatability The difference between the maximum and Check if the acceptance limit is reasonable,
related error minimum response of the calibrator exceeds troubleshoot the error, and then recalibrate.
the specified limit.
EDT Result related Edited result The result has been edited. No actions are required.
EDT Calibration Edited calibration factor The calibration factors have been edited. No actions are required.
related
ENC Result related No calculation interval The sample concentration is too high, and Check the reaction curve and the substrate
substrate depletion occurs within the lag depletion limit. Rerun the test with diluted
time of rate check measurements. sample.
EXP Result related Enzyme linearity range The high-concentration sample leads to Rerun the test with diluted sample.
extension substrate depletion during the reaction
time, and the result is calculated by using
measuring points within the lag time.
EXT Result related Extended calibration The result is obtained by extending the Take no actions, or recalibrate.
factor calibration time.
FAC Calibration Calibration slope The slope difference is applicable to linear Check if the acceptance limit is reasonable and
related difference out of range calibration only and refers to the K factor the reagent and calibrator are normal, and

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 17 Alarms and Troubleshooting

Flag Alarm Type Description Probable Causes Corrective Actions

(slope) difference between two adjacent then recalibrate.
calibrations. It exceeds the specified limit.
ICA Result related The response is normal, The chemistry has not been calibrated. Rerun it after calibration.
but results cannot be
calculated.
L! Result related Water blank fluctuation 1. The cuvette is overflowing. 1. Check if the cuvette is overflowing.
is out of range. 2. The lamp has been replaced incorrectly. 2. Check if the Replace Lamp command is
3. Cuvette check is not performed after executed during lamp replacement.
maintenance. 3. Check if the cable connectors and retaining
4. The cable connectors are not tightened. screw of the lamp have been tightened.
5. The retaining screw is not tightened. 4. Check if the cleaning liquid inside the
6. Cleaning liquid inside the cuvette is cuvette is no less than half of the cuvette.
little. 5. Check if the reaction curve fluctuates
7. The lamp is aged. irregularly. If yes, replace the lamp.
8. The photometer goes wrong. 6. If the error remains, contact our customer
service department.
LIN Result related Non-linear The measuring points for result calculation Check the reaction curve and the substrate
are nonlinear, because the sample depletion limit. Rerun the test with diluted
concentration is too high, or the substrate sample. If the alarm occurs for more than one
depletion limit is not specified or chemistry, and the reaction curve fluctuates
unreasonable. The lamp is aged. irregularly, replace the lamp.
LOW Result related Response less than that The sample concentration is lower than the For ascending calibration curve, rerun the test
of the sensitivity indicated on the reagent pack, with standard or increased sample volume; for
minimum-concentration making response less than that of the descending calibration curve, rerun the test
calibrator lowest-concentration calibrator. with diluted sample.
MBK Calibration Mixed blank absorbance The reagent goes wrong; the cuvette is not Check if the cuvette is clear and not
related out of range clear; the reaction cuvette is overflowed; or overflowed, the reagent is sufficient without
insufficient reagent is dispensed. air bubbles, and the chemistry parameters are
reasonable. If yes, replace the reagent and
then rerun the test.
MON Calibration Calibration curve not The calibration data and calibration curve Check if the calibrator is defined and placed
related monotonic are not monotonic. correctly, and then recalibrate.
NLN Result related No linear interval The high-concentration sample leads to less Rerun the test with diluted sample.
than 3 valid measuring points within the

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17 Alarms and Troubleshooting

Flag Alarm Type Description Probable Causes Corrective Actions

reaction time of rate check measurements.
NOIS Result related Electrode voltage noise 1. Electrode failure. 1. Replace the electrode.
2. Environment interference. 2. Relocate the instrument.
3. ISE main control board failure. 3. Replace the main control board of the ISE
4. Salt buildup around electrodes or tubes module.
due to fluidic leaks. 4. Clean the tubes and electrodes.
NOIS Calibration Electrode voltage noise 1. Electrode failure. 1. Replace the electrode.
related 2. Environment interference. 2. Relocate the instrument.
3. ISE main control board failure. 3. Replace the main control board of the ISE
4. Salt buildup around electrodes or tubes module.
due to fluidic leaks. 4. Clean the tubes and electrodes.
OVE Result related Overridden calibration The result is obtained by overriding a failed Take no actions, or recalibrate.
factor calibration.
PUGA Result related Air in calibrator A 1. Calibrator A is exhausted. 1. Replace the reagent pack with a new one
2. Bubbles exist in calibrator tube A 2. Perform purge B to remove bubbles
3. Pump tube A is aging, blocked, or broken. 3. /4. Replace the pump tube
4. Waste pump tube is aging, blocked, or 5. Clean the sample injection port and reinstall
broken； electrodes.
5. Sample injection port and fluidic path are 6. Replace the bubble detector.
blocked or leaking.
6. Air bubble detector failed.
PUGA Calibration Air in calibrator A 1. Calibrator A is exhausted. 1. Replace the reagent pack with a new one
related 2. Bubbles exist in calibrator tube A 2. Perform purge B to remove bubbles
3. Pump tube A is aging, blocked, or broken. 3. /4. Replace the pump tube
4. Waste pump tube is aging, blocked, or 5. Clean the sample injection port and reinstall
broken； electrodes.
5. Sample injection port and fluidic path are 6. Replace the bubble detector.
blocked or leaking.
6. Air bubble detector failed.
PUGB Result related Air in calibrator B 1. Calibrator B is exhausted. 1. Replace the reagent pack with a new one
2. Bubbles exist in calibrator tube B 2. Perform purge B to remove bubbles
3. Pump tube A is aging, blocked, or broken. 3. /4. Replace the pump tube

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 17 Alarms and Troubleshooting

Flag Alarm Type Description Probable Causes Corrective Actions

4. Waste pump tube is aging, blocked, or 5. Clean the sample injection port and reinstall
broken； electrodes.
5. Sample injection port and fluidic path are 6. Replace the bubble detector.
blocked or leaking.
6. Air bubble detector failed.
PUGB Calibration Air in calibrator B 1. Calibrator B is exhausted. 1. Replace the reagent pack with a new one
related 2. Bubbles exist in calibrator tube B 2. Perform purge B to remove bubbles
3. Pump tube A is aging, blocked, or broken. 3. /4. Replace the pump tube
4. Waste pump tube is aging, blocked, or 5. Clean the sample injection port and reinstall
broken； electrodes.
5. Sample injection port and fluidic path are 6. Replace the bubble detector.
blocked or leaking.
6. Air bubble detector failed.
PRO Result related Prozone check error Antibody excess occurs due to too high Check the reaction curve and the prozone
sample concentration. check parameters. Rerun the test with diluted
sample.
R Result related Rerun result The result is obtained by rerunning the test. No actions are required.
R4S Result related R4S One result of a run is greater than +2 Check if the reagent is qualified, control
standard deviations from the assigned mean sample is normal, and the instrument is
and the other greater than -2SDs. working correctly.
RBK Result related R1 blank absorbance out The reagent goes wrong; the cuvette is not Check if the cuvette is clear and not
of range clear; the reaction cuvette is overflowed; or overflowed, the reagent is sufficient without
insufficient reagent is dispensed. air bubbles, and the chemistry parameters are
reasonable. If yes, replace the reagent and
then rerun the test.
RCE Result related Response calculation Absorbance data for calculation is Rerun the test. If the error remains, contact
error incomplete, or the dividend is 0. our customer service department.
REC Result related Recalculated result The sample result is recalculated manually /
with the latest calibration factors.
RESP Result related ISE response check code 1. ISE communication cable failure. 1. Replace the ISE communication cable
error 2. Communication interface or pins failure 2. Replace the interface or pins.
Command format or 3. Main control board of the ISE module goes 3. Replace the main control board of the ISE
execution error wrong. module.

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17 Alarms and Troubleshooting

Flag Alarm Type Description Probable Causes Corrective Actions

4. Software error. 4. Upgrade the operating software or reinstall
it.
RESP Calibration ISE response check code 1. ISE communication cable failure. 1. Replace the ISE communication cable.
related error 2. Communication interface or pins failure 2. Replace the interface or pins.
Command format or 3. Main control board of the ISE module goes 3. Replace the main control board of the ISE
execution error wrong. module.
4. Software error. 4. Upgrade the operating software or reinstall
it
RGTE Result related Expired reagent The result is based on an expired reagent. Replace the reagent.
RGTL Result related Insufficient reagent The result is based on insufficient reagent. Replace the reagent.
RGTL Calibration Insufficient reagent The calibration result is based on Replace the reagent.
related insufficient reagent.
RRN Result related Response greater than The sample concentration exceeds the high Rerun the test with diluted sample.
that of the limit of the calibrator concentration.
maximum-concentration
calibrator
SEN Calibration Calibration sensitivity The difference of final response of the Check if the acceptance limit is reasonable and
related error maximum and minimum concentration the reagent and calibrator are normal, and
calibrators exceeds the specified limit. then recalibrate.
SJAM Result related Sample probe is clogged Probe clogging is detected during sampling Sample treatment.
or the sample probe is clogged during
sampling.
SLDR Calibration Electrode slope drift 1. Electrode or reagent pack is failed. 1. Replace the problematic electrode and
related 2. Electrode is unsteady. reagent pack.
3. New reagent pack is unsteady. 2. New electrode will become steady after 15
4. Reference electrode has been used for minutes since installed.
over 66 months. 3. Run a couple of calibrations after installing
5. ISE main control board failure. new reagent pack.
6. Ambient temperature fluctuates 4. Replace the reference electrode.
drastically 5. Replace the ISE main control board.
6. Control the ambient temperature to make
the fluctuation within +/-4℃.

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 17 Alarms and Troubleshooting

Flag Alarm Type Description Probable Causes Corrective Actions

SLEX Calibration Slope out of range 1. Electrode is not installed correctly. 1. Reinstall the electrode
related 2. Calibrator expired. 2. Replace the calibrator.
3. Electrode degenerated 3. Replace the problematic electrode and
4. Bubbles in reference electrode rerun.
5. Reference electrode has been used for a 4. Remove the electrode and clap on it to
long time eliminate bubbles. Reinstall the electrode and
6. Electrodes interfered. run calibration.
7. Module or tubing temperature above 5. Replace reference electrode and rerun.
32℃. 6. Troubleshoot the electrodes by replacing
them in different groups.
7. Monitor temperature, if too high, relocate
equipment.
SLP Result related Corrected result The result is adjusted with calculation No actions are required.
factors.
SLP Result related The results are Calibration factors instead of the default No actions are required.
produced when the ones are configured for the second time
calibration factors calibration.
instead of the default
ones are configured for
the second time
calibration.
SMPA Result related Air in sample 1. Sample is insufficient or contains many 1. Increase the sample volume. At least 90μl
bubbles after dispensing. sample should be prepared.
2. No or insufficient sample has been 2. Electrode is not installed correctly. Reinstall
dispensed into the sample injection port. it.
3. The electrodes are not properly installed, 3. Check the waste tube, and if necessary,
causing leakage. replace it.
4. The waste pump tube is aging or broken.
SMPE Result related Expired sample The sample is expired. Replace the sample.
SMPL Result related Insufficient sample The sample is insufficient during analysis. Refill the sample.
SMPL Calibration Insufficient sample The sample is insufficient during analysis. Refill the sample.
related
VDRF Result related Electrode voltage drift 1. Electrode or reagent pack is failed. 1. Replace the problematic electrode and

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17 Alarms and Troubleshooting

Flag Alarm Type Description Probable Causes Corrective Actions

2. Electrode is unsteady. reagent pack.
3. New reagent pack is unsteady. 2. New electrode will become steady after 15
4. Reference electrode has been used for minutes since installed.
over 66 months. 3. Run a couple of calibrations after installing
5. ISE main control board failure. new reagent pack.
6. Ambient temperature fluctuates 4. Replace the reference electrode.
drastically. 5. Replace the ISE main control board.
6. Control the ambient temperature to make
the fluctuation within +/-4℃
VOUT Result related Electrode Voltage 1. Electrode or reagent pack is failed. 1. Replace the problematic electrode and
Overflow 2. Electrode is unsteady. reagent pack.
3. New reagent pack is unsteady. 2. New electrode will become steady after 15
4. Reference electrode has been used for minutes since installed.
over 66 months. 3. Run a couple of calibrations after installing
5. ISE main control board failure. new reagent pack.
4. Replace the reference electrode.
5. Replace the ISE main control board.
VOUT Calibration Electrode Voltage 1. Electrode or reagent pack is failed. 1. Replace the problematic electrode and
related Overflow 2. Electrode is unsteady. reagent pack.
3. New reagent pack is unsteady. 2. New electrode will become steady after 15
4. Reference electrode has been used for minutes since installed.
over 66 months. 3. Run a couple of calibrations after installing
5. ISE main control board failure. new reagent pack.
4. Replace the reference electrode.
5. Replace the ISE main control board.
T1 Result related Reaction disk 1. The ambient temperature is out of range. 1. Check if the error is accidental.
temperature error 2. The temperature sensor goes wrong. 2. If not, contact our customer service
(component error and cable error) department.
3. The temperature protection switch goes
wrong. (component error and cable error)
4. The heater goes wrong. (component error
and cable error)
5. PCB error

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 17 Alarms and Troubleshooting

Flag Alarm Type Description Probable Causes Corrective Actions

6. Parameters are lost.
7. Electromagnetic interference exists.

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17 Alarms and Troubleshooting

17.5 Error Messages and Corrective Actions

Table 17.3 Error messages and corrective actions

Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A00006 Instruction Error Equipment / E2PROM read/write error Switch off the analyzing unit power
error configuration cannot and switch on it again. Recover
be read or saved failure by performing the Home
Error: maintenance procedure. If this
message appears for 3 times, contact
our customer service department or
your local distributor.
A01006 Sample probe Error Sample probe vertical / Sample probe vertical movement error Recover failure by performing the
unit movement error 1. Sensor status error: Home maintenance procedure. If this
Position: The sample probe assembly is probably message appears for 3 times, contact
Error: forced to move vertically. our customer service department or
your local distributor.
2. Failed to find the zero position:
Or The sample probe assembly is probably
jammed.
Sample probe 3. Collision occurs during operation other
horizontal movement than aspirating:
error The sample probe collides with other
Position: object.
Error: 4. Collision error:
The collision remains.
Or 5. Moving vertically is not allowed in current
position:
Sample syringe The sample probe moves vertically in an
movement error. unknown position.
Position: Sample probe horizontal movement error

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 17 Alarms and Troubleshooting

Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
Error: 1. Sensor status error:
The sample probe assembly is probably
forced to move horizontally.
2. Failed to find the zero position:
The sample probe assembly is obstructed
when rotating.
3. Collision occurs during horizontal
movement:
The sample probe assembly is obstructed
when rotating.
4. Moving horizontally is not allowed in
current position:
The sample probe assembly is probably
forced to move vertically.
Sample syringe movement error.
1. Sensor status error:
The syringe assembly is probably forced to
move.
2. Failed to find the zero position:
The syringe assembly is probably jammed.
A01007 Sample probe Warning Sample probe collides / Sample probe vertical movement error Sample probe vertical movement
unit with an obstacle 1. Collision occurs during aspirating: error
when aspirating The sample probe collides with other 1. Collision occurs during aspirating:
Position: object. Remove the obstacle, and then
recover failure by performing the
Home maintenance procedure.
A01021 Sample probe Error Clog detection board / Clog detection board communication error. Recover the failure. If this message
unit communication error. appears for 3 times, contact our
customer service department or your
local distributor.
A01022 Sample probe Warning Sample syringe / The aspirate volume is beyond the range of Define the aspirate volume correctly.
unit aspirates too much the syringe.

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Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
Sample ID/bar code:
Position:
A01023 Sample probe Warning Sample syringe / The dispense volume is beyond the range of Define the dispense volume
unit dispenses too much the syringe. correctly.
Cuvette No.:
Sample ID/bar code:
Chemistry:
A01024 Sample probe Warning Insufficient sample / There is no sample or insufficient sample on 1. Check if the sample is sufficient,
unit Sample position: the designated position. and then try again.
Sample ID/bar code: 2. If the error remains, contact our
or customer service department or your
local distributor.
Sample probe level
detection failed.
A01027 Sample probe Error Sample is insufficient / There is no sample or insufficient sample on 1. Check if the sample is sufficient,
unit or contains air the designated position. and then try again.
bubbles 2. If the error remains, contact our
Position: customer service department or your
Sample ID/bar code: local distributor.
or
Sample probe level
detection failed
A01028 Sample probe Error Sample probe fails to / There is no deionized water, or the 1. Check if the water supply is
unit detect liquid level deionized water is not supplied normally. normal.
during cleaning 2. Recover the failure for 3 times. If
the error remains, contact our
Customer Service Department or
your local distributor.
A01029 Sample probe Warning Sample is insufficient / 1. The sample contains clots, or is too thick 1. Check that the sample is
unit or contains fibrins or insufficient. preprocessed correctly; or check if
and clots 2. The sample probe is clogged. the sample contains foreign matters
Position: such as clot. If it does, change the
Sample ID/bar code: sample.

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Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
or 2. Check if the sample is sufficient.
Sample probe clog 3. Clean the sample probe with wash
detection failed. solution. If the problem remains,
remove the sample probe and unclog
it, and then continue with the
measurement.
A01030 Sample probe Error Sample probe is / The sample probe is clogged. 1. Clean the sample probe with wash
unit clogged during solution. Remove the sample probe
cleaning and unclog it.
Sample ID/bar code: 2. If the problem remains, contact
Position: the manufacturer.
or
Sample probe clog
detection failed.
A01033 Sample probe Warning Sample probe fails to / There is no reagent or insufficient reagent 1. Check if R1 volume is sufficient
unit detect liquid level on in the reaction cuvette. and the reagent bottle is free of air
reaction carousel bubbles, and then try again.
when dispensing. 2. If the problem remains, contact
Cuvette No.: the manufacturer.
sample ID/bar code:
chemistry:
or
Sample probe level
detection failed.
A01036 Sample probe Error Sample probe level / Level detection board communication error Recover the failure. If this message
unit detection board appears for 3 times, contact our
communication error customer service department or your
local distributor.
A01037 Sample probe Error Sample probe level / 1. The sample probe is not installed 1. Check if the sample is installed
unit detection board correctly or goes wrong. correctly or damaged.
self-calibrating failed 2. Level detection board communication 2. Recover the failure. If your
error attempt is failed, contact our
customer service department or your

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Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
local distributor.
A01038 Sample probe Error Sample probe interior / Sample probe interior wash is abnormal. Contact our customer service
unit wash is abnormal. department or your local distributor.
A02006 Reagent probe Error Reagent probe / Reagent probe vertical movement error Switch off the analyzing unit power
unit vertical movement 1. Sensor status error: and switch on it again. Recover
error The reagent probe assembly is probably failure by performing the Home
Position: forced to move vertically. maintenance procedure. If this
Error: message appears for 3 times, contact
2. Failed to find the zero position:
our customer service department or
The reagent probe assembly is probably your local distributor.
Or jammed.
3. Collision occurs during operation other
Reagent probe than aspirating:
horizontal movement The reagent probe collides with other
error object.
Position: 4. Collision error:
Error: The collision remains.
5. Moving vertically is not allowed in current
Or position:
The reagent probe moves vertically in an
Reagent syringe unknown position.
movement error Reagent probe horizontal movement error
Position: 1. Sensor status error:
Error: The reagent probe assembly is probably
forced to move horizontally.
2. Failed to find the zero position:
The reagent probe assembly is obstructed
when rotating.
3. Collision occurs during horizontal
movement:
The reagent probe assembly is obstructed
when rotating.
4. Moving horizontally is not allowed in

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Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
current position:
The reagent probe assembly is probably
forced to move vertically.
Reagent syringe movement error.
1. Sensor status error:
The syringe assembly is probably forced to
move.
2. Failed to find the zero position:
The syringe assembly is probably jammed.
A02007 Reagent probe Warning Reagent probe / Reagent probe vertical movement error Reagent probe vertical movement
unit collides with an 1. Collision occurs during aspirating: error
obstacle when The reagent probe collides with other 1. Collision occurs during aspirating:
aspirating object. Remove the obstacle and then
Position: recover the failure.
A02021 Reagent probe Warning Reagent syringe / The aspirate volume is beyond the range of Define the aspirate volume correctly.
unit aspirates too much the syringe.
Chemistry:
Position:
A02022 Reagent probe Warning Reagent syringe / The dispense volume is beyond the range of Define the dispense volume
unit dispenses too much the syringe. correctly.
Cuvette No.:
Sample ID/bar code:
Chemistry:
A02023 Reagent probe Warning Insufficient reagent / There is no reagent or insufficient reagent 1. Check if the reagent is sufficient,
unit Chemistry: on the designated position. and then try again.
Position on outer 2. If the error remains, contact our
ring: customer service department or your
Or local distributor.
reagent probe level
detection failed.
A02025 Reagent probe Warning Reagent probe / 1. The reagent probe aspirates nothing. 1. Check if the reagent satisfies the

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Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
unit dispenses insufficient requirement and is sufficient in
reagent volume, and then try again.
Cuvette No.: 2. Recover the failure. If this
Sample ID/bar code: message appears for 3 times, contact
Chemistry: our customer service department or
your local distributor.
A02026 Reagent probe Error Reagent probe fails / There is no deionized water, or the 1. Check if the water supply is
unit to detect liquid level deionized water is not supplied normally. normal.
during cleaning. 2. If the error remains, contact our
customer service department or your
local distributor.
A02027 Reagent probe Warning Water residues exist / There is deionized water left in the reaction Recover the failure. If this message
unit in the cuvette cuvette. appears for 3 times, contact our
Cuvette No.: customer service department or your
Sample ID/bar code: local distributor.
Chemistry:
Or
Reagent probe level
detection failed.
A02030 Reagent probe Error Reagent probe level / Level detection board communication error Recover the failure. If this message
unit detection board appears for 3 times, contact our
communication error customer service department or your
local distributor.
A02031 Reagent probe Error Reagent probe level / Level detection board communication error 1. Check if the reagent probe is
unit detection board installed correctly and intact.
self-calibrating failed 2. Recover the failure. If this
message appears for 3 times, contact
our customer service department or
your local distributor.
A02032 Reagent probe Warning Reagent is / 1. Air bubbles exist in the reagent bottle. 1. Check if the reagent bottle
unit insufficient or 2. The reagent bottle does not meet the contains air bubbles, and then try
contains air bubbles requirements. again.
Chemistry: 2. Check if the reagent bottle meets

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Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
Position on outer the requirements.
ring: 3. If the error remains, contact our
customer service department or your
local distributor.
A02033 Reagent probe Warning Insufficient reagent is / The reagent is insufficient, or air bubbles 1. Check if the reagent is sufficient
unit dispensed or air exist in the reagent bottle. and the reagent bottle contains air
bubbles exist bubbles, and then try again.
Cuvette No.: 2. If the problem remains, contact
Sample ID/bar code: the manufacturer.
Chemistry:
Position:
Or
Reagent probe level
detection failed.
A04006 Sample mixer Error Sample mixer vertical / Sample mixer vertical movement error Switch off the analyzing unit power
unit movement error 1. Sensor status error and switch on it again. Recover
Position: The sample mixer assembly is probably failure by performing the Home
Error: forced to move vertically. maintenance procedure. If this
message appears for 3 times, contact
2. Failed to find the zero position
our customer service department or
Or The sample mixer assembly is probably your local distributor.
jammed.
Sample mixer 3. Moving vertically is not allowed in current
horizontal movement position
error The sample mixer moves vertically in an
Position: unknown position.
Error: Sample mixer horizontal movement error
1. Sensor status error
The sample mixer assembly is probably
forced to move horizontally.
2. Failed to find the zero position
The sample mixer assembly is obstructed
when rotating.

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Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
3. Moving horizontally is not allowed in
current position
The sample mixer moves vertically in an
unknown position.
A04015 Sample mixer Error Sample mixer / The mixer is obstructed by other object or Recover failure by performing the
unit rotation error interfered by the reaction cuvette. Home maintenance procedure. If this
Rotation speed: message appears for 3 times, contact
our customer service department or
your local distributor.
A05006 Reagent mixer Error Reagent mixer / Reagent mixer vertical movement error Switch off the analyzing unit power
unit vertical movement 1. Sensor status error and switch on it again. Recover
error The reagent mixer assembly is probably failure by performing the Home
Position: forced to move vertically. maintenance procedure. If this
Error: message appears for 3 times, contact
2. Failed to find the zero position
our customer service department or
The reagent mixer assembly is probably your local distributor.
Or jammed.
3. Moving vertically is not allowed in current
Reagent mixer position
horizontal movement The reagent mixer moves vertically in an
error unknown position.
Position: Reagent mixer horizontal movement error
Error: 1. Sensor status error
The reagent mixer assembly is probably
forced to move vertically.
2. Failed to find the zero position
The reagent mixer assembly is obstructed
when rotating.
3. Moving horizontally is not allowed in
current position
The reagent mixer moves vertically in an
unknown position.
A05016 Reagent mixer Error Reagent mixer / The mixer is obstructed by other object or Recover failure by performing the
unit rotation error interfered by the reaction cuvette. Home maintenance procedure. If this

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Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
Rotation speed: message appears for 3 times,
contact our customer service
department or your local distributor.
A06006 Reaction Error Reaction carousel / Reaction carousel movement error Switch off the analyzing unit power
carousel unit movement error 1. Failed to find the home position and switch on it again. Recover
Error: The reaction carousel is obstructed or failure by performing the Home
blocked. maintenance procedure. If this
message appears for 3 times, contact
2. The coder missed steps
our customer service department or
The reaction carousel is obstructed or your local distributor.
blocked.
3. The reaction carousel missed steps when
moving to the home position.
The reaction carousel is obstructed or
blocked.
A07006 Sample Error Sample carousel / Sample carousel outer ring movement error Recover the failure. If this message
carousel unit outer ring movement 1. Failed to find the home position appears for 3 times, contact our
error The sample carousel outer ring is obstructed customer service department or your
Error: or blocked. local distributor.
2. The coder missed steps
The sample carousel outer ring is obstructed
or blocked.
3. The sample carousel outer ring missed
steps when moving to the home position.
The sample carousel outer ring is obstructed
or blocked.
A07009 Sample Error Sample bar code / The sample bar coder reader goes wrong Recover the failure. If the error
carousel unit reader error due to system failure. remains, initialize the sample bar
code reader. If the error still
remains, contact our Customer
Service Department or your local
distributor.
A07010 Sample Warning Sample bar code / Sample bar coder reader does not work Initialize the sample bar code reader

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Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
carousel unit error normally due to communication error. and try again. If your attempt is
Position: failed, contact our customer service
department or your local distributor.
A07011 Sample Error Sample bar code / Sample bar coder sending buffer is full due Recover the failure or reboot the
carousel unit sending buffer is full to communication error. analyzing unit.
A09006 Reagent Error Reagent carousel / Reagent carousel outer ring movement error Recover the failure. If this message
carousel unit outer ring movement 1. Failed to find the home position appears for 3 times, contact our
error The reagent carousel outer ring is customer service department or your
Error: obstructed or blocked. local distributor.
2. The coder missed steps
The reagent carousel outer ring is
obstructed or blocked.
3. The reagent carousel outer ring missed
steps when moving to the home position.
The reagent carousel outer ring is
obstructed or blocked.
A09011 Reagent Error Reagent bar code / The reagent bar coder reader goes wrong Recover the failure. If the problem
carousel unit reader does not work due to system failure. remains, initialize the sample bar
normally code reader. If the error still
remains, contact our Customer
Service Department or your local
distributor.
A09012 Reagent Warning Reagent bar code / Reagent bar coder sending buffer is full due Initialize the sample bar code reader
carousel unit error to communication error. and try again. If your attempt is
Position: failed, contact our customer service
department or your local distributor.
A09014 Reagent Error Reagent bar code / Reagent bar coder reader does not work Recover the failure or reboot the
carousel unit sending buffer is full normally due to communication error. analyzing unit.
Position:
A11005 Wash station Error Wash station / Wash station movement error Switch off the analyzing unit power
movement error 1. Sensor status error and switch on it again. Recover
Error: The wash station assembly is probably failure by performing the Home
maintenance procedure. If this

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Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
forced to move. message appears for 3 times, contact
2. Failed to find the home position our customer service department or
The wash station assembly is obstructed by your local distributor.
other object.
3. The wash station collides with an obstacle
when moving.
The wash station collides with other object,
or the wash probes then collide with the
reaction carousel.
A11010 Wash station Error Releasing vacuum / 1. Solenoid valves V23-V27 go wrong. 1. Check if the error is accidental.
failed 2. The vacuum pump goes wrong. 2. If the error is not accidental,
3. The vacuum sensor goes wrong. contact our customer service
department or your local distributor.
A11012 Wash station Warning Water supplying is / 1. The water unit goes wrong. 1. Check the water unit.
too slow 2. The water supply valve goes wrong. 2. Check if the water supply ball
3. The water supply ball valve is not valve is opened and the handle is
opened. level.
4. The water supply ball valve goes wrong. 3. Check if the water supply tube is
5. The low-level floater of the water tank smooth.
goes wrong. 4. Check if the water level inside the
6. The water supply tube is bent. water tank is low (at the scale of 5L).
7. The outlet filter of the water supply tube 5. Check if the error is accidental.
is clogged. 6. If the error is not accidental,
contact our customer service
department or your local distributor.
A11013 Wash station Error Water tank is empty / 1. The water unit goes wrong. 1. Check the water unit.
2. The water supply valve goes wrong. 2. Check if the water supply ball
3. The water supply ball valve is not valve is opened and the handle is
opened. level.
4. The water supply ball valve goes wrong. 3. Check if the water supply tube is
5. The low-level floater of the water tank smooth.
goes wrong. 4. Check if the water level inside the
water tank is low (at the scale of 5L).

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Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
6. The water supply tube is bent. 4. Check if the error is accidental.
7. The outlet filter of the water supply tube 5. If the error is not accidental,
is clogged. contact our customer service
department or your local distributor.
A11014 Wash station Warning Priming diluted wash / 1. The solenoid valve V06 goes wrong. 1. Check if the deionized water
solution is slow 2. The restrictor ring is clogged. pump is opened and the pressure
3. The inlet filter at the front panel is gauge reads between 40kPa-50kPa.
clogged. 2. Check the floater of the deionized
4. The deionized water circulating pump water tank.
goes wrong. 3. Check the floater of the diluted
5. The water tank is empty. wash solution tank.
6. The concentrated wash solution tank is 4. Check the floater of the
empty. concentrated wash solution tank.
7. The concentrated wash solution pump 5. Check if the error is accidental.
goes wrong. 6. If the error is not accidental,
8. The low-level floater of the diluted wash contact our customer service
solution tank goes wrong. department or your local distributor.
A11015 Wash station Error Insufficient diluted / 1. The solenoid valve V06 goes wrong. 1. Check if the deionized water
wash solution 2. The restrictor ring is clogged. pump is opened and the pressure
3. The inlet filter at the front panel is gauge reads between 40kPa-50kPa.
clogged. 2. Check the floater of the deionized
4. The deionized water circulating pump water tank.
goes wrong. 3. Check the floater of the diluted
5. The water tank is empty. wash solution tank.
6. The concentrated wash solution tank is 4. Check the floater of the
empty. concentrated wash solution tank.
7. The concentrated wash solution pump 5. Check if the error is accidental.
P05 goes wrong. 6. If the error is not accidental,
8. The low-level floater of the diluted wash contact our customer service
solution tank goes wrong. department or your local distributor.
A11016 Wash station Warning Insufficient / 1. Concentrated wash solution is exhausted 1. Check if the concentrated wash
concentrated wash and the floater status is Empty. solution is exhausted and the floater
status is Empty. If yes, fill more

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Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
solution 2. The low-level floater of the concentrated concentrated wash solution.
wash solution tank goes wrong. 2. Check if the error is accidental.
3. If the error is not accidental,
contact our customer service
department or your local distributor.
A11017 Wash station Error Liquid accumulates in / 1. The solenoid valve V27 goes wrong. 1. Check if the error is accidental.
primary vacuum 2. The waste pump P07 goes wrong. 2. If the error is not accidental,
container 3. The low-concentration waste drain tube contact our customer service
is bent. department or your local distributor.
A11018 Wash station Error High concentration / 1. The waste pump P07 goes wrong. 1. Check if the error is accidental.
waste collector is full 2. The high-concentration waste drain tube 2. If the error is not accidental,
is bent. contact our customer service
department or your local distributor.
A11019 Wash station Error Low concentration / 1. The waste pump P07 goes wrong. 1. Check if the error is accidental.
waste collector is full 2. The low-concentration waste drain tube 2. If the error is not accidental,
is bent. contact our customer service
department or your local distributor.
A11020 Wash station Error High concentration / 1. The high concentration waste tank is full 1. Check the high-concentration
waste tank is full 2. The floater of the high concentration waste tank. If it is full, replace the
waste tank goes wrong. waste tank, close the full tank and
dispose of the waste properly.
2. Check if the error is accidental.
3. If the error is not accidental,
contact our customer service
department or your local distributor.
A11027 Wash station Error Insufficient vacuum. / 1. The primary vacuum pump P08 goes 1. Check if the error is accidental.
Cleaning failed wrong. 2. If the error is not accidental,
2. The primary vacuum sensor goes wrong. contact our customer service
3. The connectors and tubes go wrong. department or your local distributor.
4. The primary vacuum container goes
wrong.
5. Solenoid valves V23-V26 go wrong.

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Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A11028 Wash station Error Water tank floater / 1. Water tank high level and low level 1. Check if the error is accidental.
logic error floater go wrong 2. If the error is not accidental,
contact our customer service
department or your local distributor.
A11029 Wash station Error Diluted wash solution / 1.High level and low level floater of diluted 1. Check if the error is accidental.
tank floater logic wash solution container go wrong. 2. If the error is not accidental,
error contact our customer service
department or your local distributor.
A11030 Wash station Error External Drain / 1. The drainage module is not turned on. Check if the drainage module is
Canister Overflow 2. The pump of the drainage module goes turned on.
wrong. 2. Check if the error is accidental.
3. High level and low level floater of the 3. If the error is not accidental,
drainage module go wrong. contact our customer service
4. The board of the drainage module go department or your local distributor.
wrong.
5. Leakage occurs in waste pipes or the
pipes are twisted.
A11031 Wash station Error Insufficient vacuum / 1. The primary vacuum pump P08 goes 1. Check if the error is accidental.
degree of the primary wrong. 2. If the error is not accidental,
vacuum container 2. The primary vacuum sensor goes wrong. contact our customer service
3. The connectors and tubes go wrong. department or your local distributor.
4. The primary vacuum container goes
wrong.
5. Solenoid valves V21,V22,V23,V25 or V27
go wrong.
A11034 Wash station Error Wash syringe sensor is / The assembly is jammed or damaged. Switch off the analyzing unit power
in incorrect status and switch on it again. Recover
failure by performing the Home
maintenance procedure. If this
message appears for 3 times, contact
our customer service department or
your local distributor.

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Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A12005 Temperature Warning Reaction carousel T1 1. The ambient temperature is out of range. 1. Check if the error is accidental.
unit temperature is out of 2. The temperature sensor goes wrong. 2. If the error is not accidental,
range (component error and cable error) contact our customer service
TDISP temperature: 3. The temperature protection switch goes department or your local distributor.
TS01: wrong. (component error and cable error)
TS02: 4. The heater goes wrong. (component error
TS03:(Adjusted and cable error)
temperature ∆T for 3 5. PCB error
Pt1000 sensors) 6. Parameters are lost.
7. Electromagnetic interference exists.
A12006 Temperature Warning Temperature of wash / 1. The ambient temperature is out of range. 1. Check the temperature of the
unit solution for cleaning 2. The temperature sensor goes wrong. deionized water for cleaning the
cuvettes is out of (component error and cable error) whole unit.
range 3. The temperature protection switch goes 2. Check if the water supply is
Temperature: wrong. (component error and cable error) normal and has the temperature
4. The heater goes wrong. (component error between 15°C-30°C.
and cable error) 3. Check if the error is accidental.
5. PCB error 4. If the error is not accidental,
6. Parameters are lost. contact our customer service
department or your local distributor.
7. Electromagnetic interference exists.
A12007 Temperature Warning Temperature of / 1. The ambient temperature is out of range. 1. Check the temperature of the
unit deionized water for 2. The temperature sensor goes wrong. deionized water for cleaning the
cleaning cuvettes is (component error and cable error) whole unit.
out of range 3. The temperature protection switch goes 2. Check if the water supply is
Temperature: wrong. (component error and cable error) normal and has the temperature
4. The heater goes wrong. (component error between 15°C-30°C.
and cable error) 3. Check if the error is accidental.
5. PCB error 4. If the error is not accidental,
6. Parameters are lost. contact our customer service
department or your local distributor.
7. Electromagnetic interference exists.
A12009 Temperature Warning Internal temperature / 1. The ambient temperature is out of range. 1. Check if the air vent is blocked.
unit of the whole unit is 2. The cooling fan goes wrong. Clean the dust screen if it is blocked.

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Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
out of range 3. The dust screen is blocked. 2. Check if enough space is reserved
Temperature: 4. The air vent is blocked in the specified between the air vent and the wall. If
range. not, reallocate the instrument.
3. Check if the error is accidental.
4. If the error is not accidental,
contact our customer service
department or your local distributor.
A14006 Reagent Warning Reagent refrigeration / 1. The ambient temperature is out of range. 1. Check if the error is accidental.
refrigeration temperature is out of 2. The temperature sensor goes wrong. 2. If the error is not accidental,
unit range (component error and cable error) contact our customer service
3. The temperature protection switch goes department or your local distributor.
wrong. (component error and cable error)
4. The cooler goes wrong. (component error
and cable error)
5. The fan goes wrong. (component error
and cable error)
6. The recycle pump goes wrong.
(component error and cable error)
7. The refrigerant goes wrong.
8. PCB error
9. Parameters are lost.
10. Electromagnetic interference exists.
A14011 Temperature Warning Refrigeration / 1. The fan is blocked. 1. Check if the error is accidental.
unit Radiating Fan1 is 2. The fan is damaged. 2. If the error is not accidental,
abnormal 3. The power supply goes wrong. contact our customer service
department or your local distributor.
A14012 Reagent Warning Reagent refrigerating / 1. The fan is blocked. 1. Check if the error is accidental.
refrigeration fan 2 is abnormal 2. The fan is damaged. 2. If the error is not accidental,
unit 3. The power supply goes wrong. contact our customer service
department or your local distributor.
A14013 Reagent Error Light source fan is / The fan is blocked. 1. Check if the error is accidental.
refrigeration abnormal The fan is damaged. 2. If the error is not accidental,

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Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
unit The power supply goes wrong. contact our customer service
department or your local distributor.
A14014 Temperature Warning Vacuum pump fan is / 1. The fan is blocked. 1. Check if the error is accidental.
unit abnormal 2. The fan is damaged. 2. If the error is not accidental,
3. The power supply goes wrong. contact our customer service
department or your local distributor.
A21001 Probe Interior Error Sensor of probe / The assembly is jammed or damaged. Switch off the analyzing unit power
Wash Unit interior wash syringe and switch on it again. Recover
is in incorrect status. failure by performing the Home
maintenance procedure. If this
message appears for 3 times, contact
our customer service department or
your local distributor.
A22001 ISE unit 1. Reinstall the electrode.
2. Replace the calibrator.
1. Electrode installation incorrect. 3. Replace the problematic electrode
2. Calibrator expired. and rerun.
3. Electrode degenerated. 4. Remove the electrode and clap on
4. Bubbles in reference electrode. it to eliminate bubbles. Reinstall the
Slope out of range,
5. Reference electrode has been used for a electrode and run calibration.
electrode:%s long time. 5. Replace reference electrode and
6. Electrodes interfered. rerun.
7. Module or tubing temperature above 6. Troubleshoot the electrodes by
32℃. replacing them in different groups.
7. Monitor temperature, if too high,
Error SLEX relocate equipment.
A22002 ISE unit 1. Sample is insufficient or contain much 1.&2. Increase the sample volume.
bubbles after dispensing. At least 90μl sample should be
2. No or insufficient sample has been prepared.
Air in sample dispensed into the sample injection port. 3. Electrode is not installed
3. Liquid leakage due to that the electrodes correctly. Reinstall it.
are not properly installed. 4. Check the waste tube, and if
Error SMPA 4. The waste pump tube is aging or broken. necessary, replace it.
A22004 ISE unit Error ISE unit cannot be / 1. ISE power supply failure. 1. Replace the 24V power supply

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Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
connected. 2. ISE communication cable failure. board.
3. Communication interface or pins failure. 2. Replace the ISE communication
4. ISE main control board failure. cable.
3. Replace the interface or pins.
4. Replace the ISE main control
board.
A22005 ISE unit 1. Replace the ISE communication
cable.
1. ISE communication cable failure.
2. Replace the interface or pins.
ISE unit response 2. Communication interface or pins failure.
3. Replace the ISE main control
error 3. ISE main control board failure.
board.
4. Software failure.
4. Upgrade the operating software or
Error / reinstall it.
A22006 ISE unit 1. Reinstall the electrode and check
for O ring.
1. Leaks exist due to improperly-installed
2. Use warm water to clean and
electrode or missing O ring.
unclog the sample injection port
2. Sample injection port or electrode inside
with fresh water and unclog the
is clogged.
electrode tube. Check the reference
Purge A and B failed. 3. Calibrator is exhausted.
electrode for crystallized salt.
4. Prime combinations are not enough.
3. Replace the reagent pack.
5. Pump tube is aging, blocked, or broken.
4. Increase the prime cycle.
6. Calibrator cannot be dispensed normally
5. Replace the pump tube.
due to clogged reagent pack tube.
6. Unclog the reagent pack tube with
Error / warm water.
A22007 ISE unit ISE reagent is going to Replace the reagent pack with a new
Calibrator is exhausted.
Warning be exhausted. / one.
A22008 ISE unit 1. Replace the problematic electrode
1. Electrode or reagent pack failed. and reagent pack.
2. Electrode is unsteady. 2. New electrode will become steady
Na+ electrode
3. New reagent pack is unsteady. after 15 minutes since installed.
voltage overflow,
4. Reference electrode has been used for 3. Run a couple of calibrations after
electrode: %s
over 6 months. installing new reagent pack.
5. ISE main control board failure. 4. Replace the reference electrode.
Error VOUT 5. Replace the ISE main control

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 17 Alarms and Troubleshooting

Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
board.
A22009 ISE unit 1. Replace the problematic electrode
and reagent pack.
1. Electrode or reagent pack failed. 2. New electrode will become steady
2. Electrode is unsteady. after 15 minutes since installed.
Electrode slope drift. 3. New reagent pack is unsteady. 3. Run a couple of calibrations after
Electrode voltage 4. Reference electrode has been used for installing new reagent pack.
drift. over 6 months. 4. Replace the reference electrode.
Electrode: 5. ISE main control board failure. 5. Replace the ISE main control
6. Ambient temperature fluctuates board.
drastically. 6. Control the ambient temperature
VDRF/ to make the fluctuation within
Error SLDR +/-4℃.
A22010 ISE unit 1. Electrode failure. 1. Replace the electrode.
2. Environment interference. 2. Relocate the instrument.
Voltage noise,
3. ISE main control board failure. 3. Replace the ISE main control
electrode: %s
4. Salt buildup around electrodes or tubes board.
Error NOIS due to fluidic leaks. 4. Clean the tubes and electrodes.
A22011 ISE unit 1. Calibrator B is exhausted. 1. Replace the reagent pack with a
2. Bubbles exist in calibrator tube B. new one.
3. Pump tube B is aging, blocked, or broken. 2. Perform purge B to remove
4. Waste pump tube B is aging, blocked, or bubbles.
Air in calibrator B
broken. 3.&4. Replace the pump tube.
5. Sample injection port and fluidic path are 5. Clean the sample injection port
blocked or leaking. and reinstall electrodes.
Error PUGB 6. Air bubble detector is failed. 6. Replace the air bubble detector.
A22012 ISE unit 1. Calibrator A is exhausted. 1. Replace the reagent pack with a
2. Bubbles exist in calibrator tube A. new one.
3. Pump tube B is aging, blocked, or broken. 2. Perform purge A to remove
4. Waste pump tube B is aging, blocked, or bubbles.
Air in calibrator A
broken. 3.&4. Replace the pump tube.
5. Sample injection port and fluidic path are 5. Clean the sample injection port
blocked or leaking. and reinstall electrodes.
Error PUGA 6. Air bubble detector is failed. 6. Replace the air bubble detector.

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17 Alarms and Troubleshooting

Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A22013 ISE unit 1. Pump tube is aging.
Pump calibration
2. Sample probe aspiration/dispensing 1. Replace the pump tube.
result error
Error / failure. 2. Replace the sample probe.
A22014 ISE unit 1. Air bubble detector board is eroded due
Air bubble detector to the leaks at the joint of sample injection
failure port and bubble detector.
Error / 2. Air bubble detector is failed. Replace the bubble detector.
A22015 ISE unit Reading reagent pack 1. Reagent pack is not installed. 1. Install reagent pack.
Error chip error / 2. Reagent pack wand is failed. 2. Replace the wand.
A22016 ISE unit Writing reagent pack 1. Reagent pack is not installed. 1. Install reagent pack.
Error chip error / 3. Reagent pack wand is failed. 3. Replace the wand.
A22017 ISE unit 1. ISE wash solution is insufficient.
2. Waste pump tube B is aging, blocked, or 1. Place sufficient ISE wash solution.
Air in ISE wash broken. 2. Replace the pump tube.
solution 3. Sample injection port and fluidic path are 3. Clean the sample injection port
blocked or leaking. and reinstall electrodes.
Error / 4. Air bubble detector is failed. 4. Replace the air bubble detector.
A22018 ISE unit 1. Waste pump tube B is aging, blocked, or
broken. 1. Replace the pump tube.
No fluid in tubing 2. Sample injection port and fluidic path are 2. Clean the sample injection port
blocked or leaking. and reinstall electrodes.
Error CALF 3. Air bubble detector is failed. 3. Replace the air bubble detector.
A22019 ISE unit 1. Replace the ISE communication
cable.
1. ISE communication cable failure.
2. Replace the interface or pins.
Saving calibration 2. Communication interface or pins failure.
3. Replace the ISE main control
result error 3. ISE main control board failure.
board.
4. Software failure.
4. Upgrade the operating software or
Error DEP reinstall it.
A22021 ISE unit 1. ISE communication cable failure. 1. Replace the ISE communication
Command format or 2. Communication interface or pins failure. cable.
execution error 3. ISE main control board failure. 2. Replace the interface or pins.
Error RESP 4. Software failure. 3. Replace the ISE main control

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 17 Alarms and Troubleshooting

Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
board.
5. Upgrade the operating software or
reinstall it.
A22022 ISE unit 1. Waste pump tube B is aging, blocked, or
broken. 1. Replace the pump tube.
Air in segment 2. Sample injection port and fluidic path are 2. Clean the sample injection port
blocked or leaking. and reinstall electrodes.
Error CALM 3. Air bubble detector is failed. 3. Replace the air bubble detector.
A22023 ISE unit No reagent module 1. Reagent pack is not installed. 1. Install reagent pack.
Error /
has been loaded. 2. Reagent pack wand is failed. 2. Replace the wand.
A22024 ISE unit 1. The communication wire between ISE and 1.Replace the communication wire
the middle-layer unit goes wrong. 2.Change the interface or the pin.
ISE response check 2. Communication interface or pin error.
Error RESP 3.Change the main control board.
code error 3.Main control board does not function. 4.Upgrade the software or reinstall
4.Software error the software.
A22025 / 1. Check the connection of the serial
port wire.
2. Remove and replug in the serial
port wire.
3. Check whether the power supply
of the analyzer is on.
Equipment cannot be
1. The serial port wire is not connected 4. Perform the Home procedure.
Error connected /
2. The power supply of the analyzer is off. 5. Reboot the PC and the analyzer.
Unit:
6. If the error still remains for
continuous three times after the
above procedures have been
performed, please contact our
customer service or your local
distributor.
A22026 / Configuring key 1. Turn off the analyzing unit power
parameters failed. and reswitch it on.
Error / Key parameters are not configured
Unit: %s 2. If the error occurs for continuous
three times, please contact our

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17 Alarms and Troubleshooting

Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
customer service or your local
distributor.
A22027 / 1. Turn off the analyzing unit power
and reswitch it on.
Error Fluidic prime failed. / Fluidic is not primed. 2. If the error occurs for continuous
three times, please contact our
customer service or your local
distributor.
A22028 / 1.Downloading key parameters failed. 1. Turn off the analyzing unit power
and reswitch it on.
Downloading key 2. Reading the parameters from E2ROM
Error / 2. If the error occurs for continuous
parameters failed. failed.
Unit: three times, please contact our
3.Configuring the parameters of the smart customer service or your local
module failed. distributor.
A22029 / 1. Turn off the analyzing unit power
and reswitch it on.
Collecting dark 2. If the error occurs for continuous
Error / Collecting dark current failed.
current failed. three times, please contact our
customer service or your local
distributor.
A22030 / 1. Turn off the analyzing unit power
and reswitch it on.
Discharging primary 2. If the error occurs for continuous
Error / Discharging primary vacuum waste failed.
vacuum waste failed. three times, please contact our
customer service or your local
distributor.
A22031 / 1. Turn off the analyzing unit power
and reswitch it on.
Establishing vacuum 2. If the error occurs for continuous
Error / Establishing vacuum failed.
failed. three times, please contact our
customer service or your local
distributor.
A22032 / Error Floater status error: / 1. Low level floater status of the water tank 1. Check the water unit and the

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 17 Alarms and Troubleshooting

Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
Floater: is full. water supply tubes.
2. The floater status of the diluted wash 2. Check the floater status of the
solution container is full. water tank, diluted wash solution
3. The floater status of the concentrated container, concentrated wash
wash solution container is full. solution container, low concentration
4. The floater status of the low waste container and the high
concentration waste container is empty. concentration waste container
5. The status of the primary vacuum 3. Check the status of the primary
container is empty. vacuum container.
6. The status of the high concentration 4. Check if the error is accidental.
waste container is empty. 5. If the error is not accidental,
contact our customer service
department or your local distributor.
A22033 / 1. Turn off the analyzing unit power
and reswitch it on.
Resetting probe
Error interior wash syringe / Resetting probe interior wash syringe failed. 2. If the error occurs for continuous
three times, please contact our
failed.
customer service or your local
distributor.
A22034 / 1. Turn off the analyzing unit power
and reswitch it on.
Resetting auto wash 2. If the error occurs for continuous
Error / Resetting auto wash syringe failed.
syringe failed. three times, please contact our
customer service or your local
distributor.
A22035 / 1. Turn off the analyzing unit power
1.Electromagnetic Valve V23,V24,V25,V26 and reswitch it on.
Releasing vacuum or V27 failure 2. If the error occurs for continuous
Error /
failed. 2. Vacuum pump failure three times, please contact our
3. Vacuum sensor failure customer service or your local
distributor.
A22036 / Initializing sample Sample bar code reader failed due to system 1. Recover failure by performing the
Error /
bar code reader error. Home maintenance procedure.

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17 Alarms and Troubleshooting

Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
failed. 2. If this error remains
contact our customer service
department or your local distributor.
A22037 / 1. Recover failure by performing the
Initializing reagent Home maintenance procedure.
Reagent bar code reader failed due to
Error bar code reader / 2. If this error remains
system error.
failed. contact our customer service
department or your local distributor.
A22038 / 1. Turn off the analyzing unit power
and reswitch it on.
Scanning reagent bar 2. If the error occurs for continuous
Error / Scanning reagent bar code failed.
code failed. three times, please contact our
customer service or your local
distributor.
A22039 / 1. Turn off the analyzing unit power
1.Version inquiry instruction failed. and reswitch it on.
Unmatched software 2. The version information of the control 2. If the error occurs for continuous
Error /
version. software does not match the one stored in three times, please contact our
the operating software. customer service or your local
distributor.
C00007 Operating Error CPU performance low / The CPU is too busy. Reboot the computer and operating
system software. If this message appears for
3 times, contact our customer
service department or your local
distributor.
C00011 Operating Error The last abnormal / The operating software is abnormal, or the Restart the operating software, and
system exit may cause instrument power is cut off unexpectedly. execute the Special Wash
carryover not maintenance command before
handled. Execute the starting analysis.
Special Wash
maintenance
command before
starting analysis to

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Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
ensure accurate
results.
C00012 Operating Warning Sound card failure / No sound card is installed. Sound card Reinstall the sound card or the sound
system failure. Incorrect sound card driver. card driver.
C01001 Instrument Error Equipment cannot be / The serial cable is not connected; or the Check the serial port connection.
connection connected analyzing unit power is switched off. Replug the cable. Check if the
analyzing unit is powered on. Start
the initialization again. Restart the
computer and analyzing unit. If three
continuous attempts are failed,
contact our customer service
department or your local distributor.
C02001 Database Error Database initialing / The database file is damaged or lost. Reboot the computer and analyzing
failed unit. If three continuous attempts
are failed, contact our customer
service department or your local
distributor.
C02002 Database Error Database upgrade / The database file is damaged or lost. Reboot the computer and analyzing
failed unit. If three continuous attempts
are failed, contact our customer
service department or your local
distributor.
C02004 Database Warning Database backup / The database file is damaged or lost. Reboot the computer and analyzing
failed unit. If three continuous attempts
are failed, contact our customer
service department or your local
distributor.
C02005 Database Warning Reading/Writing / The database does not work normally. Reboot the computer and analyzing
database failed unit. If three continuous attempts
are failed, contact our customer
service department or your local
distributor.
C03001 Result Warning Result cannot be RCE Absorbance data for calculation is Rerun the test. If the error remains,

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Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
calculation calculated incomplete, or the dividend is 0. contact our customer service
Sample ID/bar code: department or your local distributor.
Position:
Chemistry:
C03002 Result Warning Absorbance out of ABS The absorbance measured at the primary Check the sample for foreign matters
calculation range and secondary wavelength is greater than or interferents; check if the reagent
Sample ID/bar code: 3.4A. is qualified and placed in the correct
Position: position; check the cuvette is clean;
check if the photometric system is
Chemistry:
working normally. If the problem
remains, contact our customer
service department or your local
distributor.
C03003 Result Warning R1 blank absorbance RBK The reagent goes wrong; the cuvette is not Check if the reagent is sufficient
calculation out of range clear; the reaction cuvette is overflowed; or without air bubbles and the
Sample ID/bar code: insufficient reagent is dispensed. chemistry parameters are
Position: reasonable. If yes, replace the
reagent and then rerun the test.
Chemistry:
Check if the cuvette is normal. If the
error remains, contact our customer
service department or your local
distributor.
C03004 Result Warning Substrate depletion BOE The sample concentration is too high, and Check the reaction curve and the
calculation Sample ID/bar code: substrate depletion occurs during fixed-time substrate depletion limit. Rerun the
Position: measurements. test with diluted sample.
Chemistry:
C03005 Result Warning Result cannot be ENC The sample concentration is too high, and Check the reaction curve and the
calculation calculated substrate depletion occurs within the lag substrate depletion limit. Rerun the
Sample ID/bar code: time of rate check measurements. test with diluted sample.
Position:
Chemistry:
C03006 Result Warning Linearity limit out of LIN The measuring points for result calculation Check the reaction curve and the
calculation range are nonlinear, because the sample substrate depletion limit. Rerun the

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Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
Sample ID/bar code: concentration is too high, or the substrate test with diluted sample.
Position: depletion limit is not specified or
Chemistry: unreasonable.
C03007 Result Warning Prozone check error PRO Antibody excess occurs due to too high Check the reaction curve and the
calculation Sample ID/bar code: sample concentration. prozone check parameters. Rerun
Position: the test with diluted sample.
Chemistry:
C03008 Result Warning Sample concentration RRN The sample concentration exceeds the high Rerun the test with diluted sample.
calculation is higher than that of limit of the calibrator concentration.
the highest-level
calibrator
Sample ID/bar code:
Position:
Chemistry:
C03009 Result Warning Mixed blank MBK The reagent goes wrong; the cuvette is not Check if the reagent is sufficient
calculation absorbance out of clear; the reaction cuvette is overflowed; or without air bubbles and the
range insufficient reagent is dispensed. chemistry parameters are
Chemistry: reasonable. Check if the cuvette is
Calibrator: normal. Replace the reagent and
then rerun the test. If the error
Position:
remains, contact our customer
service department or your local
distributor.
C03010 Result Warning Blank response out of BLK The reagent goes wrong; insufficient Check if the reagent is sufficient
calculation range reagent is dispensed; the cuvette contains without air bubbles and the
Chemistry: air bubbles; the light drifts; or the cuvette is chemistry parameters are
Calibrator: overflowed. reasonable. Check if the cuvette is
normal. Replace the reagent and
Position:
then rerun the test. If the error
remains, contact our customer
service department or your local
distributor.
C03011 Result Warning Calibration DUP The difference between the maximum and Check if the acceptance limit is

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17 Alarms and Troubleshooting

Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
calculation repeatability exceeds minimum response of the calibrator exceeds reasonable, troubleshoot the error,
limit. Chem: the specified limit. and then recalibrate.
C03012 Result Warning Calibration sensitivity SEN The difference of final response of the Check if the acceptance limit is
calculation exceeds limit. maximum and minimum concentration reasonable and the reagent and
Chem: calibrators exceeds the specified limit. calibrator are normal, and then
recalibrate.
C03013 Result Warning Calibration curve CSD The calculated standard deviation of the Check if the acceptance limit is
calculation standard deviation calibration curve exceeds the specified reasonable and the reagent and
out of range limit. calibrator are normal, and then
Chemistry: recalibrate.
Calibrator:
Position:
C03014 Result Warning Calibration DET The calculated determination coefficient of Check if the acceptance limit is
calculation determination the calibration curve exceeds the specified reasonable and the reagent and
coefficient out of limit. calibrator are normal, and then
range recalibrate.
Chemistry:
Calibrator:
Position:
C03015 Result Warning Calibration slope FAC The slope difference is applicable to linear Check if the acceptance limit is
calculation difference out of calibration only and refers to the K factor reasonable and the reagent and
range (slope) difference between two adjacent calibrator are normal, and then
Chemistry: calibrations. It exceeds the specified limit. recalibrate.
Calibrator:
Position:
C03016 Result Warning Calibration curve not MON The calibration data and calibration curve Check if the calibrator is defined and
calculation monotonic are not monotonic. placed correctly, and then
Chemistry: recalibrate.
Calibrator:
Position:
C03017 Result Warning Calibration curve not COV For nonlinear calibration, a satisfying base Check that the reagent and
calculation convergent cannot be calculated and no calibration calibrator are normal, and then

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 17 Alarms and Troubleshooting

Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
Chemistry: curve is drawn. recalibrate. If the error remains,
Calibrator: contact our customer service
Position: department or your local distributor.
C03018 Result Warning Chemistry: 1-2s The QC result is between ±2 and ±3 standard No actions are required.
calculation Control: 1-2s warning deviations from the assigned mean
concentration.
C03019 Result Warning Chemistry: 1-3s The QC result is greater than ±3 standard Check if the reagent is qualified and
calculation Control: 1-3s out of deviations from the assigned mean control is normal. If the error
control concentration. remains, contact our customer
service department or your local
distributor.
C03020 Result Warning Chemistry: 2-2s Results of two controls or two results of one Check if the reagent is qualified and
calculation Control: 2-2s out of control within a run are simultaneously control is normal. If the error
control greater than +2 or -2 standard deviations remains, contact our customer
from the assigned mean. service department or your local
distributor.
C03021 Result Warning Chemistry: R-4s One result of a run is greater than +2 Check if the reagent is qualified and
calculation Control: R-4s out of standard deviations from the assigned mean control is normal. If the error
control and the other greater than -2SDs. remains, contact our customer
service department or your local
distributor.
C03022 Result Warning Chemistry: 4-1s Results of two runs in two-control Check if the reagent is qualified and
calculation Control: 4-1s out of evaluation or four continuous results of a control is normal. If the error
control control are greater than +1 or -1 standard remains, contact our customer
deviation from the assigned mean service department or your local
concentration. distributor.
C03023 Result Warning Chemistry: 10-x Results of five runs in two-control Check if the reagent is qualified and
calculation Control: 10-x out of evaluation or ten continuous results of a control is normal. If the error
control control that are being compared are on the remains, contact our customer
same side. service department or your local
distributor.
C03024 Result Error Biochemistry test / 1. Software error Rerun the test. Reboot the operating
calculation period time out. 2. Operating system error software, analyzing unit and

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17 Alarms and Troubleshooting

Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
Cannot continue computer. If the error remains,
contact our customer service
department or your local distributor.
C03026 Result Warning Photoelectric data is / Communication error. If the error persists, contact our
calculation lost customer service department or your
local distributor.
C03030 Result Error Photoelectric / 1. Software error 1. Rerun the operating software.
calculation measurement period 2. Reboot the operation unit.
is out of range 3. If the error remains, contact our
Sample ID/bar code: customer service department or your
Position: local distributor.
Chemistry:
C03031 Result Error Multiple / 1. Software error 1. Rerun the operating software.
calculation photoelectric 2. Reboot the operation unit.
measurements are 3. If the error remains, contact our
time out customer service department or your
Sample ID/bar code: local distributor.
Position:
Chemistry:
C04001 Sample bar Warning Duplicate sample bar / Duplicate bar code is used. Replace the duplicate sample bar
code code. code label.
Sample ID/bar code:
Position 1:
Position 2:
C04002 Sample bar Warning Bar code has no / The sample of the bar code has not been Program the sample of the bar code.
code corresponding programmed.
programming.
Sample ID
bar code: Position:
C04006 Sample bar Warning Sample is expired / The sample is loaded after its shelf life is The sample is expired. Replace the
code Sample ID/bar code: exceeded. sample and program it again. Reject
Position: the expired sample. If the sample

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 17 Alarms and Troubleshooting

Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
shelf life is too short, change it to a
reasonable one.
C04008 Sample bar Warning Sample bar code too / The bar code length is greater than the Redefine the bar code with no more
code long. Position: maximum value of 27 digits. than 27 digits.
C04009 Sample bar Warning Sample bar code is / The sample bar code is too short, less than Reprint the bar code and ensure it is
code less than 3 digits. the minimum range of 3 digits. no less than 3 digits.
position:
C04012 Sample bar Warning Sample bar code / Barcode information does not conform with Reset the barcode format or reprint
code analysis error the barcode format the barcode and scan it.
Sample bar code:
Position:
C05001 Reagent bar Warning Duplicate reagent bar / Incorrect reagent or reagent bar code is Reprint the reagent bar code, or
code code being used, or an invalid reagent bar code is replace the reagent bottle with an
Reagent: being used. Bar code is aligned with invalid bar code.
Position 1: reagents, and cannot be used again for new
reagent when a reagent is exhausted.
Position 2:
C05002 Reagent bar Warning Reagent bar code / Incorrect reagent bar code is being used, or Print the new reagent bar code with
code information error. reagent bar code is not configured correct settings and check the bar
Position: reasonably. The reagent bar code contains code against the settings. Replace
incomplete or incorrect reagent the reagent bottle, or contact the
information, such as expiration date, reagent supplier.
reagent volume, etc.
C05003 Reagent bar Warning Reagent bar code / Incorrect reagent bar code is being used, or Check the reagent bar code settings,
code analysis error reagent bar code settings are incorrect. The or reprint the reagent bar code
Position: system is failed to extract reagent against the settings. Contact the
information from the bar code. reagent supplier.
C05006 Reagent bar Error Wash solution / Reagent rather than wash solution is placed Reposition the reagent, or remove it
code position on reagent in the fixed wash solution position (D) on from the fixed reagent position.
carousel is occupied reagent carousel.
by another reagent
Position:
C05008 Reagent bar Error Physiological saline / Reagent rather than physiological saline is Reposition the reagent, or remove it

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17 Alarms and Troubleshooting

Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
code position on reagent placed in the fixed physiological saline from the fixed wash solution
carousel is occupied position (W) on reagent carousel. position.
by another reagent
Position:
C06001 Host Error LIS initialization error / Host file is damaged or does not exist. Reinstall the operating software.
communication
C06002 Host Error LIS communication / Host parameters error Re-set or modify the host
communication parameter error communication parameters.
C06003 Host Error LIS communication / Communication error If the error occurs accidentally, send
communication error or receive the instruction again. If
the error still remains, contact our
customer service department or your
local distributor.
C06004 Host Error LIS host cannot be / Abnormal network connection or the LIS Check LIS connection and network
communication connected host is not started. cable. Check if LIS host and LIS
station can start normally.
C06005 Host Warning Sending sample / Communication error If the error occurs accidentally, send
communication results failed. or receive the instruction again. If
Sample ID/bar code: the error still remains, contact our
Position: customer service department or your
local distributor.
C06006 Host Warning Sending sample / Communication error If the error occurs accidentally, send
communication information failed. or receive the instruction again. If
Sample ID/bar code: the error still remains, contact our
Position: customer service department or your
local distributor.
C06007 Host Warning Inquiring sample / LIS host failure. If the error occurs accidentally,
communication information failed. neglect it. If the error occurs
Sample ID/bar code: frequently, contact the
Position: manufacturer of LIS or contact our
customer service department or your
local distributor.
C06008 Host Warning Downloading sample / Incorrect channel settings or insufficient or Check and re-set the chemistry

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 17 Alarms and Troubleshooting

Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
communication failed. redundant chemistries on the LIS host. correspondence between the
Sample ID/bar code: operating software and the LIS host.
Position:
C07003 Light source Error Light intensity is too / 1. The lamp is not installed correctly. 1. Check if the lamp is installed
weak 2. The cuvette is contaminated. correctly.
3. The lamp is aging. 2. Perform the diluted wash
4. The wash station dispenses liquid procedure and then the lamp check
incorrectly. procedure.
3. Replace the lamp.
4. Check if the wash station
dispenses liquid with correct volume
to reaction cuvettes.
5. If your attempt is failed, contact
our customer service department or
your local distributor.
C07004 Light source Warning Cuvette blank out of / 1. The cuvette is contaminated. 1. Open the reaction carousel and
range 2. The lamp is aging. check if the lamp is turned on. If it is
Cuvette No.: 3. The lamp is not installed correctly. not, rerun the operating software.
4. The wash station dispenses liquid 2. Check if the lamp is installed
incorrectly. correctly.
5. The photoelectric collection board goes 3. Perform the diluted wash
wrong. procedure and then the cuvette
check procedure.
4. Replace or clean the failed
cuvette.
5. Replace the lamp.
6. Check if the wash station
dispenses liquid with correct volume
to reaction cuvettes.
7. If your attempt is failed, contact
our customer service department or
your local distributor.
C07005 Light source Error Lamp is not turned on / 1. The lamp is damaged. 1. Open the reaction carousel and

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17 Alarms and Troubleshooting

Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
2. The lamp cable is not connected properly. check if the lamp is turned on. If it is
3. The power board of the lamp is not not, rerun the operating software.
connected properly. 2. Check if the lamp cable is
4. The power supply of the analyzing unit is tightened.
disconnected. 3. Replace the lamp.
5. The photoelectric collection board goes 4. Check if the connect of the lamp
wrong. power board is loose, and if
necessary, reinsert the connector.
5. If your attempt is failed, contact
our customer service department or
your local distributor.
C07006 Light source Error Light intensity is too / 1. A cuvette position has no cuvette 1. Check if all cuvette positions have
strong installed. cuvettes installed.
2. The circuit gain is too high and beyond 2. Contact our customer service
the measurement range. department or your local distributor
to adjust the gain.
C07007 Light source Error Dark current is too / 1. The circuit gain is too high and beyond 3. If three continuous attempts are
high the measurement range. failed, contact our customer service
Channel: 2. The power board of the lamp is not department or your local distributor.
AD: connected properly.
3. The photoelectric collection board goes
wrong.
C07008 Light source Warning Lamp has exceeded / 1. The lamp has been used for over 2000 1. Replace the lamp.
its life span. Replace hours. 2. Perform the Replace Lamp
it immediately. 2. The lamp has been replaced incorrectly. maintenance procedure again.
C07009 Light source Error Water blank out of / 1. The cuvette is overflowing. 1. Check if the cuvette is
range (10X) 2. The lamp has been replaced incorrectly. overflowing.
3. Cuvette check is not performed after 2. Check if the Replace Lamp
maintenance. command is executed during lamp
4. The cable connectors are not tightened. replacement.
5. The retaining screw is not tightened. 3. Check if the Cuvette Check
command is executed after
6. Cleaning liquid inside the cuvette is little.
maintenance.

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 17 Alarms and Troubleshooting

Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
7. The lamp is aged. 4. Check if the cleaning liquid inside
8. The photometer goes wrong. the cuvette is no less than half of the
cuvette.
5. Check if the cable connectors and
retaining screw of the lamp have
been tightened.
6. Check if the reaction curve
fluctuates irregularly. If yes, replace
the lamp.
7. If the error remains, contact our
customer service department.
C07012 Other error of Warning Storage device error. / No U disk is inserted. No file is found in the Check if a U disk is inserted or full.
operation unit Cannot import data U disk, or file error, or file is damaged. The Check if the storage device is
U disk is locked or damaged. damaged.
C07013 Other error of Warning Storage device error. / No U disk is inserted. Insufficient disk space. Check if a U disk is inserted or full.
operation unit Cannot export data The U disk is locked or damaged. Check if the storage device is
damaged.
C07014 Other error of Warning Reagent exhausted / All reagents of the reagent type for the Refill or replace the reagent.
operation unit Chemistry: chemistry are less than the minimum limit.
Position: All reagents of the type are too little to be
detected.
C07016 Other error of Warning Insufficient wash / Insufficient wash solution on the reagent Refill the wash solution on the
operation unit solution carousel. reagent carousel.
Position:
C07017 Other error of Warning Wash solution is / The wash solution on the reagent carousel is Refill the wash solution on the
operation unit exhausted exhausted. reagent carousel.
Position:
C07022 Other error of Warning Less than X tests are / All reagents of the reagent type for the Refill or replace the reagent.
operation unit left in biochemistry chemistry are less than the minimum limit.
reagent All reagents of the type are too little to be
Chemistry: detected.
Position:

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17 Alarms and Troubleshooting

Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
C07023 Other error of Warning Chemistry: %s, 30 / The calibration factors will be expired. Recalibrate the chemistries.
operation unit minutes left for next
calibration.
C07027 Other error of Warning Calibrator %s has / The calibrator is expired. Replace the calibrator.
operation unit been expired
C07028 Other error of Warning Chemistry: %s, lot / The reagent is expired. Replace the reagent.
operation unit No.: %s, position: %s,
has been expired
C07029 Other error of Warning Chemistry: %s, lot / The uncapping time of the reagent pack is Replace the reagent.
operation unit No.: %s, too long.
position: %s, has
exceeded the
uncapping time
C07034 Other error of Warning Insufficient / Insufficient physiological saline. Refill the physiological saline on the
operation unit physiological saline reagent carousel.
Position:
C07035 Other error of Warning Physiological saline is / Physiological saline is exhausted. Refill the physiological saline on the
operation unit exhausted reagent carousel.
Position:
C07036 Other Warning Chemistry: %s. / The calibration factors have been expired. Recalibrate the chemistry.
Calibration factors
are expired
C07037 Other Warning Reagent bottle / Serial number of the reagent is changed. Recalibrate the chemistry.
number of %s
chemistry is changed.
Please recalibrate
C07038 Other Warning Reagent lot number / Lot number of the reagent is changed. Recalibrate the chemistry.
of %s chemistry is
changed. Please
recalibrate
C07039 Other Warning Calibration factors / The calibration factors are expired. Recalibrate the chemistry.
of %s chemistry are

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 17 Alarms and Troubleshooting

Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
expired. Recalibrate
C07040 Other Warning Reagent exhausted / The reagent is running out. Refill or replace the reagent.
Chemistry: The reagent is too little to be detected.
C07041 Other Error ISE reagent is less / ISE reagent inventory is below the alarm Check the inventory. If the reagent is
than %s limit insufficient, load the reagent.
C07042 Other Warning %s, lot number: %s, / Solutions and reagents other than Replace the expired reagents or
position: %s, has been biochemical reagents are expired. solutions.
expired

17-59
17 Alarms and Troubleshooting

17-60
18 Template Modifying Software

The Template Modifying Software is affiliated with the Operating

Software and used to create or edit print templates, which illustrate the
contents and format of patient reports.
The Template Modifying Software can be started separately or together
with the Operating Software. To start the Template Modifying Software,
select the Edit button on the Print page of the operating software.
The following sections introduce the Template Modifying Software by
menus and toolbars.

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18 Template Modifying Software

18.1 Main Screen

18.1.1 Main Screen
The following figure shows the main screen of the Template Modifying
Software.
Figure 18.1 Main screen

18.1.2 File (F)

The File menu is used to create, save, import/export and print out the
templates. Select File on upper-left corner of the main screen. The File
menu is displayed.

The following table explains the menu in detail.

Option Description
New Select New to create a template. The type of the template is
determined by the report that is currently selected on the report
window.
You can also use the shortcut key Ctrl+N instead.
After changing the currently-displayed template, select New to
display the following dialog box.

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 18 Template Modifying Software

Option Description

 Select Yes to save the changes and create a template.

 Select No to cancel the changes and create a template.
 Select Cancel to abort creating and return to the previous
screen.
Save Select Save to save the newly-created template or the changes
to a template.
You can also use the shortcut key Ctrl+S instead.
To save a new template, you should define the template name:

 Enter the name in the edit box.

 Select OK to save the template and add the name to the
template list on the report window.
 Select Cancel to abort saving and return to the previous
screen.
If a template with the same name already exists, the following
dialog box pops up.

 Select Yes to overwrite the template.

 Select No to cancel saving and return to the previous screen.
Save As Save the current template with another name.
If a template with the same name already exists, a dialog box

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18 Template Modifying Software

Option Description
appears to ask for your confirmation.

Preview Select this option to view the template exactly as it will be

printed out.
The main screen will be hidden when you preview a template.
The tool bar on the Preview window is as follows.

 If the template has more than one page, and are

available.
 : Go to the first page.
 : Go to the previous page.
 : Go to the specified page.
 : Go to the next page.
 : Go to the last page.

 : Select to expand the template view among 25%, 50%, 75%

and 100%. The default is 100%.

 : Select to shrink the template view.

 : Print out the template. It is equivalent to the Print

option in the File menu.

 : Select to exit the preview window and return to the

template.
Exit Select this option to close the Template Modifying Software.
You can use the shortcut key Alt+F4 instead.
If the template is changed, the following dialog box pops up.

 Select Yes to save the changes and exit the software.

 Select No to exit the software without saving the changes.
 Select Cancel to abort exiting and return to the previous
screen.

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 18 Template Modifying Software

18.1.3 Edit (E)

The Edit menu provides the functions like cut, copy, paste and delete.
Select Edit on the menu bar of the main screen. The Edit menu is
displayed.

NOTE
The control(s) you have cut or copied can only be pasted on the current Template
Modifying Software rather than another one or other software.

The following table explains the menu in detail.

Option Description
Cut Select this option to copy and delete single or multiple
controls.
You can use the shortcut key Ctrl+X instead.
This option is available only when a control(s) is selected.
Copy Select this option to copy single or multiple controls.
You can use the shortcut key Ctrl+C instead.
This option is available only when a control(s) is selected.
Paste Select this option to paste the controls that are previously cut
or copied at the same place as where the controls are from.
You can use the shortcut key Ctrl+P instead.
This option is available only when a control(s) is cut or
copied.
Delete Select this option to delete single or multiple controls
You can use the shortcut key Ctrl+D instead.
This option is available only when a control(s) is selected.

18.1.4 View (V)

The View menu is used to enable or disable the toolbars and to set up the
displaying proportion. Select View on the menu bar of the main screen.
The View menu is displayed.

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18 Template Modifying Software

The following table explains the menu in detail.

Option Description
Common Enable or disable the common toolbar.
Tool
Draw Tool Enable or disable the draw toolbar.
Property Enable or disable the property window.
Window
Report Enable or disable the report window.
Window
Status Bar Enable or disable the status bar.
25%-200% Select a proportion to display the template. The default is
100%.

NOTE
You are recommended to select 100% when saving a template.

18.1.5 Insert (I)

The Insert menu is used to create controls in the editing page. Select
Insert on the menu bar of the main screen. The Insert menu is displayed.

Only one option on the Insert menu can be selected simultaneously.

Option Description

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 18 Template Modifying Software

Option Description
Select
Select this option to change the mouse pointer to a .
When the mouse pointer changes to a , you can select single
or multiple controls in the editing area.

NOTE
Selecting a control while holding the Ctrl key copies the
control.

Line Select this option to insert a line in the editing area. The mouse
pointer changes into a +. Click once in the editing area and drag
the mouse to draw a line.
Rectangle Select this option to insert a rectangle in the editing area. The
mouse pointer changes into a +. Click once in the editing area
and drag the mouse to draw a rectangle.
Label Select this option to insert a label in the editing area. The
mouse pointer changes into a +. Click once in the editing area
and drag the mouse to draw a label.
Label is a type of text control and the contents on a label will
not change when printed.
Text Select this option to insert a text control in the editing area.
The mouse pointer changes into a +. Click once in the editing
area and drag the mouse to create a text.
The contents in a text control will be replaced by the actual
test data when printed.
Title Select this option to insert a title in the editing area. The
mouse pointer changes into a +. Click once in the editing area
and drag the mouse to create a title.
Title is a type of text control. The “%s” will be replaced by a
hospital name when printed. Please note “%s” is added by user
and not produced automatically.
Image Select this option to insert an image in the editing area. The
mouse pointer changes into a +. Click once in the editing area
and drag the mouse to create an image.
The image on the template is for illustration only and will be
replaced by corresponding curve graph when printed.

18.1.6 Format (M)

The Format menu is used to arrange the controls on a template. Select
Format on the menu bar of the main screen. The Format menu is
displayed.

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18 Template Modifying Software

The following table explains the menu in detail.

Option Description
Left Align the specified controls with the left of the
lastly-selected control.
Right Align the specified controls with the right of the
lastly-selected control.
Top Align the specified controls with the top side of the
lastly-selected control.
Bottom Align the specified controls with the bottom side of the
lastly-selected control.
Center H Align one or multiple controls to the horizontal center of
current template.
Center V Align one or multiple controls to the vertical center of
current template.
Even Space Arrange three or more controls with same space horizontally.
H
Even Space Arrange three or more controls with same space vertically.
V
Same Width Adjust the specified controls to the same width as the
lastly-selected control.
Same Adjust the specified controls to the same height as the
Height lastly-selected control.
Same Size Adjust the specified controls to the same width and height as
the lastly-selected control.

18.1.7 Set(S)
The Set menu only includes an option, Print ID. See the figure below.

Select Print ID. The Set Print ID dialog box is displayed. You can enable
or disable the print fields and view the corresponding ID of each field.

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 18 Template Modifying Software

18.1.8 Help (H)

Select Help on the menu bar of the main screen. The Help menu is
displayed.

The following table explains the menu in detail.

Option Description
About Select this option to view the version information of the
MakePrintTemplate template modifying software.

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18 Template Modifying Software

18.2 Common Tools

The common toolbar provides the shortcut buttons that enables you to
perform an operation quickly.

The following table shows the correspondence between the shortcut

buttons and menu options.
Button Menu Option
New File/New
Save File/Save (not enabled)
Save As File/Save As
Import File/Import
Export File/Export
Delete File/Delete
Print File/Print
Preview File/Preview
Cut Edit/Cut
Copy Edit/Copy
Paste Edit/Paste
Delete Edit/Delete
Zoom View/25%-200%
Property View/Property Window
Rpt List View/Report Window
Print ID Set/Print ID

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 18 Template Modifying Software

18.3 Draw Tools

The draw toolbar provides the shortcut buttons that enables you to create
and draw controls quickly.

The following table shows the correspondence between the shortcut

buttons and menu options.
Button Menu Option
Insert/Select

Insert/Line

Insert/Rectangle

Insert/Label

Insert/Text

Insert/Title

Insert/Image

Format/Left

Format/Right

Format/Top

Format/Bottom

Format/Center H

Format/Center V

Format/Even Space H

Format/Even Space V

Format/Same Width

Format/Same Height

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18 Template Modifying Software

Button Menu Option

Format/Same Size

18-12
 18 Template Modifying Software

18.4 Property Window

The property window enables you to view and edit the properties of the
selected control. If no control is selected in the window, the properties of
the current template are displayed.

18.4.1 Page
When no control is selected, the property window shows the properties of
the current template, such as paper, print type, etc.

The following table explains the template properties in detail.

Parameter Description
Paper Define the paper type of the template. There are 9 common
types available.
If the paper width and height you defined are beyond the
specified range, Custom is displayed in the Paper field.
Paper Width Define the width of the template.
Paper Define the height of the template.
Height
Grid Point Enable or disable grid points on the template.
Print Type Includes Paginal and Serial.
Combination Whether to print two reports on one piece of paper. Merging
Type reports is now not permitted.

18.4.2 Line
When a line control is selected, the property window shows the properties
of the line.

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18 Template Modifying Software

The following table explains the line properties in detail.

Parameter Description
ID Print ID of the line. The ID is 2.
Start X Set the X-coordinate value of the start point.

NOTE
The control coordinate originates from the upper-left corner of
the editing area, from which the X axis (positive) is extended
horizontally to the right and the Y axis (positive) vertically to
the bottom. The unit is mm.

Start Y Set the Y-coordinate value of the start point.

End X Set the X-coordinate value of the end point.
End Y Set the Y-coordinate value of the end point.
Line Width Set the width of the line. The unit is mm.
Group No. A group gathers multiple controls that will be used frequently
on the template. e.g. a line of controls constitutes a group.
The group No. is 0 if not defined.
Line Color Set the color of the line.
Print Enable or disable printing the line on actual reports.

18.4.3 Rectangle
When a rectangle control is selected, the property window shows the
properties of the rectangle.

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 18 Template Modifying Software

The following table explains the rectangle properties in detail.

Parameter Description
ID Print ID of the line. The ID is 1.
Start X Set the X-coordinate value of the start point (upper-left
corner).
Start Y Set the Y-coordinate value of the start point (upper-left
corner).
Width Set the width of the rectangle.
Height Set the height of the rectangle.
Frame Set the frame width of the rectangle.
Width
Group No. A group gathers multiple controls that will be used frequently
on the template. e.g. a line of controls constitutes a group.
The group No. is 0 if not defined.
Frame Color Set the color of the frame.
Print Enable or disable printing the rectangle on actual reports.

18.4.4 Label
When a label control is selected, the property window shows the
properties of the label.

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18 Template Modifying Software

The following table explains the label properties in detail.

Parameter Description
ID Print ID of the label. The ID is 4.
Text Set the text on the label. It will be printed unchanged on
actual reports.
Start X Set the X-coordinate value of the start point (upper-left
corner).
Start Y Set the Y-coordinate value of the start point.
Width Set the width of the label.
Height Set the height of the label.
Group No. A group gathers multiple controls that will be used frequently
on the template. e.g. a line of controls constitutes a group.
The group No. is 0 if not defined.
Bk Color Set the background color of the label.
Font Set the font of the label text.
Text Place Set the aligning mode of label text. It includes Left, Center
and Right.
Show Frame Enable and disable printing frame.
Frame Set the width of the label frame.
Width
Frame Color Set the color of the label frame.
Print Enable or disable printing the label on actual reports.
Text ID The ID of the label text represented by number. When it is
edited, the template is refreshed.

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 18 Template Modifying Software

Parameter Description
Replace text Choose whether to use the defined text ID to replace the text
of the control.

18.4.5 Text
When a text control is selected, the property window shows the properties
of the text.

The following table explains the text properties in detail.

Parameter Description
ID Print ID of the text. The default is 0 and means unknown ID.
Print ID indicates the meaning of the text. Correct printout
can be ensured only when print ID is set properly.
Name Set the contents to be displayed on the text control. It varies
from different IDs.
Text Set the contents displayed on the text control. It will be
replaced by actual data when printed.
Show Detail Set the text as table data.

NOTE
Only the text that not only is enabled in Show Details field
but also has a group No. is table data.

Start X Set the X-coordinate value of the start point (upper-left

corner).
Start Y Set the Y-coordinate value of the start point.
Width Set the width of the text.

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18 Template Modifying Software

Parameter Description
Height Set the height of the text.
Group No. A group gathers multiple controls that will be used frequently
on the template. e.g. a line of controls constitutes a group.
The group No. is 0 if not defined.
Text Type Reserved parameter. The default is 0.
Bk Color Set the background color of the text.
Font Set the font of the text.
Text Place Set the aligning mode of the text. It includes Left, Center
and Right.
Show Frame Enable and disable printing frame.
Frame Width Set the width of the text frame.
Frame Color Set the color of the label frame.
Print Enable or disable printing the text on actual reports.

18.4.6 Title
When a title control is selected, the property window shows the properties
of the title.

The following table explains the title properties in detail.

Parameter Description
ID Print ID of the title. The ID is 5.
Text Set the contents to be displayed on the title. “%s” will
be replaced by a hospital name and can be displayed in
any place of the title.

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 18 Template Modifying Software

Parameter Description
Start X Set the X-coordinate value of the start point (upper-left
corner).
Start Y Set the Y-coordinate value of the start point.
Width Set the width of the title.
Height Set the height of the title.
Bk Color Set the background color of the title.
Font Set the font of the title text.
Text Place Set the aligning mode of title text. It includes Left,
Center and Right.
Show Frame Enable and disable printing frame.
Frame Width Set the width of the title frame.
Frame Color Set the color of the title frame.
Print Enable or disable printing the title on actual reports.
Text ID The ID of the label text represented by number. When it
is edited, the template is refreshed.
Replace text Choose whether to use the defined text ID to replace
the text of the control.

18.4.7 Image
When an image control is selected, the property window shows the
properties of the image.

The following table explains the image properties in detail.

Parameter Description
ID Print ID of the image. The ID is 3.
Start X Set the X-coordinate value of the start point (upper-left
corner).
Start Y Set the Y-coordinate value of the start point.
Width Set the width of the image.
Height Set the height of the image.

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18 Template Modifying Software

Group No. A group gathers multiple controls that will be used

frequently on the template. e.g. a line of controls
constitutes a group. The group No. is 0 if not defined.
Print Enable or disable printing the image on actual reports.

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 18 Template Modifying Software

18.5 Report Window

The report window locates on the lower-right corner of the main screen
and shows all the templates of a selected report type.

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18 Template Modifying Software

18-22
 Electronic Interface

Description Serial interface Network interface

Interface RS232 standard RJ45 interface standard
Standard communication Serial
interface. The RXD and TXD
signal level meets the RS232
interface standard.
Interface The baud rate is 115200 bps. The communication rate
Specifications is 100 Mbps.
Interface The host receives and The analyzer sends an
Purpose executes instructions from the instruction to wake up the
PC through this interface, and PC through this interface.
returns the execution results
to the PC through this
interface.
Intended User Operator and service Operator and service
personnel personnel

Electronic Interface-1
Electronic Interface

Electronic Interface-2
 Vocabulary

Absorbance
The difference between the amount of light entering a solution (incident
light) and the amount of light passing through the solution (transmitted
light) without being absorbed, to determine the concentration of the
substance in the solution.
Analyzing unit
The analyzing unit, the analyzer, determines various clinical chemistries
in samples and displays the test results. It consists of the sample
handling system, reagent handling system, reaction system, cuvette wash
station, photometric system, and mixer assembly.
Auto rerun
When a result is beyond the defined range or satisfies the defined
conditions, the chemistry will be run again.
Auto serum index
When the Auto Serum Index function is enabled, the system will select the
SI chemistry automatically for serum or plasma samples. The SI
chemistry will also be requested automatically when you program routine
samples manually or by using the LIS host, or program STAT samples, or
program routine samples with the default panels.
Bar code reader
Fixed laser beam scanner. It scans the bar code label on sample tubes to
identify samples and match the obtained programming information with
the scanned samples.
Batch program
Batch program is to program a group of samples with identical
programming information, with the exception of the sample ID.
Blank time
Blank time refers to the period between dispensing of the second reactant
(reagent or sample) in reversed order and of the last reactant (reagent or
sample).
Bottle type

Vocabulary-1
Vocabulary
Volume of the reagent bottle.
Calibration curve
A calibration curve reflects the mathematical relation between calibrator
concentration and response. It is drawn based on the obtained response
and the multiple values between the minimum and maximum
concentrations of the calibrator.
Calibration factor
Calibration factor is obtained based on the equation of calibrator
concentration (known) and response (calibration math model).
Calibration math model
Calibration math model is used to calculate calibration factors and create
calibration curves. It includes single-point K factor, two-point linear,
multi-point linear, Logit-Log4P, Logit-Log5P, Exponential5P, Polynomial5P,
Parabola and Spline.
Calibration trend
Calibration trend summarizes a chemistry’s calibrations during a period
of time and reflect the trends of the calibrations.
Carryover
Carryover is the interference of certain substance contained in a reagent.
It can influence measurement of another chemistry or the reaction of
other mixture, resulting in inaccurate results.
Chemistry configuration
Chemistry configuration is applicable to all chemistries other than ISE
chemistry and SI, and used to enable or disable chemistries that have
been defined correctly.
Closed-reagent chemistry
Closed-reagent chemistry is run by using the reagents provided by the
analyzer manufacturer. Closed-reagent chemistries cannot be modified or
deleted.
Concentrated wash
Concentrated wash is an additional cleaning procedure performed on the
sample probe, reagent probe, mixers and reaction cuvettes with the aim
of eliminating carryover and preventing stains from leaving on exterior
and interior of the probes, mixers and cuvettes.
Concentrated wash solution
Concentrated wash solution is used to clean the reaction cuvettes with
the aim of keeping the reagents stable and analyzing samples with
increased volume.
Critical range
An allowable result range from the perspective of clinical diagnosis. If the
test result is beyond the critical range, the patient may need immediate
treatment. You may enable the auto rerun function for a chemistry, which

Vocabulary-2
 Vocabulary
will be rerun automatically once the test result is beyond the critical
range.
Current results
Current results include those that are in Incomplete status until the
current system time and those programmed and analyzed on the current
day.
Cuvette wash station
The cuvette wash station consists of the wash probes, elevating motor
and related tubing, and is used to clean the reaction cuvettes with the
eight wash probes when a test is finished.
Database
A collection of data arranged for quick search and retrieval.
Decreased
Decreased indicates the sample volume required for analysis and can be
defined on the Define/Edit Chemistries window.
Diluent
Liquid used to dilute other liquids.
Dilution factor
User-defined dilution ratio, to be multiplied with sample result to obtain
the final result.
Download
To obtain sample programming information from the LIS host and match
it with the scanned samples. The system supports real-time and manual
downloading of sample programming information.
EMF
EMF stands for Electromotive Force. The ISE module determines the
concentration of ion by measuring the electromotive force of ion with ion
selective electrodes. A calibrator with constant concentration should
have electromotive force within certain range.
Endpoint
The endpoint method, also called equilibrium method, is most ideal for
measurements. In endpoint measurements, the reaction reaches
equilibrium after a period of time. Since the equilibrium constant is quite
high, it can be considered that all substrates (analytes) have changed into
products, and the absorbance of the reactant will not change any more.
The absorbance change is directly proportional to the analytes’
concentration.
Fixed-time
In fixed-time measurements, namely, rate measurements, the reaction
velocity (v) is directly proportional to the substrate concentration [S]
within a specific period, that is, v=k[S].

Vocabulary-3
Vocabulary
Flag
Flag is a manufacturer-defined symbol, which appears on patient reports
or result list when a result is beyond the user-defined reference range or
exceeds the defined limits.
High-concentration waste
High-concentration waste is produced during the 1st-3rd phase of
cuvette cleaning and includes the ISE waste. It can be drained in a waste
tank or to the sewer according to your local or national regulations on
waste liquid disposal.
History results
Stored results are those programmed and analyzed before the current
day.
Increased
Increased indicates the sample volume required for analysis and can be
defined on the Define/Edit Chemistries window.
Initialization
Initialization is a series of operations automatically performed by the
system during the startup procedure. It includes parameters check, reset,
testing, cleaning and priming.
Inventory check
Used to check the remaining volume of the biochemistry reagents,
sample probe wash solution and reagent probe wash solution and refresh
the tests left and wash solution volume on the Reagent/Calibration
screen.
ISE
ISE is the abbreviation of Ion Selective Electrode. It consists of the Na
electrode, K electrode, Cl electrode, reference electrode, sampling and
measuring channel, syringe, heat stabilizer, degassing unit and waste
discharger. The ISE module measures the concentration of Na, K and Cl in
serum, plasma and diluted urine.
K factor
K factor is manually input for single-point linear calibration formula
C  K  ( R  R0 )
and used to calculate results.
Lamp
Lamp is located on the photometer assembly and used to measure the
absorbance of mixture in a reaction cuvette. It should be replaced
regularly.
Linearity
Degree of linearity for a reaction curve or calibration curve. Reaction
curve linearity is available in fixed-time measurements, while calibration
curve linearity specifies the allowable concentration range for result
calculation.

Vocabulary-4
 Vocabulary
LIS
LIS stands for Laboratory Information System. It is a host computer and
communicates with chemistry analyzers through the internet interface.
L-J chart
A Levey-Jennings (L-J) chart, drawn based on the QC date (X) and test
results (Y), shows the QC result trend of a chemistry during the specified
period. The graphical trends of up to 3 controls can be displayed on one
L-J chart and distinguished with different colors.
Lot number
Lot number is assigned to controls, calibrators or wash solutions of the
same lot for identifying manufacture date, quality, expiration date and
other related information.
Low-concentration waste
Low-concentration waste is produced during the 4th-8th phase of
cuvette cleaning. It can be drained to the sewer of your laboratory.
Mask/Unmask chemistries
Used when a chemistry needs to be disabled temporarily due to abnormal
result or reagent exhaustion. The masked chemistry will have a
symbol appearing on its upper-left corner, and will still be displayed on
the Sample, Quality Control and Reagent/Calibration screens but not run
for sample analysis. Masked chemistries cannot be requested until they
are unmasked.
Mixer
The system provides sample mixer and reagent mixer, which stir the
mixture inside a reaction cuvette when sample/R3 and R2/R4 are
respectively dispensed.
Multi-sample report
Containing the results of multiple samples, and can be printed out on the
Current Results and History Results screens.
Off-line dilution
Prior to analysis, samples are diluted manually based on specific ratio.
Offset
Offset is a value added or subtracted to compensate a result. It is often
used along with the slop in the equation y=kx+b, in which k is the slope
and b is the offset.
Off-system chemistry
All the chemistries that are not run by the analyzer are referred to as the
off-system chemistries.
Online help
Online help provides you with help information about the screens. If you
do not understand a parameter or an operation on a screen, you can go to

Vocabulary-5
Vocabulary
the online help for relevant information. Access the online help from the
following screens:
 Select the icon on the upper right corner to display the help topic
related to the current screen.

 Select the ? button in front of each maintenance instruction or

item to display the relevant operating instructions.

 Select the ? button in front of each error log to display the

corresponding topic.

 Click the button on a warning message window to display the

corresponding descriptions and solutions.
 Press the shortcut combination key Alt+F1 to display the topics
related to the current screen or window.
Open-reagent chemistry
Open-reagent chemistry, an opposite of the closed-reagent chemistry,
can be measured by using the reagents provided by other manufacturers.
It can be user-defined, edited and deleted.
Operation unit
The operation unit, a computer configured with the operating software,
controls the analyzing unit to finish tests and produce test results.
Output unit
A printer used to print out test results and other data.
Panel
Consists of a couple of chemistries combined together for certain clinical
purposes, such as liver function, kidney function, etc. Panels can help fast
programming of samples.
Patient demographics
Patient demographics contain information related to the patient and
sample, such as patient name, age, gender, collection date/time, etc.
Physiological saline
0.9% sodium chloride solution, used for reagent blank and sample
dilution.
Predilution
Prior to analysis, samples are diluted automatically based on the defined
dilution factor.
Primary wavelength
The primary wavelength is chosen based on the light absorption features
of the reactant and used to measure the absorbed light intensity. Options
for primary wavelength include: 340nm, 380nm, 412nm, 450nm, 505nm,
546nm, 570nm, 605nm, 660nm, 700nm, 740nm and 800nm
Prime

Vocabulary-6
 Vocabulary
Prime is an action to replace the reagents in tubing of the ISE module. A
prime is required to replace the reagents in tubing with new ones during
the startup procedure or when a reagent is changed.
Print name
Print name appears on a patient report representing a chemistry, and if
left blank, will be replaced by the short name of the chemistry.
Prozone check
Prozone check is intended to checking samples with quite different
concentrations, which may generate the equivalent amount of insoluble
antigen/antibody compound and can have the same test results. The
Prozone check can be performed in two ways: rate check and antigen
addition.
Pull-down list
A control of the software screen or window. Select the down-triangle
button on the right of a pull-down list to show multiple options.
QC panel
Used for analysis of control samples.
QC rule
A set of rules to evaluate if the QC results are under control and the
analyzing system is stable. Examples of QC rule are 1-2s, 1-3s, etc.
QC summary
Contains the mean values and standard deviations of controls analyzed
within the specified period, as well as the set mean and SD value. The
obtained results are compared with the set values to judge if the system
is working normally.
Qualitative analysis
Qualitative analysis is used to analyze every sample for the detection of
lipemia, hemolysis and icterus and calculate the numeric values of the
index. If the volume of the interferents contained in a sample is beyond
the set range, a flag will be added to the patient report.
Random error
An alarm of quality control monitoring. A random error may occur when
the lowest and highest values of QC results respectively exceed
-2SD/-3SD and +2SD/+3SD.
Reaction carousel
Reaction carousel is a turntable, and used to hold reaction cuvettes and
transmit each of them to the photometric position for signal detecting
and absorbance calculation.
Reaction curve
A reaction curve reflects the relationship of the absorbance measured at
the primary wavelength, secondary wavelength and primary-secondary
wavelength. It is drawn based on the absorbance of the sample-reagent

Vocabulary-7
Vocabulary
mixture measured within the reaction period. The system provides 4
types of reaction curves: calibration reaction curve, QC reaction curve,
sample blank reaction curve, and sample reaction curve.
Reaction cuvette
Reaction cuvette is a carrier in which reagents and samples react with
each other and then carried to the photoelectric position for signal
detecting and response calculation.
Reaction direction
Reaction direction refers to the change trend of absorbance during the
reaction process. It includes positive and negative.
Reaction time
For endpoint analysis, the reaction time refers to the time span from the
start point of the reaction to the end point; for fixed-time and Kinetic
analysis, it refers to the period from reaction equilibrium to the end of
monitoring.
Reagent blank
In the reagent blank test, the reagents react with the physiological saline,
and the blank absorbance is calculated to correct the calibration factors.
Only the reagents that are in Calibrated, Cal Time Out or Cal Required
status can be requested for reagent blank.
Reagent carousel
The reagent carousel is located on left side of the analyzer panel. It holds
reagent bottles and carries each of them to the reagent aspirate position
for aspirating.
Reagent carryover
Cross contamination between the reagent probe and the mixers. When
the number of tests between the contaminating chemistry and the
contaminated is less than or equal to the defined number (N), and no
concentrated wash is inserted between the two chemistries, it indicates
that the reagents underlie the risk of carryover.
Reagent inventory alarm limit
Alarm limit of reagents and wash solutions. When the reagent inventory is
lower than the alarm limits during or before the analysis, the system will
give an alarm and display the reagent or wash solution name in yellow on
the Reagent/Calibration screen.
Reagent probe
The reagent probe aspirates the specified amount of reagent from a
reagent bottle and then dispenses it into a cuvette for reaction and
analysis. The system has one reagent probe.
Reagent probe wash solution
Used for cleaning the reagent probe.
Reference range

Vocabulary-8
 Vocabulary
Reference range is a user-defined range consisting of low limit and high
limit. When a result is beyond the reference range, a flag will appear near
the result.
Release
Used to clear the specified sample position or all positions on the current
sample carousel. When a sample is released, its results and programming
information can be still recalled. The released position can be used for
programming of new samples.
Replicates
Number of times to run a test, to ensure accurate results.
Result statistics
Result statistics option can summarize the total chemistries and the
distribution trend of its results and provide the test data and graph.
Sample blank
Sample blank is similar to sample analysis except for use of equivalent
amount of physiological saline. Sample blank is used for removal of
non-chromogenesis reaction, such as influence of sample interference
(Hemolysis, icterus and lipemia) on absorbance readings.
Sample carousel
The sample carousel is located on right side of the analyzer panel. It
holds sample tubes and carries each of them to the sample aspirate
position for aspirating.
Sample comments
Remarks for some special samples, such as, ** sample has hemolysis; **
sample needs to be analyzed immediately, etc.
Sample log
Contains the controls and patient samples that are not complete within
the recent 24 hours due to certain reasons. Based on the sample log you
are allowed to rerun the samples or take other actions for the controls
and samples.
Sample panel
Used for analysis of patient samples.
Sample probe
The sample probe aspirates the specified amount of sample from a
sample tube and then dispenses it into a cuvette for reaction and
analysis.
Sample probe wash solution
Used to clean the sample probe and located in position D3 of the
analyzer’s front panel.
Sample type
Type of sample. The sample type options include serum, plasma, urine,

Vocabulary-9
Vocabulary
CSF and other.
Screen
Screen is a part of the software interface. It is rectangular and contains
various controls, such as edit box, function button, etc.
Secondary wavelength
The secondary wavelength is used to remove the interference in primary
wavelength values and eliminate the influence of noise, such as light
flash and drift, and scratches on cuvettes, etc. It cannot be the same as
the primary wavelength.
Serial number
Sequence number of the reagent bottle.
Slope
Multiplied with the test result to make it consistent with that obtained on
other instruments. It is often used along with the offset in the equation
y=kx+b, in which k is the slope and b is the offset.
Special calculation
Special calculation is derived from calculation of certain chemistries and
has specific clinical purposes, such as A/G, TBil-DBil, etc.
Standard deviation (SD)
Standard deviation is the mean of deviations from the mean value. It is an
index to judge the measurement accuracy under specific conditions. In
this manual, SD refers to the standard deviation of control concentration.
Standby
Standby is one of the system statuses. When the system status is
Standby, it indicates that all tests are finished and all actions of the
system have stopped.
STAT
STAT means emergent, including common STAT and quick STAT program.
STAT sample program allows emergent samples to be programmed and
analyzed with high priority. Common STAT program is used in daytime to
run emergent samples with higher priority than routine samples. Quick
STAT program is mainly used in nighttime and weekends to program
emergent samples quickly with higher priority than routine and common
STAT samples.
Symbology
Symbology is a set of rules for encoding and decoding information
contained in a bar code label. The system provides a couple of
symbologies, such as Codabar, ITF, code128, code39, UPC/EAN, and
Code93.
Systematic error
An alarm of quality control monitoring. A systematic error may occur
when both the lowest value and highest value of a QC result are on the

Vocabulary-10
 Vocabulary
same side.
Transmit
Transmit is an action sending specified sample results or QC results to
the LIS host.
Twin chemistries
Twin chemistries are run with the same reagents and calculated through
the same test. For two twin chemistries, the sample volume, volume of
shared reagent, calibration replicates, and auto calibration conditions
should be the same. When either of the two chemistries is requested for
calibration, quality control or sample analysis, the other chemistry will be
automatically requested, and finally results of both chemistries will be
calculated.
Twin-Plot chart
A twin-plot chart, drawn based on the results of control X and control Y in
the same run, is used to detect systematic errors and random errors. It
shows the recent 10 QC results of a chemistry and excludes those that
have been deleted.
Two-control evaluation
In two-control evaluation, two results are obtained: Xn and Yn, which are
used to define a point on the Twin-plot chart. In this way, a complete
twin-plot chart is drawn based on all the QC results and used for
detecting systematic errors and random errors.
Unpositioned samples
Samples without positions assigned or with positions not assigned
successfully, including those:
 downloaded from the LIS host and not positioned yet.
 that are in Incomplete status when their positions are assigned for
new samples.
 that are incomplete when their positions are released.
Westgard rule
Westgard rule is used for monitoring of quality control. In the Westgard
rule, single rules such as 12S, 13S, 22S and 41S are combined to evaluate
results of single or multiple controls.
Workload statistics
On the Workload screen, you can view test requests and reagent
application for each chemistry during a period, and sample requests and
the quantity of its chemistries

Vocabulary-11
Vocabulary

Vocabulary-12
 Index

6-8, 2
A Calibration math model, 3-34, 3-35, 4-14, 4-15,
absorbance, 4-4 4-16, 2
Absorbance, 3-22, 4-4, 4-10, 4-11, 4-17, 4-18, calibration reports, 3-36
6-7, 17-12, 17-17, 17-47, 17-48, 1 Calibration reports, 3-36
adding chemistries, 13-11 calibration rules, 2-25, 3-30, 3-34
Adding chemistries, 13-11 Calibration rules, 2-25, 3-30, 3-34
Analyzing unit, 1 calibration status, 2-9, 2-11, 2-27, 2-35, 2-47, 2-48,
Antibody, 17-17, 17-49 5-2, 5-3, 5-6, 6-2, 6-3, 6-7, 6-8, 6-12, 6-13, 6-14,
Antigen, 3-24, 4-17 6-21, 6-25, 8-34, 8-36, 9-7, 12-13, 12-17
antigen addition, 3-23, 3-24, 4-17, 4-18, 7 Calibration status, 2-9, 2-11, 2-27, 2-48, 6-3, 6-7,
Antigen addition, 3-23, 3-24, 4-17, 7 6-8, 6-12, 6-13, 6-21, 8-34, 8-36, 12-13
antigen excess, 3-23, 4-17, 4-18 calibration trends, 6-11, 6-18, 6-27, 12-12, 12-15,
Antigen excess, 3-23, 4-17, 4-18 12-16
auto calibration, 2-28, 3-34, 3-35, 6-2, 6-12, 6-13 Calibration trends, 6-11, 6-18, 6-27, 12-12,
Auto calibration, 2-28, 3-35, 6-2, 6-12, 6-13 12-15, 12-16
auto quality control, 2-33, 7-8 calibrator, 4-14
Auto quality control, 2-33, 7-8 calibrator acceptance limits, 3-30
auto rerun, 3-19, 3-27, 3-28, 8-4, 8-10, 8-11, 9-2, 2 Calibrator acceptance limits, 3-30
Auto rerun, 3-19, 3-27, 3-28, 8-4, 8-10, 8-11, 9-2, calibrator dilution, 6-4
2 Carryover, 10-1, 10-19, 10-20, 2
auto serum index, 3-2, 3-3, 8-23 CAUTION, 8-18
Auto serum index, 3-3 Check before powering on, 2-1, 2-2
Auto sleep and startup, 3-7, 11-1 Check concentrated/diluted wash solution, 2-52,
16-11
B Check deionized water connection, 2-52, 16-11
Check sample/reagent syringes, 2-52, 16-11
Background, 18-16, 18-18, 18-19 Check waste, 2-52, 16-11
Bar code reader, 1-40, 1 Checking system status, 2-1, 2-2
Batch program, 2-34, 2-37, 2-43, 1 chemistries left, 2-11, 2-48, 5-6
biochemistry maintenance, 16-6, 16-7 Chemistries left, 2-11, 2-48
Biochemistry maintenance, 16-6, 16-7 chemistry list, 2-31, 3-12, 3-13, 8-1, 8-2, 8-36,
blank time, 2-25, 3-17, 3-18, 3-23, 4-9, 4-11 10-17
Blank time, 2-25, 3-17, 3-18, 3-23, 4-9, 4-11 Chemistry list, 2-31, 3-12, 3-13, 8-2, 8-36, 10-17
Bottle type, 2-17, 2-21, 2-24, 13-15, 13-16, 1 Clean analyzer panels, 16-12
Clean mixers, 16-11
C Clean rotors, 16-12
Clean sample probe interior, 16-12
calibration curve, 4-15 Cleaning the dust screen, 16-5
Calibration curve, 6-8, 17-13, 17-15, 17-50, 2 Cleaning the filter core, 16-5
Calibration factors, 2-28, 6-12, 6-14, 6-20 Cleaning the wash wells, 16-5
calibration math model, 3-35, 4-14, 4-15, 4-16, clearing samples, 8-25

Index-1
Index

Clog detection, 1-12, 17-23 9-5

closed-reagent chemistry, 6 Error detection limits, 3-12, 3-13, 3-20, 9-2
Closed-reagent chemistry, 6 error logs, 1-30, 11-3, 12-23, 17-1, 17-3, 17-4,
concentrated wash solution, 4, 2-19, 2-20, 5-18, 17-5, 17-7, 17-8
16-19, 16-24, 16-25, 16-30, 16-71, 16-74, Error logs, 1-30, 11-3, 12-23, 17-1, 17-3, 17-4,
17-14, 17-34, 17-35, 17-34 17-5, 17-7, 17-8
Concentrated wash solution, 4, 2-19, 2-20, 5-18,
16-19, 16-24, 16-25, 16-30, 16-71, 16-74 F
Consumable, 16-4
Control, 4, 9, 1-26, 2-2, 2-30, 2-31, 2-32, 2-33, 3-8, filter core, 16-11, 16-37, 16-38, 16-47
3-10, 3-38, 3-40, 3-41, 3-42, 7-1, 7-2, 7-3, 7-5, Filter core, 16-5, 16-11, 16-37, 16-38, 16-47
7-8, 7-9, 7-10, 7-15, 7-17, 7-18, 7-19, 7-20, Fixed-time, 3-15, 3-17, 4-3, 4-7, 4-8, 3
9-2, 9-12, 10-15, 10-23, 12-18, 14-11, 5 fixed-time measurements, 4-7, 4-8, 17-12, 17-48,
control status, 2-30, 3-39, 7-3 3, 4
Control status, 7-3 Fixed-time measurements, 4-7, 4-8, 3, 4
critical range, 3-13, 3-27, 3-28, 8-4, 8-10, 8-11, Full width at half maximum, 1-19
8-31, 17-11, 2 Function buttons area, 1-28, 1-29
Critical range, 3-13, 3-27, 3-28, 8-4, 8-10, 8-11, 2 Function window, 1-28, 1-30
Current, 8-57
current results, 13-12 H
Current results, 8-41, 13-12 High limit, 3-5, 3-6
Cuvette check, 10-20, 16-6, 16-11 high-concentration waste, 1-18, 2-2, 2-3, 2-54,
cuvette wash station, 1-17, 1-18, 2-14, 16-11, 16-23, 17-35
16-36, 1, 3 High-concentration waste, 1-18, 2-2, 2-3, 2-54,
Cuvette wash station, 1-17, 1-18, 16-36, 1, 3 16-23
History, 8-57
D History results, 4
daily maintenance, 2-52, 16-19 Holographic concave flat-field gratings, 1-19,
1-36
Daily maintenance, 16-19
Host, 3-10, 7-10, 8-39, 8-40, 8-42, 8-48, 9-7,
Data alarm, 17-9, 17-10
13-13, 14-3, 14-4, 14-6, 14-7, 14-12, 17-54
Database, 17-47, 3
host communication, 3-10, 14-3, 17-54
Decreased, 3-18, 8-8, 8-9, 8-12, 8-15, 13-11,
Host communication, 3-10, 14-3
16-33, 3
default panel, 2-49, 8-23, 8-31, 10-1, 10-21,
13-5, 13-7, 1 I
Default panel, 8-23, 10-1, 10-21, 13-5, 13-7, 1 Increased, 3-18, 8-8, 8-9, 8-12, 8-15, 13-11, 4
defining a chemistry, 3-13, 6-7, 8-14 Initialization, 4
Defining a chemistry, 3-13, 6-7 Installation environment, 1-2
Delete/edit logs, 17-1, 17-4, 17-5 Installation requirements, 1-1
Demographics, 2-39, 8-43, 8-44 Inventory check, 4
Diluent, 6-5, 3 ISE chemistry parameters, 12-5
Diluted wash, 3-3, 16-11, 16-30 ISE maintenance, 16-8, 16-9
Dilution factor, 3 ISE module, 8, 1-29, 2-9, 2-25, 3-7, 3-8, 10-15,
dispenser assembly, 1-11, 1-15 10-17, 11-2, 11-13, 11-14, 12-1, 12-2, 12-5,
Dispenser assembly, 1-10, 1-11, 1-15 12-11, 12-21, 12-22, 12-23, 16-4, 16-8, 16-9,
Download, 13-9, 14-9, 3 16-19, 16-26, 16-40, 16-41, 16-42, 16-52,
dust screens, 16-5, 16-11, 16-39, 16-40, 16-43 16-77, 16-78, 16-79, 3, 4, 7
Dust screens, 16-5, 16-39, 16-40, 16-43 ISE startup primes, 3-2, 3-5

E K
endpoint, 4-4 K factor, 3-34, 3-35, 4-4, 4-14, 6-8, 6-10, 6-18,
Endpoint, 1-35, 3-15, 3-17, 4-3, 4-4, 4-5, 3 6-20, 6-25, 6-26, 9-7, 17-14, 17-50, 2, 4
endpoint measurements, 4-4, 4-5, 3 Kinetic, 4-9
Endpoint measurements, 4-4, 4-5, 3
Equilibrium, 4-7
error detection limits, 3-12, 3-13, 3-20, 9-2, 9-3,

Index-2
 Index

L Operating software, 18-1

Operation unit, 6
Lamp check, 16-6, 16-11 Output unit, 6
Light source, 1-19, 1-36, 17-55, 17-56
Light transmission component, 1-19 P
Linear, 4-14, 4-15
Linearity limit, 3-6 Panels, 2-40, 10-9, 10-10, 10-11, 10-13, 10-15,
linearity range, 3-19, 3-20, 3-21, 4-9, 4-10, 4-11, 10-21, 16-14, 16-54, 6
4-12, 4-13, 8-4, 8-11, 8-51, 17-11, 17-14 patient report, 10-11
Linearity range, 3-7, 3-19, 3-20, 3-21, 4-9, 4-10, Patient report, 18-1
4-11, 4-12, 4-13, 8-4, 8-11, 8-51 Photometric system, 1-8, 1-36, 16-6
LIS, 1-28, 1-29, 1-40, 1-41, 2-9, 3-8, 7-10, 8-23, physiological saline, 2-24, 3-19, 3-32, 5-3, 5-11,
8-26, 8-31, 8-39, 8-40, 8-42, 8-48, 8-49, 8-53, 6-7, 8-16, 8-28, 17-53, 17-58, 8, 9
9-2, 9-7, 10-21, 13-2, 13-5, 13-7, 13-13, 14-1, Physiological saline, 3-19, 5-11, 8-16, 8, 9
14-2, 14-3, 14-4, 14-5, 14-6, 14-7, 14-8, 14-9, powering off, 2-1, 2-2, 16-79
14-11, 14-12, 14-13, 14-14, 17-54, 17-55, 17-55, Powering off, 2-2, 16-79
1, 3, 5, 11 powering on, 2-4
L-J chart, 7-10, 7-12, 7-13, 5 Powering on, 2-2, 2-4
Lot number, 2-17, 2-19, 2-20, 2-21, 3-33, 5-3, Predilution, 2-37, 2-38, 2-43, 2-44, 2-46, 8-9, 6
7-19, 13-15, 13-16, 14-11, 5 Primary tube, 1-13
Low limit, 3-6 Primary wavelength, 9-5, 6
low-concentration waste, 1-18, 2-3, 16-23, Prime, 3-5, 12-4, 12-21, 16-36, 6, 7
17-35 print name, 3-15, 8-22, 9-2, 10-6
Low-concentration waste, 1-18, 2-3, 16-23 Print name, 3-15, 8-22, 10-6
print setup, 9-1
M Print setup, 9-1
Probe arm, 16-85
Main screen, 1-28, 18-2 Probe rotor, 16-85
Measuring point, 3-7, 4-7, 4-9, 4-10, 4-11, 4-12 processing parameters, 3-12, 3-13, 3-14, 9-3, 9-5
Microtube, 1-13, 2-31, 3-3, 8-15, 8-18 Processing parameters, 3-12, 3-13, 3-14
mixed blank absorbance range, 6-7 programming control samples, 2-30
Mixed blank absorbance range, 6-7 Programming routine samples, 2-1, 2-2
Mixer, 1-8, 1-19, 1-20, 1-36, 16-3, 5 Prompt message area, 1-28, 1-30
Mixer arm, 16-67 prozone check, 17-17, 17-49
mixer assembly, 1-19, 1-20, 1-36, 16-6, 17-29, Pull-down list, 7
17-30, 1
Mixer assembly, 1-19, 1-20, 1-36, 16-6, 1
Q
Mouse, 1-31, 1-40
multi-sample report, 9-13, 9-14, 11-3 QC alarms, 2-25, 7-2
Multi-sample report, 9-14, 11-3 QC panel, 7
QC reports, 7-2, 11-3
N QC rules, 3-38, 3-41, 7-2
QC summary, 7-20, 7-21, 7
Noise and fuse, 1-41 Qualitative, 10-11
non-linear calibrations, 4-14 Quality control, 2-1, 3-1, 7-2
Non-linear calibrations, 3-36, 4-14 Quantitative, 10-11

O R
off-line dilution, 2-36, 2-37, 2-43, 2-44, 2-45, 8-9, random error, 7-3, 7-4, 7-5, 7-6, 7-14, 7, 11
8-13, 8-14, 8-15 Random error, 7-3, 7-4, 7-5, 7-6, 7-14, 7, 11
Off-line dilution, 2-36, 2-37, 2-43, 2-44, 2-45, 8-9, Reaction carousel, 1-17, 1-36, 17-31, 17-37, 7
8-15 Reaction curve, 4-12, 4-17, 4, 7
off-line load of reagents, 5-14 Reaction cuvette, 1-17, 1-19, 1-36, 8
Off-line load of reagents, 5-14 reaction direction, 2-25
Offset, 3-13, 3-25, 3-26, 5 Reaction direction, 2-25
Online help, 1-31, 16-7, 16-9, 5 reaction system, 1-36, 1
on-line load of reagents, 5-12 Reaction system, 1-36, 1
On-line load of reagents, 5-12

Index-3
Index

reaction time, 2-25, 3-17, 3-18, 3-21, 3-23, 4-4, 8-49, 8-50, 8-51, 8-54, 9-12, 14-12
4-9, 4-10, 4-11, 4-13, 4-18, 17-14, 17-16, 8 Sample list, 2-31, 2-40, 7-12, 8-34, 8-43, 8-48,
Reaction time, 2-25, 3-17, 3-18, 3-21, 3-23, 4-4, 8-49, 8-50, 8-51, 8-54, 9-12
4-9, 4-10, 4-11, 4-13, 4-18, 9-5, 8 sample logs, 8-1, 8-30, 8-31
reagent blank, 3-21, 3-22, 3-32, 4-14, 6-2, 6-7, 6-8, Sample logs, 8-30, 8-31
6-9, 6-10, 6-18, 6, 8 Sample panel, 9
Reagent blank, 2-22, 3-22, 4-14, 6-1, 6-2, 6-7, 6-8, Sample probe, 15, 1-9, 1-11, 1-12, 1-35, 2-22,
6-9, 6-10, 6-18, 6, 8 16-3, 17-22, 17-23, 17-24, 17-25, 17-26, 9
Reagent carousel, 1-9, 1-13, 1-14, 1-36, 16-4, Sample probe wash solution, 2-22, 9
17-32, 8 Sample probe wash well, 15, 1-11
Reagent carryover, 8 sample status, 2-34, 8-30, 8-31, 8-34, 8-35,
reagent handling system, 1-13, 1-36, 1 10-23
Reagent handling system, 1-13, 1-36, 1 Sample status, 8-30, 8-34, 8-35
Reagent inventory alarm limit, 3-5, 5-2, 8 Sample syringe, 1-12, 16-3, 17-22, 17-23,
Reagent probe, 1-15, 1-16, 1-36, 2-20, 16-3, 17-23, 17-24
17-26, 17-27, 8 Sample type, 2-39, 3-14, 8-13, 8-15, 13-2, 14-8,
Reagent probe wash solution, 2-20, 8 14-11, 9
Reagent syringe, 1-16, 16-3, 17-27 Scheduled maintenance, 12-22, 16-10
reagent volume, 8, 2-25, 3-20, 8-22, 17-53 Screen operation logs, 17-1
Reagent volume, 8, 2-25, 3-20, 8-22 Secondary wavelength, 9-5, 10
Reference range, 3-26, 8, 9 Serial number, 2-17, 2-19, 2-20, 2-21, 13-15,
reference range flags, 3-28 13-16, 10
Reference range flags, 3-2, 3-28 Shortcut icons area, 1-28, 1-30
reference/critical range, 3-26, 3-27, 3-28, 3-29 single-point linear calibration, 4-14, 4
Reference/critical range, 3-26, 3-27, 3-28, 3-29 Single-point linear calibration, 4-14, 4
Replace cuvette, 16-12 Slope, 3-13, 3-25, 3-26, 10
Replace lamp, 16-6, 16-11 software version, 3-7, 3-8, 11-13, 11-15, 16-10
Replace reagent mixer, 16-12, 16-14 Software version, 3-7, 3-8, 11-13, 16-10
Replace sample mixer, 16-12, 16-14 special calculation, 9-3, 10-6, 10-8
Replace sample probe, 16-12 Special calculation, 10-6
Replicates, 2-37, 2-38, 2-43, 2-44, 2-46, 9 Standard deviation, 7-19, 14-12, 10
response, 4-14, 4-15 Standby, 1-29, 2-8, 2-9, 2-15, 2-16, 2-18, 2-20,
Result flag, 3-4, 3-28, 6-18, 17-9, 17-11 2-22, 2-23, 2-53, 3-7, 3-39, 5-9, 8-4, 8-19, 8-28,
result transmission, 14-1 9-2, 9-3, 9-5, 11-2, 11-4, 11-8, 12-10, 12-11,
results recall, 6-1, 7-1, 8-1, 12-18 13-12, 13-17, 14-7, 14-9, 16-19, 16-21, 16-22,
Results recall, 12-18 16-23, 16-24, 16-25, 16-26, 16-30, 16-31,
RMS, 14-1, 14-2, 14-3, 14-14, 14-15 16-33, 16-36, 16-37, 16-40, 16-41, 16-42,
16-45, 16-47, 16-49, 16-50, 16-51, 16-52,
S 16-55, 16-56, 16-57, 16-58, 16-61, 16-62, 16-65,
16-66, 16-68, 16-69, 16-70, 16-71, 16-74,
Safety classification, 1-41 16-77, 16-78, 16-79, 16-82, 16-84, 16-85,
sample blank, 9, 2-22, 2-25, 3-19, 4-5, 4-7, 6-23, 16-86, 10
7-11, 7-18, 8-16, 8-17, 8-46, 9-12, 8 STAT, 1-30, 2-1, 2-2, 2-39, 2-42, 2-43, 2-44, 2-45,
Sample blank, 9, 3-19, 4-5, 4-7, 6-23, 7-11, 5-12, 8-2, 8-4, 8-5, 8-6, 8-7, 8-13, 8-15, 8-23,
7-18, 8-16, 8-17, 8-46, 9-12, 8 8-24, 8-39, 8-42, 10-15, 13-6, 13-7, 13-11,
sample blanked response, 4-5 14-8, 1, 10
Sample blanked response, 4-5 Statistics, 8-60, 11
Sample carousel, 1-9, 1-10, 1-35, 17-31, 17-32, Status display area, 1-28, 1-29
17-32, 9 Substrate, 3-7, 4-7, 4-9, 4-10
Sample carousel assembly, 1-10 substrate depletion, 3-21, 4-7, 4-9, 4-10, 4-11,
Sample carousel outer ring, 17-31 4-13, 17-12, 17-14, 17-15, 17-48, 17-49, 17-48
sample comments, 3-7 Substrate depletion, 3-21, 4-7, 4-9, 4-10, 4-11,
Sample comments, 3-7 4-13
Sample cup, 8-18 symbology, 13-3, 13-4, 13-14, 13-15
Sample dispenser assembly, 1-10, 1-11 Symbology, 13-3, 13-4, 13-15
sample handling system, 1-10, 1-35, 1 syringe plunger assembly, 16-3, 16-82, 16-84
Sample handling system, 1-10, 1-35, 1 Syringe plunger assembly, 16-3, 16-82, 16-84
sample list, 2-31, 2-40, 7-12, 8-34, 8-43, 8-48,

Index-4
 Index

System relocation, 1-7 Unpositioned samples, 8-26, 8-34

systematic error, 7-3, 7-4, 7-5, 7-6, 7-14, 10, 11 user-defined chemistries, 3-12, 3-13, 3-14, 3-20
Systematic error, 7-3, 7-4, 7-5, 7-6, 7-14, 10, 11 User-defined chemistries, 3-12, 3-13, 3-14, 3-20

T W
Technical parameters, 1-18 WARNING, 5
Technical specifications, 1-1 Wash probe, 1-18
temperature, 4-4 water inlet filter, 16-50
Template Modifying Software, 18-1, 18-2, 18-4, Water inlet filter, 16-50
18-5 water supply module, 17, 1-23, 1-24, 2-2, 2-3,
Troubleshooting, 2-9, 12-23, 13-19, 14-13, 14-15, 2-6, 16-23
17-1, 17-7 Water supply module, 17, 1-23, 1-24
Twin-Plot chart, 3-9, 11 Wavelength, 1-19, 1-35, 3-16
Two-control evaluation, 3-41, 3-42, 7-5, 7-6, Wavelength accuracy, 1-19
7-7, 11
Z
U Zero-order reaction, 4-9
unpositioned samples, 8-1, 8-26, 8-34

Index-5
Index

Index-6
 Bibliography

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P/N: 046-005747-00(5.0)