IMMULITE 2000 Systems

IMMULITE 2500 System Immunoassay System

Operator’s Guide

601005-0004 Rev. A, 2010-10

 Operator’s Guide

© 2010 Siemens Healthcare Diagnostics. All rights reserved.

No part of this operator’s guide or the products it describes may be
reproduced by any means or in any form without prior consent in writing
from Siemens Healthcare Diagnostics.
IMMULITE and VersaCell are trademarks of
Siemens Healthcare Diagnostics.
RealTime Solutions is a servicemark of Siemens Healthcare Diagnostics.
DRD and Dual Resolution Diluter are trademarks of DRD Diluter
Corporation.
Windows and Microsoft are trademarks of Microsoft Corporation.
Lotus is a trademark of IBM Corporation.
LUMIGEN is a trademark of LUMIGEN.
Tygon is a trademark of Saint-Gobain Corporation.
Westgard QC is a trademark of Westgard QC, Inc.
Origin: US

www.siemens.com/diagnostics
The information in this operator’s guide was correct at the time of printing.
However, Siemens continues to improve products and reserves the right to
change specifications, equipment, and maintenance procedures at any time
without notice.
If the system is used in a manner differently than specified by Siemens, the
protection provided by the equipment may be impaired. Refer to caution,
warning, and import statements.

601005-0004 Rev. A
Using This Guide

This system is intended for professional use in a laboratory environment only.

Tests performed using this system are intended for in vitro diagnostic use. As with
all diagnostic tests, a definitive clinical diagnosis should not be based on the
results of a single test, but should only be made by the physician after all clinical
and laboratory findings have been evaluated.
The guide provides information for the following clinical laboratory professionals
who use the IMMULITE® 2000 systems and IMMULITE 2500 system:
• System operators who perform daily operating tasks such as preparing the
system, processing samples, reviewing results, and performing maintenance.
• System key operators who perform daily and other tasks such as reviewing
control data, managing data files, and modifying system parameters.

Organization
The following table describes how this operator’s guide is organized:
If you want to... Then refer to...
learn about system features such as no-pause sample Section 1:
reloading, System Features
learn about user interface components, how to use Hardware Overview,
online information, review the hardware and the Software Overview,
operating sequence, Technology.
process samples, monitor status, or manage sample Section 2:
results, Operating the System.
review Master Curve and 2-point adjustor principles, Section 3:
process adjustors, Adjusting the System.
learn about accessing QC, Scheduled QC Section 4:
defining quality control materials, Quality Control.
perform scheduled maintenance activities, Section 5:
record maintenance activities, Maintenance.
investigate and correct system problems, Section 6: Troubleshooting.
learn about saving results data files to an archive, Section 7:
learn about backing up your system configuration files, Data Management.
modify test definition parameters, Section 8:
modify system parameters, System Configuration.
set up LIS and LAS parameters,
review biohazard precautions, Appendix A:
review laser precautions, Safety.

601005-0004 Rev. A
1-2 Operator’s Guide: Using This Guide

If you want to... Then refer to...

view warranty, legal, and support information, Appendix B:
view contact information, Warranty and Support
Information.
view information about primary reagents, ancillary Appendix C:
reagents, and system fluids, Reagents and System Fluids.
view information about ordering supplies, Appendix D: Supplies.
view system specifications, Appendix E: Specifications.
view system symbols, Appendix F: Symbols.
view the glossary, Appendix G: Glossary.
view error messages and possible solutions, Appendix H:
Error Messages.
learn about hepatitis confirmatory testing, Appendix I:
Hepatitis Confirmatory
Testing.

Conventions
The IMMULITE 2000 systems and IMMULITE 2500 system Operator’s Guide
uses the following text and symbol conventions:
Convention Description
IMMULITE 2000 systems and Refers to instructions for the IMMULITE 2000
IMMULITE 2500 system system, IMMULITE 2500 system, and
IMMULITE 2000 XPi system.
IMMULITE 2000 systems only Refers to instructions for both the
IMMULITE 2000 system and the
IMMULITE 2000 XPi systems.
IMMULITE 2500 system only Refers to instructions for the IMMULITE 2500
system.
IMMULITE 2000 XPi system Refers to instructions for the
only IMMULITE 2000 XPi system only.
Biohazard statements alert you to potentially
biohazardous conditions.
BIOHAZARD
Laser Warning statements alert you to the risk of
exposure to lasers.
LASER WARNING
Warning statements alert you to conditions that
may cause personal injury.
WARNING

601005-0004 Rev. A
Operator’s Guide: Using This Guide 1-3

Convention Description
Caution statements alert you to conditions that may
cause product damage or loss of data.
CAUTION On the system, this symbol indicates that you
should refer to the operator’s guide for more
information.
NOTE: Note statements alert you to important information
that requires your attention.
Bold Bold type indicates commands on the user
interface, keys, or the exact text that an operator
needs to type.
For example, if the word save displays as Save, it
refers to the selecting the Save button on the user
interface.
Another example is typing a specific entry into a
text box. If the word welcome displays as
welcome, it means that you should type that word
into the specified field.
Italic Italic type refers to the title of a document or a
section title in this operator’s guide. For example,
Operating the System, in Section 2 refers to
Section 2 of this operator’s guide.
Italics are also used for latin words and phrases.

Terminology
The following table explains some of the special terminology used in this
operator’s guide and the specific actions that you need to take when you see the
terminology:
Term Description
Select To select an item, use your finger to touch the item on the touchscreen
monitor or select the item with the system pointing device.
Enter Type the specified information using the keyboard and then press
the Enter key.
Scan Move the handheld barcode scanner over the specified barcode to enter
the information.

601005-0004 Rev. A
1-4 Operator’s Guide: Using This Guide

601005-0004 Rev. A
Operator’s Guide: Contents 1-1

Contents

1 System Overview

2 Operating the System

3 Adjusting the System

4 Quality Control

5 Performing Maintenance

6 Identifying Instrument Problems

7 Data Management

8 Configuring the System

Appendix A: Safety Instructions

Appendix B: Service, Ordering, and Warranty

Appendix C: Reagents and System Fluids

Appendix D: Supplies

Appendix E: System Specifications

Appendix F: Instrument Symbols

Appendix G: Installation and Relocation

Appendix H: Error Messages

601005-0004 Rev. A
1-2 Operator’s Guide: Contents

Appendix I: Hepatitis Confirmatory Test

601005-0004 Rev. A
Operator’s Guide: System Overview

1 System Overview

IMMULITE 2000 Systems and IMMULITE 2500 System . 1-1

Control Naming Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Product Descriptions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Principles of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Output Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Hardware Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Pipetting Sequence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Kit Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Reagent Wedge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-11
Bead Packs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-13
Adjustors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-13
Adjustor Barcode Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-13
Controls (QC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-14
Adjustor Antibody. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-14
Control Antibody . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-14
Kit Barcode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-14
Package Insert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-15
Important Notices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-15
Other Test Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Chemiluminescent Substrate Module . . . . . . . . . . . . . . . . . . . . . . .1-15
Probe Wash Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-16
Diluent Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-16
Allergens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-16
Allergen Wedges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-16
Using the Consumables Report . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Software Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
IMMULITE 2000 XPi Home Screen . . . . . . . . . . . . . . . . . . . . . 1-20
Wedge Status Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20
Sample Rack Status Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20
Find Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20
Toolbar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20
Horizontal Toolbar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-21
Vertical Toolbar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-22
IMMULITE 2000 / 2500 Menu Screen . . . . . . . . . . . . . . . . . . . . . . .1-22
IMMULITE 2000 XPi Menu Screen. . . . . . . . . . . . . . . . . . . . . . 1-25
Online Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27
Navigating Online Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-27
Menu Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-28
Locating Routine Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-29

601005-0004 Rev. A
 Operator’s Guide: System Overview

Using the Index Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29

Using the Search Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29
Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-30
Data Reduction and the Chemiluminescent Reaction Internal
Calculations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-30
Chemiluminescent Reaction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31

601005-0004 Rev. A
System Overview

IMMULITE 2000 Systems and IMMULITE 2500 System

The IMMULITE® 2000 Systems and IMMULITE 2500 System Operator's Guide
describes the operation of the IMMULITE 2000 systems and IMMULITE 2500
system. This guide includes overviews of the systems, configuration instructions,
and operating, maintenance, and troubleshooting procedures.

Control Naming Conventions

To ensure control data is grouped appropriately for peer group reports and QC
alerts, the following naming conventions are used.
For Bio-Rad controls, use the control name BIOR, followed by the first two digits
of the lot number. The last three digits of the lot number are entered in the lot
number field. For example, Bio-Rad lot 40130 becomes BIOR40 lot 130. The
control level is 1, 2, or 3.
For Siemens Healthcare Diagnostics controls, use the control name and three-digit
lot number (preceded by a zero as necessary). For example, LRBC lot 0110
becomes LRBC lot 110. The control level is 1, 2, or 3. Likewise, CON6 lot
XX becomes CON6 lot 0XX. The control level is 4, 5, or 6.
For other controls, use the same ordering convention.

Product Descriptions
The IMMULITE 2000 systems are continuous random-access instrument that
perform chemiluminescent immunoassays.
The IMMULITE 2500 system performs chemiluminescent immunoassay testing
using logic driven incubation to provide dynamic resource allocation that
optimizes the use of the incubators, wash stations, and pipettors.
These instruments use serum, plasma, or urine samples for in vitro diagnostic
testing and work seamlessly with RealTime SolutionsSM and a VersaCell®
systems.
The instruments automate the entire testing procedure and accommodate high
volume testing, generating up to 200 test results per hour.
Primary, secondary, and microsample tubes may be loaded directly on the
instrument. The IMMULITE 2000 XPi also allows for loading tube top samples
on to a conductive rack. An LIS (Laboratory Information System) interface is
optional.

601005-0004 Rev. A
1-2 Operator’s Guide: System Overview

Principles of Operation
The instrument uses assay-specific antibody or antigen-coated polystyrene beads
as the solid phase.
A bead is dispensed into a specially designed reaction tube, which serves as the
vessel for the incubation, wash, and signal development processes.
After the sample is incubated with an alkaline phosphatase-labeled reagent, the
reaction mixture is separated from the bead by spinning the reaction tube at high
speed along its vertical axis. The fluid is transferred to a coaxial sump chamber,
which is integral to the bead/tube wash station. Four discrete washes occur within
seconds, allowing the reaction tubes to be processed sequentially with uniform
timing. The bead remains in the reaction tube with no residual unbound label.
The bound label is then quantified using the dioxetane substrate to produce light.
Light is emitted when the chemiluminescent substrate reacts with the alkaline
phosphatase label bound to the bead. The amount of light emitted is proportional
to the amount of analyte originally present in the sample. This light emission is
detected by the photomultiplier tube (PMT) and results are calculated for each
sample.

Output Specifications
The table below displays the output specifications for the IMMULITE 2000
systems and IMMULITE 2500. For a list of all system specifications, refer to
System Specifications‚ page E-1.
Output Specification Quantity
Throughput Up to 200 tests per hour
Time to first result IMMULITE 2000 and XPi: 35 minutes
IMMULITE 2500: 15 minutes
Tests per sample Unlimited

601005-0004 Rev. A
Operator’s Guide: System Overview 1-3

Hardware Overview
Pipetting Sequence
Sample tubes are processed in the following order, based on priorities built into
the software.
1. Adjustors
2. Controls
3. STAT samples
4. Labile, for example, intact PTH
5. Patients
6. Verifiers

System Components
The system components are described in this table:
Part Description
Bead carousel A rotating, dehumidified carousel that holds 24
bead packs.
The beads are dispensed individually from these
test-specific packs.
Bead pack barcode reader Reads barcodes on the bead packs in the bead
carousel.
NOTE: The bead pack barcode reader is not
visible in the figures.
Bead/tube wash station Washes and spins the bead after the immune
reaction (to remove any residual unbound reagent
and sample) and adds the luminogenic substrate.
Imaging scanner or Reads kit barcodes.
hand-held 2D scanner Users of allergy kits must have the imaging scanner
so allergen wedges that are loaded with allergen
vials can be scanned.
NOTE: The scanner is not visible in the figures.
Photomultiplier tube (PMT) Measures the photon counts.
NOTE: The PMT is not visible in the figures.
Reaction tube hopper gear driven Holds the empty reaction tubes.
reaction tube hopper
Reagent and sample valves Mechanism that redirects the flow of liquid used by
the sample Dual Resolution Dilutor (DRD) and the
reagent DRD.

601005-0004 Rev. A
1-4 Operator’s Guide: System Overview

Part Description
Reagent carousel A rotating carousel that holds 24 reagent wedges or
allergen wedges.
NOTE: To run allergy tests, the allergen wedge for
the allergy kit must be on the reagent carousel,
which leaves 23 positions for additional wedges.
Reagent wedges are divided into two or three
compartments, holding up to three reagents.
Wedges are identified by barcodes, which are read
by the sample/reagent barcode reader.
Allergen wedges are the wedge-shaped frames that
hold the allergen vials used in allergy testing. An
allergen wedge can hold up to six allergen vials.
Information about an allergen wedge is entered into
the database by scanning the barcodes on the side
of the wedge using the imaging scanner. Allergen
wedges also have a barcode on the edge, similar to
a reagent wedge, so the sample/reagent barcode
reader can identify their position on the reagent
carousel.
Because the reagent carousel is refrigerated
between 2º to 8°C (35.6º to 46.4 °F), reagent
wedges can be stored on the instrument. While it is
possible to store allergen vials on the instrument, it
is recommend that they be sealed with a standard
cap and stored off the instrument if they will not be
used for an extended period of time.
Reagent DRD (Dual Resolution Extracts reagent and water and moves the liquid to
Dilutor) the reagent pipettor.

Reagent pipettor Pipettes reagent onto the bead in the reaction tube.
Sample carousel A rotating carousel that holds six removable racks.
Each rack holds up to 15 specimen or diluent tubes
of varying sizes. The barcodes on the tubes are read
as the carousel rotates.
Sample dilution well Mixes specified quantities of specimen, diluent,
and water to form a homogenous mixture.
The sample probe dispenses the materials into the
well for mixing. After the diluted sample is pipetted
into the reaction tube, the dilution well insert is
spun at a high speed, discarding the unused portion
of the diluted sample.
Sample DRD Extracts sample from the sample tube and moves it
to the sample pipettor.
Sample pipettor Pipettes sample onto the bead in the reaction tube.

601005-0004 Rev. A
Operator’s Guide: System Overview 1-5

Part Description
sample/reagent barcode scanner Reads barcodes on the tubes in the sample carousel
and on the reagent and allergen wedges in the
reagent carousel.
substrate pump Dispenses 200 µL of substrate from the substrate
reservoir into a reaction tube.
tube processor Device where the immune and luminogenic
incubators reactions are incubated.
Reaction tubes are continually agitated at 37°C
(98.6°F) during these processes.
water pump Accurately dispenses water into a reaction tube at
the bead/tube wash station.

601005-0004 Rev. A
1-6 Operator’s Guide: System Overview

The following image displays the location of the various IMMULITE 2000
instrument components.

1 Sample carousel 9 Bead carousel cover

2 Reagent carousel (covered) 10 Substrate and water pumps)
3 Sample reagent barcode scanner 11 Substrate reservoir
4 Sample pipettor 12 Reagent DRD
5 Reagent pipettor 13 Sample DRD
6 Bead/tube wash station 14 Sample valve
7 Tube processor 15 Reagent valve
8 Bead carousel 16 Sample dilution well

Figure 1-1 IMMULITE 2000 System (Overhead View)

601005-0004 Rev. A
Operator’s Guide: System Overview 1-7

The following image displays the location of the various IMMULITE 2500
instrument components.

1 Sample Carousel 10 Bead Carousel

2 Reagent Carousel (Covered) 11 Bead Carousel Cover
3 Sample Reagent Barcode Scanner 12 A. Water Pumps
B. Substrate Pump
4 Sample Pipettor 13 Substrate Reservoir
5 Reagent Pipettor 14 Reagent DRD
6 PMT 15 Sample DRD
7 Incubator 16 Sample Valve
8 Substrate Probe 17 Reagent Valve
9 Water Probe 18 Sample Dilution Well

Figure 1-2 IMMULITE 2500 (Overhead View)

601005-0004 Rev. A
1-8 Operator’s Guide: System Overview

The following image displays the front view and locations of the
IMMULITE 2000 systems and IMMULITE 2500 system components, and the
items on the shelves underneath the instrument.

1 Rack loader door 9 Reaction tube hopper

2 Reagent carousel (covered) 10 Liquid waste
3 Pipettors 11 Probe wash
4 DRD priming accessories 12 Distilled water
5 Substrate reservoir 13 Solid waste
6 Bead carousel 14 Printer
7 CD/DVD drive 15 Power switch
8 Floppy drive

Figure 1-3 IMMULITE 2000 Systems and IMMULITE 2500 System (Front
View)

601005-0004 Rev. A
Operator’s Guide: System Overview 1-9

The following image displays the location of the various IMMULITE 2000 XPi
instrument components.

1 Sample Carousel 9 Bead Carousel Cover

2 Reagent Carousel (Covered) 10 Water Pump
3 Sample Reagent Barcode Scanner 11 Substrate Pump
4 Sample Pipettor 12 Substrate Reservoir
5 Reagent Pipettor 13 Reagent DRD
6 Bead/Tube Wash Station 14 Sample DRD
7 Tube Processor 15 Reagent Valve/Sample Valve
8 Bead Carousel 16 Sample Dilution Well

Figure 1-4 IMMULITE 2000 XPi System (Overhead View)

601005-0004 Rev. A
1-10 Operator’s Guide: System Overview

The following image displays the front view and locations of the IMMULITE
2000 XPi instrument components, and items held on the shelves underneath the
instrument.

1 Power switch 8 USB

2 Rack loader for sample carousel 9 Reaction tube hopper
3 Reagent carousel (covered) 10 Liquid waste
4 Sample pipettor door 11 Probe wash
5 DRD priming / substrate reservoir 12 Solid waste
6 Bead carousel 13 Distilled water
7 CD/DVD drive

Figure 1-5 IMMULITE 2000 XPi System (Front View)

601005-0004 Rev. A
Operator’s Guide: System Overview 1-11

Kit Components
Test kits include the materials needed to run assays. The components in a kit are
listed and described below:
• Adjustor antibody (for allergy kits only)
• Adjustors
• Barcode labels for adjustor tubes
• Bead packs
• Control antibody (for allergy kits only)
• Controls (for certain kits, including allergy kits)
• Diluents (for assays requiring a pre-dilution)
• Kit barcode
• Package insert
• Reagent wedges
• Important notices

Reagent Wedge
A barcoded reagent wedge contains an assay-specific enzyme conjugate. The
reagent is pipetted into the reaction tube. The reagent wedges in allergy kits
contain an anti-immunoglobulin reagent used for allergy tests with all allergens.
In the software and documentation, this reagent is referred to as universal reagent,
such as IgE or SPE. Figure 1-6 displays the reagent wedge label.

Figure 1-6 Reagent Wedge Label

601005-0004 Rev. A
1-12 Operator’s Guide: System Overview

Figure 1-7 displays the reagent wedge compartments.

Figure 1-7 Reagent Wedge Compartments

601005-0004 Rev. A
Operator’s Guide: System Overview 1-13

Bead Packs
A bead pack contains the assay-specific beads. A single bead is dropped into a
reaction tube. Figure 1-8 displays the bead pack label.

Figure 1-8 Bead Pack Label

Adjustors
Each kit contains one or two Adjustors. Kits with two adjustors have a LOW and a
HIGH adjustor, which contain different concentrations of analyte. The adjustor
can be in either liquid or lyophilized form.
For more information regarding the adjustors, refer to the package insert.

Adjustor Barcode Labels

Each kit contains adjustor barcode labels to be placed on test tubes. The label
identifies the tube as an adjustor for that particular test.

601005-0004 Rev. A
1-14 Operator’s Guide: System Overview

Controls (QC)
Controls are run to determine if adjustments are valid. They can also be used to
verify if the reagent and beads are viable. Some kits, such as infectious disease or
allergy kits, require specialized controls that are included in those kits. Controls
are available separately for other assays.

Adjustor Antibody
Allergy kits include an adjustor antibody. The adjustor antibody must be loaded in
an allergen wedge and placed on the instrument when the adjustors for an allergy
kit are run. An adjustor antibody vial contains 40 tests. Each adjustor antibody
vial has a corresponding 2D barcode that contains lot-specific information about
the adjustor antibody. The 2D barcode must be scanned before the adjustor
antibody vial is loaded into an allergen wedge.

Control Antibody
Allergy kits include a control antibody. The control antibody must be loaded in an
allergen wedge and placed on the instrument when running controls on allergy
tests. A control antibody vial contains 40 tests. Each control antibody vial has a
corresponding 2D barcode that contains lot-specific information about the control
antibody. The 2D barcode must be scanned before the control antibody vial is
loaded into an allergen wedge.

Kit Barcode
The 2D kit barcode (displayed below) is located on the box flap inside the kit.
Information specific to the kit lot is included in the barcode and must be entered
the first time a kit lot is used.

Figure 1-9 2D Kit Barcode

601005-0004 Rev. A
Operator’s Guide: System Overview 1-15

Package Insert
The package insert contains specific information regarding the assay. Be sure to
read the package insert before using a new kit.

Important Notices
Important Notices contain information regarding usage of the assay kit
components. A sticker on the outside of the kit package alerts the user that an
important notice is enclosed.

Other Test Supplies

NOTE: These supplies are not included in the kit.

Other test supplies needed to run the instrument include:

• chemiluminescent substrate
• probe wash
• diluents
• allergens (for allergy tests only)
• allergen wedge (for allergy tests only)

Chemiluminescent Substrate Module

WARNING
Do not add fill the substrate reservoir beyond the maximum capacity of 1000
tests. Filling the substrate reservoir beyond the maximum capacity may cause
substrate to enter the CO2 scrubber and cause a blockage. This can result in
damage to the instrument and possible misreporting of results. Each bottle of
chemiluinescent substrate contains enough material for 1000 tests.

The chemiluminescent substrate module includes two bottles of

chemiluminescent substrate. Store the substrate between 2º and 8°C (35.6º and
46.4°F). Each bottle of chemiluminescent substrate contains enough material for
1000 tests.

CAUTION
Do not leave substrate spills on the load scale. Spilled substrate may cause the
load scale to stick and the substrate status indicator to appear full when the
substrate reservoir is empty. This could affect results. Immediately clean up any
substrate spills using moistened tissues.

601005-0004 Rev. A
1-16 Operator’s Guide: System Overview

Probe Wash Module

The probe wash module contains two bottles of probe wash concentrate, which
should be stored at room temperature. Each 200 mL bottle must be diluted with
1800 mL of distilled/de-ionized water before it is used.

Diluent Module
Diluent tubes may be barcoded for instrument identification and used for the
onboard dilution of patient samples with analyte concentrations above the
calibration range. The diluent is packaged in bulk bottles, along with barcoded
labels that are used with 16 x 100 tubes.

Allergens
To test patient samples for an allergy, a vial containing the appropriate allergen
must be placed in an allergen wedge on the reagent carousel. Vials that contain
several allergens are used to test samples for a broader range of allergic reactions.
Allergen vials contain 20 or 40 tests, based on the allergen type. Each allergen
Vial has a 2D barcode that must be scanned like the 2D barcodes from an assay
kit.

Allergen Wedges
Allergen wedges are the wedge-shaped frames that hold the allergen vials used in
allergy testing. An allergen wedge can hold up to six allergen vials. Information
about the contents of an allergen wedge is entered into the database when the
wedge and vial barcodes are scanned with the imaging scanner. Allergen wedges
also have a barcode on the edge, like a reagent wedge, so their position on the
reagent carousel can be identified by the sample/reagent barcode reader.

Using the Consumables Report

Follow these steps to review the consumables report:
1. If the button on the Worklist screen is red, select Consumables.
2. Load any kit components that are low or missing.
NOTE: The next time the Consumables button is selected or the next time the
barcodes are read, the button returns to the original color.
3. Select CLOSE to remove the consumables report from the screen.
The assays begin processing.

Software Overview
The software provides tools to direct instrument operations and manage data. The
software also informs the operator of system conditions and provides answers to
operator questions.

601005-0004 Rev. A
Operator’s Guide: System Overview 1-17

NOTE: The computer supplied with the instrument is designed to run the included
software. The installation of third-party software applications may adversely
affect the proper operation of the instrument software and/or system.
Certain screens display automatically at the appropriate time, while others can be
accessed from the toolbar. The following image displays both the horizontal and
vertical toolbar, the buttons along the top and right side.

601005-0004 Rev. A
1-18 Operator’s Guide: System Overview

The following image displays the updated IMMULITE 2000 system and the
IMMULITE 2500 system Home screen.

1 HOME 12 PAUSE
2 WORKLIST 13 STOP
3 REVIEW 14 PRIME
4 KITS 15 COVER
5 LIS 16 WATER
6 QC 17 WASH
7 REPORTS 18 SUBSTRATE
8 MENU 19 SOLID WASTE
9 HELP 20 LIQUID WASTE
10 LOGOFF 21 TUBES
11 RUN

Figure 1-10 Home Screen for the IMMULITE 2000 System and the
IMMULITE 2500 system

601005-0004 Rev. A
Operator’s Guide: System Overview 1-19

The following image displays the IMMULITE 2000 XPi Home screen.

1 HOME 15 COVER
2 WORKLIST 16 WATER
3 REVIEW 17 WASH
4 KITS 18 SUBSTRATE
5 LIS 19 SOLID WASTE
6 QC 20 LIQUID WASTE
7 REPORTS 21 TUBES
8 MENU 22 INSTRUMENT
9 HELP 23 FIND
10 LOGOFF 24 EJECT
11 RUN 25 SAMPLE RACK
12 PAUSE 26 REAGENT CAROUSEL
13 STOP 27 BEAD CAROUSEL
14 PRIME

Figure 1-11 IMMULITE 2000 XPi Home Screen

601005-0004 Rev. A
1-20 Operator’s Guide: System Overview

IMMULITE 2000 XPi Home Screen

The IMMULITE 2000 XPi Home screen displays a graphical representation of the
sample, reagent, and bead carousels, and is touch sensitive.
At the Home screen, you can:
• Manually release a sample rack by selecting the eject symbol.
NOTE: The rack identifiers may display in uppercase or lowercase alpha or
numeric if there is a bad barcode.
• Access a sample rack by selecting the rack identifier.
• Access the reagent or bead carousel screen by selecting the reagent or bead
pack.

Wedge Status Indicators

The colors displayed on the reagent and bead wedge indicate the status:
Color Status
Red Error
Yellow Warning
White Ok to Run

Sample Rack Status Indicator

The colors displayed on the sample rack indicate the status:
Color Status
Red Error
Gray with identifier Sample rack in position without errors.
Gray without identifier No rack present

Find Button
Command Function
FIND Offers sample search capabilities.

Toolbar
The IMMULITE 2000 systems and IMMULITE 2500 system toolbar provides
quick access to commands or screens used in routine instrument operation.
The command buttons on the horizontal toolbar provide tools for data
management.
The buttons on the vertical toolbar directly affect instrument operations. The
status indicators under the horizontal toolbar display the instrument fill-levels for
water, probe wash, substrate, the tube hopper, and liquid and solid waste.

601005-0004 Rev. A
Operator’s Guide: System Overview 1-21

Use the trackball or your finger to select a button on the toolbar.

NOTE: The operator may touch the screen with a bare or gloved hand or with an
eraser. Do not use your fingernails or any hard implement such as a pen.

Horizontal Toolbar
The table below provides description of the horizontal toolbar buttons:
Command Function
HOME Returns to the Home screen.
• Select reagents or beads to view the information.
• The IMMULITE 2000 XPi Home screen displays the status of
reagent, beads, and samples currently onboard the instrument.
Refer to Home Screen for the IMMULITE 2000 System and the
IMMULITE 2500 system‚ page 1-18 or IMMULITE 2000 XPi Home
Screen‚ page 1-19.
WORKLIST Accesses the Worklist screen, allowing the operator to create or
modify a worklist. The worklist directs the instrument regarding the
test orders to perform for each patient, adjustor, control, or calibration
verifier sample.
REVIEW Used to review test results.
KITS Used to review kit information.
LIS Used to review data received from (or being sent to) the Laboratory
Information System (LIS).
When the system is configured to send data manually to the LIS,
results are tagged (for sending) from this screen.
QC Used to enter control identification information, to specify whether to
use the control results for quality control tracking, and to view control
results in graphical format
REPORTS Used to print or configure reports.
MENU Used to access tool and configuration selections.
HELP Used to access online help.
LOG OFF Initiates a system back-up and ends the working session.

601005-0004 Rev. A
1-22 Operator’s Guide: System Overview

Vertical Toolbar
The table below provides a brief description of the vertical toolbar buttons:
Command Function
RUN Starts the instrument processing.
PAUSE Stops the pipettors from processing any new tests, but allows it to
continue to process tests which are already on the instrument.
STOP Stops the instrument from processing.
All mechanical movements are stopped, completed tests are saved,
and tests in progress are terminated.
PRIME Primes the pipettors to remove air from the fluidic lines.
COVER Releases the lock on the main cover so it can be opened.

IMMULITE 2000 / 2500 Menu Screen

The Menu screen enables you to access tools and configuration settings. Select
MENU from the horizontal toolbar.

1 MENU button

Figure 1-12 New IMMULITE 2000 / 2500 Menu Screen

601005-0004 Rev. A
Operator’s Guide: System Overview 1-23

Menu Screen Tools Panel

Tools Description
Formfeed Causes the system to print all the data in the print buffer.
The system waits to print patient results until it has enough
data for a full page. A partial page of patient results will
print if no results are posted after 30 minutes.
When Formfeed displays in black, results are available for
printing. Select Formfeed to print these results.
Export Data Displays the Export Data screen, which is used to export
data to a file, the screen, or the printer.
Sample Tubes in Racks Displays a screen that displays color-coded tubes on the
sample carousel.
Temperatures Displays the Temperature screen, which is used to view the
instrument temperature and humidity levels.
Day Error Log Displays the Daily Error Log.
Debug Form For use by Siemens personnel only.
Beads and Reagents Displays details regarding the beads and reagents onboard
Onboard the instrument.
Allergens Onboard Use this command to open the Allergens Onboard window
to view information about allergens onboard the instrument.
Adjustment Log Displays an Adjustment Log displaying the adjustment
history.

Find Last Tube Displays the user to determine the rack and position where a
Location specified tube was last located.
This feature is available for bar-coded patient samples only.

Menu Screen Configurations Panel

Configurations Description
Configure Displaysscreens used to configure instrument settings
including Display Options, Automatic Dilutions, Instrument
Identification, LIS and Configuration Settings screens.
Test Ranges Specifies reference ranges.

Allergen Ranges Displays the ranges of immunoglobulin concentrations for

allergic reactions.
Reflexive Tests Specifies the test to perform when a result is outside a
specified range.
Panels Used to create or change a panel.
Units Used to change the default units for a specific test.
Auto Rack Used to view the contents of an automation rack when the
instrument is connected to a VersaCell system.

601005-0004 Rev. A
1-24 Operator’s Guide: System Overview

Configurations Description
Confirm HBS Used to order HBS confirmatory tests and printed results.

Menu Screen Task Bar

Options Description
Hide Names Used to hide patient names on the following
screens:
• Export data (Onscreen, printed, and text)
• Review
• LIS
• Worklist
About Displays the software version, a general statement
regarding the instrument software, and the
EMERGENCY SHUTDOWN button.

601005-0004 Rev. A
Operator’s Guide: System Overview 1-25

IMMULITE 2000 XPi Menu Screen

The Menu screen enables you to access tools and configuration settings. Select
MENU from the horizontal toolbar.

1 MENU button

Figure 1-13 IMMULITE 2000 XPi Menu Screen

Menu Screen Tools Panel

Tools Description
Formfeed Causes the system to print all the data in the print buffer.
The system waits to print patient results until it has enough
data for a full page. A partial page of patient results will
print if no results are posted after 30 minutes.
When Formfeed displays in black, results are available for
printing. Select Formfeed to print these results.
Export Data Displays the Export Data screen, which is used to export
data to a file, the screen, or the printer.
Refer to Exporting Data‚ page 7-1.
Sample Tubes in Racks Displays a screen that displays color-coded tubes on the
sample carousel.
Refer to IMMULITE 2000 XPi Home Screen‚ page 1-20.

601005-0004 Rev. A
1-26 Operator’s Guide: System Overview

Tools Description
Temperatures Displays the Temperature screen, which is used to view the
instrument temperature and humidity levels.
Day Error Log Displays the Daily Error Log.
Debug Form For use by Siemens personnel only.
Beads Reagents Displays details regarding the beads and reagents onboard
Onboard the instrument.
Allergens Onboard Use this command to open the Allergens On Board window
to view information about allergens onboard the instrument.
Adjustment Log Displays an Adjustment Log displaying the adjustment
history.

Find Last Tube Displays the user to determine the rack and position where a
Location specified tube was last located.
This feature is available for bar-coded patient samples only.
Scheduled QC Allows the user to define a schedule for performing quality
control assays during AutoStart.

Menu Screen Configurations Panel

Configurations Description
Configure Displays screens used to configure instrument settings
including Display Options, Automatic Dilutions, Instrument
Identification, LIS and Configuration Settings screens.
Test Ranges Specifies reference ranges.

Allergen Ranges Displays the ranges of immunoglobulin concentrations for

allergic reactions.
Reflexive Tests Specifies the test to perform when a result is outside a
specified range.
Panels Used to create or change a panel.
Units Used to change the default units for a specific test.
Auto Rack Used to view the contents of an automation rack when the
instrument is connected to a VersaCell system.
Confirm HBS Used to order HBs confirmatory tests and printed results.
Communication Used to configure the instrument to communicate via
informatics applications such as RealTime Solutions.
AutoStart Configuration Used to configure the instrument to automatically or
manually process routine maintenance tasks.

601005-0004 Rev. A
Operator’s Guide: System Overview 1-27

Menu Screen Task Bar

Options Description
Hide Names Used to hide patient names on the following
screens:
• Export data (Onscreen, printed, and text)
• Review
• LIS
• Worklist
Run AutoStart Starts the maintenance tasks automatically.
Refer to AutoStart Maintenance (IMMULITE 2000
XPi System)‚ page 5-35.
The instrument must be in STOP mode or logged
off for processing to begin.
About Displays the software version, a general statement
regarding the instrument software, and the
EMERGENCY SHUTDOWN button.

Online Help
Select HELP on the toolbar for information about the operation of the instrument
and its software. The online help is context-sensitive software including complete
operating, maintenance, and troubleshooting procedures about the currently
displayed screen.
1. At the instrument window, select HELP.
2. At the Help window, select Help Topics to display a list of help topics.

Navigating Online Help

Help is organized much like books in a library. A book icon represents each help
topic with sub-topics displayed as chapters within the topic. The toolbar buttons
can be used to display all online help topics and allow navigation within the
topics.
1. Select Help on the horizontal toolbar to display all help topics.
2. The help screen displays help topics in the left pane and information about a
highlighted topic in the right pane.
3. To move from topic to topic, select the plus symbol (+) next to the book icon.
4. Select Back to move to the previously viewed topic.
5. Select the << or >> buttons to move forward or backward through sub-topics.

601005-0004 Rev. A
1-28 Operator’s Guide: System Overview

Menu Options
The operator can access different views and display options within the Help using
the menu options.
Menu Option Function
File • Open
Allows the user to open a Help file.
• Print Topic
Allows the user to print a Help topic.
• Exit
Allows the user to exit the Help file.
Edit • Copy
Copy text from the help file to the clipboard.
• Annotate
Associate additional information with a specific topic. When a
topic is annotated, a paper clip icon displays next to the topic.
Select the paper clip icon to display the annotation text.
Bookmark Define
Allows the user to define an electronic placeholder to allow the user
to return to a specific Help topic.
Options • Keep Help on Top
Options that determine the visual position of the Help window
when other applications are open simultaneously.
- Default – Sets the Help file as always open and visibly in front
of all open applications.
- On Top – Sets the Help file as always open and visibly in front
of all open applications but inactive. The title bar at the top of the
Help file window becomes gray when another application is
opened.
- Not on Top – Sets the Help file to open upon user initiation. The
Help file minimizes when another application is opened.
• Display History Window
Opens a window that displays the history of the help topics
previously viewed. Double-clicking a topic in this window opens
that Help topic.
• Font
Changes the size of the font for Help topics.
• Use System Colors
Sets colors used in the Help file to match those that are used for
the PC.
Help • Version
Displays current version and copyright statement for Windows
Help.
• About Windows 2000
Provides WinHelp product description.

601005-0004 Rev. A
Operator’s Guide: System Overview 1-29

Locating Routine Procedures

Instrument operating procedures that are common within normal day-to-day
operation are listed in the Help window. You can locate maintenance procedures,
solutions for error messages, and checklists for secondary operator training.
To locate instructions on operating procedures, perform the following steps:
1. Select HELP.
2. In the Help window, select Help Topics to display a list of help topics.
3. Select the help topic by selecting the addition symbol to the front of the book
icon to the left of the topic.
The sub-topics within that topic display.
4. Select the sub-topic of interest.
The information on that sub-topic displays in the right panel of the Help
screen.

Using the Index Feature

Help is indexed to enable the operator to locate pertinent information
alphabetically.
To access the index, perform the following:
1. Select HELP from the Horizontal Toolbar.
2. Select Index from the Help screen to display a list of Index contents.
3. Select the index topic by clicking the topic.
The sub-topics (if applicable) within that topic display.
4. Select the index topic of interest. The information on that topic displays in the
right pane of the Help screen.

Using the Search Feature

The search feature allows the operator to search for specific words or phrases in
the Help software. Prior to initial use, a database must be created that lists every
word in the Help software.

Initializing the Search Feature

To initialize the search feature the first time, perform the following:
1. Select HELP from the Horizontal Toolbar.
2. Select Search on the Help screen.
3. Leave the default selection to minimize database size, and then select Next to
proceed.

601005-0004 Rev. A
1-30 Operator’s Guide: System Overview

4. Select Finish to complete the setup wizard.

The Search database is now ready for use.

Searching the Help Database

To conduct a search of the Help database, perform the following:

1. Select HELP.
2. Select Search.
3. In the search window, type a word or phrase, such as load.
The second window displays with matching words.
4. Select a word or phrase to narrow the search.
5. The results window displays with all topic entries that contain the word or
phrase.
6. Select the topic to display.
The topic displays in the right pane of the screen with the search results
highlighted.

Technology
Data Reduction and the Chemiluminescent Reaction
Internal Calculations
This section provides a step-by-step description of the internal calculations
performed by the system when determining test results.
1. Because the instrument's ultra-sensitive assays can produce up to several
hundred million counts per second (CPS), the instrument uses an attenuator
disk in front of the photomultiplier tube (PMT) to provide accurate readings
over a very broad range of light signals. This attenuator disk has three
positions:
• Closed - completely blocks the PMT
• Attenuated - positions a neutral density filter in front of the PMT
• Open - an open, unfiltered position
The instrument's attenuation filter restricts the amount of light striking the
PMT, ensuring an accurate count, even if the actual light output from the tube
exceeds the linear range of the PMT.
2. For each sample, the instrument takes two one-second readings (dark count in
the closed position and a decision count reading in the attenuated position).
3. If the decision count reading indicates the light level is within the working
range of the PMT, the attenuator disk moves to the open position; otherwise, it
remains in the attenuated position while the sample readings are taken.

601005-0004 Rev. A
Operator’s Guide: System Overview 1-31

4. The instrument takes five one-second readings.

5. The average of the last 10 dark count readings is subtracted from each of the
five readings of the sample tube and the average of the five readings is then
calculated.
NOTE: A dark count reading is taken every 18 seconds when a Reaction Tube
is in the read position.
6. If the counts were measured attenuated, the mean of the five individual
readings is multiplied by the instrument-specific attenuation factor to estimate
what the reading would have been if it could have been taken without the
attenuator.
7. CPS (unattenuated)= CPS(attenuated) x attenuation factor
8. To determine analyte concentrations, the instrument uses the counts together
with the adjustment data and the master curve.

Chemiluminescent Reaction
This section provides a brief overview of the chemiluminescent reaction used in
the instrument.
During the initial immune reaction between the reagent antibodies and the analyte
in the sample, that component of the reagent labeled with alkaline phosphatase
(known as the conjugate) is bound to the bead within the reaction tube. The
amount of alkaline phosphatase bound is directly proportional (for a sandwich
assay), or inversely proportional (for a competitive assay) to the concentration of
the analyte in the patient sample.
After the reaction tube is washed, a luminogenic substrate is added to the reaction
tube.
Five minutes later, the reaction tube arrives in front of the photomultiplier tube
(PMT), where the light generated by the luminogenic reaction is measured. The
enzyme-amplified reaction in the system produces a prolonged output of light
causing the tube to glow.
In the luminogenic reaction (illustrated in the next figure), the substrate (an
adamantyl dioxetane phosphate) is dephosphorylated into an unstable
intermediate by the alkaline phosphatase bound on the bead. The unstable
intermediate rapidly and spontaneously breaks down, emitting a photon of light.
The amount of light emitted is directly proportional to the amount of bound
alkaline phosphatase.
Compared to other means of detection, chemiluminescence provides the highest
degree of sensitivity available. In many cases, the sensitivity is orders of
magnitude better than that attainable with radioimmunoassays.

601005-0004 Rev. A
1-32 Operator’s Guide: System Overview

LUMIGEN PPD:
4-methoxy-4-(3-phosphatephenyl)-spiro-(1,2-dioxetane-3,2´-adamantane).

1 Dioxetane phosphate (stable

2 Alkaline phosphatase label
3 Dioxetane (unstable)
4 Light (hv)

Figure 1-14 Chemical Reaction of Instrument Substrate

601005-0004 Rev. A
 Operator’s Guide: Operating the System

2 Operating the System

Operator Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Managing Sample Racks . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Labeling and Loading Sample Tubes . . . . . . . . . . . . . . . . . . . . . 2-2
Preparing Samples for Loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
IMMULITE 2000 XPi Sample Loading . . . . . . . . . . . . . . . . . . . . . . . 2-4
Loading Microsamples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Tube Top Sample Cups (IMMULITE 2000 XPi System) . . 2-7
Automated Test Process . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
RUN Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
PAUSE Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
STOP Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
AutoStart Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Maintaining Reagent Wedges, Allergen Wedges and Bead
Packs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Checking the Status of Reagent Wedges and Allergen Wedges . . .
2-12
Reagent Status Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
Background color . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
Error messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Replacing Reagent Wedges and Allergen Wedges . . . . . . . . . . . . 2-15
Checking the Status of Bead Packs . . . . . . . . . . . . . . . . . . . . . . . . 2-19
Using the Bead Status screen . . . . . . . . . . . . . . . . . . . . . . . . . 2-19
Background Color . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19
Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20
Viewing Bead Pack Detail. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20
Replacing Bead Packs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21
IMMULITE 2000 XPi Kit Load Report. . . . . . . . . . . . . . . . . . . . 2-23
Viewing the Kit Load Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23
Printing the Kit Load Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24
Reviewing the Printed Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25
Entering a Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25
Scanning a 2D Kit Barcode Using a 2D Scanner . . . . . . . . . . . . . . 2-26
Scanning a 2D Kit Barcode Using an Imaging Scanner . . . . . . . . . 2-26
Entering Allergens and Allergen Wedges . . . . . . . . . . . . . . . . . . . . 2-28
Reviewing Kit Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31
Configuring Kit Lot Deactivation . . . . . . . . . . . . . . . . . . . . . . . . 2-31
Kit Deactivation Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33
Adjusting an Assay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33

601005-0004 Rev. A
2-2 Operator’s Guide: Operating the System

Adjustment Printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-35

Checking Adjustment Validity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-37
Running Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-37
Checking the Sample Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-37
Checking the Test Time Remaining . . . . . . . . . . . . . . . . . . . . . . . . 2-38
Checking the Tests Ordered and Time Remaining. . . . . . . . . . . . . 2-39
Find Last Tube Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-39
Viewing the Adjustment Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-40
Viewing Beads and Reagents On Board . . . . . . . . . . . . . . . . . . . . 2-41
Viewing Allergens On Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-41
Managing Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-41
Adding Patients to a Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . 2-42
Barcoded Patient Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-42
Damaged or Missing Barcodes. . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-44
Ordering STATs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-45
Adding Adjustors to the Worklist. . . . . . . . . . . . . . . . . . . . . . . . 2-46
Adding Controls to a Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . 2-46
Barcoded Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-47
Controls without Barcodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-48
Adding Calibration Verifiers to a Worklist . . . . . . . . . . . . . . . . . 2-49
Diluting Samples. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-50
Diluting Samples Onboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-50
Specifying Manually Diluted Samples. . . . . . . . . . . . . . . . . . . . . . . 2-52
Checking Kit Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-53
Test Entry Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-53
Selecting Available Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-53
Selecting a Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-55
Assigning Tests to an Entire Rack . . . . . . . . . . . . . . . . . . . . . . . . . 2-55
Assigning a Tube Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-56
Worklist Management and Display Options . . . . . . . . . . . . . . . 2-57
Displaying a Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-57
Printing a Worklist. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-57
Modifying a Worklist Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-58
Deleting a Worklist Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-58
Saving and Importing a Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-59
Reviewing Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-60
Changing the Default Time. . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-61
Searching for a Result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-62
Reviewing LIS Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-63
Sending Results to the LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-64
Resending Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-64
Clearing LIS Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-64

601005-0004 Rev. A
Operating the System

This section provides information about operating the system.

Operator Tasks
The procedures performed by the operator when running assays on the instrument
are outlined below.
1. Perform the Daily Probe Cleaning procedure.
Refer to Cleaning the Sample and Reagent Probes‚ page 5-5.
2. Select RUN IMMULITE 2000 or RUN IMMULITE 2500 on the startup screen.
3. Check the system status indicators and fill or empty the reservoirs.
Refer to Checking the Status Indicators‚ page 5-6.
4. Prime the sample and reagent pipettors, the water probe, and the substrate
probe.
Refer to Priming the Sample and Reagent Pipettors‚ page 5-13.
5. Scan any allergen wedges on the reagent carousel using the imaging scanner.
Refer to Scanning a 2D Kit Barcode Using an Imaging Scanner‚ page 2-26.
6. Load the patient samples, controls, adjustors, and diluents (as necessary) on
the sample carousel.
NOTE: The materials needed to operate the instrument are included in the
IMMULITE 2000 and IMMULITE 2500 test kits. Diluents are only included
for pre-diluted assays.
Refer to Managing Sample Racks‚ page 2-2.
7. Check that a sufficient quantity of reagent wedges and matching bead packs
are available to process the tests ordered.
Refer to Maintaining Reagent Wedges, Allergen Wedges and Bead Packs‚
page 2-12.
8. If necessary, associate the accession numbers with the tests ordered via the
Worklist screen.
Refer to Managing Worklist‚ page 2-41.
9. Select RUN to begin the automated test process.

601005-0004 Rev. A
2-2 Operator’s Guide: Operating the System

Managing Sample Racks

Procedural Notes
• Be sure to read the preliminary Sample Volume and Tube Sizes‚ page E-3
before beginning the first step.
• Use the following procedure to label and load sample tubes.

Labeling and Loading Sample Tubes

WARNING
Do not load multiple sample tubes with the same accession number on the Sample
Carousel at the same time. Only the sample in the lowest sample carousel
positions are pipetted, if multiple sample tubes with the same accession number
are onboard at the same time.
NOTE: The instrument only accepts barcodes containing the following valid
characters: the numbers 0-9, the letters A-Z, the characters (+), (-), (.), (#), (\), (~),
and a blank space ( ). Barcodes containing invalid characters will not be accepted.
The instrument recognizes five barcode symbologies:
• Code 39
• Code-A-Bar
• UPC
• Code 128
• I-2 of 5 (Interleaved)
I-2 of 5 includes different dialects; therefore, the system must be configured
before running a sample with this barcode. For information about this
configuration, contact your local technical service provider or distributor.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-3

Preparing Samples for Loading

NOTE: Before loading the controls, samples, and diluents, make sure all new kit
barcodes have been scanned and check for bubbles or moisture at the top of the
tubes.

WARNING
Handle samples carefully to avoid agitation that might introduce bubbles. Bubbles
in the sample tube can potentially cause incorrect results. Prior to processing
samples, carefully inspect the sample tubes to ensure all bubbles are eliminated.
1. Place the barcode labels on the sample tubes:
a. Make sure the labels are visible in the tube guide reading screen or
directly above the tube guide reading screen.

1 Reading screen of the tube guide

Figure 2-1 Section of a Sample Rack

b. Place the bottom edge of the label at least 0.5 in. (13mm) from the bottom
of the tube.

Figure 2-2 Label Positioning

601005-0004 Rev. A
2-4 Operator’s Guide: Operating the System

Loading Samples on the IMMULITE 2000 System and the IMMULITE 2500
System
1. At the instrument screen, select a sample rack to load by selecting the letter
corresponding to the appropriate sample rack or an empty rack position.
The sample carousel rack rotates so the rack is accessible.
2. To remove a current rack from the system, do the following:
a. Lift the sample cover.
b. Grasp the sample carousel rack using the finger indentations and pull the
rack forward until it slides out.

WARNING
Use only the tube sizes listed in Sample Volume and Tube Sizes‚ page E-3 and
ensure the tubes are firmly seated in the sample racks. If you use the wrong size
tubes or do not seat the tubes as instructed, sampling problems or incorrect results
may occur.

3. Load the controls, patient samples, and diluents in the sample rack,
positioning the tubes so the barcodes face out.
Ensure that the bottom of the barcode label is not obscured by the rack. The
entire barcode label must be readable.
4. After samples are placed in the sample rack, slide it back into the carousel,
making sure the rack snaps back into position.
5. Repeat steps 1 through 4 with the next sample carousel rack until all controls,
samples, and diluents are loaded onto the instrument.
6. Close the sample carousel door.
7. Select RUN to interrogate the sample carousel.

IMMULITE 2000 XPi Sample Loading

WARNING
Use only the tube sizes listed in Sample Volume and Tube Sizes‚ page E-3 and
ensure the tubes are firmly seated in the sample racks. If you use the wrong size
tubes or do not seat the tubes as instructed, sampling problems or incorrect results
may occur.

1. View the lights to the left of the rack loader door to determine if the
instrument is ready for a new rack.
• A solid red light on the rack loader indicates the instrument is not ready to
accept a rack.
The light remains red when the rack loader is full.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-5

• A flashing red light on the rack loader indicates the instrument has an
error loading or ejecting a rack.
• A solid green light on the rack indicates the instrument is ready to accept
a rack.
2. Lift the rack loader door.
3. Set the sample rack into the sample tray.

1 Rack loader door

2 Sample rack

Figure 2-3 Loading the Sample Carousel Rack (IMMULITE 2000 XPi
System)

4. Close the rack loader door.

The instrument automatically loads the rack onto the system when the sample
carousel has an empty rack position.

Loading Microsamples
The instrument can perform assays using samples whose volumes are less than
250 µL. The minimum sample volume for an assay is indicated in the package
insert for that assay, and with the microsampling feature, the instrument can
operate properly using at least 50 µL of additional sample.

CAUTION
Ensure the tubes for microsample cups are inserted so that they touch the bottom
of the rack. If they do not touch the bottom of the rack, it can create the risk of
erroneous results. Always follow sample loading instructions completely.

601005-0004 Rev. A
2-6 Operator’s Guide: Operating the System

Load the microsample on the instrument in a disposable 10 x 50 mm polystyrene

sample tube (catalog number LSMT). Place each tube in a re-usable microsample
tube holder (catalog number LMH15) that fits on the sample rack.
• Ensure that you insert microsample tube holders completely so that they touch
the bottom of the rack.
• Verify that barcode labels are not scratched, marred, positioned incorrectly, or
rendered unreadable by any marks or spills.
After you place the holders on the sample carousel and put the instrument into
RUN mode, the samples are ordered the same as primary and secondary tubes.
NOTE: Pipette no more than five tests from a single microsample tube.

Microsample tube holders have permanently affixed barcodes. The 10 x 50 mm

sample tubes can be barcoded to allow identification of the specimens.
For information about labeling patient sample tubes, refer to the next section

1 10 x 50 microsample tube with patient bar-code label

2 Microsample tube holder
3 Microsample holder bar code label (do not remove the label)

Figure 2-4 Microsample Tube Holder

If sample barcode labels are larger than the 10 x 50 mm tubes, assays may be run
on microsamples without barcodes. To enter patient information manually on
samples without barcodes, refer to Damaged or Missing Barcodes‚ page 2-44

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-7

Tube Top Sample Cups (IMMULITE 2000 XPi System)

NOTE: Tube top sample cups are also known as nesting cups or small sample
cups (SSC).

WARNING
Sample cups placed in the tops of primary collection tubes are not approved for
use on the IMMULITE 2000 and IMMULITE 2500 systems. Placing sample or
nesting cups in a primary tube may cause the system to use an inaccurate sample
volume during testing. The principle risk is undetected short sampling from the
cup, creating a risk of erroneous results.

Only the IMMULITE 2000 XPi instrument supports this type of testing on the
tube top rack with the approved tube top sample cups / nesting cups.

The IMMULITE 2000 XPi instrument allows you to pipette a small sample into
an approved tube top cup and place the cup back in the original sample tube and
put it in a rack on the instrument. To use tube top sample cups, you must load
them into a tube top rack designed for that purpose.
The tube top rack has a capacity of 15 tubes. However, you can only load 8 shorter
tubes (75 mm) in the front row and 7 taller tubes (100 mm) in the back row. If you
do not have that mix of tube sizes, your maximum capacity is less.
NOTE: Pipette no more than five tests from a single tube top cup.

Use an approved 1 mL or 2 mL tube top sample cup to pipette low volume

samples with a dead volume of 50 to 100 µL.
For use with this tube
Approved Cup Sizes Part Number diameter...
1 mL (tube top cup) 905288 (REF 10374178) 12 mm and 13 mm
2 mL (tube top cup) 905289 (REF 10374179) 16 mm

601005-0004 Rev. A
2-8 Operator’s Guide: Operating the System

To use tube top sample cups, perform the following steps:

1. Pipette the sample from the barcoded primary tube into the tube top sample
cup and place it inside the primary tube.

1 Tube top sample cup

2 Primary tube

Figure 2-5 Tube Top Sample Cup and Primary Tube

CAUTION
Do not use a regular sample rack for loading tube top cups. Using a regular
sample rack could cause damage to the system or report incorrect results. Use
only the racks dedicated for tube top cups. These racks use a lower-case alpha
character on the rack barcode label.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-9

2. Ensure you are using a dedicated tube top sample rack.

Tube top sample racks have a conductive surface on the pylons between
tubes. This allows the instrument to perform level sensing on the tube top
cups.
The figures below display the differences between the standard rack and the
tube top rack:
• Standard racks have no pylons between the tube holders.
• Standard racks have an uppercase letter on the barcode.
• Tube top racks have a lowercase letter on the barcode.
Tube Top Rack

Standard Rack
Load the barcoded primary tube containing the tube top sample cup into the
tube top rack on the instrument.
a. Load only 75 mm tubes in the front row of the rack.

601005-0004 Rev. A
2-10 Operator’s Guide: Operating the System

b. Load only 100 mm tubes in the back row of the rack.

c. As with regular tubes, ensure the bar code is clear of any obstruction.

1 Conductive pylons
2 100 mm tubes with tube top sample cups
3 75 mm tubes with tube top sample cups
4 Tube top rack bar code displaying a lowercase letter

Figure 2-6 IMMULITE 2000 XPi Tube Top Rack

The instrument reads the barcode and detects that all samples in the tube top
rack are tube top sample cups.
View the status and rack position on the Sample Tubes In Rack screen.

Automated Test Process

After the operator selects RUN, the instrument processes the tests and generates
the results. A step-by-step description of this process displays below:
1. A single assay-specific bead is dropped into a reaction tube.
2. Sample, assay-specific reagent, and water are pipetted onto the bead.
3. The reaction tube is moved into the incubation area, where the tube is agitated
at 37°C (98.6°F).
4. The reaction tube is washed.
5. Substrate is added and the chemiluminescent reaction occurs, generating
light.
6. The amount of light generated is measured by the photomultiplier tube (PMT)
and the test results are calculated and printed.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-11

Operating Modes
The IMMULITE 2000 Systems and IMMULITE 2500 system have the following
three operating modes:
• RUN
• PAUSE
• STOP
The IMMULITE 2000 XPi instrument has the following operating mode in
addition to those listed above:
• AutoStart

RUN Mode
Assays are in progress and the instrument is operating.

PAUSE Mode
Pipettors stop and the processing of any new tests is temporarily halted; however,
tests already on the instrument continue processing. There are four different
PAUSE modes:
NOTE: Enhanced Pause Message – All Pause, Reagent Pause, and Bead Pause
mode each display messages when sequential or pretreatment assays are running.
The messages display to let you know when it is safe to pause the instrument to
prevent sequential and pretreatment tests from being lost.
• All Pause
Stops all loading and pipetting operations, as well as bead and reagent
dispensing. The assays in progress continue to process; however, no new
samples are pipetted.
• Reagent Pause
Stops the reagent carousel, reagent DRD, and reagent pipettor so no new
reagent is dispensed. Other parts of the instrument continue processing
assays.
• Bead Pause
Stops the bead carousel so no new beads are dispensed. Other parts of the
instrument continue processing assays.
NOTE: You do not need to put the IMMULITE 2000 XPi instrument into
PAUSE mode when loading samples.
• Sample Pause
Pauses the sample carousel, sample DRD, and sample pipettor so no new
sample is dispensed. Other parts of the instrument continue processing assays.
Sample Pause may be delayed up to 36 seconds while the samples currently
being processed finish processing.

601005-0004 Rev. A
2-12 Operator’s Guide: Operating the System

STOP Mode
All mechanical movements are stopped and no new tests are processed.
STOP mode is automatically initiated when no new samples have been processed
in the last 20 minutes, as long as the instrument is not connected to an VersaCell.

AutoStart Mode

For the IMMULITE 2000 XPi Instrument Only

Starts routine maintenance tasks automatically. For more information, refer to

AutoStart Maintenance (IMMULITE 2000 XPi System)‚ page 5-35.

Maintaining Reagent Wedges, Allergen Wedges and

Bead Packs
Check the status of the reagent wedges, allergen wedges, and bead packs on board
the instrument and replace the necessary wedges or packs.

Checking the Status of Reagent Wedges and Allergen

Wedges
Follow the instructions below to check the status of reagent wedges and allergen
wedges:
1. If the Home screen is not displayed, select HOME to display it.
2. Select the REAGENTS circle.
The Reagent Status screen displays.
3. Determine which wedges on the Reagent Carousel need to be replaced using
the information in the Reagent Status screen.
4. If no wedges need to be replaced, proceed to Checking the Status of Bead
Packs‚ page 2-19.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-13

Reagent Status Screen

The Reagent Status screen displays the status of all allergen wedges and reagent
wedges on the reagent carousel. The information displayed in the Reagent Status
screen includes:
• Reagent wedge test codes or allergen wedge IDs
• Allergen vial status for each allergen wedge
• Reagent wedge lot numbers
• Error messages
• Adjustment status
• Number of tests remaining in each compartment of a reagent wedge
• Wedge positions on the reagent carousel
Wedges are displayed alphanumerically by test code, not by their positions on the
reagent carousel. Each wedge on the reagent carousel is represented by a square in
the Reagent Status screen. On allergen wedge squares, allergen vial status is
indicated in fields labeled 1 through 6, to represent the positions of allergen vials
in the allergen wedges.

Background color
The error status of a wedge is indicated by the color of its square in the Reagent
Status screen. Allergen wedge squares have fields for each allergen vial that uses
the same color scheme. The color of an allergen wedge square reflects that
allergen wedge’s highest priority error.
The following table contains a list of the background colors and the status
associated with each color:
Background Color Status
White No errors
Gray Empty position on the Reagent Carousel or in an Allergen
Wedge
Light brown An error condition exists, but the wedge or allergen can still
be used. Errors include:
• The reagent wedge has a few tests remaining.
• An allergen vial is expired.
• The adjustment is overdue for this kit.
• Kit is expired.

601005-0004 Rev. A
2-14 Operator’s Guide: Operating the System

Background Color Status

Red An error condition exists which prohibits tests from being
run. Error conditions include:
• The kit barcode was not entered on the instrument.
• The reagent wedge is empty.
• An allergen vial is empty.
• An allergen wedge was not entered on the instrument.
• The reagent wedge barcode could not be read.
• A matching bead pack is not onboard the instrument.
• The kit was never adjusted, but will run.

Error messages
If an error occurs for a reagent or allergen wedge, it displays in the square for the
wedge in the Reagent Status screen.
• A plus (+) sign at the right of the error message indicates that a second error is
associated with that wedge.
• Two plus (++) signs indicate that two or more additional errors exist for that
wedge.
Details about a wedge can be viewed in the Reagent Detail and Allergen
Wedge Detail screens. These screens include a list of all errors that have
occurred for the wedge. Refer to the next section for information about
viewing wedge detail.
The table below contains some examples of errors and how they display in the
Reagent Status screen:
Error Message Examples
Kit Expired + The kit is expired and either the reagent wedge or
bead pack has expired or an adjustment is due.
Kit Expired + + The kit has expired and both the reagent wedge and
bead pack have expired.
Adjustment Due + An adjustment is due and the number of tests
remaining is low.
Expired Beads + or Expired The bead pack has expired and an adjustment is
Matching Beads + due.
Expired Reagent + or Expired The reagent wedge has expired and an adjustment
Matching Reagent + is due.

Viewing Wedge Detail

All details for a wedge can be viewed using the Reagent Detail screen or Allergen
Wedge Detail screen. The information in this screen includes a list of errors that
have occurred for the wedge.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-15

To display the Detail screen for a wedge while the instrument is in RUN mode,
select the square for the wedge in the Reagent Status screen.
If the instrument is in PAUSE or STOP mode, follow these instructions to open
the Reagent Detail or Allergen Wedge Detail screen:
1. Select HOME.
2. Select the REAGENTS circle.
The Reagent Status screen displays.
3. Select ROTATE.
The button changes to the REVIEW button.
4. Select the square corresponding to the reagent wedge or allergen wedge to
view.
• If the square for a reagent wedge is selected, the Reagent Detail screen
displays.
• If the square for an allergen wedge is selected, the Allergen Wedge Detail
screen displays.
5. Select the Close button to close the screen.

Replacing Reagent Wedges and Allergen Wedges

WARNING
Handle reagent and allergen wedges carefully to avoid agitation that might
introduce bubbles. Bubbles in the reagent and allergen wedges can potentially
cause incorrect results. Prior to processing samples, carefully inspect the wedges
to ensure all bubbles are eliminated. Removal of the reagent carousel must be
handled with care. Improper handling of the reagent carousel can introduce
bubbles in the reagent wedge.
Follow these instructions to replace a reagent wedge or an allergen wedge.
NOTE: When loading a reagent or allergen wedge, handle carefully to avoid
agitation that might introduce bubbles.
1. Open the small reagent carousel lid.
The instrument enters Reagent PAUSE Mode. The Reagent Status screen
displays.

601005-0004 Rev. A
2-16 Operator’s Guide: Operating the System

2. If assays are running, a warning message displays requiring all doors to be

closed and to select RUN.
Depending on the type of assay running and if PAUSE MODE is intentionally
enabled, one of the following messages displays:
Sample pre-treatment assay detected on board. If you
put the instrument in pause mode you will need to
close all doors and press RUN in x minutes and xx
seconds. Would you like to put the instrument in
pause now?
[Yes] [No]
Sequential assay detected on board. If you put the
instrument in pause mode you will need to close all
doors and press RUN in x minutes and xx seconds.
Would you like to put the instrument in pause now?
[Yes] [No]
3. Select the square for the reagent wedge or allergen wedge to replace.
The reagent carousel rotates so that the selected wedge is in front of the silver
arrow.

CAUTION
Do not remove the wedge to change the position of the allergen vials within an
allergen wedge until you perform the following procedure.
a. Open the small reagent carousel lid.
b. Be sure that the instrument has entered Reagent PAUSE mode.
c. Select the wedge’s position using the Reagent Status window.
After changing the positions of the allergen vials in the allergen wedge, re-scan
the wedge before loading it on the reagent carousel.

4. Remove the wedge by lifting the narrow end of the wedge near the center of
the carousel, tilting the wedge back on its opposite end.
5. Slide the wedge toward the center of the carousel until the slot clears the tab
on the carousel.
The wedge should lift out easily.
NOTE: When adding an allergen wedge, load the wedge with allergen vials,
scan it using the imaging scanner, and follow the steps below to add it to the
reagent carousel. Refer to Entering Allergens and Allergen Wedges‚
page 2-28.
6. Inspect the new reagent and/or reagent allergen wedge for bubbles.
7. If bubbles are observed, remove the bubbles prior to placing the system into
run.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-17

8. Place the new wedge between the carousel dividers with the barcode facing
out.

Figure 2-7 Loading a Reagent Wedge

9. Tilt the side of the wedge with the barcode label down so the tab on the
reagent carousel locks into the wedge slot under the barcode label.

1 2
WEDGE *2600
ALLERGEN

1 Reagent wedge, side view

2 Allergen wedge, side view

Figure 2-8 IMMULITE System Wedges

10. Press down on the narrow side of the wedge to lock it into place.

601005-0004 Rev. A
2-18 Operator’s Guide: Operating the System

11. Push the glide of the wedge toward the center of the carousel to ensure that it
moves freely.

Check for Bubbles or Moisture at the Top of the Wedge

1. If bubbles are at the top of a reagent wedge:
a. Remove the wedge.
b. Carefully remove the glide.
c. Dry the glide and the areas surrounding it where the probe enters the
wedge.
d. Replace the glide and re-load the wedge.
2. If there is moisture at the top of an allergen wedge:
a. Remove the allergen wedge.
b. Open the allergen wedge.
c. Dry or replace the septum caps on the allergen vials and dry any liquid on
top of the allergen wedge.
d. Close the wedge and re-load it on the reagent carousel.

Procedural Notes
NOTE: Kit components can remain on the instrument until they are empty or
expired. Bead packs and reagent wedges expire 90 days after being loaded on the
instrument. Kit components should not be used after the expiration date printed on
the kit label.
NOTE: Allergen vials left on board the instrument expire 90 days after opening,
due to evaporation. Allergens can evaporate up to 5 µL per day when left on the
instrument.
To extend the life of infrequently used allergens, remove the vials from the
instrument after each use, cap them with a standard cap, and refrigerate to
minimize evaporation.
Alternatively, wrap the entire allergen wedge in parafilm, leaving the vials with
the septum caps in place and refrigerate.
Allergens stored under these conditions (refrigerated and protected from air
exposure) may be used until the expiration date printed on the vial label.

Completing the Procedure

1. Close the reagent carousel lid.
2. Apply pressure until it clicks into place.
3. Select RUN to update the reagent status screen.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-19

NOTE: An error message displays in the reagent status screen if the kit
barcode for a loaded reagent wedge was not entered. If a loaded allergen
wedge has not been scanned, a message displays.
4. Select the CLOSE button to close the Reagent Status screen and return to the
Home screen.

Checking the Status of Bead Packs

Follow the instructions below to check the status of bead packs:
1. If the Home screen is not displayed, select HOME to display it.
2. Select the BEADS circle.
NOTE: If no bead packs require replacement, proceed to Labeling and
Loading Sample Tubes‚ page 2-2.
3. Determine which bead packs on the bead carousel need to be replaced using
the information in the Bead Status screen.

Using the Bead Status screen

The Bead Status screen displays the status of all bead packs on the bead carousel.
The information displayed in the Bead Status screen includes:
• Bead pack names
• Bead pack lot numbers
• Error messages
• Number of tests remaining in bead packs
• Bead pack positions on the bead carousel
Bead packs are displayed alphanumerically by test code, not by their positions on
the bead carousel. Each bead pack on the bead carousel is represented by a square
in the Bead Status screen.

Background Color
The error status of a bead pack is indicated by the color of its square in the Bead
Status screen. The following table contains a list of the background colors and the
status associated with each color.
Background Color Status
White No errors
Gray Empty position on the bead carousel
light brown An error condition exists, but the bead pack can still be used.
Errors include the following:
• the bead pack has a few test remaining
• the adjustment is overdue for this kit

601005-0004 Rev. A
2-20 Operator’s Guide: Operating the System

Background Color Status

red An error condition exists which prohibits tests from being
run. Error conditions include:
• the kit barcode was not entered on the instrument
• the bead pack is empty
• the bead pack barcode could not be read
• a matching reagent wedge is not onboard the instrument
• the kit was never adjusted, but it will run

Error Messages
If an error occurs for a bead pack, it displays in the square for the bead pack in the
Bead Status screen.
• A plus (+) sign at the right of the error message indicates that a second error is
associated with that bead pack.
• Two plus (+) signs indicate that two or more additional errors exist for that
bead pack.
Details about a bead pack can be viewed in the Bead Detail screen. This screen
includes a list of all errors that have occurred for the bead pack. Refer to the next
section for information about viewing bead pack detail.
The following table contains some examples of errors and how they display in the
Bead Status screen.
Error Message Explanation
Kit Expired + The Kit is expired and either the reagent wedge or bead
pack is expired or an adjustment is due.
Kit Expired + + The kit is expired and both the reagent wedge and bead
pack are expired.
Adjustment Due + An adjustment is due and the number of tests remaining
is low.
Expired Beads + or Expired The bead pack is expired and an adjustment is due.
Matching Beads +
Expired Reagent + or The reagent wedge is expired and an adjustment is due.
Expired Matching Reagent +

Viewing Bead Pack Detail

All details for a bead pack can be viewed in the Bead Detail screen. The
information in this screen includes a list of errors that have occurred for the bead
pack.
To display the Bead Detail screen for a bead pack while the instrument is in RUN
mode, select the square for the bead pack in the Bead Status screen.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-21

If the instrument is in PAUSE or STOP mode, follow these instructions to open

the Bead Detail screen:
1. Select HOME.
2. Select the BEADS circle.
The Bead Status screen displays.
3. Select ROTATE.
The button changes to the REVIEW button.
4. Select the square corresponding to the bead pack to be viewed. The Bead
Detail screen displays.
5. Select CLOSE.

Replacing Bead Packs

Follow these instructions to replace a bead pack.
1. Swing the monitor out of the way and open the bead carousel lid.
The instrument enters BEAD PAUSE mode. If the reagent carousel lid is not
closed when the bead carousel lid is opened, a screen displays indicating that
the instrument is in Multiple PAUSE Mode.
2. Select the button corresponding to the bead status screen.
3. If assays are running, a warning message displays requiring all doors to be
closed and to select RUN.
Depending on the type of assay running and if PAUSE MODE is intentionally
enabled, one of the following messages displays:
Sample pre-treatment assay detected on board. If you
put the instrument in pause mode you will need to
close all doors and press RUN in x minutes and xx
seconds. Would you like to put the instrument in
pause now?
[Yes] [No]
Sequential assay detected on board. If you put the
instrument in pause mode you will need to close all
doors and press RUN in x minutes and xx seconds.
Would you like to put the instrument in pause now?
[Yes] [No]
4. Select the square for the bead pack to be replaced. The bead carousel rotates
so that the selected bead pack is in front of the black arrow.
5. Remove the bead pack to be replaced.
a. Lift the barcoded edge of the bead pack and tilt it toward the center of the
bead carousel.

601005-0004 Rev. A
2-22 Operator’s Guide: Operating the System

b. Slide the bead pack away from the center of the carousel until the bead
pack plunger clears the opening at the center of the carousel. The bead
pack should lift out easily.
6. Load the new bead pack.
a. Place the bead pack between the carousel dividers with the barcode facing
out.
b. Tilt the side of the bead pack opposite the barcode label down and insert
the plunger into the opening at the center of the carousel.
c. Snap the barcoded side of the bead pack into position on the carousel. Be
sure it is locked in place.

Figure 2-9 Loading the Bead Pack

7. Close the bead carousel lid.

8. Select RUN to update the Bead Status screen.
• An error message displays in the Bead Status screen if the kit barcode for
the loaded bead pack has not been entered.
Refer to Entering a Kit‚ page 2-25.
• Kit components can remain on the instrument until they are empty or
expired.
• Bead packs and reagent wedges expire 90 days after being loaded on the
instrument. Kit components should not be used after the expiration date
printed on the kit label.
9. Select the CLOSE button to close the Bead Status screen and return to the
Home screen.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-23

IMMULITE 2000 XPi Kit Load Report

The Kit Load Report feature of the IMMULITE 2000 XPi helps the operator
prepare for the anticipated day’s workload by generating a list of tests needed
based on current instrument inventory and historical assay consumption. The
report provides the estimated daily average of assays processed over a selected
period and a list of the recommended number of tests needed to meet the average
workload.

Viewing the Kit Load Report

To generate a Kit Load Report for viewing, do the following:
1. At the tool bar, select REPORTS.
The Reports window displays.
2. At the Reports window, select KIT LOAD REPORT.
The Kit Load Report review window displays.
NOTE: The default period is the selection made when the report was last
generated. The default period for initial entry into the report is 4 weeks. The
maximum period is 8 weeks.
3. To change the default number of days or weeks, select the number and day or
week from the drop-down lists next to “Display average use from last:”
Example:
To report the average usage for the last 6 Tuesdays, select 6 from the left
drop-down list and Tuesday from the right drop-down list.
4. Select the type of information to display from the following buttons:
Buttons Description
Immunoassay Generate report details for immunoassay activity for a selected
period. If immunoassay activity occurs during the period being
reported, Immunoassay is the default selection.
Allergy Generate report details for allergy activity for a selected period. If
no immunoassay activity occurs during the period being reported,
Allergy is the default selection.

5. Select Refresh.
NOTE: Kit Load Report details are not refreshed automatically. A box in the
upper right corner of the window displays the date and time the report data
was last refreshed.
6. To change the sort order, select the appropriate column header.

601005-0004 Rev. A
2-24 Operator’s Guide: Operating the System

Kit Load Report Data

Column Data Description

Assay A list of Assays tested during the period selected.
Average Use The average daily number of tests run per assay for the selected
period.
Processed Today The number of tests per assay that have been processed for the
current day.
Tests Onboard The number of tests per assay that remain in the kits currently
onboard.
Load Estimate The number of assays recommended to meet the estimated
workload (Load Estimate = Average Use - Tests Onboard);
0 if sufficient kit components are onboard.

NOTE: The report’s default sort order is by Load Estimate, descending quantities.

Printing the Kit Load Report

To print the Kit Load Report, do the following:
1. At the Kit Load Report window, select Refresh.
NOTE: Printing does not refresh the Kit Load Report.
2. At the Kit Load Report window, select Print.
The print configuration window displays.
3. In the ASSAY TYPE box, select one of the following options:
ASSAY TYPE Description
Immunoassay Include only a list of immunoassay kits recommended to load.
Allergy Include only a list of allergy kits recommended to load.
All Assays Include a list of all kits recommended to load. All Assays is
the default selection.

4. In the REPORT DATA box, select one of the following options:

REPORT DATA Description
Exceptions Only Limit the printed report to only those immunoassay or allergy
tests that are estimated to need more kit components.
Exceptions Only is the default selection.
All Print a report of all immunoassay and/or allergy tests
displayed in the Kit Load Report review window.

5. To print the report, select Print Report.

The instrument prints the report, and the print configuration window closes.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-25

Reviewing the Printed Report

The report header details are as follows:
• Instrument ID
• Instrument Name
• The date and time the report was last refreshed.
• The period the usage was averaged over (Display average use from last).
• The type of data (Immunoassay or Allergy).
The printed report data is sorted by the same criteria, and in the same order as the
Kit Load Report review window data.
Data Description
Assay A list of Assays tested during the period selected.
If the Assay name is followed by an asterisk (*), the assay requires
diluent onboard to run.
Kit Lot The Kit Lots for each assay onboard are separated by commas.
NOTE: If no kits are onboard for this assay, the Kit Lot list is
empty.
Average Use The average daily number of tests run per assay for the selected
period.
Processed Today The number of tests per assay that have been processed for the
current day.
Tests Onboard The number of tests per assay that remain in the kits currently
onboard.
Load Estimate The number of assays recommended to meet the estimated
workload (Load Estimate = Average Use - Tests Onboard);
0 if there are sufficient kit components onboard.

Entering a Kit
NOTE: Scan the kit lot barcode before loading reagents onto the system.

Before using a new kit, the new kit lot must be entered on the instrument using the
hand-held scanner. After a kit is entered, existing kit information can be reviewed.
Reviewing Kit Information‚ page 2-31. Follow the instructions below to enter a
new kit.
NOTE: Before using a new assay or kit lot number, adjustments must be run.
Refer to Adjusting an Assay‚ page 2-33 for instructions.

For Non Allergy Kits

Scan the 2D barcode located on the inner flap of the kit box. Refer to Scanning a
2D Kit Barcode Using a 2D Scanner‚ page 2-26.

601005-0004 Rev. A
2-26 Operator’s Guide: Operating the System

For Allergy Kits

If allergy kits are used, follow the instructions for scanning a 2D barcode using an
imaging scanner. Follow the instructions below for the appropriate scanner.
• If three different kit lots for the same assay are in the database and a fourth kit
lot for that assay is scanned, a prompt displays to select which existing kit lot
to delete.
• If a kit lot that is already in the system is re-scanned, a prompt displays asking
if the active kit information should be overwritten with the new kit
information.
• If Overwrite is selected, the slope and intercept for the kit being
overwritten will revert back to the slope and intercept of the Master
Curve.
• If the new kit is not adjusted, patient results are flagged with ADJ.
Refer to Flags Associated with Results‚ page H-4.

Scanning a 2D Kit Barcode Using a 2D Scanner

1. Hold the scanner 2 to 3 inches away from the 2D barcode.
2. Keep the angled face of the scanner parallel to the barcode.
3. Press and hold the trigger button on the scanner.
An orange beam displays.
4. Begin scanning in the white area above the 2D barcode.
5. Move the scanner at an even rate over the entire barcode.
A clicking noise during scanning indicates that the barcode is being read. A
high-pitched tone sounds when the scan is successful. If the scan was not
successful, a low-pitched tone may sound. Rescan the barcode until a
high-pitched tone is heard.
The Kits screen displays information about the kit.

Scanning a 2D Kit Barcode Using an Imaging Scanner

1. Hold the scanner 5–7 inches away from the 2D barcode.
2. Keep the angled face of the scanner parallel to the barcode.
3. Press and hold the trigger button on the scanner and point the scanner beam at
the center of the barcode.
4. Scan at the center of the barcode.
NOTE: Do not move the scanner over the entire barcode as you would with a
2D scanner.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-27

5. Hold the scanner button until a tone sounds to indicate that the barcode was
read successfully.
The Kits screen displays information about the kit.The table below explains
each field in the Kits screen.
Field Explanation
Find button Used to enter a test code and lot number to display
information about a particular assay.
Previous Kit/Next Kit Displays information for the previous kit or next kit in the
buttons database.
Kit information in the database is displayed for one kit at a
time, in alphanumerical order by test code.
Allergens / Kits button Displays information about allergens in the database. The
button changes to the Kits button.
Select the Kits button to display information about assay kits
in the database. The button changes to the Allergens button.
Test Code Code used to indicate a specific assay.
Kit Lot Kit lot number.
Bead Lot Bead lot number used by the kit.
Reagent Lot Reagent lot number used by the kit.
Low Adjustor Lot Lot number of the low adjustor.
Low Adjustor CPS The master curve CPS for the low adjustor.
Adjustor Allergen Lot Lot number of the high adjustor.
Control Allergen Lot Lot number for the kit’s control antibody.
This field is inactive for immunoassay kits.
Last Adjustment Date of the last adjustment.
Next Adjustment Date a readjustment is due.
Adjustment Status Current kit adjustment status:
• Over Due – the kit adjustment is overdue.
• Adjusted – the kit is adjusted.
• Not Adjusted – the kit barcode was scanned but the kit
was not adjusted.
Kit Status Current kit status:
• Expired – the kit is expired.
• Valid – the kit has been adjusted and is not expired.
• New Kit – the kit barcode has been scanned but the kit
has not been adjusted.
Diluent Name of the diluent used by the kit.
Kit Expiration Kit expiration date.
Slope Slope calculated for the last adjustment.
Intercept Intercept calculated for the last adjustment.

601005-0004 Rev. A
2-28 Operator’s Guide: Operating the System

Field Explanation
Slope Limits Kit-specific slope ranges used to determine if an adjustment
was successful.
Scanning the 2D kit barcode enters kit-specific slope ranges
into the database. This field displays in gray when viewing
information about an immunoglobulin kit.
Sample Volume µl Amount of sample needed for the test to run.
Parameter 1 Values used together to define the master curve for this kit
lot.
Parameter 2

Entering Allergens and Allergen Wedges

Every kit contains a reagent wedge that must be loaded on the instrument before
performing assays for that kit. If an allergy kit is loaded, enter at least one allergen
wedge and place it on the reagent carousel before running allergy tests.
Specific allergens are required to test patient samples for allergic reactions. The
vials containing specific allergens must be entered in the system individually
using a 2D barcode similar to those for assay kits.
The allergen vials must then be loaded into allergen wedges. One allergen wedge
can hold up to six allergen vials. The loaded allergen wedges must then be entered
in the system using the imaging scanner.
This establishes the locations of allergens on the instrument when the allergen
wedges are placed on the reagent carousel.
Each allergen vial has an affixed barcode label and a corresponding 2D barcode
label. Barcode labels identifying the same allergen vial have the same
human-readable code, such as d1.
NOTE: Do not take the allergen wedges apart. If the allergen wedges are taken
apart and re-assembled incorrectly, such as incorrectly matching the pieces
together, the instrument will pipette from the wrong allergen vial.
Each allergen wedge is labeled with one barcode on the spine and one on the inner
black portion. The barcode labels must match. Otherwise, the wedge location and
contents will not be correctly recorded and the vials will be incorrectly pipetted.
Allergen vials are flagged with the 2D barcode label before they are shipped. The
2D barcode contains all the information the system requires to use that vial for
allergy tests.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-29

Follow these instructions to enter an allergen wedge.

1. Scan the 2D barcode for each allergen vial to be loaded in the allergen wedge.
The allergen kit screen displays information about the allergen.
Field Explanation
Allergens button Select this button to display information about immunoassay
kits in the database.
The button changes to the Kits button.
Find button Select this button to enter an allergen code and lot number to
display information about that allergen.
Previous AGN/ Select these buttons to display information for the previous
Next AGN allergen or next allergen in the database.
Allergen information in the database is displayed for one
allergen at a time, in alphanumerical order by allergen code.
Allergen Code Code used to indicate a specific allergen.
Allergen Lot Allergen Lot Number
Allergen Status Current allergen status:
• Expired – the allergen is expired
• Valid – the allergen is not expired
Allergen Expiration Allergen expiration date.
Date

NOTE: When running an adjustor, one of the allergen wedges loaded on the
reagent carousel must contain one adjustor antibody. Be sure to scan the 2D
barcode for the adjustor antibody just as with any other allergen.
2. Remove the 2D barcode labels from the vials scanned in step 1.
Be sure the standard barcodes remain affixed to each vial.
3. Replace the cap on each allergen vial with a septum cap, and then place the
vial in the allergen wedge.
Be sure the barcode on each allergen vial faces out, so it is visible when the
allergen wedge is closed.

601005-0004 Rev. A
2-30 Operator’s Guide: Operating the System

NOTE: When storing opened allergen vials off the instrument, replace the
septum cap with a new standard cap to prevent evaporation. When using the
allergen vial again, replace the standard cap with a new septum cap.

Figure 2-10 Allergen Vial Caps

Figure 2-11 displays how the vials are inserted in the wedge.

Figure 2-11 Loading Vials in an Allergen Wedge

4. Hold the scanner steady, about 5 inches from the allergen wedge, being sure
not to obscure any of the barcodes on the allergen wedge or the allergen vials.
5. Press and hold the scanner button.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-31

6. Point the scanner beam at the center of the allergen barcodes.

The allergen barcodes, the outside allergen wedge barcode, and any barcodes
behind the empty vial spaces should be read in a single scan.
The Allergen Wedge Detail screen displays details about the allergen wedge
scanned.
NOTE: If any information in the Allergen Wedge Detail screen displays in
red, a scanner misread has occurred. Scan the allergen wedge again.
7. Select the Close button to close the Allergen Wedge Detail screen.
A message displays stating not to swap allergen vials.
8. Select OK.
NOTE: If the allergens are changed or the allergen vials are rearranged in an
allergen wedge previously scanned, scan the allergen wedge again before
loading it on the instrument.
9. Load the allergen wedge on the reagent carousel.
NOTE: Select a position on the carousel to load the allergen wedge.

Reviewing Kit Information

To review existing kit information, follow the instructions below:
1. Select the KITS button on the toolbar.
2. Select one of the following options:
• Select the Previous Kit or Next Kit buttons to view information for the
kits currently entered in the system.
• Select the Find button.
3. To view the appropriate kit information, type the test code (located on the 2D
Barcode label) and the kit lot number, and then select the Find Kit button.
NOTE: The kit can also be found by entering just the test code.
4. To toggle back and forth between kit and allergen information, select Kits and
Allergen.

Configuring Kit Lot Deactivation

Follow these steps to deactivate or activate a kit lot:
NOTE: Any tests in progress or in queue continue to run and result as usual after
a kit lot is deactivated.
1. At the tool bar, select KITS.
The Kits window displays.
NOTE: Use Previous Kit, Next Kit, or Find to locate a particular kit lot.

601005-0004 Rev. A
2-32 Operator’s Guide: Operating the System

2. Select Kit Deactivation.

The Kit Lot Deactivation window displays.
3. From the drop-down list, select an assay for which you want to activate/
deactivate kit lots.
4. To deactivate a single kit lot for the selected assay, select its option box in the
grid under the headers Deactivated Patient Samples or Deactivated for All
Samples.
A check mark displays in the box indicating the kit's current status.
NOTE: Alternatively, to activate a single kit lot for the selected assay, select
its option box in the grid under the header Active for All Samples.
5. To deactivate all kit lots for the selected assay, select the header Deactivated
Patient Samples or Deactivated for All Samples.
Check marks display for each kit lot in the column.
NOTE: Alternatively, to activate all kit lots for the selected assay, select the
header Active for All Samples.
Option Description
Active for All Samples: Can process all orders with this kit lot.
Deactivated Patient Samples: Can process only adjustor, control, and verifier
orders with this kit lot.
Deactivated for All Samples: Cannot process orders with this kit lot.

NOTE: In integrated mode, if kits are either deactivated for patient samples or
all samples, “No Inventory” is displayed for that assay on the VersaCell
system.
NOTE: The kit lot is added or removed from the list of Currently Deactivated
Kits after selecting SAVE.
6. Select SAVE to accept the changes or CANCEL to ignore them.
7. To configure additional kit lots, select a different assay from the drop-down
box next to the “For this TEST:” heading and repeat this procedure.
8. To exit the Kit Lot Deactivation window, select CLOSE.
To access the Kit Deactivation window from other windows:
• From the Reagent detail window, select Kit Deactivation.
The Kit Deactivation window displays.
• From the Beads detail window, select Kit Deactivation.
The Kit Deactivation window displays.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-33

Kit Deactivation Status

Indicators display as follows when a kit lot is deactivated:
Window Description
KITS The deactivation status displays in the upper right corner
of the KITS window if a kit lot is deactivated.
Reagents Shading of a reagent indicates a deactivated status. Select
a wedge for more information.
Beads Shading of a bead pack indicates a deactivated status.
Select bead pack for more information.
Reagent Detail The deactivation status displays in the Current
Deactivation Status box. If necessary, select Kit
Deactivation to change the kit's deactivation status.
Refer to Configuring Kit Lot Deactivation for more
information.
Bead Detail The deactivation status displays in the Current
Deactivation Status box. If necessary, select Kit
Deactivation to change the kit's deactivation status.
Refer to Configuring Kit Lot Deactivation for more
information.
Consumables Report The status of a deactivated kit displays on the
Consumables Report window.
Worklist Display/Edit Deactivated displays in the Status column when an order
cannot run if a kit lot is deactivated.
Sample Tubes in Racks Samples with orders associated with deactivated kits are
coded KIT ERROR/DEACTIVATED.
Rack Detail In the textbox, Deactivated displays next to the test code
when an order cannot run due to kit deactivation.

Adjusting an Assay
Before using a new kit lot, an adjustment must be run. This initial adjustment
corrects for any variations in performance between your instrument and the
manufacturer's instrument.
In addition, kits must be readjusted periodically. The adjustment schedule for a kit
is indicated in the kit's package insert. The Reagent Status and Bead Status screens
indicate if an adjustment is due. Refer to Checking the Status of Reagent Wedges
and Allergen Wedges‚ page 2-12 and Checking the Status of Bead Packs‚
page 2-19.
Follow the instructions below to adjust an assay:
1. Remove the adjustor barcode labels from the kit.
2. Place a label for an A adjustor on one tube and a label for a B adjustor on
another tube.

601005-0004 Rev. A
2-34 Operator’s Guide: Operating the System

NOTE: When a kit contains only one adjustor, use the A adjustor label.
3. Remove the adjustor bottles from the kit and transfer each adjustor to the
corresponding tube.
4. To adjust an allergy assay:
• Enter the adjustor antibody by scanning its 2D barcode.
• Place the adjustor antibody in an allergen wedge.
• Enter the allergen wedge using the imaging scanner.
• Load the allergen wedge on the reagent carousel.
Refer to Entering Allergens and Allergen Wedges‚ page 2-28 for more
information about using adjustor antibodies.
5. Select HOME.
6. Select the letter for the sample rack in which to load the adjustors.
The sample carousel rotates so that the rack is accessible.
NOTE: The instrument must be in PAUSE or STOP mode for the rack to
rotate. If the rack does not rotate, open the sample carousel door to initiate the
SAMPLE PAUSE mode.
7. Open the sample carousel door and grasp the rack using the finger
indentations.
8. Pull the rack forward until it slides out of the sample carousel.
NOTE: Be sure that the bottom of the barcode label is not hidden by the rack.
The entire barcode label must be readable.
9. Load the adjustor tubes on the sample rack so the barcodes face out.
NOTE: You may not adjust an assay while the previous adjustment for that
assay is still running.
10. Depending on the instrument, perform the following steps:
For the IMMULITE 2000 system or the IMMULITE 2500 system:
a. Slide the rack back into the carousel.
b. Be sure it snaps into position.
c. Close the Sample Carousel door.
For the IMMULITE 2000 XPi system:
a. Set the sample rack into the sample tray.
b. Close the cover.
11. Select RUN.
The sample carousel is interrogated.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-35

12. When the sample carousel has been interrogated completely, select the
WORKLIST button.
The Worklist screen displays.
13. Display the information for the A adjustor in the Worklist screen.
The A adjustor is level 01.
a. If adjustors with barcodes have been loaded:
Browse the records using the Previous and Next buttons. Locate the
record with the adjustor's lot number in the Adjustor Lot # field and 01 in
the Adjustor Level field.
b. If the adjustor barcode is damaged or missing:
c. Select Adjustor.
d. Select New.
e. Enter the adjustor lot number and the adjustor level.
f. Associate the tube and its position with the unique sample accession
number.
Refer Assigning a Tube Position‚ page 2-56.
14. Enter the lot number of the kit you are adjusting in the Kit Lot # field.
15. When adjusting an allergy assay, enter the lot number for the adjustor
antibody loaded in step 4 in the Adj Allergen Lot # field.
16. Select ACCEPT ADJUSTOR.
If the system is in RUN mode, the next barcoded record displays.
NOTE: The A adjustor must be accepted first.
17. If the assay being adjusted has one a B adjustor, repeat steps 13 through 16 to
assign a kit lot number to it.
The B adjustor level is 02.
18. Select Display/Edit.
19. At the Display Worklist screen, select the UPDATE SCREEN button and use
the Status column to determine the status of the samples.

Adjustment Printout
The adjustment printout displays interpretive information to aid in the evaluation
of adjustments. In addition, the adjustment printout indicates whether or not the
adjustment is complete. The following table displays information about 2 adjustor
assays;
Calculation Description
Instrument slope range Plus or minus 20% of the average instrument slope
Previous slope range Plus or minus 10% of the previous successful adjustment for
a specific kit lot

601005-0004 Rev. A
2-36 Operator’s Guide: Operating the System

Calculation Description
Assay average slope Average slope of all successful adjustments for an assay.
Intercept guideline • Sandwich assays
30% of the low adjustor CPS from the kit barcode
• Competitive assays
2% of curve parameter 1

The following table displays information about a single adjustor assay.

Feature Description
Previous assay adjustment index Adjustment index of the last successful adjustment

Adjustment Complete
• If the slope for the adjustment does not exceed the rejection limits, the
adjustment printout displays this message at the bottom of the page:
Adjustment Complete

• If the CVs of the replicates of the low and high Adjustor are within the
acceptable limits, the adjustment displays this message:
Adjustment Complete

• For any adjustment marked Adjustment Complete, review the adjustment

guidelines to determine if the adjustment is valid.

Adjustment was not Successful

• If the CVs of the replicates are outside the acceptable limits, the adjustment
displays this message:
CV of High (or Low) adjustors not within limit.

Both the low and high adjustors must be run again before running patient
samples.
• If the slope is outside the rejection limits, the Adjustment report displays this
message:
Exceeded rejection limits for slope

The slope limit failed.

NOTE: The instrument continues to process and report controls and patient
samples on adjustments exceeding rejection limits. Readjust assays exceeding
the adjustment rejection limits to ensure accurate patient results.
NOTE: If the adjustment slope fails, patient results are flagged ADJ, and the
instrument uses the last valid adjustment slope and intercept for the kit lot to
calculate patient results. If no previous valid adjustment is available, the
instrument uses the Master Curve.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-37

Refer to Viewing the Adjustment Log‚ page 2-40 for more information.

Checking Adjustment Validity

When judging adjustment validity, evaluate the control results, slope, and
intercept according to the table below:
Guideline Description
Control results After control ranges are established, controls must be run to
verify kit adjustment before patient samples are processed. If the
controls are out of range:
• Follow accepted laboratory protocols for investigating QC
failure; correct any problems found and run the controls
again.
• If they are still out of range, and no other problem can be
identified, re-adjust the kit.
• If the problem persists, contact your local service provider
or distributor.
Refer to Master Curve/Two-Point Adjustment‚ page 3-1 for more
information on Master Curve generation and for more
information on the two-point adjustment process.
Slope • Initial adjustment of a new kit lot:
The slope should fall within the instrument slope range,
meaning plus or minus 20% of the mean slope for that
instrument.
• Re-adjustment of same kit lot:
Within a kit lot, the slope calculated during readjustment
should fall within 10% of the previous slope. Refer to
Master Curve/Two-Point Adjustment‚ page 3-1.
Intercept Check the intercept of adjustment.
The absolute value of the intercept should be less than or equal to
the intercept guideline.
Refer to Intercept of Adjustment for an Immunometric
(Sandwich) Assay‚ page 3-5 for further information on
evaluation of intercepts.

Running Assays
To run the assays, at the instrument screen, select RUN.
As tests are completed, results display on the Home screen.
NOTE: If not enough kit components (bead packs, reagent wedges, or diluents)
are onboard to run the tests, or if a barcode label is missing, the Consumables
button turns red.

Checking the Sample Status

Follow the instructions below to check the status of the samples onboard the
instrument:

601005-0004 Rev. A
2-38 Operator’s Guide: Operating the System

For IMMULITE 2000 System or IMMULITE 2500 System

1. At the instrument menu, select Tools.
2. Select Show Sample Tubes in Racks.
3. Proceed to step 3 in the next section.

For IMMULITE 2000 XPi System

1. At the instrument screen, select MENU.
2. Select Sample Tubes in Racks.
3. To access the Sample Rack Detail screen, select a rack letter.
4. Select a specific sample tube position (1-15) on a rack to access the detailed
sample information on the Sample Rack Detail screen.
5. Select Update to display the most current information on the samples.
6. Select Close to leave the screen.

Checking the Test Time Remaining

Follow the instructions below to view the test time remaining for assays that meet
the search criteria. For example, viewing the test time remaining for all TSH
assays.
1. In the Home screen, select FIND.
The Find Sample screen displays.
The default entry in both the From and To fields is the current date.
2. Follow the instructions in this step to enter a different date range.
a. Click the From field.
The calendar view of the Find Sample screen displays.
b. Use the Month and Year buttons to display the calendar of the first month
in the date range.
c. Select the day to begin the date range.
The date changes in the From field.
d. Select the To field.
e. Use the Month and Year buttons to display the calendar of the last month
in the date range.
f. Select the day to end the date range.
The date changes in the To field.
g. Select the OK button to accept the entries and close the calendar view of
the screen.
3. Make any selections in the Accession #, Name, Test Type and Allergen
Type fields to enter other details about the sample.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-39

NOTE: Enter a single letter in the Name field to find samples with names that
begin with that letter.
4. Select FIND.
The Records Found screen displays displaying information about the samples
that match the criteria entered.
5. To view historical results for a patient or sample:
a. Select a record in the Records Found screen.
b. Select REVIEW.
The Review screen for this patient or sample displays.

Checking the Tests Ordered and Time Remaining

With the instrument in RUN mode, follow the instructions below to view the tests
ordered and the test time remaining for a particular sample.
1. From the Home screen, select the appropriate rack.
The Sample Rack Detail screen displays, displaying:
• The samples currently onboard the selected Sample Rack
• The name, sample type, and tube type for the selected sample
• The tests running for the selected sample with the time remaining
• The tests resulted for the selected sample
The sample description next to the numbers (1-15) indicates the sample type.
Sample Type Sample Description
Patient Displays as either the accession number or the patient’s name.
Adjustor Begins with ~A.
Control Begins with ~C or can be user-defined.
Calibration Verifier Begins with ~V.
Diluent Begins with ~D.
2. To select a new sample, select the field to the right of the sample number
(1–15).
The information on the right side of the screen changes.
3. Select the CLOSE button to return to the previous screen.
NOTE: Select SAMPLE TUBES to return to the Sample Status screen.

Find Last Tube Location

Follow these instructions to determine the rack and position where a specified
tube was last located. This feature is available for barcoded patient samples only.

601005-0004 Rev. A
2-40 Operator’s Guide: Operating the System

NOTE: At the Configurations – Display Options screen, ensure that Use Barcode
Rack Identifier is turned on. The Find Last Tube Location feature will not work
unless it is activated.

For IMMULITE 2000 System or IMMULITE 2500 System

1. At the instrument menu, select Tools.
2. Select Find Last Tube Location.
3. Proceed to step 3 in the next section.

For IMMULITE 2000 XPi System

1. At the instrument screen, select MENU.
2. Select Find Last Tube Location.
3. In the Find Last Tube Location window, enter the unique accession number of
the tube to search.
4. Select FIND.

Viewing the Adjustment Log

Follow the instructions below to view the adjustment log, displaying the
adjustment history.

For IMMULITE 2000 System or IMMULITE 2500 System

1. At the instrument menu, select Tools.
2. Select View Adjustment Log.
3. Proceed to step 3 in the next section.

For IMMULITE 2000 XPi System

1. At the instrument screen, select MENU.
2. Select Adjustment Log.
3. At the adjustment log, select the FROM and TO dates by clicking in the FROM
and TO fields, and then selecting dates from the calendar.
4. Use the down arrow to the right of the TEST TYPE field, and then select the
test.
5. Select FIND.
The Adjustment Log View screen displays a list of adjustments, beginning
with the most recent adjustment.
6. To review adjustment data, select an adjustment and select REVIEW.
7. At the Adjustment Review screen, select PRINT to print the screen.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-41

8. Select CLOSE on the Adjustment Review screen.

The Adjustment Log View screen displays.
9. Select CLOSE.

Viewing Beads and Reagents On Board

Follow the instructions below to view the beads and reagents currently on board
the instrument.
NOTE: If an adjustment is due in the next 24 hours, the adjustment due date
displays in yellow.

For IMMULITE 2000 System or IMMULITE 2500 System

1. At the instrument menu, select Tools.
2. Select View Bead Reagents On Board.
3. Proceed to step 3 in the next section.

For IMMULITE 2000 XPi System

1. At the instrument screen, select MENU.
2. Select Bead Reagents Onboard.
NOTE: If the screen is blank, select the BEADS ONBOARD or the
REAGENTS ONBOARD button.
3. Select CLOSE.

Viewing Allergens On Board

To view information about the Allergens currently on board the instrument, select
View Allergens On Board.

For IMMULITE 2000 System or IMMULITE 2500 System

1. At the instrument menu, select Tools.
2. Select View Allergens On Board.

For IMMULITE 2000 XPi System

1. At the instrument screen, select MENU.
2. Select Allergens Onboard.

Managing Worklist
A worklist specifies which tests to run for each sample. If the instrument is
connected to an LIS, worklists for patient samples are entered automatically.

601005-0004 Rev. A
2-42 Operator’s Guide: Operating the System

The operator uses the Worklist screen to do these tasks:

• Add patients to a worklist, if necessary:
• When the system is not connected to an LIS.
• If barcodes are damaged or missing.
• Specify tests for control and calibration verifier samples.
• Adjust assays.
• Order dilution samples (onboard and manually).
• Specify STAT samples.
• Check kit components.
Test entry options include the ability to select tests from a list of available tests or
panels, assign tests to an entire sample rack, or assign a tube position, if necessary,
such as when the barcode is damaged or missing).
Worklist management and display options allow the operator to:
• Display a worklist
• Print a worklist
• Modify a worklist
• Delete worklist entries
• Save a worklist
• Import a previously saved worklist

Adding Patients to a Worklist

NOTE: The kit lot barcodes must be scanned before adding or downloading
patients to the worklist.
If a sample barcode is damaged or missing, or the instrument is not connected to
an LIS, patients must be added to the worklist manually. Depending upon the
reason for adding the patients manually, the instructions differ. When there is no
LIS connection and samples are barcoded, follow the instructions below. If a
sample barcode is damaged or missing, refer to Damaged or Missing Barcodes‚
page 2-44.
NOTE: Do not load multiple sample tubes with the same accession number on the
sample carousel at the same time. If you do this, the instrument pipettes all tests
associated with that accession number from the sample tube in the lowest sample
rack position. Keep sample tubes with the same accession numbers on different
sample carousels.

Barcoded Patient Samples

Follow the instructions below to add patients to the worklist when the instrument
is not connected to an LIS.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-43

NOTE: The samples must be loaded and RUN must be selected before proceeding
with the steps below.
1. Select WORKLIST.
NOTE: If the instrument is paused while viewing the Worklist Entry screen,
the screen is cleared.
2. Select Previous and Next to locate the information about the patient sample
to add to the worklist.
NOTE: If the tube has a damaged barcode, refer to Damaged or Missing
Barcodes‚ page 2-44.
3. If applicable, enter the patient's name, ID number, and birth date, and the
physician's name in the proper fields.
4. Enter the tests to run on the patient sample.
• Select TESTS to open the Available Tests screen and select the tests to
run.
Refer to Selecting Available Tests‚ page 2-53.
• Order tests one at a time in the Worklist screen.
To enter a test, enter the code in the TESTS field and then select Enter.
Continue in this manner until all tests are ordered.
Each entered test displays in the Tests Ordered field. The TESTS field is
cleared for the next entry.
NOTE: To remove a test from the Tests Ordered field, select the test name.
The test name turns gray. To activate the test again, select the test name. The
test name turns black.
5. To order a STAT test, select STAT, and then select the test name in the Tests
Ordered field.
The test name turns red.
6. Select ACCEPT PATIENT.
Information about the next barcoded sample on the sample carousel displays
in the Worklist screen. If the other samples on the sample carousel have no
barcodes, the fields in the Worklist screen are cleared.
7. Repeat steps 4 through 6 until tests are assigned for each patient sample.
NOTE: To specify another test for a patient already added to the worklist,
perform one of the following actions:
• Select New and then enter the unique accession number and the new test.
• Select Previous and Next to locate the accession number of the previous
entry and then enter the new test.
8. Verify that all patient samples have been added to the worklist.

601005-0004 Rev. A
2-44 Operator’s Guide: Operating the System

9. Select Display/Edit.
The Display Worklist screen displays.
• In the Sort List By field, select the Patients selection to view patient
samples in the worklist.
• Select UPDATE SCREEN to view the most current information.
• Be sure the tests added display in the worklist.
LIS Status Description
Time Time remaining for the test to be completed.
Resulted Test complete; answer has not been sent to LIS.
Waiting The sample is on the instrument, but the test has not started.
No Sample The sample is not on the instrument.
Sent This record was previously sent to LIS.
In-Queue The test is close to being processed.
Kit Error There is a problem with the Bead, Reagent, or Diluent.
Sample Error There is a problem with the Sample Tube, for instance not enough
sample or clot detected.

Damaged or Missing Barcodes

After the instrument interrogates the sample carousel, the Consumables Report
lists samples with damaged or missing barcodes as no barcodes. Refer to
Checking Kit Components‚ page 2-53.
NOTE: The samples must be loaded and RUN must be selected before proceeding
with the steps below.
Follow the instructions below to add a patient to the worklist when the barcode is
missing or damaged.
NOTE: Manually assigned tubes need to be identified each time the sample
carousel is paused and re-interrogated.
1. Select WORKLIST.
NOTE: To select the sample type, use the Manual Entry Options to select
PATIENT, ADJUSTOR, CONTROL, or CALIB. VER. (calibration verifier).
The last option selected is automatically selected the next time the Worklist
screen is accessed.
2. Select PATIENT.
3. Select New to clear the screen.
4. If necessary, select the SKIP NAME or the SKIP DEMOGRAPHICS options.
Select this... To do this...
SKIP NAME skip the Name field

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-45

Select this... To do this...

SKIP DEMOGRAPHICS skip the demographics fields (Patient ID, Birthdate,
and Physician)
5. Type the accession number in the Accession # field.
6. Select Assign Tube Position.
7. Under Select Rack To Use, select the letter corresponding to the sample rack
where the sample is located.
8. Under Select Position To Use, a graphical depiction of the positions on the
sample rack displays.
Standard samples are displayed as circles and microsamples are displayed as
squares. The sample status is indicated by the color of the numbered circle or
square. Refer to the key for the status associated with each color.
9. Under Select Position To Use, select the position by clicking on a white
circle or square.
The position turns red and the rack and position display at the bottom of the
screen.
10. Select OK.
The Worklist screen displays. The tube position (rack and number) displays to
the right of the Assign Tube Position button for this sample.
11. If applicable, type the patient's name, ID number, and birth date, and the
physician's name in the proper fields.
12. In the TESTS field, type the test name, and then select Enter.
NOTE: It may be easier to select from a list of available tests by selecting
TESTS. Refer to Selecting Available Tests‚ page 2-53.
The test name is added to the Tests Ordered screen and the TESTS field is
cleared for the next entry.
13. To deselect a test, select the test name in the Tests Ordered screen.
The test name is now gray. To select the test again, select the test name in the
Test Ordered screen.

Ordering STATs
1. To indicate a STAT sample, select STAT, and then select the test name in the
Tests Ordered screen.
The test name turns red, indicating this test now has a STAT priority and runs
first.
2. Select ACCEPT PATIENT.

601005-0004 Rev. A
2-46 Operator’s Guide: Operating the System

Adding Adjustors to the Worklist

Follow the instructions below to add adjustors to the worklist:
NOTE: Adjustors must be loaded with barcodes, and the RUN button must be
selected before proceeding with the steps below.
1. Select WORKLIST.
2. If the ADJUSTOR button is not highlighted, select ADJUSTOR.
3. Select Previous and Next to locate the information about the adjustor to add
to the worklist.
NOTE: The A (or 01) level of adjustor must be entered first.
4. Enter the kit lot number in the Kit Lot field.
5. To adjust an allergy assay, enter the lot number for the adjustor antibody in the
Adj Allergen Lot # field.
6. Select ACCEPT ADJUSTOR.
7. Repeat steps 2 through 6 for next level of adjustor.
8. Select Display/Edit.
The Display Worklist screen displays.
9. In Sort List By field, select Adjustors.
The adjustors display at the top of the worklist.
The information from adjustor barcode labels displays in the ACCESSION #
column of the Worklist.
• The first two characters (~A), identify the tube as an adjustor.
• The next three characters identify the test type.
• The next five characters identify the adjustor lot and level (the first three
identify the adjustor lot and the last two identify the level: 01 for low and
02 for high).
10. If the barcode is damaged or missing, do the following steps
a. Type in the Adjustor Lot Number and Adjustor Level.
b. Associate the tube and its position with the sample accession number.
Refer to Assigning a Tube Position‚ page 2-56 for more information.

Adding Controls to a Worklist

Follow the instructions below to add control tests to the Worklist.
• Barcoded Controls‚ page 2-47.
• Controls without Barcodes‚ page 2-48.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-47

Barcoded Controls
Follow the instructions below to add control tests to the Worklist.
NOTE: Load control samples with barcodes, and select RUN before proceeding
with the steps below. Tests for control samples are not automatically added to the
worklist via the LIS.
1. Select the WORKLIST button on the toolbar.
The Worklist screen displays.
If the instrument is paused while viewing the Worklist Entry screen, the
screen is cleared.
2. Select the Previous and Next buttons to locate the control record to review.
If the barcode is damaged or missing, refer to Controls without Barcodes‚
page 2-48.
3. Enter the tests to run on the control sample:
a. Select TESTS to open the Available Tests screen and select the tests to
run.
Refer to Selecting Available Tests‚ page 2-53.
b. Enter the code in the TESTS field, and then select Enter.
c. Continue until all tests are ordered.
Tests may be entered one at a time in the Worklist screen.
4. To run an allergy kit control, enter the control antibody in the TESTS field.
When running an allergy kit control, do not enter any other tests.
Each test added displays in the Tests Ordered field in the Worklist screen.
5. To remove a test from the Tests Ordered field, select the test name.
The test name turns gray. To activate the test, select the test name. The test
name turns black.
6. If more than one kit lot for an assay is onboard the instrument, enter the kit lot
number in the Kit Lot # field to run the control for a particular lot of that
assay.
7. If a control antibody was entered in step 3, enter the lot number for the control
antibody in the Agn Lot # field.
NOTE: You must select ACCEPT CONTROL for the worklist entry to be
accepted. If you do not, the worklist entry is deleted.
8. Select ACCEPT CONTROL.
Information about the next barcoded sample on the sample carousel displays
in the Worklist screen. If the other samples on the sample carousel have no
barcodes, the fields in the Worklist screen are cleared.
9. Select Display/Edit.
The Display Worklist screen displays.

601005-0004 Rev. A
2-48 Operator’s Guide: Operating the System

10. Select UPDATE SCREEN and verify that the controls added display in the
worklist.

Controls without Barcodes

NOTE: The samples must be loaded and RUN must be selected before proceeding
with the steps below.
Follow the instructions below to add a control to the worklist when the barcode is
missing or damaged.
1. Select WORKLIST.
A blank Worklist screen displays.
2. If it is not Control is not already highlighted, select CONTROL.
3. Enter the accession number for the particular level of control into the
Accession # field.
This accession number is the same number that was assigned to a particular
level of control when the control information was entered into the system.
To retrieve this number, do the following:
a. Select QC, and then select Data Entry.
b. Use Previous Control or Next Control to locate the control material.
c. Copy the accession number that corresponds to the particular level of
control, and paste it into the Accession # field of the Worklist screen.
Alternatively, make a note of the accession number and type it into the
Worklist screen.
4. On the keyboard, select the Enter key.
The control name, lot number, and level display on screen.
5. Select TESTS, and then order the appropriate tests.
6. Select Assign Tube Position.
7. Under Select Rack To Use, select the letter corresponding to the sample rack
where the sample is located.
8. Under Select Position To Use, a graphical depiction of the positions on the
sample rack displays.
Standard samples are displayed as circles and microsamples are displayed as
squares. The sample status is indicated by the color of the numbered circle or
square. Refer to the key for the status associated with each color.
9. Under Select Position To Use, select the position by clicking on a white
circle or square.
The position turns red and the rack and position display at the bottom of the
screen.
10. Select OK.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-49

11. The Worklist screen displays.

The tube position (rack and number) displays to the right of the Assign Tube
Position button for this sample.
12. Select ACCEPT CONTROL.
13. To add an additional level of control, select New and repeat steps 3 to 12 for
each level of control.

Adding Calibration Verifiers to a Worklist

Follow the instructions below to add calibration verifiers to a worklist:
1. Select WORKLIST.
A blank Worklist screen displays.
2. Select CALIB. VER.
The Calibration Verifier Worklist screen displays.
3. Type the kit lot number, verifier lot number, and verifier level into the
appropriate fields.
4. If available, enter the High Range and the Low Range.
5. Order additional replicates:
a. Select TESTS.
b. Select the test from the Available Tests screen.
c. Select REPLICATES, and then order the appropriate number of replicates.
d. Select OK to close the Replicates screen.
e. Select OK on the Available Tests screen.
NOTE: To deselect a test, select the test name in the Tests Ordered screen.
The test name is now gray. To select the test again, select the test name.
6. Select Assign Tube Position.
The Assign Tube Position screen displays.
a. Under Select Rack To Use, select the letter corresponding to the sample
rack where the sample is located.
b. Under Select Position To Use, a graphical depiction of the positions on
the sample rack displays.
The sample status is indicated by the color of the numbered circle or
square. Refer to the key for the status associated with each color.
c. Under Select Position To Use, select a position by clicking on the white
circle or square.
The position turns red and the rack and position display at the bottom of
the screen.
d. Select OK.

601005-0004 Rev. A
2-50 Operator’s Guide: Operating the System

The Worklist screen displays. The tube position (rack and number)
displays to the right of the Assign Tube Position button for this sample.
7. Select ACCEPT VERIFIER.
8. Repeat steps 2 through 7 until tests are assigned for each calibration verifier
sample.
NOTE: Calibration verifier reports (as well as other reports) are printed
automatically if these options are selected in the Configuration Settings
screen.

Diluting Samples
Use this procedure to dilute samples online or you can perform manual dilutions
offline and then place the sample onto the instrument.
Do not exceed a combined onboard and manual dilution factor greater than
99,999. Refer to Diluting Samples Onboard‚ page 2-50 or Specifying Manually
Diluted Samples‚ page 2-52.
NOTE: If a manual dilution was previously assigned, this dilution factor will be
included in the automatic dilution factor. Refer to Specifying Manually Diluted
Samples‚ page 2-52.

Diluting Samples Onboard

Follow the instructions below to dilute a sample onboard:

CAUTION
Do not use IMMULITE diluent for onboard dilutions. Use only IMMULITE 2000
diluent or IMMULITE 2500 diluent, as appropriate. Use all diluents before the
expiration date printed on the packaging.

Predilutions are done automatically for assays that require running prediluted
patient samples. The dilution factor is 1 on the Display Worklist screen. If a
further dilution is necessary, it must be performed manually. Refer to Specifying
Manually Diluted Samples‚ page 2-52 for more information.
1. Find a patient record:
a. At the Worklist screen, select the Display/Edit button.
b. Select the patient record, and then select the EDIT RECORD button.
The Worklist screen for that patient displays.
2. Select Dilution.
3. Select the assay to dilute in the Tests Ordered screen.
The Dilution Factor screen displays on the Worklist screen.
NOTE: The barcoded diluent tube must be on the sample carousel.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-51

4. Select one of the listed dilution factors:

Dilution Factor Dilution
X3 1 in 3
X5 1 in 5
X10 1 in 10
X20 1 in 20
X40 1 in 40
X100 1 in 100
After the dilution is selected, the Dilution Factor screen closes and the
dilution factor displays on the Worklist screen.
Refer to Dilution Volume Specifications‚ page E-2.
5. Select ACCEPT PATIENT.
NOTE: If the diluent barcode cannot be read, the diluent can be entered in the
Worklist screen (for a patient sample) by assigning a diluent name in the
Accession # field.
Select Assign Tube Position to define the sample position. Diluents are
identified by the prefix ~D, followed by the corresponding diluent name, such
as ~DHCG. The diluent name may be found in the Kits screen. Do not assign
tests to a diluent tube.

Canceling an Onboard Dilution

Follow these instructions to cancel a dilution:

1. To find a patient record, do the following:
a. Select Display/Edit on the Worklist screen.
b. Select the patient record, and then select EDIT RECORD.
The Worklist screen for that patient displays.
2. At the Worklist screen, select Dilution.
3. Select the assay to dilute in the Tests Ordered screen.
The Dilution Factor screen displays on the Worklist screen.
4. Select X1 to change the dilution factor to one.
The sample will not be diluted.

601005-0004 Rev. A
2-52 Operator’s Guide: Operating the System

Specifying Manually Diluted Samples

If the dilution was prepared manually and then placed on the instrument, follow
the instructions below to specify a dilution.

CAUTION
Do not use IMMULITE diluent for onboard dilutions. Use only IMMULITE 2000
diluent or IMMULITE 2500 diluent, as appropriate. Use all diluents before the
expiration date printed on the packaging.

Use IMMULITE 2000 diluent or IMMULITE 2500 diluent to prepare manual

dilutions. IMMULITE 2000 diluent and IMMULITE 2500 diluent are
concentrated. Prior to use as a manual diluent, the IMMULITE 2000 diluent and
IMMULITE 2500 diluent must be diluted 1 part diluent to 1.5 parts water.
NOTE: Do not perform reflexive testing on a manually diluted sample.

Samples that require a dilution factor other than those programmed for onboard
dilutions may have a manual dilution factor applied to them. When a manual
dilution factor is applied to a sample, all tests ordered on that sample are
multiplied by that dilution factor.
If a manual dilution is specified on a panel that has an automatic dilution, the
dilution factors are combined.
Do not exceed a combined onboard and manual dilution factor greater than
99,999.
When a patient sample is diluted either manually or onboard, the instrument will
automatically calculate the actual concentration of the patient sample by
multiplying the diluted patient sample result by the dilution factor.
1. Find a patient record:
a. Select Display/Edit on the Worklist screen.
b. Select the patient record, and then select EDIT RECORD.
The Worklist screen for that patient displays.
2. At the Tests Ordered screen, select the assay that was diluted offline.
3. Select Manual Dilution.
The Manual Dilution screen displays:
4. Type the manual dilution factor, and then select OK.
For all tests ordered on this sample, the manual dilution factor displays on the
Worklist screen under Dilution Factor.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-53

5. Select ACCEPT PATIENT.

CAUTION
Do not attempt to enter manual dilution factors for samples that are in queue or in
progress. The dilution factor is ignored and the result will not be corrected for the
manual dilution.

Checking Kit Components

Follow these instructions to check the status of the kit components onboard the
instrument, including the bead packs, reagent wedges, and diluents.
NOTE: If the instrument detects that kit components or consumables are needed
to run the current worklist, the Consumables button turns red.
1. After the instrument is in RUN mode, select Consumables on the Worklist
screen.
2. If appropriate, print the report by selecting Print Report.
3. Load any needed kit components.
4. Close all instrument covers.
5. Select RUN to begin processing.
NOTE: The next time the Consumables button is selected or the next time the
sample barcodes are read, the button returns to the original color.
6. To close the Consumables Report screen, select CLOSE.

Test Entry Options

When manually specifying tests, the Worklist screen allows the operator to:
• Select tests from a list of available tests.
• Select a panel from a list of available panels.
• Assign tests to an entire sample rack.

Selecting Available Tests

It may be easier to select from a list of available tests when selecting the tests to
run on a particular sample. Follow the instructions below to select from a list of
available tests.
NOTE: If the instrument is connected to an LIS, the tests to run for each sample
are automatically entered in the worklist.
1. In the Worklist screen, select TESTS.
The Available Tests screen displays a list of available tests.

601005-0004 Rev. A
2-54 Operator’s Guide: Operating the System

NOTE: Select the ACTIVE KITS buttons to view all kits entered in the
database.
2. Add immunoassays to the worklist:
To exclude immunoassays in the worklist, proceed to step 3.
a. Select the Immunoassay ON BOARD button.
A button for every available immunoassay displays in the center of the
screen.
b. Select the button for each immunoassay to add to the worklist.
The code for the assay selected displays in the Tests Selected field.
3. Add allergy tests to the worklist:
To exclude allergy tests in the worklist, proceed to step 4.
a. Select the Allergy ON BOARD button.
A button for every available allergy test displays in the center of the
screen. Selections for universal allergy reagents display below the Test
Categories field.
b. Select the universal reagent, such as SPE, to use for the allergy test added
to the worklist.
c. Select the button for the allergy test to add to the worklist.
The code for the test selected displays in the Tests Selected field.
d. Continue selecting universal reagents and tests for each allergy test to add
to the worklist.
NOTE: To remove a test selected in the Available Tests screen, select the
button for that test. To remove an allergy test, select the universal reagent and
then select the button for the allergy test to remove.
4. Specify replicates of the tests added to the worklist.
Proceed to step 5 if replicates are not needed.
a. Select a test in the Tests Selected field, and then select REPLICATES.
The Replicates screen displays.
b. Display the number of replicates to perform using the arrow buttons.
The number can also be changed using the keyboard.
c. Select OK to enter this number, and then close the Replicates screen.
d. Repeat this process for all tests that require replicates.
5. When finished selecting tests, select OK in the Available Tests screen to save
the entries and close the screen.
The tests selected display in the Tests Ordered field in the Worklist screen.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-55

Selecting a Panel
Follow the instructions below to select a panel of tests to run for a particular
sample.
NOTE: The panels are configured on the Panel Configuration screen. Refer to
Panel Configuration‚ page 8-18.
1. At the Worklist screen, select PANELS.
The Available Panels screen displays a list of available panels.
2. Select the appropriate PANEL button.
The tests included in this panel display in the Tests Ordered screen.
NOTE: The color of the test name in the Tests Ordered screen corresponds
with the panel name.
3. Select other PANEL buttons, as applicable.
To deselect a panel, select the PANEL button again.
4. Select OK.
The Worklist screen displays.

Assigning Tests to an Entire Rack

It may be more convenient to assign tests to an entire sample rack than to specify
tests one at a time. Follow the instructions below to assign tests to an entire
sample rack of barcoded samples. For non-barcoded samples, refer to Damaged
or Missing Barcodes‚ page 2-44.
NOTE: If the system is connected to an LIS, the tests to run for each sample are
automatically entered in the Worklist.

CAUTION
Do not add additional tests to a sample rack while it is between pipetting and
incubation.

1. Load the samples on the sample rack, place the rack on the instrument, and
select RUN.
2. At the Worklist screen, select Batch Tests by Rack.
3. Select one or more of the available sample racks.
NOTE: To deselect a sample rack, select the rack again.
4. Perform one of the following options to select the tests to run:
• Type the test name in the field next to the TESTS button and select Enter.
Continue this process until all tests are ordered.
• Select TESTS to select from a list of available tests.

601005-0004 Rev. A
2-56 Operator’s Guide: Operating the System

Refer to Selecting Available Tests‚ page 2-53 for more information.

• Select PANELS and select from a list of available panels.
The tests display in the Tests Selected screen.
NOTE: Use the CLEAR button to clear the entries from the Tests Selected
screen.
5. Select a dilution to be applied to the rack:
• For onboard dilutions, select Dilution.
The Dilution Factor screen will display. Select the appropriate onboard
dilution.
NOTE: When a manual dilution factor is entered for a Sample Rack, the
entered dilution factor will be applied to all samples in that rack.
• For manual dilutions, select Manual Dilution.
The Manual Dilution Factor screen will display. Enter the dilution factor
and select OK. The sample must be diluted by the operator prior to
loading onto the system.
NOTE: Do not exceed a combined onboard and manual dilution factor
greater than 99,999.
• For a combined onboard and manual dilution, the instrument combines
the dilution factors.
6. Select ACCEPT when finished.

Assigning a Tube Position

If the barcode is damaged or missing, associate the tube and its position with the
sample accession number by following the steps below.
NOTE: Manually assigned tubes need to be identified each time the sample
carousel is paused and re-interrogated.
1. Enter the sample information on the Worklist screen.
2. From the Worklist screen, select Assign Tube Position.
3. Under Select Rack To Use, select the letter corresponding to the sample rack
where the sample was placed.
4. Under Select Position To Use, a graphical depiction of the positions on the
sample rack displays.
Standard samples are displayed as circles and microsamples are displayed as
squares. The sample status is indicated by the color of the numbered circles or
squares. Select the position by clicking on a white circle or square.
The position turns red.
5. Select OK.
The Worklist screen displays. The tube position (rack and number) displays to
the right of the Assign Tube Position button for this sample.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-57

Worklist Management and Display Options

Worklist management and display options allow the operator to:
• Display a worklist.
• Print a worklist.
• Modify a worklist entry.
• Delete a worklist entry.
• Save and import a worklist.

Displaying a Worklist
At the Worklist screen, view all current records by following the instructions
below:
1. Select DISPLAY/EDIT.
The Display Worklist screen displays.
2. Sort the Worklist by selecting one of the options next to Sort List By.
The Display Worklist can be sorted by:
• Accession Number
• Entered Order
• Test Name in alphabetical order
• Patient Name in alphabetical order
• Rack Order
• Adjustors (to display Adjustors first)
• Controls (to display Controls first)
• Patients (to display Patients first)
• Calibration Verifiers (to display Calibration Verifiers first)
• Status (to display samples by current status)
NOTE: The Sample Type column displays either A for Adjustor, C for
control, P for patient, or V for calibration verifier.
3. To scroll through the Worklist, select the UP or DOWN buttons.

Printing a Worklist
Either an individual record or the entire Worklist can be printed from the Worklist
screen.
1. From the Worklist screen, select PRINT ALL.
2. If necessary, select one of the Sort Printout By options.
3. Select the type of record to print by selecting one of the Print options.
4. Select PRINT.

601005-0004 Rev. A
2-58 Operator’s Guide: Operating the System

Modifying a Worklist Entry

Worklist entries can be modified from either the Worklist or the Display Worklist
screen.

Modifying a Worklist Entry from the Worklist Screen

NOTE: A record can be modified only if the sample is currently onboard the
instrument and that particular test is not in progress.
1. Select Previous and Next to locate the record.
2. Make any changes and select ACCEPT PATIENT.

Modifying a Worklist Entry from the Display Worklist Screen

NOTE: Modifications can be made to all records that are not in progress.
1. At the Worklist screen, select Display/Edit.
2. Select Update Screen to refresh the worklist.
3. Select the record.
4. Select EDIT RECORD.
The Worklist screen displays, displaying the selected record.
5. Make any changes and select ACCEPT PATIENT.
The Display Worklist screen displays.

Deleting a Worklist Entry

A worklist entry can be deleted from either the Worklist or the Display Worklist
screen.

Deleting a Worklist Entry from the Display Worklist Screen

NOTE: A record can be deleted only if the sample is currently onboard the
instrument.
1. Select Previous and Next to locate the record.
2. Select DELETE PATIENT.
The record is deleted.

Deleting a Worklist Entry from the Display Worklist Screen

1. At the Worklist screen, select Display/Edit.
2. Select the record(s).
NOTE: Select more than one record to delete multiple records at a time.
3. Select DELETE RECORD.
The selected records are deleted.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-59

Saving and Importing a Worklist

The Save and Import functions are used to save a common worklist for future use.
Follow these instructions to save a worklist.
1. After completing a worklist, select DISPLAY/EDIT to view the entire
Worklist.
The Display Worklist screen displays.
2. Select SAVE WORKLIST.
The Export Worklist screen displays:
3. Select Binary File (a coded file) or ASCII File (a text file).
NOTE: Use ASCII File when the file is to be imported into another
application, such as Lotus or Microsoft Office Excel.
4. Select OK.
The Save As screen displays.
5. Double-select on the directory where the worklist file should be stored.
NOTE: The scroll bar may be needed to view all the directories.
6. Type a name in the Filename field, and then select Save.
The Save As screen closes and the Worklist is saved.

Importing a Worklist

Follow the instructions below to import a previously saved worklist.

1. From the Worklist, select DISPLAY/EDIT.
The Display Worklist screen displays.
2. Select IMPORT WORKLIST.
The following screen displays.
3. Select the file format used when the file was saved, either Binary File or
ASCII File.
4. Select OK.
5. Double-select the directory where the file is stored.
NOTE: The scroll bar may be needed to view all the directories and files.
6. Double-select the filename.
7. The name displays in the Filename field.
8. Select Open.
The screen is removed from the Display Worklist screen and the imported
Worklist displays.

601005-0004 Rev. A
2-60 Operator’s Guide: Operating the System

Reviewing Results
The results review function is used to review results from a sample previously
run. Follow the instructions below to review results.
1. Select REVIEW.
A blank Review screen displays.
NOTE: The default time option is Today Only. To change the default time,
Changing the Default Time‚ page 2-61.
2. Select one of the option buttons listed below, indicating the result type:
• All
• Patient
• Adjustor
• Control
• Verifier (for calibration verifier)
NOTE: The type of data displayed on the Review screen varies depending on
whether the result is a patient, control, adjustor, or calibration verifier.
NOTE: If reference ranges were entered, they are displayed for the first test
results, which are highlighted. Refer to Defining Test Ranges‚ page 8-12 for
information on entering ranges.
3. Use the buttons to view the results or to print a particular patient's results.
The buttons on the Review screen are described in the table below:
Button Description
PgUp or PgDn Displays the previous or next page of results for
this patient.
Up and Down Scrolls through the results for a particular patient
one by one.
Previous and Next Displays the previous or next patient's results.
Print Patient, Adjustor, Control, Prints all the results for the patient with this
or Verifier Accession number.
Search Allows the operator to search for a specific result.
Refer to Searching for a Result‚ page 2-62 for more
information. The search option is not available if
All is selected.

4. Select the appropriate result to view the reference ranges for this test.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-61

Changing the Default Time

To change the default period for the records displayed, follow the instructions
below.
1. From the Review screen, select Time.
2. Select the appropriate button according to the information in the table below:
Button Function
FROM TO Displays the results from a specified time and date
NOTE: The operator must enter the times and dates in the From
and To fields (using the calendar and the clock) and select the OK
button.
TODAY ONLY Displays results for the current date.
ALL Displays all the patient control, Adjustor or calibration verifier
results (depending on the button selected in step 2). If ALL was
selected in step 2, all records in the database are displayed.
3. If the TODAY ONLY or ALL button was selected in step 2, select OK.
The new default time specification displays to the right of the Time button (on
the Review screen).
4. If the FROM TO button was selected in step 2, select in the mm/dd/yyyy field
under From.
The Select Time Method screen displays a calendar.
5. To change:
• The month, select the arrows to the left and right of the month for the
previous or next month.
• The year, select the arrows to the left and right of the year for the previous
or next year.
• The day, select the date.
6. Select in the hh:mm:ss am/pm field under From.
A digital clock displays.
NOTE: The time defaults to 12:00:00 am.
7. Select the up and down arrows to change the time (hours, minutes, or
seconds) and select the OK button under the clock.
8. Repeat steps 1 though 4 for the To date and time fields.
NOTE: The time defaults to 11:59:59 pm.
9. Select the OK button.
The new default time specification displays to the right of the Time button on
the Review screen.

601005-0004 Rev. A
2-62 Operator’s Guide: Operating the System

Searching for a Result

Follow the instructions below to search for a record.
1. Select REVIEW.
A blank Review screen displays:
2. From the Review screen, select one of the option buttons listed below,
indicating the type of result to review:
• Patient
• Adjustor
• Control
• Verifier (for calibration verifier)
NOTE: A search cannot be performed if ALL is selected.
3. Select Search.
NOTE: The Search screen varies depending on the record type: patient,
control, adjustor, or calibration verifier.
The Search screen searches for patient results. The search options for adjustor,
control, or calibration verifier results are listed in the table below:
Result Type The available search options are:
Control • Control Name
• Control Lot
• Test Type
• Allergen Type
Adjustor • Test Type
• Kit Lot
Calib. Verifier • Verifier Lot Number
• Test Type
• Kit Lot
• Verifier Level
4. Select Time to set the time frame searched.
The default is the current date.
5. Type the search information, and then select OK.
The Search Results screen displays the results meeting the search criteria.
NOTE: Select the Exact Match option to view the results that identically
meet the search criteria. If the Exact Match checkbox is not selected,
anything similar to the entered data will be displayed.
6. Select a result, and then select OK.
The Review screen for that result displays.

601005-0004 Rev. A
Operator’s Guide: Operating the System 2-63

Reviewing LIS Results

The LIS button is used to review information received from the LIS and the
results being sent to the LIS.
Follow the instructions below to display and sort the data received from the LIS
and the results to be sent to the LIS.
1. At the instrument window, select LIS.
The LIS screen displays the data.
The viewing options selected the last time the LIS screen was accessed,
determine the information displayed when the LIS button is selected.
NOTE: For the data status, refer to the color key along the bottom of the
screen.
LIS Status Description
Time Time remaining for the test to be completed.
Resulted Test complete; answer has not been sent to LIS.
Waiting The sample is on the instrument, but the test has not started.
No Sample The sample is not on the instrument.
Sent This record was previously sent to LIS.
In-Queue The test is close to being processed.
Kit Error There is a problem with the bead, reagent or diluent.
Sample Error There is a problem with the sample tube, such as not enough sample
or clot detected.
If applicable, select Show Sent to display results already sent to the LIS.
NOTE: The button will change to Hide Sent.
2. Sort the LIS data by selecting the Sort By... button.
3. If applicable, specify a period other than Prior 24 Hours by selecting Define
Range:
• Select the MM/DD/YYYY field to access the calendar and select a date.
• Select the HH:MM:SS xm field to access the clock and select a time.
4. To sort the results, select one of the sort buttons:
• Accession Number
• Order Created
• Name
• Test Type
5. Select Print List to print the list.
6. To clear the LIS data, refer to Clearing LIS Data‚ page 2-64.

601005-0004 Rev. A
2-64 Operator’s Guide: Operating the System

Sending Results to the LIS

The system can be configured to send data to the LIS automatically. If the system
is not configured to send results automatically, follow the instructions below to
send results to the LIS manually.
NOTE: Hepatitis test results are held until two reflexive tests are completed. After
all three tests complete, the instrument auto-sends the one test result to the LIS
and marks all three as sent. However, you may manually send all three test results
to the LIS.
1. From the LIS screen, select Hide Sent to hide results that were already sent to
the LIS.
2. Select the results to be sent by clicking on them or select Tag All to tag all
results for transmission to the LIS.
3. Select Send to transmit the tagged results to the LIS.
N/A results can not be manually or automatically sent to LIS.

Resending Data
Results previously sent to the LIS can be resent by following these instructions:
1. From the LIS screen, select Show Sent.
The previously sent LIS results display.
2. Select the results to be sent by clicking on them.
3. Select Re-Send to transmit the results to the LIS.

Clearing LIS Data

NOTE: The Clear button does not delete records from the database.

To clear records from the LIS window:

1. From the LIS screen, perform one of the following actions to select the
records to be cleared:
• Select the records
• Select Tag All.
2. Select Clear at the LIS window.
The message “Do you wish to permanently Clear ALL selected records from
the LIS Screen?” displays.
3. Select Clear Records.
The selected records no longer display in the LIS window.

601005-0004 Rev. A
Operator’s Guide: Adjusting the System

3 Adjusting the System

Master Curve/Two-Point Adjustment . . . . . . . . . . . . . . . . 3-1

Adjustment Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Master Curve Generation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Four-Parameter Logistic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1
Point-To-Point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
Two-Point Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Judge Adjustment Validity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6
Readjustment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6
Master Cutoff Generation for Qualitative Assays . . . . . . 3-6
Measure the Cutoff for an Assay . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Calculation of Ratios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8

601005-0004 Rev. A
Operator’s Guide: Adjusting the System

601005-0004 Rev. A
Adjusting the System

Master Curve/Two-Point Adjustment

Instrument calibration uses a stored master curve in conjunction with a two-point
adjustment procedure. This section provides an overview of this calibration
method.

Adjustment Overview
Analyte concentration is determined by a stored master curve. This curve is
generated by the manufacturer for each lot of reagents and is provided in the kit
barcode. Adjustors are then used to correlate the counts per second (CPS) of the
customer's instrument to those of the instrument used to generate the master
curve.

Master Curve Generation

Master curves for each lot of reagents are generated on a single instrument by
running replicates of a set of standards spanning the reportable range of the assay.
The number of standards varies with the analyte and ranges from six, for Total T4
(range 1 to 24 µg/dL), to 15, for TSH (range 0.002 to 75 µIU/mL). The standards
are analyzed multiple times in several runs in random order. Replicates of a low
and high Adjustor are included in every run.
Generally, the master curve is fitted using a four-parameter logistic model. For
certain reagents, such as the universal reagent for specific allergy assays, a
point-to-point curve model is used.

Four-Parameter Logistic
For the four-parameter logistic method, the master curve generated is the equation
of the line that best fits the master curve data.
NOTE: The numerical values of the equation's four parameters vary from reagent
lot to reagent lot. These values are encoded in the kit barcode label. The average
CPS of the low and high adjustors, which were analyzed at the same time the
standards used for the master curve were analyzed, are also encoded in the kit
barcode label.

601005-0004 Rev. A
3-2 Operator’s Guide: Adjusting the System

The instrument uses two different forms of the general four-parameter logistic
equation:
• Form for competitive assays:
CPS= P1+ P2
1+EXP(-(P3+P4xLn(Dose)))
where: P1 = maximum CPS (Bo)
• P2 = minimum-maximum CPS (NSB - Bo)
• P3 = intercept of a logit-log plot
• P4 = - slope of the logit-log plot
• Form for immunometric (sandwich) assays:
CPS= P2+ P1 - P2
1 + (Dose/P3)P4
where: P1 = maximum CPS
• P2 =minimum CPS (NSB)
• P3 =dose at half the maximum CPS
• P4 =- slope of the logit-log plot

Point-To-Point
In the point-to-point curve model, the calibration curve is generated when each
standard is connected point-to-point by a straight line.

Two-Point Adjustment
Because the calibration data used to generate the master curve uses a single
instrument, the signal (CPS) for any other laboratory instrument must match the
signal of the Master Curve instrument to directly use the master curve to calculate
results.
Because no two photomultiplier tubes (PMT) give exactly the same measured
CPS for the same amount of light, the signal of each laboratory instrument must
be adjusted to match that of the Master Curve instrument for the master curve to
be used across all instruments. This is done using the two-point adjustment
process.

601005-0004 Rev. A
Operator’s Guide: Adjusting the System 3-3

If a full standard curve is run on both the Master Curve and the customer
instruments, the relationship between the measured CPS from the two instruments
(Master Instrument vs. customer instrument) is consistently linear. For example,
possible data for an assay with six standards is displayed in the table below.
Standard Master Curve Instrument CPS Customer Instrument CPS
Std A 85,176 75,112
Std B 329,714 293,703
Std C 1,079,469 961,223
Std D 5,112,318 4,568,847
Std E 10,125,798 9,050,371
Std F 25,087,126 22,424,222

This relationship can be used to modify, or adjust, the CPS obtained on the
laboratory instrument to be what they would have been for the same samples run
on the Master Curve instrument. Because the relationship between the laboratory
instrument and the Master Curve CPS values is a straight line, only two points are
required to characterize the line.
These two points are defined by the two adjustors. Comparing the average CPS of
the adjustors run on the master instrument (from the kit barcode label) and the
CPS run on the customer instrument during an adjustment, the slope and intercept
of the linear relationship are calculated. Using the equation below, the slope and
intercept are then used to adjust the CPS for any sample to the CPS that would
have been observed if the sample was run on the Master Curve instrument.
Master Curve CPS = CPSunknown x Slope + Intercept
The adjusted CPS can now be used to calculate the result directly from the Master
Curve.
The purpose of the initial adjustment of a new kit lot is to correlate the CPS of the
laboratory instrument to that of the Master Curve instrument. Subsequent
readjustments update the correlation for changes in the reagent enzyme activity
over time.

Judge Adjustment Validity

The guidelines listed below can be used to establish whether a given adjustment
has been successful. They are presented in order of importance:
1. Control values run immediately following an adjustment.
2. The slope of an adjustment.
3. The intercept of an adjustment.
If an adjustment does not display to be valid (using these guidelines),
readjustment may be necessary.

601005-0004 Rev. A
3-4 Operator’s Guide: Adjusting the System

NOTE: The adjustment printout will have a slope, intercept, and message
indicating whether or not the adjustment was complete.

Controls Run Immediately Following an Adjustment

Results from quality control samples run immediately following an adjustment are
the primary means of validating an adjustment and should be within the
established limits for acceptable performance.
Special care should be taken to note situations where all quality control results are
at the same (high or low) limit of acceptance as this may indicate a bias in the
adjustment.

The Adjustment Slope for an Initial Adjustment

An initial adjustment slope refers to the first slope generated on a new kit lot. The
initial adjustment slope generally falls within ± 20% of the mean slope for the
instrument.
The mean slope is the average of at least ten initial slopes of adjustment on a
single instrument, using one of the following adjustments:
• Initial adjustments of more than one type of assay, excluding assays with
single adjustors.
• Initial adjustments of more than one lot of reagent, if only one assay is being
used.
NOTE: If fewer than ten adjustments are run, an average can still be
calculated. However, this average should be regarded as preliminary and must
be recalculated when ten adjustments are completed.

601005-0004 Rev. A
Operator’s Guide: Adjusting the System 3-5

For example, using the following data:

Kit Lot Slope
COR 109 0.687
E2 107 0.986
E2 109 0.894
E2 110 0.983
TSH 110 1.009
TSH 125 0.993
TSH 127 0.989
T4 127 1.053
T4 117 1.008
TU 113 No slope calculated for TU
T3 115 0.998
1. The mean (average) slope is calculated as follows:
Mean = Sum of the slopes / 10 = 0.96
2. The acceptable 20% deviation from the mean is calculated as follows:
Deviation = Mean x 0.20 = 0.96 x 0.20 = 0.19
3. The range for an acceptable slope is calculated as follows:
High Limit = Mean + 20% = 0.96 + 0.19 = 1.15
Low Limit = Mean - 20% = 0.96 - 0.19 = 0.77
Range = Mean +/- 20% = 0.77 to 1.15

Intercept of Adjustment for an Immunometric (Sandwich) Assay

A large intercept affects the calculation of results only at very low concentrations.
If no controls are being run at these concentrations, an acceptable intercept may
be interpreted as follows:
absolute value of the intercept = low Adjustor CPS
of the master curve instrument x 30%
The low adjustor CPS refers to the adjustor CPS information found on the Kit
screen or the adjustment printout, not to the CPS measured during adjustment.
CPS of low Adjustor = 83,000
Acceptable intercept: 83,000 x 0.30 = 24,900
The guideline maximum intercept is 24,900.

Intercept of Adjustment for a Competitive Assay

A large intercept can affect values across the curve, especially those in the very
high range of the assay.

601005-0004 Rev. A
3-6 Operator’s Guide: Adjusting the System

For competitive assays, an acceptable intercept should be ≤ 2% of curve

parameter P1 found on the Kit screen.
P1 = 61,500,000
Acceptable intercept: 61,500,000 x.02 = 1,230,000

Summary
• Controls run immediately after an adjustment should be within acceptable
limits.
• The slope of an adjustment should fall within ± 20% of the mean slope for
that instrument.
• The intercept of an adjustment generally falls below a maximum calculated
intercept limit.
• Based on these guidelines, if an adjustment does not display to be valid,
readjustment may be necessary.

Readjustment
Every assay must be periodically readjusted, as indicated in the kit's package
insert, to correct for the reagent's normal loss of activity.

Slopes of Readjustment

Slopes of readjustments should fall within 10% of the previous adjustment.

NOTE: Slope variation is caused by normal statistical variation of the assay and a
10–15% loss in enzyme activity over the lifetime of a kit.

Intercepts of Readjustments

Readjustment intercepts should be judged according to the above criteria.

Master Cutoff Generation for Qualitative Assays

In qualitative assays, the results are classified as non-reactive or reactive, or
possibly indeterminate. The results in these assays are calculated by comparing
the signal obtained for a patient sample to a cut-off signal.

Immunometric (sandwich) assays

If patient CPS > cutoff, the result is reactive.
If patient CPS < cutoff, the result is non-reactive.

Competitive assays
If patient CPS < cutoff, the result is reactive.
If patient CPS > cutoff, the result is non-reactive.

601005-0004 Rev. A
Operator’s Guide: Adjusting the System 3-7

Where an indeterminate region is defined, it is usually a percentage above and

below the cutoff.

Indeterminate assays
If the percentage = 10% cutoff, then...
0.9 x cutoff < Indeterminate < 1.1 x cut-off

Measure the Cutoff for an Assay

The cutoff for an assay is usually established in one of two ways:
• A cutoff is determined statistically.
A cutoff is calculated which achieves the optimal sensitivity and specificity.
Several hundred patients, both reactive and non-reactive, whose clinical status
has been established by another method, are assayed on the instrument.
• An alternate method for choosing cutoff, used especially for allergy assays, is
based on the variability in signal response seen with a very large number of
non- reactive patient samples.
Qualitative assays have a single adjustor (or calibrator) used to establish the
relationship of the master cutoff to an individual instrument. For example, if the
cutoff for an assay is determined to be 100,000 CPS, and an adjustor (or
calibrator) run at the same time reads 80,000 CPS, a ratio of 1.25 (100,000/
80,000) is used with the adjustor to correctly establish the cutoff for a specific
instrument.
The single adjustor is supplied with the kit, and the ratio of the adjustor CPS to the
cutoff value is supplied in the kit barcode label as Parameter 1 (P1). At
adjustment, the average CPS of the adjustor obtained from the instrument is
multiplied by P1 to determine the specific cutoff for that instrument.
Parameter 2 (P2) and Parameter 3 (P3) are factors used as appropriate to set the
upper limit (P2) and lower limit (P3) of the indeterminate region. If an
indeterminate region is defined, then P2 x the adjustor CPS and P3 x
the adjustor CPS will give the signal above and below the cutoff defining
the indeterminate region. The percentage above and below the cutoff is defined by
P2/P1*100 and P3/P1*100. If no indeterminate is defined for an assay, P2
and P3 are 0.
For assays with a single adjustor, an adjustor index is calculated upon adjustment.
This is the ratio of the CPS obtained during the adjustment to the CPS of the
adjustor on the Master Curve instrument at Siemens, which is found on the kit
barcode.
Adjustor Index = Adjustor CPS
Kit Barcode Adjustor CPS

601005-0004 Rev. A
3-8 Operator’s Guide: Adjusting the System

NOTE: The adjustor index is not used in the calculation. Instead, it is calculated
as a guideline to the validity of the adjustment. Results obtained with Quality
Control samples are still the primary way to judge an adjustment.

Calculation of Ratios
The instrument can also report qualitative assays by means of a ratio. The
instrument can report the numerical ratio, followed by an indication of R, NR, or I
representing reactive, non-reactive, and indeterminate, respectively. Ratios are
determined by the following calculations:

Immunometric (Sandwich) Infectious Disease Assays

Ratio = CPS of Sample
Cutoff
Cutoff = P1 x Adjustor CPS

Competitive Infectious Disease Assays

Ratio = Cutoff
CPS of Sample
Cutoff = P1 x Adjustor CPS

Qualitative flags are determined by the following equations:

If the Ratio is greater than or equal to (1+P2/P1), the result is marked as

Reactive (R).
Ratio³(1+P2/P1)
If the Ratio is less than (1-P3/P1), the result is marked as Non-Reactive (NR).
Ratio < (1-P3/P1)
If the Ratio is greater than or equal to (1-P3/P1), but less than (1+P2/P1),
the result is marked as Indeterminate (I).
(1-P3/P1) < Ratio ‹(1+P2/P1)

601005-0004 Rev. A
Operator’s Guide: Quality Control

4 Quality Control

Entering New Control Information . . . . . . . . . . . . . . . . . . 4-1

Acceptance Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2
Using Controls that Are Not Online QC . . . . . . . . . . . . . . . . . . . . . . .4-2
Using Single Rule QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3
Using Multi Rule QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3
Completing the QC Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3
Additional Control Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Qualitative Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Controls Reported as Ratios. . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Adding a Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Changing a Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Editing Control Information . . . . . . . . . . . . . . . . . . . . . . . 4-7
Reviewing Control Data. . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Adding Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Creating Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Removing Points. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Deleting Tests for a Control . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Quality Control Management . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Control Not for On-line QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12
Single Rule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12
Multi Rule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12
Scheduling QC Assays . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
Scheduling a QC Worklist. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
Adding a QC Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-15
Editing a QC Worklist. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-15
Adding a Control in a QC Worklist . . . . . . . . . . . . . . . . . . . . . . . . . .4-15
Editing a Control in a QC Worklist . . . . . . . . . . . . . . . . . . . . . . . . . .4-16
Copying a Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Deleting a Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17

601005-0004 Rev. A
 Operator’s Guide: Quality Control

601005-0004 Rev. A
Quality Control

Entering New Control Information

To enter control identification information, follow the instructions below:
NOTE: This information is required for the instrument to calculate and report
control data.
1. Select QC.
2. Select DATA ENTRY.
3. Select New Control.
4. Enter a name of the control.
The name can be no more than six characters in the Name field.
5. Enter the source and lot # for the control.
6. Select Expiration Date.
NOTE: The default calendar entries are the current month and year.
7. Select the expiration date for the control from the calendar:
NOTE: The Expiration Date must be selected from the calendar in the
following order: month, year, and day.
a. Use the month arrow keys to select a month.
b. Use the year arrow keys to select a year.
c. Select a day.
d. Select OK.
8. Select Add New Tests.
9. Select ACTIVE KITS or ON BOARD:
• If the ACTIVE KITS button is selected, a button for every immunoassay or
allergy test scanned onto the Instrument displays in the center of the
window.
• If the ON BOARD button is selected, a button for every immunoassay or
allergy test physically residing on the instrument displays in the center of
the window.
10. For Immunoassay, select the appropriate immunoassay button.
The code for the selected assay displays in the Tests Selected field.
11. For Allergen, do the following steps:
a. Select the universal reagent, such as SPE, to be used for the allergy test.
b. Select the appropriate allergen test button.

601005-0004 Rev. A
4-2 Operator’s Guide: Quality Control

The code for the selected allergen displays in the Tests Selected field.
Two different kinds of allergy controls may be run:
• Allergy Kit Controls
This type of control tests the performance of the universal allergy kit.
These controls are provided with allergy kits. To run these controls, the
Specific-IgE Control Antibody provided with that kit must have been
entered and loaded.
Refer to Entering Allergens and Allergen Wedges‚ page 2-28
• Specific-Allergen Controls
These controls test the performance of a particular allergen.
Specific-allergen controls are available for the most common allergies. To
run these controls, the allergen whose performance is to be tested must be
entered and loaded.
12. Select OK.
13. Enter the control level, and then select OK.
The instrument automatically assigns an accession number to the control
level. For a control without a barcode, this accession number must be entered
into the Worklist screen to complete the order.
Refer to Controls without Barcodes‚ page 2-48.
14. If necessary, overwrite the instrument-generated accession number, such as
when an LIS control accession number is in use.
NOTE: If the accession number in the software does not match the LIS
control accession number, QC data will not be uploaded to the LIS and the
QC Levey-Jennings Control Graph.

Acceptance Criteria
In the upper right corner of the Control Entry window, select one of the
acceptance criteria options:
• Control Not for On-Line QC
• Use Single Rule
• Use Multi Rule (not available for allergy controls)
Refer to Quality Control Management‚ page 4-11.

Using Controls that Are Not Online QC

If the control is not for online QC, follow these steps:
1. Enter the Mean, SD, and SD Multiplier.
2. Select the Calculate Range button to calculate the Low and High Limits.
The SD Multiplier reflects the range for the standard deviation.
The default is 2.

601005-0004 Rev. A
Operator’s Guide: Quality Control 4-3

Using Single Rule QC

If you are using Single Rule QC, follow these steps:
1. Enter the Mean, SD, and SD Multiplier.
2. Select the Calculate Range button to calculate the Low and High Limits.
The SD Multiplier reflects the range for the standard deviation.
The default is 2.

Using Multi Rule QC

If you are using Multi Rule QC, follow these steps:
1. Enter the Mean and SD.
2. Select the appropriate rule options.
The default is 1(2s) Rule.

Completing the QC Procedure

1. Select Save.
A confirmation message displays if the accession number for this level of
control was changed.
2. Select Yes to confirm the change, or No to cancel it.
3. Select OK.

Additional Control Procedures

• To add another level for the same test, refer to Adding a Level‚ page 4-5.
• To add another test for the same control, follow steps 8 through 16.
• To add a new control, select New Control and follow steps 3 through 16.
• To view tests and ranges for other controls, select Previous Control and Next
Control.

601005-0004 Rev. A
4-4 Operator’s Guide: Quality Control

Qualitative Controls
To enter information about a qualitative control, follow the steps in the Entering
New Control Information‚ page 4-1 and Acceptance Criteria‚ page 4-2, and then
follow the instructions below.
NOTE: Each level of qualitative control must be entered as a separate control
record in the Control Entry window.
1. Enter the level for the control record in the New Control Level window based
upon the information in the following tables:
For qualitative controls with three levels:
For this level Enter
Non-Reactive 1
Low Reactive 2
Reactive 3

For qualitative controls with two levels:

For this level Enter
Non-Reactive 1
Reactive 2
2. At the upper right corner of the Control Entry window, select Control Not for
On-Line QC.
3. In the Mean field, enter 1.
4. In the SD field, enter 1.
5. In the SD Multiplier field, enter 1.
6. In the Low Limit field, enter 0.0.
7. In the High Limit field, enter 1.
8. Select Save.
9. Select OK.

Controls Reported as Ratios

Assay controls that report ratios require entry of the control ranges for the Mean
and Standard Deviation. Preliminary values for the Mean and Standard Deviation
can be found in the control package insert included with the controls.

601005-0004 Rev. A
Operator’s Guide: Quality Control 4-5

As with qualitative control entry, each level of control must be entered as a

separate control name in the Control Identification window. The control name
must be identical to the name printed on the control barcode label. Follow the
steps for Entering New Control Information‚ page 4-1 and enter the control ranges
from the package insert.

Adding a Level
Follow the instructions below to add a level to an existing control in the Control
Entry window. To open the Control Entry window, follow steps 1 and 2 of the
Entering New Control Information‚ page 4-1.
1. From the Name list, select the control to which to add a level.
2. From the Test Type list, select the assay for which to add a control level.
3. Select Add New Level.
The New Control Level window displays.
4. Enter the new level, and then select OK.
5. At the upper right corner of the Control Entry window, select one of the
acceptance criteria options:
• Control Not for On-Line QC
• Use Single Rule
• Use Multi Rule (not available for allergy controls)
Refer to Quality Control Management‚ page 4-11 for more information about
the acceptance criteria.
Based on the option selected in step 5, follow steps 6 through 10:
6. If you selected Control Not for On-Line QC, perform the following steps:
a. Enter the Mean, SD, and SD Multiplier.
b. Select Calculate Range to calculate the Low and High Limits.
The SD Multiplier reflects the range for the standard deviation. The
default is 2.
7. If you selected Use Single Rule, perform the following steps:
a. Enter the Mean, SD, and SD Multiplier.
b. Select Calculate Range to calculate the Low and High Limits.
The SD Multiplier reflects the range for the standard deviation. The
default is 2.
8. If you selected Use Multi Rule, perform the following steps:
a. Enter the Mean and SD.
b. Select the appropriate rule options.
1(2s) Rule is the default.
9. Select Save.

601005-0004 Rev. A
4-6 Operator’s Guide: Quality Control

10. Select OK.

Changing a Level
Follow the instructions below to change a level for an existing control in the
Control Entry window. To open the Control Entry window, follow steps 1 and 2 of
the Entering New Control Information‚ page 4-1.
1. From the Name list, select the control level to change.
2. From the Test Type list, select the assay for which to change the control level.
3. Select the test name and level in the Current Test field.
NOTE: A control level cannot be changed to a level that already exists. For
example, if a control for levels 4, 5, and 6 was entered, level 6 cannot be
changed to level 5.
4. Select Change Level.
5. Enter the new control level, and then select OK.
The test name that displays in the Control Level Change Alert message is
determined by the test selected in Step 3.
6. Select Yes.
7. At the upper right corner of the Control Entry window, select one of the
acceptance criteria options:
• Control Not for On-Line QC
• Use Single Rule
• Use Multi Rule (not available for allergy controls)
Refer to Quality Control Management‚ page 4-11 for more information about
the acceptance criteria.
Based upon the option selected in step 7, follow these steps:
8. If you selected Control Not for On-Line QC, perform these steps:
a. Enter the Mean, SD, and SD Multiplier.
b. Select Calculate Range to calculate the Low and High Limits.
The SD Multiplier reflects the range for the standard deviation. The
default is 2.
9. If you selected Use Single Rule, perform these steps:
a. Enter the Mean, SD, and SD Multiplier.
b. Select Calculate Range to calculate the Low and High Limits.
The SD Multiplier reflects the range for the standard deviation. The
default is 2.
10. If you selected Use Multi Rule, perform these steps:
a. Enter the Mean and SD.

601005-0004 Rev. A
Operator’s Guide: Quality Control 4-7

b. Select the appropriate rule options.

1(2s) Rule is the default.
11. Select Save.
The Record Saved window displays.
12. Select OK.
13. To view tests and ranges for other controls, select Previous Control or Next
Control.

Editing Control Information

Follow the instructions below to edit existing control information.
1. Select QC on the toolbar.
2. Select DATA ENTRY.
The Control Entry screen displays.
NOTE: If the Use Multi Rule option is selected, the last four results display
under the Use Control for QC section.
3. Select the down arrow in the Name field and select the control.
4. Select the down arrow in the Test Type field and select the appropriate assay.
5. Select the test and level.
6. Type the new control identification information.
7. Select Save.
Depending on the control identification data changed, a window may display
confirming the change. All test types defined for that control are
automatically updated.
8. To view other tests and ranges, select Previous Control or Next Control.

Reviewing Control Data

Control data can be reviewed by accessing a graph that plots data for different
dates.
NOTE: Within the date display section, if the selected date range spans two years,
each data point in the later year will be dated for the following day. For example,
for a date range spanning 2001 and 2002, a QC sample processed on January 2,
2002 displays with a January 3, 2002 date on the QC graph. This issue only occurs
in the Date Display on the QC Graph and does not affect the data table and printed
reports.
To review control data, follow the instructions below:
1. Select QC.

601005-0004 Rev. A
4-8 Operator’s Guide: Quality Control

2. Select GRAPHS.
The Controls Graph Selection window displays.
NOTE: When the range is 25 days or less, each date displays on the graph;
otherwise, some dates are represented by points.
3. Select the From field:
NOTE: The From date must be selected from the calendar in the following
order: month, year, and day.
a. Use the arrow keys to select the appropriate month and year.
b. Select the appropriate date.
c. Select OK
NOTE: The To date default is today’s date. This field can be changed if
appropriate.
4. Select the down arrow to the right of the first selection field, to the right of the
To field, and select the test.
5. Select the down arrow to the right of the next selection field and select the
control name.
6. Select the down arrow to the right of the next selection field and select the
control level.
7. Select the down arrow to the right of the last selection field and select the lot
number.
The Controls Graph window displays the plotted data points and the results
used to plot the graph.
The following list describes the content of the plotted graph portion of the
screen:
• Data points can be a square, a circle, or a triangle.
• Data points of the same color are from the same Kit Lot.
• Different colors indicate new Kit Lot numbers.
• Data points of the same color and shape indicate the controls were run on
the same Kit Lot, with the same adjustment.
• Data points of the same color and a different shape indicate the controls
were run on the same Kit Lot, with a different adjustment.
The following list describes the content of the Results Portion of the screen:
• Results highlighted in pink are out of 4SD range and are not included in
the graph.
• The standard deviation is based on the target mean entered in the Control
Entry window.
8. Sort data by selecting a column.
For example, to sort the data by Z score, select the Z column.

601005-0004 Rev. A
Operator’s Guide: Quality Control 4-9

9. For an explanation of the Controls Graph screen, select the How to read this
graph? button.
10. To review details for an individual data point:
a. Move the pointer over the data point (with the trackball) and right-click.
The data corresponding to this data point displays in green on the Results
portion of the screen.
b. Select Yes to remove this point from the graph.
Refer to Removing Points‚ page 4-11.
The Point Info window closes.
• On the Results portion of the screen, the data corresponding to this
point displays in red and the plus (+) sign changes to a minus (–) sign.
• On the printout, there is a line through the result corresponding to the
removed data point.
11. To copy the graph, print the graph, magnify a portion of the graph, eliminate
the graph gridlines, or change the graph title refer to the table below.
To do this... Select...
Copy the graph, The camera button.
NOTE: The graph can be pasted in the Microsoft Paint
application and saved as a bitmap file.
To access Microsoft Paint, do the following:
1. On the Microsoft taskbar, select Start.
2. Select Programs, and then select Accessories.
3. Select Paint.
Copy the data, The scissors button.
NOTE: The data can be pasted and saved in another
application (MS Word or MS Excel).
Print the graph, The printer button.
NOTE: It is recommended that operators avoid printing
graphs while the instrument is in RUN mode. Runtime errors
may occur if the operator attempts to print QC graphs while
the instrument is performing tests.
Magnify part of the The magnifier button.
screen, Select and drag the cursor over the area to magnify.
NOTE: To restore the screen to its original size, select the
magnifier button again.
View the screen with the The vertical lines button.
vertical grid lines, NOTE: To remove the grid lines, select the vertical lines
button again.
View the screen with the The horizontal lines button.
horizontal grid lines, NOTE: To remove the grid lines, select the horizontal lines
button again.

601005-0004 Rev. A
4-10 Operator’s Guide: Quality Control

To do this... Select...
Change the graph titles, The graph edit button.
In the Titles window, type the titles to display as follows:
• At the top of the graph
• To the left of the graph
• To the right of the graph
• At the bottom of the graph
12. To leave the Controls Graph screen, select another screen.

Adding Comments
To add a comment to a result on the Controls Graph screen, perform these steps:
1. At the Controls Graph screen, select the Comment field for a particular line
of data.
A Comment Selection window displays.
2. Select a comment.
The comment displays in the Comment field.

Creating Comments
When none of the available comments are appropriate, create a comment:
1. At the Controls Graph screen, select Edit Comments List.
2. Select the Edit Comments List window where the comment will display.
For example, click under the last comment to add the comment to the end of
the list.
3. Select Add New to List.
New Comment displays in the window to the left of CLOSE.
4. Type the new comment, and then select Enter.
• Enter alphanumeric characters only.
• If a non-alphanumeric character, such as an apostrophe, is entered, it can
be edited in the Edit Comments List window.
5. The new comment displays in the Edit Comments List window, above the
original highlighted comment, and the top line of the New Comment window
defaults to empty.
NOTE: To remove a comment from the list, highlight the comment and select
Remove from List.
6. Select CLOSE to close the Edit Comments List window.

601005-0004 Rev. A
Operator’s Guide: Quality Control 4-11

Removing Points
An invalid result can be removed so it is not included in the graph.
At the Controls Graph screen, select the plus sign (+) to the left of the control
result to be removed.
The data corresponding to this result changes color and the plus sign (+) becomes
a minus sign (-), indicating this result is not included in the controls graph.
The graph changes to reflect the change in data, the n value is updated, and the
Actual Mean, SD, and CV (%) figures are recalculated. See the Controls Graph
displaying results not in the graph.
NOTE: To include data previously removed, select the minus sign (-) to the left of
the result. The minus sign (-) becomes a plus sign (+), the actual calculations are
updated, and the graph is updated to reflect the new data.

Deleting Tests for a Control

Follow the steps below to delete tests for a control:
1. Select QC on the toolbar.
2. Select DATA ENTRY.
3. Select the down arrow in the Name field and select the control.
4. Select the down arrow in the Test Type field and select the appropriate assay.
5. Select Delete Control.
6. Complete the procedure:
• To delete all tests for that control, select Yes.
• To delete the highlighted test, select No, and then select Yes to delete.

Quality Control Management

The instrument software provides several statistical control options that allow the
operator to tailor the system based on the laboratory’s specific needs with respect
to online quality control. The operator can select either the single rule or multi
rule approach to statistical quality control to determine if a control is acceptable.
The system can also be configured not to use control results for online quality
control.
NOTE: Control specifications are configured on the Control Entry screen.

The system can be configured to prohibit unacceptable results from being

automatically sent to the LIS. These autosend options are included on the LIS
Configuration screen. Refer to Configuring the System‚ page 8-1.

601005-0004 Rev. A
4-12 Operator’s Guide: Quality Control

Control Not for On-line QC

This option is selected on the Control Entry screen when the control result is not
to be used for online quality control. If the system is configured to autosend
results to the LIS, patient results will be transmitted regardless of the Quality
Control status.
The mean, standard deviation (SD), and the standard deviation multiplier (SD
Multiplier) are entered and the system calculates the high and low limits.

Single Rule
The Single Rule method uses a single measurement to determine if the control
result is acceptable. The mean, standard deviation (SD), and the standard
deviation multiplier (SD Multiplier) are entered. The following formula is used to
determine the acceptable range.
Range = Target Mean ± (Standard Deviation x Standard
Deviation Multiplier)

After the test is complete, the instrument evaluates the control result. If a control
result is within range, the control printout displays:
Control passed all selected rules.

If the system is configured to autosend results to the LIS, patient results will be
sent.
If a control result is outside of the range, the control printout displays:
Control failed rules.

The printout lists the rule that was violated. If the system is configured to
autosend results to the LIS, patient results will not be sent.

Multi Rule
NOTE: When Multi rule options are used, the control’s range on QC reports is
listed as N/A.
The Multi Rule options available on the instrument are based on the Westgard QC
Multi Rule system for improving control procedure performance.
The Westgard QC Multi Rule system utilizes up to five control rules
simultaneously to decrease the probability of false rejections, while increasing the
probability of detecting both random and systematic errors. These rules work
most efficiently when analyzing three control materials (or levels).
To utilize the rules, the target mean and standard deviation (SD) are entered on the
QC Control Entry screen. Up to five rules may be evaluated for each control
result. The number of rules evaluated depends on the number of rules selected on
the Control Entry screen.

601005-0004 Rev. A
Operator’s Guide: Quality Control 4-13

It is important to note that the same control rules are not automatically applied to
all analytes. The instrument supports the use of different control rules for each
analyte, for example, the rules used for TSH may be different than the rules used
for Estradiol.
The rules are as follows:
Rule Description
1 (2s) This is the entry, or initial rule and compares the QC value to a 2 SD
control range.
This rule is used as a warning to initiate the evaluation of the control result
using subsequent rule(s), if selected. If this rule fails, all other selected
control rules are evaluated and reported to the operator.
1 (3s) After a QC value exceeds the 1 (2s) rule, the system will compare it to a 3
SD control range, if selected. Failure of the 3 SD rule marks the assay out
of control. If this rule passes, for example, result within 3 SD range,
subsequent selected rule(s) are checked.
2 (2s) The 2(2s) rule checks for prior, consecutive control value exceeding +/-
the same 2 SD control range. Failure of this rule marks the assay as out of
control. If this rule passes, subsequent selected rule(s) are checked. This
rule is evaluated by looking at the most recent result obtained from the
same control material, within the same control material.
R (4s) If the range or span of the most recent, prior, consecutive control value
compared to the current QC value exceeds 4 SD, the assay is marked as
out of control. If this rule passes, the final rule, if selected, is checked.
4 (1s) This rule fails when 4 consecutive control values exceed 1 SD on the same
side (+/-) of the target mean. The assay will be marked as out of control.
As with the 2 (2s) rule, this rule is evaluated historically across controls
and within the same control material.

After the test for the control sample is complete, the IMMULITE 2000 system
evaluates the result. If a control result is within range for all the rules selected, the
control printout displays:
Control passed all selected rules.

If a control result is outside of range for any of the selected rules, the control
printout displays:
Control failed rules.

The printout lists which rule failed. The operator then follows laboratory
procedures for an out-of-range control. The information regarding the violated
rule may help determine the cause of the problem.

601005-0004 Rev. A
4-14 Operator’s Guide: Quality Control

Scheduling QC Assays
NOTE: This section refers to the IMMULITE 2000 XPi system only.

The IMMULITE 2000 XPi AutoStart feature allows you to schedule the
instrument to perform quality control assays when you select Run AutoStart or
when a scheduled AutoStart occurs. You can also define selected QC assays for
selected days of the week.
This section describes the following procedures:
• Scheduling a QC worklist
• Adding or editing a QC worklist to the schedule
• Adding or editing a control to a QC worklist
• Copying a QC worklist
• Deleting a worklist

Scheduling a QC Worklist
To schedule a QC worklist to run with AutoStart, perform the following steps:
1. At the instrument window, select MENU.
2. In the Tools panel, select Schedule QC.
The Worklist Name dropdown list is blank until you add a QC worklist. The
worklist displays in the worklist table:
• Select the Samples tab to view the worklist by the control name.
• Select the Orders tab to view the worklist by individual test order.
3. Select SCHEDULE.
The Scheduled QC screen displays worklists that are currently scheduled. You
can use the Day of week dropdown list to display schedules for each day or
select ALL to display the entire week.
4. Select Add.
5. At the Schedule QC Worklist screen, select the QC Worklist Name you want
to schedule.
6. At the Schedule Type dropdown list, select Autostart.
Autostart is currently the only selection.
7. Select one or more days to schedule the selected worklist.
8. Select OK.
The Scheduled QC screen displays the added worklist schedule.
9. Select Close.

601005-0004 Rev. A
Operator’s Guide: Quality Control 4-15

Adding a QC Worklist
NOTE: Controls must be defined on the system before you can create a worklist.

To add a new QC worklist, do the following:

1. At the QC Worklist Display screen, select ADD.
2. At the QC Worklist Entry screen, enter a name for the new worklist in the
QC Worklist Name textbox.
3. Select Add Control.
4. At the QC Control Entry screen, select a control from the Control Name
dropdown list.
5. Ensure that the appropriate control level and control lot are selected.
6. Select TEST SELECTION.
7. At the AVAILABLE TESTS screen, select the tests to include with the control
on this worklist.
8. Select OK.
9. At the QC Control Entry screen, set dilutions as necessary, and then select
Accept.
The new QC Orders display in the QC Worklist Entry screen.
10. Repeat steps 3 through 9 for each control you add to the QC screen.
11. To save the worklist, select Save.

Editing a QC Worklist
To edit a QC worklist or change a worklist name, do the following:
1. At the QC Worklist Display screen, select the worklist you want to edit.
2. Select EDIT.
3. To add or edit a control in your worklist, refer to the next section, Adding a
Control in a QC Worklist‚ page 4-15 or Editing a Control in a QC Worklist‚
page 4-16.

Adding a Control in a QC Worklist

To add a control, do the following:
1. At the QC Worklist Display screen, select the appropriate worklist.
2. Select EDIT.
3. At the QC Worklist Entry screen, select Add Control.
4. At the QC Control Entry screen, select a control from the Control Name
dropdown list.

601005-0004 Rev. A
4-16 Operator’s Guide: Quality Control

5. Use the appropriate dropdown lists to select the control level and the control
lot.
6. Select TEST SELECTION.
7. At the AVAILABLE TESTS screen, select the test to add.
8. Select OK.
9. At the QC Control Entry screen, select Accept.
The new control displays in the QC worklist.
10. To save changes, select Save.

Editing a Control in a QC Worklist

To edit a control, do the following:
1. At the QC Worklist Display screen, select the appropriate worklist.
2. Select EDIT.
3. At the QC Worklist Entry screen, select the control to edit.
4. Select Edit Control.
5. At the QC Control Entry screen, make the necessary changes to the displayed
control.
6. At the QC Control Entry screen, select Accept.
The edited control displays in the QC worklist.
7. To save changes, select Save.

Copying a Worklist
If you want to create a worklist that is similar to another worklist, you could copy
a worklist and modify it as necessary.
To copy a worklist, perform the following steps:
1. At the instrument window, select MENU.
2. In the Tools panel, select Schedule QC.
3. At the QC Worklist Display screen, select the worklist you want to copy.
4. Select Copy.
5. At the New QC Worklist Name screen, enter the name for the new worklist.
6. Select Save.
The QC Worklist Display screen displays the new name for the selected
worklist. You can now customize the new worklist.

601005-0004 Rev. A
Operator’s Guide: Quality Control 4-17

Deleting a Worklist
If you want to delete a worklist you first must delete all occurrences of the
worklist in the Scheduled QC.
To delete a worklist, perform the following steps:
1. At the instrument window, select MENU.
2. Select Scheduled QC.
3. Select Schedule.
4. Delete each occurrence of the worklist:
a. Select an occurrence.
b. Select Delete.
c. Repeat these steps until all occurrences of the worklist are deleted.
5. Select Close.
6. At the QC Worklist Display screen, use the Worklist Name dropdown list to
select the worklist you are deleting.
7. Select Delete.
The instrument displays a message asking if you want to delete the worklist.
8. Select Yes.
9. To exit the QC Worklist Display screen, select Close.

601005-0004 Rev. A
4-18 Operator’s Guide: Quality Control

601005-0004 Rev. A
Operator’s Guide: Performing Maintenance

5 Performing Maintenance

Daily Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Preparing the System for Daily Maintenance . . . . . . . . . . . . . . . 5-2
Performing Maintenance Tasks . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Logging Off the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Initializing Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Cleaning the Sample and Reagent Probes . . . . . . . . . . . . . . . . 5-5
Restarting the Computer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Checking the Status Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Filling the Reaction Tube Hopper . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Checking and Filling the Water Bottle. . . . . . . . . . . . . . . . . . . . . 5-7
Disconnecting and Reconnecting Water and Probe Wash Bottles . .5-8
Checking and Filling the Probe Wash. . . . . . . . . . . . . . . . . . . . . 5-9
Checking and Filling the Substrate . . . . . . . . . . . . . . . . . . . . . . 5-10
Checking the Waste Containers . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Solid Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-11
Liquid Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-12
Priming the Sample and Reagent Pipettors . . . . . . . . . . . . . . . 5-13
Priming the Water Probe (IMMULITE 2000 Systems) . . . . . . . 5-14
Priming the Substrate Probe. . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
Weekly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
Cleaning the Waste Tube (IMMULITE 2000 Systems) . . . . . . . 5-16
Cleaning the Waste Tube (IMMULITE 2500 System) . . . . . . . . 5-17
Performing the Probe Angle Diagnostic . . . . . . . . . . . . . . . . . . 5-18
Monthly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19
Checking the Dispense Angle of the Reagent Probe . . . . . . . . 5-19
IMMULITE 2000/2000 XPi Water TestPM . . . . . . . . . . . . . . . . 5-20
IMMULITE 2500 Water TestPM. . . . . . . . . . . . . . . . . . . . . . . . . . . .5-21
Evaluating Water TestPM Results . . . . . . . . . . . . . . . . . . . . . . . . . .5-24
Cleaning the Fan Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-24
Decontaminating the Clot Detection Transducer . . . . . . . . . . . 5-27
Decontaminating the Bottles and Lines . . . . . . . . . . . . . . . . . . 5-27
Decontaminating the Bottles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-28
Decontaminating the Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-28
Quarterly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 5-29
Replacing the CO2 Scrubber . . . . . . . . . . . . . . . . . . . . . . . . . . 5-29
As Needed Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . 5-30
Cleaning the Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30
Cleaning the Trackball . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30
Maintaining the Sample Racks . . . . . . . . . . . . . . . . . . . . . . . . . 5-31

601005-0004 Rev. A
 Operator’s Guide: Performing Maintenance

Replacing Sample Rack Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31

Water System Routine Maintenance . . . . . . . . . . . . . . . . . . . . 5-31
Flushing Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31
Water Test Procedure (IMMULITE 2000 System) . . . . . . . . . . 5-32
Water Test Procedure (IMMULITE 2500 System) . . . . . . . . . . 5-33
Evaluating WATERTEST Results . . . . . . . . . . . . . . . . . . . . . . . 5-34
AutoStart Maintenance (IMMULITE 2000 XPi System) . 5-35
AutoStart Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35
Manual AutoStart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36
AutoStart Countdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36
AutoStart Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36
Worksheets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37
IMMULITE 2000 Systems and IMMULITE 2500 System
Adjustment Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-38

601005-0004 Rev. A
Performing Maintenance

• Daily maintenance
• Monthly maintenance
• Quarterly maintenance
• As needed maintenance
• AutoStart maintenance (IMMULITE 2000 XPi system only)
• Worksheets

Daily Maintenance
Perform the required maintenance procedures on a daily basis.

For the IMMULITE 2000 System and the IMMULITE 2500 System

Perform all daily maintenance tasks as listed in the following sections:

• Preparing the System for Daily Maintenance‚ page 5-2.
• Performing Maintenance Tasks‚ page 5-2.
For images of the IMMULITE 2000 system and IMMULITE 2500 system, refer
to the following figures:
• IMMULITE 2000 System (Overhead View)‚ page 1-6
• IMMULITE 2500 (Overhead View)‚ page 1-7
• IMMULITE 2000 Systems and IMMULITE 2500 System (Front View)‚
page 1-8

For the IMMULITE 2000 XPi System

You may perform daily maintenance tasks as listed in the section for
IMMULITE 2000 systems or IMMULITE 2500 systems or you can use the
AutoStart maintenance.
If you use the AutoStart for your daily maintenance, you can schedule an
AutoStart Maintenance, refer to AutoStart Maintenance (IMMULITE 2000 XPi
System)‚ page 5-35, or select RUN AUTOSTART.
For images of the IMMULITE 2000 XPi instrument, refer to the following
figures:
• IMMULITE 2000 XPi System (Overhead View)‚ page 1-9
• IMMULITE 2000 XPi System (Front View)‚ page 1-10

601005-0004 Rev. A
5-2 Operator’s Guide: Performing Maintenance

Preparing the System for Daily Maintenance

Some of the procedures involve checking the instrument status indicator. The
status indicator is located at the bottom of the vertical toolbar at the instrument
window. The indicator displays the status of empty and full levels.
1. Select RUN IMMULITE 2000 or RUN IMMULITE 2500.
2. Select OK when the system initialization is complete.
The Home screen and the toolbar display.
3. Scan any allergen wedges that changed on the instrument.
When scanning an allergen wedge, the Allergen Wedge Detail window
displays.
4. Confirm that the information is correct, and then select OK.
Refer to Replacing Reagent Wedges and Allergen Wedges‚ page 2-15.
5. Check the system status indicators.
Refer to Checking the Status Indicators‚ page 5-6.
6. If necessary, fill the consumables, or empty the waste container(s).
7. Fill the paper supply in the printer, if necessary.
8. Prime the sample and reagent pipettors.
Refer to Priming the Sample and Reagent Pipettors‚ page 5-13.
9. Prime the water probe.
Refer to Priming the Water Probe (IMMULITE 2000 Systems)‚ page 5-14
10. Prime the substrate probe.
Refer to Priming the Substrate Probe‚ page 5-16.
11. Close the main cover.

Performing Maintenance Tasks

1. Log off the system, if the system has not been turned off in the last 24 hours.
Refer to Logging Off the System‚ page 5-3.
2. Initialize the Diagnostic software.
Refer to Initializing Diagnostics‚ page 5-3.
3. Clean the sample and reagent probes.
Refer to Cleaning the Sample and Reagent Probes‚ page 5-5.
4. Restart the instrument computer.
Refer to Restarting the Computer‚ page 5-6.

601005-0004 Rev. A
Operator’s Guide: Performing Maintenance 5-3

Logging Off the System

NOTE: On the IMMULITE 2000 XPi instrument, if you use the AutoStart
procedure, this procedure is performed automatically. If you do not use AutoStart,
follow these instructions.
Logging off the system each day automatically initiates a system back-up, which
stores current data. This process optimizes software performance and allows
recent data to be restored in the event of a serious system error. Log off daily so
that if a serious system error occurs, recent data is available when the system is
restored.
NOTE: Failure to put the instrument in STOP mode before logging off may cause
the final reagent and bead test counts to be inaccurately stored.
1. Select STOP.
NOTE: If active tubes are in progress, a message displays stating the
time-to-completion. Select the appropriate button to either cancel or continue
the log-off process.
2. If you are logging off for an extended period, perform these steps:
a. Remove patient samples, controls, diluent, and adjustors from the sample
carousel.
b. Remove any allergen wedges from the reagent carousel and seal the
allergen vials with standard caps before storing them.
3. Select LOG OFF.
The following message displays.
Would you like to Log Off of the IMMULITE 2000
software and return to the Start-Up menu?
4. Select OK.
The following message displays.
Preparing to Back up Files...Please Wait
You are about to delete all patient records over 62
days and control, verifier and adjustor records over
366 days.
5. Increasing the number of days data is stored, by selecting the CHANGE DAYS
button, may slow the system response time.
6. Select CONTINUE.
The system logs off.

Initializing Diagnostics
NOTE: On the IMMULITE 2000 XPi instrument, if you use the AutoStart
procedure, this procedure is performed automatically. If you do not use AutoStart,
follow these instructions.

601005-0004 Rev. A
5-4 Operator’s Guide: Performing Maintenance

To initialize the diagnostic software, use the following procedure:

NOTE: Diagnostics can not be run if the instrument software is running. If
necessary, log off of the instrument software before proceeding.
1. At the Windows desktop, double-select the Diagnostics icon.
2. After the instrument initializes, select Condensed Run Program.
The Load Program screen displays. Refer to Diagnostic Programs‚ page 6-4.
3. Select the appropriate option:
• Home All Motors – 2000 (IMMULITE 2000 system)
• IMM 2500 Home All Motors (IMMULITE 2500 system)
• Home All Motors – 2000 XPi (IMMULITE 2000 XPi system)
4. Select RUN.
5. When Home All Motors is complete, select Load Program.
6. Select one of the following options:
• Cover Unlock – 2000 (IMMULITE 2000 systems)
• IMM 2500 Cover Unlock (IMMULITE 2500 system)
7. Select RUN.
The cover unlocks automatically during the daily probe cleaning diagnostic.
8. Lift the cover.
9. Select Load Program to load the list of diagnostics.
10. Run the appropriate diagnostic.

Exiting the Diagnostic Program

1. If necessary, select Stop.
2. Select Exit.
The Diagnostics main menu displays.
3. Select QUIT.

601005-0004 Rev. A
Operator’s Guide: Performing Maintenance 5-5

Cleaning the Sample and Reagent Probes

NOTE: On the IMMULITE 2000 XPi instrument, if you use the AutoStart
procedure, this procedure is performed automatically. If you do not use AutoStart,
follow these instructions.
Follow the instructions below to clean the Sample and Reagent Probes. A Probe
Cleaning Kit (part number L2KPM) is required to complete these instructions.
This procedure maintains optimal performance of the probes and prevents
carryover.

CAUTION
Do not insert anything into the probe. Permanent damage may occur.

1. If necessary, initialize diagnostics.

Refer to Initializing Diagnostics‚ page 5-3.
2. Select one of the following options:
• Daily Probe Cleaning – 2000
• Daily Probe Cleaning – 2000 XPi
• IMM 2500 Daily Probe Cleaning
3. Select RUN.
This homes all motors, unlocks the cover, and initializes the diagnostic.
4. Lift the cover after it unlocks.
5. Load a 12 x 75 sample tube containing 1.5 mL of probe cleaning solution onto
the sample rack (Position 1-1).
NOTE: Follow the package insert instructions for pipetting the probe
cleaning solution into the sample tube.
6. Place an empty reaction tube in the shuttle.
After the instrument cleans and primes the probes, the cover will unlock
automatically. If necessary, lift the cover.
7. Select Lift Cover, Place an Empty Reaction Tube on the Shuttle to
continue.
8. Select Lift the Cover and Press to Observe Dispense Angle and check the
dispense angle of the sample probe.
9. Observe the liquid that is dispensed from the sample probe.
It should be a straight solid stream into blind hole. If not, the sample probe
may need to be replaced.
10. Select PRESS TO STOP DISPENSE to end the diagnostic.

601005-0004 Rev. A
5-6 Operator’s Guide: Performing Maintenance

11. After the screen displays the Program Complete message, verify that the
sample probe does not touch the inside wall of the blind hole.
12. Remove the sample tube from the instrument and discard the probe cleaning
solution.
NOTE: The reaction tube is automatically removed by the system.
13. To continue running diagnostics, select Load Program and load the
appropriate diagnostic.
14. To stop running diagnostics, select EXIT, and then select QUIT.

Restarting the Computer

NOTE: On the IMMULITE 2000 XPi instrument, if you use the AutoStart
procedure, this procedure is performed automatically. If you do not use AutoStart,
follow these instructions.
Follow these steps to restart the computer. The steps are slightly different
depending on the computer's operating system (Windows NT or Windows XP).
1. Select the Start button on the lower left-hand corner of the screen.
2. Select Shut Down or Turn Off Computer.
3. Select Restart the computer? and then select Yes or Restart, depending on
which prompt displays.
NOTE: Press CTRL, Alt, and Delete keys simultaneously if prompted by the
software after the computer restarts.
4. Press Enter at the Log on Information window.
A password is not required.

Checking the Status Indicators

At the instrument window, check the status indicator on the vertical toolbar and
refill or empty reservoirs as necessary. Refer the next sections for maintaining
system reservoirs:
• Filling the Reaction Tube Hopper‚ page 5-6.
• Checking and Filling the Water Bottle‚ page 5-7.
• Checking and Filling the Probe Wash‚ page 5-9.
• Checking and Filling the Substrate‚ page 5-10.
• Checking the Waste Containers‚ page 5-11.

Filling the Reaction Tube Hopper

When the reaction tube hopper is empty, the instrument goes into PAUSE mode
automatically. To fill the reaction tube hopper, follow these instructions:
1. Open the front cabinet doors.

601005-0004 Rev. A
Operator’s Guide: Performing Maintenance 5-7

2. Grasp the reaction tube hopper handle and swing it towards you.
3. Fill the reaction tube hopper.
NOTE: Reaction tubes are single use only. Dispose of after each use. Do not
fill above the tube hopper fill-level mark.

LIQUID
WASTE

Figure 5-1 Filling the Reaction Tube Hopper

4. Swing the hopper back into place until it clicks.

5. Close the front cabinet doors or continue performing maintenance.

Checking and Filling the Water Bottle

Check the status indicator. If the water bottle needs to be filled, follow these
instructions:
1. Open the front cabinet doors.
2. Locate the water bottle.
3. Pull the water bottle forward until the screw cap at the front of the bottle is
accessible.
The bottle remains seated on the load scale, held in place by the molded notch
on the bottom of the bottle that engages the front edge of the load scale
platform.
NOTE: Do not disconnect the tubing from the valve at the back of the water
bottle while the instrument is in RUN mode. For detailed instructions on
disconnecting the water bottle, refer to Disconnecting and Reconnecting
Water and Probe Wash Bottles‚ page 5-8.

601005-0004 Rev. A
5-8 Operator’s Guide: Performing Maintenance

4. Unscrew the cap and fill the water bottle with distilled/de-ionized water from
a clean container.
5. Replace the cap and gently slide the water bottle back into place until it is
seated properly on the load scale.
6. Ensure that the tubing is not constricted so that water can flow freely.
7. Close the front cabinet doors or continue performing maintenance.

Disconnecting and Reconnecting Water and Probe Wash

Bottles
To disconnect (and reconnect) the water or probe wash bottles from the
instrument, follow the instructions below:
NOTE: Do not disconnect the tubing while the instrument is in RUN mode.
1. Press the silver button to release the valve and remove the tubing.
2. Remove the bottle from the instrument.

Figure 5-2 Disconnecting the Water Bottle

601005-0004 Rev. A
Operator’s Guide: Performing Maintenance 5-9

3. Reconnect by inserting the valve at the end of the tubing until it clicks into
place.

Figure 5-3 Disconnecting the Probe Wash Bottle

4. Prime at least ten times to remove air from the system.

Checking and Filling the Probe Wash

Check the status indicator. If the probe wash bottle needs to be filled, follow the
instructions below.
1. Open the front cabinet doors.
2. Locate the probe wash bottle.
NOTE: Do not disconnect the tubing from the valve at the back of the probe
wash bottle while the instrument is in RUN mode. For detailed instructions on
disconnecting the probe wash bottle, refer to Disconnecting and Reconnecting
Water and Probe Wash Bottles‚ page 5-8.
3. Unscrew the cap and fill with probe wash.
4. Replace the cap and gently slide the probe wash bottle back into place until it
is seated properly on the load scale.
5. Ensure that the tubing is not constricted so that probe wash can flow freely.
6. Close the front cabinet doors or continue performing maintenance.

601005-0004 Rev. A
5-10 Operator’s Guide: Performing Maintenance

Checking and Filling the Substrate

Check the status indicator. If the substrate reservoir needs to be filled, follow the
instructions below.

CAUTION
Do not leave substrate on the instrument for more than 30 days. Leaving substrate
on the instrument for more than 30 days could affect results.

NOTE: Do not overfill the substrate bottle. The indicator strip on the substrate
bottle displays the substrate level.
1. Allow the substrate to reach room temperature.
Remove the substrate from the refrigerator 20 minutes before using. For more
information, refer to the package insert.
2. Open the cover over the Dual Resolution Dilutors (DRD) priming accessories
and locate the substrate reservoir.
3. Lift the tab on the substrate reservoir.

WARNING
Do not add fill the substrate reservoir beyond the maximum capacity of 1000
tests. Filling the substrate reservoir beyond the maximum capacity may cause
substrate to enter the CO2 scrubber and cause a blockage. This can result in
damage to the instrument and possible misreporting of results. Each bottle of
chemiluinescent substrate contains enough material for 1000 tests.

601005-0004 Rev. A
Operator’s Guide: Performing Maintenance 5-11

4. Pipette the appropriate amount of substrate from the refill bottle into the
substrate reservoir.
Do not exceed the 1000 tests mark.

Figure 5-4 Filling the Substrate

5. Close the tab on the substrate bottle and close the cover.

CAUTION
Do not leave substrate spills on the load scale. Spilled substrate may cause the
load scale to stick and the substrate status indicator to appear full when the
substrate reservoir is empty. This could affect results. Immediately clean up any
substrate spills using moistened tissues.

Checking the Waste Containers

The instrument has a solid waste and a liquid waste container. Check the status
indicator. If the solid or liquid waste needs to be emptied, follow the instructions
below:

BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Safety
Instructions‚ page A-1 for recommended precautions when working with
biohazardous materials.

Solid Waste
1. Open the front cabinet doors.
2. Locate the solid waste container.
3. Remove the solid waste container and flip back the tube deflector.

601005-0004 Rev. A
5-12 Operator’s Guide: Performing Maintenance

4. Remove the biohazard bag filled with used reaction tubes and dispose the bag
into a biohazard container.
5. Put a new biohazard bag (part number 10-901807) in the solid waste
container, spreading out the bag so it lies against the sides of the container.
6. Be sure the bag is fully opened so the used reaction tubes can drop to the
bottom of the container.
7. Flip the tube deflector forward and replace the container in the system, with
the deflector at the back end.
8. Close the front cabinet doors or continue performing maintenance.

Liquid Waste

BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Safety
Instructions‚ page A-1 for recommended precautions when working with
biohazardous materials.

1. Open the front cabinet doors.

2. Locate the liquid waste bottle.
3. Push the dark gray button with one hand to release the valve, while pulling the
tube out with the other hand.
4. Remove the liquid waste bottle.

Figure 5-5 Removing the Liquid Waste Bottle

601005-0004 Rev. A
Operator’s Guide: Performing Maintenance 5-13

5. Empty the liquid waste bottle and place it on the instrument.

NOTE: Do not pour waste from the gray connection. Open the white cap to
empty the waste.
6. Reconnect by inserting the valve at the end of the waste line tubing until it
clicks into place.

WARNING
Do not leave the valve until it clicks into place. If it does not click into place,
liquid waste could back up in the waste tubing and overflow onto the floor.
7. Close the front cabinet doors or continue performing maintenance.

Priming the Sample and Reagent Pipettors

NOTE: Priming the sample and reagent pipettor is part of the AutoStart
maintenance procedures for the IMMULITE 2000 XPi instrument.
NOTE: The instrument must be in STOP mode to open the cover. If necessary,
select the STOP button before proceeding with the instructions below.
The following procedure primes the sample and reagent pipettors, as well as the
water probe on the IMMULITE 2500 system. The water probe on the
IMMULITE 2000 systems must be primed separately.
To prime the sample and reagent pipettors, follow these instructions:
1. Select COVER to release the lock.
2. Swivel the monitor out of the way and raise the main cover.
3. Press the green PRIME button until priming starts.
Alternatively, the PRIME button on the monitor can be used instead of the
green PRIME button.

601005-0004 Rev. A
5-14 Operator’s Guide: Performing Maintenance

4. Continue priming until there are no bubbles in the dual resolution dilutors or
the tubing.

Figure 5-6 Priming the Sample and Reagent Pipettors

Priming the Water Probe (IMMULITE 2000 Systems)

Follow these steps to prime the water probe on the IMMULITE 2000 systems.
NOTE: The water probe on the IMMULITE 2500 is primed automatically during
when the sample and reagent pipettors are primed. Refer to Priming the Sample
and Reagent Pipettors‚ page 5-13.
1. Remove the water probe from the bead/tube wash station.

WARNING
Do not lift the water probe unless you are standing away from the reagent pipettor
drain. The reagent pipettor automatically moves away from the reagent pipettor
drain when the water probe is lifted.

601005-0004 Rev. A
Operator’s Guide: Performing Maintenance 5-15

2. Hold the water probe over the reagent pipettor drain.

Figure 5-7 Priming the Water Probe

3. Press and release the green PRIME button.

The pump primes four times.
4. Continue to prime until there is a steady stream of water and no air in the
tubing.
5. Allow the priming sequence to complete and then place the water probe back
into the bead/tube wash station.
6. Be sure that the probe is fully seated.
The reagent pipettor moves back to its original position.

601005-0004 Rev. A
5-16 Operator’s Guide: Performing Maintenance

Priming the Substrate Probe

To prime the substrate probe, follow the instructions below:

CAUTION
Do not insert anything into the probe. Permanent damage may occur.

1. Remove the substrate probe from its holder next to the bead/tube wash station.

WARNING
Do not lift the substrate probe unless you are standing away from the reagent
pipettor. The reagent pipettor automatically moves away from the reagent pipettor
drain when the substrate probe is lifted.

2. Check for white precipitate at the end of the substrate nozzle.

If necessary, gently wipe the nozzle with a clean swab or lint-free, dry tissue.
3. Hold the substrate probe over a clean beaker or other external container.
NOTE: Do not prime the substrate probe into the reagent pipettor drain.
4. Press and release the green PRIME button.
The pump primes four times.
5. Continue to prime until there is a steady stream of substrate and no air in the
tubing.
6. Place the substrate probe back into its holder.
NOTE: The reagent pipettor returns to its original position.

Weekly Maintenance
The maintenance procedures described below should be performed on a weekly
basis. Refer to Worksheets‚ page 5-37 for maintenance records that can be copied
and used to keep track of maintenance items.

Cleaning the Waste Tube (IMMULITE 2000 Systems)

Follow these instructions to clean the liquid waste tube on the IMMULITE 2000
systems. Refer to Cleaning the Waste Tube (IMMULITE 2500 System)‚ page 5-17
for the IMMULITE 2500 procedure.
1. If necessary, initialize diagnostics.
Refer to Initializing Diagnostics‚ page 5-3.
2. Select Waste Tube Cleaning - 2000.

601005-0004 Rev. A
Operator’s Guide: Performing Maintenance 5-17

3. Select RUN.
4. When the program is finished initializing, place a sample tube with 3 mL
probe cleaning solution into position 1 of the sample rack.
5. Add 3 mL of probe cleaning solution to compartment A of the probe cleaning
wedge and place the wedge into position 1 of the reagent carousel.
6. Select Press When Sample Tube and Reagent Wedge are Loaded.
7. Allow the program to complete its running cycle.
Approximate time to completion is 20 minutes. Program Complete displays
on the screen.
8. To continue running diagnostics, select Load Program and load the
appropriate diagnostic.
9. To stop running diagnostics, select EXIT, and then select by QUIT.

Cleaning the Waste Tube (IMMULITE 2500 System)

Follow the instructions below to clean the liquid waste tube on the
IMMULITE 2500 system.
1. If necessary, initialize diagnostics.
Refer to Initializing Diagnostics‚ page 5-3.
2. Select IMM 2500 Waste Tube Cleaning.
3. Run the program by selecting RUN at the top of the window.
4. When the program is finished initializing, place a probe cleaning wedge
containing at least 10 mL of the probe wash solution into position 1 of the
reagent carousel.
5. Select Press to Continue.
Remove two reaction tubes from the Tube Hopper.
6. Select Press to Continue.

601005-0004 Rev. A
5-18 Operator’s Guide: Performing Maintenance

7. Load 1 reaction tube into the shuttle.

Figure 5-8 Reaction Tube in Shuttle Position

8. Select Load tube in Shuttle.

The reaction tube is pushed into the shuttle.
9. Repeat steps 7 and 8 for the second tube.
10. Allow the program to complete its running cycle.
Approximate time to completion is 20 minutes. Program Complete displays
on the screen.
11. To continue running diagnostics, select Load Program and load the
appropriate diagnostic.
12. To stop running diagnostics, select EXIT, and then select QUIT.

Performing the Probe Angle Diagnostic

NOTE: Perform this procedure weekly if you are using AutoStart on your
IMMULITE 2000 XPi instrument.
To check the sample probe angles, follow these instructions:
1. Log off the system.
Refer to Logging Off the System‚ page 5-3.
2. Depending on the instrument, perform one of these options:
• For IMMULITE 2000 instruments and IMMULITE 2500 instruments,
initialize diagnostics, and continue with step 3.
Refer to Initializing Diagnostics‚ page 5-3.
• For IMMULITE 2000 XPi instruments, proceed to step 8.
3. At the Windows desktop, double-select the Diagnostics icon.

601005-0004 Rev. A
Operator’s Guide: Performing Maintenance 5-19

4. After the instrument initializes, select Condensed Run Program.

5. Select Home All Motors, and then select RUN.
6. Select Cover Unlock and lift the instrument cover.
7. At the monitor, select Load Program.
8. Select Sample Probe Angle, and then select RUN.
9. To begin, at the monitor, select Press to Dispense Water.
10. Visually check the liquid the sample probe is dispensing.
It should be a straight solid stream. If not, refer to Diagnostic Programs‚
page 6-4.
11. To end the test, at the monitor, select Press to Stop.
12. To close the sample probe angle diagnostic program, select EXIT.
13. To exit Diagnostics, select Quit.

Monthly Maintenance
Maintenance procedures to perform monthly are listed and described below. Refer
to Worksheets‚ page 5-37 for maintenance records that can be copied and used to
keep track of maintenance items.

Checking the Dispense Angle of the Reagent Probe

Follow the instructions below to check the reagent probe dispense angle.
1. If necessary, initialize diagnostics.
Refer to Initializing Diagnostics‚ page 5-3.
2. Select one of the following options:
• Reagent Probe Dispense Angle – 2000
• IMM 2500 Reagent Probe Dispense Angle
• Reagent Probe Dispense Angle – XPi
3. Select RUN.
4. Select the Press to Dispense Water button to begin.
5. Observe the liquid that is dispensed from the reagent probe.
It should be a straight solid stream.
6. Select the Press to End Program button.
7. To continue running diagnostics, select Load Program and load the
appropriate diagnostic.
8. To stop running diagnostics, select EXIT, and then select QUIT.

601005-0004 Rev. A
5-20 Operator’s Guide: Performing Maintenance

IMMULITE 2000/2000 XPi Water TestPM

This feature tests the instrument for alkaline phosphatase contamination. An
updated copy of the IMMULITE 2000, 2500, and 2000 XPi Monthly and
Quarterly Maintenance Record log is included with this document.
Before performing the Water TestPM, follow the instructions below to prepare the
instrument:
1. If necessary, initialize diagnostics.
Refer to Initializing Diagnostics‚ page 5-3.
2. If necessary, prime the substrate probe.
Refer to Priming the Substrate Probe‚ page 5-16.
Follow the instructions below to test the instrument for alkaline phosphatase
contamination:
1. To load the list of diagnostics, select Load Program.
2. At the Diagnostic Program window:
• For the IMMULITE 2000, select WatertestPM – 2000.
• For the IMMULITE 2000 XPi, select WatertestPM – 2000XPi.
3. Select RUN.
The instrument automatically homes all motors.
4. When prompted, place a clean, empty 12 x 75 tube in position 1 of a sample
rack.
5. Place the sample rack in position 1 of the Sample Carousel.
6. After the tube is loaded on the instrument, select Load tube and press to
continue.
7. When prompted, remove the Water Probe from the Wash Station.
8. Place the Water Probe in the tube (from Step 4).
9. Select Place Water Probe in tube 1-1.
10. Select Press to dispense from the Water Probe.
Collecting Water from the Water Probe displays.
NOTE: If the Water Probe touches the water inside the sample tube, wipe the
Water Probe with a lint-free cloth before returning it to the Wash Station.
11. When prompted, remove the Water Probe from the tube and return it to the
Wash Station.
12. Select Replace Water Probe.
The instrument primes the Sample and Reagent Probes, pipettes water, transfers
the reaction tubes to the Luminometer, and dispenses substrate. Subsequently, the
Photomultiplier Tube (PMT) reads the reaction tubes.

601005-0004 Rev. A
Operator’s Guide: Performing Maintenance 5-21

After the instrument reads the tubes, Program Complete displays, and the
instrument generates a report of the results. Table 5-1 is an example report of the
results.
Table 5-1 Example Water TestPM Results for the IMMULITE 2000/2000 XPi
Systems

IMMULITE 2000 (XPi)

WATER TEST PM
mm-dd-yy hh:mm:ss

Serial Number: nnnnnn

Operator:

NOTE: All results have been multiplied by the PMT factor.

Subtract the Substrate Only CPS from the individual water CPS

Sample Probe CPS: xxx.x - (Substrate Only) =

Reagent Probe CPS: xxx.x - (Substrate Only) =

Water probe CPS: xxx.x - (Substrate Only) =

Substrate Only CPS: xxx.x

13. When the instrument finishes generating the report, fill in the operator’s
name.
Using the results, refer to Evaluating Water TestPM Results‚ page 5-24.
14. To continue running diagnostics, select Load Program and load the
appropriate diagnostic.
15. To stop running diagnostics, select EXIT, then select QUIT.

IMMULITE 2500 Water TestPM

This feature tests the instrument for alkaline phosphatase contamination. An
updated copy of the IMMULITE 2000, 2500, and 2000 XPi Monthly and
Quarterly Maintenance Record log is included with this document.
Before performing the Water TestPM, prepare the instrument:
1. If necessary, initialize diagnostics.
Refer to Initializing Diagnostics in the IMMULITE 2000/2500/2000 XPi
Operator’s Guide.

601005-0004 Rev. A
5-22 Operator’s Guide: Performing Maintenance

2. If necessary, prime the substrate probe.

Refer to Priming the Substrate Probe in the IMMULITE 2000/2500/2000 XPi
Operator’s Guide.
Follow the instructions below to test the instrument for alkaline phosphatase
contamination:
1. To load the list of diagnostics, select Load Program.
2. At the Diagnostic Program window, select IMM 2500 WatertestPM.
3. Select RUN.
The instrument automatically homes all motors.
4. When prompted, load a reaction tube into the shuttle.
5. Select the Load tube in Shuttle then press to continue.
Repeat this 6 more times until the prompt and button disappear.
NOTE: Although 7 reaction tubes are loaded on the instrument, only 5 results
generate. The instrument adds water from the wash station to the other 2 tubes
and later discards them.
The Instrument primes the Sample and Reagent probes and distributes water and
substrate as needed. After the incubation completes, the PMT reads the reaction
tubes.
When the process completes, the instrument generates a report of the results.
Table 5-2 on page 5-23 is an example report of the results.

601005-0004 Rev. A
Operator’s Guide: Performing Maintenance 5-23

Table 5-2 Example Water TestPM Results for the IMMULITE 2500 System

IMMULITE 2500

WATER TEST PM
mm-dd-yy hh:mm:ss

Serial Number: nnnnnn

Operator:

NOTE: All results have been multiplied by the PMT factor.

Subtract the Substrate Only CPS from the individual water CPS

Sample Probe CPS: xxx.x - (Substrate Only) =

Reagent Probe CPS: xxx.x - (Substrate Only) =

Water probe1 CPS: xxx.x - (Substrate Only) =

Water probe2 CPS: xxx.x - (Substrate Only) =

Substrate Only CPS: xxx.x

6. When the instrument finishes generating the report, fill in the operator’s
name.
Using the results, refer to Evaluating Water TestPM Results‚ page 5-24.
7. To continue running diagnostics, select Load Program and load the
appropriate diagnostic.
8. To stop running diagnostics, select EXIT, then select QUIT.

601005-0004 Rev. A
5-24 Operator’s Guide: Performing Maintenance

Evaluating Water TestPM Results

This section explains how to evaluate the Water TestPM results.
Table 5-1 on page 5-21 displays an example of a report generated by IMMULITE
2000/2000 XPi systems.
Table 5-2 on page 5-23 displays an example of a report generated by an
IMMULITE 2500 system.
To evaluate an IMMULITE system, do the following:
1. Ensure the CPS measurement for each reaction tube meets the following
criterion appropriate for the system:
• For the IMMULITE 2000/2000 XPi systems, < 1100 CPS
If the Open CPS measurement of any reaction tube is > 1100, the
instrument may be contaminated.
• For the IMMULITE 2500 system, < 1250 CPS
If the Open CPS measurement of any reaction tube is > 1250, the
instrument may be contaminated.
If necessary, repeat the WatertestPM.
2. Enter the Substrate Only CPS value in the first blank on the line for each tube.
3. Subtract the Substrate Only CPS from the individual water CPS.
4. Enter the result in the second blank on the line for each tube.
If the difference between the CPS measurement of each tube and the Substrate
Only CPS measurement is < 200 CPS, the water test passed.

Cleaning the Fan Filter

Follow the instructions below to clean the Fan Filter:
1. Move the monitor out of the way.
2. Open the cover.

601005-0004 Rev. A
Operator’s Guide: Performing Maintenance 5-25

3. Press down on the screw while turning to release the screw.

Figure 5-9 Cleaning the Fan Filter

4. Pull the side door panel open.

The door is held in place magnetically and opens easily.

Figure 5-10 Pulling Open the Side Door Panel

601005-0004 Rev. A
5-26 Operator’s Guide: Performing Maintenance

5. Remove the fan filter guard by unscrewing the top and bottom screws.

Figure 5-11 Removing the Fan Filter Guard

6. Remove the fan filter from the instrument.

NOTE: If necessary, gently move the silver frame of the fan filter to loosen it.

Figure 5-12 Removing the Fan Filter

7. Clean the fan filter by holding it under running water and rubbing gently to
remove the dust.

601005-0004 Rev. A
Operator’s Guide: Performing Maintenance 5-27

NOTE: The fan filter can be vacuumed, instead of running it under water.
8. Blot the fan filter dry and place it back on the instrument.
9. Replace the fan filter guard, using the top and bottom screws.
10. Finger tighten the screw that holds the side door panel in place.

Decontaminating the Clot Detection Transducer

Decontaminate the clot detection transducer following these instructions:
1. If necessary, initialize diagnostics.
Refer to Initializing Diagnostics‚ page 5-3.
2. Select Transducer Decon - 2000, IMM 2500 Transducer Decon, or
Transducer Decon - 2000 XPi
3. Select RUN.
Follow the prompts on the screen. A prompt displays instructing the user to
place a 12 x 75-mm sample tube with 2.5 mL of 0.1 M sodium hydroxide
(NaOH) in position 1.
• Use only NaOH for this procedure.
• When you order this diagnostic, the instrument places the correct rack for
easy access.
4. Place the tube in position 1.

BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Safety
Instructions‚ page A-1 for recommended precautions when working with
biohazardous materials.

5. Select Press to Continue after the tube is in place.

Watch the prompts. The Program Complete prompt indicates when the
program is finished.
6. To continue running diagnostics, select Load Program and load the
appropriate diagnostic.
7. To stop running diagnostics, select EXIT, and then select QUIT.

Decontaminating the Bottles and Lines

Clean the probe wash bottle, water bottle, and lines according to the procedures
below.

601005-0004 Rev. A
5-28 Operator’s Guide: Performing Maintenance

To test for water contamination, refer to one of these topics:

• Water Test Procedure (IMMULITE 2000 System)‚ page 5-32.
• Water Test Procedure (IMMULITE 2500 System)‚ page 5-33.
Obtain the materials needed to decontaminate the bottles and lines:
• Empty beaker
• Decontamination bottles (included with instrument)
• 350 mL of probe wash (prepared 10X dilution) or 0.1M NaOH
• Fresh distilled/de-ionized water

Decontaminating the Bottles

1. Thoroughly rinse the inside the probe wash and water supply bottles with
70% isopropyl alcohol to decontaminate them.
2. Rinse well with distilled/de-ionized water.
3. Let dry until ready to use.
4. Refill water bottle with fresh distilled/de-ionized water.
5. Refill probe wash bottle with freshly prepared probe wash.

Decontaminating the Lines

NOTE: Do not use alcohol to decontaminate water and probe wash lines. Use
alcohol only to clean bottles.
1. If necessary, initialize diagnostics.
Refer to Initializing Diagnostics‚ page 5-3.
2. Select Decontamination - 2000 or IMM 2500 Decontamination, and then
select RUN.
A prompt instructs the user to run Home All Motors before proceeding.
3. Select Read Alert Message. Click to Continue.
A prompt displays:
Place the water probe into the reagent pipettor
drain.
4. Depending on the instrument, do one of the following:

WARNING
Do not lift the water probe unless you are standing away from the reagent pipettor
drain. The reagent pipettor automatically moves away from the reagent pipettor
drain when the water probe is lifted.

a. For the IMMULITE 2000 systems, remove the water probe.

601005-0004 Rev. A
Operator’s Guide: Performing Maintenance 5-29

b. For the IMMULITE 2500 system, remove two reaction tubes from the
tube hopper and place them in front of the shuttle.
5. After the water probe is removed from the bead/tube wash station, the
following prompt is displayed:
Disconnect water and probe wash lines. Place them
into an empty beaker. Press button when ready.
NOTE: For detailed instructions on disconnecting the probe wash and water
bottles, Disconnecting and Reconnecting Water and Probe Wash Bottles‚
page 5-8.
6. Complete the prompt instructions and select the Press to Continue button.
The pumps will be emptied.
7. When prompted, connect the water and probe wash lines to the
decontamination bottle containing 350 mL of prepared probe wash.
NOTE: 0.1M NaOH may be used.
8. Select Press to Continue.
Probe wash will be pumped through the lines. The following prompt displays:
Disconnect water and probe wash lines. Place them
into an empty beaker. Press button when ready.
9. Complete the prompt instructions and select Press to Continue.
The pumps will be emptied and the following prompt displays:
Please connect the Water and Probe Wash lines to the
bottles. Press button when ready.
10. Follow the instructions and then select Press to Continue.
The system primes the water and probe wash into the lines.
11. Select Replace Water Probe when prompted.
12. To continue running diagnostics, select Load Program and load the
appropriate diagnostic.
13. To stop running diagnostics, select EXIT, followed by QUIT.
14. Close the front cabinet doors.

Quarterly Maintenance
Replacing the CO2 Scrubber
Replace the CO2 scrubber quarterly (every three months), following the
instructions below. Blockage of the CO2 scrubber may affect the dispense of
substrate from the reservoir. The location of the scrubber may vary from the figure
below.

601005-0004 Rev. A
5-30 Operator’s Guide: Performing Maintenance

Refer to Worksheets‚ page 5-37 for maintenance records that can be copied and
used to keep track of maintenance items.
1. Remove the old CO2 scrubber by pulling the tube away from the holding clips.
2. Write the date on the new CO2 scrubber.
3. Take the clear plastic end off the new CO2 scrubber, connect it to its tubing
and insert it into the tube into the holding clips.
NOTE: To maintain proper airflow and to reduce the chance of developing an
obstruction, the bottom end of the CO2 scrubber tube must not touch the load
scale plate.

Figure 5-13 Substrate Reservoir and CO2 Scrubber

As Needed Maintenance
Cleaning the Monitor
Clean the monitor as needed:
1. Turn off the monitor.
2. Wipe the monitor with a damp cloth.

Cleaning the Trackball

Follow the instructions below to clean the trackball:
1. Remove the trackball by grasping it and pulling it straight up.

601005-0004 Rev. A
Operator’s Guide: Performing Maintenance 5-31

2. Clean the ball using a 70% isopropyl alcohol solution.

3. Dry the trackball with a lint-free wipe and place it back in the holder.

Maintaining the Sample Racks

Follow these instructions to clean the sample racks:
1. Clean the sample racks with warm soapy water.
2. Rinse the sample racks thoroughly before using.
3. Ensure the barcode labels are not cracked or peeling.

Replacing Sample Rack Labels

When you have to replace a sample rack barcode label, ensure that you use the
correct label type for the sample rack.
• Standard sample racks use barcode labels that display uppercase letters.
• Tube top sample racks use barcode labels that display lowercase letters.

Water System Routine Maintenance

The routine maintenance required for the instrument water system consists of
flushing. The water system is self-contained and has no operator serviceable parts.
NOTE: This procedure is only applicable to instruments that have the optional
Direct Water Feed option installed.
Minimal daily use of the IMMULITE 2000 systems and IMMULITE 2500
system, running 300 tests per day or more, will aid in preventing contamination of
the system with alkaline phosphatase producing organisms. Flushing of the water
system will eliminate most contamination.
The water system needs to be flushed if:
• The instrument has not been run for 48 hours or more.
• Less than 300 tests per day have been performed.

Flushing Procedure
1. Open the left front door, and lift the water bottle off its load cell.
2. Disconnect the inlet and outlet tubings at the quick disconnect fittings.
3. Unplug the sensor wires leading to the float switch at the quick disconnect.
4. Unscrew the large, white cap from the water bottle.
5. Pour the water from the water bottle into a sink or drain.
6. Place the empty bottle back on the water load cell and allow the bottle to
automatically refill.
7. Repeat steps 5 and 6 two times.

601005-0004 Rev. A
5-32 Operator’s Guide: Performing Maintenance

8. Reconnect the cleaned water bottle to the tubings and sensor wires.
NOTE: Assure the electrical connector is dry before reconnecting.
9. Return the bottle to the instrument and allow the water system to refill with
water.

Water Test Procedure (IMMULITE 2000 System)

Follow the instructions below to test the water for alkaline phosphatase
contamination.
1. If necessary, initialize diagnostics.
Refer to Initializing Diagnostics‚ page 5-3.
2. Select Cover Unlock – 2000.
3. Select RUN.
The cover unlocks.
4. Lift the cover.
5. Select Load Program to load the list of diagnostics.
6. Select SUBSTRATE PRIME - 2000.
7. Select RUN.
8. Remove the probe when prompted.
9. Hold the probe over a clean beaker or other external container and select
Press to Prime.
The substrate will begin to prime.
10. When a clean, straight stream is dispensed, select Press to stop priming.
11. Replace the probe when prompted.
12. Select Load Program to return to the Diagnostic Program screen.
13. Select WATERTEST - 2000.
14. Select RUN.
15. Select Press to Start Initialization.
16. At the next prompt, pipette 50 µl of water into the first of two reaction tubes.
NOTE: The procedure requires manually pipetting 50 µL water (from the
water source) into a reaction tube and loading the tube on the tube processor
shuttle. No bead is required in this tube.
17. Place the tube into the shuttle.
18. Select Load tube in shuttle.

601005-0004 Rev. A
Operator’s Guide: Performing Maintenance 5-33

19. Place an empty reaction tube into the shuttle and select Load tube into
shuttle.
The following messages display:
Loading tube in luminometer
Adding Substrate
Starting a 5 minute substrate incubation
Reading tubes at PMT
20. After 5 minutes, when prompted, select the Test complete press to stop
button to stop the diagnostic and generate a printout.
The Water Test procedure calculates results using the PMT factor. Table 5-3 on
page 5-34 displays an example of a report generated by IMMULITE 2000/2500/
2000 XPi systems.

Water Test Procedure (IMMULITE 2500 System)

Follow the instructions below to test the water for alkaline phosphatase
contamination.
1. If necessary, initialize diagnostics.
Refer to Initializing Diagnostics‚ page 5-3.
2. Select IMM 2500 Cover Unlock.
3. Select RUN.
The cover unlocks.
4. Lift the cover.
5. Select Load Program to load the list of diagnostics.
6. Select IMM 2500 SUBSTRATE PRIME.
7. Select RUN.
8. Remove the probe when prompted.
9. Hold the probe over a clean beaker or other external container and select
Press to Start Priming.
The substrate will begin to prime.
10. When a clean, straight stream is dispensed, select Press to Stop Priming.
11. Replace the probe when prompted.
12. Select Load Program to return to the Diagnostic Program screen.
13. Select IMM 2500 WATERTEST.
14. Select RUN.
15. At the next prompt, pipette 50 µL of water into the first of two reaction tubes.

601005-0004 Rev. A
5-34 Operator’s Guide: Performing Maintenance

NOTE: The procedure requires manually pipetting 50 µL water (from the

water source) into a reaction tube and loading the tube on the tube processor
shuttle. No bead is required in this tube.
16. Place the tube into the shuttle.
17. Select Load tube in shuttle.
18. Place an empty reaction tube into the shuttle and select the Load Tube button.
The following messages display:
Transferring to Luminometer
Dispensing Substrate
Program Running
19. When the process is complete, a printout is generated.
Table 5-3 on page 5-34 displays an example of a report generated by
IMMULITE 2000/2500/2000 XPi systems.

Evaluating WATERTEST Results

Table 5-3 Example Water Test Results for the
IMMULITE 2000/2500/2000 XPi systems

IMMULITE (2000) (2500) (2000 XPi)

WATER TEST
mm-dd-yy hh:mm:ss

Serial Number: nnnnnn

Operator:

NOTE: All results have been multiplied by the PMT factor.

Subtract the Substrate Only CPS from the Source Water CPS

Source Water CPS: xxx.x - (Substrate Only) =

Substrate Only CPS: xxx.x

This section explains how to evaluate the Water Test results.

Table 5-3 on page 5-34 displays an example of a report generated by
IMMULITE 2000/2500/2000 XPi systems.
To evaluate the water test results, do the following:
1. Ensure the CPS measurement for each reaction tube meets the criterion
appropriate for the system:

601005-0004 Rev. A
Operator’s Guide: Performing Maintenance 5-35

• For the IMMULITE 2000/2000 XPi systems, < 1100 CPS

If the Open CPS measurement of any reaction tube is > 1100, the source
water may be contaminated.
• For the IMMULITE 2500 system, < 1250 CPS
If the Open CPS measurement of any reaction tube is > 1250, the source
water may be contaminated.
If necessary, repeat the Water Test Procedure.
2. Enter the Substrate Only CPS value in the first blank on the line for the
Source Water.
3. Subtract the Substrate Only CPS from the Source Water CPS.
4. Enter the result in the second blank on the line.
If the difference between the CPS measurement of the source water and the
Substrate Only CPS measurement is < 200 CPS, the water test passed.

AutoStart Maintenance (IMMULITE 2000 XPi System)

Starts the following routine maintenance tasks automatically:
• Restarts the computer.
This is only when the instrument is running for more than 24 hours.
• Runs probe clean routine.
• Primes instrument water and wash stations.
If any of the following conditions are true, the instrument continues with the
maintenance procedures:
• The Auto Substrate Dispense routine is successful.
• The instrument has been running continuously.
• You manually dispensed substrate in the last 2 hours.
As long as the Substrate Dispense procedure is performed within 2 hours of
AutoStart maintenance.
• Starts and initializes instrument.
• Runs scheduled control samples (optional).
The instrument must be in STOP mode or logged off for processing to begin.
NOTE: The substrate must be manually primed or programmed for auto dispense
to run the QC Worklist. To access information about scheduling controls, refer to
Scheduling a QC Worklist‚ page 4-14.

AutoStart Configuration
The AutoStart Configuration screen allows you to schedule automated
maintenance procedures by day and time, and enable or disable automatic
substrate dispensing. Refer to AutoStart Configuration Screen‚ page 8-22.

601005-0004 Rev. A
5-36 Operator’s Guide: Performing Maintenance

Manual AutoStart
Use the manual AutoStart feature to begin processing routine tasks when the
instrument is in STOP mode or logged off.
You can use the AutoStart button at the Startup screen or Menu screen:
1. Load probe clean on the instrument and ensure the consumables are full.
2. Load control materials, optional, on the instrument.
3. Prime the substrate probe.
4. At the Startup screen or Menu screen, select Run AutoStart.

AutoStart Countdown
Five minutes before an AutoStart is scheduled, the AutoStart Countdown window
displays a countdown of time remaining before the instrument automatically
begins processing.
You can allow the countdown to proceed or select one of the following options:
• To begin processing immediately, select Start Now.
• To stop the instrument from automatically processing, select Cancel.

AutoStart Monitor
The AutoStart Monitor window displays after the instrument begins processing
automatically. A progress bar allows you to see the status and the specific task
currently running.
NOTE: Selecting Abort may not stop the procedure. The AutoStart procedure
may be at a point in the procedure where it must continue to the end.
Select Abort to discontinue automatic processing.

601005-0004 Rev. A
Operator’s Guide: Performing Maintenance 5-37

Worksheets
This section includes the following worksheets:
• IMMULITE 2000 systems and IMMULITE 2500 system Adjustment Log
• IMMULITE 2000 systems and IMMULITE 2500 system Daily and Weekly
Maintenance Record
• IMMULITE 2000 systems and IMMULITE 2500 system Monthly and
Quarterly Record
These items can be copied and used as needed.

601005-0004 Rev. A
5-38 Operator’s Guide: Performing Maintenance

IMMULITE 2000 Systems and IMMULITE 2500 System

Adjustment Log

601005-0004 Rev. A
Operator’s Guide: Performing Maintenance 5-39

601005-0004 Rev. A
5-40 Operator’s Guide: Performing Maintenance

601005-0004 Rev. A
 IMMULITE 2000/2500/2000 XPi
Monthly & Quarterly Maintenance Record
Serial #_______________

Monthly and Quarterly maintenance for the year beginning ___________ , ______ to the year ending ___________ , ______
Operator’s Guide: Performing Maintenance

month year month year

Monthly Maintenance List JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC
Clean Water Bottle and Probe Wash bottle
Decontaminate the Lines
Transducer Decontamination
Reagent Probe Angle
Clean the Fan Filter
Water TestPM
Operator Initials

Supervisor Initials

Quarterly Maintenance List Replacement Replacement Replacement Replacement

Date 1 Date 2 Date 3 Date 4
Replace CO2 Scrubber
Operator Initials
Supervisor Initials
5-41

601005-0004 Rev. A
5-42 Operator’s Guide: Performing Maintenance

601005-0004 Rev. A
Operator’s Guide: Identifying Instrument Problems

6 Identifying Instrument Problems

Viewing the Error Report Screen . . . . . . . . . . . . . . . . . . . 6-1

Viewing the Error/Event Logs. . . . . . . . . . . . . . . . . . . . . . 6-2
Viewing the Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Day Error Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Viewing Instrument Temperatures . . . . . . . . . . . . . . . . . . . . . . . 6-3
Diagnostic Programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Diagnostic Program Descriptions . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Electrical Power Loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Probe Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Waste Chute Clean Out Tool . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
Detecting and Correcting Clots . . . . . . . . . . . . . . . . . . . 6-10
System Clot Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
Sample Clots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-10
Clinging Clots. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-11
Handling Clots on the IMMULITE 2000 System and the
IMMULITE 2500 System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Gel Clots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-11
Hanging Clots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-12
Air in the Clot Detection Transducer . . . . . . . . . . . . . . . . . . . . . . . .6-12
Handling Clots on the IMMULITE 2000 XPi System. . . . . . . . . 6-13
Gel Clots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-13
Hanging Clots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-13
Air in the Clot Detection Transducer . . . . . . . . . . . . . . . . . . . . . . . .6-13
Quick Reference Assay Troubleshooting Guide . . . . . 6-14
Troubleshooting Controls Post Adjustment . . . . . . . . . . . . . . . . . . .6-15

601005-0004 Rev. A
 Operator’s Guide: Identifying Instrument Problems

601005-0004 Rev. A
Identifying Instrument Problems

Instrument troubleshooting uses the following screens:

• Error Report screen
• View Event Log screen
• Day Error Log screen
• Temperature screen
This section also includes the list diagnostic programs. Refer to Viewing the
Adjustment Log‚ page 2-40 for procedures on viewing the adjustment log, beads
and reagents on board, and allergens on board. For information on exporting data,
refer to Data Management‚ page 7-1.
NOTE: When the instrument detects a jam, the instrument software program may
be minimized. If this occurs, select the close button (x) to exit the instrument
software. Relaunch the program by double-selecting the IMMULITE 2000 icon or
the IMMULITE 2500 icon from the Windows desktop. Select View Event Log to
determine the cause of the jam.

Viewing the Error Report Screen

The Error Report screen lists the current system errors. It displays automatically
when the instrument detects an error.
NOTE: You can move the scroll bar to the right to view the end of a long error
message.
The buttons on the Error Report screen are described in the table:
Button Function
Help Provides help for correcting the problem that
caused the error.
Sound On When Sound On is selected, the system will beep
Sound Off when the Error screen displays. The button changes
to Sound Off.
When Sound Off is selected, the system will not
beep when the Error screen displays. The button
changes to Sound On.
Close Closes the Error screen.
Print Errors Prints the current errors.

601005-0004 Rev. A
6-2 Operator’s Guide: Identifying Instrument Problems

Viewing the Error/Event Logs

There are two Error Log screens:
• View Event Log
• Day Error Log

Viewing the Event Log

The View Event Log screen provides an event and error history, recording the
error messages from the past 90 days. Follow the instructions below to view the
event log. For more information about reading the error log and the error
messages that may display, refer to Appendix E.
NOTE: If tests are in progress, they will be lost when STOP is selected.
1. Select STOP.
A warning message displays to confirm the stopping of the instrument.
2. Select Log Off.
3. Select OK.
4. Select CONTINUE.
5. The system logs off and the Startup screen displays.
6. Select View Event Log.
7. Under TIME RANGE, select Whole Event Log to view the entire error
history or select Selected Time Range to specify a date and time.
NOTE: Error messages are stored for 90 days.
If you select Selected Time Range, do the following:
a. Select the Start Date field, and then select a date from the calendar.
b. Select the Start Time field, and then select a time from the clock.
c. Select the End Date field, and then select a date from the calendar.
d. Select the End Time field, and then select a time from the clock.
8. Under ERRORS, select All Error Types to view all errors or Selected Range
to view specific errors, for example, only pipettor tip jam errors.
If you select Selected Range, enter the displayed event numbers for the
errors in the From and To windows.
9. Under SEVERITY, select All Severity Levels to view all errors or Selected
Levels to view only a certain level of error.
If you select Selected Levels, select the WARNINGS, ERRORS, or SEVERE
ERRORS button.

NOTE: More than one button can be selected. Severe errors are errors that
affect test results or interrupt instrument operation.

601005-0004 Rev. A
Operator’s Guide: Identifying Instrument Problems 6-3

10. Sort the errors by either Date And Time or Event Number by clicking the
appropriate option under Sort Order.
11. Select SEARCH.
The View Event Log screen displays listing the errors that meet the criteria
selected on the View Event Log Specification screen.
12. Select the Previous Page, Next Page, Home, and End buttons to scroll
through the event messages.
NOTE: This log may be hundreds of pages long; selecting the Print Error
Log button will print every page. Before printing, refine the search and print
only the relevant events.
13. Select Print Error Log to print the Error Log.
14. Select CLOSE.

Day Error Log

The Day Error Log screen displays the error messages for the current day only.
Follow these instructions to view the Day Error Log.

For IMMULITE 2000 System or IMMULITE 2500 System

1. From the instrument drop-down menu, select Tools.
2. Select View Day Error Log, and proceed to step 2 in the next section.

For IMMULITE 2000 XPi System

1. At the instrument window, select MENU and Day Error Log.
2. Use the Previous Page and Next Page buttons to page through the errors.
NOTE: Select the Home and End buttons to move to the beginning and end
of the error list respectively.
3. Select CLOSE.

Viewing Instrument Temperatures

Follow the instructions below to view the current instrument temperatures and the
humidity level.

For IMMULITE 2000 System or IMMULITE 2500 System

1. From the instrument drop-down menu, select Tools.
2. Select View Temperature, and proceed to step 2 in the next section.

601005-0004 Rev. A
6-4 Operator’s Guide: Identifying Instrument Problems

For IMMULITE 2000 XPi System

1. At the instrument window, select MENU and Temperatures.
The Temperatures and Humidity screen displays.
2. Select PRINT or CANCEL.

Diagnostic Programs
Diagnostic programs are used to diagnose or correct system problems. After
loading a program, instructions display which are specific to that program.
For information about initializing the diagnostic software, refer to Initializing
Diagnostics‚ page 5-3.
NOTE: Diagnostics can not be run if the instrument software is running. If
necessary, log off of the instrument software before proceeding. Refer to Logging
Off the System‚ page 5-3.

601005-0004 Rev. A
Operator’s Guide: Identifying Instrument Problems 6-5

Diagnostic Program Descriptions

The diagnostic programs are listed and described in the table below.
NOTE: Diagnostic programs have different names on the IMMULITE 2000
systems and IMMULITE 2500 system.
• For the IMMULITE 2000 systems, each diagnostic name ends with – 2000.
• For the IMMULITE 2500 system, each diagnostic name begins with
IMM2500.
Program Name Description
Substrate & Water Primes the substrate and water probe.
Prime NOTE: The program includes prompts to remove the
substrate and water probes from the bead/tube wash station
before each is primed.
SUBSTRATE PRIME Primes the substrate probe.
NOTE: The substrate probe must be removed from the bead/
tube wash station before priming.
Transducer Decon

BIOHAZARD:
Wear personal protective equipment. Use universal
precautions. Refer to Safety Instructions‚ page A-1 for
recommended precautions when working with biohazardous
materials.
In its solid form, sodium hydroxide is caustic. when using a
sodium hydroxide solution, avoid contact with skin or
clothing. With either the solid or the solution, take
customary laboratory precautions.
Decontaminates the clot detection mechanism using 0.1M
NaOH in a 12 x 75-mm sample tube. After loading
Transducer Decon, follow the instructions on the screen.
NOTE: A prompt displays instructing the operator to place a
12 x 75-mm sample tube with 2.5 mL of 0.1 M sodium
hydroxide (NaOH) in position 1.
Tube Chute Test Tests the sensors in the exit tube chute.
Waste Tube Cleaning Takes probe cleaning solution from the sample carousel and
reagent wedge and cleans the waste tube from the wash/spin
station. Part of weekly maintenance.
Refer to Weekly Maintenance‚ page 5-16.
Water Probe Prime Primes the water probe.
NOTE: The water probe must be removed from the bead/
tube wash station before priming.

601005-0004 Rev. A
6-6 Operator’s Guide: Identifying Instrument Problems

Program Name Description

WATERTEST NOTE: WATERTEST uses two reaction tubes.
Used to test the water for alkaline phosphatase
contamination. After loading WATERTEST, follow the
on-screen instructions. For detailed instructions (including
how to evaluate the results).
Refer to Water Test Procedure (IMMULITE 2000 System)‚
page 5-32 or Water Test Procedure (IMMULITE 2500
System)‚ page 5-33.

Electrical Power Loss

NOTE: The Uninterruptible Power Supply (UPS) battery backup unit is optional
for customers outside the U.S.
The instrument is equipped with a UPS battery backup unit and will continue
operation for a limited time after loss of power. The duration of battery backup for
a fully charged UPS is approximately 30 minutes.
It is recommended that the operator stop the run as soon as possible and then
power off the instrument. This allows the system to shut down safely and avoids
possible damage to the database that may occur if the battery backup is allowed to
completely discharge. Turning the power off will also avoid a possible surge when
the main power returns.
NOTE: Although the instrument will continue to operate on battery power for a
limited time after the loss of power, no new tests should be put on the instrument.
In the event of an unexpected loss of electrical power, perform the following steps
as soon as possible:
1. Restart the computer.
Refer to Restarting the Computer‚ page 5-6.
2. Depending on the amount of time before power is restored, note the
following:
• For up to one hour of power loss, the instrument will need about one hour
to re-stabilize all temperatures.
• For 6 to 12 hours of power loss, the instrument will need two or more
hours to stabilize temperatures and humidity levels.
• If you anticipate 12 to 24 hours of power loss, remove and refrigerate all
reagent wedges.
• For 24 hours of power loss or more, remove the bead packs and protect
them against adverse humidity levels.

601005-0004 Rev. A
Operator’s Guide: Identifying Instrument Problems 6-7

Probe Replacement

BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Safety
Instructions‚ page A-1 for recommended precautions when working with
biohazardous materials.

If a probe fails the probe angle test, replace the probe following the instructions
below.
1. Remove the probe tube retaining clip from the reagent/sample arm column.
2. Unscrew the probe from the arm mount, and remove the probe from the arm.
3. Unscrew the black probe extension from the manifold block, turning both the
entire probe and extension piece together.
4. Unscrew the probe extension from the probe.
The extension piece will be reused to mount the new probe.
5. Properly discard the old probe.
6. Attach the probe extension to the fitting of the new probe.
a. Hold the probe fitting secure with a 5/16” wrench while turning the
extension only.
b. Ensure a secure fit.
7. Attach the probe extension to the manifold block by turning both the entire
probe and the extension piece together.
NOTE: Take care to prevent twisting or kinking the probe tubing.
8. Insert the probe into the arm mount and tighten securely.
9. Verify the tubing is on the left side of the sample/reagent arm.

601005-0004 Rev. A
6-8 Operator’s Guide: Identifying Instrument Problems

10. Attach the probe tubing to the inside of the retaining clip on the reagent/
sample arm.

1 Probe extension
2 Probe fitting
3 Retaining clip
4 Arm mount
5 Probe arm
6 Probe

Figure 6-1 Probe in Arm Mount

11. Secure the probe tubing with the retaining clip.

12. Properly prime all air from the new probe.

601005-0004 Rev. A
Operator’s Guide: Identifying Instrument Problems 6-9

Waste Chute Clean Out Tool

Follow the instructions below to safely clear a solid waste chute jam. This
procedure requires the waste chute clean out tool (Part Number 400918).

BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Safety
Instructions‚ page A-1 for recommended precautions when working with
biohazardous materials.

1. Put the instrument in Stop mode and open the instrument top cover and the
front panel doors.

CAUTION
Do not insert the waste chute clean out tool into the top of the waste chute.
Inserting the waste chute clean out tool into the top of the waste chute may
damage the instrument.

2. Remove the solid waste container and check to see if it is full.

WARNING
Do not replace the red biohazard bag improperly or place the solid waste container
in backward. Replacing the bag improperly or putting the solid waste container in
backwards can cause the solid waste to back up in the waste chute. Use care in
replacing the biohazard bag and solid waste container.

3. Place a shallow container or an absorbent cloth over the solid waste load
scale, toward the back wall.
This will protect the load scale and catch any reaction tubes. It also prevents
falling beads from rolling under the load scale.
4. Locate the waste chute opening in the upper left-hand corner of the solid
waste container area.
5. Insert the waste chute clean out tool or flexible tubing such as Tygon
(approximately 15 inches in length and ¾ inch in diameter) into the waste
chute opening from the bottom.
6. Dislodge the jam by using repeated short up and down movements.
7. Remove the tool.
The jammed reaction tubes and beads will fall onto the shallow container or
absorbent pad.

601005-0004 Rev. A
6-10 Operator’s Guide: Identifying Instrument Problems

Located on top of the instrument behind the wash spin station is the waste
chute cover.
8. Remove the waste chute cover.
9. Using a flashlight, look into the opening for the presence of reaction tubes.
None should be visible.
10. If tubes are present, manually remove them.
11. To make sure that the blockage was removed, drop an empty reaction tube
marked with an x down the solid waste chute.
The marked reaction tube should travel freely down the chute to the tray or
cloth in the solid waste container area.
12. If the marked reaction tube does not drop through, repeat steps, as necessary.

Detecting and Correcting Clots

System Clot Detection
The system differentiates between two types of clots: sample clots and clinging
clots.

Sample Clots
Sample clots occur when the clot remains in the sample. The system successfully
draws a slug of air after the clot is detected, indicating the pipettor is not
obstructed.
1. Select WORKLIST.
2. Select Display/Edit.
The Display Worklist window displays sample errors.
3. Locate the clotted sample on the worklist.
Sample Error displays in the status column.
4. Remove the sample rack from the instrument.
For the IMMULITE 2000 system or the IMMULITE 2500 system, perform
the following steps:
a. Open the sample access door.
The system enters SAMPLE PAUSE mode.
b. Select the rack letter where the clotted sample is located.
The rack moves to the front.
c. Remove the rack.
For the IMMULITE 2000 XPi system, eject the rack using the rack loader.
5. Remove the sample rack from the instrument.

601005-0004 Rev. A
Operator’s Guide: Identifying Instrument Problems 6-11

6. Remove the clotted sample and return the sample rack.

For the IMMULITE 2000 Instrument or the IMMULITE 2500 Instrument

1. Close the rack loader door.
2. Press RUN to resume instrument operation.

Clinging Clots
A clinging clot occurs when the clot is stuck to the sample pipettor. The system is
unsuccessful when it draws a slug of air, indicating the pipettor is obstructed. No
additional samples are pipetted until the clot is removed.
Three possibilities can be observed:
• Gel clot
The pipettor entered the gel in a gel separator tube.
• Hanging clot
A clot is hanging on the end of the pipettor.
• Air in the system
Air is present in the clot detection module.

Handling Clots on the IMMULITE 2000 System and the

IMMULITE 2500 System
Gel Clots
1. Select PAUSE.
The system enters PAUSE mode.
2. Select COVER to open the instrument cover.
3. Visually inspect the probe.
4. Replace the probe if it entered the gel barrier of a tube.
Refer to Probe Replacement‚ page 6-7 for more information.
5. Select PRIME to prime the DRDs.
6. Locate and remove the clotted sample.
7. Close the cover.
8. Select RUN.

601005-0004 Rev. A
6-12 Operator’s Guide: Identifying Instrument Problems

Hanging Clots
Follow these steps to remove a hanging clot.

CAUTION
Do not insert anything into the probe. Permanent damage may occur.

1. Select CLOSE on the red error message box.

2. Select PAUSE.
The system enters PAUSE mode.
3. Select COVER to open the instrument cover.
4. Visually inspect the probe.
5. Use a lint-free wipe to remove the clot with a downward wiping motion.
6. Select PRIME to prime the DRDs.
7. Locate and remove the sample.
8. Close the instrument cover.
9. Select RUN to resume instrument operation.

Air in the Clot Detection Transducer

Follow these steps to remove air from the clot detection module.
1. Select PAUSE.
The system enters PAUSE mode.
2. Select COVER to open the instrument cover.
3. Visually inspect the probe.
4. Allow the samples in progress to complete.
5. Select STOP.
6. Select PRIME to prime the DRDs.
7. Log off of the instrument.
8. Initialize diagnostics.
Refer to Initializing Diagnostics‚ page 5-3.
9. Select Clot Prime diagnostic.
10. Allow the diagnostic to run for several minutes to ensure that all of the air is
eliminated.

601005-0004 Rev. A
Operator’s Guide: Identifying Instrument Problems 6-13

Handling Clots on the IMMULITE 2000 XPi System

Gel Clots
1. Open the pipettor cover.
The instrument enters SAMPLE PAUSE mode.
2. Visually inspect the probe.
3. Replace the probe if it entered the gel barrier of a tube.
Refer to Probe Replacement‚ page 6-7 for more information.
4. Close the pipettor cover.
5. Select PRIME to prime the DRDs.
6. Locate and remove the clotted sample.
7. Select RUN.

Hanging Clots
Follow these steps to remove a hanging clot.

CAUTION
Do not insert anything into the probe. Permanent damage may occur.

1. Select CLOSE on the red error message box.

2. Open the pipettor cover.
The instrument enters SAMPLE PAUSE mode.
3. Visually inspect the probe.
4. Use a lint-free wipe to remove the clot with a downward wiping motion.
5. Close the pipettor cover.
6. Select PRIME to prime the DRDs.
7. Locate and remove the sample.
8. Close the pipettor cover.
9. Select RUN to resume instrument operation.

Air in the Clot Detection Transducer

Follow these steps to remove air from the clot detection module.
1. Open the pipettor cover.
The instrument enters SAMPLE PAUSE mode.
2. Visually inspect the probe.

601005-0004 Rev. A
6-14 Operator’s Guide: Identifying Instrument Problems

3. Allow the samples in progress to complete.

4. Select STOP.
5. Select PRIME to prime the DRDs.
6. Log off of the instrument.
7. Initialize diagnostics.
Refer to Initializing Diagnostics‚ page 5-3.
8. Select Clot Prime diagnostic.
9. Allow the diagnostic to run for several minutes to ensure that all of the air is
eliminated.

Quick Reference Assay Troubleshooting Guide

These tables may be used as a helpful guide when investigating unusual results.
NOTE: Factors such as instrument maintenance and onboard consumables will
affect results if not properly maintained.

Sandwich Assays

Condition Expected Result

No Bead Error or < lower assay limit
No Sample < lower assay limit
No Reagent Error; < assay limit; Extremely low results
No Substrate Error and CPS will be < 100 CPS

Competitive Assays

Condition Expected Result

No Bead Error
No Sample < Lower assay limit
No Reagent Error; > Upper assay limit
No Substrate Error; CPS will be < 100 CPS

601005-0004 Rev. A
Operator’s Guide: Identifying Instrument Problems 6-15

Pre-Treated Assays

Condition Expected Result

No Bead Error
No Sample < Lower assay limit
No Reagent (1) Pretreatment < Lower assay limit
No Reagent (2) Error; > upper assay limit
No Substrate Error; CPS will be < 100 CPS

Troubleshooting Controls Post Adjustment

Recommended
Controls Slope Intercept Troubleshooting
Exceed acceptable > 10% previous Exceeds limit Adjustors
limits adjustment or
outside slope range
Within acceptable limits > 10% previous Exceeds limit Reagent wedge
adjustment or
outside slope range
Exceed acceptable Within 10% of Within limits Controls
limits or biased previous
compared to historical adjustment or
performance within slope range

601005-0004 Rev. A
6-16 Operator’s Guide: Identifying Instrument Problems

601005-0004 Rev. A
Operator’s Guide: Data Management

7 Data Management

Exporting Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Saving Files to CD or DVD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Saving Files to a USB Storage Device . . . . . . . . . . . . . . . . . . . . 7-3
Viewing Results and Sending Data to the LIS . . . . . . . . . . . . . . 7-4
Restarting the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5

601005-0004 Rev. A
 Operator’s Guide: Data Management

601005-0004 Rev. A
Data Management

Exporting Data
Export data when troubleshooting a problem:
• Data resulted during a specific time period
• A particular type of data, such as patient or adjustor
• Data for a particular test
Follow the instructions below to export data.

For IMMULITE 2000 System or IMMULITE 2500 System

1. From the instrument drop-down menu, select Tools.
2. Select Export Data, and proceed to step 2 in the next section.

For IMMULITE 2000 XPi System

1. At the instrument window, select MENU and Export Data.
2. In the START panel:
a. Select the Date field and select the start date from the calendar.
b. Select the Time field and select the start time from the clock.
3. In the END panel:
a. Select the Date field and select the end date from the calendar.
b. Select the Time field and select the end time from the clock.
4. In the Data panel, select the data type, Patient, Adjustor, Control, or Verifier,
or select All to export all data types.
5. Under Test Type, select the test type or select ALL to export all test types.
6. Under Export Method, select one of these options:
• Screen to view the selected data on the screen.
• File to export the selected data to a file.
• Printer to print the selected data.
7. If File was selected as the Export Method, the Save As window displays:
a. Select the Save in: dropdown menu to display all available directories.
You can also select Desktop if you are going to save the file to a CD or
DVD.
b. Select the directory to store the file.
NOTE: The scroll bar may be needed to view all the directories and files.

601005-0004 Rev. A
7-2 Operator’s Guide: Data Management

c. Type a name in the Filename field, and then select the Save button.
The Save As window closes and the file name displays under File
Information.
d. At the Field Delimiter prompt, select a delimiter:
• Select Tab to separate the data with tabs.
• Select Comma to separate the data with commas.
NOTE: Formatting a floppy disk erases any information stored on the disk.
8. Select the PERFORM EXPORT button to export the data.
NOTE: The error message “Error writing export file, disk full. Please refer to
the operator’s manual” may occur during export. This indicates that the
floppy disk has run out of sufficient space to complete the operation. Try the
export again with a new, unused floppy disk or reformat the current disk.

Saving Files to CD or DVD

Follow these steps to save data files to a CD or DVD using the CD/DVD burner.
NOTE: The CD/DVD burner is not available on all instruments.
1. Export the necessary data to the desktop.
Refer to Exporting Data‚ page 7-1.
NOTE: The instrument must be logged off before using this software.
2. Log off the instrument.
3. Double-select the Nero StartSmart icon on the Windows desktop.
The Nero window displays.
4. Depending on the disc format in use, select CD or DVD, from the upper right
corner.
5. Select Data, and then select Make Data Disc.
The Disc Content window displays.
6. Select the Add button to select the files to burn to disc.
7. Select the appropriate file(s) to add to the disc.
8. Select Add.
9. Continue to select and add files as necessary.
10. Select the Finished button after adding files.
The Disc Content window displays listing the files to be written to disc.
11. Confirm all appropriate files are listed.
12. Select Next.
The Final Burn Settings window displays.

601005-0004 Rev. A
Operator’s Guide: Data Management 7-3

13. Enter the name of the disc in the Disc name field.
14. Set the Writing speed to 48x (7,200 KB/s).
15. Select the Number of copies to burn.
16. Select More.
The Final Burn Settings window expands to display more options.
NOTE: Do not select the Allow files to be added later (multisession disc)
field.
17. Select the Finalize Disc checkbox.
No additional data can be written to the disc after it is finalized.
18. Insert a blank CD/DVD into the burner.
19. From the Final Burn Settings window, select the Burn button.
After the burn process begins, a status window displays.
20. At the status window, follow these steps:
a. Select Burn new CD using Nero StartSmart.
b. Check the Always do the selected action box.
c. Select the OK button.
21. From the Burn Process window, select Next.
22. Remove the CD/DVD from the burner.
23. Select Exit.
24. If prompted to save the project, select No.
25. At the Nero window, select the button to exit the software.

Saving Files to a USB Storage Device

USB storage devices are also known as thumb drives or flash drives. They are
devices you can insert into a USB port for the purpose of transferring data.
Follow these steps to save data files to a storage device.
NOTE: USB ports are not available on all instruments.
1. At the instrument window, select MENU.
2. Insert the USB storage device into the USB port on the keyboard tray.
3. Select Export Data.
4. In the START panel:
a. Select the Date field and select the start date from the calendar.
b. Select the Time field and select the start time from the clock.

601005-0004 Rev. A
7-4 Operator’s Guide: Data Management

5. In the END panel:

a. Select the Date field and select the end date from the calendar.
b. Select the Time field and select the end time from the clock.
6. In the Export Data panel, select File
The Save As window displays:
a. Select the Save in: dropdown menu to display all available directories.
The USB directory is usually drive E:. It may take a few moments to
display.
b. Select the USB directory.
c. Type a name in the Filename field, and then select the Save button.
The Save As window closes and the file name displays under File
Information.
d. At the Field Delimiter prompt, select a delimiter:
• Select Tab to separate the data with tabs.
• Select Comma to separate the data with commas.
7. Select the PERFORM EXPORT button to export the data.
8. When the export is complete, use the pointing device to locate the new
hardware icon on the Windows taskbar.
The icon usually displays a downward pointing green arrow. When you rest
the pointer on it, the icon displays the following popup message:
Safely Remove Hardware

9. Select the icon, and then remove the USB device.

Viewing Results and Sending Data to the LIS

Follow the instructions below to view results and send data to the LIS.
1. Select LIS on the toolbar.
The LIS screen displays the data. The last selected viewing options, Hide
Sent, Show Sent, or Sort By, determine the information displayed when the
LIS button is selected.
a. To hide data sent to the LIS, select the Hide Sent button.
The button changes to Show Sent.
b. To display all data, select the Show Sent button.
The button changes to Hide Sent.
2. Sort the LIS data by selecting the Sort By... button.
The Sort By screen displays.

601005-0004 Rev. A
Operator’s Guide: Data Management 7-5

3. If appropriate, specify a period other than Prior 24 Hours by selecting Define

Range:
a. Select the Start Time MM/DD/YYYY field to select a date from a calendar.
b. Select the Start Time HH:MM:SS field to select a time from a clock.
c. Repeat this process with End Time.
4. To sort the data, select one of the sort buttons listed below:
• Accession Number
• Order Created
• Name
• Test Type
NOTE: Select the Print List button to print the list.
5. If the system is not configured to send data automatically:
• From the LIS screen, select the Hide Sent button to hide data that was
already sent to the LIS.
The button changes to Show Sent.
• Select the records to be sent by clicking on them or select the Tag All
button to tag all results for transmission to the LIS.
If Tag All is selected, the button changes to Un-Tag All.
• Select the Send button to transmit the tagged results to the LIS.
If Clear is selected, it will permanently clear all selected data information
from the database.

Restarting the System

Logging off the system each day automatically initiates a system back-up, which
stores current data. This process optimizes software performance and allows
recent data to be restored in the event of a serious system error. Log off daily so
that if a serious system error occurs, recent data is available when the system is
restored.
NOTE: Failure to put the instrument in STOP mode before logging off may cause
the final reagent and bead test counts to be inaccurately stored.
1. Select STOP.
If active tubes are in progress, a message displays stating the
time-to-completion.
2. Select Continue.
3. Remove patient specimens, controls, diluent, and adjustors from the sample
carousel.
4. Remove any allergen wedges from the reagent carousel and seal the allergen
vials with standard caps before storing them.

601005-0004 Rev. A
7-6 Operator’s Guide: Data Management

5. Select LOG OFF.

The following message displays.
Would you like to Log Off of the IMMULITE 2000
software and return to the Start-Up menu?
6. Select OK.
The following messages display.
Preparing to Back up Files...Please Wait
You are about to delete all patient records over 62
day and control, verifier and adjustor records over
366 days.
NOTE: If you select CHANGE DAYS and increase the number of days data is
stored, it can slow the system response time.
7. Select CONTINUE.
The system logs off.
8. Select Start on the lower left-hand corner of the screen.
9. Select Shut Down or Turn Off Computer.
10. Select Restart the computer? and then, depending on which prompt
displays, select Yes or Restart.

601005-0004 Rev. A
Operator’s Guide: Configuring the System

8 Configuring the System

Configuring the System . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

Selecting Display Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Configuring Auto Dilutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Configuring ID Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Using the Configuration Settings Screen . . . . . . . . . . . . . . . . . . 8-4
LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
FSE Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Processing Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11
Password Protected Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11
Configuring System Functions. . . . . . . . . . . . . . . . . . . . 8-11
Resetting the Load Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11
Defining Test Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12
Defining Allergen Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13
Reflexive Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14
Activating Reflexive Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14
Setting up Reflexive Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14
Editing Reflexive Testing Configurations . . . . . . . . . . . . . . . . . 8-16
Using Reflexive Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-16
Ordering Additional Reflexive Tests for a Range. . . . . . . . . . . . . . .8-16
Adding or Editing a Dilution Factor . . . . . . . . . . . . . . . . . . . . . . . . .8-17
Removing a Reflex Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-17
Deleting a Reflexive Test Range . . . . . . . . . . . . . . . . . . . . . . . . . . .8-17
Panel Configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-18
Creating a New Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-18
Immunoassay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-18
Allergen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-18
Defining Allergen Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19
Allergy Kit Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-19
Specific-Allergen Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-19
Editing a Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-20
To Add a Test to the Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-20
To Remove a Test from the Panel . . . . . . . . . . . . . . . . . . . . . . . . . .8-20
To Change the Dilution Factor for an Immunoassay . . . . . . . . . . . .8-20
Deleting a Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-20
Units Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-21
AutoStart Configuration Screen . . . . . . . . . . . . . . . . . . . 8-22
Automatic Substrate Dispense . . . . . . . . . . . . . . . . . . . . . . . . . 8-22
Communications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-23

601005-0004 Rev. A
 Operator’s Guide: Configuring the System

Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-23
Editing Chartable Patient Reports . . . . . . . . . . . . . . . . . . . . . . 8-23
Configuring the Laboratory Name . . . . . . . . . . . . . . . . . . . . . . 8-24
Enabling or Disabling Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-24
Moving Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-25
Manually Printing the Chartable Patient Report . . . . . . . . . . . . 8-25
Restoring the Template. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-26
Changing Windows Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . 8-26
Resetting the Date and Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-26
Setting the Time Zone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-27
Changing the Sound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-27
Calibrating the Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-27
Updating the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-28

601005-0004 Rev. A
Configuring the System

The system must be configured upon receipt of the instrument. You also use the
configuration screens to update system functions.

Configuring the System

This section describes the screens and options available for configuring the
system.

Selecting Display Options

The Display Options screen allows the operator to specify how text, numbers,
times, and dates are displayed. Follow the instructions below to configure this
screen.
NOTE: The instrument must be in STOP mode to make changes to this screen.
You must Log off, and log on again, for changes in the Display Options screen to
take effect.

For IMMULITE 2000 System or IMMULITE 2500 System

1. At the instrument window drop-down menu bar, select Configurations.
2. Select Configure.
3. Proceed to step 3 in the next section.

For IMMULITE 2000 XPi System

1. At the instrument window, select MENU.
2. At the Menu screen, select Configure.
3. Select Display Options.
4. In the Time Format box, select a format:
• Select 12 Hour to display time using am and pm.
• Select 24 Hour to display time in a 24-hour format.
5. In the Date Format box, select a format for displaying the date.
• MM/DD/YYYY
• DD/MM/YYYY
• YYYY/MM/DD
6. In the Number Format box, select a number format:
• Select 1,234.56 to display one thousand, two hundred thirty-four and
fifty-six one hundredth as 1,234.56.

601005-0004 Rev. A
8-2 Operator’s Guide: Configuring the System

• Select 1.234,56 to display one thousand, two hundred thirty-four and

fifty-six one hundredth as 1.234,56.
7. Select a language.
8. Select the Use barcode rack identifier option to display the sample’s
location on the instrument by the rack letter.
NOTE: Select the use barcode rack identifier to use the Find Last Tube
Position feature.
Leave this option blank to display the sample’s location by position.
Position 1 on the carousel displays as Position A on the rack.
9. Select the Hide Names option to hide patient names on the data review
screens.
Leave this option blank to display patient names on the data review screens.
NOTE: The Kit Expiration Flag is enabled when the software is installed, but
can be disabled. The Kit Expiration Flag always displays at the Kits window
whether it is disabled or not. The Kit Expired Flag does not display for
Allergens.
10. To Configure the Kit Expiration Flag, do the following:
a. At the instrument window, select MENU.
b. At the Menu screen, select Configure.
c. Select Display Options.
d. To disable the Kit Expiration Flag, select Disable Kit Expiration Flag.
e. Select Save.
If the Kit Expired Flag is disabled and the kit is Immunoassay or
confirmatory, Expired displays in blue in the Kit Status field at the KITS
window.
NOTE: When the instrument is connected to an LIS, a letter (or letters)
identifying the laboratory may be part of the accession number.
11. To remove this letter (or letters):
a. Select Number of Characters To Trim From Left (or Right) of
Accession Number.
b. Select all appropriate trim options.
NOTE: If further changes are planned for the ID Information, Configuration
Settings, or LIS screens, select Save after all changes have been made.
Access another screen by selecting the appropriate button on the Display
Options screen.
12. Select Save.

601005-0004 Rev. A
Operator’s Guide: Configuring the System 8-3

Configuring Auto Dilutions

The Auto Dilutions screen is used to specify the automatic dilution factor for
out-of-assay-range samples. Specify dilution factors for each test according to the
instructions below.
NOTE: The Dilution Volume Specifications‚ page E-2 displays the amount of
sample, water, and diluent used for onboard dilutions.

For the IMMULITE 2000 System or IMMULITE 2500 System

1. At the instrument window drop-down menu bar, select Configurations.
2. Select Configure, and proceed to step 3 in the next section.

For the IMMULITE 2000 XPi System

1. At the instrument window, select MENU.
2. At the Menu screen, select Configure.
3. Select Auto Dilutions.
4. Select the Test Name field.
A list of the test codes for all the tests in the system displays.
5. Select a test.
NOTE: Tests only display if the new kit was entered using the 2D or imaging
scanner.
The test displays in the Test Name field and the dilution factors display.
NOTE: Samples that require a dilution factor other than those programmed
for onboard dilutions may have a manual dilution factor applied to them.
When a manual dilution factor is applied to a sample, all tests ordered on that
sample are multiplied by that dilution factor.

CAUTION
Do not type a value in the Dilution Factor field. Typing in a value that is not
supported will perform the assay without any dilutions and will display as
> assay limit. Only those dilution factors listed are supported.

601005-0004 Rev. A
8-4 Operator’s Guide: Configuring the System

6. Select one of the listed dilution factors:

Dilution Factor Dilution
X3 1 in 3
X5 1 in 5
X10 1 in 10
X20 1 in 20
X40 1 in 40
X100 1 in 100
After the dilution is selected, the Dilution Factor screen closes and the
dilution factor displays on the Worklist screen.
Refer to Dilution Volume Specifications‚ page E-2.
7. Select Save.

Configuring ID Information
The ID Information screen is used to enter customer information. The hospital or
laboratory name displays on patient and adjustment reports. Follow the
instructions below to enter this information.

For the IMMULITE 2000 System or IMMULITE 2500 System

1. From the drop-down menu bar, select Configurations.
2. Select Configure.
3. Proceed to step 3.

For the IMMULITE 2000 XPi System

1. At the instrument window, select MENU.
2. At the Menu screen, select Configure.
3. Select ID Information.
4. In the Customer Name field, type the hospital or laboratory name.
This name displays on Adjustment and Patient Reports.
5. Type the instrument serial number in the Instrument ID field.
6. Select Save.

Using the Configuration Settings Screen

The Configuration Settings screen is used to specify system settings that affect
how the instrument operates in relation to testing and reporting. Follow the
instructions below to configure this screen.

601005-0004 Rev. A
Operator’s Guide: Configuring the System 8-5

For the IMMULITE 2000 System and IMMULITE 2500 System

1. At the instrument window, select Configurations.
2. Proceed to Step 2 in the next section.

For the IMMULITE 2000 XPi Instruments

1. At the instrument window, select MENU.
2. Select Configure.
3. Select Configuration Settings.
4. Select options according to the table below:
Option Description
Default Sample Tube The tube type normally used can be selected.
Type • Primary tube
Blood collection tube in which the serum is separated
from the blood cells by a gel barrier. Selecting this
configuration causes the probe to stop before
penetrating the gel barrier.
Refer to the Primary Tube Sample Guide (Part Number
901835) sent with the instrument for more information.
• Secondary tube
Sample tube in which the serum is aliquotted to a
different tube. Selecting this configuration causes the
probe to move further into the tube before aspirating the
sample.
NOTE: You must make changes to the Default Sample Tube
Type setting before placing samples on the system.
Otherwise, it is necessary to log off the software and delete
the worklist after changing the Default Sample Tube Type.
Automatically Print the Select which report type(s) are to be printed automatically
Following Reports when results are completed.
Select the checkbox to select the report(s) to be printed. All
reports, individual report(s) or no reports can be selected.
NOTE: Controls must be selected. If controls are not
selected, QC results will not be evaluated against the
selected QC rules or ranges. Further, patient results may not
be sent to the LIS.
Results Statistics • Mean
Displays the mean of the replicates on the Review
screen and on the report printout.
• CV
Displays the % CV of the replicates on the Review
screen and on the report printout.

601005-0004 Rev. A
8-6 Operator’s Guide: Configuring the System

Option Description
Auto Eject Options Configures Auto Eject when to eject rack(s) automatically.
Select whether to eject when samples in a rack are:
• Pipetted
• Resulted
• To disable Auto Eject, select None.
Testing Options • Reflexive Testing
The system will automatically perform another test if
the result from the first test falls outside, or within, a
specified range. This option must be selected to activate
reflexive testing.
• Auto Dilution
Automatically dilutes out-of-assay-range samples. This
option must be selected to activate Auto Dilution.
NOTE: Dilution instructions are entered via the Auto
Dilutions window.
Low Test Flag Designates when a warning message displays on the Bead or
Reagent Status screens based on the number of tests
remaining in a bead pack or a reagent wedge.
For example, if 10 is entered in this field, a warning
displays when a bead pack or reagent wedge has sufficient
volume for only nine more tests. Applies to all bead packs
and reagent wedges on board.
Large Allergen Low Designates when a warning message displays in the Reagent
Test Flag Status screen based on the number of tests remaining in a
40-test allergen vial.
For example, if 10 is entered in this field, a warning displays
when an allergen vial has sufficient volume for only nine
more tests.
Small Allergen Low Designates when a warning message displays in the Reagent
Test Flag Status screen based on the number of tests remaining in a
20-test allergen vial.
For example, if 2 is entered in this field, a warning displays
when an allergen vial has sufficient volume for only one
more test.
Allergen Reagent(s) in Displays scanned allergy kits. Multiple kits can be selected.
use NOTE: Selected reagents are displayed by default in the
Available Tests window.

601005-0004 Rev. A
Operator’s Guide: Configuring the System 8-7

Option Description
Allergen Results and The selections made in this field determine how the results
Scoring Type of allergy tests are reported when they are displayed on the
screen and printed.
• Concentration
If this selection is marked, the antibody concentration in
patient samples will be included in the results for allergy
tests.
• Standard Class
If this selection is marked, allergy test results will be
based on Standard Class scoring criteria.
• Extended Class
If this selection is marked, allergy test results will be
based on Extended Class scoring criteria.
Report Qualitative • Qualitative Only
Infectious Disease Infectious Disease results will be reported as either
Assay Results Reactive, Non-Reactive, or Indeterminate.
• Qualitative and Ratio
Infectious Disease results are reported as a ratio, and as
either Reactive, Non-Reactive, or Indeterminate.
5. Select Save.

LIS
The LIS Configuration window is used to configure the system to communicate
with the LIS. Follow these instructions to enter LIS information in the software.

For the IMMULITE 2000 System or IMMULITE 2500 System

1. At the instrument window drop-down menu bar, select Configurations.
2. Select Configure.
3. Proceed to step 3 in the next section.

For the IMMULITE 2000 XPi System

1. At the instrument window, select MENU.
2. Select Configure.
3. At the Display Options screen, select LIS.
4. In the LIS Host Query Mode box, select the type of interface used for
communication between the instrument and the LIS.
• None
• Uni-Directional
• Bi-Directional

601005-0004 Rev. A
8-8 Operator’s Guide: Configuring the System

NOTE: If you select Bi-Directional Query, the Query Control and

Re-Query Patients fields are enabled.
• Bi-Directional Query
NOTE: If Bi-Directional Query is selected, the Query Control and Re-Query
Patients fields are enabled.
5. In the LIS Allergen Results and Scoring Type box, select the allergy test result
information that should be transmitted to the LIS.
You can select to transmit antibody concentration as well as standard and
extended class scoring.
NOTE: For allergy tests, concentration information is always sent to the LIS.
6. Enter the appropriate information in the fields on the left side of the window
based upon the explanations in the following table.
Field Description
Password The LIS Password.
NOTE: Contact your LIS provider for this information.
Receiver ID A name identifying the LIS.
NOTE: Contact your LIS provider for this information.
Sender ID A name identifying the instrument.
NOTE: Contact your LIS provider for this information.
Baud Rate The baud rate (line transmission speed) provided by the LIS.
NOTE: Acceptable entries include 1200, 2400, 4800, or
9600, or 115200 when connected to the VersaCell system.
COM Parameters An alphanumeric character identifying the parity, bits, and
stop bits.
Serial Port The serial port number for the LIS connection.
Diagnostics The value should be left at 0.

7. Mark the appropriate selections in the window based upon the explanations in
the following table:
Field Description
Hide Sent Hides results previously sent to the LIS.
Auto Send Patient Automatically sends patient results to the LIS.
Results Results associated with an overdue adjustment, failed
control, review range failure, error, and N/A results are not
sent. When this option is selected, the Send button on the
LIS screen changes to the Auto Send button.
Auto-Send Invalid Allows results associated with an overdue kit adjustment to
Adjustment be sent to the LIS.

601005-0004 Rev. A
Operator’s Guide: Configuring the System 8-9

Field Description
Auto-Send Invalid Allows results associated with an out-of-range control to be
Control automatically sent to the LIS.
Control results are evaluated based on the type of QC rule
selected, such as Single Rule, Multi Rule.
Auto-Send Invalid Allows results that are out-of-review range to be
Range automatically sent to the LIS.
Auto Send Control Automatically sends control results to the LIS.
Results
Display Controls on LIS Displays control results on the LIS Data Management
Screen screen. Control results are not displayed on the LIS Data
Management screen unless configured to do so.
Query Controls Provides another method of sending QC orders from the LIS
to the instrument.
NOTE: If the Query Controls checkbox is selected, the
Re-Query Controls field is enabled.
Re-Query Patients NOTE: Bi-directional Query must be selected.
Allows the LIS to be re-queried when patient tube barcodes
are re-read on the sample carousel, allowing test requests to
be re-sent.
A dropdown list allows one of the following functions to be
performed on the LIS:
• No Requery
• All Orders
• New Orders only
NOTE: LIS system must be able to support re-query
function. Check with your LIS provider.
Re-Query Controls Bi-directional Query must be selected.
Allows the LIS to be re-queried when controls are re-read on
the sample carousel, allowing test requests to be re-sent.
A dropdown list allows one of the following functions to be
performed on the LIS:
• No Requery
• All Orders
• New Orders only
NOTE: LIS system must be able to support re-query
function. Check with your LIS provider.

601005-0004 Rev. A
8-10 Operator’s Guide: Configuring the System

Field Description
Report Qualitative Select how results of qualitative infectious disease are to be
Assay Results sent to the LIS. Results can be sent as either:
• Qualitative Only
• Ratio Only
For the Displayed on the LIS Screen as field, select how
results will be displayed on the instrument LIS screen.
Results can be displayed as either:
• Qualitative Only
• Qualitative and Ratio
For the Sent aHB and BcM to the LIS as field, select how
aHB and BcM results are sent to the LIS. Results can be sent
as either:
• Qualitative Only
• Concentration Only
For the Display aHB and BcM on the LIS screen as field,
select how aHB and BcM results are displayed on the
Instrument LIS screen. Results can be displayed as either:
• Qualitative Only
• Qualitative and Concentration

8. Select Save.
NOTE: For the changes you entered in the Configuration window to take
effect, select the Log Off button and exit the software, then restart the
software.

FSE Configuration
The FSE Configuration screen is a password-protected screen used by authorized
personnel to change the default mode for sample processing. To request a
processing mode change, contact your local service provider or distributor.
Assays are assigned a priority with regard to the stability of the analyte in the
patient sample. The priority number is contained in the kit barcode and is
transferred to the database when the kit is scanned.

601005-0004 Rev. A
Operator’s Guide: Configuring the System 8-11

Processing Modes
NOTE: The order in which samples are processed will vary, depending on the
mode selected.
• Random Access (default)
The instrument pipettes patients in the most efficient order.
• Batch
The instrument pipettes patients in alphabetical order by test code, going from
sample to sample.
• User Entered Order
Tests are processed in the order in which they were entered on the Worklist.

Password Protected Modes

• Load Scale
The Load Scale screen is a password-protected screen used by authorized
personnel. Contact your local service provider or distributor.
• Instrument Mode
The Instrument Mode screen is a password-protected screen used by Siemens
personnel. Contact your local service provider or distributor.

Configuring System Functions

This section allows you to perform the following configurations:
• Resetting the Load Scale
• Defining Test Ranges
• Defining Allergen Ranges

Resetting the Load Scale

Use this section to reset the load scale that monitors the levels of liquid and solid
waste, water, probe wash, and substrate. If there is a discrepancy between the
consumable indicator on the HOME screen and the actual volume available, the
load scales may be reset.
NOTE: If the instrument is not in STOP mode, a reminder message displays.

For the IMMULITE 2000 System and IMMULITE 2500 System

1. Place the instrument in STOP mode.
2. At the instrument window drop-down menu bar, select Configurations.
3. Select Configure.
4. Proceed to step 3 in the next section.

601005-0004 Rev. A
8-12 Operator’s Guide: Configuring the System

For the IMMULITE 2000 XPi Systems

1. Place the instrument in STOP mode.
2. At the instrument window, select MENU, and then select Configure.
3. Select Reset Load Scale.
4. Select the load scale to be reset, using the Previous or Next arrows.
The Name field changes accordingly with all associated data.
5. After the appropriate load scale is selected, select the Reset Scale button.
6. Remove the container from the selected load scale.
7. Select OK.
The Reset Load Scale message displays.
8. Place the container back on the load scale, and select OK.
To reset a different container, repeat steps 5 to 8, or select Cancel to return to
the HOME screen.

Defining Test Ranges

The Test Ranges screen is used to specify the reference ranges for test results that
display in the Patient Review window and print on the chartable patient report.
Follow the instructions below to specify reference ranges.
NOTE: Test ranges do not apply to allergens. Allergen ranges can be set up in the
Allergen Ranges window.

For the IMMULITE 2000 System and IMMULITE 2500 System

1. At the instrument window, select Configurations.
2. Select Test Ranges.
3. Proceed to step 2 in the next section.

IMMULITE 2000 XPi Instruments

1. At the instrument window, select MENU.
2. Select Test Ranges.
3. Select a test from the Test Name list.
The ranges for the selected test display in the range fields. The units of the
range values display at the right side of the window.
4. For the Normal range, enter the Low and High limits in the appropriate fields.
5. In the Range 2 through Range 7 fields, enter the additional ranges to be
displayed in the Patient Review window.
6. If the system is configured to send results to the LIS automatically, you can
enter Low and High values in the Review Range fields.

601005-0004 Rev. A
Operator’s Guide: Configuring the System 8-13

If a result is outside of the review range, it is not be sent to the LIS.

If the low and high values of Range 1 (Normal) are within the low and high
values of the review range, patient results that are outside of range 1 (normal)
are not be flagged. Refer to the example below:
• Normal Range = 0.4 to 4.0
• Review Range = 0.2 to 6.0
• Result 5.0
Because the result is within the review range, it would not be flagged even
though it is higher than the normal range.
7. Select Save.

Defining Allergen Ranges

The Allergen Ranges window displays the ranges of immunoglobulin
concentrations for allergic reactions. You can use this window to specify the
concentration for a class 0/I reaction. You can enter the concentration for both
standard and extended scoring.
The other ranges displayed in this window cannot be changed. They are entered
when you scan the 2D barcode on the kit. The ranges in this window display for
allergy tests in the Patient Review screen and on reports. Follow the instructions
below to specify the Class 0/I reference ranges for allergy tests.

For the IMMULITE 2000 System and IMMULITE 2500 System

1. At the instrument window, select Configurations.
2. Select Allergen Ranges.
3. Proceed to step 3 in the next section.

For IMMULITE 2000 XPi Instruments

1. At the instrument window, select MENU.
2. Select Allergen Ranges.
3. In the Test Name list, select the allergy kit for which to enter the Class 0/I
reference range.
Default reference ranges for the kit selected displays in the Class fields. The
units for the range values display at the right side of the window.
The classes of allergic reactions are listed on the left side of the window. The
class names are aligned between the fields that contain their range values.
For example, the first field in the Standard column contains a 0. The field
beneath it could contain 0.20. Class 0 is the name next to these two fields.
Therefore, in the Patient Review screen and on reports, a Standard Class 0
result would be displayed for antibody concentrations of 0 to 0.20 IU/mL.

601005-0004 Rev. A
8-14 Operator’s Guide: Configuring the System

4. Enter the reference range values in the Class 0/I Cutoff fields.
You can enter values for Standard and Extended scoring.
5. Select Save.

Reflexive Tests
Follow the instructions in this section to specify tests to run automatically if a
result is either below, within, or above a specified range.
NOTE: Reflexive testing cannot be performed on a manually diluted sample.

Activating Reflexive Testing

Follow these instructions to activate reflexive testing:

For the IMMULITE 2000 System and IMMULITE 2500 System

1. From the drop-down menu bar, select Configurations, and then select
Configure, and proceed to step 2.

For the IMMULITE 2000 XPi instruments

1. At the Menu screen, select Configure.
2. Select Configuration Settings.
3. Select the Reflexive Testing option in the Testing Options box.
4. Select Save.

Setting up Reflexive Testing

Follow these instructions to set up reflexive testing for assays or allergens:

For the IMMULITE 2000 System and IMMULITE 2500 System

1. If necessary, activate reflexive testing.
2. At the menu bar, select Configurations.
3. From the Configurations menu, select Reflexive Tests.
4. Proceed to step 3 in the next section.

For the IMMULITE 2000 XPi instruments

1. At the instrument window, select Menu.
2. At the Menu screen, select Reflexive Tests.

601005-0004 Rev. A
Operator’s Guide: Configuring the System 8-15

3. Select a Principle Test Selection.

This selection determines what tests display in the Principle Test field.
Principle Test Selection Description
Immunoassay – All Available All assays scanned into system
Immunoassay – Configured Assays configured for reflexive testing
for Reflex
Allergy – All Available All allergens and universal reagents scanned into
the system
Allergy – Configured for Allergens/universal reagent combinations
Reflex configured for reflexive testing
4. Select a Principle Test and Universal Reagent, if applicable.
5. Select a type of new range:
• Only one Below range and one Above range can be configured per assay,
or allergen and universal reagent combination.
The Below and Above ranges cannot overlap.
• Unlimited Within ranges can be configured if the values do not overlap
with the Below and Above ranges.
• The New Range options for qualitative assays are Non Reactive,
Indeterminate, and Reactive.
Only one of each may be added.
6. Select Add Range.
7. Enter the Reflex Range value(s) based on the type of range that was selected
in step 5.
The Reflex Range field is not available for qualitative assays. Proceed to step
8.
8. Select the IMMUNOASSAY or ALLERGY button in the TEST CATEGORIES
box.
If ALLERGY is selected, select the appropriate universal reagents.
9. Select the buttons that correspond to the individual reflexive tests for this
range (up to 15 tests per reflexive range).
If necessary, use the Next Page and Previous Page buttons to locate additional
tests.
NOTE: The Do Not Autosend option will be enabled if a reflexive test
matching the principle test is selected. Select the Do Not Autosend option to
prevent the results of the principle test and the matching reflexive test from
being sent to the LIS. For example, if HCG reflexes to HCG and TSH and Do
Not Autosend is selected, only the TSH result will be sent to the LIS.

601005-0004 Rev. A
8-16 Operator’s Guide: Configuring the System

10. To add a dilution for a reflexive test:

a. Select a test under the Tests Selected heading.
b. Select the DILUTION button.
The Dilution Factor window displays.
c. Select the dilution factor.
11. Select Save after selecting all of the necessary reflexive tests.
12. Repeat steps 5 though 11 to configure additional ranges for a principle test, or
steps 2 through 11 to order reflex tests for a different assay or allergen.
13. To print the contents of the Current Ranges box, select Print.
14. Select Close to close the Reflexive Testing Configuration screen.

Editing Reflexive Testing Configurations

Follow these instructions to edit existing reflexive testing configurations:

For the IMMULITE 2000 System and IMMULITE 2500 System

1. At the instrument window menu bar, select Configurations.
2. Select Reflexive Tests and then proceed to step 2 in the next section.

For the IMMULITE 2000 XPi instruments

1. At the Menu screen, select MENU, and then select Reflexive Tests.
2. Select one of the following options:
• Immunoassay - Configured for Reflex
• Allergy - Configured for Reflex.
3. Select a Principle Test and Universal Reagent, if applicable.
4. Select the range to edit in the Current Ranges box on the right side of the
screen.
Update the reflex range depending on the selection.
5. Select Edit.

Using Reflexive Tests

Follow these procedures to order additional reflexive tests, add a dilution factor,
or remove a reflexive test:

Ordering Additional Reflexive Tests for a Range

Select the buttons that correspond to the individual reflexive tests for this range.
To switch between assays and allergens, select the IMMUNOASSAY or ALLERGY
button in the TEST CATEGORIES box.

601005-0004 Rev. A
Operator’s Guide: Configuring the System 8-17

Adding or Editing a Dilution Factor

1. Select the test under the Tests Selected heading
2. Select the DILUTION button.
3. Select the dilution factor.

Removing a Reflex Test

1. Select the test under the Tests Selected heading, and then select the REMOVE
button.
2. After all edits to this range are complete, select the SAVE button.
3. Repeat steps 2 through 7 to edit additional reflexive testing configurations.
4. To print the contents of the Current Ranges box, select the Print button.
5. Select the Close button to close the Reflexive Testing Configuration screen.

Deleting a Reflexive Test Range

Follow these instructions to edit existing reflexive testing configurations.

For the IMMULITE 2000 System and IMMULITE 2500 System

1. At the instrument window drop-down menu, select Configurations.
2. Select Reflexive Tests.
3. Proceed to step 3 in the next section.

For the IMMULITE 2000 XPi instruments

1. At the instrument window, select MENU.
2. Select Reflexive Tests.
3. Select one of the following options:
• Immunoassay - Configured for Reflex
• Allergy - Configured for Reflex.
4. Select a Principle Test and Universal Reagent, if applicable.
5. Select the range to edit in the Current Ranges box on the right side of the
screen.
6. Select the Delete button.
7. Select the Yes button.
8. Repeat steps 3 through 7 to delete additional ranges.
9. To print the contents of the Current Ranges box, select the Print button.
10. Select Close to close the Reflexive Testing Configuration screen.

601005-0004 Rev. A
8-18 Operator’s Guide: Configuring the System

Panel Configuration
A panel may be used to group tests that are routinely ordered together. The Panel
Configuration window is used to create a panel or edit an existing panel. The
operator assigns a panel name and the tests to include in the panel. Up to one
hundred tests may be assigned to a panel.

Creating a New Panel

Follow the instructions below to create a new panel.

For the IMMULITE 2000 System and IMMULITE 2500 System

1. At the instrument window drop-down menu, select Configurations.
2. Select Panels.
3. Proceed to step 3 in the next section.

For the IMMULITE 2000 XPi instruments

1. At the instrument window, select MENU.
2. Select Panels.
3. Select ADD NEW PANEL.
4. Enter a panel name in the Panel Name field.
The panel name can have no more than 10 characters.
5. Select one of the Panel Color buttons, 1 through 15.
The color selected distinguishes the tests belonging to this panel in the
Available Panels window.
6. Select the Test Name.
7. Select ACTIVE KITS or ON BOARD.
• If ACTIVE KITS is selected, every immunoassay or allergy test scanned
onto the instrument displays in the center of the window.
• If ON BOARD is selected, every immunoassay or allergy test physically
residing on the instrument displays in the center of the window.

Immunoassay
Select the appropriate immunoassay.
The code for the selected assay displays in the Tests Selected field.

Allergen
1. Select the universal reagent, such as SPE, to be used for the allergy test.

601005-0004 Rev. A
Operator’s Guide: Configuring the System 8-19

2. Select allergen test.

The code for the selected allergen displays in the Tests Selected field.

Defining Allergen Controls

Two different kinds of allergy controls may be run:
• Allergy kit controls
• Specific-allergen controls

Allergy Kit Controls

This type of control tests the performance of the universal allergy kit. These
controls are provided with allergy kits. To run these controls, the Specific-IgE
Control Antibody provided with that kit must have been entered and loaded.

Specific-Allergen Controls
These controls test the performance of a particular allergen. Specific-allergen
controls are available for the most common allergies. To run these controls, the
allergen whose performance is to be tested must be entered and loaded.
1. Specify replicates of the tests in the panel.
If replicates are not to be ordered, proceed to Step 8.
2. Select the test in the Tests Selected field, and then select REPLICATES.
3. Change the number of replicates to be performed using the arrow buttons.
The number can also be entered using the keyboard.
4. Select OK to enter the number displayed, and then close the Replicates
window.
5. Repeat this process for all tests that require replicates.
6. To save the entries and close the window, select OK in the Available Tests
window.
7. At the Panel Configuration window, specify any dilution factors necessary to
apply to the immunoassays in the panel to be created.
8. Select Dilution Factor.
9. Select the immunoassay in the Tests Selected field to apply the dilution
selected to that test.
10. Repeat these steps for each onboard dilution needed.
NOTE: The Dilution Volume Specifications‚ page E-2 displays the amount of
sample, water, and diluent used for onboard dilutions.
11. Select SAVE PANEL.

601005-0004 Rev. A
8-20 Operator’s Guide: Configuring the System

Editing a Panel
Follow the instructions below to edit an existing panel.

For the IMMULITE 2000 System and IMMULITE 2500 System

1. At the instrument window drop-down menu, select Configurations.
2. Select Panels.
3. Proceed to step 3 in the next section.

For the IMMULITE 2000 XPi instruments

1. At the instrument window, select MENU.
2. Select Panels.
3. Select EXISTING PANELS.
4. Select the panel from the Panel Name list, and then select ACCEPT.
The panel you select displays in the Panel Configuration window. Follow the
appropriate instructions below for the changes to be made.

To Add a Test to the Panel

1. Select Test Name.
2. Follow step 7 in Creating a New Panel‚ page 8-18.

To Remove a Test from the Panel

In the Panel Configuration window, select the test to remove in the Tests Selected
field.

To Change the Dilution Factor for an Immunoassay

1. In the Panel Configuration window, select the dilution factor needed.
2. Select the test in the Test Selected field to which to apply the dilution.
The Dilution Volume Specifications‚ page E-2 displays the amount of sample,
water, and diluent used for onboard dilutions.
3. Select SAVE PANEL in the Panel Configuration window to save the changes
entered.

Deleting a Panel
Follow the instructions below to delete an existing panel.

For the IMMULITE 2000 System and IMMULITE 2500 System

1. At the instrument window drop-down menu, select Configurations.
2. Select Panels.

601005-0004 Rev. A
Operator’s Guide: Configuring the System 8-21

3. Proceed to step 3 in the next section.

For the IMMULITE 2000 XPi instruments

1. At the instrument window, select MENU.
2. Select Panels.
3. Select EXISTING PANELS.
4. Select the panel to be deleted from the Panel Name list.
5. Select ACCEPT.
Information about the selected panel displays in the Panel Configuration
window.
6. Select DELETE PANEL.
7. Select Yes.

Units Configuration
The Units Configuration screen allows the operator to change the reporting units
for a specific test. To change from the default units, follow the instructions below.
NOTE: Changing the reporting units for a specific assay will cause the software
to recalculate all results automatically in the database for that assay, including
Quality Control results and reference ranges. Subsequent printouts of Quality
Control results, export data, or reprints of patient results will display with
re-calculated results and the updated units.

For the IMMULITE 2000 System and IMMULITE 2500 System

1. At the instrument window drop-down menu, select Configurations.
2. Select Units.
3. Proceed to step 3 in the next section.

For the IMMULITE 2000 XPi instruments

1. At the instrument window, select MENU.
2. Select Units.
3. Select the arrow to the right of Test Name window.
The drop-down window displays the available tests.
4. Select the test.
The units options for this particular test display, with the current reporting unit
selected.
Up to four different units may display.
5. Select the unit.

601005-0004 Rev. A
8-22 Operator’s Guide: Configuring the System

6. Select Save.
7. Select Done.

AutoStart Configuration Screen

NOTE: This feature is only available on the IMMULITE 2000 XPi system.

The AutoStart Configuration screen allows you to schedule automated

maintenance procedures by date and time, and enable or disable automatic
substrate dispensing.
Use the AutoStart Configuration screen to define your automatic procedures:
• Select the days of the week for AutoStart to run.
• View control worklists to run during schedule AutoStart procedure.
To configure the instrument to AutoStart:
1. At the instrument window, select MENU.
2. Select AutoStart Configuration.
The AutoStart Configuration screen displays.
3. Select the day(s) of the week to schedule AutoStart.
4. For each day of the week you selected, enter the time of day to schedule
AutoStart.
5. To see the Scheduled QC worklists assigned for a particular day, select View
Worklist next to the appropriate day of the week.
Refer to Scheduling QC Assays‚ page 4-14.
6. Select Substrate Dispense ON or Substrate Dispense OFF.
Refer to the section below, Automatic Substrate Dispense.
7. Select Save.

Automatic Substrate Dispense

NOTE: When the probe is inactive for more than 2 hours, the operator must
manually prime the first time for this routine to continue.
Every 2 hours the Substrate Dispense ON selection automatically moves a
reaction tube into the substrate station and dispenses substrate material into the
tube, then clears the tube off of the instrument to ensure the probe is clean.
The Substrate Dispense OFF selection disables the substrate from automatically
dispensing. This option is only recommended if you perform automated
maintenance tasks, and will not be running the automated QC Worklist.
Additionally, if the instrument is running tests up until AutoStart begins, the
substrate will have recently dispensed during the course of processing tests;
therefore, the probe will be ready.

601005-0004 Rev. A
Operator’s Guide: Configuring the System 8-23

Communications
The Communications screen is used to configure the instrument to communicate
via informatics applications, such as RealTime Solutions.

Reports
Follow the instructions below to configure reports.
1. Ensure the instrument is in STOP mode.
2. At the instrument window, select REPORTS.
3. Select CONFIGURE REPORT.
4. To automatically print this report:
• In short format, select the Short Format option.
• In chartable format, select the Chartable Format option.
5. Select SAVE to save this change.
6. Select CLOSE.

Editing Chartable Patient Reports

Follow the instructions below to edit the chartable patient report.

For IMMULITE 2000 System or IMMULITE 2500 System

1. Ensure the instrument is in STOP mode.
2. At the instrument window, select REPORTS.
3. Select the CONFIGURE REPORT button.
4. Select Chartable Format.
5. Select the Edit Template button.
6. Single select one of the four corners of the box to resize the Property
Toolbox.
7. When the black double arrow displays, drag the box to increase or decrease
the box size.
Do not close the Property Toolbox. To display it, press the F4 key on the
keyboard.
8. Click on a field label to edit.
A text box will surround the field label.

601005-0004 Rev. A
8-24 Operator’s Guide: Configuring the System

Configuring the Laboratory Name

The laboratory name is stored in the database and must be configured separately,
as follows.
NOTE: Do not modify the section headings, PageHeader, GroupHeader, Detail,
PageFooter, or GroupFooter1.
1. Select the appropriate property, for example Caption, in the Property Toolbox.
2. Edit the field.
If a field extends beyond the printable range, a red line displays, indicating
that each page will print on two pieces of paper. Adjust fields accordingly to
avoid this behavior.
3. Press Enter.
4. Select the Font section in the Property Toolbox to edit the font type and size.
5. Select PREVIEW to view the changes.
6. Select Print icon while previewing the template to print a sample report.
7. Select SAVE to save any changes.

Enabling or Disabling Fields

Follow the instructions below to enable or disable fields and field labels in the
chartable patient report.
1. Ensure the instrument is in STOP mode.
2. At the instrument window, select REPORTS.
3. Select CONFIGURE REPORT.
4. Select Chartable Format.
5. Select Edit Template.
The Design screen displays.
6. Select the appropriate field or field label.
A text box surrounds the field.
7. Select the Visible field in the Property Toolbox.
A drop-down arrow displays.
8. Select the drop-down arrow and select and option:
Although hidden on the report, the field label displays in the template.
• True - to enable the field.
• False - to hide the field.
9. Select PREVIEW to view the changes.
10. Select the Print icon while previewing the template to print a sample report.

601005-0004 Rev. A
Operator’s Guide: Configuring the System 8-25

11. Select the SAVE button to save any changes.

12. Repeat steps 1 - 6 as necessary for all fields and field labels.

Moving Fields
Follow the instructions below to arrange field labels and fields.
1. Ensure the instrument is in STOP mode.
2. At the instrument window, select REPORTS.
3. Select CONFIGURE REPORT.
4. Select Chartable Format.
5. Select Edit Template.
The Design screen displays.
6. Select the appropriate field or field label.
7. Select a field or field label to move it to the appropriate position.
To select multiple fields, select and hold the CTRL key while clicking on
fields/field labels, or select and drag a selection box around the fields/field
labels.
8. While pressing the mouse button, drag the field or field label to the new
location.
9. Release the mouse button.
The field label displays in the new location
10. To change the size of a field or field label, select the field and click and drag
the black squares to resize the field.
11. Select PREVIEW to view the changes.
12. Select the Print icon while previewing the template to print a sample report.
13. Select SAVE to save any changes.
NOTE: Text and data in fields will word wrap in the report. Avoid
overlapping fields on the template. Overlapping fields may result in
overlapping text and data in the chartable patient report.

Manually Printing the Chartable Patient Report

Follow the instructions below to manually print the chartable patient report. This
feature allows the operator to test-print the chartable patient report without
waiting for it to automatically print.
1. Ensure the instrument is in STOP mode.
2. At the instrument window, select REPORTS.
3. Select PRINT REPORT.

601005-0004 Rev. A
8-26 Operator’s Guide: Configuring the System

4. Enter the Accession Number.

5. Select the Patient Name from the dropdown list.
The report cannot be printed if all tests are not resulted for the selected
accession number and patient.
6. Enter any additional information to display on the report in the Comment
field.
7. Select PRINT.

Restoring the Template

Follow the instructions below to delete the customized template and overwrite it
with the Siemens provided template.
1. At the instrument window, select REPORTS.
2. Select CONFIGURE REPORT.
3. Select Restore Template.
4. Select YES to restore the Siemens template, or select NO to cancel.

Changing Windows Settings

The Windows settings are configured by the Siemens personnel when the system
is installed. Refer to Resetting the Date and Time‚ page 8-26 and Changing the
Sound‚ page 8-27 to adjust these settings.

Resetting the Date and Time

Follow the instructions below to reset the computer’s date and time.
NOTE: Do not follow these instructions when a Daylight Savings time change is
needed. A prompt will display to change the time on the proper date.
1. Select Start at the lower left corner of the screen.
NOTE: Do not change the Regional Settings on the Control Panel.
2. Use the trackball to highlight Settings, and then select Control Panel.
The Control Panel screen displays the Control Panel icons.
3. If necessary, select the Date & Time tab.
4. Double select the Date/Time icon.
5. At the Date/Time Properties window, select the Time Zone tab.
6. Select the arrow to the right of the month field and highlight the current
month.
7. If the year is incorrect, use the up and down arrow buttons to the right of the
year field to display the current year.

601005-0004 Rev. A
Operator’s Guide: Configuring the System 8-27

8. On the calendar, select the current date.

9. Type the current time in the time field.
• If the time zone at the Current time zone prompt is incorrect, continue
with the instructions below for setting the time zone.
• If the time zone at the Current time zone prompt is correct, select the OK
button to close the Date/Time Properties screen.
10. Select the close button (x) at the upper right corner of the Control Panel.

Setting the Time Zone

1. Select Start at the lower left corner of the screen.
NOTE: Do not change the Regional Settings on the Control Panel.
2. Use the trackball to highlight Settings, and then select Control Panel.
The Control Panel screen displays showing the Control Panel icons.
3. At the Date/Time Properties screen, select the Time Zone tab.
4. Select the down arrow to the right of the time zone.
5. A list of time zones display.
6. Select the time zone.
7. Select OK to close the Date/Time Properties window.
8. Select the Close button (x at the upper right corner of the Control Panel
screen).
The Control Panel window closes.

Changing the Sound

CAUTION
Do not use the Windows NT volume control located on the desktop task bar. A
known Windows issue may adversely affect the operating system.
Sounds are used to call attention to the instrument. Use the volume controls
located on the monitor to raise or lower the sound volume or turn the sound off.

Calibrating the Touchscreen

Follow the instructions below to calibrate the touchscreen.
1. Select the Start button at the lower left corner of the screen.
2. Use the trackball to highlight Settings and select Control Panel.
The Control Panel screen displays showing the Control Panel icons.

601005-0004 Rev. A
8-28 Operator’s Guide: Configuring the System

3. Double select the Touchscreen icon.

The Touch Selection screen displays.
4. Select the Calibrate button.
The Touch Calibration screen displays.
5. Follow the instructions on the screen, selecting the target.
The following message displays:
Touch different areas on the screen.

Does the cursor jump to your fingertip?

6. Select the Yes button.

The Touch Calibration screen closes and the Touch Selection screen
redisplays.
7. Select the OK button.
The Touch Selection screen closes.
8. Select the Close button (x) in the upper right corner of the Control Panel to
close this screen.

Updating the System

The system arrives with the latest version of the instrument software installed. CD
ROMs containing software updates or new releases are sent periodically. To
install new software, follow the instructions accompanying the CD.

601005-0004 Rev. A
Appendix A: Safety Instructions

This information summarizes the established guidelines for handling laboratory

biohazards. This summary is based on the guidelines developed by the Centers for
Disease Control, the Clinical and Laboratory Standards Institute Document
M29-A3, Protection of Laboratory Workers from Occupationally Acquired
Infections, and the Occupational Safety and Health Administration’s Bloodborne
Pathogens Standard.1 – 3

Protecting Yourself from Biohazards

Use this summary for general information only. It is not intended to replace or
supplement your laboratory or hospital biohazard control procedures.
By definition, a biohazardous condition is a situation involving infectious agents
biological in nature, such as the hepatitis B virus, the human immunodeficiency
virus, and the tuberculosis bacterium. These infectious agents may be present in
human blood and blood products and in other body fluids.
The following are the major sources of contamination when handling potentially
infectious agents:
• needlesticks
• hand-to-mouth contact
• hand-to-eye contact
• direct contact with superficial cuts, open wounds, and other skin conditions
that may permit absorption into subcutaneous skin layers
• splashes or aerosol contact with skin and eyes

601005-0004 Rev. A
A-2 Operator’s Guide: Safety Instructions

To prevent accidental contamination in a clinical laboratory, strictly adhere to the

following procedures:
• Wear gloves while servicing parts of the instrument that have contact with
body fluids such as serum, plasma, urine, or whole blood.
• Wash your hands before going from a contaminated area to a
noncontaminated area, or when you remove or change gloves.
• Perform procedures carefully to minimize aerosol formation.
• Wear facial protection when splatter or aerosol formation are possible.
• Wear personal protective equipment such as safety glasses, gloves, lab coats
or aprons when working with possible biohazard contaminants.
• Keep your hands away from your face.
• Cover all superficial cuts and wounds before starting any work.
• Dispose of contaminated materials according to your laboratory’s biohazard
control procedures.
• Keep your work area disinfected.
• Disinfect tools and other items that have been near any part of the instrument
sample path or waste area with 10% v/v bleach.
• Do not eat, drink, smoke, or apply cosmetics or contact lenses while in the
laboratory.
• Do not mouth pipet any liquid, including water.
• Do not place tools or any other items in your mouth.
• Do not use the biohazard sink for personal cleaning such as rinsing coffee
cups or washing hands.
To prevent needlestick injuries, needles should not be recapped, purposely bent,
cut, broken, removed from disposable syringes, or otherwise manipulated by
hand.

References
1. Centers for Disease Control. 1988. Update: Universal precautions for
prevention of transmission of human immunodeficiency virus, hepatitis B
virus and other bloodborne pathogens in healthcare settings. MMWR, 37:377
– 382, 387, 388.
2. Clinical and Laboratory Standards Institute (formerly NCCLS). Protection of
Laboratory Workers from Occupationally Acquired Infections; Approved
Guideline - Third Edition. CLSI Document M29-A3.[ISBN 1-56238-567-4].
Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite
1400, Wayne, Pennsylvania 19087-1898 USA, 2005).
3. Federal Occupational Safety and Health Administration. Bloodborne
Pathogens Standard. 29 CFR 1910. 1030.

601005-0004 Rev. A
Operator’s Guide: Safety Instructions A-3

Precautions Table
Operational precautions are included throughout this manual. The table below
provides a comprehensive list of all the precautions to take for optimal instrument
operation.
Category Precaution
Specimen Tubes Barcode labels on specimen tubes must face out when in a
Sample Rack.
Do not use specimen tubes that exceed 100 mm in height or are
less than 12 mm in diameter.
Bead Packs Do not use a Bead Pack if the barcode label was damaged or
removed.
Reagents Use only IMMULITE 2000 system reagents with the
IMMULITE 2000 systems, and IMMULITE 2500 system
reagents with the IMMULITE 2500.
Do not reuse IMMULITE 2000 or IMMULITE 2500 Reagent
Wedges.
Do not use a reagent wedge if the barcode label was damaged or
removed.
Kits Read and carefully follow the package insert instructions
supplied with each kit prior to use.
Water Water used in the water bottle must be alkaline phosphatase-free.
The chemiluminescent substrate used in the instrument is very
sensitive to alkaline phosphatase.
Reaction Tubes Use only the specially designed IMMULITE 2000 systems and
IMMULITE 2500 system reaction tubes. The reaction tubes
must be disposed of after single use.
Dilutions Diluents should not be used beyond the indicated expiration date.
To prevent damage to the dilution well, the polypropylene
dilution well insert must be in place before performing dilutions.
Ventilation Do not block the fan vents on the sides and back panel of the
instrument.
Electrical The instrument must be connected to a dedicated 220V power
service.
Priming The water and substrate probes must be removed from their
stations before priming.
Microsampling Do not use a microsample tube holder with a damaged or dirty
barcode label.
Solid and Liquid Solid and liquid waste may contain biohazardous material.
Waste Follow Universal Precautions when handling.

601005-0004 Rev. A
A-4 Operator’s Guide: Safety Instructions

601005-0004 Rev. A
Appendix B: Service, Ordering, and Warranty

This section provides the following information:

• address of the Siemens authorized representative, which is the Siemens
contact within the European community
• addresses for obtaining service and technical information and for ordering
supplies
• system warranty and service delivery policy information

Siemens Authorized Representative

Siemens Healthcare Diagnostics Inc.
Flanders, NJ 07836-9657 USA

Limited Warranty
LIMITED WARRANTY. Siemens warrants that the software will substantially
conform to specifications and to the documentation, provided that it is used on the
computer hardware and with the operating system for which it is designed.
Siemens also warrants the disks on which the software is recorded to be free from
defects in material and workmanship under normal use for a period of ninety (90)
days from the date of purchase.
Siemens warrants that the items delivered hereunder are of good material and
workmanship, and are free from defects in design and manufacture. Siemens’
responsibility is limited to repairing or replacing any item or part, for a period of
one (1) year after delivery to the original purchaser. Defects caused by improper
operating conditions, misuse, negligence, or alteration of the product void this
warranty. Siemens shall not be liable for any direct, indirect, incidental, or
consequential damages arising out of possession or use of the items.
Consumables, as defined in the appropriate Siemens Price List for
Instrument-Related Parts. Racks and Consumables, are not covered by this
Warranty.
CUSTOMER REMEDIES. Siemens’ entire liability and your exclusive remedy
shall be replacement of the software that does not meet Siemens Limited Warranty
and which is returned to Siemens. The Limited Warranty is void if failure of the
software has resulted from accident, abuse, or misapplication.

601005-0004 Rev. A
B-2 Operator’s Guide: Service, Ordering, and Warranty

NO OTHER WARRANTIES. Because software is inherently complex and may

not be completely free of errors, you are advised to verify your work. The
software and related documentation are provided “as is.” Siemens disclaims all
other warranties, either express or implied, including but not limited to implied
warranties of merchantability and fitness for a particular purpose, with respect to
the software and the accompanying written materials. Siemens shall not be liable
for any direct, indirect, incidental, or consequential damages arising out of
possession or use of this product.

Contacts
This section provides the following information:
• the address of the Siemens authorized representative, which is the Siemens
contact within the European community
• the Siemens addresses for obtaining service and technical information and for
ordering supplies

Addresses
For technical assistance, contact your local technical support provider. For
customer service or additional information, contact your local technical support
distributor.
www.siemens.com/diagnostics

601005-0004 Rev. A
Appendix C: Reagents and System Fluids

The IMMULITE 2000 systems and IMMULITE 2500 system water system is an
automated filling device for the onboard distilled water bottle. It consists of a
valve assembly, which connects the laboratory’s purified water system to the
instrument. The instrument’s onboard water bottle is filled automatically as the
water is utilized by the instrument.
The laboratory is responsible for providing the purified water to the valves at
proper pressure (not to exceed 20 psi). A shut-off valve in the supply line near the
instrument is recommended. This will provide a way to interrupt the water supply
during service.

Instrument Water System

The IMMULITE 2000 systems and IMMULITE 2500 system water system is
self-contained and requires minimal maintenance by the operator. It is
recommended that a minimum of 300 tests per day be processed on an instrument
using the automated water system.

Operation of the Instrument Water System

The IMMULITE 2000 systems and IMMULITE 2500 system water system
functions by detecting the level of water in the water bottle and refilling it by
activating a set of valves. These valves control the flow of water from the
laboratory’s water system into the water bottle.
The level of water in the water bottle is measured utilizing the instrument load
cell. The load cell sits underneath the water bottle and measures its weight. As
water is used by the instrument, the water bottle becomes lighter. This signals
control valves in the water system manifold to open, filling the water bottle until
the weight returns to the full/maximum value.
There is also a float switch located inside the water bottle, which prevents
overfilling. Water will not be allowed to flow into the water bottle unless the float
switch is below the preset open position. This is important in situations where the
water bottle is removed from the load cell for any length of time or the load cell is
damaged or malfunctions.
For more information about maintaining the water system, refer to the following
sections:
• Decontaminating the Bottles and Lines‚ page 5-27
• Water System Routine Maintenance‚ page 5-31

601005-0004 Rev. A
C-2 Operator’s Guide: Reagents and System Fluids

Bypassing the IMMULITE 2000 Water System

The water system may be bypassed if it fails, or it becomes necessary to return the
instrument to the standard water bottle. Contact Technical Service prior to bypass
the Water System.
To fill the water bottle, refer to Checking and Filling the Water Bottle‚ page 5-7.
Turn off the direct water feed power switch located behind the sample carousel.
Look for the label marked water supply.

Troubleshooting and Frequently Asked Questions

The following are some common troubleshooting scenarios and frequently asked
questions.
Situation Possible Cause Solution
Water Bottle does not Water supply is turned off. Turn water supply on.
fill
Connections to the water Properly attach tubing or
bottle are not attached, such wire.
as tubings and sensor wire.
The load cell is not working Check the consumables graph
properly. on the Home screen of the
instrument. If it displays full
and the bottle is empty, call
technical service.
Water Bottle overfills Water supply pressure is too Adjust supply pressure to less
high. than 20 PSI.
Float valve not properly Check and re-seat the float
seated. valve.
Water bottle not seated Assure the bottle is fully
properly on the load cell. seated on the load cell and the
tubings and wires are not
impinged.
Water source is contaminated. Contact water supplier for
correction.
Less than 300 tests are run Empty water bottle and allow
per day. it to refill before use.
Instrument has been idle for Empty water bottle and allow
greater than 48 hours. it to refill before use.
Water system valve is Contact technical service for
contaminated. service. Bypass the water
system to continue running.
Refer to Bypassing the
IMMULITE 2000 Water
System‚ page C-2.

601005-0004 Rev. A
Appendix D: Supplies

Consumables and Accessories

IMMULITE 2000 Systems and 2500 System consumables and accessories are
listed in the table below. To place an order, contact Siemens or a distributor.
NOTE: Those outside the United States should contact a National Distributor to
place an order.
Part Number Description Quantity
L2ATC Allergen Tube Caps* 1000
L2ATS2 Allergen Tube Septa* 250
L2AW1 Allergen Wedge Set 33
400920 Allergy Imaging Scanner 1
Training Guide
901863 Barcode Label Printer Ribbon 1
901864 Barcode Label Stock 1
400790 Barcode Printer Kit 1
400925-01 Barcode Scanner (Standard) 1
400925-02 Barcode Scanner (Wedge 1
Allergy Assay)
10-901807 Biohazard Bags* 20
422023 CO2 Scrubber Kit 1
CON6 Con6 Multivalent Control 2
Module
400763 Decontamination Bottle 1
500912 Dilution Well Insert (2) 2
501705 Distilled Water Bottle (6L) 1
901689 Extension Cable for Monitor 1
901801 Fan Filter 1
902666 Image Drum (OKI 14E) 1
Not available for
IMMULITE 2000 XPi.
902934 Image Drum (OKI B4200) 1
Not available for
IMMULITE 2000 XPi.

601005-0004 Rev. A
D-2 Operator’s Guide: Supplies

Part Number Description Quantity

901824 Ink cartridge - black ink 1
(710C printer) Not available for
IMMULITE 2000 XPi.

902058 Ink cartridge - black ink 1

(810C printer) Not available for
IMMULITE 2000 XPi.
902058-02 Ink cartridge - black ink 1
(970C printer) Not available for
IMMULITE 2000 XPi.
902057-02 Ink cartridge - color ink 1
(970C printer) Not available for
IMMULITE 2000 XPi.
901825 Ink cartridge - color ink 1
(710C printer) Not available for
IMMULITE 2000 XPi.
902057 Ink cartridge - color ink 1
(810C printer) Not available for
IMMULITE 2000 XPi.
901205 In-Line Filters* 6
400753-54 Keyboard (English - U.K.) 1
400753-53 Keyboard (English - U.S.) 1
400753-58 Keyboard (French) 1
400753-55 Keyboard (German) 1
400753-57 Keyboard (Italian) 1
400753-56 Keyboard (Spanish) 1
400753-59 Keyboard (Swedish) 1
901728 Keyboard Cover 1
400271 LIS ASTM Specifications 1
422013 LIS Comm Program 1
501706 Liquid Waste Bottle (6L) 1
LMH5 Microsample Inserts - set of 5 5
LMH15 Microsample Inserts - set of 15
15
LSMC Microsample Tube Caps* 1000
LMST Microsample Tubes* 1000
400755 Monitor Power Cable 1
901729 Paper (1 ream) 1
400767 Power Cord (US) 1

601005-0004 Rev. A
Operator’s Guide: Supplies D-3

Part Number Description Quantity

901836-01 Power Cord (Argentina, 1
Austria, Brazil, Finland,
France, Germany,
Netherlands, Norway,
Sweden)
901836-02 Power Cord (Hong Kong, 1
Singapore, United Kingdom)
901836-03 Power Cord (Australian, New 1
Zealand)
901836-04 Power Cord (Denmark) 1
901836-05 Power Cord (Switzerland) 1
901836-06 Power Cord (Chile, Italy) 1
901836-07 Power Cord (Israel) 1
901836-08 Power Cord (South Africa) 1
901835 Primary Tube Sample Guide 1
400537 Probe Assembly 2
L2KPM Probe Cleaning Kit 1
L2PWSM Probe Wash (2 Bottles) 1
400706 Probe Wash Bottle (2L) 1000
422223 Printer: Okidata 4250 1
Not available for
IMMULITE 2000 XPi.
LRXT Reaction Tubes 26 (A-Z)
400726-01 Reagent Bottle Assembly 1
(substrate)
650104 Sample Rack Letters 1
400756 Sample Racks 1
901519 Scanner Cable 1
400749 Side Tray 1
472021 Software Barcode Label 20
Printer
400634 Solid Waste Container 2
10-901807 Solid Waste Container 1
Biohazard Bags
400794 Substrate (2 Bottles) 1
400726-01 Substrate Reservoir (250 mL) 1
901865 Thermal Cleaning Kit 1

601005-0004 Rev. A
D-4 Operator’s Guide: Supplies

Part Number Description Quantity

902665 Toner Cartridge (OKI 14E) 1
Not available for
IMMULITE 2000 XPi.
902933 Toner Cartridge (OKI B4200) 1
Not available for
IMMULITE 2000 XPi.
901427 Touchscreen Monitor 1
400754 Trackball 1
403034 Tube Top Sample Rack 2
Only available for
IMMULITE 2000 XPi.
901720 UPS 1400 VA Output 1
(Approx. 20 minutes)
901721 UPS 1800 VA Output 1
(Approx. 25 minutes)
901722 UPS 2200 VA Output 1
(Approx. 30 minutes)
400918 Waste Chute Clean Out Tool 1
400909-01 Water Feed Control System 1
501705 Water Supply Bottle 1
905288 Tube Top Sample Cups 1000
REF 0374178
905289 Tube Top Sample Cups 1000
REF 10374179
* For single use only. Do not reuse.

601005-0004 Rev. A
Appendix E: System Specifications

Specifications Tables
This section includes the following IMMULITE 2000 systems and IMMULITE
2500 system specification tables.
• Output Specifications
• Fluid Usage Specifications
• Computer System Specifications
• Dilution Volumes

Output Specifications
The Output Specifications Table below displays the expected outputs for the
IMMULITE 2000 systems and IMMULITE 2500 system.
Output Specification Quantity
Throughput Up to 200 tests per hour
Time to first result IMMULITE 2000 systems: 35 minutes
IMMULITE 2500 system: 15 minutes
Tests per sample Unlimited

Fluid Usage Specifications

The fluid specifications are listed in the table below:
Volume
Used Per Volume of Full Approx. Number of
Fluid Test‡ Container Tests Per Container†
Water 7.5 mL 6000 mL 800
Probe Wash 2.0 mL 2000 mL 1000
Substrate 0.2 mL 205 mL 1025
†Number of Tests Per Full Container may vary depending upon amount of priming performed.
‡Volume Used Per Test is based upon a one-cycle, undiluted assay. Add 3 mL for a two-cycle
(sequential) assay. If an assay is diluted onboard, add an additional 1 ml.

601005-0004 Rev. A
E-2 Operator’s Guide: System Specifications

Computer Specifications
The current specifications for the computer supplied with the IMMULITE 2000 systems and
IMMULITE 2500 system display in the table below. These specifications are subject to change
without notice.

WARNING
The computer supplied with the instrument was designed to run the included
software. The installation of third-party software programs may adversely affect
the proper operation of the instrument software or analyzer and may void the
product warranty. Refer to Limited Warranty for more information.

For IMMULITE 2000 and IMMULITE 2500 Systems

Specification Description
Processor Pentium II with a minimum 800 Mhz
RAM 256 megabyte
Hard Drives (3) • 40-gigabyte user
• 40-gigabyte back-up
• 40-gigabyte control
Monitor 19-inch flat screen monitor with Surface Acoustic
Wave touchscreen

For IMMULITE 2000 XPi Systems

Specification Description
Processor Integrate Core 2 Duo, 2.13 GHz
RAM 2 GB
Hard Drives (3) • SATA hard drive user
• DVD-RW drive backup
External Port USB
Monitor 19-inch flat screen monitor with Surface Acoustic
Wave touch-screen

Dilution Volume Specifications

The Dilution Volumes Specification Table below displays the amount of sample,
water, and diluent used for onboard dilutions.
Sample
Dilution Volume (μL) Water Volume (μL) Diluent Volume (μL)
3X 67 80 53
5X 40 96 64
10X 20 108 72

601005-0004 Rev. A
Operator’s Guide: System Specifications E-3

Sample
Dilution Volume (μL) Water Volume (μL) Diluent Volume (μL)
20X 10 114 76
40X 5 117 78
100X 5 297 198

Sample Volume and Tube Sizes

WARNING
Sample cups placed in the tops of primary collection tubes are not approved for
use on the IMMULITE 2000 and IMMULITE 2500 systems. Placing sample or
nesting cups in a primary tube may cause the system to use an inaccurate sample
volume during testing. The principle risk is undetected short sampling from the
cup, creating a risk of erroneous results.

Only the IMMULITE 2000 XPi instrument supports this type of testing on the
tube top rack with the approved tube top sample cups / nesting cups.

WARNING
Ensure that you use only these tube sizes, and that the tubes are firmly seated in
the Sample Racks. Otherwise, sampling problems or incorrect results may occur.

WARNING
Ensure that you use only 16 x 100 mm tubes for diluents. Using narrower or
shorter tubes can cause short-sampling of the diluent under certain conditions.
To determine the correct primary tube sample volume, see the Sample Tube Guide
(Part Number 901835). The following primary and secondary round bottom tube
sizes may be used.
Approved Tube Sizes
12 x 75 mm 12 x 100 mm
13 x 75 mm 13 x 100 mm
16 x 75 mm 16 x 100 mm

To process small sample volumes, use only the microsample tubes and tube
holders available with the IMMULITE 2000 and IMMULITE 2500 instruments.
Refer to Loading Microsamples‚ page 2-5.

601005-0004 Rev. A
E-4 Operator’s Guide: System Specifications

The Sample Racks are labeled alphabetically: A, B, C, D, E, F, etc.

NOTE: Sample rack labels are available from A-Z.

Do not use two or more Sample Racks with the same letter – the instrument will
not run.
The sample volume required varies with the assay to be run and the number of
replicates requested on that sample.
The exact sample volume required for each test can be found in the corresponding
package insert. An additional 250 µl of sample is required for proper instrument
operation.
If there is insufficient volume, an error message displays and “Sample Error”
displays on the Display Worklist screen.

601005-0004 Rev. A
Appendix F: Instrument Symbols

Icon Glossary
IVD Symbols are International representations of information and/or instructions
on the Instrument's labeling. The following table displays the International
symbols that display on the Instrument's labeling and their definitions.
Symbol Description
Consult instructions for use

Do not re-use

Fragile, handle with care.

Caution, refer to accompanying documents

Batch code

Catalog number
Serial number
Use by (expiration date)

Sterile

Sterilized using aseptic processing techniques

Sterilized using radiation

Sterilized using ethylene oxide

Sterilized using steam or dry heat

Biological risk

Non-sterile

Do not re-sterilize

601005-0004 Rev. A
F-2 Operator’s Guide: Instrument Symbols

Symbol Description
Keep away from heat

Keep dry

Protect from heat and radioactive source

Lower limit of temperature

Temperature limitation

Upper limit of temperature

Control

Negative control

Positive control

Date of manufacture

Do not use if package is damaged

In vitro diagnostic medical device

Manufactured by

Contains sufficient for <X> tests

For Performance Evaluation only

Representative in European Community

601005-0004 Rev. A
Appendix G: Installation and Relocation

Overview - Installation Preparation

The IMMULITE 2000 systems and IMMULITE 2500 system must be installed by
an authorized Siemens Diagnostics Service Representative. Before the Service
Representative's arrival, make a few simple preparations to expedite the
installation process.
Upon receipt of the instrument and computer, inspect the shipping container. If
there is any external damage to the container, notify your shipping department and
call Technical Service.
Next, select a suitable location for the system based on the power, space, and
temperature requirements described in this section.

Choosing a Location
Select a suitable location for the instrument in the laboratory, based on power,
space, and temperature requirements.

Power Requirements
Keep the following requirements in mind when choosing a location for the
system.
Use one of the following dedicated voltage power supply services.
• 200
• 208
• 220
• 230
• 240

CAUTION
Do not place the system near centrifuges, ultrasound or X-ray machinery, NMR
scanners, or other sources of magnetic fields.

601005-0004 Rev. A
G-2 Operator’s Guide: Installation and Relocation

Space Requirements
Keep the following space requirements in mind when choosing a location for the
system:
• The instrument must be on a level floor.
• For proper airflow, leave at least 4 inches of space around the sides and back
of the instrument.
• The IMMULITE 2000 system and IMMULITE 2500 system dimensions are
59.7 inches wide, 29.7 inches deep, and 79 inches high.
• The IMMULITE 2000 XPi system dimensions are 63 inches wide, 36 inches
deep, and 72 inches high.

Temperature Requirements
Keep the following temperature requirements in mind when choosing a location
for the system:
• The temperature should be between 18° and 32° Celsius.
• The relative humidity should be less than 80% for a temperature up to 32°
Celsius.
• The IMMULITE 2000 systems and IMMULITE 2500 system generates 3,413
BTU/hr.

Water Requirements
Distilled or de-ionized water of consistent quality is required. Water used should
meet NCCLS Type 1 reagent water standards at the time of preparation. Prior to
using any water, it should be tested for alkaline phosphatase contamination.
For detailed instructions, including how to evaluate the results, refer to Water Test
Procedure (IMMULITE 2000 System)‚ page 5-32 or Water Test Procedure
(IMMULITE 2500 System)‚ page 5-33.
IMMULITE systems are sensitive to the presence of alkaline phosphatase
resulting from microbial contamination of the water or the containers used.
Properly maintained commercial water treatment systems commonly used in
laboratories generally produce reagent water that meets the requirements of Type
1 water standards at the time of preparation.

601005-0004 Rev. A
Operator’s Guide: Installation and Relocation G-3

Often, high quality reagent water becomes contaminated during storage and
transport. To ensure water quality on the system:
• Keep commercial water systems appropriately maintained.
• Do not use water from a commercial water system while maintenance is being
performed. After maintenance, verify water system cleanliness and test the
water for alkaline phosphatase contamination.
• Maintain cleanliness of storage containers, transfer containers, spigots, hoses
or other plumbing used to transfer water from its source to the instrument.
• Limit the length of plumbing between the source and the instrument. Long
plumbing lines increase the likelihood of introducing contamination.
NOTE: On rare occasions, non-alkaline phosphatase water contaminants may
interfere with individual assays. The Water Testing Procedure used to detect
alkaline phosphatase will not detect these contaminants. For assistance, call
Technical Service.

601005-0004 Rev. A
G-4 Operator’s Guide: Installation and Relocation

601005-0004 Rev. A
Appendix H: Error Messages

When the Instrument encounters an error, two messages

are generally reported; one from the Control Side
computer and one from the User Side computer.
• Control Side Computer
Controls the motion of all instrument motors. Messages from this computer
include raw data about events, such as bad bead pack. These messages
indicate what is wrong but are not specific.
• User Side Computer:
• Displays instrument screens and performs result management functions. This
computer receives messages from the control side computer and provides
more specific information, such as, Rerunning test HCG marked as bad by
bead pack error.

Reading both messages allows the operator to better

understand what event occurred and why. This section
discusses error message severities and priorities,
explains some of the common errors and solutions,
covers flags associated with results, and lists common
errors and solutions.

Error Message Severity and Priority

Error messages display on-screen within either white or

red boxes, or are written to the daily error log
without displaying on the screen. For error messages
that are displayed, the box color indicates the
severity of the message – white boxes contain
informative messages and instrument status, while red
boxes contain important warnings and errors.
• WARNING – indicates the Instrument requires attention soon. It does not
affect the patient results or the operation of the Instrument.
• ERROR – requires the operator's attention but does not stop the entire
Instrument from running. Typically, only one compartment is stopped.
• SEVERE – may stop the Instrument and requires the operator's immediate
attention.

601005-0004 Rev. A
H-2 Operator’s Guide: Error Messages

Within each severity level (white or red box) are

several priority levels. The higher the priority, the
greater the importance of the error message. In
addition, priorities within a specific severity level
are differentiated by the color text used or the
accompanying icon. For example, a message about a low
luminometer temperature displays in a white box with
black print and has a low priority (1), while a message
about an instrument status that needs attention
displays in a white box with red print and has a higher
priority (3).

The following table describes the types of messages

that are displayed:
Priority Severity Description
0 Daily Error Information messages that become apparent on result
Log printouts and appropriate screens, such as no reagent on
board.
1 White box Informative messages indicating instrument has taken an
black print automatic action, such as reordering a test.
2 White box Messages indicating Instrument status that will result in a
blue print problem if left unattended, such as substrate low.
3 White box Messages indicating Instrument status that needs attention
red print and will imminently result in a problem, such as substrate is
empty.
11 Red box Circumstances not addressed by priorities 12 and 13 that
warning require immediate attention.
icon
12 Red box Instrument has entered Pause mode and is no longer
error icon processing new samples.
13 Red box Instrument shut down; only the Luminometer is active.
severe icon

Common Errors and Solutions

Following is a list of some of the more common errors

and how they may be resolved. For more detailed
information on error messages, causes, and solutions,
refer to List of Error Messages‚ page H-4.
• (237) Sample Pipettor Did Not Level Sense

601005-0004 Rev. A
Operator’s Guide: Error Messages H-3

This usually indicates an insufficient (i.e., short) sample amount. Add

additional sample and repeat.
• (287, 302, 392) Sample, Reagent, or Bead Carousel has Jammed While
Homing
Reseat the sample rack, reagent wedge, or bead pack as necessary.
• (380) Errors Have Shutdown the MCP Routine
Check for sample, bead, and reagent carousel jams and re-run the
IMMULITE 2000 program.
• (524) Sample Door or Main Cover is Open
Close the appropriate doors or covers; IMMULITE 2000 will continue to
initialize.
• (534) Tip Jam Reagent Pipettor
This message indicates that the pipetting probe has physically contacted
something solid. Check to see that the reagent wedge is properly seated and
the reagent wedge glide is properly attached and moves freely.
• (547) Reagent Probe False Level Sensed at top or above wedge
Remove the reagent wedge and open the glide (lid). Dry the top of the reagent
wedge with a clean, lint free wiper and re-install the glide.
• (555) No Reaction Tube Detected Going into Bead Pause
Refill the tube hopper as needed and check for jams in the orientation chute.
• (594) Marking Sample Tube as Bad
This usually indicates an insufficient (i.e., short) sample amount. Add
additional sample and repeat.
• (595) Marking Reagent Pack as Bad
• Check the associated error message, such as Reagent False Level Sense, to
correct the situation.
• (12400) Substrate Low (or Empty)
Refill the substrate reservoir.
• (12406) Probe Wash Low (or Empty)
Refill the probe wash bottle.
• (12408) Water Supply Low (or Empty)
• Refill the distilled/de-ionized water bottle.
• (12506) Substrate Temperature Low
• If this message continues for more than 10 minutes, it may indicate a failure
with the substrate probe heater. In this situation, contact your local service
provider or distributor.

601005-0004 Rev. A
H-4 Operator’s Guide: Error Messages

Flags Associated with Results

The following flags may appear with results. For more

detailed information on error messages, causes, and
solutions, List of Error Messages‚ page H-4.
Flag Description
QC One or more controls have failed for this assay.
HIGH Result is greater than the operator-specified normal range (i.e., above
the first line of the test range).
Refer to Defining Test Ranges‚ page 8-12 for more information about
defining test ranges.
LOW Result is less than the operator-specified normal range (i.e., below the
first line of the test range).
Refer to Defining Test Ranges‚ page 8-12 for more information about
defining test ranges.
ADJ • Adjustment for this assay failed due to slope limits
• Adjustment for this assay is overdue for readjustment by more
than 24 hours
• The assay was never adjusted.
• The kit was overwritten.
ERROR Unable to calculate the result. The result should be verified.
EXP The Kit expired.
TMP The Substrate, Luminometer, and/or Incubator temperature was out of
range when this result was calculated.
Review Low Result is less than the operator-specified review range.
Refer to Defining Test Ranges‚ page 8-12 for more information about
defining test ranges.
Review High Result is greater than the operator-specified review range.
Refer to Defining Test Ranges‚ page 8-12 for more information about
defining test ranges.

List of Error Messages

The IMMULITE 2000/2500 error messages are listed in

numerical order:

0-100
Programming Errors
Occurs when underlying hardware errors cause software communication issues.
§If the message persists, call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-5

101
Z8 and MCP not communicating
Communication Error between Control PC and Slave card.
§Call Technical Service.

102
Programmer error
Communication Error between Control PC and Slave card.
§Call Technical Service.

103
Cannot locate the POSITION.IML file
The missing file was either deleted or moved to another directory.
§Call Technical Service.

104
Cannot locate the current version of POSITION.IML file
The file is corrupt and contains invalid information.
§Call Technical Service.

105
POSITION.IML is corrupt
The file is corrupt and contains invalid information.
§Call Technical Service.

106
LmiMoveMotor has taken longer than 18 seconds.
A MoveMotor motion to a configured position has taken longer than 18 seconds.
§Call Technical Service.

108
LmiMoveSensor has taken longer than 18 seconds.
A MoveMotor motion to a sensor position has taken longer than 18 seconds.
§Call Technical Service.

601005-0004 Rev. A
H-6 Operator’s Guide: Error Messages

111
LmiMoveHome has taken longer than 18 seconds.
A Motor move to a HOME sensor position has taken longer than 18 seconds
have.
§Call Technical Service.

114
LmiReadPMT has taken longer than 18 seconds.
The PMT read has taken longer than 18 seconds.
§Call Technical Service.

115
LmiMoveEnc cannot move more than 65535 motor steps.
The MoveEncoder has calculated that it must take more than 65,535 steps to
reach a configured encoder position.
§Call Technical Service.

116
LmiDrawDiluter has taken longer than 18 seconds.
A DRD/Aspiration motion to a configured position has taken longer than 18
seconds.
§Call Technical Service.

118
LmiDispenseDilutor has taken longer than 18 seconds.
A DRD/Dispense motion to a configured position has taken longer than 18
seconds.
§Call Technical Service.

120
LmiDrawBiphasic has taken longer than 18 seconds.
A DRD Aspiration Probe Wash motion to a configured position has taken longer
than 18 seconds.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-7

122
LmiDispenseBiPhasic has taken longer than 18 seconds.
A DRD/Dispense (Probe Wash) motion to a configured position has taken longer
than 18 seconds.
§Call Technical Service.

124
LmiMoveDilutorEnc cannot move than 65535 motor steps.
The DRD MoveEncoder has calculated that it must take more than 65,535 steps
to reach a configured encoder position.
§Call Technical Service.

125
LmiMoveBiPhasic cannot move more than 65535 motor
steps.
A Timed Tube Spinner motion has taken longer than 18 seconds.
§Call Technical Service.

126
Tube spinner exceeded the 18 seconds
A Timed Tube Spinner motion has taken longer than 18 seconds.
§Call Technical Service.

127
LmiTimedDilutionWell has taken longer than 18 seconds.
A Timed Dilution Well motion has taken longer than 18 seconds.
§Call Technical Service.

128
Sample Pipettor jammed in the X direction
Sample Pipettor has jammed while moving in the horizontal direction.
§Check that the sample tube or diluent tube is seated correctly.
§Check the movement of Pipettor is not obstructed.
§Check for unauthorized tube tops (sample cups sitting on top of tubes).
§Check that the Sample Probe is not bent.
§If the message persists, call Technical Service.

601005-0004 Rev. A
H-8 Operator’s Guide: Error Messages

129
Sample Pipettor exceeded 18 seconds in the X direction
Sample Pipettor horizontal movement to a configured position has taken longer
than 18 seconds.
§Call Technical Service.

130
Sample Pipettor movement exceeded 65535 steps in the X
direction
Sample Pipettor has calculated that it must take more than 65535 steps to reach a
configured encoder position.
§Call Technical Service.

132
Sample Pipettor jammed in the Z direction
Sample Pipettor has jammed while moving in the vertical direction.
§Check that the sample tube or diluent tube is seated correctly.
§Check the movement of Pipettor is not obstructed.
§Check for caps on sample tubes.
§Check for unauthorized tube tops (sample cups sitting on top of tubes).
§Check that the Sample Probe is not bent.
§If the message persists, call Technical Service.

133
Sample Pipettor exceeded 18 seconds in the Z direction
Sample Pipettor vertical movement to a configured position has taken longer than
18 seconds.
§Call Technical Service.

134
Sample Pipettor movement exceeded 65535 steps in the Z
direction
Sample Pipettor has calculated that it must take more than 65535 steps to reach a
configured encoder position.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-9

136
Sample Pipettor jammed in the Z direction
Sample Pipettor has jammed while moving in the vertical or Z out direction.
§Check that the sample tube or diluent tube is seated correctly.
§Check the movement of Pipettor is not obstructed.
§Check for caps on sample tubes.
§Check for unauthorized tube tops (sample cups sitting on top of tubes).
§Check that the Sample Probe is not bent.
§If the message persists, call Technical Service.

137
Sample Pipettor exceeded 18 seconds in the Z direction
A single Sample Pipettor's Z out movement to a configured position has taken
longer than 18 seconds.
§Call Technical Service.

139
Sample valve jammed
The Sample Valve has jammed.
§Call Technical Service.

140
Sample valve exceeded 18 seconds
A single Sample Valve movement to a configured position has taken longer than
18 seconds.
§Call Technical Service.

141
Sample valve movement exceeded 65535 steps
Sample Valve has calculated that it must take more than 65535 steps to reach a
configured encoder position.
§Call Technical Service.

143
Reagent Pipettor jammed in the X direction
The Reagent Pipettor has jammed while moving in the horizontal direction.
§Check that the Reagent Wedge is seated correctly.
§Movement of Pipettor is obstructed.
§If the message persists, call Technical Service.

601005-0004 Rev. A
H-10 Operator’s Guide: Error Messages

144
Reagent Pipettor exceeded 18 seconds in the X direction
A single Reagent Pipettor movement to a configured position in the X (horizontal)
direction has taken longer than 18 seconds.
§Call Technical Service.

145
Reagent Pipettor movement exceeded 65535 steps in the X
direction
Reagent Pipettor has calculated that it must take more than 65535 steps to reach
a configured encoder position in the X (horizontal) direction.
§Call Technical Service.

147
Reagent Pipettor jammed in the Z direction
Reagent Pipettor has jammed while moving in the vertical direction.
§Check that the Glide is on correctly.
§Check that the Wedge is seated correctly.
§If the message persists, call Technical Service.

148
Reagent Pipettor exceeded 18 seconds in the Z direction
A single Reagent Pipettor movement to a configured position in the Z (vertical)
direction has taken longer than 18 seconds.
§Call Technical Service.

149
Reagent Pipettor movement exceeded 65535 steps in the Z
direction
Reagent Pipettor has calculated that it must take more than 65535 steps to reach
a configured encoder position in the Z (vertical) direction.
§Call Technical Service.

151
Reagent Pipettor jammed in the Z direction
The Reagent Pipettor has jammed while moving in the vertical or Z-out direction.
§Check that the Glide is on correctly.
§Wedge is not seated correctly.
§If the message persists, call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-11

152
Reagent Pipettor exceeded 18 second in the Z direction
A single Reagent valve movement to a configured position has taken longer than
18 seconds.
§Call Technical Service.

154
Reagent valve jammed
Reagent Valve has jammed.
§Call Technical Service.

155
Reagent valve exceeded 18 seconds
A single Reagent valve movement to a configured position has taken longer than
18 seconds.
§Call Technical Service.

156
Reagent valve movement exceeded 65535 steps
Reagent Valve has calculated that it must take more than 65535 steps to reach a
configured encoder position.
§Call Technical Service.

158
Tube indexer jammed
Tube Indexer has jammed.
§Verify correct Reaction Tube is used.
§Check for a malformed tube.
§Check for obstructions.
§If the message persists, call Technical Service.

159
Tube indexer exceeded 18 seconds
A single Tube Indexer movement to a configured position has taken longer than
18 seconds.
§Call Technical Service.

601005-0004 Rev. A
H-12 Operator’s Guide: Error Messages

160
Tube indexer movement exceeded 65535 steps
Tube Indexer has calculated that it must take more than 65535 steps to reach a
configured encoder position.
§Call Technical Service.

162
Tube transport jammed
Tube Transport Chain has jammed.
§Verify correct tubes are used.
§Check for malformed tube.
§Visually inspect chain for any kind of interference.
§If the message persists, call Technical Service.

163
Tube transport exceeded 18 seconds timer
A single Tube Transport chain movement to a configured position has taken
longer than 18 seconds.
§Call Technical Service.

164
Tube transport movement exceeded 65535 steps
Tube Transport Chain has calculated that it must take more than 65535 steps to
reach a configured encoder position.
§Call Technical Service.

166
Tube Transport cannot find home flag
Tube Transport chain cannot find home.
§Call Technical Service.

167
Processor shuttle has jammed
Processor Shuttle has jammed a second time while trying to move a fixed number
of steps.
§Remove mispositioned Reaction Tube.
§If the message persists, call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-13

168
Processor shuttle movement has exceeded 18 second timer
A single Processor shuttle movement to a configured position has taken longer
than 18 seconds.
§Call Technical Service.

169
Processor shuttle movement exceeded 65535 steps
The Processor Shuttle has calculated that it must take more than 65535 steps to
reach a configured encoder Position.
§Call Technical Service.

171
Incubator chain jammed
Incubator chain has jammed.
§Check for obstruction at the pipetting area. Remove tube.
§If the message persists, call Technical Service.

172
Incubator chain exceeded 18 second timer
A single Incubator Chain movement to a configured position has taken longer than
18 seconds.
§Call Technical Service.

173
Home sensor missed Incubator chain flag
Incubator chain cannot find home.
§Call Technical Service.

175
Luminometer shuttle has jammed
Luminometer shuttle has jammed.
§Check for overfilled or incorrectly seated solid waste container.
§Check for correct Biohazard Bags.
§Clear the Exit Chute using the Waste Chute Clean Out tool and check for
Reaction Tubes obstructing the chute.
§Check Reaction Tubes in the Tube Hopper for any abnormalities.
§Check for clear plastic protruding from the upper trap opening and for plastic
pieces in the Solid Waste Container.
§If the message persists, call Technical Service.

601005-0004 Rev. A
H-14 Operator’s Guide: Error Messages

176
Luminometer shuttle exceeded 18 second timer
A single Luminometer Shuttle movement to a configured position has taken longer
than 18 seconds.
§Call Technical Service.

178
Tube lifter has jammed
Tube Lifter has jammed.
§Call Technical Service.

179
Tube lifter exceeded 18 second timer
A single Tube Lifter movement to a configured position has taken longer than 18
seconds.
§Call Technical Service.

180
Tube lifter movement exceeded 65535 steps
A single Tube Lifter movement to a configured position has taken longer than 18
seconds.
§Call Technical Service.

182
Luminometer chain has jammed
Luminometer Chain has jammed.
§Check for overfilled or incorrectly seated Solid Waste container.
§Check for correct Biohazard Bags.
§Clear the Exit Chute and check for Reaction Tubes obstructing the chute.
§Check Reaction Tubes in the Tube Hopper for any abnormalities.
§Call Technical Service.

183
Luminometer chain exceeded 18 second timer
A single Luminometer Chain movement to a configured position has taken longer
than 18 seconds.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-15

185
PMT shutter has jammed
An error was detected in the vertical movement of the PMT shutter. The
Instrument tries to correct itself and continue processing assays. If the error
cannot be corrected, the Instrument stops processing tubes and another error
message appears. The results for tubes following this second error message are
lost.
§Call Technical Service.

186
PMT shutter exceeded 18 second timer
A single PMT Shutter movement to a configured position has taken longer than 18
seconds.
§Call Technical Service.

187
PMT shutter movement exceeded 65535 steps
The PMT shutter has calculated that it must take more than 65535 steps to reach
a configured encoder Position.
§Call Technical Service.

189
Attenuator disk has jammed
Attenuator Disk has jammed.
§Call Technical Service.

190
Attenuator disk exceeded 18 second timer
A single Attenuator Disk movement to a configured position has taken longer than
18 seconds.
§Call Technical Service.

191
Attenuator disk movement exceeded 65535 steps
The Attenuator Disk has calculated that it must take more than 65535 steps to
reach a configured encoder Position.
§Call Technical Service.

601005-0004 Rev. A
H-16 Operator’s Guide: Error Messages

193
Dilution well exceeded 18 second timer
The dilution well has taken longer than 18 seconds to process a command.
§Call Technical Service.

194
Sample dilutor has jammed aspirating sample
Sample DRD has jammed while aspirating.
§Check for physical obstruction preventing the DRD from moving.
§Check for Sample Probe obstruction.
§If the message persists, call Technical Service.

195
Sample dilutor exceeded 18 second timer
A single one-speed Sample DRD draw motion, such as draw air slug, has taken
longer than 18 seconds.
§Call Technical Service.

197
Sample dilutor has jammed aspirating probe wash
Sample DRD has jammed a second time while aspirating probe wash.
§Check for physical obstruction preventing the DRD from moving.
§Check for Sample Probe obstruction.
§If the message persists, call Technical Service

198
Sample dilutor exceeded 18 second timer
A single two-speed Sample DRD draw motion (e.g., draw probe wash) has taken
longer than 18 seconds.
§Call Technical Service.

200
Sample dilutor has jammed dispensing sample
Sample DRD has jammed a second time while dispensing.
§Check for physical obstruction preventing the DRD from moving.
§Check for Sample Probe obstruction.
§If the message persists, call Technical Service

601005-0004 Rev. A
Operator’s Guide: Error Messages H-17

201
Sample dilutor exceeded 18 second timer
A single two-speed Sample DRD draw motion (e.g., draw probe wash) has taken
longer than 18 seconds.
§Call Technical Service.

203
Sample dilutor has jammed during biphasic dispense
Sample DRD has jammed a second time while dispensing.
§Check for physical obstruction preventing the DRD from moving.
§Check for Sample Probe obstruction.
§If the message persists, call Technical Service.

204
Sample dilutor exceeded 18 second timer
A single two-speed Sample DRD dispense motion has taken longer than 18
seconds.
§Call Technical Service.

206
Sample dilutor has jammed dispensing into blind hole
Sample DRD has jammed.
§Check for physical obstruction preventing the DRD from moving
§Check for physical obstruction of pipettor movements.
§If the message persists, call Technical Service.

207
Sample dilutor exceeded 18 second timer
A Sample DRD motion to a configured position has taken longer than 18 seconds.
§Call Technical Service.

208
Sample dilutor movement exceeded 65535 steps
The Sample DRD has calculated that it must take more than 65,535 steps to
reach a configured encoder position.
§Call Technical Service.

601005-0004 Rev. A
H-18 Operator’s Guide: Error Messages

210
Sample dilutor has jammed
Sample DRD has jammed a second time while moving to a configured position
and performing a two-speed move.
§Check for physical obstruction preventing the DRD from moving.
§Check for physical obstruction of pipettor movements.
§Call Technical Service.

211
Sample dilutor exceeded 18 second timer
A Sample DRD motion to a configured position using a two-speed move has
taken longer than 18 seconds.
§Call Technical Service.

212
Sample dilutor movement exceeded 65535 steps
The Sample DRD has calculated that it must take more than 65,535 steps to
reach a configured encoder position using a two-speed move.
§Call Technical Service.

214
Reagent dilutor has jammed aspirating reagent
Reagent DRD has jammed a second time while performing a one-speed draw
motion (air slug, sample, etc).
§Check for physical obstruction preventing the DRD from moving.
§If the message persists, call Technical Service.

215
Reagent dilutor exceeded 18 second timer
A single one-speed Reagent DRD draw motion, such as draw air slug, has taken
longer than 18 seconds.
§Call Technical Service.

217
Reagent dilutor has jammed aspirating probe wash
Reagent DRD has jammed a second time while performing a two-speed draw
motion (probe wash aspiration).
§Check for physical obstruction preventing the DRD from moving.
§If the message persists, call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-19

218
Reagent dilutor exceeded 18 second timer
A single two-speed Reagent DRD draw motion (e.g., draw probe wash) has taken
longer than 18 seconds.
§Call Technical Service.

220
Reagent dilutor has jammed dispensing reagent
Reagent DRD has jammed.
§Check for physical obstruction preventing the DRD from moving.
§If the message persists, call Technical Service.

221
Reagent dilutor exceeded 18 second timer
A single one-speed Reagent DRD dispense motion has taken longer than 18
seconds.
§Call Technical Service.

223
Reagent dilutor has jammed during biphasic dispense
Reagent DRD has jammed.
§Check for physical obstruction preventing the DRD from moving.
§If the message persists, call Technical Service.

224
Reagent dilutor exceeded 18 second timer
A single two-speed Reagent DRD dispense motion has taken longer than 18
seconds.
§Call Technical Service.

226
Reagent dilutor has jammed dispensing into blind hole
Reagent DRD has jammed.
?Check for physical obstruction preventing the DRD from moving.
§If the message persists, call Technical Service.

601005-0004 Rev. A
H-20 Operator’s Guide: Error Messages

227
Reagent dilutor exceeded 18 second timer
A Reagent DRD motion to a configured position has taken longer than 18
seconds.
§Call Technical Service.

228
Reagent dilutor movement exceeded 65535 steps
The Reagent DRD has calculated that it must take more than 65,535 steps to
reach a configured encoder position.
§Call Technical Service.

230
Reagent dilutor has jammed
Reagent DRD has jammed a second time while moving to a configured position
and performing a two-speed move.
§Call Technical Service.

231
Reagent dilutor exceeded 18 second timer
A Reagent DRD motion to a configured position using a two-speed move has
taken longer than 18 seconds.
§Call Technical Service.

232
Reagent dilutor movement exceeded 65535 steps
The Reagent DRD has calculated that it must take more than 65,535 steps to
reach a configured encoder position using a two-speed move.
§Call Technical Service.

234
Sample pipettor Z direction has jammed during level
sense
Something interfered with the vertical movement of the pipettor arm. The
Instrument tries to correct itself and continue processing assays. If the error

601005-0004 Rev. A
Operator’s Guide: Error Messages H-21

cannot be corrected, the pipetting stops. If the Sample Pipettor caused the error,
the tests on-board continue to process.
§Check that the sample tube or diluent tube is seated correctly.
§Check the movement of Pipettor is not obstructed.
§Check for caps on sample tubes.
§Check for unauthorized tube tops (sample cups sitting on top of tubes).
§Check that the Sample Probe is not bent.
§If the message persists, call Technical Service.

236
Sample pipettor Z direction exceeded 18 second timer
A Sample Pipettor motion to a configured position using a two-speed move has
taken longer than 18 seconds.
§Call Technical Service.

237
Sample pipettor did not level sense
Sample Pipettor has reached the tube bottom, diluent bottom or dilution well
bottom position and has not level sensed.
§Check for insufficient sample.
§Check for bubble on sample.
§Check for unauthorized tube tops (sample cups sitting on top of tubes).
§Verify a tube is present in the position.
§If the message persists, call Technical Service.

238
Reagent pipettor Z direction has jammed during level
sense
Something interfered with the vertical movement of the pipettor arm. The
Instrument tries to correct itself and continue processing assays. If the error
cannot be corrected, the pipetting stops. If the Reagent Pipettor caused the error,
the tests on-board continue to process.
§Check that the sample tube or diluent tube is seated correctly.
§Check the movement of Pipettor is not obstructed.
§Check that the Reagent Probe is not bent.
§If the message persists, call Technical Service.

240
Reagent pipettor Z direction exceeded 18 second timer
A Reagent Pipettor motion to a configured position using a two-speed move has
taken longer than 18 seconds.
§Call Technical Service.

601005-0004 Rev. A
H-22 Operator’s Guide: Error Messages

241
Reagent pipettor did not level sense
Reagent Pipettor has reached the reagent bottom position and has not level
sensed.
§Check to see if the Glide is on correctly.
§Check to see if the Wedge is seated correctly.
§If the message persists, call Technical Service.

258
Rack transfer error during homing. Remove rack if
present and retry
Rack transfer error during homing.
§Remove rack if present and retry.

260
Rack transfer jammed while moving to home position.
Remove rack if present and retry
§Rack transfer jammed while moving to home position.
§Remove rack if present and retry.

261
Rack transfer timed out during homing. Contact
Technical Service
§Contact Technical Service.

262
Rack transfer has not found home. Contact Technical
Service.
§Contact Technical Service.

263
Rack transfer communication error during homing.
Contact Technical Service.
§Contact Technical Service.

265
Rack transfer has jammed. Remove rack if present and
retry.
Rack transfer has jammed.
§Remove rack if present and retry.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-23

266
Rack transfer timed out. Contact Technical Service.
§Contact Technical Service.

267
Rack transfer movement exceeded maximum steps. Contact
Technical Service.
§Contact Technical Service.

268
Rack transfer communication error. Contact Technical
Service.
§Contact Technical Service.

269
Rack gripper error during homing. Remove rack if
present and retry.
Rack gripper error during homing.
§Remove rack if present and retry.

271
Rack gripper has jammed while moving to home position.
Remove rack if present and press Run button to attempt
recovery.
Rack gripper has jammed while moving to home position.
§Remove rack if present and press Run button to attempt recovery.

272
Rack gripper timed out during homing. Contact Technical
Service.
§Contact Technical Service.

273
Rack gripper has not found home. Contact Technical
Service.
§Contact Technical Service.

274
Rack gripper communication error during homing. Contact
Technical Service.
§Contact Technical Service

601005-0004 Rev. A
H-24 Operator’s Guide: Error Messages

275
Sample pipettor X direction has jammed looking for home
Something interfered with the horizontal movement of the pipettor arm.
The Instrument tries to correct itself and continue processing assays. If the
Instrument cannot correct the error, the pipetting stops. If the Sample Pipettor
caused the error, the tests on-board continue to process.
§Check that the sample tube or diluent tube is seated correctly.
§Check the movement of Pipettor is not obstructed.
§Check for caps on sample tubes.
§Check for unauthorized tube tops (sample cups sitting on top of tubes).
§Check that the Sample Probe is not bent.
§If the message persists, call Technical Service.

276
Sample pipettor X direction exceeded 18 second timer
A Sample Pipettor X-direction (horizontal) movement to Home has taken longer
than 18 seconds.
§Call Technical Service.

277
Sample pipettor did not find HOME in the X direction
While attempting to return to the home position, the Sample Pipettor did not find
the home sensor in the X direction (horizontal).
§Call Technical Service.

278
Sample pipettor Z direction has jammed looking for
home.
The Sample Pipettor jammed a second time while attempting to do a homing
routine in the Z direction (vertical). This may also occur if one of the sample
devices has jammed and the Instrument is homing all the sample devices.
§Check that the sample tube or diluent tube is seated correctly.
§Check the movement of the pipettor is not obstructed.
§Check for caps on the sample tubes.
§Check that the Sample Probe is not bent.
§If the message persists, call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-25

279
Sample pipettor Z direction exceeded 18 second timer
A Sample Pipettor Z-direction (vertical) motion to Home has taken longer than 18
seconds.
§Call Technical Service.

280
Sample pipettor did not find HOME in the Z direction
While attempting to return to the home position, the Sample Pipettor did not find
the home sensor in the vertical direction.
§Check that the sample tube or diluent tube is seated correctly.
§Check the movement of Pipettor is not obstructed.
§Check for caps on sample tubes.
§Check for unauthorized tube tops (sample cups sitting on top of tubes).
§Check that the Sample Probe is not bent.
§If the message persists, call Technical Service.

281
Sample valve has jammed while homing
The Sample Valve jammed.
§Call Technical Service.

282
Sample valve exceeded the 18 second timer
A Sample Valve motion to Home has taken longer than 18 seconds. This error
should never occur in normal operation.
§Call Technical Service.

283
Sample valve did not find HOME
While attempting to return to the home position, the Sample Valve did not find the
home sensor.
§Call Technical Service.

284
Sample dilutor has jammed while homing
The Sample Diluter jammed.
§Check for physical obstruction preventing the DRD from moving.
§Check for clotted probe.
§If the message persists, call Technical Service.

601005-0004 Rev. A
H-26 Operator’s Guide: Error Messages

285
Sample dilutor exceeded the 18 second timer
A Sample Dilutor motion to Home has taken longer than 18 seconds.
§Call Technical Service.

286
Sample dilutor did not find HOME
While attempting to return to the home position, the Sample Dilutor did not find the
home sensor.
§Check for physical obstruction preventing the DRD from moving.
§If the message persists, call Technical Service.

287
Sample carousel has jammed while homing
The Sample Carousel jammed.
§Check the placement of the Sample Racks, ensuring the racks are properly
attached to the Instrument.
§Ensure that the tubes are positioned correctly in the Sample Racks and that
none of the tubes are too tall.
§If the message persists, call Technical Service.

288
Sample carousel exceeded the 18 second timer
A Sample Carousel motion to Home has taken longer than 18 seconds.
§Call Technical Service.

289
Sample carousel did not find HOME
While attempting to return to the home position, the Sample Carousel did not find
the home sensor.
§Check the placement of the Sample Racks, ensuring the racks are properly
attached to the Instrument.
§Ensure that the tubes are positioned correctly in the Sample Racks and that
none of the tubes is too tall.
§If the message persists, call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-27

290
Reagent pipettor X direction has jammed
Something interfered with the horizontal movement of the pipettor arm.
The Instrument tries to correct itself and continue processing assays. If the
Instrument cannot correct the error, the pipetting stops.
§Reagent Wedge may not be seated correctly.
§Movement of Pipettor is obstructed.
§If the message persists, call Technical Service.

291
Reagent pipettor exceeded the 18 second timer in the X
direction
A Reagent Pipettor X-direction motion to Home has taken longer than 18
seconds.
§Call Technical Service.

292
Reagent pipettor did not find HOME in the X direction
While attempting to return to the home position, the Reagent Pipettor did not find
the home sensor.
§Reagent Wedge may not be seated correctly.
§Movement of Pipettor is obstructed.
§If the message persists, call Technical Service.

293
Reagent pipettor Z direction has jammed
Something interfered with the vertical movement of the pipettor arm. The
Instrument tries to correct itself and continue processing assays. If the error
cannot be corrected, the pipetting stops.
§Check to see if the Glide is on correctly.
§Check to see if the Wedge is seated correctly.
§If the message persists, call Technical Service.

294
Reagent pipettor exceeded the 18 second timer in the Z
direction
A Reagent Pipettor motion to Home has taken longer than 18 seconds.
§Call Technical Service.

601005-0004 Rev. A
H-28 Operator’s Guide: Error Messages

295
Reagent pipettor did not find HOME in the Z direction
While attempting to return to the home position, the Reagent Pipettor did not find
the home sensor.
§Check to see if there are any obstructions around the reagent Pipettor.
§If the message persists, call Technical Service.

296
Reagent valve has jammed
The Reagent Valve jammed.
§Call Technical Service.

297
Reagent valve exceeded the 18 second timer
A Reagent Valve motion to Home has taken longer than 18 seconds.
§Call Technical Service.

298
Reagent valve did not find HOME
While attempting to return to the home position, the Reagent Valve did not find the
home sensor.
§Call Technical Service.

299
Reagent dilutor has jammed
The Reagent Dilutor jammed.
§Check for physical obstruction preventing the DRD from moving.
§If the message persists, call Technical Service.

300
Reagent dilutor exceeded the 18 second timer
A Reagent Dilutor motion to Home has taken longer than 18 seconds.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-29

301
Reagent dilutor did not find HOME
While attempting to return to the home position, the Reagent Dilutor did not find
the home sensor.
§Check for physical obstruction preventing the DRD from moving.
§If the message persists, call Technical Service.

302
Reagent carousel has jammed
The Reagent Carousel jammed.
§Reseat Wedge or carousel tray.
§Check the Wedge Glide is properly installed.
§If message persists, call Technical Service.

303
Reagent carousel exceeded the 18 second timer
A Reagent Carousel motion to Home has taken longer than 18 seconds.
§Call Technical Service.

304
Reagent carousel did not find HOME
While attempting to return to the home position, the Reagent Carousel did not find
the home sensor.
§Reseat Wedge or carousel tray.
§Check Wedge Glide for proper installation.
§If the message persists, call Technical Service.

305
Tube Indexer has jammed
At initialization and while returning to run from All Pause, Bead Pause, or Stop,
the Tube Indexer jammed a second time while attempting to do a homing routine.
§Check for obstructions.
§Check that the proper Reaction Tube is used.
§Check for a malformed Reaction Tube.
§If the message persists, call Technical Service.

306
Tube Indexer exceeded the 18 second timer
A Tube Indexer motion to Home has taken longer than 18 seconds.
§Call Technical Service.

601005-0004 Rev. A
H-30 Operator’s Guide: Error Messages

307
Tube Indexer did not find HOME
While attempting to return to the home position, the tube Indexer did not find the
home sensor.
§Check for obstructions.
§If the message persists, call Technical Service.

308
Tube Transport has jammed
The Tube Transport Chain jammed.
§Verify correct Reaction Tube is used.
§Check for a malformed tube.
§Visually inspect chain for any kind of interference.
§If the message persists, call Technical Service.

309
Tube Transport exceeded the 18 second timer
A Tube Transport chain motion to Home has taken longer than 18 seconds.
§Call Technical Service.

310
Tube Transport did not find HOME
While attempting to return to the home position, the tube transport chain did not
find the home sensor.
§Verify correct Reaction Tube is used.
§Check for a malformed tube.
§Visually inspect chain for any kind of interference.
§If the message persists, call Technical Service.

311
Processor Shuttle has jammed
The Processor Shuttle jammed.
§Check for mispositioned Reaction Tube.
§If the message persists, call Technical Service.

312
Processor Shuttle exceeded the 18 second timer
A Processor shuttle motion to Home has taken longer than 18 seconds.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-31

313
Processor Shuttle did not find HOME
While attempting to return to the home position, the processor shuttle did not find
the home sensor.
§Check for mispositioned Reaction Tube.
§If the message persists, call Technical Service.

314
PMT Shutter has jammed looking for home.
An error was detected in the vertical movement of the PMT shutter.
The Instrument tries to correct itself and continue processing assays. If the error
can not be corrected, the Instrument stops processing tubes, and another error
message appears. The results for tubes following this second error message are
lost.
§Call Technical Service.

315
PMT Shutter exceeded the 18 second timer.
A PMT Shutter motion to Home has taken longer than 18 seconds.
§Call Technical Service.

316
PMT Shutter did not find HOME.
While attempting to return to the home position, the PMT shutter did not find the
home sensor.
§Call Technical Service.

317
Luminometer Chain has jammed
The Luminometer chain jammed.
§Check for overfilled or incorrectly seated solid waste container.
§Check for correct Biohazard Bags.
§Check the Exit Chute for Reaction Tubes and clear it.
§Check Reaction Tubes in the Tube Hopper for any abnormalities.
§Call Technical Service.

318
Luminometer Chain exceeded the 18 second timer
A Luminometer Chain motion to Home has taken longer than 18 seconds.
§Call Technical Service.

601005-0004 Rev. A
H-32 Operator’s Guide: Error Messages

319
Luminometer Chain did not find HOME
While attempting to return to the home position, the Luminometer Chain did not
find the home sensor.
§Check for overfilled or incorrectly seated solid waste container.
§Check for correct Biohazard Bags.
§Check the Exit Chute for Reaction Tubes and clear it.
§Check Reaction Tubes in the Tube Hopper for any abnormalities.
§If the message persists, call Technical Service.

320
Luminometer Shuttle has jammed
The Luminometer Shuttle jammed.
§Check for overfilled or incorrectly seated solid waste container.
§Check for correct Biohazard Bags.
§Correct and clear the Exit Chute.
§Check Reaction Tubes in the Tube Hopper for any abnormalities.
§Call Technical Service.

321
Luminometer Shuttle exceeded the 18 second timer
A Luminometer Shuttle motion to Home has taken longer than 18 seconds.
§Call Technical Service.

322
Luminometer Shuttle did not find HOME
While attempting to return to the home position, the Luminometer Shuttle did not
find the home sensor.
§Check for overfilled or incorrectly seated solid waste container.
§Check for correct Biohazard Bags.
§Correct and clear the Exit Chute.
§Check Reaction Tubes in the Tube Hopper for any abnormalities.
§If the message persists, call Technical Service.

323
Tube Lifter has jammed
At initialization and while returning to run from Stop, the Tube Lifter jammed a
second time while attempting to do a homing routine.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-33

324
Tube Lifter exceeded the 18 second timer
A Tube Lifter motion to Home has taken longer than 18 seconds.
§Call Technical Service.

325
Tube Lifter did not find HOME
While attempting to return to the home position, the Tube Lifter did not find the
home sensor.
§Call Technical Service.

326
Incubator Chain has jammed
Incubator Chain has jammed.
§Call Technical Service.

327
Incubator Chain exceeded the 18 second timer
An Incubator Chain motion to Home has taken longer than 18 seconds.
§Call Technical Service

328
Incubator Chain did not find HOME
While attempting to return to the home position, the Incubator Chain did not find
the home sensor.
§Call Technical Service.

329
Attenuator Disk has jammed
The PMT Attenuator was unable to reach the correct position.
§Call Technical Service.

330
Attenuator Disk exceeded the 18 second timer
An Attenuator Disk motion to Home has taken longer than 18 seconds.
§Call Technical Service.

601005-0004 Rev. A
H-34 Operator’s Guide: Error Messages

331
Attenuator Disk did not find HOME
While attempting to return to the home position, the Attenuator Disk did not find
the home sensor.
§Call Technical Service.

332
Rack Loader sensor did not detect ejected rack. Remove
rack if present and retry.
§Remove rack if present and retry.

333
Unexpected error. Contact Technical Service.
§Contact Technical Service.

334
Unexpected error. Contact Technical Service.
§Contact Technical Service.

338
Error opening configuration file RLCfg.IMR. Contact
Technical Service.
§Contact Technical Service.

339
Error reading configuration file RLCfg.IMR. Contact
Technical Service.
§Contact Technical Service.

340
Unexpected error. Contact Technical Service.
§Contact Technical Service.

363
Rack gripper has jammed. Press Run button to attempt
recovery.
Rack gripper has jammed.
§Press Run button to attempt recovery.

364
Rack gripper timed out. Contact Technical Service.
Rack gripper timed out.
§Contact Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-35

365
Rack gripper movement exceeded maximum steps. Contact
Technical Service.
§Contact Technical Service.

366
Rack gripper communication error. Contact Technical
Service.
§Contact Technical Service.

367
Inner rack door error during homing. Remove rack if
present and retry.
Inner rack door error during homing.
§Remove rack if present and retry.

369
Inner rack door has jammed while moving to home
position. Remove rack if present and retry.
Inner rack door has jammed while moving to home position.
§Remove rack if present and retry.

370
Inner rack door timed out during homing. Contact
Technical Service.
§Contact Technical Service.

371
Inner rack door has not found home. Contact Technical
Service.
§Contact Technical Service.

372
Inner rack door communication error during homing.
Contact Technical Service.
§Contact Technical Service.

374
Inner rack door has jammed. Remove rack if present and
retry.
Inner rack door has jammed.

§Remove rack if present and retry.

601005-0004 Rev. A
H-36 Operator’s Guide: Error Messages

375
Bar Code and Encoder position do not match
Instrument has failed to read a reagent barcode.
§Call Technical Service.

376
Partial reagent bar code read
Instrument has failed to read a reagent barcode.
§Check the integrity of the Wedge label.
§Clean label and re-interrogate.
§If the message persists, call Technical Service.

377-379
Programming Errors
Occurs when underlying hardware errors cause software communication issues.
§Check error log for hardware errors and resolve them.
§If the message persists, call Technical Service.

380
Errors have shut down the MCP routine
Errors at start-up have shut down the MCP routine. More specific error messages
will be generated.
§Check Event Log for associated mechanical jams. Correct and reinitialize.
§If unsuccessful, call Technical Service.

381
Large Reagent Door is open during start-up. Close door
to continue.
The Large Reagent Door is open.
§Ensure that the Reagent door is fully closed before start up.
§If error persists, call Technical Service.

392
Bead Carousel has jammed.
Bead Carousel has jammed a second time while trying to move to a configured
position.
§Ensure that the Bead Packs are positioned correctly in the Bead Carousel.
§If the message persists, call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-37

393
Bead Carousel has exceeded 18 second cycle shutting
down instrument.
A Bead Carousel movement to home has taken longer than 18 seconds.
§Call Technical Service.

394
Bead Carousel has not detected home sensor
While attempting to return to the home position, the Bead Carousel did not find the
home sensor.
§Call Technical Service.

401
Allergen not found/rerun test
The required Allergen was not found on the Reagent Carousel, assay(s) cannot
be processed.
§Check inventory and verify that the allergen is in the allergen wedge.
§If the problem persists, call Technical Service.

402
No reaction tube detected at the tube indexer.
Sensor does not see a tube at the indexer.
§Check for Reaction Tubes in the Tube Hopper.
§Fill Hopper.
§Verify correct Reaction Tube is used.
§Check for a malformed tube.
§Check for jam in the Orientation Chute.
§If the message persists, call Technical Service.

403
No bead dispensed rerunning test
No bead detected in tube after dispense.
§Check if the bead pack is seated properly, and ensure beads are moving freely.
§If error persists, call Technical Service.

601005-0004 Rev. A
H-38 Operator’s Guide: Error Messages

405
Luminometer Shuttle pushed again
Luminometer Shuttle attempted to push tube from the Wash Station into the
luminometer a second time and failed. The sensor detected that the tube was still
at the Wash Station after the push.
§Call Technical Service.

406
Tube Lifter not in the up position rerunning test
At the beginning of the wash cycle, the tube lifter detected that the tube was not in
the Up position.
§If the message persists, call Technical Service.

407
Extra bead detected rerunning test
Instrument detects a bead prior to the bead dispense.
§If the message persists, call Technical Service.

408
Two beads detected rerunning test
Instrument detects two beads in the tube after the bead dispense.
§If the message persists, call Technical Service.

409
Clot detection has timed out. Call Technical Service.
Clot detection board did not respond in the allowable time. Control Software is
locked, and all tests on board will be lost.
§Call Technical Service.

410
Sample Pipettor has jammed in the X direction
Sample Pipettor has jammed a second time while trying to move a fixed number
of steps in the X direction (horizontal).
§Check that the sample tube or diluent tube is seated correctly.
§Check that the movement of the Pipettor is not obstructed.
§Check for caps on sample tubes.
§Check for unauthorized tube tops (i.e., sample cups sitting on top of tubes).
§Check that the Sample Probe is not bent.
§If the message persists, call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-39

412
Sample Pipettor exceeded the 18 second timer in the X
direction
Sample Pipettor has taken longer than 18 seconds moving to a configured
position in the X direction (horizontal).
§Call Technical Service.

413
Sample Pipettor has jammed in the Z direction
Sample Pipettor has jammed a second time while trying to move a fixed number
of steps in the Z direction (vertical).
§Check that the sample tube or diluent tube is seated correctly.
§Check that the movement of the Pipettor is not obstructed.
§Check for caps on sample tubes.
§Check for unauthorized tube tops (i.e., sample cups sitting on top of tubes).
§Check that the Sample Probe is not bent.
§If the message persists, call Technical Service.

415
Sample Pipettor exceeded the 18 second timer in the Z
direction
Sample Pipettor has taken longer than 18 seconds moving to a configured
position in the Z direction (vertical).
§Call Technical Service.

416
Sample Valve has jammed
Sample Valve has jammed a second time while trying to move a fixed number of
steps.
§Call Technical Service.

418
Sample Valve exceeded the 18 second timer
Sample Valve has taken longer than 18 seconds to move a fixed number of steps.
§Call Technical Service.

601005-0004 Rev. A
H-40 Operator’s Guide: Error Messages

419
Sample Carousel has jammed
Sample Carousel has jammed a second time while trying to move a fixed number
of steps.
§Check the placement of the Sample Racks, ensuring the racks are properly
attached to the Instrument.
§Ensure that the tubes are positioned correctly in the Sample Racks and that
none of the tubes are too tall.
§If the message persists, call Technical Service.

421
Sample Carousel exceeded the 18 second timer
Sample Carousel movement to a configured position has taken longer than 18
seconds.
§Call Technical Service.

422
Reagent Pipettor has jammed in the X direction
Reagent Pipettor has jammed a second time in the X direction (horizontal) while
trying to move a fixed number of steps.
§Check to see if the Reagent Wedge is seated correctly.
§Check to see if the Movement of the Pipettor is obstructed.

424
Reagent Pipettor exceeded the 18 second timer in the X
direction
Reagent Pipettor has taken longer than 18 seconds moving to a configured
position in the X direction (horizontal).
§Call Technical Service.

425
Reagent Pipettor had jammed in the Z direction
Reagent Pipettor has jammed a second time while trying to move a fixed number
of steps in the Z direction (vertical).
§Check to see if the Glide is on correctly.
§Check to see if the Wedge is positioned properly.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-41

427
Reagent Pipettor exceeded the 18 second timer in the Z
direction
Reagent Pipettor movement to a configured position has taken longer than 18
seconds.
§Call Technical Service.

428
Reagent Valve has jammed
Reagent Valve has jammed a second time while trying to move a fixed number of
steps.
§Call Technical Service.

430
Reagent Valve exceeded the 18 second timer
Reagent Valve movement to a configured position has taken longer than 18
seconds.
§Call Technical Service.

431
Reagent Carousel has jammed
Reagent Carousel has jammed a second time while trying to move a fixed number
of steps.
§Check for mispositioned Wedge or carousel tray.
§Check Wedge glide for proper installation

433
Reagent Carousel exceeded the 18 second timer
Reagent Carousel motion to a configured position has taken longer than 18
seconds.
§Call Technical Service.

434
Bead Carousel has jammed
Bead Carousel has jammed a second time while trying to move to a configured
position.
§Ensure that the Bead Packs are positioned correctly in the Bead Carousel.
§If the message persists, call Technical Service.

601005-0004 Rev. A
H-42 Operator’s Guide: Error Messages

436
Bead carousel exceeded the 18 second timer
Bead Carousel movement to a configured position has taken longer than 18
seconds.
§Call Technical Service.

437
Tube Transport has jammed
Tube Transport Chain has jammed a second time while trying to move a fixed
number of steps.
§Verify correct Reaction Tube is used.
§Check for a malformed tube.
§Visually inspect chain for any kind of interference.

439
Tube Transport exceeded the 18 second timer
Tube Transport Chain movement to a configured position has taken longer than
18 seconds.
§Call Technical Service

440
Incubator Chain has jammed
Incubator Chain has jammed a second time while trying to move a fixed number of
steps.
§Check for obstruction at the Reagent Pipetting area. Remove tube.
§Call Technical Service.

442
Incubator Chain exceeded the 18 second timer
Incubator Chain movement to a configured position has taken longer than 18
seconds.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-43

443
Luminometer Shuttle has jammed
Luminometer Shuttle has jammed a second time while trying to move a fixed
number of steps.
§Check for overfilled or incorrectly seated solid waste container.
§Check for correct biohazard bags.
§Correct and clear the Exit Chute.
§Check the Reaction Tubes in the Tube Hopper for abnormalities, extra flashing,
etc.
§Call Technical Service.

445
Luminometer Shuttle exceeded the 18 second timer
Luminometer Shuttle movement to a configured position has taken longer than 18
seconds.
§Call Technical Service.

446
Tube Lifter has jammed
Tube Lifter has jammed a second time while trying to move a fixed number of
steps.
§Call Technical Service.

448
Tube Lifter exceeded the 18 second timer
Tube Lifter movement to a configured position has taken longer than 18 seconds.
§Call Technical Service.

449
Luminometer Chain has jammed
Luminometer Chain has jammed.
§Check for overfilled or incorrectly seated solid waste container.
§Check for correct biohazard bags.
§Correct and clear the Exit Chute.
§Check the Reaction Tubes in the Tube Hopper for abnormalities, extra flashing,
etc.
§Call Technical Service.

601005-0004 Rev. A
H-44 Operator’s Guide: Error Messages

451
Luminometer Chain exceeded the 18 second timer
Luminometer Chain movement to a configured position has taken longer than 18
seconds.
§Call Technical Service.

452
Luminometer Shutter has jammed
An error was detected in the vertical movement of the PMT shutter.
The Instrument tries to correct itself and continue processing assays. If the error
can not be corrected, the Instrument stops processing tubes, and another error
message appears. The results for tubes following this second error message are
lost.
§Call Technical Service.

454
Luminometer Shutter exceeded the 18 second timer
Luminometer Shutter movement to a configured position has taken longer than 18
seconds.
§Call Technical Service.

455
Attenuator Disk has jammed
Attenuator Disk has jammed a second time while trying to move a fixed number of
steps.
§Call Technical Service.

457
Attenuator Disk exceeded the 18 second timer
Attenuator Disk movement to a configured position has taken longer than 18
seconds.
§Call Technical Service.

458
Processor Shuttle has jammed
Processor Shuttle has jammed a second time while trying to move a fixed number
of steps.
§Remove mispositioned Reaction Tube.
§If the message persists, call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-45

460
Processor Shuttle exceeded the 18 second timer
Processor Shuttle movement to a configured position has taken longer than 18
seconds.
§Call Technical Service.

461
Sample Carousel has jammed
The Sample Carousel jammed.
§Check the placement of the Sample Racks, ensuring the racks are properly
attached to the Instrument.
§Ensure that the tubes are positioned correctly in the Sample Racks and that
none of the tubes is too tall.
§If the message persists, call Technical Service.

462
Sample Carousel exceeded the 18 second timer
A single Sample Carousel movement to a configured position has taken longer
than 18 seconds.
§Call Technical Service.

463
Sample Carousel has exceeded the 65535 steps
The Sample Carousel has calculated that it must take more than 65535 steps to
reach a configured encoder position.
§Call Technical Service.

465
Reagent Carousel has jammed
Reagent Carousel has jammed a second time while trying to move to a configured
position.
§Reseat Wedge or carousel.
§Check Wedge Glide for proper installation.
§If the message persists, call Technical Service.

466
Reagent Carousel exceeded the 18 second timer
A single Reagent Carousel movement to a configured position has taken longer
than 18 seconds. This error should never occur in normal operation.
§Call Technical Service.

601005-0004 Rev. A
H-46 Operator’s Guide: Error Messages

467
Reagent Carousel has exceeded the 65535 steps
The Reagent Carousel has calculated that it must take more than 65535 steps to
reach a configured encoder position.
§Call Technical Service.

469
Bead Carousel has jammed
Bead Carousel has jammed.
§Ensure that the Bead Packs are positioned correctly in the Bead Carousel.
§If the message persists, call Technical Service.

470
Bead Carousel exceeded the 18 second timer
A single Bead Carousel movement to a configured position has taken longer than
18 seconds.
§Call Technical Service.

471
Bead Carousel has exceeded the 65535 steps
The Bead Carousel has calculated that it must take more than 65535 steps to
reach a configured encoder position.
§Call Technical Service.

473
Reaction Tube is not in the pipetting position
Instrument does not detect a tube at the pipetting position.
§Check for mispositioned Reaction Tube.
§If the message persists, call Technical Service.

494
Luminometer Chain has exceeded 65535 steps.
The Luminometer Chain has calculated that it must take more than 65,535 steps
to reach Home.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-47

495
Luminometer Shuttle has exceeded 65535 steps
The Luminometer Shuttle has calculated that it must take more than 65,535 steps
to reach Home.
§Call Technical Service.

496
Sample Pipettor has jammed in the Z direction
Sample Pipettor Z Motor has jammed.
§Check that the sample tube or diluent tube is seated correctly.
§Check the movement of Pipettor is not obstructed.
§Check for caps on sample tubes.
§Check for unauthorized tube tops (sample cups sitting on top of tubes).
§Check that the Sample Probe is not bent.
§If the message persists, call Technical Service.

498
Sample Pipettor exceeded the 18 second timer in the Z
direction
Sample Pipettor Z Motor motion to a configured position has taken longer than 18
seconds.
§Call Technical Service.

499
Sample Pipettor has exceeded 65535 steps
Sample Pipettor Z Motor has calculated that it must take more than 65535 steps
to reach a configured encoder position.
§Call Technical Service

500
Reagent Pipettor has jammed in the Z direction
Reagent Pipettor Z Motor has jammed a second time while trying to move to a
configured position.
§Check to see if the Glide is on correctly.
§Check to see if the Wedge is seated correctly.

601005-0004 Rev. A
H-48 Operator’s Guide: Error Messages

502
Reagent Pipettor exceeded the 18 second timer
Reagent Pipettor Z Motor motion to a configured position has taken longer than
18 seconds.
§Call Technical Service.

503
Reagent Pipettor has exceeded 65535 steps
Reagent Pipettor Z Motor has calculated that it must take more than 65535 steps
to reach a configured encoder position.
§Call Technical Service.

504
Rerun test designated bad by Initializing Run Mode
A sequential assay was unable to receive second reagent because the Instrument
was initializing the Run Mode from the Pause Mode.
§If the message persists, call Technical Service.

505
Rerun test designated bad by Pause Mode
A sequential assay was unable to receive second reagent because the Instrument
was in Pause Mode.
§If the message persists, call Technical Service.

506
Rerun test designated bad by In-Cycle Prime Mode
A sequential assay was unable to receive second reagent because the Instrument
was performing an In-cycle prime.
§Call Technical Service.

507
Rerun test designated bad by Sample Tube
A problem was detected with a sample tube during sample pipetting.
§Check sample.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-49

508
Rerun test designated bad by Reagent Pack
A problem was detected with a reagent pack during reagent pipetting.
§Check reagent pack.
§If the message persists, call Technical Service.

509
Rerun test designated bad by Bead Pack
A problem was detected with a Bead Pack while attempting to dispense a bead.
§Check Bead Pack for static. Tap gently and return it to the Bead Carousel.
§Check for empty pack.
§Manually dispense bead.
§Rerun.

510
Rerun test designated bad by Running Error
Jam in a reagent or sampling device preventing the pipetting of reagent for a
sequential assay or further processing of B12 and Folate.
§Check Error Log for associated errors.
§Correct the errors if possible.
§If the message persists, call Technical Service.

511
Rerun test designated bad by Sample 1 Not Found
The required Sample1 was not found on the Sample Carousel. Assay(s) can not
be processed.
§Call Technical Service.

512
Rerun test designated bad by Sample 2 Not Found
The required Sample2 was not found on the Sample Carousel. Assay(s) can not
be processed.
§Call Technical Service.

513
Rerun test designated bad by No Diluent
The appropriate, required onboard diluent was not found when an onboard
dilution had been requested.
§Put diluent on board.
§If the message persists, call Technical Service.

601005-0004 Rev. A
H-50 Operator’s Guide: Error Messages

514
Rerun test designated bad by Reagent 1 Not Found
The required Reagent 1 was not found on the Reagent Carousel. Assay(s) can
not be processed.
§Call Technical Service.

515
Rerun test designated bad by Reagent 2 Not Found
The required Reagent 2 was not found on the Reagent Carousel. Assay(s) can
not be processed.
§Call Technical Service.

516
Rerun test designated bad by No Bead
The required Bead Pack was not found on the Bead Carousel. Assay(s) can not
be processed.
§Check Bead Pack for obstructions to dispense.
§Manually dispense bead.
§Reseat Bead Pack and try again.
§Rerun.

517
Rerun test designated bad by Motor Jam
A Motor Jam error has occurred preventing the sampling and/or continued
processing of an assay(s).
§Call Technical Service.

518
Rerun test designated bad
An unknown error has prevented a sample or reagent from being pipetted. This
should not occur in normal operation.
§Call Technical Service.

519
IMMULITE 2000 doors must be closed for operation
A door, or doors, are not properly closed, or there is a failure of door sensor(s).
§Close the door.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-51

520
Processor Shuttle has jammed
The Processor Shuttle has jammed a second time while moving to the BACK
position.
§Remove mispositioned Reaction Tube.
§If the message persists, call Technical Service.

521
Processor Shuttle exceeded the 18 second timer
Processor shuttle motion has taken longer than 18 seconds.
§Call Technical Service.

522
Processor Shuttle has exceeded 65535 steps
The Processor Shuttle has calculated that it must take more than 65,535 steps to
reach a configured encoder position.
§Call Technical Service.

524
Sample Door or Main Cover is open
The Sample Door or the Instrument cover was not closed before RUN was
selected.
§Close the door or cover.

525
Reagent Door is open
Reagent Access Door or Reagent Cover is open.
§Close the door.

526
Bead Door is open
Bead Chamber Door is open.
§Close the door.

601005-0004 Rev. A
H-52 Operator’s Guide: Error Messages

530
Tip Jam
The probe has not found liquid.
§Check that the sample tube or diluent tube is seated correctly.
§Check the movement of Pipettor is not obstructed.
§Check for caps on sample tubes.
§Check for unauthorized tube tops (sample cups sitting on top of tubes).
§Check that the Sample Probe is not bent.
§If the message persists, call Technical Service.

531
Tip Jam Sample Pipettor
Sample Pipettor has not found liquid.
§Check that the sample tube or diluent tube is seated correctly.
§Check the movement of Pipettor is not obstructed.
§Check for caps on sample tubes.
§Check for unauthorized tube tops (sample cups sitting on top of tubes).
§Check that the Sample Probe is not bent.
§If the message persists, call Technical Service.

532
Tip Jam Sample Pipettor
Sample Pipettor has not found liquid.
§Check that the sample tube or diluent tube is seated correctly.
§Check the movement of Pipettor is not obstructed.
§Check for caps on sample tubes.
§Check for unauthorized tube tops (sample cups sitting on top of tubes).
§Check that the Sample Probe is not bent.
§If the message persists, call Technical Service.

533
Tip Jam Sample Pipettor
Sample Pipettor has not found liquid.
§Check that the sample tube or diluent tube is seated correctly.
§Check the movement of Pipettor is not obstructed.
§Check for caps on sample tubes.
§Check for unauthorized tube tops (sample cups sitting on top of tubes).
§Check that the Sample Probe is not bent.
§If the message persists, call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-53

534
Tip Jam Reagent Pipettor
Reagent Pipettor has not found liquid.
§Ensure that the Glide is seated correctly on the Reagent Wedge.
§Ensure that Reagent Wedge is seated correctly.
§Ensure the pack lid opener is retracted.
§If the message persists, call Technical Service.

535
Tip Jam Reagent Pipettor
A Reagent Z pipettor motion for a fixed number of steps has encountered a Tip
Jam.
§Ensure that the Glide is seated correctly on the Reagent Wedge.
§Ensure that Reagent Wedge is seated correctly.
§Ensure the pack lid opener is retracted.
§If the message persists, call Technical Service.

536
Tip Jam Reagent Pipettor
A Reagent Z pipettor motion to a configured position has encountered a Tip Jam.
§Ensure that the Glide is seated correctly on the Reagent Wedge.
§Ensure that Reagent Wedge is seated correctly.
§Ensure the pack lid opener is retracted.
§If the message persists, call Technical Service.

537
Tip Jam Reagent Pipettor
A Reagent Z level sense motion has encountered a tip jam. This can only occur
when going into the Reagent Wedge.
§Ensure that the Glide is seated correctly on the Reagent Wedge.
§Ensure that Reagent Wedge is seated correctly.
§Ensure the pack lid opener is retracted.
§If the message persists, call Technical Service.

538
Bead Dispenser jammed - motor does not move
The Bead Dispenser has been unsuccessful in dispensing a bead.
§Be sure Bead Pack is seated correctly.
§Remove the Bead Pack, invert it, and then re-install it.
§Manually dispense a bead.
§If the message persists, call Technical Service.

601005-0004 Rev. A
H-54 Operator’s Guide: Error Messages

539
Bead Dispenser jammed - cannot find bead dispense
sensor
The Bead Dispenser has been unsuccessful in dispensing a bead.
§Be sure Bead Pack is seated correctly.
§Remove the Bead Pack, invert it, and then re-install it.
§Manually dispense a bead.
§If the message persists, call Technical Service.

540
Bead Dispenser jammed - in dispense position
The Bead Dispenser has been unsuccessful in dispensing a bead.
§Be sure Bead Pack is seated correctly.
§Remove the Bead Pack, invert it, and then re-install it.
§Manually dispense a bead.
§If the message persists, call Technical Service.

541
Bead Dispenser jammed - cannot find home
The Bead Dispenser has been unsuccessful in dispensing a bead.
§Be sure Bead Pack is seated correctly.
§Remove the Bead Pack, invert it, and then re-install it.
§Manually dispense a bead.
§If the message persists, call Technical Service.

542
Reagent Lid Opener jammed - pack lid opener not
extending
The Reagent Lid Opener has tried to open a Wedge unsuccessfully.
§Call Technical Service.

543
Reagent Lid Opener jammed - cannot find reagent open
The Reagent Lid Opener has tried to open a Wedge unsuccessfully.
§Call Technical Service.

544
Reagent Lid Opener jammed - cannot find home
The Reagent Lid Opener has tried to retract unsuccessfully.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-55

546
Sample False Level Sensed
A sample z-pipettor level sense motion has level sensed higher than expected.
§Check the position of the tube in the Sample Rack
§Ensure there is sufficient sample in the tube.
§Check for and eliminate any bubbles in the tube.
§Check for splashing near the pipettor.
§Check that approved tube size was used.
§Confirm that an unapproved tube insert was not used.
§If the message persists, call Technical Service.

547
Reagent Probe False Level Sensed at top or above wedge
A Reagent z-Pipettor level sense motion has level sensed higher than expected
§Check the position of the Reagent Wedge in the Reagent Carousel.
§Make sure the Reagent Wedge lid is positioned correctly and that it moves
freely.
§Ensure there are not bubbles in the reagent.
§Check for a reagent fluid film under the Wedge Glide.
§Check for splashing on or near the probe.
§If the message persists, call Technical Service.

548
Bad Bead Pack
A Bead Pack has failed to dispense three beads in a row.
§Remove Bead Pack from carousel and invert.
§Reseat the Bead Pack.

549
Wash Station spinner exceeded the 18 second timer
The Wash Station motor has taken longer than 18 seconds to complete a spin.
§Call Technical Service.

550
Bad spin at Wash Station
The Wash Station motor has spun at an incorrect speed.
§Call Technical Service

601005-0004 Rev. A
H-56 Operator’s Guide: Error Messages

551
Dilution Well exceeded the 18 second timer
The Dilution Well motor has taken longer than 18 seconds to complete a spin.
§Call Technical Service.

552
Bad spin at Dilution Well
The Dilution Well motor has spun at an incorrect speed.
§Call Technical Service

553
Incubator Shaker has stopped
The Incubator Shaker motor is not moving.
§Call Technical Service

554
Tube Escalator has jammed or Hopper left open
The sensor indicates that the Tube Escalator belt is not moving. This may be
caused by a jam, or by the Hopper being left open.
§Close the Hopper.
§Clear out Orientation chute.
§Check for obstruction in the Hopper or Escalator.
§Check for obstruction preventing closure of Hopper.
§If the message persists, call Technical Service.

555
No reaction tube detected going into bead pause
No Reaction tube detected in at the Tube Indexer.
§Check for Reaction Tubes in the Tube Hopper.
§Fill Hopper.
§Check for jam in the Orientation Chute.
§Verify correct Reaction Tube is used.
§Check for a malformed tube.
§If the message persists, call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-57

556
Substrate Probe missing - Is probe fully seated?
Error is generated during Start-Up or Initialization if the Substrate Probe is not
detected.
§Ensure the Substrate probe is seated correctly.
§If the message persists, call Technical Service.

557
Water Probe missing - Is probe fully seated?
Error is generated during Start-Up or Initialization if the Water Probe is not
detected.
§Ensure the Water Probe is seated correctly.
§If the message persists, call Technical Service.

558
Trigger Probe missing - Is probe fully seated?
Error is generated during Start-Up or Initialization if the Trigger Flag is not
detected.
§Call Technical Service.

559
Marked bad and rerunning test – water dispense error
A tube needs to be spun during the current cycle and the water probe was not
detected.
§If the message persists, call Technical Service.

560
Marked bad and rerunning test – substrate dispense
error
A tube needs to receive substrate during the current cycle and the substrate
probe was not detected.
§If the message persists, call Technical Service.

561
Marked bad and rerunning test – trigger reagent
dispense error
A tube needs to receive the trigger reagents during the current cycle and the
trigger flag was not detected.
§Call Technical Service.

601005-0004 Rev. A
H-58 Operator’s Guide: Error Messages

562
Clot detected in sample tube - sample will not be run
The Instrument has determined that a clot has been detected in the sample tube,
but is not clinging to the outside of the probe.
§Check sample. Spin down tube to remove clot.
§Rerun sample.

563
Clot detected in sample tube. Clean exterior of sample
probe before resuming operation.
The Instrument has determined that a clot has been detected in the sample tube
and is clinging to the outside of the probe.
§Remove Clinging clot.
§Look in the mirror by the Sample Probe for air bubbles; if air is detected run Clot
Prime diagnostics.
§If Sample Probe has entered gel barrier, change the probe.
§If the message persists, call Technical Service.

564-568
Programmer Error
§Call Technical Service.

569
Bar Code was read but tube in place sensor did not see
tube
Bar Code was read but tube in place sensor did not see tube
§Call Technical Service.

570
Programmer Error
Position from reading the bead carousel is outside the valid range.
§Call Technical Service.

571
Unrecognized port
Instrument does not recognize port for sample/reagent barcode reader
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-59

572
Unrecognized port
Instrument does not recognize port for Bead Pack barcode reader
§Call Technical Service.

573
Instrument jammed
Please Reboot System
Instrument has recognized an error in the system but cannot identify error. This
error should not occur in normal operation.
§Call Technical Service.

575
Sample Pipettor jammed inside incubator only
luminometer working
Sample Pipettor is jammed inside the incubator. All attempts to clear jam errors
have failed. Only the Luminometer is active.
§Ensure nothing is blocking the sample pipettor at the reagent/sample pipetting
area.
§Check for misalignment of the Sample Probe at the pipetting area.
§Check the Sample Probe is not bent.
§If the message persists, call Technical Service.

576
Sample Pipettor jammed above Pipettor position - front
end shut down
Sample Pipettor jammed above Reaction Tube. All attempts to clear jam errors
have failed.
§Check the movement of Pipettor is not obstructed.

578
Sample Pipettor is clogged due to clot
The sample pipettor or sample DRD jammed during the clinging clot test.
§Remove Clinging clot.
§Look in the mirror by the Sample Probe for air bubbles; if air is detected run Clot
Prime diagnostics.
§If Sample Probe has entered gel barrier, change the probe.
§If the message persists, call Technical Service.

601005-0004 Rev. A
H-60 Operator’s Guide: Error Messages

579
Corrective Jam Actions has also jammed going into Pause
Mode
The system tried to clear a sample device jam unsuccessfully.
§See associated error message to determine cause of jam.
§If the message persists, call Technical Service.

580
Sample Carousel has jammed during bar code read going
into pause
Sample Carousel has jammed.
§Check that the sample tube or diluent tube is seated correctly.
§Check that the Sample Racks are seated correctly.
§If the message persists, call Technical Service.

581
Homing sample devices resulted in a jam returning to
Pause Mode
Homing routines have failed during re-initialization, following Error 579.
§Check for associated error messages and resolve them.
§If the message persists, call Technical Service.

582
Reagent Pipettor has jammed only the luminometer is
active
Reagent Pipettor is jammed inside the incubator. All attempts to clear jam errors
have failed. Only the Luminometer is active.
§Ensure nothing is blocking the Reagent pipettor at the reagent/sample pipetting
area.
§Check for misalignment of the Reagent probe at the pipetting area.
§Check the Reagent probe is not bent.
§If the message persists, call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-61

583
Reagent Pipettor has jammed shutting down
sample-reagent pipettors
Reagent Pipettor jammed above Reaction Tube. All attempts to clear jam errors
have failed.
§Ensure nothing is blocking the Reagent pipettor at the reagent/sample pipetting
area.
§Check for misalignment of the Reagent probe at the pipetting area.
§Check the Reagent probe is not bent.
§If the message persists, call Technical Service.

585
Homing reagent devices resulted in a jam going into
pause mode
To clear a Reagent device jam (Error 584) the Instrument attempted to home all
reagent devices. However, the homing routine encountered an error.
§See associated error message to determine the cause of the jam.
§If the message persists, call Technical Service.

586
Homing reagent devices has resulted in a jam returning
to pause mode
Homing routines have failed during re-initialization after Error 585.
§Check for related error messages and resolve them.
§If the message persists, call Technical Service.

587
Reagent Carousel has jammed during bar code read going
into Pause
Reagent Carousel has jammed during barcode read.
§Reseat Wedge or carousel tray.
§Check Wedge Glide for proper installation.

589
Homing sample tube devices resulted in a jam going into
pause mode
The system tried to clear a tube/bead device jam unsuccessfully.
§See associated error message to determine the cause of the jam.
§If the message persists, call Technical Service.

601005-0004 Rev. A
H-62 Operator’s Guide: Error Messages

590
Homing tube loading devices resulted in a jam.
Returning to Pause mode.
Homing routines have failed during re-initialization after Error 589.
§Check for related error messages and resolve them.
§If the message persists, call Technical Service.

591
Bead Carousel has jammed during bar code read going
into pause
Bead Carousel has jammed.
§Check for mispositioned Bead Pack.
§If the message persists, call Technical Service.

592
INSTRUMENT ENTERED FRONT END SHUTDOWN
Device in incubator has jammed.
§See associated error message to determine cause of the jam.
§If the message persists, call Technical Service.

593
INSTRUMENT ENTERED STOP MODE
Device in the Luminometer has jammed or semaphore errors have shut down
instrument.
§See associated error message to determine cause of the jam.
§If the message persists, call Technical Service.

594
Marking sample tube as bad
Result of physical error on sample tube (e.g., clot detected, empty tube)
§See associated error message.
§Check sample volume.
§Check sample for clot.
§Check that Sample Probe is not bent.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-63

595
Marking reagent pack as bad
Result of physical error on reagent pack (e.g., empty pack)
§Check position of Reagent Wedge.
§Check that Glide is on correctly.
§Check for sufficient amount of reagent.
§Check for bubbles on the Wedge.
§If the message persists, contact Technical Service

596
Marking bead pack as bad
Result of physical error on Bead Pack (e.g., failure to dispense three beads)
§Check for empty Bead Pack.
§Invert and reseat Bead Pack in Bead Carousel and try again.
§Visually inspect plunger for obstruction.
§Manually dispense a bead.
§If the message persists, call Technical Service

597
Marking sample tube empty
Insufficient sample
§Check sample volume.

598
Marking reagent pack empty
Insufficient reagent.
§Check reagent volume.

599
Attempting to use a NULL RAMP TABLE. Switching to
default speed
Unrecognizable data was passed to the control side.
§Call Technical Service.

600
Jammed while washing the dilution well. Returning to
pause mode.
While cleaning the dilution well, a device jammed.
§Call Technical Service.

601005-0004 Rev. A
H-64 Operator’s Guide: Error Messages

603
Cannot enter run with the bulk exit chute blocked
Sensor(s) indicate that the solid waste chute is blocked.
§Check for overfilled or incorrectly seated solid waste container.
§Check for correct biohazard bags.
§Check the Waste chute for blockage.
§Check for clear plastic protruding from the upper trap opening and for plastic
pieces in the Solid Waste Container.
§If the message persists, call Technical Service.

604
Bulk Exit Chute is blocked. Entering pause mode
Sensor(s) indicate that the solid waste chute is blocked.
§Check for overfilled or incorrectly seated solid waste container.
§Check for correct biohazard bags.
§Clear the Exit Chute.
§Check for clear plastic protruding from the upper trap opening and for plastic
pieces in the Solid Waste Container.
§If the message persists, call Technical Service.

605
Tube Transport is not in position. Tube might be on
component deck
Occurs after the Instrument experiences unusual stop mode and a tube may have
been left on the transport chain. The tube will fall on the component deck during
initialization.
§Check for associated error message to determine the cause.
§If the message persists, call Technical Service.

606
Processor Shuttle has jammed
Processor Shuttle has jammed.
§Remove mis-positioned Reaction Tube.
§If the message persists, call Technical Service.

611
Homing Bead Carousel has resulted in a jam. In pause
mode now
Bead Carousel has jammed for a third time as it has attempted to clear jams.
§If the message persists, call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-65

612
Homing Bead Dispenser has resulted in a jam. In pause
mode now.
Bead Dispenser has jammed for a third time as it has attempted to clear jams.
§If the message persists, call Technical Service.

613
Homing Tube Indexer has resulted in a jam. In pause
mode now
Tube Indexer has jammed for a third time as it has attempted to clear jams.
§Verify correct Reaction Tube is used.
§Check for malformed tube or tube abnormalities.
§Visually inspect chain for any tube abnormality.
§If the message persists, call Technical Service.

614
Homing Tube Transport has resulted in a jam. In pause
mode now
Tube Transport has jammed for a third time as it has attempted to clear jams.
§Verify correct Reaction Tube is used.
§Check for malformed tube or tube abnormalities.
§Visually inspect chain for any tube abnormality.
§If the message persists, call Technical Service.

615
In pause now. Remove reaction tube in front of the
processor shuttle
Processor shuttle has jammed and not recovered.
§Check for obstruction near the Reagent/Sample pipetting area.
§If the message persists, call Technical Service.

618
Sample Probe level sense error in Dilution Well.
Entering Sample Pause mode.
Instrument did not level sense in the dilution well.
§Check for a bent probe.
§Check probe angle.
§Check that the dilution well insert is seated correctly.
§If the message persists, call Technical Service.

601005-0004 Rev. A
H-66 Operator’s Guide: Error Messages

619
Third bead pack marked bad in a row. Entering Bead
Pause Mode.
Third Bead Pack marked bad in a row. Entering Bead Pause Mode
§Reseat Bead Pack in Bead Carousel and try again
§Visually inspect plunger for obstruction
§Manually dispense a bead if first two steps do not correct.
§If the message persists, call Technical Service.

620
Unknown ucMode detected. Entering Stop Mode.
User side has sent unrecognizable instrument status mode.
§Call Technical Service.

621
Barcode queue has overflowed.
While reading the sample carousel, more than 99 barcodes were detected.
§Instrument will re-interrogate the sample carousel.
§If unsuccessful, error 646 will be posted.

622
Inner rack door movement exceeded maximum steps.
Contact Technical Service.
§Contact Technical Service.

623
Tube queue has overflowed.
Encoder queue has overflowed.
§Instrument will re-interrogate the sample carousel.
§If unsuccessful, error 646 will be posted.
§If the message persists, call Technical Service.

624
Attention!! - water probe is out.
Water Probe sensor is not detecting the probe
§Reseat Water Probe.
§If the message persists, call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-67

625
Attention!! - substrate probe is out.
Substrate Probe sensor is not detecting the probe
§Reseat Substrate Probe.
§If the message persists, call Technical Service.

626
Attention!! - trigger probe is out.
The plug that is used in place of the trigger probe is not detected by the sensor.
§Call Technical Service.

627
Reaction Tube is missing at bead drop position.
Rerunning test.
The sensor at the bead drop position is not detecting a tube.
§Check Tube Hopper for Reaction tubes.
§Check for obstruction in the Orientation chute.
§If the message persists, call Technical Service.

628
Tube at indexer disk sensor is struck high.
Sensor at the bottom of the tube chute continues to see a tube when none can be
there.
§Check for mispositioned tube in front of sensor.
§If the message persists, call Technical Service.

629
Tube shaker sensor is stuck high.
Sensor at Tube Shaker continues to see a tube when none should be there.
§Call Technical Service.

601005-0004 Rev. A
H-68 Operator’s Guide: Error Messages

630
Tube ladder sensor is stuck high.
Sensor at ladder continues to see a tube when none should be there.
§Ensure the front and side panel doors are closed.
§Select the Diagnostics icon located on the desktop.
§Select the Hopper Elevator Test.
§Manually move reaction cups away from escalator.
§Once the hopper elevator advances, stop the diagnostic.
§Exit Diagnostics and select RUN IMMULITE.
§If the message persists, call Technical Service.

631
Reaction tube at pipette position sensor is stuck high.
Sensor at pipette position continues to see a tube when none should be there.
§Call Technical Service.

632
Bulk Exit chute is blocked. Entering Stop mode.
The solid waste chute is blocked.
§Check for overfilled or incorrectly seated solid waste container.
§Check for correct biohazard bags.
§Check the Waste chute for blockage.
§Check for clear plastic protruding from the upper trap opening and for plastic
pieces in the Solid Waste Container.
§If the message persists, call Technical Service.

633
Clean Dilution Well Fail-Safe triggered.
A sample error resulted in the need to clean the dilution well or the dilution well
insert is not fully seated.
§Check for associated bead, reagent, or sample errors.
§If the message persists, call Technical Service.

637
DPRAM semaphore locked up for longer than 18 sec.
Entering STOP mode.
Communication between the User and Control sides has been interrupted.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-69

640
Wash spinner is not operating correctly. Rerunning
test.
Wash Spinner has failed to reach appropriate speed while processing test.
§Call Technical Service

641
Cannot enter RUN because wash spinner is not operating
correctly.
Wash Spinner has failed to reach appropriate speed during initialization from Stop
to Run.
§Call Technical Service.

642
Inner rack door communication error. Contact Technical
Service.
§Contact Technical Service.

646
Fatal Sample Carousel position mismatch, carousel was
not read. Please Call Technical Service immediately.
Sample carousel reread triggered by Error 642, 643, 644, 645 or 655 has resulted
in another carousel reading error.
§Check integrity of barcode labels.
§Manually assign sample identification.
§If message persists, call Technical Service.

650
Fatal Reagent Carousel position mismatch, carousel was
not read. Please Call Technical Service immediately.
Reagent carousel reread triggered by Error 647, 648, 649 or 656 has resulted in
another carousel reading error.
§Check integrity of label.
§Check position of reagent wedge.
§If message persists, call Technical Service.

601005-0004 Rev. A
H-70 Operator’s Guide: Error Messages

655
Rack detected in rack loader after load operation
complete. Check Rack Loader area.
A rack was still detected in the rack loader after a load operation completed.
Causes include, but are not limited to: Debris in front of rack in place sensor.

§Check Rack Loader area.

658
Sample Barcode misread during carousel read.
§The barcode reader returned two different strings for the same accession
number on a sample tube.
§Check integrity of barcode labels.
§Manually assign sample identification.
§If the message persists, call Technical Service.

659
Mismatch between first and second read of accession
number.
After the second carousel read, there is a mismatch between the accession
numbers for a sample tube.
§Check integrity of barcode labels.
§Manually assign sample identification.
§If the message persists, call Technical Service.

660
Mismatch between first and second read of the rack ID.
After the second carousel read, there is a mismatch between the rack identifiers
for the sample carousel.
§Check integrity of barcode label.
§Ensure the rack is seated correctly.
§If the message persists, call Technical Service.

661
Mismatch between first and second read of the Reagent
Pack barcode.
After the second carousel read, there is a mismatch between the Reagent pack
barcodes.
§Check integrity of barcode label.
§Ensure wedges are seated correctly.
§If the message persists, call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-71

662
Mismatch between first and second read of the Bead Pack
barcode.
After the second carousel read, there is a mismatch between the Bead pack
barcodes.
§Check integrity of barcode label.
§Ensure Bead Packs are seated correctly.
§If the message persists, call Technical Service.

670
RGT_BKLS.iml file is missing
File could not be found.
§Call Technical Service.

671
DilWelLS.IML file is missing
File could not be found.
§Call Technical Service.

672
PRIMECNT.IML file is missing
File could not be found.
§Call Technical Service.

673
Bad mix at Dilution Well
Sample and diluent were not properly mixed in the Sample Dilution Well.
§Call Technical Service.

676
ReagFLS.IML file is missing.
File could not be found.
§Call Technical Service.

601005-0004 Rev. A
H-72 Operator’s Guide: Error Messages

677
Reagent Probe False Level Sensed out of tolerance.
A Reagent z-Pipettor level sense motion has level sensed higher than expected
§ Check the position of the Reagent Wedge in the Reagent Carousel.
§Make sure the Reagent Wedge lid is positioned correctly and that it moves
freely.
§Ensure there are no bubbles in the reagent.
§Check for a reagent fluid film under the Wedge Glide.
§Check for splashing on or near the Reagent Probe.
§Replace the Reagent Wedge with a new one and try again.
§If the message persists, call Technical Service.

679
Clot detection mechanism failure entering front end
shutdown. Contact Technical Service.
Peak clot feedback is less than minimum
§Call Technical Service.

680
Tube size discrepancy detected scanning Rack 1,
rescanning all sample racks.
Instrument has detected a change on the sample rack that was not being
rescanned.
§If the message persists, call Technical Service.

735
Sample Transfer Status message was received before
REINIT1.
Analyzer was unable to properly communicate with the SMS.
§On the SMS, select the STOP button.
§Select the LOGOFF button and log off the SMS.
§Restart the SMS.
§If the message persists, call Technical Service.

736
Query Analyzer Status message has the wrong length.
SMS query message has wrong length.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-73

737
Sequence number error in Query Analyzer Status message.
Sequence number error in Query Analyzer Status message.
§Call Technical Service.

738
Query Analyzer Status message was received before
REINIT 1
Analyzer was unable to properly communicate with the SMS.
§On the SMS, select the STOP button.
§Select the LOGOFF button and log off the SMS.
§Restart the SMS.
§If the message persists, call Technical Service.

739
Reinitialize Communications message has unknown
Recovery Type.
SMS used unknown protocol
§If the message persists, call Technical Service.

740
Reinitialize Communications message has the wrong
length.
SMS message has the wrong length
§If the message persists, call Technical Service.

741
Unknown message ID.
SMS sent unknown message
§If the message persists, call Technical Service.

742
ACK has wrong length.
SMS ACK message has a length that does not follow protocol
§If the message persists, call Technical Service.

601005-0004 Rev. A
H-74 Operator’s Guide: Error Messages

743
Sequence number in ACK doesn’t match last sent message.
The sequence number in the ACK (acknowledgement between the SMS and the
analyzer) does not match the sequence number of any message sent and was
therefore not acknowledged by the Control computer.
§Call Technical Service.

744
ACK was not expected.
All messages sent by the Control computer have been acknowledged; this ACK
(acknowledgement between the SMS and the analyzer) is invalid.
§Call Technical Service.

745
Cannot match ACK to a sent message.
An ACK (acknowledgement between the SMS and the analyzer) could not be
matched to the message sent between the analyzer and the SMS.
§Call Technical Service.

746
NAK has the wrong length.
SMS sends NAK that does not follow the length protocol
§Call Technical Service.

747
Sequence number in NAK doesn't match last sent message.
SMS sends NAK in response to the wrong message
§Call Technical Service.

748
Cannot match NAK to a sent message.
SMS sends NAK in response to the message that was never sent
§Call Technical Service.

749
Message has an invalid message type.
SMS sends a message other than ACK, NAK, or data.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-75

750
AutoSendQueue has overflowed.
The serial communication is broken
§Call Technical Service.

751
Accession number to be sent is longer than 20 char.
Programming error
§Call Technical Service.

752
Cannot switch into INTEGRATED mode when not in STOP.
The Control computer received a command to switch to Integration mode while
the analyzer was running or paused.
§On the analyzer, select the STOP button.
§From the IMMULITE 2000 Home screen, select Configure from the
Configurations menu.
§Select the Instrument Mode button.
§Select the Integrated option and select the Save button.
§Select the Save button.
§Select the RUN button to begin processing samples.
§If the message persists, call Technical Service.

753
Cannot switch into STAND ALONE mode when not in STOP.
The Control computer received a command to switch to Non-Integrated mode
while the analyzer was running or paused.
§On the analyzer, select the STOP button.
§From the IMMULITE 2000 Home screen, select Configure from the
Configurations menu.
§Select the Instrument Mode button.
§Select the Non-Integrated option and select the Save button.
§Select the Save button.
§Select the RUN button to begin processing samples.
§If the message persists, call Technical Service.

754
Switching to PAUSE due to timeout. Automation may be
active!!!
Attempting to switch to Pause mode after communication timeout with SMS
§Press Run to continue processing samples.

601005-0004 Rev. A
H-76 Operator’s Guide: Error Messages

755
Switching to STOP due to timeout. Automation may be
active!!!
Attempting to switch to stop mode after communication timeout with SMS
§Press Run to continue processing samples.

756
Test made bad by Reinitialize 1 command.
Re-initialize message was received while a sample was waiting to be pipette.
§This message is for informational purposes only. No action is required.

757
Please clear the IMMULITE 2000 of automation tubes.
A fault was detected when the Sample Carousel was interrogated at start up.
§On the analyzer, open the Top Cover and remove the sample tubes from
Automation Rack on the Sample Carousel.
§On the analyzer, select the RUN button.
§If the sample tubes were not run, place them on the SMS and rerun them.

759
Received Reinitialize 1
SMS is trying to reset the communications
§This message is for informational purposes only. No action is required.

760
Automation tube appears to have been misplaced. Going
to sample pause.
A sample tube was improperly placed on the analyzer.
§On the analyzer, open the Top Cover and remove the sample tubes from
Automation Rack on the Sample Carousel.
§Select the RUN button.
§If the sample tubes were not run, place them on the SMS and rerun them.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-77

762
IMMULITE time out waiting for Place – Sample SMS
Transfer Reply. Going to sample pause.
Sample tube was not placed within the allotted time. The analyzer timed out
waiting for a reply from the SMS.
§On the analyzer, open the Top Cover and remove the sample tubes from
Automation Rack on the Sample Carousel.
§On the analyzer, select the RUN button.
§If the sample tubes were not run, place them on the SMS and rerun them.

763
IMMULITE time out waiting for Pick – Sample Transfer
Reply. Going to sample pause.
Sample tube was not picked up by the SMS within the allotted time. The analyzer
timed out waiting for a reply from the SMS.
§On the analyzer, open the Top Cover and remove the sample tubes from
Automation Rack on the Sample Carousel.
§On the analyzer, select the RUN button.
§If the sample tubes were not run, place them on the SMS and rerun them.

764
Please clear the IMMULITE 2000 of automation tubes.
Going to sample pause.
A fault was detected when the Sample Carousel was interrogated.
§On the analyzer, open the Top Cover and remove the sample tubes from
Automation Rack on the Sample Carousel.
§On the analyzer, select the RUN button.
§If the sample tubes were not run, place them on the SMS and rerun them.

765
Please clear the IMMULITE 2000 of automation tubes.
Going to sample pause.
A fault was detected when the Sample Carousel was interrogated.
§On the analyzer, open the Top Cover and remove the sample tubes from
Automation Rack on the Sample Carousel.
§On the analyzer, select the RUN button.
§If the sample tubes were not run, place them on the SMS and rerun them.

601005-0004 Rev. A
H-78 Operator’s Guide: Error Messages

766
Please clear the IMMULITE 2000 of automation tubes.
Going to sample pause.
A fault was detected when the Sample Carousel was interrogated.
§On the analyzer, open the Top Cover and remove the sample tubes from
Automation Rack on the Sample Carousel.
§On the analyzer, select the RUN button.
§If the sample tubes were not run, place them on the SMS and rerun them.

767
Please clear the IMMULITE 2000 of automation tubes.
Going to sample pause.
A fault was detected when the Sample Carousel was interrogated.
§On the analyzer, open the Top Cover and remove the sample tubes from
Automation Rack on the Sample Carousel.
§On the analyzer, select the RUN button.
§If the sample tubes were not run, place them on the SMS and rerun them.

768
Please clear the IMMULITE 2000 of automation tubes.
Going to sample pause.
A fault was detected when the Sample Carousel was interrogated.
§On the analyzer, open the Top Cover and remove the sample tubes from
Automation Rack on the Sample Carousel.
§On the analyzer, select the RUN button.
§If the sample tubes were not run, place them on the SMS and rerun them.

769
Please clear the IMMULITE 2000 of automation tubes.
Going to sample pause.
A fault was detected when the Sample Carousel was interrogated.
§On the analyzer, open the Top Cover and remove the sample tubes from
Automation Rack on the Sample Carousel.
§On the analyzer, select the RUN button.
§If the sample tubes were not run, place them on the SMS and rerun them.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-79

770
Please clear the IMMULITE 2000 of automation tubes.
Going to sample pause.
A fault was detected when the Sample Carousel was interrogated.
§On the analyzer, open the Top Cover and remove the sample tubes from
Automation Rack on the Sample Carousel.
§On the analyzer, select the RUN button.
§If the sample tubes were not run, place them on the SMS and rerun them.

771
Robot Status message has the wrong length.
SMS status message does not follow length protocol
§This message is for informational purposes only. No action is required.

772
Sequence number error in Robot Status message.
SMS status message does not match any sent message
§This message is for informational purposes only. No action is required.

773
Robot Status message was received before REINIT1.
Analyzer was unable to properly communicate with the SMS.
§On the SMS, select the STOP button.
§Select the LOGOFF button and log off the SMS.
§Restart the SMS.
§If the message persists, call Technical Service.

774
Logoff message has the wrong length.
The log off message does not follow the length protocol
§This message is for informational purposes only. No action is required.

775
Data Error on UART3.
Hardware problem in serial card
§Call Technical Service.

800
Test reordered - Instrument power failure.
The software detected a PMT power glitch after reading PMT results.

601005-0004 Rev. A
H-80 Operator’s Guide: Error Messages

801
A request mutex call timed out. Contact Technical
Service.
Unexpected Error. On 2000 - The sample Pipettor timed out waiting to gain
exclusive access to enter the incubator.
§Contact Technical Service.

802
A request mutex call timed out. Contact Technical
Service.
Unexpected Error. On 2000 - The sample Pipettor timed out waiting to gain
exclusive access to enter the incubator.
§Contact Technical Service.

803
A request mutex call timed out. Contact Technical
Service.
Unexpected Error. On 2000 - The sample Pipettor timed out waiting to gain
exclusive access to enter the incubator.
§Contact Technical Service.

804
A request mutex call timed out. Contact Technical
Service.
Unexpected Error. On 2000 - The sample Pipettor timed out waiting to gain
exclusive access to enter the incubator.
§Contact Technical Service.

805
A request mutex call timed out. Contact Technical
Service.
Unexpected Error. On 2000 - The sample Pipettor timed out waiting to gain
exclusive access to enter the incubator.
§Contact Technical Service.

806
A request mutex call timed out. Contact Technical
Service.
Unexpected Error. On 2000 - The sample Pipettor timed out waiting to gain
exclusive access to enter the incubator.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-81

808
Instrument power failure, entering Stop mode. Contact
Technical Service.
The PMT power failed signal is detected for 3 consecutive cycles in Run or Pause
mode.
§Contact Technical Service.

810
Bead Carousel error. Going to Bead Pause Mode. Check
that Bead Packs are properly inserted.
An unrecoverable jam occurred on the Bead carousel.
§Check for improperly inserted Bead pack.

811
Bead Dispenser error. Going to Bead Pause Mode. Check
that Bead Packs are properly inserted.
An unrecoverable jam occurred on the bead dispenser.
§Check for improperly inserted Bead pack.
§This error could also indicate a hardware failure.

812
Tube Indexer error. Going to Bead Pause Mode. Check
Tube Indexer.
An unrecoverable jam occurred on the tube indexer.
§Check the tube indexer and tube queue.
§The indexer may have a deformed tube jamming it.

814
Error reading configuration file TubeTop.IML. Contact
Technical Service.
§Contact Technical Service.

815
Failed to detect bottom of Tube Top Sample Cup.
Tube Top Sample Cup was not detected during the bottom finding routine.
§Check that you placed the tube top cup in sample tube.

816
Unexpected error. Contact Technical Service.
§Contact Technical Service.

601005-0004 Rev. A
H-82 Operator’s Guide: Error Messages

817
Unable to load rack. Eject a rack if the sample
carousel is full, or press Run to scan the carousel.
Either the Sample Carousel is full, or there is no known empty position to load a
rack into. If there are any empty Positions, they were set to “Unknown”.

818
Close the sample door to eject rack.
An eject was ordered, but the external sample door is open.
§Remove any rack in the loader area, and close the external sample door.

819
Remove rack from loader to allow rack to eject.
An eject was ordered, but there’s a rack in the loader area.
§Remove any rack in the loader area, and close the external sample door.
§If there is no rack present, this may indicate a rack in place sensor failure.

820
Unexpected error. Contact Technical Service.
§Contact Technical Service.

821
Error reading configuration file AutoStrt.IML. System
will continue. Contact Technical Service.
§Contact Technical Service.

822
Probe clean tube not found for AutoStart. Probe clean
was not performed.
AutoStart Probe clean tube not found in Sample Carousel.

823
Level sense error in probe clean tube. Probe clean was
not performed.
AutoStart Sample Probe clean Level Sense Failure.

§Make sure enough probe clean solution within the tube.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-83

824
False level sense error in probe clean tube. Probe
clean was not performed.
False Level sense error. The sample probe level-sensed above the probe clean
tube during AutoStart.
§Check if there is a (wet) cap on the probe clean tube.
§Otherwise someone must have touched the probe, or the level sense hardware
is oversensitive

825
Failed to load reaction tube. AutoStart not performed.
AutoStart Probe clean Fail to get Reaction Tube. Tube was not detected at the
incubator pipette position.
§Check inventory of Tube Hopper.
§Make sure Hopper is closed.
Make sure tubes lined-up in the Tube Chute canal.

826
Failed to load reaction tube at Tube Indexer.
While getting a tube for Autostart (probe clean, wash prime, or substrate
dispense), the Tube indexer did not see a tube. Either the tube queue is clogged,
or the hopper is completely empty.
§Check the fill of the tube hopper. Check for jammed tubes in reaction tube chute.

§Otherwise it may be a failure to get the sensor signal.

827
Reaction tube not found at Incubator pipette position.
Aborting AutoStart routine.
While getting a tube for Autostart (probe clean, wash prime), the tube was not
seen in the Incubator after the processor shuttle push. Possibly a sensor error, or
the tube did not push in far enough for the sensor to see.
§If it persists, have the Inc0 sensor checked.

831
Unexpected error. AutoStart not performed. Contact
Technical Service.
§Contact Technical Service.

832
Unexpected error. AutoStart not performed. Contact
Technical Service.
§Contact Technical Service.

601005-0004 Rev. A
H-84 Operator’s Guide: Error Messages

833
Unexpected error. AutoStart not performed. Contact
Technical Service.
§Contact Technical Service.

834
Unexpected error. AutoStart not performed. Contact
Technical Service.
§Contact Technical Service.

835
Unexpected error. AutoStart not performed. Contact
Technical Service.
§Contact Technical Service.

836
Unexpected error. AutoStart not performed. Contact
Technical Service.
§Contact Technical Service.

837
Unexpected error. AutoStart not performed. Contact
Technical Service.
§Contact Technical Service.

838
Unexpected error. AutoStart not performed. Contact
Technical Service.
§Contact Technical Service.

839
Unexpected error. AutoStart not performed. Contact
Technical Service.
§Contact Technical Service.

840
Unexpected error. AutoStart not performed. Contact
Technical Service.
§Contact Technical Service.

841
Unexpected error. AutoStart not performed. Contact
Technical Service.
§Contact Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-85

842
Unexpected error. AutoStart not performed. Contact
Technical Service.
§Contact Technical Service.

843
Unexpected error. AutoStart not performed. Contact
Technical Service.
§Contact Technical Service.

844
Unexpected error. AutoStart not performed. Contact
Technical Service.
§Contact Technical Service.

845
Unexpected error. AutoStart not performed. Contact
Technical Service.
§Contact Technical Service.

846
Unexpected error. AutoStart not performed. Contact
Technical Service.
§Contact Technical Service.

847
Invalid tube or rack for probe clean. Probe clean will
not be performed.
Probe clean tube was wrongly placed into a dedicated rack, within micro-sample
tube, or other unknown tube type is assigned.

848
Failed to home all motors during AutoStart. AutoStart
will not be performed.
Home all motors failed at the beginning of AutoStart.
§If repeated attempts fail, contact Technical Service.

849
Failed to scan Sample Carousel. AutoStart will not be
performed.
Scan of Sample carousel failed prior to AutoStart. May have been a jam. If
repeated attempts fail it is likely a configuration, mechanical, or hardware issue
§If repeated attempts fail, contact Technical Service.

601005-0004 Rev. A
H-86 Operator’s Guide: Error Messages

850
Auto Substrate Dispense parameter is out of range. Auto
Substrate Dispense will not be performed. Contact
Technical Service.
§Contact Technical Service.

851
Tube not found at Incubator pipette position. Aborting
Auto Substrate Dispense routine. Manually prime the
substrate.
While getting a tube for Substrate Dispense, the tube was not seen in the
Incubator after the processor shuttle push. Possibly a sensor error, or the tube did
not push in far enough for the sensor to see.
§If it persists, have the Inc0 sensor checked.

852
Unexpected error during Auto Substrate Dispense
routine. Auto Substrate Dispense will not be performed.
Contact Technical Service.
§Contact Technical Service.

853
Substrate Probe is not in place. Aborting Auto
Substrate Dispense routine. Manually prime the
substrate.
Error during Auto Substrate Dispense. The Substrate probe was not in place at
the time of dispense of substrate.
§Please put the substrate probe back in place.

854
Failed to load reaction tube. AutoStart not performed.
Error during AutoStart. Tube did not physically reach the Incubator pipette
position.
§Check tube load area.
§Check that tube hopper is not empty.
§Retry AutoStart.

855
Tube Lifter error.
Error during AutoStart. Possibly tube lifter jammed. Wash Station tube lifter may
have jammed.
§Check tube lifter.
§Retry AutoStart.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-87

856
Wash Station spinner failed.
Error during AutoStart. Error with the Wash Station spinner motor. Wash Station
Spinner failed.
§Retry AutoStart

857
Water Probe is not in place.
The Water probe is not in place. Error occurred during AutoStart.
§Please put the water probe back in place.
§Retry AutoStart.

860
Failed to home all motors. Auto Substrate Dispense will
not be performed. Contact Technical Service.
§Contact Technical Service.

861
Unexpected error during Auto Substrate Dispense. Auto
Substrate Dispense will not be performed. Contact
Technical Service.
§Contact Technical Service.

862
Unexpected error during Auto Substrate Dispense. Auto
Substrate Dispense will not be performed. Contact
Technical Service.
§Contact Technical Service.

863
Unexpected error during Auto Substrate Dispense. Auto
Substrate Dispense will not be performed. Contact
Technical Service.
§Contact Technical Service.

864
Unexpected error during Auto Substrate Dispense. Auto
Substrate Dispense will not be performed. Contact
Technical Service.
§Contact Technical Service.

867
Unexpected error. Contact Technical Service.
§Contact Technical Service.

601005-0004 Rev. A
H-88 Operator’s Guide: Error Messages

868
Unexpected error. Contact Technical Service.
§Contact Technical Service.

869
Unexpected error. Contact Technical Service.
§Contact Technical Service.

870
Unexpected error. Contact Technical Service.
§Contact Technical Service.

871
Unexpected error. Contact Technical Service.
§Contact Technical Service.

872
Unexpected error. Contact Technical Service.
§Contact Technical Service.

873
Unexpected error. Contact Technical Service.
§Contact Technical Service.

874
Unexpected error. Contact Technical Service.
§Contact Technical Service.

875
Unexpected error. Contact Technical Service.
§Contact Technical Service.

876
Unexpected error. Contact Technical Service.
§Contact Technical Service.

877
Unexpected error. Contact Technical Service.
§Contact Technical Service.

878
Unexpected error. Contact Technical Service.
§Contact Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-89

879
Unexpected error. Contact Technical Service.
§Contact Technical Service.

880
An empty sample rack was detected. Rack will be
ejected.
A sample rack with no tubes was inserted, or a rack with tubes was inserted, but
the tubes were not detected by the tube height sensors or the barcode reader.

881
Unexpected error. Contact Technical Service.
§Contact Technical Service.

882
Unexpected error. Contact Technical Service.
§Contact Technical Service.

883
Unexpected error. Contact Technical Service.
§Contact Technical Service.

884
Unexpected error. Contact Technical Service.
§Contact Technical Service.

885
Unexpected error. Contact Technical Service.
§Contact Technical Service.

886
Unexpected error. Contact Technical Service.
§Contact Technical Service.

887
Inner rack door will not open. Close all covers. Reopen
main cover.
Normally, when opening the cover, the rack transfer door opens automatically. If
you have the external rack loader door opened, this will be skipped.
§Closing the rack loader door prior to popping the hood will prevent this.

888
Unexpected error. Contact Technical Service.
§Contact Technical Service.

601005-0004 Rev. A
H-90 Operator’s Guide: Error Messages

889
Rack Loader door is open.
The rack loader door is open during initialization.
§Close the door to continue.
Occurs if the rack loader door is opened. May also occur if sensor fails or
becomes disconnected

890
Unexpected error. Contact Technical Service.
§Contact Technical Service.

891
Unexpected error. Contact Technical Service.
§Contact Technical Service.

892
Unexpected error. Contact Technical Service.
§Contact Technical Service.

893
Error reading configuration file RLCfg.IMR. Contact
Technical Service.
§Contact Technical Service.

894
Unexpected error. Contact Technical Service.
§Contact Technical Service.

895
Rack Loader unavailable. Close door.
The rack loader door was opened while the rack loader is busy. This is hazardous
and not advised. Alternatively, the rack loader door sensor assembly may be
malfunctioning.
§Take care to not open rack loader door when red light is lit.

896
Unexpected error. Contact Technical Service.
§Contact Technical Service.

897
Unexpected error. Contact Technical Service.
§Contact Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-91

898
Rack Loader device jammed while homing. Returning to
Pause Mode. Check Rack Loader area.
The Rack Gripper, Rack Transfer, or Rack Transfer Door jammed during the
transition from Pause mode to Run.
§Check Rack Loader area.

899
Unexpected error. Contact Technical Service.
§Contact Technical Service.

901
Automation Rack cannot be ejected.
The instrument is configured in nonintegrated mode, detects a tube in the auto
rack, operator attempts to eject it.

902
Main cover is open.
The Main Cover door is opened during Initialization.
§Close the door to continue.
May also occur if the sensor fails or becomes disconnected. This error is reported
one time if the door is open.

903
Sample pipettor door is open.
The sample pipettor (Top) Door (aka Clot Door) is open during initialization.
§Close the door to continue.
May also occur if the sensor fails or becomes disconnected.

904
Main cover is open. AutoStart will not be performed.
The Main Cover was open when AutoStart began.
§Close the door and re-run the operation.
May also occur if the sensor fails or becomes disconnected.

905
Sample pipettor door is open. AutoStart will not be
performed.
The sample pipettor (Top) Door (aka Clot Door) was open when AutoStart began.
§Close the door and re-run the operation.
May also occur if the sensor fails or becomes disconnected.

601005-0004 Rev. A
H-92 Operator’s Guide: Error Messages

906
Sample rack loader door is open. AutoStart will not be
performed.
The Rack Loader External Door was open when AutoStart began.
§Close the door and re-run the operation.
May also occur if the sensor fails or becomes disconnected.

907
Main cover is open. Automatic Substrate Dispense will
not be performed.
The Main Cover was open when Auto substrate dispense began.
§Close the cover and re-run the operation.
May also occur if the sensor fails or becomes disconnected.

908
Sample pipettor door is open. Automatic Substrate
Dispense will not be performed.
The sample pipettor (Top) door (aka Clot Door) was open when Auto substrate
dispense began.
§Close the door and re-run the operation.
May also occur if the sensor fails or becomes disconnected.

909
Sample rack loader door is open. Automatic Substrate
Dispense will not be performed.
The Rack Loader External Door was open when Auto substrate dispense began.
Close the door and re-run the operation.
May also occur if the sensor fails or becomes disconnected.

910
Main cover is open. AutoStart is running. Close cover.
The Main Cover was open while AutoStart operation was active.
§Close the door.
May also occur if the sensor fails or becomes disconnected.

911
Sample pipettor door is open. AutoStart is running.
Close door.
Sample pipettor (Top) Door (aka Clot Door) was open while AutoStart operation
was active.
§Close the door.
May also occur if the sensor fails or becomes disconnected.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-93

912
Unexpected error. Contact Technical Service.
§Contact Technical Service.

913
Main cover is open. Automatic Substrate Dispense is
running. Close cover.
The Main Cover was open while Automatic substrate dispense operation was
active.
§Close the door.
May also occur if the sensor fails or becomes disconnected.

914
Sample pipettor door is open. Automatic Substrate
Dispense is running. Close door.
The sample pipettor (Top) Door (aka Clot Door) was open while Automatic
substrate dispense was active.
§Close the door.
May also occur if the sensor fails or becomes disconnected.

917
Empty unbarcoded rack detected. Rack will be ejected.
A rack that has no detectable tubes on it, and no rack barcode (or an unreadable
barcode) has been detected on the system. Because the instrument suspects the
rack was loaded but cannot be seen, it will be ejected.

918
Rack transfer has jammed during retract. Remove rack if
present and retry.
A retract motion jammed or failed. Some Causes may be an obstruction restricting
motion, improper configuration, failure due to a electrical issue, etc.
§Remove rack if present and retry.

919
A sample rack changed status unexpectedly. Sample
carousel must be rescanned. Retry the operation to
rescan the carousel.
A rack either disappeared or appeared since the last scan when the rack has
never been accessed via the rack loader or the main cover is open.
§Retry the operation to rescan the carousel.

601005-0004 Rev. A
H-94 Operator’s Guide: Error Messages

920
Sample rack status cleared. After closing main cover,
press Run prior to resuming use of Rack Loader.
Opening the main cover (on XPi systems) causes the instrument to consider all
sample carousel positions as unknown because the operator may now insert/
remove racks directly from the sample carousel without the instrument’s
knowledge.

921
Aborting transition to Run Mode due to errors.
Returning to Stop Mode.
An error (specified via a different error code) has caused the MCP to abort the
transition to run mode from stop mode. The instrument is returning to pause
mode.
§Resolve the accompanying errors.

922
Aborting transition to Run Mode due to errors.
Returning to Pause Mode.
An error (specified via a different error code) has caused the MCP to abort the
transition to run mode from pause mode. The instrument is returning to pause
mode.
§Resolve the accompanying errors.

923
The Results Buffer has overflowed. Test Rerun.
The results Buffer has overflowed. The control side cannot put the result in the full
buffer, so the data is lost. (actually it is saved in “results.dat” which is in the control
side c:\bin directory).

1002
Bead Dispenser fatal timeout.
Bead Dispenser has failed to respond to a command in the allowable time.
Instrument shut down. All tests on board are lost.
§Call Technical Service.

1003
Test designated bad – Pretreatment transfer scheduling
issue – Test Rerun.
Unable to transfer pre-treatment tube. Test will be reordered.
§No action required. If this problem, persists, call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-95

1004
Error has forced Error Pause Mode. RUN Button is
deactivated until STOP mode is entered.
Incubator 1, Incubator 2, Wash Station 1 or Wash Station 2 has shut down.
Instrument is in Error Pause mode and will not enter RUN mode.
§Wait until all tests on the system complete, then enter STOP mode.

1005
IMMULITE 2500 doors must be closed for operation.
A door, or doors are not properly closed.
§Verify that the Bead Carousel, Large Reagent, Small Reagent, Main Cover and
Sample Loading doors are closed. If all doors are fully closed, a sensor may
be malfunctioning.
§Call Technical Service.

1006
Please clear the $IM2K$ of automation tubes.
When SMS messages to the IMMULITE serious enough error with the pick or
place of a Sample Tube that the operator needs to clear the error
§Open the top cover and remove the sample tubes from the automation rack on
the Sample Carousel.
§Select the RUN button. If sample tubes were not run, place them on the SMS
and rerun them.

1007
Please clear the $IM2K$ of automation tubes. Going into
sample pause.
SCAS Error - Tube On board
§Open the top cover and remove the sample tubes from the automation rack on
the Sample Carousel.
§Select the RUN button. If sample tubes were not run, place them on the SMS
and rerun them.

1008
Please clear the $IM2K$ of automation tubes. Going into
sample pause.
Three tubes on AR.
§Open the top cover and remove the sample tubes from the automation rack on
the Sample Carousel.
§Select the RUN button. If sample tubes were not run, place them on the SMS
and rerun them.

601005-0004 Rev. A
H-96 Operator’s Guide: Error Messages

1009
Please clear the $IM2K$ of automation tubes. Going into
sample pause.
Auto A - DPR Mismatch #1
§Open the top cover and remove the sample tubes from the automation rack on
the Sample Carousel.
§Select the RUN button. If sample tubes were not run, place them on the SMS
and rerun them.

1010
Please clear the $IM2K$ of automation tubes. Going into
sample pause.
Auto B - DPR Mismatch #1
§Open the top cover and remove the sample tubes from the automation rack on
the Sample Carousel.
§Select the RUN button. If sample tubes were not run, place them on the SMS
and rerun them.

1011
Please clear the $IM2K$ of automation tubes. Going into
sample pause.
Auto C - DPR Mismatch #1
§Open the top cover and remove the sample tubes from the automation rack on
the Sample Carousel.
§Select the RUN button. If sample tubes were not run, place them on the SMS
and rerun them.

1025
Event 1 has fatally timed out.
An earlier error has caused a timeout in a portion of the Instrument. This portion
will be shutdown.
§Allow the Instrument to complete tests in progress.
§Call Technical Service.

1026
Event 2 has fatally timed out.
An earlier error has caused a timeout in a portion of the instrument. This portion
will be shutdown.
§Allow the Instrument to complete tests in progress.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-97

1027
Event 3 has fatally timed out.
An earlier error has caused a timeout in a portion of the instrument. This portion
will be shutdown
§Allow the Instrument to complete tests in progress.
§Call Technical Service.

1031
Luminometer Belt calculated an excessive time for a
move.
Unexpected error. An internal timing error for the Luminometer Belt has caused
the Instrument to shut down. All tests on board are lost.
§Call Technical Service.

1032
Luminometer Belt calculated an excessive distance for a
move.
Unexpected error. An internal timing error for the Luminometer Belt has caused
the Instrument to shut down. All tests on board are lost.
§Call Technical Service.

1033
Incubator 1 Belt calculated an excessive time for a
move.
Unexpected error. An internal timing error for Incubator 1 has caused the
Instrument to shut down. No new tests will be loaded.
§Allow the Instrument to complete tests in progress.
§Call Technical Service.

1034
Incubator 1 Belt calculated an excessive distance for a
move.
Unexpected Error. An internal timing error for Incubator Belt 1 has caused
Incubator 1 to shut down. No new tests will be loaded.
§Allow the Instrument to complete tests in progress.
§Call Technical Service.

601005-0004 Rev. A
H-98 Operator’s Guide: Error Messages

1035
Incubator 2 Belt calculated an excessive time for a
move.
Unexpected Error. An internal timing error for Incubator Belt 2 has caused both
Incubators to shut down. Instrument will attempt to complete tests in the
Luminometer. No new tests will be loaded.
§Allow the Instrument to complete tests in progress.
§Call Technical Service.

1036
Incubator 2 Belt calculated an excessive distance for a
move.
Unexpected Error. An internal timing error for Incubator Belt 2 has caused both
Incubators to shut down. Instrument will attempt to complete tests in the
Luminometer. No new tests will be loaded.
§Allow the Instrument to complete tests in progress.
§Call Technical Service.

1037
Incubator 1 Belt movement timeout. Incubator 1 will
shut down.
Unexpected Error. An internal timing error for Incubator Belt 2 has caused
Incubator 1 to shut down. Instrument will attempt to complete tests in the
Luminometer. No new tests will be loaded.
§Allow the Instrument to complete tests in progress.
§Call Technical Service.

1038
Incubator 2 Belt movement timeout. Incubator 2 will
shut down.
Unexpected Error. An internal timing error for Incubator Belt 2 has caused both
incubators to shut down. Instrument will attempt to complete tests in the
Luminometer. No new tests will be loaded.
§Allow the Instrument to complete tests in progress.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-99

1039
Luminometer Belt movement timeout. Luminometer will
shut down.
Unexpected Error. The Luminometer Belt has been asked to move for a longer
time than permitted. The Instrument will shut down. All tests on board are lost.
§Call Technical Service.

1040
A single motor attempted two simultaneous motor moves.
Unexpected error. Sample Arm X motor attempted two simultaneous moves.
Instrument will attempt to enter Sample Pause.
§Allow the Instrument to complete tests in progress.
§Call Technical Service.

1041
A single motor attempted two simultaneous motor moves.
Unexpected error. Sample Arm Z motor attempted two simultaneous moves.
Instrument will attempt to enter Sample Pause.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

1042
A single motor attempted two simultaneous motor moves.
Unexpected error. Sample Valve motor attempted two simultaneous moves.
Instrument will attempt to enter Sample Pause.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

1043
A single motor attempted two simultaneous motor moves.
Unexpected error. Sample Dilutor motor attempted two simultaneous moves.
Instrument will attempt to enter Sample Pause.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

601005-0004 Rev. A
H-100 Operator’s Guide: Error Messages

1044
A single motor attempted two simultaneous motor moves.
Unexpected error. Sample Carousel motor attempted two simultaneous moves.
Instrument will attempt to enter Sample Pause.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

1045
A single motor attempted two simultaneous motor moves.
Unexpected error. Reagent Arm Z motor attempted two simultaneous moves.
Instrument will attempt to enter Reagent Pause.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

1046
A single motor attempted two simultaneous motor moves.
Unexpected error Reagent Arm X motor attempted two simultaneous moves.
Instrument will attempt to enter Reagent Pause.
§Allow the Instrument to complete tests in progress.
§Call Technical Service.

1047
A single motor attempted two simultaneous motor moves.
Unexpected error. Reagent Valve motor attempted two simultaneous moves.
Instrument will attempt to enter Reagent Pause.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

1048
A single motor attempted two simultaneous motor moves.
Unexpected error. Reagent Dilutor motor attempted two simultaneous moves.
Instrument will attempt to enter Reagent Pause.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-101

1049
A single motor attempted two simultaneous motor moves.
Unexpected error. Reagent Carousel or Pack Lid Opener motor attempted two
simultaneous moves. Instrument will attempt to enter Reagent Pause.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

1050
A single motor attempted two simultaneous motor moves.
Unexpected error. Bead Carousel or Bead Dispenser motor attempted two
simultaneous moves. Instrument will attempt to enter Bead Pause.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

1051
A single motor attempted two simultaneous motor moves.
Unexpected error. Tube Indexer motor attempted two simultaneous moves.
Instrument will attempt to enter Bead Pause.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

1052
A single motor attempted two simultaneous motor moves.
Unexpected error. Tube Transport motor attempted two simultaneous moves.
Instrument will attempt to enter Bead Pause.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

1053
A single motor attempted two simultaneous motor moves.
Unexpected error. Incubator Belt 1 motor attempted two simultaneous moves.
Instrument will attempt to shut down Incubator 1
§Allow Instrument to complete tests in progress.
§Call Technical Service.

601005-0004 Rev. A
H-102 Operator’s Guide: Error Messages

1054
A single motor attempted two simultaneous motor moves.
Unexpected error. Incubator Belt 2 motor attempted two simultaneous moves.
Instrument will attempt to shut down Incubator 1 and 2.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

1055
A single motor attempted two simultaneous motor moves.
Unexpected error. Luminometer Belt motor attempted two simultaneous moves.
Instrument will attempt to shut down.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

1069
Substrate probe not fully seated.
Substrate probe is not fully seated.
§Ensure that the Substrate probe is in place and fully seated
§If the error persists, call Technical Service.

1070
A beaded tube is marked bad due to a problem with a
pre-treatment tube.
A beaded tube is marked bad due to a problem with a pre-treatment tube.
§If the error persists, call Technical Service.

1073
Test Designated bad - the inter-cycle sample movements
timed out - Rerun Test
The Sample Diluter did not finish the move within a certain amount of time.
§If the error persists, call Technical Service.

1074
Test Designated bad - the inter-cycle reagent movements
timed out - Rerun Test
The Reagent Diluter did not finish the move within a certain amount of time.
§If the error persists, call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-103

1077
Pretreatment aborted due to pause mode or error
condition.
A pretreatment tube was marked bad because the Instrument is in Pause Mode
due to a prior error condition.
§Test will be re-run.
§If the error persists, call Technical Service.

1078
Dilution aborted due to pause mode or error condition.
The first dilution replicate was marked bad because the Instrument is in Pause
Mode due to a prior error condition.
§Test will be re-run.
§If the error persists, call Technical Service.

1079
Scheduler Error
A Wash was scheduled while the test was on Incubator 1.
§If the error persists, call Technical Service

1086
Missing the file SAMPSCAN.IML. Sample access monitoring
will be turned off.
The program can not find the Sampscan.iml file, and the feature will be turned off.
§Call Technical Service.

1087
Missing the file LAUNCHSP.IML. Launch Spacing is
turned OFF.
The launch spacing .iml file is missing.
§Call Technical Service.

1088
SampleZ move to fixed position has failed. Test marked
bad and reordered.
The Sample Pipettor could not aspirate a pretreatment test.
§Test will be rerun. If error continues, call Technical Service

601005-0004 Rev. A
H-104 Operator’s Guide: Error Messages

1175
Wash 1 Transfer jammed during recovery.
Wash Transfer 1 jammed. Tests in Incubator 1 are lost. No new tests will be
loaded. Instrument will attempt to complete tests in Incubator 2 and Luminometer.
If jam blocks Incubator 2, all tests in Incubator 2 will also be lost.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

1176
Wash 1 Transfer fatal timeout.
Wash Transfer 1 did not respond to a move command within 18 seconds.
§Call Technical Service.

1178
Tube Lifter 1 jammed during recovery.
Tube Lifter 1 jammed. Tests in Incubator 1 are lost. No new tests will be loaded.
Instrument will attempt to complete tests in Incubator 2 and Luminometer.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

1179
Tube Lifter 1 fatal timeout.
Tube Lifter 1 did not respond to a move command within 18 seconds.
§Call Technical Service.

1180
Tube Lifter 1 exceeded maximum steps
Tube Lifter exceeded maximum steps.
§Call Technical Service.

1185
Incubator Belt Transfer jammed during recovery.
The Belt Transfer jammed while attempting to recover from a jam. No new tests
will be loaded. Instrument will attempt to complete tests in Luminometer.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-105

1186
Incubator Belt Transfer fatal timeout.
The Belt Transfer did not respond to a move command in the allowable time.
§Call Technical Service.

1187
Incubator Belt Transfer exceeded maximum steps.
Unexpected Error. Belt Transfer has been asked to move more than the
allowable number of steps.
§Call Technical Service.

1244
Luminometer Disk jammed during recovery.
The Luminometer Disk has jammed. Instrument Shutdown. All tests on board
lost.
§Call Technical Service.

1246
PMT Transfer jammed during recovery.
The PMT Transfer has jammed. Instrument shutdown. All tests on board lost.
§Call Technical Service.

1248
PMT Transfer fatal timeout.
The PMT transfer did not respond to a command in the allowable time. Instrument
shutdown. All tests on board are lost.
§Call Technical Service.

1249
PMT Transfer exceeded maximum steps.
Unexpected Error. PMT Transfer has been asked to move more than the
allowable number of steps.
§Call Technical Service.

1250
PMT Transfer home not found.
The PMT Transfer has jammed looking for Home.
§Call Technical Service.

601005-0004 Rev. A
H-106 Operator’s Guide: Error Messages

1252
Wash 1 cycle exceeded time limit.
The wash thread for Wash Station 1 ran longer than permitted. Tests on
Incubator 1 Belt and Incubator 2 Belt are lost. No new tests will be loaded.
Instrument will attempt to complete tests in Luminometer.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

1253
Processor Shuttle move timed out.
Incubator 1 was waiting or the Processor Shuttle and was unable to move in the
allowable time. Tests in Incubator 1 are lost. No new tests will be loaded.
Instrument will attempt to complete tests in Incubator 2 and Luminometer.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

1254
Incubator 1 Belt Transfer timed out.
Incubator Chain 1 timed out waiting for the Belt Transfer to finish. Tests in
Incubator 1 are lost. No new tests will be loaded. Instrument will attempt to
complete tests in Incubator 2 and Luminometer.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

1255
Wash 1 Transfer timed out at Incubator 2.
Incubator Chain 2 timed out waiting for wash Transfer 1 to finish.
§Call Technical Service.

1256
Wash 2 Transfer timed out at Incubator 2.
Incubator 2 was waiting for Wash Transfer 2 and was unable to move in the
allowable time. Tests in both Incubators are lost. No new tests will be loaded.
Instrument will attempt to complete tests in the Luminometer.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-107

1257
Reagent dispense timed out at Incubator 1.
Incubator 1 was waiting for the Reagent Arm and was unable to move in the
allowable time. Tests in Incubator 1 are lost. No new tests will be loaded.
Instrument will attempt to complete tests in Incubator 2 and Luminometer.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

1258
Sample Pipettor timed out at Incubator 1.
Incubator 1 was waiting for the Sample Arm and was unable to move in the
allowable time. Tests in Incubator 1 are lost. No new tests will be loaded.
Instrument will attempt to complete tests in Incubator 2 and Luminometer.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

1266
Luminometer Disk initialization step jammed during
recovery.
The Luminometer Disk has jammed. Instrument shutdown. All tests on board
lost.
§Call Technical Service.

1267
Luminometer Disk initialization step fatal timeout.
Luminometer Disk has not responded in the allowable time. Instrument
shutdown. All tests on board are lost.
§Call Technical Service.

1270
Luminometer Belt timed out at Luminometer Disk.
The Luminometer Disk was waiting for the Luminometer Chain and was unable to
move in the allowable time. Instrument shutdown. All tests on board are lost.
§Call Technical Service.

1271
Substrate dispense timed out.
The Substrate Dispense consumed more time than was allotted.
§Call Technical Service.

601005-0004 Rev. A
H-108 Operator’s Guide: Error Messages

1272
Time in the Luminometer out of range.
Tests in the Luminometer exceeded allowable time. Tests will be marked bad and
reordered.
§Call Technical Service.

1273
Luminometer Disk timed out at Luminometer Belt.
The Luminometer Chain was waiting for the Luminometer Disk and was unable to
move in the allowable time. Instrument shutdown. All tests on board are lost.
§Call Technical Service.

1274
A Wash Station shut down. Some tests may not complete.
The Wash Station experienced mechanical problems.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

1314
Incubator 2 Belt step jammed during recovery.
Incubator 2 jammed. Tests in both Incubators are lost. No new tests will be
loaded. Instrument will attempt to complete tests in Luminometer.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

1316
Incubator 2 Belt step fatal timeout.
Incubator Chain 2 has not responded in the allowable time.
§Call Technical Service.

1320
Wash 1 Transfer home jammed during recovery.
Wash Transfer 1 has jammed while homing. Instrument will not run until this
condition is corrected.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-109

1321
Wash 1 Transfer home fatal timeout.
Wash Transfer 1 has not responded in the allowable time. Instrument will not run
until this condition is corrected.
§Call Technical Service.

1322
Wash 1 Transfer home not found.
Wash 1 Transfer has jammed looking for Home. Instrument will not run until this
condition is corrected.
§Call Technical Service.

1323
Tube Lifter 1 has jammed.
The Tube Lifter 1 Home has jammed while attempting to recover from a jam. The
Instrument will not run until the condition is corrected.
§Call Technical Service.

1324
Tube Lifter 1 exceeded the 18 second timer.
Tube Lifter 1 has timed out during homing. The Instrument will not run until the
condition is corrected.
§Call Technical Service.

1325
Tube Lifter 1 did not find Home.
Tube Lifter 1 has jammed looking for Home. The Instrument will not run until the
condition is corrected.
§Call Technical Service.

1330
Attenuator Disk home fatal timeout.
Attenuator Disk has not responded in the allowable time. The Instrument will not
run until the condition is corrected.
§Call Technical Service.

601005-0004 Rev. A
H-110 Operator’s Guide: Error Messages

1331
Control side computation error – Call Technical
Service.
Unexpected Error – the Instrument has shut down.
§Call Technical Service.

1332
Luminometer Disk fatal timeout.
Luminometer Disk has not responded in the allowable time. Instrument shutdown.
§Call Technical Service.

1333
Luminometer Disk exceeded maximum steps.
Luminometer Disk has been asked to move more than the allowable number of
steps. Instrument shutdown. All tests on board are lost.
§Call Technical Service.

1334
Luminometer Disk home not found.
Luminometer Disk has jammed looking for Home. Instrument will not run until this
condition is corrected.
§Call Technical Service.

1335
Exit Transfer home not found.
Exit Transfer has jammed looking for home. Instrument will not run until this
condition is corrected.
§Call Technical Service

1338
Exit Transfer jammed during recovery.
The Exit Transfer has jammed while trying to recover from a jam. If running, the
Instrument will immediately enter STOP mode. The Instrument cannot run until
the jam is corrected.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-111

1339
Exit Transfer fatal timeout.
The Exit Transfer has not responded in the allowable time. Instrument shutdown.
All tests on board are lost.
§Call Technical Service.

1340
Exit Transfer exceeded maximum steps.
The Exit Transfer has been asked to move more than the allowable number of
steps. Instrument will not run until this condition is corrected.
§Call Technical Service.

1342
Exit Transfer Home jammed during recovery.
The Exit Transfer has jammed looking for Home. The Instrument will not run until
this condition is corrected.
§Call Technical Service.

1343
Exit Transfer fatal timeout.
The Exit Transfer failed to find its home sensor.
§Call Technical Service.

1347
Reagent Dispense timed out at Incubator 2.
Incubator Chain 2 was waiting for the Reagent dispense and was unable to move
in the allowable time. Tests in both Incubators are lost. No new tests will be
added. Instrument will attempt to complete tests in the Luminometer.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

1348
Wash 2 timed out.
Wash Station 2 has not responded in the allowable time. Instrument shutdown.
All tests on board are lost.
§Call Technical Service.

601005-0004 Rev. A
H-112 Operator’s Guide: Error Messages

1349
Incubator 2 Belt Transfer timed out.
The Incubator Chain 2 was waiting for the Belt Transfer and was unable to move
in the allowable time. All tests in Incubator 1 are lost. No new tests will be added.
Instrument will attempt to complete tests in Incubator 2 and Luminometer.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

1350
Wash 1 Transfer timed out at Luminometer.
The Luminometer Chain was waiting for Wash Transfer 1 and was unable to
move in the allowable time. Instrument shutdown. All tests on board are lost.
§Call Technical Service.

1351
Wash 2 Transfer timed out at Luminometer.
The Luminometer Chain was waiting for Wash Transfer 2 and was unable to
move in the allowable time. Instrument shutdown. All tests on board are lost.
§Call Technical Service.

1352
Incubator 2 Belt home not found.
Incubator Chain 2 has jammed looking for Home.
§Call Technical Service.

1353
Belt home jammed during recovery.
Incubator Belt 2 has jammed. Both incubator belts will shut down. Instrument will
attempt to complete tests in Luminometer. All other tests on board will be lost.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

1354
Incubator 2 Belt home fatal timeout.
Incubator Chain 2 has not responded in the allowable time. Instrument shutdown.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-113

1359
Wash 2 Transfer jammed during recovery.
The Wash 2 Transfer has jammed while attempting to recover from a jam. No
new tests will be loaded. The Instrument will attempt to complete tests in
progress.
§Call Technical Service.

1361
TIMECYCL.IML is corrupt. Exiting MCP.
The file TIMECYCL.IML was unable to be opened
§Call Technical Service.

1362
Wash 2 Transfer fatal timeout.
Wash Transfer 2 has not responded in the allowable time. Instrument shutdown.
§Call Technical Service.

1363
Wash 2 Transfer home not found.
Wash Transfer 2 has jammed looking for Home. Instrument will not run until this
condition is corrected.
§Call Technical Service.

1364
Wash 2 Transfer home jammed during recovery.
The Wash 2 Transfer Home has jammed while attempting to recover from a jam.
Instrument will not run until the condition is corrected.
§Call Technical Service.

1365
Wash 2 Transfer home fatal timeout.
Wash Transfer 2 has not responded in the allowable time. Instrument will not run
until this condition is corrected.
§Call Technical Service.

1366
TimeCycl.iml is missing or has an incorrect format.
The TimeCycle.iml file is missing or corrupt.
§Call Technical Service.

601005-0004 Rev. A
H-114 Operator’s Guide: Error Messages

1368
Tube Lifter 2 jammed during recovery.
Tube Lifter 2 is jammed. Any active test currently in Wash Station 2 will be
marked bad. Instrument will continue to run with Wash Station 1.
§Call Technical Service.

1369
Tube Lifter 2 fatal timeout.
Tube Lifter 2 failed to respond to respond in the allowable time. Any active test
currently in Wash Station 2 will be marked bad. Instrument will continue to run
with Wash Station 1.
§Call Technical Service.

1370
Tube Lifter 2 exceeded maximum steps.
Unexpected Error. Tube Lifter 2 has been asked to move more than the allowable
number of steps. Any active test currently in Wash Station 2 will be marked bad.
Instrument will continue to run with Wash Station 1.
§Call Technical Service.

1371
Tube Lifter 2 home not found.
Tube Lifter 2 has jammed looking for Home.
§Call Technical Service.

1372
Tube Lifter 2 home jammed during recovery.
Tube Lifter 2 home has jammed while attempting to recover from a jam. The
Instrument will not run until the condition is corrected.
§Call Technical Service.

1373
Tube Lifter 2 home fatal timeout.
Tube Lifter 2 has not responded in the allowable time. Instrument will not run until
this condition is corrected.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-115

1374
Tube Lifter 1 is not at expected Wash position.
Tube Lifter 1 is not in its expected position during a wash. This may be due to a
previous tube lifter error. Any test at Wash Station 1 will be marked bad and
reordered.
§If this error persists, call Technical Service.

1375
Tube not detected in Luminometer at Wash Station 1.
A tube was not detected at the Luminometer when expected. The Instrument will
not run until this condition is corrected.
§Call Technical Service.

1376
Tube not detected in Luminometer at Wash Station 2.
A tube was not detected at the Luminometer when expected. The Instrument will
not run until this condition is corrected.
§Call Technical Service.

1377
Empty all tubes has failed to complete. Entering Stop
Mode.
The Instrument has failed to empty all tubes in the allowable time. The Instrument
will not run until this condition is corrected.
§Attempt to enter Run mode again. If this error persists, call Technical Service.

1378
Wash Station 2 was not primed.
Due to previous errors, the wash station could not be primed.
§Log off, and then log back on.

1379
Wash Stations 1 and 2 were not primed.
Due to previous errors in the wash station, the pumps cannot be primed.
§Log off, and then log back on.

601005-0004 Rev. A
H-116 Operator’s Guide: Error Messages

1380
Programmer Error: HmiAlignIncChain2To Wash was passed
invalid parameter value.
An unexpected error has occurred in the software. Do not attempt to run.
§Call Technical Service.

1381
No empty baffles found on Incubator 2 while homing Wash
Transfer 1.
Instrument was unable to home properly because it detected that Incubator 2 was
full.
§Call Technical Service.

1382
No empty baffles found on Incubator Belt 2 while homing
Wash Transfer 2.
Instrument was unable to home properly because it detected that Incubator 2 was
full.
§Call Technical Service.

1384
Requested number of primes did not complete due to Wash
Spinner 1 failure.
The Wash 1 Spinner failed during a prime. Attempt to re-prime pumps. If error
reoccurs, do not run instrument.
§Call Technical Service.

1385
Requested number of primes did not complete due to a
Wash Spinner 2 failure.
The Wash 2 Spinner failed during a prime.
§Attempt to re-prime the pumps.
§If the error persists, do not run the Instrument, and call Technical Service.

1386
Requested number of primes did not complete due to a
Wash Pump 1 failure.
Wash 1 Pump failed during a prime.
§Attempt to re-prime the pumps.
§If the error persists, do not run the Instrument, and call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-117

1387
Requested number of primes did not complete due to a
Wash Pump 2 failure.
Wash 2 Pump failed during a prime.
§Attempt to re-prime the pumps.
§If the error persists, do not run the Instrument, and call Technical Service.

1388
Requested number of primes did not complete due to Tube
Lifter 1 failure.
Tube Lifter 1 failed during a prime.
§Attempt to re-prime the pumps.
§If the error persists, do not run the Instrument, and call Technical Service.

1389
Requested number of primes did not complete due to Tube
Lifter 2 failure.
Tube Lifter 2 failed during a prime.
§Attempt to re-prime the pumps.
§If the error persists, do not run the Instrument, and call Technical Service.

1390
Wash 2 Spinner has taken longer than 18 seconds.
Wash 2 Spinner timed out. Instrument will be shut down. All tests on board are
lost.
§Call Technical Service.

1391
Wash 2 Spinner has failed to spin correctly.
Bad Spin at Wash Station 2. Test will be marked bad and reordered.
§If this error persists, call Technical Service.

1392
Wash Stations 1 and 2 both failed. Requested number of
primes did not complete.
An error occurred at both wash stations. The instrument cannot run until the
errors are corrected.
§Call Technical Service.

601005-0004 Rev. A
H-118 Operator’s Guide: Error Messages

1393
We can not enter RUN because Wash Spinner 1 is not
operating correctly.
Wash Spinner 1 has failed during initialization. The instrument will not run until
this error is corrected.
§Call Technical Service.

1394
We can not enter RUN because Wash Spinner 2 is not
operating correctly.
Wash Spinner 2 has failed during initialization. The instrument will not run until
this error is corrected.
§Call Technical Service.

1395
Instrument is running with only one wash station. Call
Technical Service.
Wash station 1 was shut down as a result of a hardware problem.
§Call Technical Service.

1396
Instrument is running with only one wash station. Call
Technical Service.
Wash station 1 was shut down as a result of a hardware problem
§Call Technical Service.

1398
Instrument cannot enter RUN because both wash stations
are disabled. Call Technical Service.
Both wash stations have been shut down due to hardware problems. You can not
run tests if none of the wash stations work.
§Call Technical Service.

1401
Test designated bad – Allergen not found – Test rerun.
Allergen necessary for ordered test was not found. Test was marked bad and
reordered.
§Verify the correct allergen is on board, and rescan the wedge, or replace the
allergen, as necessary.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-119

1443
Wash 1 transfer initialization step jammed during
recovery.
Wash Transfer 1 has jammed during initialization. Instrument will not run until this
condition is corrected.
§Call Technical Service.

1445
Wash 1 Transfer initialization step fatal timeout.
Wash Transfer 1 has not responded in the allowable time. Instrument will not run
until this condition is corrected.
§Call Technical Service.

1453
Wash 2 Transfer initialization step jammed during
recovery.
Wash 2 Transfer has jammed during initialization. Instrument will not run until this
condition is corrected.
§Call Technical Service.

1454
Wash 2 Transfer step fatal timeout.
Wash Station 2 has not responded in the allowable time. Instrument shutdown.
§Call Technical Service.

1481
Exit Resource was not found during wash Station 1
recovery.
Unexpected Error. Instrument is unable to schedule the removal of a tube marked
bad, due to an error at Wash Station 1. Instrument shut down.
§Call Technical Service.

1482
Exit Resource was not found during Wash Station 2
recovery.
Unexpected Error. Instrument is unable to schedule the removal of a tube marked
bad, due to an error at Wash Station 2. Instrument shut down.
§Call Technical Service.

601005-0004 Rev. A
H-120 Operator’s Guide: Error Messages

1483
Recover Resource Error during Wash Station 1 recovery.
Unexpected Error. Instrument is unable to reschedule tests marked for Wash
Station 1. Incubator 2 is shut down. Instrument will attempt to complete tests in
the Luminometer.
§Call Technical Service.

1484
Recover Resource Error during Wash Station 2 recovery.
Unexpected Error. Instrument is unable to reschedule tests marked for Wash
Station 2. Incubator 2 is shut down. Instrument will attempt to complete tests in
the Luminometer.
§Call Technical Service.

1495
Wash 1 Transfer home exceeded maximum steps.
Unexpected Error. Wash Transfer 1 has been asked to move more than the
allowable number of steps. Instrument will continue to run with Wash Station 1.
§Call Technical Service.

1497
Requested belt move exceeds limits.
Unexpected Error. Requested belt move exceeds limits.
§Allow Instrument to complete tests in progress.
§Call Technical Service.

1498
Wash 2 Transfer home not found.
Wash Transfer 2 has jammed looking for Home. Instrument will continue to run
with Wash Station 1.
§Call Technical Service.

1500 – 1639
An event semaphore timed out. Contact Technical
Service.
Unexpected Error.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-121

1641-1699
An event semaphore timed out. Contact Technical
Service.
Unexpected Error.
§Call Technical Service.

1700-1799
A request mutex call timed out. Contact Technical
Service.
Unexpected Error - Request for a mutex.
§Call Technical Service.

1877
Flag not detected at sensor.
A sensor was not found during a motor move. More specific errors will arise.
§Troubleshoot the additional errors as they arise.
§Call Technical Service.

1878
Flag not detected a sensor due to a jam.
A motor error has occurred. The Instrument will attempt to correct.
§Troubleshoot the additional errors as they arise.
§Call Technical Service.

1879
Config.iml file is missing.
The config.iml file is missing, or there are invalid values in config.iml. This file
holds value for diagnostic configurations.
§Contact Technical Service

1880
Incubator Belt Transfer cannot find home.
The Belt Transfer could not find its home sensor. This could indicate a bad motor,
bad home sensor, or bad board (6)
§Call Technical Service.

601005-0004 Rev. A
H-122 Operator’s Guide: Error Messages

1881
Tube Lifter 1 is not at expected spin position.
Tube Lifter 1 is in an unexpected position during a spin. This is likely due to a prior
error.
§Call Technical Service.

1882
Tube Lifter 2 is not at expected wash position.
Tube Lifter 2 is in an unexpected position during a wash. This is likely due to a
prior error
§Call Technical Service.

1883
Tube Lifter 2 is not at expected spin position.
Tube Lifter 2 is in an unexpected position during a spin. This is likely due to a prior
error.
§Call Technical Service.

1884-1904
Scheduler Error.
The scheduler was unable to complete a test in progress due to a resource
conflict.
§Allow the Instrument to complete tests in progress.
§Call Technical Service.

1905
Assay time exceeds scheduler limit.
The assay requires more time than the resource allocator will permit. The
scanned kit barcode may contain invalid information.
§Allow instrument to complete tests in progress.
§Call Technical Service.

1906
Assay cycles exceeds scheduler limit.
The assay requires more time than the resource allocator will permit. The
scanned kit barcode may contain invalid information.
§Allow instrument to complete tests in progress.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-123

1907
Tube designated bad – Reagent dispense not performed
due to conflicting sample draw – Test Rerun.
The reagent arm has been scheduled to dispense to Incubator Chain 1 on the
same cycle as a sample transfer draw.
§The Instrument will continue to operate, unless other specific errors are raised.
§The test will be re-run.
§Call Technical Service.

1908
No data available for next reagent dispense.
A reagent dispense has been scheduled, but there is no data for the carousel or
arm to act upon.
§Call Technical Service.

1909
No data available for next sample pipette.
A sample action has been scheduled, but there is no data for the carousel or arm
to act upon.
§Call Technical Service.

1910
Incubator 1 Belt shutting down. Incubator 2 Belt
continues.
The Incubator Chain 1 has shut down. Incubator Chain 2 is still attempting to
process tests.
§Allow instrument to complete tests in progress.
§Call Technical Service.

1911
Incubator 1 Belt flag not detected at sensor.
Incubator 1 has failed to reach its position. The Instrument shut down, and all
tests on board are lost.
§Call Technical Service.

1912
Incubator 2 Belt flag not detected at sensor.
Incubator 2 has failed to reach its position. The Instrument shut down, and all
tests on board are lost.
§Call Technical Service.

601005-0004 Rev. A
H-124 Operator’s Guide: Error Messages

1913
Luminometer Belt flag not detected at sensor.
The Luminometer Belt flag was not detected at the sensor. The Instrument
shutdown, and all tests on board are lost.
§Call Technical Service.

1914
Wash 1 position sensor can not find an empty baffle on
Luminometer Belt.
The Tube in Place sensor at the Luminometer Chain near Wash Station 1 can not
find an empty baffle. This could be due to a bad TIP sensor.
§Call Technical Service.

1915
Wash 2 position sensor can not find an empty baffle on
Luminometer Belt.
The Tube in Place sensor at the Luminometer Chain near Wash Station 2 can not
find an empty baffle. This could be due to a bad TIP sensor.
§Call Technical Service.

1916
Wash 1 failed. Wash 2 continues.
Wash Station 1 has shut down. Wash Station 2 will attempt to process some tests.
§Allow instrument to complete tests in progress.
§Call Technical Service.

1917
Wash 2 failed. Wash 1 continues.
Wash Station 2 has shut down. Wash Station 1 will attempt to process some tests.
§Call Technical Service.

1918
The second wash station has had a fatal error
One of the wash stations had previously shut down. The second wash station just
shut down. We will be in front-end shutdown.
§Allow instrument to complete tests in progress.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-125

1919
Scheduler Error.
Unexpected Error – the Instrument will attempt to complete tests in the
Luminometer. Incubator 1 and Incubator 2 have shut down.
§Call Technical Service.

1920
Test designated bad – Wash 1 dispense failed – Test
Rerun.
A test is marked bad due to a bad pump in Wash Station 1. Two bad pumps in a
row occurred which suggests a bad Wash 1 Linear Actuator pump.
§The Instrument will re-order a test and attempt to complete tests onboard. This
error will be followed by Error 1916.
§Allow the Instrument to complete tests in progress.
§Call Technical Service.

1921
Test designated bad – Wash 2 dispense failed – Test
Rerun.
A test is marked bad due to a bad pump in Wash Station 2. Two bad pumps in a
row occurred which suggests a bad Wash 2 Linear Actuator pump.
§The Instrument will re-order a test and attempt to complete tests onboard. This
error will be followed by Error 1917.
§Allow the Instrument to complete tests in progress.
§Call Technical Service.

1922
Test designated bad – Wash 1 Transfer failed – Test
Rerun.
Wash Transfer 1 failed, and a test is marked bad.
§The Instrument will re-order a test and attempt to complete tests onboard. This
error will be followed by Error 1916.
§Allow the Instrument to complete tests in progress.
§Call Technical Service.

601005-0004 Rev. A
H-126 Operator’s Guide: Error Messages

1923
Test designated bad – Wash 2 Transfer failed – Test
Rerun.
Wash Transfer 2 failed, and a test is marked bad.
§The Instrument will re-order a test and attempt to complete tests onboard. This
error will be followed by Error 1917.
§Allow the Instrument to complete tests in progress.
§Call Technical Service.

1924
Test designated bad – Tube Lifter 1 move failed – Test
Rerun.
Tube Lifter 1 failed, and a test is marked bad.
§The Instrument will re-order the test due to a Tube Lifter 1 error.

1925
Test designated bad – Tube Lifter 2 move failed – Test
Rerun.
Tube Lifter 2 failed, and a test is marked bad.
§The Instrument will re-order the test due to the Wash Station 2 error.

1926
Test designated bad – Tube Lifter 2 not in the up
position – Test Rerun.
Tube Lifter 2 is not in the expected position, and a test is marked bad.
§The Instrument will re-order the test due to the Tube Lifter 2 error.

1927
Test designated bad – Wash 2 spin failed – Test Rerun.
Tube Spinner 2 or Tube Lifter 2 has failed, and a test is marked bad.
§The Instrument will re-order the test lost due to the Wash Station 2 error.

1928
Test designated bad – Wash 2 Transfer to Luminometer
retry failed – Test Rerun.
Wash Transfer 2 has failed to push a tube into the Luminometer Chain, and a test
is marked bad.
§The Instrument will re-order the test lost due to the Wash Station 2 error

601005-0004 Rev. A
Operator’s Guide: Error Messages H-127

1931
Incubator Belt Transfer home jammed during recovery.
The Belt Transfer jammed while attempting to recover from a jam during a home.
This may indicate a bad home sensor, motor, encoder, or board (6).
§Call Technical Service.

1932
Incubator Belt Transfer home fatal timeout.
The Belt Transfer has failed to respond to a home command within 18 seconds.
This may indicate a bad backplane or board (6).
§Call Technical Service.

1934
Tube designated bad – Incorrect substrate dispense –
Test Rerun.
Incorrect substrate dispense during run caused a tube re-order.
§While in Stop mode, examine the end of the substrate probe, and attempt to
clean any substrate deposits.
§If this error occurs after cleaning the probe, call Technical Service.

1935
Incorrect substrate dispense during priming.
The substrate pump did not dispense the correct amount of fluid. This may be due
to a defect in the substrate probe, calcification of substrate at the end of the
probe, or a bad Substrate Linear Actuator pump.
§While in Stop mode, examine the end of the substrate probe, and attempt to
clean any substrate deposits.
§If this error occurs after cleaning the probe, call Technical Service.

1936
Substrate Pump has failed. Only tests in the
Luminometer will complete.
The substrate pump did not dispense the correct amount of fluid enough times
that we will enter a front-end shutdown.
§Allow the Instrument to complete tests in progress.
§Call Technical Service.

601005-0004 Rev. A
H-128 Operator’s Guide: Error Messages

1938
Attenuator Disk home not found.
The attenuator disk did not find its home. This may be due to a bad home sensor,
motor, or board (3).
§Call Technical Service.

1940
Rerun test designated bad by reagent pipetting error.
Reagent arm failed to level sense. This may indicate a reagent pack that was not
properly seated, a reagent pack lid that will not open easily, a bad level sensor, on
an incorrect configuration of the Reagent Arm.
§While in Reagent Pause mode, check if the reagent marked bad is seated
correctly, and verify if the lid allows access to the reagent by lightly pushing it.
§If the error still occurs once the wedge is checked, call Technical Service.

1941
Scheduler Error
The scheduler was unable to complete a test in progress due to a resource
conflict.
§Allow the Instrument to complete tests in progress.
§Call Technical Service.

1942
Scheduler Error
The scheduler was unable to complete a test in progress due to a resource
conflict.
§Allow the Instrument to complete tests in progress.
§Call Technical Service.

1943
Sample data missing for a sample dilution or dispense.
A sample dilution or dispense was ordered without the sample data. This defect is
due to a bad barcode or a software defect.
§Attempt to re-scan the kit.
§If this error persists, call Technical Service.

1944
Scheduler Error.
There were 2 tests in a row that need a dilution at the beginning of the test .
§Test will be reordered.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-129

1945
Incubator Belt Transfer home sensor stuck on.
The home sensor was found for the belt transfer where it wasn't expected. This
could be a home sensor defect, a motor defect, or a board defect (6).
§Call Technical Service.

1946
Incubator 1 Belt movement timeout. Incubator 1 will
shut down.
Incubator 1 will shut down, since it took too long to move. This could be due to a
bad TimeCycl.iml, a motor, or board(2) problem.
§Call Technical Service.

1947
Incubator 2 Belt movement timeout. Incubator 2 will
shut down.
Incubator 2 will shut down, since it took too long to move. This could be due to a
bad TimeCycl.iml, a motor, or board(2) problem
§Allow the Instrument to finish tests in progress.
§Call Technical Service.

1948
Luminometer Belt movement timeout. Luminometer will
shut down.
Luminometer will shut down, since it took too long to move. This could be due to a
bad TimeCycl.iml, or a motor or board(3) problem.
§Allow the Instrument to finish tests in progress.
§Call Technical Service.

1950
Pack Lid Opener jammed during recovery
Reagent Opener open jammed during recovery. This could be due to a jammed
reagent cover, a misconfigured pack lid opener, a bad sensor, motor, or board (1).
§The Instrument will attempt to clear the error and continue with the next test.
§If unable to clear the error, the Instrument will enter Reagent Pause.
§Call Technical Service.

601005-0004 Rev. A
H-130 Operator’s Guide: Error Messages

1951
Pack Lid Opener fatal timeout.
Reagent Opener open fatal timeout. This may be due to a problem with a
backplane or the board (1).
§Call Technical Service.

1952
Pack Lid Opener exceeded maximum steps.
Reagent Opener open did not find the sensor within the step parameters given to
it via diagnostics' position.iml. This could be due to a bad sensor, configuration or
board (1)
§Call Technical Service.

1954
Pack Lid Opener home fatal timeout
Reagent Opener home attempting recovery after jam. This could be due to a
misconfigured Reagent Opener or Reagent Carousel, or a pack that is not
properly seated, or that has a stuck lid.
§Call Technical Service.

1956-1964
Scheduler Error
The scheduler was unable to complete a test in progress due to a resource
conflict.
§Allow the Instrument to complete tests in progress.
§Call Technical Service.

1965
There are too many immortal threads.
Unexpected software error.
§Place the Instrument in Pause mode to prevent new tests from loading.
§Call Technical Service.

1966
Tube in Place Sensor error. Entering Stop Mode.
A tube was detected at the Belt Transfer position on Inc2 when none was
expected. This indicates a sensor malfunction. Note that errors 1966-1981 can be
turned-off by an .iml file.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-131

1967
Tube in Place Sensor error. Entering Stop Mode.
No tube was detected at the Belt Transfer position on Inc2 when one was
expected. This indicates a sensor malfunction. Note that errors 1966-1981 can be
turned-off by an .iml file.
§Call Technical Service.

1968
Tube in Place Sensor error. Entering Stop Mode.
A tube was detected at the Wash 1 position on Inc2 when none was expected.
This indicates a sensor malfunction. Note that errors 1966-1981 can be turned-off
by an .iml file.
§Call Technical Service.

1969
Tube in Place Sensor error. Entering Stop Mode.
No tube was detected at the Wash 1 position on Inc2 when one was expected.
This indicates a sensor malfunction. Note that errors 1966-1981 can be turned-off
by an .iml file. A tube was detected at the Wash 1 position on Inc2 when none was
expected. This indicates a sensor malfunction. Note that errors 1966-1981 can be
turned-off by an .iml file.
§Call Technical Service.

1970
Tube in Place Sensor error. Entering Stop Mode.
A tube was detected at the Wash 1 position on Inc2 when none was expected.
This indicates a sensor malfunction. Note that errors 1966-1981 can be turned-off
by an .iml file.
§Call Technical Service.

1971
Tube in Place Sensor error. Entering Stop Mode.
No tube was detected at the Wash 1 position on Inc2 when one was expected.
This indicates a sensor malfunction. Note that errors 1966-1981 can be turned-off
by an .iml file.
§Call Technical Service.

601005-0004 Rev. A
H-132 Operator’s Guide: Error Messages

1972
Tube in Place Sensor error. Entering Stop Mode.
A tube was detected at the Wash 1 position on Inc2 when none was expected.
This indicates a sensor malfunction. Note that errors 1966-1981 can be turned-off
by an .iml file.
§Call Technical Service.

1973
Tube in Place Sensor error. Entering Stop Mode.
No tube was detected at the Wash 1 position on Inc2 when one was expected.
This indicates a sensor malfunction. Note that errors 1966-1981 can be turned-off
by an .iml file
§Call Technical Service.

1974
Tube in Place Sensor error. Entering Stop Mode.
A tube was detected at the Wash 1 position on Inc2 when none was expected.
This indicates a sensor malfunction. Note that errors 1966-1981 can be turned-off
by an .iml file.
§Call Technical Service.

1975
Tube in Place Sensor error. Entering Stop Mode.
A tube was detected at the Wash 2 position on Inc2 when none was expected.
This indicates a sensor malfunction. Note that errors 1966-1981 can be turned-off
by an .iml file.
§Call Technical Service.

1976
Tube in Place Sensor error. Entering Stop Mode.
No tube was detected at the Wash 2 position on Inc2 when one was expected.
This indicates a sensor malfunction. Note that errors 1966-1981 can be turned-off
by an .iml file
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-133

1977
Tube in Place Sensor error. Entering Stop Mode.
A tube was detected at the Wash 2 position on Inc2 when none was expected.
This indicates a sensor malfunction. Note that errors 1966-1981 can be turned-off
by an .iml file.
§Call Technical Service.

1978
Tube in Place Sensor error. Entering Stop Mode.
No tube was detected at the Wash 2 position on Inc2 when one was expected.
This indicates a sensor malfunction. Note that errors 1966-1981 can be turned-off
by an .iml file.
§Call Technical Service.

1979
Tube in Place Sensor error. Entering Stop Mode.
A tube was detected at the Wash 2 position on Inc2 when none was expected.
This indicates a sensor malfunction. Note that errors 1966-1981 can be turned-off
by an .iml file.
§Call Technical Service.

1980
Tube in Place Sensor error. Entering Stop Mode.
No tube was detected at the Wash 2 position on Inc2 when one was expected.
This indicates a sensor malfunction. Note that errors 1966-1981 can be turned-off
by an .iml file.
§Call Technical Service.

1981
Tube in Place Sensor error. Entering Stop Mode.
A tube was detected at the Wash 2 position on Inc2 when none was expected.
This indicates a sensor malfunction. Note that errors 1966-1981 can be turned-off
by an .iml file
§Call Technical Service.

601005-0004 Rev. A
H-134 Operator’s Guide: Error Messages

1982
Invalid tube detected in Luminometer at Wash Station 1
At the end of clearing tubes off of the system, a tube was detected on the
Luminometer near wash station 1. This probably indicates that this sensor is stuck
high.
§The Instrument will not run until this condition is corrected.
§Call Technical Service.

1983
Invalid tube detected in Luminometer at Wash Station 2
At the end of clearing tubes off of the system, a tube was detected on the
Luminometer near wash station 2. This probably indicates that this sensor is stuck
high.
§Call Technical Service.

1984
A test assigned to Wash Station 1 was reordered because
of the wash station failure.
Wash Station 1 failed because of a jam. Wash Station 2 is still alive. All tests in
the incubator that were to use Wash Station 1 are reordered
§Call Technical Service.

1985
A test assigned to Wash Station 2 was reordered because
of the wash station failure.
Wash Station 2 failed because of a jam. Wash Station 1 is still alive. All tests in
the incubator that were to use Wash Station 2 are reordered
§Call Technical Service.

1986
Test designated bad – Wash 1 failed – Test Rerun.
Wash Station 1 had a Bad Spin. The test where the bad spin occurred will be
marked bad and reordered.
§Call Technical Service.

10903
A serious error has occurred with the hepatitis
confirmatory test feature. Communications to the LIS

601005-0004 Rev. A
Operator’s Guide: Error Messages H-135

has been paused. Please do not reactivate LIS

communication and contact Technical Service.
Database error occurred while sending a report to LIS.
§Call Technical Service.

11503
8 adjustors are needed. Less than 8 adjustors have been
ordered
One or more of the eight adjustors was deleted or the Instrument was unable to
pipette all eight adjustor samples. Adjustment cannot be calculated.
§Check error log for associated errors that need to be resolved.
§If the message persists, call Technical Service.

11509
Incorrect Kit Parameters
Scanned kit parameters are incorrect.
§Re-scan the kit.

11510
Division by zero while transforming dose to golden
counts
Division by zero.
§Call Technical Service.

11511
CV of Low adjustors not within limit
Precision of the low adjustor is greater than 10 or 15 %.
§Check associated error messages to determine cause.
§Ensure sufficient volume of adjustor.

11512
Log(0) or Log(-x) are illegal - Adjustor concentration
error
Adjustment concentration error.
§Call Technical Service.

601005-0004 Rev. A
H-136 Operator’s Guide: Error Messages

11513
CV of High adjustors not within limit
Precision of the high adjustor is greater than 15%.
§Check associated error messages to determine cause.
§Ensure sufficient volume of adjustor.

11515
CV of both High and Low adjustors not within limit
Precision of the low and high adjustors are greater than 10 or 15 %.
§Check associated error messages to determine cause.
§Ensure sufficient volume of adjustor.

11516
Mean of Low adjustors = 0
Malfunctioning PMT
§Call Technical Service.

11517
Mean of High adjustors = 0
Malfunctioning PMT
§Call Technical Service.

11701
No Unique Record ID passed to update in worklist
object. Contact Technical Service
While working in the Worklist screen the operator tried to order a test for which a
unique record ID was not generated by the system.
§Call Technical Service.

11702
There is no accession number passed to the worklist
object. Contact Technical Service.
While working in the Worklist screen the operator tried to order a test for which no
accession number had been assigned by the system.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-137

11703
Attempted to save a record in the worklist but the test
is not in the data base
Attempted to save an imported record from a worklist file or the LIS to the Worklist
but the test is not in the data base
§Ensure the kits are in the database.
§If the message persists, call Technical Service.

11704
This adjustor is already in progress. You need to wait
until it is completed to order another one.
The operator attempted to order a second adjustment for the same kit and lot
before one ordered had been completed.
§Wait for initial adjustment to be completed.
§Check the error log for kit errors that need to be resolved.
§If the message persists, call Technical Service.

11705
This control information does not match what is
currently on the system. Record cannot be added at
this time. Check your information and try again.
This control information does not match what is currently on the system. Record
cannot be processed.
§Verify that control information, such as lot number and expiration date, is entered
correctly.
§If the message persists, call Technical Service.

11800
Cannot open the DPR path. Startup aborted
Communication between the User and Control sides cannot be opened.
§Call Technical Service.

11801
Semaphore failure. Startup Aborted.
Semaphore failure. Startup Aborted.
§Call Technical Service.

601005-0004 Rev. A
H-138 Operator’s Guide: Error Messages

11802
DPR WRITE failure. Startup Aborted.
There is a failure of communication between the User and Control side because
of a DPR WRITE failure. Startup Aborted.
§Call Technical Service.

11803
DPR READ failure. Startup Aborted.
There is a failure of communication between the User and Control side because
of a DPR READ failure. Startup Aborted.
§Call Technical Service.

11804
Communication could not be established with instrument.
Communication between the User and Control sides cannot be established.
§Call Technical Service.

11805
The instrument is in Panic Mode. Hit Run to try to run
again or log off.
The instrument is in Stop Mode due to a mechanical jam or similar error.
§Check associated error message to determine cause.
§If the message persists, call Technical Service.

11806
No Value for Head Pointer
Problem was encountered when reading the head pointer from a queue.
§Call Technical Service.

11807
No Value for Tail Pointer
Problem was encountered when reading the tail pointer from a queue.
§Call Technical Service.

11808
Problem Incrementing Pointer
Problem was encountered when a pointer from a queue was incremented.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-139

11809
Error while getting instrument status in initialization
Error while getting instrument status in initialization
§Call Technical Service.

12000
Control Computer did not shut down properly
MCP was not properly exited when trying to go into Stop or when Logging off.
Control side is in host mode.
§Call Technical Service.

12001
Kit Not Adjusted
For some reason the adjustment was not completed.
§Run the kit adjustment.
§Check the error log for other issues that need to be addressed.
§If the message persists, call Technical Service.

12002
Unrecognized Reagent on board for test. Cannot run
test.
The kit information has not yet been entered into the database.
§Scan and adjust the kit and then attempt to run the test again.
§If the message persists, call Technical Service.

12003
No reagent on board to run test.
The software does not register the reagent barcode as being present on the
reagent carousel.
§Verify that sufficient and correct reagents are on board.
§Verify kit is scanned into database.
§Inspect reagent barcode label for damage.
§Ensure Wedge is seated correctly.
§If the message persists, call Technical Service.

601005-0004 Rev. A
H-140 Operator’s Guide: Error Messages

12004
Not enough reagent to run test.
The indication in the software is that the amount of reagent remaining in Wedge is
insufficient to run tests
§Verify that sufficient and correct reagents are on board.
§If the message persists, call Technical Service

12005
Unrecognized bead on board for test. Cannot run test.
The kit information has not yet been entered into the database.
§Verify beads are on board.
§Verify kit is scanned into database.
§Ensure Bead Pack is seated correctly.
§If the message persists, call Technical Service.

12006
No beads on board to run test.
The software does not register the bead bar code as being present on the bead
carousel.
§Verify that sufficient and correct beads are on board.
§Verify kit is scanned into database.
§Inspect bead barcode label for damage.
§Ensure Bead Pack is seated correctly.
§If the message persists, call Technical Service.

12007
Not enough beads to run test.
The indication in the software is that the amount of beads remaining in the pack is
insufficient to run tests.
§Verify that sufficient and correct beads are on board and add as necessary.
§If the message persists, call Technical Service.

12008
There is no diluent sample tube on board to run test.
The software does not register the diluent bar code as being present on the
sample carousel.
§Check the barcode is facing out.
§Place sample diluent on board.
§Check for the correct sample diluent.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-141

12009
Problem Retrieving Tail Pointer from the Loader Q
Tail pointers are used to determine the number of tests in queue. When
calculating time to result and when checking to see if loader or STAT queue is
empty, the User side requests the Tail Pointer from the DPR. If the Tail Pointer is
not obtained, this error is posted.
§Call Technical Service.

12010
Problem Retrieving Head Pointer from the Loader Q
Head pointers are used to determine the number of tests in queue. When
calculating time to result and when checking to see if loader or STAT queue is
empty, the User side requests the Head Pointer from the DPR. If the Head
Pointer is not obtained, this error is posted.
§Call Technical Service.

12100
Trying to insert unknown result record from result
buffer!
The test record has been deleted before the test resulted.
§Confirm that the record was not deleted from the LIS screen.
§Confirm that a record was not deleted from the Worklist.
§If the message persists, call Technical Service.

12101
Print Report Function Error
General error indicating an error occurred when a report was being generated for
the printout
§Check for ink in the ink cartridges.
§Check for printer paper.
§Ensure the printer power is on.
§If the message persists, call Technical Service.

12102
Error occurred inserting 0 into reserved space
Software communication error.
§Call Technical Service.

601005-0004 Rev. A
H-142 Operator’s Guide: Error Messages

12103
Error occurred inserting record into STAT loader queue
Software communication error.
§Call Technical Service.

12104
STAT Loader queue Pointer not updated properly
An error occurred when attempting to increment the STAT loader queue pointer.
§Call Technical Service.

12105
Problem Retrieving Head Pointer from the Routine Q
During the function that checks to see if the Control side has updated the loader
queue, a problem occurred in retrieving the Head pointer.
§Call Technical Service.

12106
Error occurred inserting record into Routine loader
queue
An error occurred while inserting a record into the Routine loader queue.
§Call Technical Service.

12107
Routine Loader queue Pointer not updated properly
An error occurred when attempting to increment the Routine loader queue
§Call Technical Service.

12108
Problem retrieving Result Buffer Head Pointer
During the function that checks to see if the Control side has updated the Result
Buffer, a problem occurred in retrieving the Head pointer.
§Call Technical Service.

12109
Problem retrieving Result Buffer Tail Pointer
During the function that checks to see if the Control side has updated the Result
Buffer, a problem occurred in retrieving the Tail pointer.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-143

12110
Problem Retrieving Head Pointer from the Routine Q
During the function that checks to see if there is a free space in the routine loading
queue to insert another record, an error was detected when retrieving the Head
Pointer.
§Call Technical Service.

12111
Problem Retrieving Tail Pointer from the Routine Q
During the function that checks to see if there is a free space in the routine loading
queue to insert another record, an error was detected when retrieving the Tail
Pointer.
§Call Technical Service.

12112
Problem Retrieving Head Pointer from the STAT Q
During the function that checks to see if there is a free space in the STAT queue
to insert another record, an error was detected when retrieving the Head Pointer.
§Call Technical Service.

12113
Problem Retrieving Tail Pointer from the STAT Q
During the function that checks to see if there is a free space in the STAT queue
to insert another record, an error was detected when retrieving the Tail Pointer.
§Call Technical Service.

12114
Test in progress deleted during initialization.
If the worklist is deleted during initialization, this error indicates that deleted items
were still in progress. This occurs only after the user-side computer was
previously shut down (e.g., run time error, emergency shut down) while tests were
still in progress.
§Call Technical Service.

12115
Instrument running with Clot Detection Deactivated.
Upon Initialization, the program has determined that Clot detection is turned off
and warns the user that they may not want to operate the instrument in this mode.
§Call Technical Service.

601005-0004 Rev. A
H-144 Operator’s Guide: Error Messages

12116
Unable to determine Clot Detection status.
Upon Initialization, the program to trying to determine if the clot detection is on or
off, if this error occurs it is because of a DPRAM, semaphore issue or an inability
of the Control side to read the Board.iml file.
§Call Technical Service.

12300
LIS- Carriage return or Line Feed missing from message.
Carriage return and/or Line Feed are required but missing from the message.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

12301
LIS- Incorrect or Missing Frame Number.
The frame number for a message is not present or is an incorrect value
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

12302
LIS- Incorrect Checksum.
The checksum, a scheme to indicate whether a message was received properly,
is incorrect.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

12303
LIS- Message is too short (< 5 characters).
LIS message received is less than the requisite five characters.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

12304
LIS- Invalid Password in Header Message.
The Password received does not match the Password entered in the LIS
configuration.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-145

12305
LIS- Invalid Sender ID in Header Message.
The Sender ID received from the LIS does not match the Sender ID entered on
the LIS configuration screen.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

12306
LIS- Invalid Receiver ID in Header Message.
The Receiver ID received from the LIS does not match the Receiver ID entered on
the LIS Configuration screen.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

12307
LIS- No Header message received.
Records were received from the LIS without a header message.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

12308
LIS- Several LIS errors have occurred the past hour.
There may be a communication Problem.
Multiple communication errors occurred between the LIS and the IMMULITE 2000
within an hour.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

12309
LIS- Null or Missing Patient ID in Patient Record.
The Patient ID field, a required field in the patient message, is not present.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

12310
LIS- Invalid Test Code or Format in Order record.
The test code in an order message from the LIS does not match any of the test
codes entered on the IMMULITE 2000.
§Call Technical Service.

601005-0004 Rev. A
H-146 Operator’s Guide: Error Messages

12311
LIS- LIS cannot accept message after sending message 7
times.
The IMMULITE 2000 unsuccessfully attempted to send a message to the LIS
seven times before communication was aborted
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

12312
LIS- Time-out, 30 seconds expired and no data was
received from LIS.
After the initial data was received from the LIS and a response was sent,
additional data was not received within 30 seconds and communication was
aborted.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

12313
LIS- EOT received prematurely while receiving data.
An EOT was sent before the transmission was completed.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

12314
LIS- An error occurred sending LIS query request. Host
query aborted.
An unrecognized error occurred when sending a query to the LIS.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

12315
LIS-Time-out, No response from LIS after waiting 15
seconds.
After data was sent from the IMMULITE 2000 to the LIS, there was no response
and communication was aborted.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-147

12316
LIS- <ENQ> Contention.
The LIS was attempting to communicate with the IMMULITE 2000 at the same
time that the IMMULITE 2000 was attempting to communicate with the LIS.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

12317
LIS- No accession number in order record.
An accession number was missing from an order message received from the LIS.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

12318
LIS- The LIS encountered an error for a query.
The LIS informed the IMMULITE that the LIS encountered an error in a request for
a patient record from a query message.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

12319
LIS- The LIS has no information for a record when
queried.
The IMMULITE 2000 requested information from the LIS regarding a particular
sample that the LIS did not have
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

12320
LIS- An invalid terminator code was received from the
LIS.
An invalid or unsupported terminator code was received from the LIS.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

601005-0004 Rev. A
H-148 Operator’s Guide: Error Messages

12321
LIS- Unique ID does not match retrieved file. Please
call Technical Service.
All records are stored on the IMMULITE 2000 with a unique number. A retrieved
file was expected to have a particular number and was incorrect.
§Call Technical Service.

12322
LIS- Record could not be marked sent, record not found.
A sent record could not be found in the database to be sent to the LIS.
§Call Technical Service.

12323
LIS- Record could not be sent to LIS, record not found.
A tagged record could not be found in the data base to be sent to the LIS.
§Call Technical Service.

12324
LIS- There are no "TAGGED" records to sent to the LIS.
The operator pressed the Send or Re-Send buttons on the LIS screen and no
records are tagged.
§Call Technical Service.

12325
LIS- You can only display 10,000 records at one time.
More than 10,000 records meet the search criteria and the LIS screen cannot
display more than 10,000.
§Call Technical Service.

12326
LIS- Received Order Record before Patient Record.
The patient message must precede the order message in the LIS message. The
LIS has received the order message before receiving the patient message.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-149

12327
LIS: Data is being received from the LIS or IMMULITE
is already sending data to the LIS.
The LIS is currently receiving data or the IMMULITE is actively sending data to the
LIS.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

12328
LIS- LIS reports an error in query request.
There was an error in the query request as it was sent from the IMMULITE to the
LIS.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

12329
LIS- LIS reports no information for Accession Number in
query request.
There was no information for an Accession number in a query.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

12330
LIS- An error occurred sending LIS query request. Host
query aborted.
An unrecognized error occurred when sending a query to the LIS.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

12331
LIS- Parse error occurred when downloading in Control
format.
The Control information was sent from the LIS in the wrong format.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

601005-0004 Rev. A
H-150 Operator’s Guide: Error Messages

12332
LIS- Parse error occurred when downloading in Adjustor
format.
The Adjustor information was sent from the LIS in the wrong format.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

12333
LIS- Control downloaded from LIS is new to the system.
The control requested in the download from LIS is new to the system.
§Call Technical Service.

12334
LIS- Parse error occurred when downloading in Verifier
format.
The Calibration verifier information was sent from the LIS in the wrong format.
§Contact your laboratory LIS provider.
§If the message persists, call Technical Service.

12335
LIS- Sort Error
An error was exhibited when trying to sort in the LIS.
§Call Technical Service.

12336
LIS- Mail Error
An application error generated when the mail procedure was running.
§Call Technical Service.

12337
LIS- Display Error
An application error generated when the display procedure was running.
§Call Technical Service.

12338
LIS- Record Count Error
An application error generated when the record count procedure was running.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-151

12339
LIS- Send LIS Error
An application error generated when the mail procedure was running.
§Call Technical Service.

12340
LIS- Sort Error
An LIS Data Management Screen error – this occurs when sorting by accession
number.
§Call Technical Service.

12341
LIS- Check Message Error
An error occurred in the Check Sum Message routine when building the message.
§Call Technical Service.

12342
LIS- Parse Error
A programmer error was generated during the parsing routine.
§Call Technical Service.

12343
LIS- Listen Error
A programmer error occurred when receiving information from the LIS.
§Call Technical Service.

12344
LIS- Check Error
A check sum error occurred within the LIS program.
§Call Technical Service.

12400
Substrate Low.
The substrate load scale indicates that the volume of fluid remaining in the bottle
is lower than the warning level as configured in the database.
§Replenish the Substrate Bottle.
§Check the position of the Substrate Bottle on the load scale.
§If the message persists, call Technical Service.

601005-0004 Rev. A
H-152 Operator’s Guide: Error Messages

Note: The Instrument continues to process tubes through the Luminometer

and flags all bad results. These tests must be repeated.

12401
Substrate Empty.
The substrate load scale indicates that the volume of fluid remaining in the bottle
is lower than the low level as configured in the database.
§Replenish the Substrate Bottle.
§Check the position of the Substrate Bottle on the load scale.
§If the message persists, call Technical Service.

Note: The Instrument continues to process tubes. These tests must be

repeated.

12402
Trigger A Low.
The Trigger A load scale indicates that the volume of fluid remaining in the bottle
is lower than the warning level as configured in the database. The Trigger A load
cell is not currently active.
§Call Technical Service.

12403
Trigger A Empty.
The Trigger A load scale indicates that the volume of fluid remaining in the bottle
is lower than the low level as configured in the database. The Trigger A load cell
is not currently active.
§Call Technical Service.

12404
Trigger B Low.
The Trigger B load scale indicates that the volume of fluid remaining in the bottle
is lower than the warning level as configured in the database. The Trigger B load
cell is not currently active.
§Call Technical Service.

12405
Trigger B Empty.
The Trigger B load scale indicates that the volume of fluid remaining in the bottle
is lower than the low level as configured in the data base. The Trigger B load cell
is not currently active.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-153

12406
Probe Wash Low.
The Probe Wash load scale indicates that the volume of fluid remaining in the
bottle is lower than the warning level as configured in the database.
§Refill the Probe Wash Bottle.
§Ensure Probe Wash bottle is level on the Load Scale.
§Check to see if the tubing is tucked inside the Instrument and does not interfere
with the front doors. If the doors are closed on the tubing, it can tip the bottle.
§If the message persists, call Technical Service.

Note: The Instrument continues to process tubes. These tests must be

reviewed.

12407
Probe Wash Empty.
The Probe Wash load scale indicates that the volume of fluid remaining in the
bottle is lower than the low level as configured in the database.
§Refill the Probe Wash Bottle.
§Ensure Probe Wash bottle is level on the Load Scale.
§Check to see if the tubing is tucked inside the Instrument and does not interfere
with the front doors. If the doors are closed on the tubing, it can tip the bottle.
§If the message persists, call Technical Service.

Note: The Instrument continues to process tubes. These tests must be

repeated.

12408
Water Supply Low.
The Water Supply load scale indicates that the volume of fluid remaining in the
bottle is lower than the warning level as configured in the database.
§Refill the Water Supply Bottle.
§Ensure Water Supply bottle is level on the Load Scale.
§Check to see if the tubing is tucked inside the Instrument and does not interfere
with the front doors. If the doors are closed on the tubing, it can tip the bottle.
§If the message persists, call Technical Service.

Note: The Instrument continues to process tubes. These tests must be

reviewed.

601005-0004 Rev. A
H-154 Operator’s Guide: Error Messages

12409
Water Supply Empty.
The Water Supply load scale indicates that the volume of fluid remaining in the
bottle is lower than the low level as configured in the database.
§Refill the Water Supply Bottle.
§Ensure Water Supply bottle is level on the Load Scale.
§Check to see if the tubing is tucked inside the Instrument and does not interfere
with the front doors. If the doors are closed on the tubing, it can tip the bottle.
§If the message persists, call Technical Service.

Note: The Instrument continues to process tubes These tests must be

repeated

12410
Liquid Waste Almost full.
The Liquid Waste load scale indicates that the volume of fluid remaining in the
bottle exceeds the warning level as configured in the database.
§Empty the Liquid Waste Container.
§Ensure Liquid Waste bottle is level on load Scale.
§If the message persists, call Technical Service.

12411
Liquid Waste FULL.
The Liquid Waste load scale indicates that the volume of fluid remaining in the
bottle exceeds the full level as configured in the database.
§Empty the Liquid Waste Container.
§Ensure Liquid Waste bottle is level on load scale.
§If the message persists, call Technical Service.

12412
Solid Waste Almost Full.
The Solid Waste load scale indicates that the weight of the Solid Waste Container
exceeds the warning level as configured in the database.
§Empty the Solid Waste Container.
§Ensure Solid Waste Container is level on Load Scale.
§If the message persists, call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-155

12413
Solid Waste FULL.
The Solid Waste load cell indicates that the weight of the Solid Waste Container
exceeds the full level as configured in the database.
§Empty the Solid Waste Container.
§Ensure Solid Waste Container is level on Load Scale.
§If the message persists, call Technical Service.

12414
Tube hopper requires refilling.
The tube hopper sensor indicates that the level of tubes in the hopper has fallen
below the low sensor.
§Check Reaction Tube level and fill as necessary.
§Manually move tubes around to cover the upper sensor.
§If the message persists, call Technical Service.

12415
Tube Hopper Elevator Error
Something interfered with the Tube Hopper Elevator's ability to move tubes from
the Tube Hopper.
§Open the Tube Hopper and check the elevator path for a jam. Clear any jams.
§If the message persists, call Technical Service.

12500
Luminometer Temperature Low [Low Severity]
The temperature in the Luminometer is below the acceptable range.
§Monitor temperature for two hours to determine if temperature is coming into
range.
§If the message persists, call Technical Service.

12501
Luminometer Temperature High [Low Severity]
The temperature in the Luminometer is above the acceptable range.
§Monitor temperature for two hours to determine if temperature is coming into
range.
§If the message persists, call Technical Service.

601005-0004 Rev. A
H-156 Operator’s Guide: Error Messages

12502
Incubator Temperature Low [Low Severity]
The temperature in the Incubator is below the acceptable range.
§Monitor temperature for two hours to determine if temperature is coming into
range.
§If the message persists, call Technical Service.

12503
Incubator Temperature High [Low Severity]
The temperature in the Incubator is above the acceptable range.
§Monitor temperature for two hours to determine if temperature is coming into
range.
§If the message persists, call Technical Service.

12504
Reagent Temperature Low
The temperature in the Reagent Carousel is below the acceptable range.
§Monitor temperature for two hours to determine if temperature is coming into
range.
§If the message persists, call Technical Service.

12505
Reagent Temperature High
The temperature in the Reagent Carousel is above the acceptable range.
§Monitor temperature for two hours to determine if temperature is coming into
range.
§If the message persists, call Technical Service.

12506
Substrate Temperature Low
The temperature of the Substrate Probe is below the acceptable range.
§Monitor temperature for two hours to determine if temperature is coming into
range.
§If message persists, call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-157

12507
Substrate Temperature High
The temperature of the Substrate Probe is above the acceptable range.
§Monitor temperature for two hours to determine if temperature is coming into
range.
§If the message persists, call Technical Service.

12508
Instrument Ambient Temperature Under Cover High
Indicates that the ambient temperatures under the Instrument cover are above the
acceptable range.
§Call Technical Service.

12509
Bead chamber humidity High for more than 50 cycles
The humidity reported from the Bead Chamber was above 20% relative humidity
for more than 50 cycles.
§Check for high ambient humidity.
§Check to see if the Instrument was left in Diagnostics.
§If the message persists for more than 6 hours, call Technical Service.

12510
Luminometer Temperature Low
The temperature of the Luminometer is below the acceptable range.
§Monitor temperature for two hours to determine if temperature is coming into
range.
§If the message persists, call Technical Service.

12511
Luminometer Temperature High
The temperature of the Luminometer is above the acceptable range.
§Monitor temperature for two hours to determine if temperature is coming into
range.
§If the message persists, call Technical Service.

601005-0004 Rev. A
H-158 Operator’s Guide: Error Messages

12512
Incubator Temperature Low
The temperature of the Luminometer is below the acceptable range.
§Monitor temperature for two hours to determine if temperature is coming into
range.
§If the message persists, call Technical Service.

12513
Incubator Temperature High
The temperature of the Luminometer is above the acceptable range.
§Monitor temperature for two hours to determine if temperature is coming into
range.
§If the message persists, call Technical Service.

12514
Temperature Mail Event Error
An error occurred during temperature data collection.
§Call Technical Service.

12600
Kit found but no matching Volume data. Call Technical
Service.
Information for this kit is missing from the volume table of the main database.
§Call Technical Service.

12601
Dark count has exceeded the defined limit.
Dark count has exceeded the defined limit.
§Call Technical Service.

12602
Dark count is excessively high. Result is invalid.
Please notify Technical Service
Dark count is excessively high.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-159

12603
Result cannot be calculated. Kit lot deleted from
database.
Kit lot not in database; deleted during run.
§Rescan kit lot.
§Rerun adjustments, controls, and/or patients.
§If the message persists, call Technical Service.

12604
The Accession Number has been overwritten.
Operator overwrote accession number.
§Result may be invalid. Confirm results and/or rerun sample.

12605
.
This error will only be seen in conjunction with Event 12604. It allows the software
to post the original accession number.
§See Event 12604.

12606
Multiple racks have been identified with the same rack
letter. Please remove all duplicates.
Multiple racks on board with the same rack letter.
§Remove duplicate racks from sample carousel.

12607
Error occurred while printing. Verify all results have
printed.
The printer is not installed or the print spooler is disabled.
§Make sure that the printer cartridges are full and installed correctly.
§Check for printer jams.
§If the message persists, call Technical Service.

13000
Invalid Data was received from the scanner
Bad scan of the Allergen Wedge barcode. No Allergen Wedge information
appears on the reagent screen.
§Call Technical Service.

601005-0004 Rev. A
H-160 Operator’s Guide: Error Messages

13001
Duplicate allergen wedge id.
There are multiple Allergen Wedges with the same ID.
§Remove duplicate wedges.

13002
One or more accession numbers on the sample carousel
contains an invalid character.
Invalid character used in the sample barcode
§Enter sample ID manually.
§If the message persists, call Technical Service.

14000
(Error Number): Unexpected Error. Please Contact
Technical Service.
An unexpected software error has occurred.
§Write down the exact message on the screen for further troubleshooting.
§Call Technical Service.

14001
Unable to request Dual Port Ram Message Semaphore.
User software was unable to communicate with the DPR.
§The Instrument will try again. This error will occur periodically during normal
operation. Continued instances of this error will lead to other more severe
errors.

14011
Unable to determine current instrument mode.
The Control computer was unable to determine which mode (Integrated or
Non-Integrated) was selected on the analyzer.
§Call Technical Service.

14012
Unable to set integrated mode on control PC. Please
Contact Technical Service
The Control computer was not set to the Integrated mode that was selected on the
analyzer.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-161

14013
Unable to set integrated mode on User PC. Please
Contact Technical Service.
The User computer was not set to the Integrated mode that was selected on the
analyzer.
§Call Technical Service.

14014
Unable to set non-integrated mode on Control PC.
Please Contact Technical Service.
The Control computer was not set to the Integrated mode that was selected on the
analyzer.
§Call Technical Service.

14015
Unable to set non-integrated mode on User PC. Please
Contact Technical Service.
The User computer was not set to the Integrated mode that was selected on the
analyzer.
§Call Technical Service.

14016
Database error.
A problem occurred while querying the worklist for orders.
§Call Technical Service.

14017
Unable to read the Auto-Rack data.
An error occurred while trying to get the auto rack data from the DPRam.
§Call Technical Service.

14019
Unable to update loader queue.
While using SMS to process orders, an error occurred when trying to load a work
order into the Loader queue.
§Processing will continue, but if an error occurs multiple times, call Technical
Service.

601005-0004 Rev. A
H-162 Operator’s Guide: Error Messages

14020
Error occurred while sending query to the LIS.
While the SMS was querying the LIS for a specific accession number, an error
occurred.
§Processing will continue, but if an error occurs multiple times, call Technical
Service.

14030
Automation Rack cannot be used to process Control,
Adjustor or Verifier.
A control, adjustor, or verifier was placed on the SMS.
§Rerun the test after placing the control, adjustor, or verifier on the Sample
Carousel of the analyzer.
§If the message persists, call Technical Service.

14031
Please check the LIS screen to verify that all records
are untagged. Call Technical Service
When switching from Integrated to Non-integrated mode, an error occurred while
the LIS result records were being untagged.
§Call Technical Service.

14032
Changed to non-integrated mode. All result records have
been untagged.
When switching between Integrated and Non-integrated modes, all result records
are untagged, possibly preventing some records from being sent to the LIS.
§Go to the LIS screen.
§Manually tag results and resend.
§If the message persists, call Technical Service.

14033
System ordered tests may not have been sent to the
worklist. Please Call Technical Services.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-163

14034
Error building or sending system ordered test to the
Versacell.
An error occurred when the tests in the SMSHold table in the main data file were
being retrieved to sent to the VersaCell, or when the orders are being deleted
from the SMSHold table after being retrieved

14035
Error retrieving or deleting records to send to VersaCell.
An error occurred when test order messages are being created or while they are
being transmitted from the IMMULITE 2000/2500 to the VersaCell. (ASTM
protocol is used for these messages)

14036
Please select Run VersaCell from the VersaCell start screen.
VersaCell not running
§If the instrument is in integrated mode, startup the VersaCell program from the
Desktop.

14040
Error With Work Order Time Out.
A sample tube was placed on an Instrument, but an order was not received. This
can occur because the order was deleted on the Instrument, but not on the SMS,
or because the order was sent to the Instrument, but not saved (e.g., a “~C”
control was placed on the SMS).
§If the order was intentionally deleted on the Instrument, delete it on the SMS,
re-query as necessary, ensure the query option is active, and run the test
manually.
§Do not put “~C” controls on the SMS.
§If the message persists, call Technical Service.

15000
(Acc #): Invalid Online Dilution has been ordered for
the sample. Test not run.
Invalid dilution ordered.
§Reorder the dilution using a valid selection.
§If the message persists, call Technical Service.

601005-0004 Rev. A
H-164 Operator’s Guide: Error Messages

15100
Database Error – Cannot retrieve the dilution factor.
Results may not be valid. Call Technical Service.
While accessing information on the Find/Display screen an error occurred while
retrieving a dilution factor from result information.
§Call Technical Service.

15101
Adjustor CPS Value equal 0. Please notify Technical
Service immediately.
Kit information was correctly scanned into database, or possible database
corruption.
§Call Technical Service.

15102
Error calibrating Substrate Load Scale. Contact
Technical Service for assistance.
While trying to calibrate the Substrate Load scale, an error occurred. The value
returned is not acceptable and the default value will be used.
§Call Technical Service.

15103
Error calibrating ProbeWash Load Scale. Contact
Technical Service for assistance.
While trying to calibrate the Probe Wash Load scale an error occurred. The value
returned is not acceptable and the default value will be used.
§Call Technical Service.

15104
Error calibrating Water Load Scale. Contact Technical
Service for assistance.
While trying to calibrate the Water Load scale an error occurred. The value
returned is not acceptable and the default value will be used.
§Call Technical Service.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-165

15105
Error calibrating Liquid Waste Load Scale. Contact
Technical Service for assistance.
While trying to calibrate the Liquid Waste Load scale an error occurred. The value
returned is not acceptable and the default value will be used.
§Call Technical Service.

15106
Error calibrating Solid Waste Load Scale. Contact
Technical Service for assistance.
While trying to calibrate the Solid Waste Load scale an error occurred. The value
returned is not acceptable and the default value will be used.
§Call Technical Service.

15107
Error in result calculation.
When calculating the dose, there was a calculation error with a formula.
§Call Technical Service.

15108
Database Error. Please contact Technical Service.
Database may be corrupt or there was a problem writing information to the
database.
§Call Technical Service.

15114
Database Error. Qualitative Parameters are not
available. Call Technical Service.
Qualitative parameters are not available, contain incorrect data, or a qualitative
test has an invalid result.
§Call Technical Service.

15120
Failed printing the confirmatory results report.
An error occurred while printing confirmatory test results.
§Ensure printer is online with adequate paper.

601005-0004 Rev. A
H-166 Operator’s Guide: Error Messages

15121
Failed printing the screen.
An error occurred while trying to do a screen print confirmatory test option screen.
§Ensure printer is online with adequate paper.

15122
Failed ordering confirmatory HBS tests.
When ordering confirmatory tests on the screen, an error occurred when the Save
button was selected.
§Check to make sure the required information was entered.
§Contact Technical Service.

15125
Report cannot be sent to printer
A report cannot be reprinted for a specific accession number because of a printer
issue (printer driver not installed or printer not configured)

15126
Printer Error
A Printer error of some type occurred.
§Check that printer is online.
§Check that there is paper and ink.
§Check that cables are secure.

15127
Report cannot be printed. Patient information is invalid or
missing.
When the program is preparing to print the report either the Patient ID number, the
Accession number, or Test type is missing from the record to be printed.

15128
Error during Report Editing.
While editing the report format on the screen an error occurs because data or
formatting is not correct.

15130
Error reading Sample carousel Data. Instrument will finish
transitioning into Run mode and then enter Sample Pause
mode. This could take several minutes…Please wait.
The User-side software does not know what sample racks were scanned because
information was not retrieved from the DPRam.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-167

15132
Failed printing the reflexive test range report.
The Reflexive test range report was not able to print because of a printer problem
or because the program could not access the data in the database.

17000
No incubation time data. This is not a valid $IM2K$ Kit
Barcode.
The incubation time in the kit barcode is showing zero for the test kit being
scanned in on a 2500, which means this is not a valid 2500 kit.
§Verify that the kit is for the IMMULITE 2000 Instrument.
§If the problem persists, call Technical Service.

17001
Kit barcode signature incorrect. This is not a valid
$IM2K$ Kit Barcode.
The Kit barcode signature is incorrect for the instrument where the kit is being
scanned. Trying to scan a 2500 kit on 2000 instrument or visa versa.
§Verify that the kit is for the IMMULITE 2000 Instrument.
§If the problem persists, call Technical Service.

17008
Unable to read luminometer belt.
§Contact Technical Service.

17009
Error occurred while loading tests onto the STAT loader
queue.
A communications error occurred in the user software.
§The Instrument will re-send the message.

17010
Error occurred while loading tests onto the routine
loader queue.
A communications error occurred in the user software.
§The Instrument will re-send the message.

601005-0004 Rev. A
H-168 Operator’s Guide: Error Messages

17011
Could not find volume table data for this kit.
The Test Type and Kit Lot number could not be found in the database where the
test volumes are stored.
§Rescan the Kit, and if the problem persists, call Technical Service.

17012
There is a problem with the registry on this system.
Please contact Technical Services.
The program is trying to determine the Instrument type (2000 or 2500) by reading
the registry and cannot find the information.
§The registry information is written during installation of version 4.0 or higher.
§Reinstall program, and if the problem persists, call Technical Service.

17014
Duplicate accession numbers found on the Sample
Carousel.
2 or more sample tubes with the sample accession number were found during a
sample carousel read. Different cases of the same accession number are
detected as being duplicates.

17015
The user side software has shut down due to an
unexpected error. Press the RUN IMMULITE button after
closing this message to continue the current run.
Contact Technical Service to report this error
Unexpected Error was generated in a procedure during program execution. See
Daily Event log file for more information.

17100
Allergy Rescan configuration has been turned off.
Allergy Rescan Override configuration setting has been changed from On to Off.

17101
Allergy Rescan configuration has been turned on.
Allergy Rescan Override configuration setting has been changed from Off to On.

17102
User acknowledged that no Allergy wedges were changed
while logged off.
The user acknowledged that no Allergy wedges were changed while logged off by
pressing the Yes button of the confirmation (second prompt) message box at
initialization.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-169

17103
User acknowledged that all changed Allergy wedges were
rescanned.
The user acknowledged that all changed Allergy wedges were rescanned by
pressing the Yes button on the confirmation (second prompt) message box
initiating the transition to Run.

17104
Deleting Allergy wedge data because of user
acknowledgement timeout.
The IMMULITE is automatically deleting Allergy wedge data because the user
failed to respond to the message box initiating the transition to run.

17105
Deleted Allergy wedge data because of incomplete
reagent scans on the previous run.
The IMMULITE is automatically deleting Allergy wedge data because incomplete
reagent scans on the previous run could result in specific allergens to be reported
out of place

17111
No Configured Language! Defaulted to English.
The program could not find the configuration setting for the Language, the
program will log the information in the Event log and continue to run using English
as a default.

18000
PM Appointment
Message box window title for PM Tracker feature.

18001
Please call Technical Service to schedule a
Preventative Maintenance appointment.
For Non- RTS customers this message will be displayed when the current test
count reached the threshold count set by the FSE indicating a PM is needed.

18002
PM Schedule notification acknowledged.
This message goes into the Errorlog database when the User Acknowledges the
PM notification message for Non-RTS customers. For RTS customers the
message goes in the errorlog automatically when they reach the test count
threshold.

601005-0004 Rev. A
H-170 Operator’s Guide: Error Messages

18003
PM Performed--See PM Tracker Log
This message goes into the Errorlog database when the PM has been performed
through the PM Tracker Utility.
§Field Service is only one authorized to do this operation.

18004
Threshold Test Count Updated--See PM Tracker Log
This message goes into the Errorlog database when threshold counts are
updated through the PM Tracker utility.
§Field Service is only one authorized to do this operation.

19001
This confirmatory test is not defined. Please Contact
Technical Service.
The confirmatory test is not defined in the confirmatory kit definition table. Either
there is an error reading the test name or there is a database problem.

19005
Kit Error. No valid HBS diluent tube onboard.
An error occurred while trying to place the HBS Confirmatory test into the queue
because there was no diluent available.

19006
Kit Error. No valid HBS bead pack onboard.
An error occurred because the program could not find the required beads on
board the instrument for the HBS Confirmatory tests being ordered.

19007
Kit Error. Not enough HBS beads onboard.
The program has determined that there is not enough beads to run the pair of
confirmatory tests that are being ordered and posts the error.

19008
Kit Error. A valid HBS Negative Control result is not
available.
The program has checked the Control Status of the primary HBS kit that is
currently active and the control status is not valid and cannot be used.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-171

19009
Kit Error. The HBS Negative Control result has
expired.
The program has checked the expiration date of the controls and found that they
are expired or have not date.

19010
Kit Error. No valid HBS reagent wedge onboard.
There are no matching HBS reagents on board or a reagent that is on board is not
available for use.

19011
Kit Error. Not enough HBS reagent onboard.
There is not enough tests left in the HBS reagent compartment needed for tests
being ordered.

19012
Kit Error. No valid HBS Confirmatory reagent wedge
onboard.
There are no matching HBS Confirmatory reagents on board or a reagent that is
on board is not available for use.

19013
Kit Error. Not enough HBS Confirmatory reagent
onboard.
There is not enough tests left in the HBS Confirmatory reagent compartment
needed for tests being ordered.

19016
Invalid Confirmatory test ordered from LIS.
The confirmatory test is sent via the LIS or SMS, does not have the correct format
or the test was not found in the Kits table.

19017
Confirmatory Testing Enabled.
When confirmatory testing is enabled in the registry, there will be a configuration
option to enable/disable Confirmatory, when the box is checked this message will
be logged.

19018
Confirmatory Testing Disabled.
When confirmatory testing is enabled in the registry, there will be a configuration
option to enable/disable Confirmatory, when the box is unchecked this message
will be logged.

601005-0004 Rev. A
H-172 Operator’s Guide: Error Messages

19021
Eject rack command failed.
User Side Failed to write Eject command to DPRam. This may be because the
User side thinks it is a invalid rack position, the queue that holds instrument
messages is full, or a semaphore cannot be accessed.

19022
Duplicate rack identified. Rack will be ejected
automatically.
Two or more racks loaded on the system have the same Rack ID.

20000
Unexpected error while initializing instrument. Contact
Technical Service.
This is the failure message displayed to the operator if the Feature Configuration
Component Fails during Start-up. Registry is probably corrupted
§Requires Tech Service intervention to correct registry issue or reinstall software.

20001
Handheld scanner error. Contact Technical Service.
This message is displayed to the operator if com port 10 is not detected by the
Operating System and an Invalid Port error (8002) is generated.

20100
AutoStart will not be performed due to insufficient
water supply.
Not enough water to run AutoStart processing.
§Ensure there is sufficient water supply (No RTS)

20101
Automatic Substrate dispense will not be performed due
to insufficient substrate supply.
Not enough substrate to run substrate dispense processing.
§Ensure there is sufficient substrate (No RTS)

20102
AutoStart will not be performed due to insufficient
probe wash.
Not enough probe wash to run AutoStart processing.
§Ensure there is sufficient probe wash (No RTS)

601005-0004 Rev. A
Operator’s Guide: Error Messages H-173

20104
AutoStart will not be performed due to insufficient
water and probe wash.
Not enough water and not enough probe wash for AutoStart processing.
§Ensure there is sufficient probe wash and water (No RTS)

20107
AutoStart will not be performed due to an error while
checking consumables.
An error was encountered while checking consumables specifically for water,
substrate, and probe wash levels.

20108
Unexpected error during AutoStart processing. Contact
Technical Service.
An unexpected general error in AutoStart processing.
§Retrieve Daily Events log and error log for SW investigation

20109
AutoStart cancelled by Operator.Unexpected error during
AutoStart processing. Contact Technical Service.
User cancelled AutoStart routine by selecting the cancel button from the interface.
This message is logged for informational purposes.
§No action needed (No RTS).

20111
Unexpected error during AutoStart processing. Contact
Technical Service.
General AutoStart processing error. Unexpected error or Control side may have
gone into Stop because of an error.

20120
Manual AutoStart initiated.
Manual AutoStart processing has begun.

20121
Scheduled AutoStart initiated.
Automatic AutoStart processing has begun.

601005-0004 Rev. A
H-174 Operator’s Guide: Error Messages

20122
Substrate has not been primed. QC Worklist will not
run.
Substrate not in a ready to run state.. It has not been primed in the necessary time
frame (2 hours) QC Worklist will not run

20123
AutoStart processing complete.
AutoStart processing (daily maintenance tasks) complete.

20124
AutoStart aborted by Operator.
Operator selected to abort AutoStart, information will be logged.

20125
Instrument was in an invalid state to run scheduled
AutoStart.
Instrument not in valid state to launch AutoStart (automatic AutoStart).
§Manual - must be in Stop or splash screen.
§Automatic – must be at desktop, Splash screen, stop mode, or Integrated with no
tests running.

20126
AutoStart was cancelled from the countdown screen.
Operator selected to cancel AutoStart from the AutoStart countdown screen.
Normal informative message.

20150
Automatic substrate dispense initiated.
Normal informative message when automatic substrate dispense is initiated

20151
Automatic Substrate Dispense complete.
Normal informative message when automatic substrate dispense is completed.

20152
Automatic substrate dispense aborted by Operator.
Operator selected to abort automatic substrate dispense.

601005-0004 Rev. A
Operator’s Guide: Error Messages H-175

20153
Instrument was in an invalid state to run automatic
substrate dispense.
Instrument not in a defined valid state for Autostart automatic substrate dispense
processing.
§Manual: must be in Stop or splash screen.
§Automatic: desktop. Splash screen, stop mode, Integrated with no tests running

20154
Substrate dispense cancelled from the countdown screen.
Operator selected to cancel substrate dispense from the countdown screen.

20155
Substrate dispense processing timed out.
Can be any of the causes in errors 861-864.

20156
Failure reported in substrate dispense processing.
Any error on the control side that causes the instrument to stop substrate
dispense processing.

20200
Unexpected error. AutoStart will not be performed.
Contact Technical Service.
Unexpected error retrieving data in the component that retrieves data from the
database.
§Try again.
§If failure still occurs, contact Technical Service. Retrieve daily events log and
error log for SW

20201
Unexpected database error. AutoStart will not be
performed. Contact Technical Service.
More than one record in the AutostartSubstrateDispenseProcessing table. Should
only be one record in Table.

20202
Unexpected error. AutoStart will not be performed.
Contact Technical Service.
Unexpected error in AutostartDailyMaint.DLL component.
§Contact Technical Service. Retrieve daily events log and error log for SW
investigation

601005-0004 Rev. A
H-176 Operator’s Guide: Error Messages

20203
Unexpected error. AutoStart will not be performed.
Contact Technical Service.
Error occurred trying to kick off AutoStart processing.
§Retry AutoStart processing may help, otherwise contact Technical Service.

20205
AutoStart processing timed out waiting for logoff.
User software took longer than expected to log off the User side software.
(Possible hang-up on database backup or RTS transfer).
§Logoff software and try manual AutoStart from splash screen.

20206
AutoStart failed to launch the IMMULITE 2000 XPi
software.
Failure occurred while trying to launch or re-launch user software from the
AutostartDailyMaint.DLL (external component).
§Retry AutoStart processing from splash screen.

20207
Unexpected error. AutoStart will not be performed.
Contact Technical Service.
Autostart could not read the registry. Registry value missing for AutoStart
processing. Possibly corrupted registry keys.
§Retrieve daily events log and error log for SW investigation.

20208
AutoStart failed to open the daily event log.
Error occurred while attempting to log an event or an error to the unexpected
event log.
§May resolve when AutoStart is run again, otherwise contact Technical Service.
§Retrieve daily events log and error log for SW investigation

20209
Instrument is not in a valid state for AutoStart
processing.
Instrument is not in one of the defined valid states for AutoStart processing.
§Manual: must be in Stop or splash screen.
§Automatic: desktop. Splash screen, stop mode, Integrated with no tests running

601005-0004 Rev. A
Operator’s Guide: Error Messages H-177

20210
Unexpected error. AutoStart will not be performed.
Contact Technical Service.
A fatal error occurred while trying to calculate a the memory offset location in the
DPRAM.
§Contact technical service Retrieve daily events log and error log for SW
investigation

20211
Unexpected error. AutoStart will not be performed.
Contact Technical Service.
A fatal error occurred while trying to communicate with the DPRAM.
§Retry AutoStart. If that fails, Retrieve daily events log and error log for SW
investigation

20212
Error logging operating system logon time.
Error occurred when the operating system started that caused the time that the
operating system was started to not be logged.

20214
Error while ordering scheduled QC. One or more QC
orders may not run.
If there is any error in creating the QC worklist orders, then one or more QC may
not run.
§No operator action is needed.

20215
Autostart timed out waiting for substrate dispense to
complete.
The substrate dispense completion message did not get sent/received within the
timeout period.
§Get spy file.
§Check that the control side performed the substrate dispense actions.
§Check other error messages that may have occurred around the same time.

20220
Scheduled QC Worklist has been ordered.
The QC Worklist was ordered successfully.

20221
Scheduled QC Worklist has been canceled.
The QC Worklist was canceled by the operator.

601005-0004 Rev. A
H-178 Operator’s Guide: Error Messages

21000
Instrument lost communication with external systems.
Contact Technical Service for assistance.
Failed to communicate with external subsystem, because we are no longer
communicating with the i2i Service.
§Call Tech service to investigate

21001
Failed to Send Instrument Error to the following
subsystem(s): <List of Subsystems> Contact Technical
Service if the problem persists.
Communication send failure. Failed to build Instrument Error message using i2i
§Call Tech service to investigate

21002
Failed to Send Instrument Status to the following
subsystem(s): <List of Subsystems> Contact Technical
Service if the problem persists.
Communication send failure. Failed to build Instrument Status message using i2i.
§Call Tech service to investigate

21003
Failed to Send Instrument Inventory to the following
subsystem(s): <List of Subsystems> Contact Technical
Service if the problem persists.
Communication send failure. Inventory error message. Inventory message was
not build based on the requested parameters
§Call Tech service to investigate

21004
Failed to Send Adjustor Results to the following
subsystem(s): <List of Subsystems> Contact Technical
Service if the problem persists.
Communication send failure. Error in building Calibration Test result message
§Call Tech service to investigate

21005
Failed to Send Control Results to the following
subsystem(s): <List of Subsystems> Contact Technical
Service if the problem persists.
Communication send failure. Error in building Control Test Result message
§Call Tech service to investigate

601005-0004 Rev. A
Operator’s Guide: Error Messages H-179

21006
Failed to Send Patient Results to the following
subsystem(s): <List of Subsystems> Contact Technical
Service if the problem persists.
Communication send failure. Error in building Patient Test Result message
§Call Tech service to investigate

21007
Failed to Send Verifier Results to the following
subsystem(s): <List of Subsystems> Contact Technical
Service if the problem persists.
Communication send failure. Error in building Verifier Test Result message
§Call Tech service to investigate

21008
Failed to Send the QC Comment change to the following
subsystem(s): <List of Subsystems> Contact Technical
Service if the problem persists.
Communication send failure. Error in building QC Comments update message
§Call Tech service to investigate

21009
Failed to Send the Kit Adjustment status to the
following subsystem(s): <List of Subsystems> Contact
Technical Service if the problem persists.
Communication send failure. Error in building Kit Adjustment status message
§Call Tech service to investigate

21010
Configuration file, controlling communications with
external subsystems, has changed. Please log off the
IMMULITE software for the changes to take effect.
If the Operator changes the I2I configuration file when the IMMULITE software is
running using i2i.
§Operator is not supposed to change the i2i configuration file.

601005-0004 Rev. A
H-180 Operator’s Guide: Error Messages

21011
The channel status for an external subsystem has
changed. Cannot communicate with subsystem <name>
The communication with an external subsystem was paused or deactivated
outside of the IMMULITE 2000 software. Channel status can be
• Paused
• Stop
• Not Active
• Error
§Call Tech service to investigate

21012
Instrument communication feature is currently
unavailable, due to start up error(s). Please restart
the system to correct this problem. Contact Technical
Services if the problem persists.
Failed to start i2i service because of one of the following issues:
• Invalid i2i Configuration settings provided (such as Profile name)
• Missing or corrupted i2i Configuration file
• i2i Service is not started
§Call Tech service to investigate

21013
Failed to shutdown the external communications. ???
Contact Technical Services if the problem persists ???
Failed to shutdown i2i service.

21014
Unsupported request from external subsystem was
received. Instrument will not send a reply to this
request. ??? Contact Technical Services if the problem
persists ???
Inventory error message. Inventory message was not built based on the
requested parameters
Invalid request for Adjustor result was received for Adjustor< Kit, Lot>
Invalid request for Control (Accession number) result was received
Invalid request for Patient result was received
Invalid request for Kit Adjustment status was received
Invalid request for Verifier result was received
§Call Tech service to investigate

601005-0004 Rev. A
Operator’s Guide: Error Messages H-181

601005-0004 Rev. A
H-182 Operator’s Guide: Error Messages

601005-0004 Rev. A
Appendix I: Hepatitis Confirmatory Test

Manual Confirmatory Testing

The Hepatitis Confirmatory Testing feature enables the instrument to associate the
patient accession number with the Confirmatory Sample ID, perform calculations,
and report the percent signal reduction and an interpretation confirmed or
unconfirmed.
NOTE: Prepare confirmatory samples offline before running manual
confirmatory testing.

HBsAg Positive Control

The HBsAg Positive Control supplied with the IMMULITE 2000 HBsAg (HBS)
kit is required and is used as quality control material to monitor assay
performance of the HBsAg Confirmatory Kit.
Prepare and run undiluted blocked and unblocked samples of the HBsAg Positive
Control once, each time HBsAg Confirmatory tests are performed.
Barcode labels are provided for the Positive Confirmatory Control Blocked (CB)
and Control Unblocked (CU) samples.
NOTE: A negative HBS control is required for confirmatory calculations and
must be run before the HBsAg confirmatory tests. This control is typically run as
part of routine HBS testing.

Order Hepatitis Confirmatory Tests

To order Hepatitis Confirmatory Tests on the Instrument, follow the instructions
below.

For the IMMULITE 2000 System and IMMULITE 2500 System

1. At the instrument window drop-down menu, select Screens.
2. Select Confirm HBS.
3. Proceed to step 3 in the next section.

For the IMMULITE 2000 XPi instruments

1. At the instrument window, select MENU.
2. At the Menu screen, select Confirm HBS.

601005-0004 Rev. A
I-2 Operator’s Guide: Hepatitis Confirmatory Test

3. To enter the original sample ID, perform one of these options:

• Scan the patient sample tube barcode label
• Manually enter the number into the Original Sample ID field.
4. To enter the confirmatory sample ID, perform one of these options:
• Scan the confirmatory sample ID barcode label
• Manually enter the number into the Original Sample ID field.
Maximum 4 numerical characters.
All blocked and unblocked fields for undiluted and diluted samples, and
positive confirmatory controls will automatically populate.
5. Select the HBS kit lot number from the drop-down list.
This list displays the number of tests remaining for each kit lot on board the
instrument, and is refreshed each time the screen is opened.
NOTE: This is the lot number of the HBS kit used for testing. Do not enter the
kit lot of the HBsAg Confirmatory Kit.
6. Select ORDER for the appropriate sample type(s) to be run:
• undiluted
• diluted
• both
The instrument only creates orders for the sample types for which the you
selected using the ORDER button.
NOTE: To cancel an order, select CANCEL before selecting ACCEPT.
7. Select ACCEPT.
The HBS confirmatory test orders are sent to the worklist and the fields are
cleared.

Order Positive Confirmatory Control

Order the positive confirmatory control by performing the steps below.
1. Enter HBS POS in the Original Sample ID field.
NOTE: Do not scan the HBS control barcode label.
2. To enter the positive confirmatory control ID, perform one of these options:
• Scan the confirmatory control barcode label
• Manually enter the number into the Confirmatory Sample ID field
3. Select ORDER for the Positive Confirmatory Control.
4. Select ACCEPT.
5. To print the screen information, select PRINT SCREEN.
6. Select CLOSE to exit the HBS Confirmatory Test Entry screen.

601005-0004 Rev. A
Operator’s Guide: Hepatitis Confirmatory Test I-3

Load and Process Manual Confirmatory Samples

After ordering HBsAg confirmatory tests, follow the instructions below to load
the samples on the Instrument for processing.
1. Lift the sample access door to enter SAMPLE PAUSE mode.
NOTE: The instrument does not query the LIS for the HBsAg confirmatory
test samples.
2. Place the prepared and labeled Hepatitis confirmatory samples in the rack(s)
and select RUN.
The instrument processes the tests:
• The confirmatory test samples print automatically, qualitative or
qualitative and ratio results and results are not automatically sent to the
LIS.
• Reflexive testing is not performed on HBS confirmatory samples.

Reviewing Results of Manual Confirmatory Testing

Detailed confirmatory results are available on the HBS Confirmatory Report.
Follow the instructions below to print the HBS Confirmatory Report.

For the IMMULITE 2000 System and IMMULITE 2500 System

1. At the instrument window drop-down menu, select Screens.
2. Select Confirm HBS.
3. Proceed to step 3 in the next section.

For the IMMULITE 2000 XPi instruments

1. At the instrument window, select MENU.
2. At the Menu screen, select Confirm HBS.
3. Select DATE TIME RANGE.
The Select Time Method screen displays.
4. Select dates and times from the FROM and TO fields.
5. Select OK.
6. Select PRINT RESULTS.

601005-0004 Rev. A
I-4 Operator’s Guide: Hepatitis Confirmatory Test

601005-0004 Rev. A
Index
Numerics tests 2-53, 2-55
2D Scanner tube position 2-56
scanning kits 2-26 authorized representative B-1
auto dilutions 8-3
A automated test process 2-10
adding AutoStart Mode 2-12
adjustors to worklist 2-46 available tests 2-53
calibration verifiers 2-49
B
levels of control 4-5
panels 8-18 barcodes
patients to worklist 2-42 adjustors 1-13
adjustments 2-33 controls without barcodes 2-48
adjustment log 2-40 kits 1-14, 2-26
printout 2-35 patients without barcodes 2-44
sample data 2-37 batch by rack 2-55
two-point adjustment 3-2 bead packs
validity 2-37, 3-3 Bead Status window 2-19
adjustors 1-13 onboard the Instrument 2-41
adding to worklist 2-46 overview 1-13
antibody 1-14 replacing 2-21
barcode labels 1-13 status 2-19
allergens 1-16 bottles
configuring ranges 8-13 decontaminating 5-28
entering 2-28 disconnecting and reconnecting 5-8
on board 2-41 C
ranges 8-13 cancelling on board dilutions 2-51
replacing wedges 2-15 capacity 1-2
status of wedges 2-12 chartable patient report 8-23
vials 2-28 disabling fields 8-24
wedges 1-16, 2-28 enabling fields 8-24
antibody moving fields 8-25
adjustor 1-14 printing 8-25
control 1-14 restoring the template 8-26
as needed maintenance 5-30 checking
cleaning the monitor 5-30 dispense angle of Reagent Probe 5-19
assays kit components 2-53
adjusting 2-33 reagent and allergen wedges 2-12
tests ordered 2-39 sample status 2-37
time to completion 2-38 Substrate 5-10
troubleshooting guide 6-14 test time remaining 2-38
assigning tests ordered 2-39

601005-0004 Rev. A
2 Operator’s Guide: Index

Waste Containers 5-11 controls 1-14

Water Bottle 5-7 adding a level 4-5
chemiluminescent reaction 1-31 changing a level 4-6
cleaning control antibody 1-14
Fan Filter 5-24 Control Not for On-line QC 4-12
Monitor 5-30 deleting tests 4-11
Sample and Reagent Probes 5-5 editing information 4-7
trackball 5-30 entering new information 4-1
clearing LIS records 2-64 levels 4-5, 4-6
Clot Detection Transducer 5-27 loading 2-2
clots 6-10 Multi Rule 4-12
air in the system 6-12, 6-13 naming conventions 1-1
clinging 6-11 qualitative controls 4-4
Clot Detection Transducer 5-27 reported as ratios 4-4
gel 6-11, 6-13 reviewing data 4-7
hanging 6-12, 6-13 Single Rule 4-12
sample 6-11 troubleshooting post adjustment 6-15
CO2 Scrubber replacement 5-29 with barcodes 2-47
common errors and solutions H-2 without barcodes 2-48
components creating a panel 8-18
kits 1-11 customer service B-2
system 1-3 D
computer
restarting 5-6 daily
settings 8-26 maintenance 2-12, 5-1
specifications E-2 shutdown 7-5
CONFIGURATIONS damaged or missing barcodes
Auto Dilutions 8-3 patients 2-44
configurations data
Allergen Ranges 8-13 clearing LIS data 2-64
Configuration Settings 8-4 exporting 7-1
Display Options 8-1 resending to LIS 2-64
ID Information 8-4 reviewing control data 4-7
LIS 8-7 saving to a CD or DVD 7-2
Panels 8-18 viewing and sending to LIS 7-4
Reflexive Tests 8-14 Date and Time 8-26
Reset Load Scale 8-11 date and time
Test Ranges 8-12 resetting 8-26
units configuration 8-21 decontaminating
confirmatory testing bottles and lines 5-27
manual confirmatory testing I-1 deleting
consumables panel 8-20
report 1-16 reflexive test range 8-17
Control Not for On-line QC 4-12 tests for a control 4-11

601005-0004 Rev. A
Operator’s Guide: Index 3

worklist entries 2-58 cleaning 5-24

DIAGNOSTICS filling
list of programs 6-5 Probe Wash Bottle 5-7
diagnostics reaction tube hopper 5-6
initializing 5-3 Substrate 5-10
diluent 1-16 Water Bottle 5-9
loading 2-2 filter
dilutions 2-50 fan 5-24
Auto Dilutions screen 8-3 finding
loading diluent 2-2 tubes 2-39
manual 2-52 flags H-4
onboard 2-50 fluid usage E-1
samples 2-50 four-parameter logic 3-1
volumes E-2 H
disconnecting
Water and Probe Wash Bottles 5-8 help
Display Options 8-1 searching 1-29
hepatitis confirmatory testing
E manually I-1
editing I
control information 4-7
panels 8-20 ID information 8-4
Reflexive Testing configurations 8-16 Imaging Scanner
electrical scanning kits 2-26
power loss 6-6 important notices 1-15
power requirements G-1 importing
entering worklist 2-59
allergens and allergen wedges 2-28 in vitro diagnostics (IVD) symbols F-1
Kits 4-1 Instrument parts 1-3
Entering New Control Information 4-1 intercept of an adjustment, competitive 3-5
error messages H-1 intercept of an adjustment, sandwich 3-5
common errors and solutions H-2 internal calculations 1-30
error log 6-2 K
Error Report screen 6-1 Kit Deactivation
flags H-4 Configuring 2-31
list H-4 Kit Load Report 2-23
severity H-1 kits 4-1
event log 6-2 barcodes 1-14, 2-26
exporting checking components 2-53
data 7-1 components 1-11
to a CD or DVD 7-2 entering 4-1
F reviewing information 2-31
Fan Filter

601005-0004 Rev. A
4 Operator’s Guide: Index

L worklist entries 2-58

labeling Monitor
patient sample tubes 2-2 cleaning 5-30
Limited Warranty B-1 Monthly Maintenance 5-19
lines Multi Rule 4-12
decontaminating 5-28 O
liquid waste 5-12 onboard dilutions 2-50
LIS cancelling 2-51
clearing data 2-64 operator tasks 2-1
configuring 8-7 options
resending data 2-64 test entry 2-53
reviewing results 2-63 output E-1
sending results 2-64 specifications 1-2
view and send data 2-64, 7-4
load scale P
resetting 8-11 package insert 1-15
loading panels 8-18
controls, samples, diluents 2-2 creating 8-18
location of tube 2-39 deleting 8-20
Logging Off 5-3 editing 8-20
logs selecting 2-55
adjustment 2-40 parts
error 6-2 Instrument 1-3
M patient samples
labelling 2-2
maintenance 5-1 PAUSE 2-11
as needed 5-30 pipetting sequence 1-3
daily 2-12, 5-1 point-to-point method 3-2
monthly 5-19 power
weekly 5-16 loss 6-6
manual confirmatory testing I-1 power requirements G-1
HBsAg Positive Control I-1 priming
ordering positive control I-2 Sample and Reagent Probes 5-13
ordering tests I-1 Substrate Probe 5-16
reviewing results I-3 Water Probe 5-14
manual dilutions 2-52 principles of operation 1-2
master curve 1-31 printing
generation 3-1 chartable patient report 8-25
microsampling 2-5 worklists 2-57
modes 2-11 probe wash 1-16
PAUSE 2-11 checking and filling 5-9
RUN 2-11 disconnecting and reconnecting 5-8
STOP 2-12 probes
modifying

601005-0004 Rev. A
Operator’s Guide: Index 5

cleaning 5-5 reports 8-23

priming 5-13, 5-14, 5-16 representative
replacing 6-7 authorized B-1
product description 1-1 requirements
power G-1
Q
space G-2
qualitative controls 4-4 water G-2
Quality Control Management 4-11 resending results 2-64
quarterly maintenance 5-29 resetting
R load scale 8-11
racks restarting
assigning tests 2-55 computer 5-6
Random Access 8-11 system 7-5
ranges results
allergens 8-13 flags H-4
tests 8-12 reviewing 2-60
ratios searching for 2-62
calculating 3-8 WATERTEST 5-34
Reaction Tube Hopper, filling 5-6 reviewing
readjustment 3-6 control data 4-7
intercepts 3-6 kit information 2-31
slopes 3-6 LIS results 2-63
Reagent Probe results 2-60
checking dispense angle 5-19 routine maintenance 5-1
cleaning 5-5 as needed 5-30
priming 5-13 daily 2-12, 5-1
replacing 6-7 monthly 5-19
reagent wedges 1-11 weekly 5-16
Reagent Status window 2-13 RUN 2-11
replacement 2-15 running assays 2-37
status 2-12 S
reagents wedges Sample Probe
on board 2-41 cleaning 5-5
Reflexive Testing 8-14 priming 5-13
editing configurations 8-16 replacing 6-7
Reflexive Tests Sample Single Adjustor Assay Data (Complete)
deleting ranges 8-17 2-37
setting up 8-14 samples
replacing diluting 2-50
bead packs 2-21 labeling patients 2-2
CO2 Scrubber 5-29 loading 2-2
reagent and allergen wedges 2-15 status 2-37
sample and reagent probes 6-7 tube location 2-39

601005-0004 Rev. A
6 Operator’s Guide: Index

tube position 2-56 specifications E-1

tube sizes E-3 T
with barcodes 2-42
without barcodes 2-44 temperatures
saving requirements G-2
data 7-1 viewing 6-3
data to a CD or DVD 7-2 tests
scanning assigning to a rack 2-55
kit barcodes 1-14, 2-26 entry 2-53
searching ranges 8-12
help 1-29 reflexive 8-14
results 2-62 time remaining 2-38
sending results to LIS 2-64 time
service B-1, B-2 test time remaining 2-38
shutdown 7-5 time zone
Single Rule 4-12 setting 8-27
Single-Adjustor Assays 2-36 toolbar 1-20
software Touch Screen
overview 1-16 cleaning 5-30
toolbar 1-20 trackball
updating 8-28 cleaning 5-30
solid waste 5-11 troubleshooting
sound 8-27 assay troubleshooting guide 6-14
space requirements G-2 competitive assays 6-14
specifications controls post adjustment 6-15
computer E-2 Error Report screen 6-1
dilution volumes E-2 list of errors H-4
fluid usage E-1 pre-treated assays 6-15
output E-1 sandwich assays 6-14
system E-1 Tube Hopper 5-6
STATs tube location 2-39
ordering 2-45 tube position
status assigning 2-56
bead packs 2-19 tube sizes E-3
reagent and allergen wedges 2-12 two-point adjustment 1-31, 3-2
Reagent Status window 2-13 U
samples 2-37 units 8-21
STOP 2-12 updating the system 8-28
substrate 1-15 user entered order 8-11
checking and filling 5-10
Substrate Probe V
priming 5-16 validity
system adjustments 2-37, 3-3
components 1-3 verifiers

601005-0004 Rev. A
Operator’s Guide: Index 7

adding to worklist 2-49 importing 2-59

viewing management 2-57
adjustment log 2-40 modifying entries 2-58
allergens onboard 2-41 overview 2-41
beads and reagents onboard 2-41 printing 2-57
day error log 6-3
event log 6-2
Instrument temperatures 6-3
volume controls 8-27
W
waste chute clean out tool 6-9
Waste Containers
checking 5-11
liquid waste 5-12
solid waste 5-11
Waste Tube Cleaning 5-16, 5-17
Waste Tube cleaning
IMMULITE 2000 5-16
IMMULITE 2500 5-17
water
requirements G-2
Water Bottle
checking and filling 5-7
decontaminating 5-27
disconnecting and reconnecting 5-8
Water Probe
priming 5-14
Water System TestPM
Evaluating Results 5-24
IMMULITE 2000/2000 XPi 5-20
IMMULITE 2500 5-21
water tests
WATERTEST (IMMULITE 2000) 5-32
WATERTEST (IMMULITE 2500) 5-33
WATERTEST results 5-34
weekly maintenance 5-16
worklist
adding adjustors 2-46
adding patients 2-42
adding verifiers 2-49
deleting entries 2-58
display options 2-57
displaying 2-57

601005-0004 Rev. A
8 Operator’s Guide: Index

601005-0004 Rev. A