IMM English (Rev K)

IMMULITE® Automated Immunoassay System
Operator's Manual
April 2004
Document number: 600032
Revision K
Copyright © 1991-2004 by Diagnostic Products Corporation. ALL RIGHTS RESERVED.
This manual, and the software described in this manual, are copyrighted. No part of this manual or the described
software may be copied, reproduced, translated or reduced to any electronic medium or machine-readable form
without the prior written consent of Diagnostic Products Corporation except that you may make one copy of the
program CD solely for back-up purposes.
IMMULITE® is a registered trademark of Diagnostic Products Corporation.

All other products mentioned are trademarks of their respective companies.
Diagnostic Products Corporation

Certificate No: A3493
Table of Contents
SECTION 1: INTRODUCTION ..................................................................................................................... 1-1
ABOUT THIS MANUAL .......................................................................................................................................... 1-1
Conventions ..................................................................................................................................................... 1-1
IMMULITE® PRODUCT DESCRIPTION ................................................................................................................. 1-2
How it Works ................................................................................................................................................... 1-2
Test Process Overview..................................................................................................................................... 1-3
Instrument Diagrams....................................................................................................................................... 1-4
Kit Components ............................................................................................................................................... 1-7
Other Test Supplies........................................................................................................................................ 1-11
IMMULITE SOFTWARE OVERVIEW .................................................................................................................. 1-13
Primary Screen .............................................................................................................................................. 1-14
OUTPUT SPECIFICATIONS.................................................................................................................................... 1-16
TECHNICAL ASSISTANCE .................................................................................................................................... 1-17
Placing an Order........................................................................................................................................... 1-17
SECTION 2: INSTALLATION PREPARATIONS ...................................................................................... 2-1
UPON RECEIPT OF THE SYSTEM ............................................................................................................................ 2-1
CHOOSING A LOCATION........................................................................................................................................ 2-1
Power Requirements........................................................................................................................................ 2-1
Space Requirements......................................................................................................................................... 2-2
Temperature .................................................................................................................................................... 2-2
Environmental Specifications .......................................................................................................................... 2-2
Water Requirements ........................................................................................................................................ 2-3
SECTION 3: UPDATING AND CONFIGURING THE SOFTWARE....................................................... 3-1
UPDATING THE SOFTWARE ................................................................................................................................... 3-1
CONFIGURING THE SOFTWARE ............................................................................................................................. 3-1
Setting the Facility Name ................................................................................................................................ 3-2
Changing the Assay Settings............................................................................................................................ 3-3
Changing the Long Report Format ................................................................................................................. 3-5
Selecting a Printer ......................................................................................................................................... 3-10
Changing the Auto-Backup Default............................................................................................................... 3-10
Setting the LIS Parameters ............................................................................................................................ 3-11
SECTION 4: ROUTINE OPERATION ......................................................................................................... 4-1
INTRODUCTION ..................................................................................................................................................... 4-1
DAILY START-UP PROCEDURE .............................................................................................................................. 4-2
Preparing Reagents ......................................................................................................................................... 4-2
Initializing the Software................................................................................................................................... 4-2
Perform Daily Maintenance ............................................................................................................................ 4-5
Loading Reagents .......................................................................................................................................... 4-13
RUNNING ASSAYS .............................................................................................................................................. 4-18
Loading a Sample .......................................................................................................................................... 4-18
Removing Sample Cup Holders..................................................................................................................... 4-18
Performing a STAT Procedure ...................................................................................................................... 4-19
RUNNING ADJUSTORS......................................................................................................................................... 4-20
Adjustment Procedure ................................................................................................................................... 4-20
RUNNING CONTROLS .......................................................................................................................................... 4-26
Identifying Controls....................................................................................................................................... 4-26
Running the Controls..................................................................................................................................... 4-27
RUNNING CALIBRATION VERIFIERS .................................................................................................................... 4-31
PRINTING ............................................................................................................................................................ 4-32
IMMULITE Operator’s Manual 600032-K i

ADDING OR CHANGING REAGENTS ..................................................................................................................... 4-33
AUTOMATIC PAUSE AND STOP............................................................................................................................ 4-34
AutoPAUSE Mode ......................................................................................................................................... 4-34
AutoSTOP Mode............................................................................................................................................ 4-34
DAILY SHUTDOWN ............................................................................................................................................. 4-35
Stopping the Instrument................................................................................................................................. 4-35
Logging Off the System.................................................................................................................................. 4-36
Backing up the System ................................................................................................................................... 4-36
Cleaning the Probe........................................................................................................................................ 4-38
Removing and Emptying Test Supplies.......................................................................................................... 4-39
QUALITY CONTROL ............................................................................................................................................ 4-40
Control Results .............................................................................................................................................. 4-40
Patient Results ............................................................................................................................................... 4-46
SECTION 5: THE MAIN MENU.................................................................................................................... 5-1
OVERVIEW............................................................................................................................................................ 5-1
DATA ENTRY ........................................................................................................................................................ 5-3
Worklist Entry.................................................................................................................................................. 5-4
Patient Entry.................................................................................................................................................... 5-8
Kit Entry ........................................................................................................................................................ 5-10
Control Entry................................................................................................................................................. 5-12
LIS ................................................................................................................................................................. 5-15
System Status ................................................................................................................................................. 5-18
Reagent Status ............................................................................................................................................... 5-19
Temps/Dark Counts ....................................................................................................................................... 5-19
Select Reports ................................................................................................................................................ 5-20
View Error Log.............................................................................................................................................. 5-28
HISTORY REVIEW ............................................................................................................................................... 5-30
Patient Review ............................................................................................................................................... 5-31
Adjustor Review............................................................................................................................................. 5-33
Review Controls............................................................................................................................................. 5-34
LOG OFF ............................................................................................................................................................. 5-35
SECTION 6: ROUTINE MAINTENANCE ................................................................................................... 6-1
INTRODUCTION ..................................................................................................................................................... 6-1
DAILY MAINTENANCE .......................................................................................................................................... 6-2
WEEKLY MAINTENANCE ...................................................................................................................................... 6-7
Cleaning Water Bottle ..................................................................................................................................... 6-7
MONTHLY MAINTENANCE .................................................................................................................................... 6-8
Cleaning Probe Wash Bottle ........................................................................................................................... 6-8
Replacing End-of-Line Filters ......................................................................................................................... 6-8
Cleaning Load Platform, Sample Collection Tray, and Sample Pipetting Area ............................................. 6-8
Replacing the Substrate Spike ......................................................................................................................... 6-9
Changing the Small Syringe Tip.................................................................................................................... 6-11
Testing the Water Supply............................................................................................................................... 6-12
System ............................................................................................................................................................ 6-18
Decontamination ........................................................................................................................................... 6-18
SEMI-ANNUAL MAINTENANCE............................................................................................................................ 6-21
Changing the Large Syringe Tip ................................................................................................................... 6-21
AS NEEDED MAINTENANCE................................................................................................................................ 6-23
Cleaning Barcode Drive Wheel O-ring ......................................................................................................... 6-23
Changing the Pipetting Probe ....................................................................................................................... 6-24
Replacing Fuses............................................................................................................................................. 6-25
ii 600032-K IMMULITE Operator’s Manual

SECTION 7: DIAGNOSTICS ......................................................................................................................... 7-1
INTRODUCTION ..................................................................................................................................................... 7-1
RUNNING DIAGNOSTIC PROGRAMS ...................................................................................................................... 7-2
Running GETDATAT....................................................................................................................................... 7-4
Running PC ..................................................................................................................................................... 7-4
DIAGNOSTIC PROGRAMS ...................................................................................................................................... 7-5
SECTION 8: DATA REDUCTION AND THE CHEMILUMINESCENT REACTION........................... 8-1
INTRODUCTION ..................................................................................................................................................... 8-1
INTERNAL CALCULATIONS ................................................................................................................................... 8-1
MASTER CURVE GENERATION / TWO-POINT ADJUSTMENT .................................................................................. 8-3
Calibration Overview ...................................................................................................................................... 8-3
Master Curve Generation................................................................................................................................ 8-3
Two-Point Adjustment ..................................................................................................................................... 8-4
Judging Adjustment Validity............................................................................................................................ 8-6
Summary ........................................................................................................................................................ 8-12
Readjustment ................................................................................................................................................. 8-13
MASTER CUTOFF GENERATION FOR QUALITATIVE ASSAYS ............................................................................... 8-13
Measuring the Cutoff for an Assay ................................................................................................................ 8-13
THE CHEMILUMINESCENT REACTION ................................................................................................................. 8-15
SECTION 9: ASSAY TYPES .......................................................................................................................... 9-1
INTRODUCTION ..................................................................................................................................................... 9-1
ASSAY TYPE TABLE ............................................................................................................................................. 9-1
SECTION 10: THE ON-LINE TUTORIAL............................................................................................... 10-1
INTRODUCTION ................................................................................................................................................... 10-1
USING THE TUTORIAL ......................................................................................................................................... 10-2
Starting the Tutorial ...................................................................................................................................... 10-2
Navigating ..................................................................................................................................................... 10-2
Exiting the Tutorial........................................................................................................................................ 10-2
TUTORIAL MAIN MENU ...................................................................................................................................... 10-3
Instrument...................................................................................................................................................... 10-3
Software......................................................................................................................................................... 10-3
Chemistry....................................................................................................................................................... 10-4
Checklist ........................................................................................................................................................ 10-4
Index .............................................................................................................................................................. 10-4
Exit................................................................................................................................................................. 10-4
SECTION 11: TROUBLESHOOTING ...................................................................................................... 11-1
OVERVIEW.......................................................................................................................................................... 11-1
PROBLEMS / SOLUTIONS ..................................................................................................................................... 11-2
Instrument Problems ..................................................................................................................................... 11-2
Result Problems............................................................................................................................................. 11-5
Imprecision Problems.................................................................................................................................... 11-7
Miscellaneous Problems.............................................................................................................................. 11-11
ERROR MESSAGE / SOLUTION TABLE ............................................................................................................... 11-12
FIXING OR RESTORING A DATABASE ................................................................................................................ 11-40
Running FIXIT............................................................................................................................................. 11-40
Restoring a Lost or Damaged Database ..................................................................................................... 11-40
APPENDIX A : SYSTEM SPECIFICATION TABLES............................................................................... A-1
IMMULITE Operator’s Manual 600032-K iii

APPENDIX B : IMMULITE PACKAGE CONTENTS ................................................................................B-1
Package Contents ............................................................................................................................................B-1
APPENDIX C : INSTALLATION PREPARATIONS ................................................................................. C-1
OVERVIEW............................................................................................................................................................C-1
Choosing a Location........................................................................................................................................C-1
Power Requirements........................................................................................................................................C-1
Space Requirements.........................................................................................................................................C-2
Temperature ....................................................................................................................................................C-2
Environmental Specifications ..........................................................................................................................C-2
Water Quality Specifications ...........................................................................................................................C-2
APPENDIX D : OPERATIONAL PRECAUTIONS..................................................................................... D-1
APPENDIX E : IN VITRO DIAGNOSTIC SYMBOLS................................................................................E-1
APPENDIX F : QUICK CARD AND WORKSHEETS ................................................................................F-1
iv 600032-K IMMULITE Operator’s Manual

Section 1: Introduction
About this The IMMULITE® Operator’s Manual describes the operation of the
Manual IMMULITE system and its software. It is a reference guide that includes an
overview of the IMMULITE system, installation, and configuration
instructions, and complete operating, maintenance, and troubleshooting
procedures.
Conventions The following conventions are used throughout this manual.
Item Convention Used

Messages on the instrument Courier font
Display Panel For example:
DPC IMMULITE IDLE
System messages (on the Courier font
monitor)
Computer keyboard keys Bold and within brackets
For example:
Press [Enter].
IMMULITE System buttons Uppercase and bold
For example:
Press the GO button.
Anything the operator must Courier font
type For example:
Type “b: install”
Menu options Bold
For example:
. . . choose Data Entry
Field names Bold
List of items Box-bullet
List involving a choice Box-bullet filled
Equations Courier font
For example:
Slope = 1.219
IMMULITE Operator’s Manual 600032-K 1-1

IMMULITE® The IMMULITE Automated Immunoassay System is a continuous, random
Product access instrument that performs automated chemiluminescent
Description immunoassays.
How it Works The IMMULITE System utilizes assay-specific, antibody, or antigen-coated

plastic beads as the solid phase, alkaline phosphatase-labeled reagent, and a
chemiluminescent substrate. The coated bead is housed in a proprietary
plastic device, namely a Test Unit. This Test Unit serves as the reaction
vessel for the immune reaction, the incubation and washing processes, and
the signal development.
The IMMULITE System automates the entire assay process. After
incubating the bead with the sample and the alkaline phosphatase reagent, the
reaction mixture is separated from the bead by spinning the Test Unit at high
speed on its vertical axis. The entire fluid contents (the sample, excess
reagent, and wash solution) are transferred to a coaxial waste chamber in the
Test Unit. The bead is left with no residual, unbound label. The bound label
is then quantitated with a dioxetane substrate that produces light. Light
emission is measured by a photomultiplier tube (PMT) and the results are
calculated for each sample. Printed reports for each sample are generated by
the system's computer. The IMMULITE test process is outlined in Figure 1
and explained further in the next section.
The IMMULITE has two operating modes: Standard and Turbo. The Turbo
mode essentially operates the same as the Standard mode, except the time to
first result is faster. This allows for true “STAT” functionality for urgent
situations such as cardiac markers or pregnancy detection. This manual
covers both modes of operation concurrently since they are identical, other
than speed.
Note: Different assay kits are required for each mode. Standard (Non-Turbo)
kits cannot be run while in Turbo mode and Turbo kits cannot be run while
in Standard (Non-Turbo) mode.
1-2 600032-K IMMULITE Operator’s Manual

Figure 1
IMMULITE Test Unit and Test Process
Test Process The steps below provide an overview of the testing process. The operator
Overview interface is very simple (steps 1-3). For systematic operational instructions,
see Section 4: Routine Operation.
1. The operator loads the samples in barcoded sample cup holders and
places them onto a Load Platform (see Figure 3).
Note: The materials needed to operate the IMMULITE are included in

the IMMULITE Test Kits. For more information, see Kit Components
in Section 1: Introduction.
2. The operator then loads up to five barcoded Test Units after each sample,
in any order, for the tests desired on that sample (see Figure 3).
Note: Additional samples and Test Units can be added at any time, and
STATs can be placed at the beginning of the Load Platform.

3. The operator presses GO (on the IMMULITE Display Panel) and the
Test Units are conveyed into the System for barcode identification and
then moved onto the Main Incubation Carousel.
4. The pipettor adds sample and alkaline phosphatase-labeled reagent.
(The Reagent Carousel accommodates up to twelve resident assays.) A
non-labeled material is added to sequential assays during this cycle.
Note: Reagent changes can be made during instrument operation by

pressing the PAUSE button that stops the Load Chain and the pipettor.
Normal operation resumes when the GO button is pressed.
5. Depending on the assay type, the Test Units are incubated on the Main
Carousel at 37ºC for either 30 or 60 minutes (either 8 or 16 minutes in
Turbo mode).
6. The Test Units are shuttled to the spin/wash station, where bound and
free label are separated.
7. Substrate is added and the Test Units are transferred to the Luminometer
Chain.
8. A 10-minute incubation (6-minute incubation in Turbo mode) at 37ºC
begins, that causes the signal to reach maximum limits.
9. The photon counts are measured with a photomultiplier tube (PMT).
With respect to the photon counts, IMMULITE employs the following
principles:
Automatic filtration (attenuation) of the light signal increases the
dynamic range of the measuring system 100-fold, enabling accurate
measurements at both extremely high and extremely low
concentrations.
Counts per second (cps) are converted to analyte concentrations
(doses) using stored master curves.
Instrument A diagram of the IMMULITE Display Panel is shown in Figure 2. Figures 3

Diagrams and 4 are diagrams of an overhead and side view of the IMMULITE System.
The Display Panel (located on the front of the instrument) displays
IMMULITE instructions and error messages. There are three buttons on the
Display Panel (ALARM MUTE, PAUSE, and GO) that are referred to
throughout this manual.

Figure 2
IMMULITE Display Panel
ALARM PA U S E RUN
The IMMULITE Display Panel buttons are explained in the table below:
Button Function
ALARM MUTE Silences the audible alarm.
PAUSE Temporarily stops pipetting and Load Chain
movements only.
Shuts down the IMMULITE when pressed repeatedly.
Note: Using PAUSE to shut down the instrument
ensures all parts are in the home position.
GO Activates the initialization (start-up) procedure and the
accompanying instructional messages appearing on the
Display Panel.
Also activates a reading of the Reagent Wedge
barcodes if the instrument is in pause mode when GO
is pressed.

Figure 3
IMMULITE System

Figure 4
IMMULITE System Side View
Kit The IMMULITE Test Kit includes the materials needed to run assays. The
Components components in a kit are listed and described below:
Barcoded Reagent Wedge
Barcoded Test Units
Adjustors
Package insert
Important notices
Barcode information

Barcoded Reagent Wedge
A barcoded Reagent Wedge contains an assay-specific enzyme conjugate. A
Reagent Wedge (both top and back views) are shown below:
Barcoded Test Units

Barcoded Test Units contain assay-specific, plastic beads. The Test Unit
serves as a reaction vessel where the immune reaction, incubation, wash, and
signal development processes occur. A diagram of a Test Unit is shown
below:
Adjustors
For most assays, the Adjustor includes two vials, designated LOW and HIGH
that contain different concentrations of analyte. The Adjustor can be in
either liquid or lyophilized form. For more information regarding Adjustors,
see the package insert.

Package Insert
The package insert contains specific information regarding the assay. An
illustration of a package insert is shown below:

Important Notices
Important notices include information the operator should read before using
the kit. A sample appears below:
Barcode Information
Barcode information (shown below) is located on the inside flap of each kit.
The kit lot number and component lot numbers are printed on the side of the
box.

Other Test Other test supplies needed to run the IMMULITE include:
Supplies
Chemiluminescent Substrate
Probe Wash
Sample Cups
Barcoded Sample Cup Holders
These items can be found in separate packages that are described on the next
page:
Chemiluminescent Substrate Module
The Chemiluminescent Substrate Module (catalog # LSUBX) includes two
bottles of Chemiluminescent Substrate (shown below). Before use, store the
substrate between 2 and 8° C. The substrate can remain on the instrument for
up to 30 days.
Note: Each bottle of Chemiluminescent Substrate contains enough material

for five hundred tests.

Probe Wash Module
The Probe Wash Module (catalog # LPWS2) contains two bottles of Probe
Wash Concentrate (shown below) that should be stored at room temperature
and out of direct sunlight. Before using, each 100mL bottle must be diluted
with 900 mL of distilled water.

IMMULITE For an overview of the IMMULITE software, refer to the table below that
Software briefly describes each of the Start-up menu options.
Overview
Option Description
RUN IMMULITE Downloads the IMMULITE operating software
from the computer to the instrument.
Accesses the Primary Screen that enables the
operator to observe graphically, the current location
of the Test Units.
START TURBO Downloads the TURBO operating software from
the computer to the instrument.
Accesses the Primary Screen that enables the
operator to observe graphically, the current location
of the Test Units.
QUALITY Allows the operator to view statistical data on a group
CONTROL of controls over a period of time. This data is in the
form of a Levy-Jennings plot/graph or in a printed log.
CONFIGURATIONS Includes menu options that allow the operator to:
personalize the header for the software screens
change the assay settings for the reference range
and the units of measure
modify the long report printout
select an alternate printer
turn automatic backup on or off
DIAGNOSTICS Programs used to troubleshoot instrument problems and
perform routine and special maintenance procedures.
BACKUP/RESTORE Allows the operator to back-up all patient, and adjustor
results generated in the past 31 days and quality control
data from the last six months.
LIS PARAMS Allows the operator to configure LIS (Laboratory
Information System) parameters.
TUTORIAL Provides access to an on-line tutorial.
EXIT TO DOS Provides easy access to the DOS command line.

Primary Screen The Primary Screen (Figure 5) provides the operator with an overview of the
system status. The Primary Screen Table describes the items shown on the
Primary Screen.
Note: This screen also provides access to the four menu items (listed across
the top). For complete descriptions of these menu items see Section 5: The
Main Menu.
Figure 5
Primary Screen (Standard and Turbo)

Primary Screen Table
Item Description
Reagent Shows a color-coded representation of the reagents available in the Reagent
Carousel Carousel.
The colored circles correspond to the assay's color code, shown in the
REAGENT STATUS display, and the position number on the carousel (1 to
12).
Reagent Status Identifies assays in the Reagent Carousel by color and Test Code.
The number to the left of the Test Code is the number of tests remaining in
that Reagent Wedge. This number will appear after the reagent is accessed
for the first time, and represents an estimate, accurate within about four tests.
Level sensing occurs each time the reagent is pipetted.
The number to the right of the Test Code is the position of the Reagent
Wedge on the carousel.
The letter to the far right (A, B, or C) represents the reagent component.
(See Sequential Assays in the Assay Type Table in Section 9: Assay Types
for more information.)
If any Reagent Wedges are low or empty, a message identifying these
wedges appears under REAGENT STATUS.
Load Chain Colored circles on the Main Carousel represent sample cups and Test Units that
and Main were read by the Barcode Reader.
Carousel
Yellow, numbered circles represent sample cups.
Colored circles following a sample cup identify the assays to be performed
on that specimen.
Colored circles surrounded by a white ring or halo indicate multiple
incubations are required.
Note: If a white ring is not present, the assay is on its last incubation cycle.
Test Unit colors correspond to the Test Codes shown in the Reagent
Carousel.
Note: Solid white circles indicate an error condition pertaining to that Test
Unit. Test Units with mismatched lot numbers or Test Units that were short-
sampled, as well as Test Units with bad barcode reads, appear as white
circles on the Primary screen.
The sample cup holder number appears on the corresponding colored circle
after sample is pipetted.

Item Description
Time-to-result The indicators that are displayed in three positions around the main Incubation
indicators Carousel show when results will be available for the Test Units adjacent to the
indicator.
30/60 indicates the wait time before results – either 30 minutes, for a one-
cycle assay, or 60 minutes, for a two-cycle assay.
A two-cycle assay has a wait time of 60 minutes when it passes this indicator
in the first cycle. At this time, the Test Unit is shown as a colored circle
surrounded by a white ring. At the beginning of the second cycle, the white
ring disappears.
Note: Turbo mode incubation periods are considerably less than the Standard
mode example shown above.
Results Box Shows results as the Test Units are read in the Luminometer.
Results are identified by sample cup holder number and Test Code.
As processing for each sample cup is completed, all results for the sample
are printed.
Output The table below shows the expected output from the IMMULITE System.
Specifications (For a list of all system specifications, see Appendix A: System
Specification Tables.)
Standard Mode:
Item Specification
Throughput Up to 120 tests per hour
Time to First Result 42 minutes for a one-cycle assay or 72 minutes
for a two-cycle assay
Tests per Sample Up to 5 Test Units per sample cup
Turbo Mode:
Item Specification
Time to First Result <15 minutes for a one-cycle assay or
<22 minutes for a two-cycle assay

Technical For technical questions concerning the IMMULITE System, call DPC Cirrus
Assistance DPC Technical Service at the telephone number below:
Note: If you are located outside the United States, contact your National
Distributor.
DPC Instrument Systems Division

62 Flanders-Bartley Road
Flanders, NJ 07836-4715
Tel: (800) 372-1782 or (973) 927-2828
Fax: (973) 927-4101
Placing an To place an order, call DPC or your distributor. DPC’s address and
Order telephone number is listed below:
Diagnostic Products Corporation

5700 West 96th Street
Los Angeles, CA 90045-5597
Tel: (800) 372-1782
Fax: (800) 234-4372

Section 2: Installation Preparations
Upon Upon receipt of the IMMULITE System and the desktop computer, inspect
Receipt of the shipping container. If there is any external damage to the container,
the System notify your shipping department and contact DPC Technical Service.
Choosing a Choose a suitable location for the IMMULITE System in the laboratory,
Location based on the system requirements. The requirements to consider when
choosing a location are listed and described below:
Power
Space
Environmental
Temperature
Power Keep the following power requirements in mind when choosing a location
Requirements for the system:
The power consumption during operation is 700 W for 120 VAC
instruments and 800 W for 220 VAC instruments.
Use a dedicated, grounded power supply line for the IMMULITE System,
printer, and computer.
Each instrument is set at the factory to run on 100 VAC, 110 VAC, 220
VAC, or 240 VAC. The orange label near the power supply (on the right
side of the instrument) shows the required voltage.
Note: The frequency can be either 50 or 60 Hz.
We recommend the use of an uninterruptible power supply or line

conditioner, which is available through DPC. To order this item, contact
your DPC representative.
CAUTION: Do not place the system near centrifuges, ultrasound or X-ray

machinery, NMR scanners, or other sources of magnetic fields.

British Thermal The heat output of the IMMULITE is 920 BTUs/hour .
Unit (BTU)
Specifications
Space Keep the following space requirements in mind when choosing a location
The System must be placed on a level surface.
The instrument requires 100 inches (254 cm) of bench space to
accommodate the IMMULITE, computer, and printer.
The bench depth must be at least 21 inches (54 cm).
Any overhead cabinets must be at least 22 inches (56 cm) above the
bench.
The computer can be installed on either side of the IMMULITE System;
however, placing it on the right side is recommended. This will facilitate
easy access to the computer while loading samples.
Temperature Keep the following temperature requirements in mind when choosing a

location for the system:
Ambient temperature should be between 18º and 30º C.
The relative humidity should be 20% - 80% with no condensation.
CAUTION: The System should not be placed in direct sunlight or in front

of an air conditioning vent, heat vent, or heat-producing equipment.
Environmental The equipment is designed for safe use under the following conditions:
Specifications
Indoor usage
Altitude up to 2,000 meters
Main supply voltage does not exceed +/- 10% of the nominal voltage
Transient overvoltages according to Installation Category II
Pollution Degree 2 in accordance with IEC Standard 664

Water Distilled water of consistent quality is required. Water used should meet
Requirements NCCLS Type 1 reagent water standards at time of preparation. Prior to
using the water, it must be tested for alkaline phosphatase contamination.
The DPC representative will check the water source before using with
the IMMULITE. For complete instructions, see Testing the Water
Supply in Section 6: Routine Maintenance.

Section 3: Updating and Configuring the Software
Updating the The system will arrive with the latest version of the IMMULITE software
Software installed. Diskettes containing software updates or new releases are sent out
periodically. To install new software, follow the instructions accompanying
the diskettes.
Configuring This section includes instructions for performing the following software
the Software configuration processes:
Setting the facility name
Changing the assay settings
Changing the long report format
Selecting a printer
Changing the default for automatic backup
Setting the Laboratory Information System (LIS) parameters
Every procedure except Setting the LIS Parameters, involves accessing the
Configurations menu from the Start-up menu. Turning the computer on
accesses the Start-up menu.
Figure 6
Start-up Menu

Use the arrow keys to select CONFIGURATIONS and press [Enter]. The
following screen appears:
Figure 7
Configurations Menu
Setting the Follow the steps below to set the facility name.
Facility Name
1. From the Configurations menu, select CHANGE NAME and press
[Enter].
The following screen appears:
Figure 8

2. Type the facility name and press [Enter].
The name of the facility appears at the top of the next screen.
Figure 9
3. At the prompt, either:

Confirm that the name is correct by pressing [Y] (for yes)
Or
If the facility name is incorrect, press [N] (for no) and re-enter the
correct name
Changing the Follow the steps below to change the assay settings:
Assay Settings
1. From the Configurations menu, select ASSAY SETTINGS and press
[Enter].
Figure 10
2. Type the desired Test Code (for example, T4) and press [Enter].
The current unit of measure for reporting is displayed, along with the
default units and alternate units.

Figure 11
3. Use the right and left arrow keys to select either the default units or the
alternate units and press [Enter].
The following screen now appears, with the current Low Result Limit
and High Result Limit displayed in the top row.
Note: Results are flagged according to the ranges listed in the top row
only.
Figure 12

4. Change the values in the top row as desired. Add up to six additional
ranges in the remaining rows if the long report format is used.
Notes: Values must be entered in the units identified in the previous

step.
The Low and High Result Limits from the first row are used only to
flag results on the printout (regardless of the report format) and may be
edited at any time. These two values would typically represent the
lower and upper limits of the reportable range established for the assay.
5. Press [Esc] to exit.

The following prompt appears:
SAVE CHANGES? Y/N
6. Press [Y] to save.
Changing the The long report format and its content can be changed.
Long Report
Format
Note: Changes to the report format affect only the printed version of the
long report. Changes do not affect the information on the corresponding
screens (the Patient Entry and Patient History screens).
Long report modification processes include:

Entering new text
Modifying or moving existing text fields
Repositioning or deleting the selected text fields
Entering and positioning expected ranges
Entering New Text

The operator can enter text anywhere outside existing fields on the Report
Format screen. The text will appear on the printout exactly as it is shown on
the screen.
Examples of text that may be added include:
An expanded address
Telephone and fax numbers in the heading
To enter new text:
1. From the Start-up menu, select CONFIGURATIONS (using the arrow

keys).
2. Select REPORT FORMAT and press [Enter].
The Report Format Screen appears (see Figure 13).
3. Move the cursor to the desired position on the screen (using the arrow
keys, [Page Up], or [Page Down]).
4. Type the new text.
5. Save the changes by pressing the [Alt] and [S] keys simultaneously.
Note: To print a copy of the newly configured report, press [F10].
Figure 13
Report Format Screen
Note: The keys listed at the bottom of the screen provide additional
functions (as indicated).

Modifying Existing Text
Following the steps below can modify text fields that are not highlighted on
the Report Format Screen:
Note: Highlighted fields have an alternate background color.
1. From the Start-up menu, select CONFIGURATIONS and press

[Enter].
2. Select REPORT FORMAT and press [Enter] (see Figure 7).
3. Use the arrow keys, [Page Up], or [Page Down] to position the cursor in
the desired field.
4. Press the [Delete] key until all the characters in the field are deleted.
5. Type the new text.
6. Save the changes by pressing [Alt] and [S] simultaneously.
Notes: Change the report header, Your Town Hospital, to correspond

to the facility name entered on page 3-2, Setting the Facility Name.
(The maximum number of characters in this field is 32.)
To print a copy of the newly configured report, press [F10].
Moving Existing Text
Note: Highlighted fields have an alternate background color.
Text fields that are not highlighted on the Report Format Screen can be
moved to a new location by following the steps below:
[Enter].
3. Use the arrow keys to position the cursor on the first letter in the desired
field.
4. Press [Enter].
The field is highlighted, to indicate it can now be moved.
5. Use the arrow keys to move the field to a new location and press
[Enter].
6. Save the changes by pressing [Alt] and [S] simultaneously.

Moving Highlighted (Blue) Text Fields

Following the steps below can move text fields that are highlighted in blue
on the Report Format Screen:
Note: Information in the highlighted fields cannot be modified.

[Enter].
3. Use the arrow keys to position the cursor on the desired field and press
[Enter].
The field turns green, indicating it can now be moved.
4. Use the arrow keys to move the field to the new location and press
[Enter].
5. When all the modifications are complete, save the changes by pressing
[Alt] and [S] simultaneously.
Deleting Highlighted (Blue) Text Fields

Text fields that are highlighted (in blue) on the Report Format Screen can be
deleted by following the steps below:
[Enter].
3. Position the cursor in the desired field and press the [Delete] key.
Note: Press the [Alt] and [U] keys to undelete the deleted field.
4. If there are no more modifications, save the changes by pressing [Alt]

and [S] simultaneously.
Entering Expected Ranges

The long report can be configured to print up to seven ranges for each test

(per report). Follow the steps below to enter expected ranges:
1. From the Start-up menu, select CONFIGURATIONS.
2. Select ASSAY SETTINGS and press [Enter] (see Figure 7).
3. Type the desired Test Code and press [Enter].
4. Choose either default or alternate units and press [Enter] (see Figure
11).
5. Enter up to seven expected ranges for the assay chosen, pressing [Enter]
after each entry.
These ranges will appear on the printed long report.
Note: Results are flagged as High or Low according to the expected

ranges entered on the first line only.
6. To exit, press [Esc].

7. Press [Y] to save the changes or [N] to delete the changes.
Positioning Expected Ranges

The expected ranges can be moved on the long report by following the steps
below:
3. Press [Page Down].
4. Put the cursor in the Range.Type1 field and press [Enter].
Note: Range.Type1 represents the expected ranges for T-1 (test

result 1). Up to seven ranges can be entered and printed for this test.
There can be up to five test results per sample, and each test result can
have up to seven ranges printed on the long report.
5. Using the arrow keys, move the field to the new position and press
[Enter].
6. Continue moving fields in this manner.

7. If there are no more modifications, save the changes by pressing [Alt]
and [S] simultaneously.
Selecting a Follow the steps below to select a printer:

Printer
2. Choose SELECT PRINTER and press [Enter].
Figure 14
Printer Selection Screen
3. Type the appropriate selection number and press [Enter].

The Citizen 200GX (or Swift 9), the Citizen GSX-190, the Panasonic
P2180, and the Epson LX-810 (or LX-850) are fully supported by the
software.
If the desired printer is not shown, or is not compatible with one of
the printers listed, select OTHER.
IMPORTANT: The printer must be configured to print graphics. Printers

shipped as part of the IMMULITE System are properly configured. For all
others, consult the printer operating manual to configure the graphics mode.
Changing the Auto-Backup automatically makes a copy of the IMMULITE database on

Auto-Backup the computer’s hard drive every day. This feature provides extra protection
Default in the event of a system crash.

Follow the instructions below to change the Auto-Backup default:
2. Select BACKUP ON/OFF and press [Enter].
3. Use the right or left arrow keys to select Auto-Backup On or
Auto-Backup Off and press [Enter].
Note: Auto-Backup is not the same as Backup. The Backup procedure, that
is not automatic, removes old data and copies information to a diskette.
It is suggested that the Auto-Backup On selection remain enabled.
Setting the LIS If the IMMULITE System is connected to a Laboratory Information System
Parameters (LIS), set the LIS parameters so the LIS can communicate with the
IMMULITE. Before proceeding with the instructions below, determine the
type of LIS communication interface used. Refer to the table below for a
description of each interface.
LIS Communication Description

Interface
Uni-Directional Allows the IMMULITE to send results one-way to
the host LIS computer.
Bi-Directional Allows two-way communication from the
IMMULITE to the host LIS computer and from the
host LIS computer to the IMMULITE. Records are
typically sent to the IMMULITE from the LIS in a
batch.
Bi-Directional Host Allows two-way communication from the
Query IMMULITE to the host LIS computer and from the
host LIS computer to the IMMULITE. A request for
individual patient data is sent to the LIS from the
IMMULITE when the accession number is entered
on the IMMULITE.
To set the LIS parameters, follow the instructions below:

1. From the Start-up menu, select LIS PARAMS and press [Enter].

2. Type connect and press [Enter].
The LIS Parameters Screen appears.
Figure 15
LIS Parameters Screen
3. In the Activate the LIS feature? field, type Y (for yes).

4. In the Activate Host Query field, type:
Y if the lab has Bi-Directional Host Query communications
N if the lab does not have Bi-Directional Host Query
communications
5. In the Activate Uni Directional Mode field, type:
Y if the lab has Uni-Directional communications
N if the lab has Bi-Directional communications
Note: The information requested in the next four steps (regarding

Header Message Password, Receiver ID, Sender ID, and Baud Rate)
must be supplied by the LIS provider, not DPC/Cirrus.
6. In the Enter Header Message Password field, type the Header Message
Password used by the LIS. If the LIS does not use a Header Message
Password, leave this field blank.
7. In the Enter Receiver ID field, type the LIS Sender ID.
8. In the Enter Sender ID field, type the LIS Receiver ID.

9. In the Enter Baud Rate field, type the baud rate (speed of the line
transmission) provided by the LIS.
Note: Acceptable entries include 1200, 2400, 4800, or 9600.
10. Press [Esc].

Would you like to save the changes? Y/N
11. Press [Y] to save the changes or [N] to delete the changes.

Section 4: Routine Operation
Introduction Routine operation is organized into the following processes:

Daily start-up
Running assays
Running Adjustors
Running controls
Running calibration verifiers
Printing
Adding or changing reagents
Automatic pause and stop
Daily shutdown
Quality Control

Daily The daily start-up procedure includes the following steps:
Start-up
Procedure
1. Prepare the reagents.
2. Initialize the IMMULITE software.
3. Perform daily maintenance.
4. Load the reagents.
The pages that follow include step-by-step instructions for each of these
procedures.
Preparing Follow the steps below to prepare reagents for use in the IMMULITE
Reagents System.
1. Remove the kits from the refrigerator. To assure optimal performance,
avoid mixing reagents together.
2. Allow the Test Units to reach room temperature.
CAUTION: Do not open the Test Unit packages until they reach room
temperature. Moisture caused by condensation can compromise the
stability of the Test Units. The Test Units are supplied in re-sealable
bags containing desiccant to maintain the bead quality for the next use.
Seal the bags securely after each use.
3. Reconstitute lyophilized materials, as needed, following the instructions

on the package inserts.
Initializing the Leave the System power on at all times, so it is always at operating
Software temperature and ready to use. Initialize the IMMULITE software following
the steps below:
1. Ensure the IMMULITE System power is on.
IMPORTANT: The IMMULITE Display Panel must show the

following message before proceeding with next step.
DPC IMMULITE IDLE
Select RUN IMMULITE to begin.
If any other message appears, press ALARM MUTE and GO (on the
IMMULITE) simultaneously to put the IMMULITE in idle.
Also, the Reagent Carousel tray must be in place.

2. Turn on the power to the computer, monitor, and printer.
The Start-up menu appears.
Figure 16
Start-up Menu
3. Make sure the printer is on-line by checking the ON LINE light on the
printer control panel. If necessary, press the ON LINE button.
4. Make sure there is enough paper in the printer.
CAUTION: PC Communication errors can occur when the printer runs

out of paper.
5. From the Start-up menu, select RUN IMMULITE or START TURBO

and press [Enter].
The system indicates that communication with the IMMULITE has been
established, and begins to download the software.
Note: If EXIT TO DOS is accidentally selected, type start and

press [Enter] at the DOS prompt.

6. At the prompt which reads:
Turn on Report Printing? (Y/N)
Press [Y] (for yes) or [N] (for no).
Note: Do not press [Enter] after pressing [Y] or [N]. If [Enter] is

accidentally pressed, the system defaults to No Reports. The report
printing option can be turned on later by choosing System Status and
Select Reports from the Primary Screen.
If [Y] is selected. . . If [N] is selected. . .

Results will be printed as the Results will be stored on the computer
tests for each sample cup are until a printout is requested.
measured in the Luminometer.
Skip to step 8.
Note: In either case, the printer must be online.

<S>hort or <L>ong Reports?
Select either [S] or [L]. (Do not press [Enter].)
A short report includes several results printed per page. A long report
includes the results of just one sample cup per page. (For detailed
information regarding each report format, see Select Reports in Section
5: The Main Menu.)
Note: If [Enter] is accidentally pressed (instead of [S] or [L]), the

software will default to the long report format. This can be changed
later (at any time during IMMULITE operation) by choosing System
Status and Select Reports from the Primary Screen.

Enter Your Name or User ID
Type the operator’s initials or ID number (up to eight characters) and
press [Enter].
Are the Time and Date Correct?
Check the time and date in the upper left hand corner of the screen.
10. Type [Y] if the time and date are correct, or [N] if either one is incorrect.
If [N] is pressed, follow the system prompts to enter the correct
information and confirm the changes.

Note: The time must be entered in 24-hour format. For example,
16:05:00 is 4:05 p.m. (the last two zeros represent seconds).
After verifying the date and time, the Primary Screen appears on the
monitor (see Figure 5) and the following message appears on the Display
Panel:
DPC IMMULITE
Press GO to start
CAUTION: If the date and time are set earlier than the date and time
of the most recent IMMULITE result, an error message regarding a date
and time conflict appears. Call DPC Technical Service.
11. Press GO to initiate a component check and the start-up instructions

(which appear on the Display Panel).
The following message appears while the system initializes (which takes
only a few seconds).
DPC IMMULITE INITIALIZING.
Please wait.
Next, the following prompt appears:
Remove all tubes from load chain,
Press GO when completed.
Perform Daily Follow the steps below to perform daily maintenance.

Maintenance
1. Lift the IMMULITE cover.
2. Remove any Test Units or sample cups from the first green arrow on the
Load Platform to the Main Carousel (refer to Figure 17).

Figure 17
Load Chain
Remove Test Units and sample cups from this area.
Note: This will ensure that sample cups not identified by the Barcode
Reader will not move onto the Main Carousel, causing a jam.
3. Press GO (on the IMMULITE).

The following message will appear briefly:
DPC IMMULITE Initializing
Please wait
The Load Chain will advance two more steps.
4. Remove any Test Units or sample cups that may have been in the
Barcode Reader position.
When the initialization procedure is complete, the IMMULITE displays
the prompt:
Load water and substrate containers.
Empty waste container and press GO.
5. Check the 2-liter water reservoir (blue cap). (For precautions regarding
the water supply see Appendix C: Operational Precautions.) If the
water is low or empty:
Remove the cap from the 2-liter water bottle.
CAUTION: Do not touch the submerged portion of the tubing. If

the IMMULITE is in operation, do not lift the tubing completely out
of the water.

Holding the cap to one side with the tubing still inside the container,
refill the water container with distilled water only.
Re-tighten the cap and ensure the blue fitting on top of the cap is
tight.
6. Check the 1-liter Probe Wash concentrate (yellow cap). If the probe
wash is low or empty (For precautions regarding supply see Appendix
C: Operational Precautions.):
Using a clean 1-liter bottle, dilute the Probe Wash Concentrate by
adding 900 mL of distilled water to one bottle of probe wash
concentrate (catalog #LPWS2). Swirl gently to mix.
Note: One bottle of Probe Wash Concentrate = 100 mL.
Remove the cap from the empty wash container, hold it off to one
side, and pour in the fresh wash solution.
Re-tighten the cap and ensure the yellow fitting on top of the cap is
tight.
7. Check the substrate bottle, and replace the bottle if it is empty. Only
replace it if it is empty.
Pull the current substrate bottle off the dispensing station by firmly
holding the bottle and pulling upwards.
CAUTION: To prevent contamination, do not touch the substrate

spike.
Pull the plastic cap off the new substrate bottle and place the bottle
on the spike upside down, puncturing the rubber stopper. The bottle
should be firmly seated on the spike.
CAUTION: Do not touch the top of the substrate bottle (after

removing the plastic cap) to prevent contamination.
If the substrate level in the reservoir is below the fill-line, squeeze

the soft gray button on the front of the substrate module, filling the
reservoir to the proper volume.
Note: Do not over-fill the Substrate Reservoir.

8. Empty the liquid waste bottle and the Solid Waste container.
CAUTION: Replace the Test Unit waste container securely so the flow
of Test Units into the container is not inhibited.
9. Press GO (on the IMMULITE).

The following message appears:
IMMULITE is priming the syringes.
Please wait.
The IMMULITE automatically primes once and the following message
appears on the IMMULITE Display Panel:
Prime the syringes, substrate and water.
Press GO when done.
10. Ensure that the thumbscrews under the syringes are tight and the syringe
barrels are securely attached at the top.
11. Press the Syringe Prime button at least five times.
Note: Figure 18 shows two different syringe pump assemblies. Only

one will be seen on the IMMULITE.
13. Ensure that the syringes and lines are free of bubbles. Continue priming
if necessary.

Figure 18
Syringes
(Two syringe assemblies shown)
Hamilton Syringe Pump DPC Syringe Pump
14. Check the end of the Substrate Nozzle for residue that could interfere
with dispensing substrate into the Test Units.
Remove the thumbscrew holding the Substrate Heater and water
nozzle.
Lift the Substrate Heater (vertically) and check for white precipitate
(dried substrate) at the end of the Substrate Heater Nozzle.
CAUTION: To ensure the wires behind the Substrate Heater are not
disconnected, do not pull the Substrate Heater all the way.

Gently wipe the nozzle and nozzle seat with a lint-free, moist tissue.
CAUTION: Avoid touching the tip of the nozzle against any

surface that could contaminate the tip (such as bare skin or a
contaminated glove). Also do not allow the nozzle tip to rest or drop
against a hard surface, which could damage the tip and alter the
dispense pattern.
15. Inspect the Substrate Reservoir to make sure that it is filled to the fill-
line.
To replenish the reservoir, squeeze the gray Prime button above the
reservoir.
Note: If the substrate level falls significantly below the fill-line, an

alarm sounds and an error message appears. At this point, enough
substrate for only twenty-five tests remains. Do not over-fill the
Substrate Reservoir.
16. Cycle the Substrate Pump five times to ensure air bubbles are removed
from the line. Perform the priming procedure daily to ensure that the
substrate dispenses in a straight stream with no splattering, dripping, or
hanging drops.
Note: The priming buttons for the Substrate and Water Pumps are
clearly marked on the pump case (refer to Figures 19A and 19B).
A. For the Cirrus Substrate Pump (see Figure 19A), press and release
the prime button.
B. For the Linear Actuator Substrate Pump (see Figure 19B), press and
hold the prime button.
17. Cycle the Water Pump five times to ensure air bubbles are removed from
the line. Perform the priming procedure daily to ensure the water
dispenses in a straight fluid stream with no splattering, dripping, or
hanging drops.
A. For the Cirrus Water Pump (see Figure 19A), press and release the
prime button.
B. For the Linear Actuator Water Pump (see Figure 19B), press and
hold the prime button.
18. Press GO on the IMMULITE.
The IMMULITE System now displays the following prompt:
IMMULITE is priming the syringes.

Please wait.
The large syringe will prime and the following message appears:
Load reagents, samples and Test Units.
Press GO to read reagents.
Note: Continue with the next section, Loading Reagents.

Figures 19A
Cirrus Substrate and Water Pump

Figure 19B
Linear Actuator Substrate and Water Pumps
Loading To load the reagents, follow the steps below:

Reagents
1. Lift the Reagent Tray from the Reagent Carousel and load desired
reagents. Do not pipette leftover reagent into a new wedge.
Note: If a new kit lot is being used, refer to Kit Entry in Section 5:
The Main Menu before running this assay.
Load each Reagent Wedge into the Reagent Tray by inserting the tab
at the bottom of the wedge (see Figure 20) into the slot on the outer
rim of the Reagent Tray.
Note: Position the Reagent Wedges between the section guides (see
Figure 22).
Firmly press the front of the Reagent Wedge down into the tray until
it snaps into place (see Figure 21).

Figure 20
Reagent Wedge (Top and Back Views)
Figure 21
Placing a Wedge into the Reagent Carousel Tray

Figure 22
Reagent Carousel Tray (Top view)
2. Place the Reagent Tray into the Reagent Carousel by positioning the
Reagent Tray so the line on the tray handle is aligned with the line on the
carousel spindle. Press down firmly so the spindle top is flush with the
top of the tray handle.
Note: The Reagent Tray can only be seated on the carousel spindle if
the two lines are properly aligned.

3. Open the caps on the reagents and snap them down into position. When
starting a new Wedge, remove the white-colored paper, the foil seal, and
any gummy residue. Then check the surface of the liquid for bubbles.
Break any bubbles with a disposable pipette tip.
CAUTION: Probe damage will occur if the caps or seals are left on the
Reagent Wedges during operation.
Note: If more than one Reagent Wedge of the same kit lot is placed on
the Reagent Tray, the Reagent Wedge in the highest numbered tray
position is emptied first; therefore, partially used wedges should be
placed in higher numbered positions.
4. Close the reagent lid on the instrument firmly.

5. Press GO on the IMMULITE. The IMMULITE System reads the
barcodes and displays the following messages:
IMMULITE is now reading reagent barcodes,
Please Wait.
Notice: Reagent Read Completed
Resuming normal operation in xx seconds.
The On-board Reagent Status screen appears.
Figure 23
On-board Reagent Status Screen
The On-board Reagent Status screen identifies reagents found on the

Reagent Carousel by Test Code (abbreviated assay name), Reagent
Wedge, and the corresponding Test Unit lot numbers.
Note: If NEW KIT or OVERDUE appears in the LAST CURVE

ADJUST column, the assay must be adjusted before running patient
samples. (See Running Adjustors on page 4-20 and Running
Controls on page 4-27.)

6. Check the On-board Reagent Status screen to confirm that all the kits are
present and that each is adjusted.
If the message Kit Not Found appears, the kit barcode must be
entered into the computer using the Kit Entry screen (see Kit Entry in
Section 5: The Main Menu for more information).
Note: After the kit information has been entered, the Reagent Carousel
must be re-read to update the on-board reagent status. This can be
accomplished by simply lifting the Reagent Carousel out and then
replacing it, causing the IMMULITE to automatically pause and re-read
the reagents.
7. Press [Esc] to return to the Primary screen.

8. Once the reagent barcode is read, the Load Chain begins advancing and
the following message appears on the Display Panel:
DPC IMMULITE RUNNING.
To add or change reagents, press PAUSE.
Samples can now be loaded at any time. The Daily Start-up procedure is
now complete.

Running The process of running assays involves:
Assays
Loading samples
Removing sample cup holders
Performing a STAT procedure
Note: The Primary Screen enables the operator to observe, in real-time, the
exact location of the Test Units.
Loading a Follow the instructions below to load a sample:

Sample
1. Transfer a patient sample into a clear plastic sample cup and place the
cup into a black sample cup holder. For more information on sample
volume, refer to the information below; otherwise, skip to step 2.
Sample Volume
The sample volume required in the sample cup varies with the assay(s)
to be run on that sample and with the number of replicates. The exact
sample volume needed for each test can be found in the corresponding
package insert. An additional 100 µL is required for instrument
operation. If the sample volume is 100 µL, an additional 250 µL is
required for instrument operation.
If the IMMULITE system senses insufficient volume, an error message
appears and the Test Unit is shown as a white circle on the Primary
screen.
2. Place the sample cup holder onto the Load Chain, followed by up to five
Test Units. The Test Units can be loaded in any order. Visually inspect
each Test Unit for the presence of a bead before loading it onto the
system.
Note: To associate the sample cup holder number with the patient
accession number and/or last name, choose Data Entry and Worklist
Entry from the Primary Screen.
3. Make sure there are no bubbles on the surface of the liquid in the sample
or the Reagent Wedges. Bubbles could cause false level-sensing and a
short sample or reagent draw.
Removing The unused sample can be removed from the Sample Collection Tray at any
Sample Cup time. When the tray is full, the IMMULITE will automatically pause, stop
Holders the Load Chain, and stop pipetting until the tray is emptied.

Two alarms (one on the IMMULITE and one on the computer monitor) alert
the operator when the pause mode is initiated. Press ALARM MUTE to
silence the alarm on the IMMULITE and press the [Esc] key to silence the
alarm on the computer monitor.
Note: None of the tests in process will be adversely affected by either the
alarm or the automatic pause.
To remove the sample cup holders:

1. With the IMMULITE in pause mode, remove the sample cup collection
tray.
Note: If the IMMULITE is not in pause mode, press PAUSE once.

Before continuing, wait until the Display Panel reads:
IMMULITE is now in PAUSE Mode.
Hit PAUSE to stop or GO to read reagents.
2. Remove the sample cup holders.
Note: The sample cup holders are re-usable.
3. Replace the sample cup collection tray.

4. Press GO on the IMMULITE to continue operation.
CAUTION: After pressing GO, do not attempt to remove the Sample

Collection Tray. If a sample cup or Test Unit is moving into the Sample
Collection Tray when the tray is removed, a Load Chain positioning
error could occur.
Performing a To run tests immediately, follow the STAT procedure instructions below:
STAT
Procedure
1. Remove the sample cup holder and the associated Test Units closest to
the first arrow on the left front corner of the Load Platform.
Note: The displaced sample and Test Units can be moved to any
available space on the platform.
2. Place the STAT sample and its Test Units in the space created.

Running The IMMULITE system uses stored master curves, which eliminate the
Adjustors need to process standard curves with each run. The master curve for each
kit lot is generated by DPC, and the parameters describing this curve are
encoded in the kit barcodes (which appear on the inside flap of the kit box).
Before a new kit lot can be used, these barcodes must be entered into the
IMMULITE. If a new kit lot is being used, follow the instructions under Kit
Entry in Section 5: The Main Menu to enter the new kit lot information.
Each new kit lot must also be adjusted before it is used. This initial
adjustment corrects for any variations between the performance of the
instrument in the lab and the performance observed at DPC during master
curve generation.
CAUTION: If patient samples are processed without first adjusting the kit,
the results will not be accurate.
In addition, each kit lot must be periodically readjusted at the interval

specified in the package insert. This adjustment corrects for any change in
the reagents. If a new kit lot is not being used or the current kit is not due for
a re-adjustment, skip the next section and continue with Running Controls
on page 4-27.
Adjustment To adjust a kit, lot-specific Adjustors must be processed (either one Adjustor
Procedure or a pair of Adjustors – depending on the assay). Before running the
Adjustor, the sample must be identified as an Adjustor.
Identifying a Sample as an Adjustor

The procedure for identifying an Adjustor to the IMMULITE is described
below.
Note: The procedure includes accessing the Patient Entry Screen, where
special records for patients, Adjustors, controls, and verifiers are created.
IMPORTANT: Four replicates (Test Units) must follow each Adjustor.
1. Access the Patient Entry screen from the Primary Screen by selecting
Data Entry and Patient Entry. The following screen appears:

Figure 24
Sample Cup Entry Screen
2. With the cursor in the Sample Cup # field, type # for an Adjustor.
Note: The #, $ and &, symbols are displayed at the bottom of the
screen as a reminder (# signifies an Adjustor, $ signifies a control, and
& signifies calibration verification material)
3. Type the number of the sample cup holder to be used for the Adjustor
(immediately following the # sign) and press [Enter].
IMPORTANT: For the results to be tracked properly Adjustors must

be identified on the Patient Entry screen with a sample cup holder
number before the Adjustor and the Test Units are read by the Barcode
Reader.
A small window appears which requests the following:

a Test Code for the assay to be adjusted
lot number for the kit
lot number for the Adjustor
whether the sample is a Low Adjustor (A) or a High Adjustor (B)
(indicated on the vial label). Qualitative assays using only one
adjustor should be identified as Low (L).

4. Answer the questions, pressing [Enter] after each question.
CAUTION: Do not use arrow keys to move between fields.
5. For each Adjustor level, repeat this process with a different sample cup
holder number.
Note: An Adjustor is processed in the same manner as any other

sample. More than one kit can be adjusted at the same time, and kits
can be readjusted at any time without interfering with IMMULITE
operation.
Running Adjustors
1. Place the sample cup into the previously identified sample cup holder.
2. Dispense the appropriate amount of Adjustor material into the sample
cup.
3. Place the sample cup holder onto the Load Platform, and place four Test
Units in the positions immediately following the sample cup (see Figure
25).
IMPORTANT: Adjustors must be run in quadruplicate for both the

Low and High Adjustor. An error message regarding an incorrect
number of Test Units will not be indicated until the end of the
Adjustment.
Figure 25
Processing Adjustors in Quadruplicate

Note: Sample volume required in a sample cup varies with the assay(s)
run on that sample and the number of replicates. The exact sample
volume needed for each test can be found in the corresponding package
insert. If the sample volume is less than or equal to 100 µL, an
additional 100 µL is required for instrument operation. If the sample
volume is greater than or equal to100 µL, an additional 250 µL is
required for instrument operation.
If the IMMULITE senses insufficient volume, an error message appears
and the Test Unit is shown as a white circle on Primary screen.
4. Press GO.
The IMMULITE system prints an adjustment report after the Adjustors
have been read by the photomultiplier tube (PMT). A slope and
intercept is calculated for the kit being adjusted (see Section 8: Data
Reduction and the Chemiluminescent Reaction for further
information). Depending on the assay, the accompanying printout shows
either a slope and intercept (for a quantitative assay) or an
Adjustment Successful message (for a qualitative assay). The
test type, kit lot, slope, and intercept are displayed in the error log when
the adjustment is completed.
In addition, adjustment status can be viewed by selecting Data Entry
and Kit Entry. Press the [Page Down] key to view the current kits.

Figure 26
Quantitative Assay: Sample Adjustment Data
*******************************Adjustor******************************
Sample Cup# 8
Test Code TSH
Kit Lot# 262
Adjustor Lot# 12
Adjustor Cps 44089
Level Low
TSH 34,738 Cps R 93 T67 11/06/03 1:04:25 PM
TSH 32,935 Cps R 93 T67 11/06/03 1:04:56 PM
TSH 34,577 Cps R 93 T67 11/06/03 1:05:27 PM
TSH 36,068 Cps R 93 T67 11/06/03 1:05:58 PM
*******************************Adjustor******************************
Sample Cup# 9
Test Code TSH
Kit Lot# 262
Adjustor Lot# 12
Adjustor Cps 12076630
Level High
TSH 11,216,643 Cps R 93 T67 11/06/03 1:06:28 PM
TSH 10,486,215 Cps R 93 T67 11/06/03 1:06:57 PM
TSH 11,137,495 Cps R 93 T67 11/06/03 1:07:28 PM
TSH 11,083,253 Cps R 93 T67 11/06/03 1:08:00 PM
TSH Kit Lot 262 Slope = 1.0992314 Intercept = 6078.127

Figure 27
Qualitative Assay: Sample Adjustment Data
*******************************Adjustor******************************
Sample Cup# 58
Test Code HBS
Kit Lot# 144
Adjustor Lot# 10
Adjustor Cps 27000
Level Low
HBS 29445 Cps R 93 T5 11/13/03 12:55:51 PM
HBS 28004 Cps R 93 T5 11/13/03 12:56:22 PM
HBS 24926 Cps R 93 T5 11/13/03 12:56:53 PM
HBS 24101 Cps R 93 T5 11/13/03 12:57:23 PM
HBS Kit Lot 144 CURVE ADJUST SUCCESSFUL

Running Before the IMMULITE system can track controls, control information must
Controls be entered and the controls must be identified.
Follow the instructions under Control Entry in Section 5: The Main Menu
before continuing with the procedures below.
Identifying Controls must be identified in the Patient Entry Screen with a sample cup
Controls holder number before the sample cup holder enters the IMMULITE
Barcode Reader.
To identify the controls, follow the steps below:

1. From the Primary Screen, select Data Entry and Patient Entry.
Figure 28
2. With the cursor in the Sample Cup # field, type a $ sign (to signify a
control) followed by the sample cup holder number and press [Enter].

The Control Entry Screen appears (see Figure 29). Control names
previously entered into the system are listed. Refer to Control Entry in
Section 5: The Main Menu for more information.
Figure 29
Control Entry Screen
3. Select the control to be run and press [Enter].

The Patient Entry Screen appears.
4. Either identify additional controls (if desired), or press [Esc] to return to
the Primary Screen.
Running the To run controls, follow the instructions below:

Controls
1. Dispense the control into a sample cup and place the cup into the
appropriate sample cup holder.
2. Place the sample cup holder onto the Load Platform, and follow it by the
desired Test Units (up to five).
The IMMULITE prints a Control Report after the controls are read by
the photomultiplier tube (PMT). The Detail information entered on the
Control Entry Screen prints, as well as the low and high limits. Refer to
the next page to view a sample Control Report.

SAMPLE CONTROL DATA
**************************************************************
Sample Cup# 10
Run Date 10/26/03
Control ID CON4 Control Lot# 18
Control Source Level 1 Expiration 05/31/06
Low Limit TSH .22 High Limit TSH .37
TSH 0.265 uIU/mL R 97 T 69 672897

3:47:33 PM
**************************************************************
Sample Cup# 11
Run Date 10/26/03
Control ID CON5 Control Lot# 18
Low Limit TSH 2.78 High Limit TSH 4.18
TSH 3.39 uIU/mL R 97 T 69 7770063

3:49:05 PM
**************************************************************
Sample Cup# 12
Run Date 10/26/03
Control ID CON6 Control Lot # 18
Low Limit TSH 17.2 High Limit TSH 25.6
TSH 20.9 uIU/mL R 97 T 69 39645341
3:20:13 PM
**************************************************************

Acceptability Criteria
Once an adjustment is complete, determine whether it is acceptable. The
software will fail an adjustment only if one of the following situations exists:
the replicates exhibit unacceptable precision (the cv% is high)

fewer than four replicates are measured
the Adjustors are reversed or misidentified
there was a mathematical calculation error
If no errors occur, a slope and an intercept are calculated and printed. These
values, along with the control results, must be judged for acceptability using
the three acceptability guidelines described in the following table:
Guideline Description
Control Once control ranges have been established, controls must be
Results run to verify kit adjustment before patient samples are
processed. If the controls are out of range:
First, repeat the controls.
If they are still out of range and no other problem can be
identified, re-adjust the kit.
If the problem persists, contact DPC Technical Service
immediately.
See Section 8: Data Reduction and the Chemiluminescent
Reaction for more information on Master Curve generation
and the two-point adjustment process.
Slope The slopes for all assays should agree within plus or minus
20% of the mean slope that was determined during the
installation of the IMMULITE system.
Within a kit lot, the slope calculated during readjustment
should agree, within 10%, with the slope calculated for the
previous adjustment on the instrument. See Section 8: Data
Reduction and the Chemiluminescent Reaction for more
information.

Intercept Check the intercept of adjustment.
For Immunometric (sandwich) assays, a large intercept affects
the results but only at very low concentrations. The best
method to validate an adjustment is to run QC samples with
low concentrations. If no QC samples are available at these
low concentrations, the adjustment intercept may be used to
validate the adjustment as follows:
Generally, the absolute value of the intercept falls below the
low Adjustor cps of the master curve x 30%.
The Low Adjustor cps refers to the Adjustor cps information
found on the Kit Entry screen or the adjustment printout. Do
not refer to the observed cps measured for the low adjustor.
For an example, see Intercept of Adjustment in Section 8:
Data Reduction and the Chemiluminescent Reaction.
For competitive assays, the absolute value of the intercept
generally falls below 2% of curve parameter P1 is found on
the Kit Entry screen.
See Judging Adjustment Validity in Section 8: Data
Reduction and the Chemiluminescent Reaction for more
information.

Running To run calibration verifiers, follow the instructions below:
Calibration
Verifiers
1. From the Primary Screen, select Data Entry and Patient Entry.
2. With the cursor in the Sample Cup # field, type “&” and the number of
the sample cup holder and press [Enter].
Figure 30
Verifier Entry Screen
3. Type the verifier ID in the Accession # field and press [Enter].
Note: To review the verifier sample cup holder assignments, press

[Page Up] or [Page Down].

Printing With the exception of the Primary Screen, all IMMULITE software screens
and the DOS operating system screens can be printed according to the
instructions below:
To Print: Press:
The Worklist or LIS Data Management Screen [F3]
Any IMMULITE software screen (with the exception of [F10]
the Primary Screen).
Any DOS screens [Print Screen]
Note: The LIS Data Management Screen can only be accessed by

IMMULITE systems connected to an LIS (Laboratory Information System).

Adding or The IMMULITE must be in pause when changing reagents or removing the
Changing Sample Collection Tray. Pausing does not interrupt any assays in progress.
Reagents The Incubation Carousel, Spin Station, and Luminometer will continue to
function normally.
To add or change reagents, follow the instructions below:
1. Press the PAUSE button on the IMMULITE Display Panel to stop the
loading process.
2. After pressing PAUSE, before proceeding, wait until the pipettor stops
moving and the Display Panel shows the following message:
IMMULITE is now in PAUSE mode.
CAUTION: The pipettor continues to operate when a sequential assay

moves into the pipetting position.
3. Remove the Reagent Carousel.

4. Add or change the Reagent Wedges.
5. Replace the Reagent Carousel.
An automatic Reagent Carousel read will initiate and the following
message will appear:
IMMULITE is now reading reagent barcodes.
Please wait.
After reading the Reagent Carousel, the Reagent Status screen appears
and the following message is shown on the instrument Display Panel:
Notice: Reagent read completed.
Resuming normal operation in xx seconds.
Note: Reagents loaded on-board must be either all Standard (Non-

Turbo) Reagent Wedges or all Turbo Reagent Wedges. The system will
not run if there is a combination of the two types of reagents on-board.

Automatic The IMMULITE System automatically pauses or stops operation (setting the
Pause and Instrument in either AutoPAUSE or AutoSTOP mode) depending upon the
Stop situation.
AutoPAUSE The AutoPAUSE (automatic pause) mode is initiated for the following
Mode reasons:
The Reagent Carousel tray was removed without pressing PAUSE.
The Sample Collection Tray is full or has been removed.
A reagent is empty and another Reagent Wedge is not available on the
Reagent Carousel.
The Test Unit and Reagent Wedge lots are mismatched (see Section 11:
Troubleshooting for more information).
Test Unit and Reagent Wedge lot numbers do not match the components
of a recognized kit lot.
An instrument error occurred, which inhibits normal operation, and the
system is unable to correct the error (i.e. a sequential assay component is
missing) See Section 11: Troubleshooting for more information.
Any time AutoPAUSE is initiated, an error message appears. Under certain
circumstances, there is also an alarm, which can be silenced by pressing
ALARM MUTE.
AutoSTOP The instrument automatically switches to STOP mode after ten minutes if
Mode all three of the following statements are true:
no new samples have entered the system
the system is empty
the system is not in pause mode
The Load Chain, pipetting action, Incubation Carousel, and Luminometer
chain will stop. The following message appears on the Display Panel:
DPC IMMULITE
Press GO to start.
Note: It is not necessary to log off the system to re-start since the
IMMULITE is still on.
Press GO (on the IMMULITE) to resume, as indicated on the Display Panel.

Daily The following is an overview of the daily shutdown procedure:
Shutdown
Stop the instrument
Log off the system
Backup the system
Clean the Probe
Remove/empty test supplies
Stopping the To stop the instrument, follow the instructions below.

Instrument
1. If the Display Panel reads . . .
DPC IMMULITE RUNNING.
To add or change reagents, press PAUSE.
Press PAUSE on the IMMULITE.
CAUTION: If the IMMULITE is shut down during a run, any assays
in progress will be lost.
IMMULITE is now in PAUSE mode.
2. Press PAUSE again.
The following message appears and an alarm sounds.
IMMULITE shut down -- ARE YOU SURE?
3. Press PAUSE again.
IMMULITE will shut down shortly, please wait.
After a short delay, the following message appears:
DPC IMMULITE IDLE
Select RUN IMMULITE to begin
Note: If the instrument is in AutoSTOP mode, press the ALARM MUTE

and GO buttons (on the IMMULITE) simultaneously to clear the
IMMULITE program. The Display Panel shows the following message:
DPC IMMULITE IDLE

Continue with Logging Off the System on page 4-36.

Logging Off the To log off the system:
System
From the Main menu, select Log Off and Log Off System
The Start-up menu reappears.
If there are. . The following question appears:

Tests still in progress There are tubes still on the
system, Log Off anyway?
(Y/N)
Tests without answers Remove records without
answers? (Y/N)
(i.e. records were created
in the worklist, but the
corresponding samples
were not run)
LIS records which have Delete the LIS Worklist
not been sent to the LIS (Y/N?)
Respond by pressing [Y] or [N], as desired.
CAUTION: Do not turn off the computer before logging off or the
software and database will be damaged.
If this occurs, follow the instructions under Running FIXIT in Section
11: Troubleshooting. The FIXIT program will delete any records
without answers.
Backing up the The Backup function creates a backup copy of the databases so the most
System recent data can be restored in the event of a serious error. The backup saves
patient, control, and Adjustor results for the past thirty-one days, quality
control data from the past six months, and all control definitions.
The IMMULITE software should be backed up every day. Dedicate two,
3.5-inch diskettes for backup, alternating the diskettes daily. By alternating
diskettes, the previous day’s data is available if the diskette with the most
current data is damaged.
More than one diskette may be needed for daily backup. If this is the case,
more than the two diskettes (recommended previously) will be needed. For
example, if the backup requires two diskettes, dedicate four diskettes so they
can be alternated daily.

Follow the steps below to make a backup copy of the day's activity:
1. After logging off the system, select BACKUP/RESTORE from the
Start-up menu.
2. Select BACKUP DATA BASE and press [Enter].

A message appears indicating that the database will be backed up and all
patient and adjustment data older than 31 days will be deleted.
3. Press [Y] to continue.
A message appears, telling the operator that a temporary backup is being
made and that this may take from 1-3 minutes.
A second message appears:
This is your last chance to abort the
procedure. Do you wish to continue? (Y/N)
4. Press [Y] again, to initiate the backup procedure, or press [N] to return to
the Start-up menu.
While the backup is in progress, the screen displays the following
messages:
Packing Result Database - This procedure MAY
take up to 15 minutes.
Packing QC Database - This procedure MAY take
up to 15 minutes.
When the database is compressed and packed, a prompt appears to insert
a formatted disk into the 3.5 disk drive.
5. Insert a 3.5 inch disk and press any key to continue.

6. Press [Y] when asked whether to overwrite the data currently on the
diskette.
Note: Depending on the volume of data, a prompt for inserting another

diskette may appear.
A final message, Backup Complete, will be displayed before the

Start-up menu re-appears.
Note: To replace a damaged or lost database, use the Restore function

(Refer to Section 11: Troubleshooting).
Cleaning the Follow the instructions below to clean the Probe. A Probe Cleaning Kit is
Probe required to complete these instructions.
1. Pipette 2 mL Probe Cleaning Solution into a reusable plastic Probe
Cleaning Wedge.
2. Place the Probe Cleaning Wedge into position number 1 on the Reagent
Carousel.
IMPORTANT: The Probe Cleaning Wedge must be placed in position

number 1.
3. From the Start-up menu, select Diagnostics and Diagnostics and press
[Enter].
4. Use the arrow keys to select the PROBWASH program and press
[Enter].
5. When the loading is complete, press [Enter] again.
6. Press GO (on the IMMULITE) when instructed to do so. The procedure
takes about 10 minutes. When this procedure is complete, the probe
centers over the Home Well. The message Press Go to run PROBE
ANGLE test appears on the Display Panel.
7. Press GO (on the IMMULITE) to continue. Water is dispensed through
the probe. Observe that the water dispenses in a straight stream and no
splashing occurs. The probe may need to be replaced if splashing is
observed or the water is dispensing at an angle. (Refer to Changing the
Pipetting Probe in Section 6: Routine Maintenance for instructions).
8. Simultaneously press ALARM MUTE and GO to end the process. DPC
IMMULITE Idle Select RUN IMMULITE to begin appears
on the Display Panel.

9. Remove the Probe Cleaning Wedge, discard the remaining Probe
Cleaning Solution, and rinse the wedge with distilled water. Store the
wedge in the Probe Cleaning Kit for future use.
10. Press [Esc] to return to the Start-up menu and select Exit to DOS.
11. Turn off the computer (CPU and monitor).
Note: The IMMULITE power should remain on to ensure the System is

at proper operating temperature and ready for operation at all times. If
the System is turned off, allow at least one hour for the IMMULITE to
stabilize at the proper operating temperature before using.
Removing and Remove or empty the test supplies according to the instructions below:
Emptying Test
Supplies
1. Empty the Solid Waste container.
2. Empty the Liquid Waste container.
3. Empty the Sample Collection Tray.
4. Remove the Reagent Carousel Tray. Remove the Reagent Wedges and
proceed as follows:
Wipe off any excess reagent that has accumulated around the
Reagent Wedge opening using a dry, lint-free tissue. Excess reagent
around the Wedge opening can prevent the cap from seating
properly.
Set the Wedge on a hard surface, such as a countertop, and apply
uniform pressure across the entire cap until it is felt to “snap” or
“click” into place.
If the cap cannot be “snapped” shut, cover the opening securely with
Parafilm or similar material to prevent evaporation.
Refrigerate the reagents at 2-8° C.
5. Replace the Reagent Tray.
Note: Substrate can remain on the instrument for up to 30 days or until

the substrate expiration date (whichever comes first).

Quality The Quality Control menu includes:
Control
Control Results
Patient Results
Briefly, Control Results allows the operator to view statistical data on a
group of controls over a period of time. This data is in the form of a Levey-
Jennings plot or graph. Patient Results allows the operator to view patient
data for a selected assay (Test Code) over a period of time in the form of a
Levey-Jennings plot. Both screens are described in detail below.
Control Results This option provides an overview of the statistical data for a selected group
of controls over a defined period of time.
The Levey-Jennings plot provides:
A record of the observed doses (concentration results) for all selected
controls run during the specified time period
A statistical summary
Note: Outlying points can be edited.
The following rules apply to the graph and control data:

To plot a graph, at least two days of data must be selected and a minimum
of two control results must have been run.
A graph can be plotted for any length of time up to 90 days.
Control data is maintained for six months on the computer’s hard drive.

Plotting Control Results
To generate a Levey-Jennings plot for a control, follow the instructions
below:
1. From the Start-up menu, select Quality Control, press [Enter], then [1]
Controls.
2. Select [1] to plot and/or print the data.

3. Type the Beginning date for the time interval to cover in the calculation,
pressing [Enter] after the month, day, and year have been entered.
A prompt appears for the Ending date.
4. Type the Ending date, pressing [Enter] after the entire date has been
entered.
Note: An interval of up to 90 days can be specified.

5. Select an assay by typing the Test Code and pressing [Enter].

All controls defined for the assay appear (a sample screen is shown
below).
Figure 31
Control QC screen Showing Controls Defined for the Assay
6. Select a control name, and press [Enter].

The control name is removed from the screen.
7. Select Complete and press [Enter].

8. Select [1] or [2] based on the information in the table below:
To: Follow these instructions:
graph the Select [1].
data The following appears, giving a choice of plotting
limits:
Select: To:
[1] plot with the observed 2SD limits
[2] plot with user-defined limits
Note: Prompts appear for the Low and High
Limits (for the control). Type the limits, pressing
[Enter] after each field.
A plot of all control results for the selected time interval
appears.
The upper and lower lines represent either observed
2SD limits or user-defined limits.
The center line represents the mean of the data
generated.
On the screen, each control is color-coded and identified
using the legend (at the top of the screen). There is no
comparable way to distinguish controls on the printout.
Note: If a data point falls above or below the limits of the
graph, an upward or downward pointing symbol
(∧, ∨) appears. An “E” designates any excluded points.
Press [F10] to print.
Note: The keyboard is disabled while printing the plot
and the associated numerical data, which takes up to two
minutes.
Press [Esc] to quit or [Enter] to plot a new graph.
print data Select [2].
used to
The mean and 1SD range for each control specified is
generate the
automatically printed.
graph

Editing Control Results
Control results are edited by excluding individual data points from the
calculation of the means and 2SD range limits. To edit control results,
follow the steps below:
1. From the Start-up menu, select Quality Control, press [Enter], then [1]
Controls.
2. Select [2] to edit the data.

The following prompts appear:
3. Enter the Start Date and Start Time of the data points to be excluded.
Note: Start Time refers to when the records were opened (i.e. when
the Test Units were read by the Barcode Reader, not when the results
were generated).


A list of all control results generated by the assay since the designated
start date and time appears.
5. Select any record (line of data) containing a control result to exclude

from the calculations and press [Enter].
Note: The record remains selected when the cursor is moved to another
line.
6. Press [Esc] after editing the control results.

The following screen reappears:
The next time a Levey-Jennings plot for the control is generated (see
Plotting Control Results on page 4-41) an “E” appears on the screen
for every result excluded. (The printout uses the word “EXCLUDED” as

opposed to an “E”.)
Note: The summary statistics are calculated without reference to the

excluded data points. Re-selecting these records can reinstate data
points that were excluded.
7. Press [Esc] to quit.
Patient Results This option allows the operator to view patient data for a selected assay (Test
Code) over a defined period of time. The screen displays a plot of the results
for all patient assays over the requested time period, and lines representing
the mean and either 2SD or the user-defined limits. Long-term population
trends can be observed and the laboratory result range can be evaluated.
Note: At least two days of data must be selected to plot a graph.
After a routine backup, results from the past six months remain available for
plotting patient Quality Control data.
Plotting Patient Results

To display a Levey-Jennings plot of the patient results, follow the
instructions below:
1. From the Start-up menu, select Quality Control, then [2] Patients.

2. Select [1] to plot and/or print the data.
The following appears:
3. Type the Beginning date for the time interval to cover in the calculation,
pressing [Enter] after the month, day, and year have been entered.
A prompt appears for the Ending date.
4. Type the Ending date, pressing [Enter] after the entire date has been
entered.


6. Select [1] or [2] based on the information in the table below:
graph the data Select [1].
The following appears, giving a choice of plotting
limits:
Select: To:
[1] plot with the observed 2SD limits
[2] plot with user-defined limits
Note: Prompts appear for the Low and High
Limits (for the patient). Type the limits,
pressing [Enter] after each field.
A plot of all patient results for the selected time interval
appears.
The upper and lower lines represent either observed
2SD limits or user-defined limits.
The center line represents the mean of the data
generated.
Note: If a data point falls above or below the limits of
the graph, an upward or downward pointing symbol
(∧, ∨) appears. An “E”designates any excluded points.
Press [F10] to print.
Note: The keyboard is disabled while printing the
plot and the associated numerical data, which takes
up to two minutes.
Press [Esc] to quit or [Enter] to plot a new graph.

print the data Select [2].
used to
The mean and 1SD range for each patient population
generate the
specified is automatically printed.
graph

Editing Patient Results
Patient results can be excluded from the statistical calculations in the same
manner as control results are excluded. Follow the instructions below to edit
patient results:
1. From the Start-up menu, select Quality Control, then [2] Patients.
2. Select [2] to edit the data.

3. Enter the Start Date and Start Time of the data points to be excluded.
Note: Start Time refers to when the records were opened (i.e. when
the Test Units were read by the Barcode Reader, not when the results
were generated).


A list of all patient results generated by the assay since the designated
start date and time appears.
5. Select any record (line of data) that contains a patient to exclude from
the calculations and press [Enter].
Note: The record remains selected when the cursor is moved to another
line.
6. Press [Esc] when you are done editing patient results.

The cursor returns to the Plot/Print Data option.
The next time a Levey-Jennings plot is generated (see Plotting Patient
Results on page 4-46) an “E” will appear on both the screen and the
printout for every result excluded.
Note: The summary statistics are calculated without reference to the

excluded data points. Re-selecting these records can reinstate excluded
data.
7. Press [Esc] to return to the Primary Screen.

Section 5: The Main Menu
Overview The Primary Screen enables the operator to observe graphically, in real-time,
the exact location of the Test Units at any particular moment.
The Primary Screen also provides access to the Main Menu, which includes
four menu options, listed across the top of the screen:
Data Entry
System Status
History Review
Log Off
These options access the IMMULITE data management tools.
Figure 32
Main Menu
To access one of these options, use the arrow keys to select the desired item
and press [Enter]. Press [Esc] to return to the Primary Screen.

Notes: To access a different menu from any screen, hold down the [Alt] key
and press the first letter of the menu title. (For example, pressing [Alt]-[S]
accesses the System Status Menu.)
All menu options can be accessed while the IMMULITE System is
operating.
To print any IMMULITE screen, except the Primary Screen, press [F10].
Press [F3] to print the Worklist or LIS list.
The remainder of this section describes each menu option.

Data Entry The table below provides an overview of the Data Entry menu options and
their functions.
Menu Option Function

Worklist Entry Associate the sample cup holder number with the patient’s
last name and/or accession number.
Patient Entry Add patient demographic data associated with a
sample cup.
Search for patient results.
Identify sample cup holder numbers as controls,
Adjustors, and verifiers.
Kit Entry Used to review kit information or enter barcode
information including:
lot numbers
expiration dates
parameters for the master curve and Adjustors
adjustment information
Control Entry Used to enter control information including:
name
assay
range
expiration date
lot number
LIS Used to:
review data which will be sent to or received from the
LIS (Laboratory Information System)
send data to the LIS
Note: This menu option only appears if the LIS has been
activated (using LIS PARAMS on the Start-up menu).

Worklist Entry The Worklist Entry Screen allows the operator to associate accession
numbers and/or patient last names with sample cup holder numbers. Patients
can be entered into the worklist in any order and at any time before the Test
Units are read by the Photomultiplier Tube (refer to Figure 5 in Section 1:
Introduction for a diagram that displays the location of the PMT). The
information entered on this screen is automatically stored in the Patient Entry
database.
In addition, a dilution factor can be entered from the Worklist Entry Screen.
Note: A sample can be re-run by making a new record in the Worklist Entry
Screen.
Associating Accession Numbers and/or Patient Last Names with Sample

Cup Holder Numbers
To associate accession numbers and/or patient last names with sample cup
holder numbers, follow the procedure below:
1. Select Data Entry and Worklist Entry.
The following screen appears.
Figure 33
Worklist Entry Screen
IMPORTANT: If the IMMULITE communicates with an LIS, refer to

Further Instructions for LIS Users (on page 5-6) before proceeding with
step 2.
2. Type each sample cup holder number, accession number, and/or patient
last name, pressing [Enter] after each entry.
As each sample is entered, it appears at the bottom of the list.
Note: The laser scanner can also be used to enter sample cup holder
numbers and barcoded patient accession numbers. Point the scanner
towards the barcode (approximately 4-6 inches or 10-15 cm away) so the
red light beam scans the barcode. Depending on the scanner, either:

press the trigger to read the barcode
the barcode is read automatically
A beep indicates the barcode information was entered successfully. The
number appears in the field where the cursor is located.
The Barcode Readers can read several barcode symbols. (Refer to the
laser scanner manual to program the laser scanner to recognize your
codes.)
If a prompt appears to edit or create a new patient, see Create a New

Patient on page 5-6.
3. Use [PgUp] and [PgDn] to page through the sample list quickly.
Press:
[F1] to toggle Skip Last Name on and off.
When Skip Last Name is on, this field is skipped automatically.
[F2] to toggle Auto Sample Numbering on and off.
Turn Auto Sample Numbering off when a sample cup holder
number is missing from the sequence. Enter the desired sample cup
holder number and patient information and toggle Auto Sample
Numbering back on to re-start the sequencing.
Turn Auto Sample Numbering on to generate subsequent numbers
sequentially after entering the starting sample cup holder number.
[F3] to print the entire worklist
4. Press [Esc] to return to the Primary screen.

Further Instructions for LIS Users:
Type of Interface Instructions

Uni-directional The accession number must be entered from the
Worklist Entry Screen; otherwise, the results
will not be sent to the LIS.
Bi-directional Host The accession number must be entered from the
Query Worklist Entry Screen; otherwise, the results
will not be sent to the LIS.
Note: When a patient accession number is
entered on the Worklist Entry Screen, a prompt
appears to create an LIS record for samples that
are unknown to the LIS.
Bi-directional interface Either the Worklist Entry Screen or the LIS
Data Management screen can be used to assign
sample cup numbers to accession numbers (see
page 5-16).
Create a New Patient

For each sample cup holder number, a record is opened (or created) when:
an accession number is entered into the worklist
the sample cup holder is read by the Barcode Reader
The record remains open until all Test Units associated with the sample cup
have been read by the PMT (photomultiplier tube), and the record is closed.
When a sample cup holder number is associated with an open record, and
that number is re-entered on the Worklist or Patient Entry Screen, a window
appears. From this window, a record can be edited or a new record can be
opened.
Note: The most recent record created for the sample cup holder number is
shown.

Follow the instructions in the table below:

edit this record Press [Enter].
Edit the accession number or press [Enter]
to move to the Last Name field.
Type the last name, if applicable, and press
[Enter].
create a new record for Use the down arrow key to select
another sample with the CREATE A NEW PATIENT.
same sample cup holder
Press [Enter].
number
Note: The [Delete], [BackSpace], [Insert]
and arrow keys can be used for editing or
adding sample cup information.
Note: The sample cup holder number cannot be changed after the Barcode
Reader has read it. Once all Test Units associated with a sample cup pass the
PMT, none of the data in the record can be edited since the record is now
closed.
Entering a Dilution Factor
Note: Before entering the dilution factor, make and load the diluted sample
on the IMMULITE.
To enter a dilution factor, follow the steps below:

1. Press [F4] from either the ACCESSION NUMBER or PATIENT
NAME field (on the Worklist Entry screen).
The dilution factor field appears:
Figure 34
Worklist Entry Screen showing dilution factor field

2. Type the dilution factor for that sample and press [Enter].
Note: The dilution factor must be a whole number.
3. Type the accession number or the patient data, pressing [Enter] when
finished.
The patient result is automatically corrected for the dilution factor. Both
the patient records and the printout will reflect the corrected value.
Patient Entry This menu option is used to add patient demographic information associated
with a particular sample cup, view sample results and sample status, and
identify a sample cup as an Adjustor, control, or verifier.
Note: Samples entered in the Worklist Entry Screen can also be accessed
from the Patient Entry screen.
1. To access the Patient Entry Screen, select Data Entry and Patient
Entry.
The following screen appears.
Figure 35

2. Follow instructions according to the table below:

search for samples entered Move the cursor to one of the following fields:
today • Sample Cup #
(with or without associa- • Last Name
tions in the worklist)
• Accession #
Note: A search can only be conducted from
these fields.
Enter the sample cup number, the last name,
or the accession number.
Press [F1] to search.
The sample appears, showing all the worklist
information and the sample status.
search for a sample Press [Esc] to return to the Primary screen.
entered before today
Access the Patient Review Screen by choosing
History Review and Patient Review.
Follow the instructions in the previous box.
add demographic data for Type the available information, pressing
samples [Enter] after each field.
Note: Closed records Move to the Comments field, using the arrow
(tubes already past the keys, and press [Enter] to store all
PMT) cannot be modified. demographics.
Note: Press [PgUp] and [PgDn] to view more
sample records. To access the first screen of the
day (which is always an empty Sample Entry
screen), press [Ctrl] and [Home] simultaneously.
For the last screen of the day (in sample cup
holder number order), press [Ctrl] and [End]
simultaneously.
identify a sample cup as an Type “#” in the Sample Cup # field to identify an
Adjustor Adjustor. (Refer to Identifying a Sample as an
Adjustor in Section 4: Routine Operation.)
identify a sample cup as a Type a “$” sign in the Sample Cup # field to
control identify a control. (Refer to Identifying Controls
in Section 4: Routine Operation.)
identify a sample cup as a Type a “&” in the Sample Cup # field to identify
verifier a verifier. (Refer to Running Calibration
Verifiers in Section 4: Routine Operation.)

Kit Entry When starting a new kit lot, the master curve parameters must be entered into
the IMMULITE database. In addition, component lot numbers, Adjustor
parameters, and expiration dates must also be entered. To enter this
information, use the laser scanner to read the barcodes located on the inside
panel of the kit box. The field labeled Adjustor Barcode must be entered
first.
The IMMULITE System utilizes stable, stored master curves, which
eliminate the need to generate standard curves with each run or on a daily
basis. The master curve for each kit lot is generated by DPC. The
parameters describing the curve are encoded in the kit barcodes. There are
usually four parameters, P1 through P4. Before using a new kit lot, this
barcoded information must be entered into the IMMULITE database.
A new kit lot must be adjusted before patient samples or controls are run.
Adjusting the kit lot normalizes the counts per second (cps) generated on the
lab's IMMULITE in relation to those from the original instrument (where the
master curve parameters were generated). Assays must also be periodically
readjusted (as indicated in the kit's package insert) to correct for changes in
the reagents or in the operating conditions.
Entering New Kit Lot Information

To enter new kit lot information, follow the instructions below:
1. Select Data Entry and Kit Entry. The following screen appears.
Figure 36
Kit Information Screen

Note: The cursor should be in the Adjustor Barcode field. Move the
cursor to this field (using the arrow keys) if it is not there already.
Barcoded kit lot information can be entered by either:

using the laser scanner to enter each barcode
or:
typing the series of letters and numbers below the barcodes
2. To use the laser scanner, hold the scanner approximately 4-6 inches (10-
15 cm) from the barcode so the red light beam scans the barcode.
Depending on the scanner type, either:
press the trigger to read the barcode
or:
the barcode is read automatically
A beep indicates the barcode has been read. The code appears in the first
barcode field, and the cursor moves to the next barcode field.
Note: If a laser scanner is not being used, the information must be

typed in the proper fields, pressing [Enter] after each field.
3. Enter the remaining barcodes from the kit box label.
Notes: When entering a third kit lot, a prompt appears asking the
operator to select a kit lot to replace (since two kit lots are already
entered for the Test Code).
If the operator tries to re-enter barcodes for a kit lot already residing in
the IMMULITE database, a message appears indicating the kit lot is
active. The operator is asked if he or she wants to Overwrite the
current kit or Abort. Overwrite replaces all current kit information
(including the adjustment data), with information from the kit box
barcode label. In most cases, Abort will be selected, so nothing is
modified. (Pressing [Esc] also exits without changing the kit
information.)
When all barcodes have been entered, the following information appears:
Kit and component lots
Test Code

Adjustor cps
Master curve parameters
4. To print the current Kit Information screen, press the [F10] key.
Note: Two different kit lots for the same Test Code can be run, but matching
components must be available.
For example, if Lot 1 Reagent Wedges work only with Lot 1 Test Units, but
Lot 2 Test Units are accidentally loaded, an error message will appear
regarding the mismatch and the instrument will automatically go into pause
mode along with an audible Instrument alarm.
The IMMULITE also goes into pause mode if there is no Reagent Wedge
available when a Test Unit is read at the Barcode Reader or when it gets onto
the carousel to be pipetted. The error message explains the cause of the
error.
Control Entry This option allows the operator to enter information regarding the controls
used in the lab. This control information is used for future Levey-Jennings
plots. Control information (which includes background information and
expected ranges for the controls) only needs to be entered initially.
Note: For information on plotting or printing of Control data, see Quality

Control in Section 4: Routine Operation.

Entering Control Information
To enter control information, follow the instructions below:
1. Select Data Entry and Control Entry.
Figure 37
Control Entry Screen
2. Either:
Select one of the controls listed to edit existing control information
Or:
Select Enter New to enter a new control
Note: The IMMULITE software can accommodate up to twenty-five

control definitions. Once twenty-five controls have been defined, a
control must be deleted before defining another.
3. Type the new control definitions (or modify the current definitions) for
each of the following, pressing [Enter] after each field:
control name
expiration date
control source
lot number
4. Type the Test Code, and press [Enter].
Note: The Test Code can be found on the kit label.

5. Enter the control's expected values, or lower and upper range limits,
using the instrument's default concentration units for the assay, pressing
[Enter] after each field.
These control values will be converted to reportable units on the Control
Report.
Note: To change the units of measure used for reporting results from
the default units to the alternate units, choose CONFIGURATIONS
and ASSAY SETTINGS from the Start-up menu.
These limits flag results outside the given range. They can be edited at
any time to more closely correspond to the range limits established in
your laboratory. An example of a Control Entry screen showing all the
control definition prompts appears below:
Figure 38
Control Entry screen showing control definitions
6. When finished, press [Enter] to save the changes or additions to the

Control Information Screen.
7. Add any other expected values for the assays associated with this
control, pressing [Enter] after each field.
8. Press [Page Down] to return to the previous Control Entry screen.

10. Once the control entry process is complete, follow the instructions under
Running Controls in Section 4: Routine Operation to identify the
controls. This enables the software to track the results.
Deleting Control Records

Delete control records when a control is no longer being tracked and all data
for this control has been printed (i.e. when a control lot number is changed or
a new control is used). To remove control records and their definitions,
follow these steps:
1. Select Data Entry and Control Entry.
The Control Entry Screen appears (see Figure 6).
2. Select the control to be deleted and press [Enter].
Delete control [control name]? Y/N
3. Respond by pressing either [Y] (for Yes) or [N] (for No).
After pressing: Then:

Y The following prompt appears:
Are you sure? Y/N
Press [Y] to delete the control.
N The normal control entry process begins (see
Entering Control Information on page 5-13).
LIS If the IMMULITE communicates with a Laboratory Information System

(LIS), refer to the information below to:
1. assign sample cup numbers to patient accession numbers (for Bi-
directional Batch Download and Bi-directional Host Query interfaces
only)
2. send results to the LIS
3. print results
4. delete LIS records
5. review information received from the LIS

Assigning Sample Cup Numbers to Patient Accession Numbers
If the system communicates with the IMMULITE via a Bi-directional Batch
Download or Bi-directional Host Query interface, sample cup numbers can
be assigned to patient accession numbers using the LIS Data Management
Screen (as well as the Worklist Entry Screen). Follow the instructions on the
next page:
1. Choose Data Entry and LIS.
The LIS Data Management Screen appears.
Figure 39
LIS Data Management Screen
2. Use the arrow keys to select the sample where the numbering process
should begin.
Note: Numbering or re-numbering can begin anywhere in the list.
3. Press [F2] and type the starting number.

The sample cup numbers are assigned in numerical order.
Note: If the record is closed, the following message is printed:

Accession # [number] in progress or resulted

Sending Results to the LIS
Results must be tagged to be sent to the LIS. To tag LIS results, follow the
steps below:
The LIS Data Management Screen appears (see Figure 39).
2. Either:
tag all results by pressing [F4]
Or:
tag or untag individual results by selecting the desired result and
pressing [F5]
Note: Pressing the [F4] or [F5] keys again will untag the results.
3. Press [F1] to send the results to the LIS.
Note: Once sent, the results are deleted from the LIS Data Management
Screen; however, they still appear in the Patient Entry and Patient
Review screens.
Printing LIS Results

The LIS Data Management Screen can be printed before the results are sent
to the LIS. To print this screen, follow the instructions below:
2. Press [F3].
The following menu appears, allowing you to print the Worklist by
Accession number, Sample Cup Number, Test, or Received order.
3. Select the appropriate number and the list will automatically print.

Deleting LIS Records
To delete LIS records from the LIS Data Management Screen, follow the
instructions below:
Note: You are automatically prompted to delete unsent records when

logging off the system.

2. Use the arrow keys to move to the desired record and press [F5] to select
this record.
3. Press [Ctrl] and [D] simultaneously.
A message appears asking if the record should be deleted.
4. Press [Y] to delete the record from the LIS Data Management Screen.
Note: The result will remain on both the Patient Entry and Patient
Review screens.
System The System Status Menu options include:

Status
Reagent Status
Temps/Dark Counts
Select Reports
View Error Log
The table below provides an overview of each option:
Menu Option Description
Reagent Status Displays the same screen after the Reagent Carousel
is read.
Temps/Dark Counts Used to view the current temperatures in all areas of
the IMMULITE System, as well as the last dark
count taken by the Luminometer.
Select Reports Allows the operator to select or modify the type of
report to print.
View Error Log Allows the operator to review, before logging off,
any errors that may have occurred during the current
session on the IMMULITE.

Each of these options is described in detail below:
Reagent Status Reagent Status allows the operator to review the status of all reagents
currently on-board the IMMULITE. To review the reagent status:
Select System Status and Reagent Status.
The following screen appears, which displays:
component lot numbers for the kits
the reagents’ position on the Reagent Carousel
the kit adjustment status
the kit expiration date
Figure 40
Reagent Status Screen
A kit's adjustment status is indicated by the number of days since the last
adjustment was performed for that kit lot. If an adjustment is overdue, a
warning message displays.
In the example above, it has been 31 days since the last adjustment. The
adjustment period for FSH is 28 days; therefore, this kit is overdue for
re-adjustment by 3 days.
Temps/Dark This option allows the operator to view the current temperature readings for
Counts certain areas of the System and the last dark count taken by the PMT.
Temps/Dark Counts also displays observed temperatures (averaged over
the past five minutes) and acceptable temperature ranges. To display
temperature information:
1. Select System Status and Temps/Dark Counts.
The screen displays the following information (see Figure 41):
latest temperatures for each area of the instrument
the normal temperature range
the average over the last ten minutes
the latest counts per second (cps) measured during the last session

(For more information on these counts, refer to Internal
Calculations in Section 8: Data Reduction and the
Chemiluminescent Reaction.
Figure 41
Temperature Information Screen
If a temperature exceeds the specified range, an error message appears.

In addition, the results will be flagged on the printout.
Note: Every time the [Space Bar] is pressed, a new temperature

reading is taken.
2. To print the data, press [F10].

Select Reports Report printing options that were specified in the initial startup procedure
included: whether or not to print reports, and (if so) which format to use
(short or long).
Note: During start-up, if the operator pressed [Enter] when asked whether
to print long or short reports, the system defaults to the long report format.

Select Reports is used to activate or change the report printing option while
the IMMULITE is running. Ordinarily, reports are printed when all the
assays for a particular sample cup are complete. To print the reports later,
turn report printing off from the Select Reports screen. Follow the
instructions below to change report printing.
1. Select System Status and Select Reports.

Figure 42
Report Selection Screen
2. Select the desired report option by pressing [1], [2], [3], [4] or [5].
The available report formats are described below.
Short Reports
Multiple test results for each sample are printed on the same page. The Short
Report includes:
sample cup holder number
patient accession number
last name
run date
the Test Code (abbreviated assay name)

the concentration result (dose) and its units of measure
lot numbers for the Reagent Wedge (preceded by an R)
lot numbers for the Test Unit (preceded by an T)
the observed response (in counts per second)
time read at the PMT
the dilution factor
Low and High flags (if applicable)
Note: Remember that these flags, which are typically used to select
patient results falling outside a reference range, can be edited from the
Start-up menu by selecting CONFIGURATIONS and ASSAY
SETTINGS.
An example is shown below:
Figure 43
Short Report
Sample Cup # 64
Dilution Factor x 1
Accession # 9311180825
Patient Name Smith J
Run Date 01/18/2001
T4 5.1 ug/dL R 7 T 15 39,911,096 4:06:15 PM
TSH 1.5 mIU/L R 8 T 8 150,032 4:36:15 PM
Note: Error reports are also printed when the error occurs.
Long Reports
A full page is devoted to each sample (see Figure 44). The Long Report
format includes:
the items listed above for the Short Report
a personalized heading
patient demographics
assay range types
Note: The Long Report can be customized by selecting

CONFIGURATIONS and REPORT FORMAT from the Start-up menu.

Figure 44
Long Report Sample
GENERAL HOSPITAL
DATE: 01/15/2001 OPERATOR: gaj
Sample # 5 Dilution Factor 1
Accession # 47682 Soc Sec # 141-48-7023
Patient Name Jones, T. Doctor Mantle
Birth date 05/18/1922 Sex M
Comments
TEST RESULTS REAG.LOT TEST LOT ADJ.STAT ANL.TIME
TSH 3.62 uIU/mL 3:33:45 PM
T4 10.1 ug/dL 3:03/27 PM
TEST LOW LIMIT HIGH LIMIT
TSH EUTHYROID 0.4 - 4.0

HYPERTHYROID 0.0 - 0.01
HYPOTHYROID 7.1 - 75.0
T4 normal range 0.4 - 24.0

Turn Off Reports
This option turns off report printing. The reports can be printed later.
Print Reports Not Yet Printed Today

This option prints all results that have not yet been printed. Before activating
this option, a report format (long or short) must be selected.
Note: This option cannot be selected while the IMMULITE is processing

Test Units.
Print Reports by Date and Time

Select this option to reprint reports. Before activating this option, select a
report format (long or short).
Enter the Start Date and Start Time for the desired results.
Notes: This option cannot be selected while the system is processing Test
Units.
Start Time refers to when the records were opened (read by the Barcode
Reader). It does not refer to when the results were generated.
Individual screens, as well as patient records, displayed on the Primary
screen can be printed at any time by pressing [F10].
Consolidating Patient Reports

Patient reports can be consolidated using the export program. This program
allows the operator to access data by test time and date and test type. The
information can be viewed, printed, or saved in ASCII format to a diskette.
The ASCII file is compatible with other software (i.e. spreadsheets).
Note: Export is not a menu option. You must exit the IMMULITE software
to run this program.
To run the export program, follow the steps below:

1. From the Start-up menu, select EXIT TO DOS.
2. Type export and press [Enter].

3. Either type 3 characters or press [Enter] to skip this option.

4. At the Enter the starting date prompt, type the starting date (the year
must be four digits) for generating the data or press [Enter] to accept the
default start-date.
Note: Information for the past 31 days can be generated. You can
generate either a single day or several days at once.

5. At the Enter the ending date prompt, type the ending date (the year
must be four digits) or press [Enter] to accept the default.
Note: The test time is the time the sample cup was read at the Barcode
Reader or entered into the worklist, not the time the Test Unit was
measured by the PMT.
6. At the Enter the starting time prompt, type the starting time for
generating the data or press [Enter] to accept the default start-time.
7. At the Enter the ending time prompt, type the ending time or press
[Enter] to accept the default.
8. At the Enter the test type prompt, type the Test Code or press [Enter]
to accept the default (which is all test types).
9. Results for controls, Adjustors, and patients can be printed together or
separately. Select either:
1 - Control
2 - Adjustors
3 - Patients
4 – All
The following screen appears, giving the option to print, display, or put
the data on disk:

10. Type the appropriate letter (P, D, A, B, or C), as desired.
The following is an example of export data:
The export output file includes:

date
sample cup holder number
Test Code
accession number
patient last name
dose (concentration result)
dilution
response (in cps)
kit lot
analysis time

11. Press [Enter].
12. Press [N] to exit or [Y] to continue retrieving data.

If [N] was selected, the c: prompt reappears. Type start and press
[Enter] to access the Start-up menu.
View Error Log This option is a valuable diagnostic aid for reviewing any errors that
occurred during the current operating session. Errors appear on the screen
and are printed at the time they occur (even if report printing has been turned
off).
Viewing the Current Session's Errors

To view the current session's errors:
1. Select System Status and View Error Log.

A sample Error Log screen appears below:
Figure 45
Error Log Screen
2. Use the [PgDn] key to scroll through the log.

See the Error Message / Solution Table in Section 11:
Troubleshooting for more information regarding IMMULITE error
messages.
After logging off the system, the current session's error log is added to a
Cumulative Error Log. This on-going log is a standard ASCII file. The
file is cumulative for the entire history of the instrument.
Viewing the Cumulative Error Log

To view the cumulative error log:
1. From the Start-up menu, choose Exit to DOS.
2. Type status and press [Enter].
The Cumulative Error Log appears:

Figure 46
Cumulative Error Log Screen
3. Press [Page Up] or [Page Down] to view the errors for the desired date
or press [Ctrl] [Page Down] to view the most recent entry.

4. To select and print a portion of the Error Log:
Press [F4] to begin marking.
Use the arrow keys to select the desired area.
Press [F3] to print this area.
Caution: Remember to select a portion of the Error Log before

printing. Failure to do so will result in a cumulative printout of the
entire Error Log.
Note: To unmark the area, press [F4] again. Continue viewing errors
by pressing [Page Up] or [Page Down].
5. Press [F1] to quit.

The following message appears: Lose changes Y/N
6. Press [Y] for yes.
The following message appears: Quit E16 Y/N
7. Press [Y] for yes.
You will return to the following prompt: c:\Cirrus\IMM>
8. Type start to return to the Start-up menu.
History The History Review Menu options include:

Review
Patient Review
Adjustor Review
Review Controls
The table below provides an overview of three options.
Menu Option Purpose

Patient Review To review all patient data generated on an individual
basis for the past 31 days.
Adjustor Review To review all Adjustor data generated for the past 31
days.
Review Controls To review all control data generated for the past 31
days.

Each of these menu options is described in detail below.
Patient Review Patient Review allows the operator to review all patient data generated for
the past month.
To access the Patient Review Screen, follow the steps below:
1. Select History Review and Patient Review.
Figure 47
Patient Review Screen (with blank fields)
At first, the fields are empty. A search can be performed using any of
these fields:
Sample Cup #
Accession #
Last Name
The search is the quickest using Accession # or Last Name; however,
only use these fields if the information was entered and associated with a
sample cup holder number through the Worklist or Patient Entry screens
when the sample was tested.
2. Use [PgDn] and [PgUp] to scroll through the records, looking for the
date and time of analysis and the desired record.
3. Search for a patient by placing the cursor in one of the search fields,
Sample Cup #, Accession #, or Last Name.
4. Type the appropriate information, and press [F1] to search.
CAUTION: Do not press [Enter] before pressing [F1].
When test results for that patient are found, the results will appear. (An
example is shown on the next page.)

Figure 48
Patient Review Screen

Adjustor This option allows the operator to review all Adjustor records generated for
Review the past month.
To view the Adjustor Display Screen, follow the steps below:
1. Select History Review and Adjustor Review.
The Adjustor Display Screen appears.
Figure 49
Adjustor Display Screen
2. Use [PgDn] and [PgUp] to browse through the Adjustor records or press
[Ctrl] [End] to view the most recent entry.
Note: Records are in chronological order.

Review This option allows the operator to review all individual control records
Controls generated. To access the Control Display Screen, follow the steps below:
1. Select History Review and Review Controls.

The Control Display Screen appears:
Figure 50
Control Display Screen
2. Use [PgDn] and [PgUp] to browse through each control record or press
[Ctrl] [End] to view the most recent entry.
Note: Records are in chronological order.

Log Off To safely exit the IMMULITE software, the Log Off option is used.
CAUTION: Turning off the computer’s power or resetting the computer

without first logging off can damage critical files. The following message
appears the next time the software is initialized:
Database needs repair in line 0 of module Pcxxx at
address xxxx:yyyy. Hit any key to return to the
system.
Refer to this error message in the Error Message / Solution Table in
Section 11: Troubleshooting for further instructions.
To log off the system, select Log Off and Log Off System.
If tests are in progress when Log Off is selected, the following message
appears:
There are tubes on the system. Log Off anyway?
Y/N.
If you press: Result:

[Y] The following message appears:
Delete records without answers? Y/N
Typing a Y again will remove the open, incomplete
records. The results for these Test Units will be lost.
[N] The Primary screen will re-open without adversely
affecting the assays in progress
If the IMMULITE is connected to a LIS (Laboratory Information System),

and there are records that have not yet been sent to the LIS, the following
message appears:
Delete the LIS Worklist (Y/N?)
If you press: Result:

[Y] The LIS records are deleted
[N] The LIS records remain in the system to be sent to the
LIS at another time
After logging off, the Start-up Menu appears.

Section 6: Routine Maintenance
Introduction This section describes the daily, weekly, monthly, and semi-annual
maintenance requirements and procedures. This section also includes as-
needed maintenance. The operator can find Maintenance Records in
Appendix D, which can be copied and used to track IMMULITE
maintenance.
CAUTION: Do not remove the front, side, or top panels of the Instrument.
Due to the risk of electrical shock, these panels are only to be removed by a
Field Service Engineer. There are no user serviceable parts in these areas.
IMPORTANT: To reduce the risk of contamination, wear gloves while

performing maintenance procedures.

Daily The table below lists maintenance to be performed on a daily basis and
Maintenance the accompanying instructions.
Daily Instructions
Maintenance
Check printer Ensure there is enough paper in the printer for the entire run.
paper Refill if necessary.
CAUTION: PC Communication errors can occur when the
printer runs out of paper.
Check the 2-liter Note: Approximate water usage = 3 mL per Test Unit. Water
water container can be refilled during a run without compromising IMMULITE
(blue cap) operation.
If the water is low or empty . . .
Remove the cap from the 2-liter water bottle.
CAUTION: Do not touch the submerged portion of the
tubing or the End of Line Filters. If the IMMULITE is in
operation, do not lift the tubing completely out of water.
Holding the cap to one side, with the tubing still inside the
container, refill the water container with distilled water only.
Ensure the End of Line Filters are in place.
Re-tighten the cap and ensure the blue fitting on top of the
cap is tight.
Note: See Appendix C: Operational Precautions for more
information.
Check 1-liter Note: Approximate wash solution usage = 1 mL per Test Unit.
probe wash Probe wash can be refilled during a run without compromising
container IMMULITE operation.
(yellow cap)
If the probe wash is low or empty . . .
Using a clean, 1-liter bottle, dilute the Probe Wash
concentrate by adding 900 mL of distilled water to one
bottle of probe wash concentrate (catalog #LPWS2). Swirl
gently to mix. Do not touch the submerged portion of the
tubing or the End of Line Filter.
Remove the cap from the empty wash container, hold the
cap to one side, and pour in the fresh wash solution. Ensure
the End of Line Filters are in place.
Re-tighten the cap and ensure the yellow fitting on top of the
cap is tight.

Daily Instructions
Maintenance
Check substrate Note: Approximate substrate usage = 0.20 mL per Test Unit.
bottle Substrate can be replaced during a run without compromising
IMMULITE operation.
If the bottle is empty, change the substrate, following the
instructions below:
To remove the substrate bottle from the dispensing station,
firmly hold the bottle and pull upwards.
Note: To prevent contamination, do not touch the substrate
spike.
Pull the plastic cap off the new substrate bottle, invert the
bottle, and place it on the spike upside down, puncturing the
rubber stopper.
If the level of substrate in the reservoir is below the fill-line,
squeeze the gray button on the front of the substrate module
until the reservoir reaches the proper level.
Notes:
1. To prevent contamination, do not touch the top of
the substrate bottle (after removing plastic cap).
2. Ensure the bottle is firmly seated on the spike.
3. Do not over-fill the Substrate Reservoir.
Empty waste Empty the liquid waste bottle and the Test Unit waste container.
Tighten syringes Ensure that the thumbscrews located beneath the syringes are
/ thumbscrews tight. Ensure that the top of the syringe barrels are “finger
tight.”
Prime syringes Press the Syringe Prime button at least five times. Hold the
button for at least two seconds to activate the prime cycle.
Refer to Figure 18 in Section 4: Routine Operation for the
location of the Prime button.
To ensure that the syringes and lines are free of bubbles,
continue priming.

Daily Instructions
Maintenance
Check substrate Remove the thumbscrew holding the Substrate Heater and
dispensing water nozzle.
nozzle
Lift the Substrate Heater vertically and tilt backward. Check
for white precipitate (dried substrate) at the end of the
Substrate Heater nozzle.
Note: To ensure the wires behind the Substrate Heater do not
become loose or disconnected, do not pull the Substrate Heater
all the way.
Gently wipe the nozzle and nozzle seat with a clean swab,
dampened with distilled water, or with a lint-free, moist
tissue.
Note: Avoid touching the tip of the nozzle against any surface
that could contaminate the tip (such as bare skin or a
contaminated glove). Also, do not let the nozzle tip rest or drop
against a hard surface, which could damage the tip and alter the
dispense pattern.
Check substrate Prime the reservoir to the fill-line by squeezing the gray
level button on the front of the substrate module. (This can be
done while the Analyzer is running.)
Note: Each Chemiluminescent Substrate bottle contains 105
mL of substrate, which is enough for 500 tests. If the substrate
level drops 1.5 mL below the fill-line, an alarm, a printed
message, and an error message on the monitor alert the operator
that the reservoir is low. The IMMULITE goes into
AutoPAUSE mode. However, should the reservoir empty
completely, there is enough substrate to complete 25 additional
tests.
Prime the Press and hold the Substrate Pump Prime button to
substrate and dispense 400 µl of substrate. The Cirrus Substrate Pump
water pumps dispenses 200 µl of substrate (refer to the Perform Daily
Maintenance section in Section 4: Routine Operation.)
Perform this sequence at least 5 times until any air bubbles
are removed from the line.
Press and hold the Water Pump Prime button to dispense
400 µl of water. The Cirrus Water Pump dispenses 200 ∝l
of water (refer to the Perform Daily Maintenance section
in Section 4: Routine Operation.) Perform this sequence
at least 5 times until any air bubbles are removed from the
line.
Note: Must be done daily to ensure the substrate and water
dispense in a straight and steady stream without splattering,
drips, or hanging drops.

Daily Instructions
Maintenance
Back up the Note: Backup is part of the daily shutdown procedure.
IMMULITE
From the Primary screen, choose Log Off and Log off
database
System.
(Backup must be
done once in a From the Start-up menu, select BACKUP/RESTORE.
24-hour period.)
Select BACKUP DATABASE and press [Enter].
Press [Y] to continue. Another message appears, stating that
this is the last chance to abort the procedure.
Press [Y] again to initiate the backup procedure.
Insert a 3.5-inch, formatted disk into the disk drive and press
any key to continue.
Press [Y] to overwrite the current information on the
diskette.
Note: A prompt may appear to insert another diskette.
A final message: Backup Complete, is displayed and the
Start-up menu reappears.
Note: Dedicate two, 3.5-inch diskettes for backup,
alternating the diskettes daily. You may need more than one
diskette for daily backup. Refer to Section 4: Routine
Operation for more information.

Daily Instructions
Maintenance
Clean the Probe Note: The probe is cleaned after backing up the system. A
Probe Cleaning Kit is required to complete these instructions.
Pipet 2 mL of Probe Cleaning Solution into a Probe
Cleaning Wedge.
CAUTION: Probe Cleaning Solution is an alkaline
material. Wear gloves while handling this solution.
Place the uncapped Probe Cleaning Wedge into Position 1
on the Reagent Carousel.
From the Start-up menu, select Diagnostics and press
[Enter].
Select Diagnostics again and press [Enter].
Use the arrow keys to select the PROBWASH program and
press [Enter].
After the download is complete, press [Enter] again.
Press GO on the IMMULITE display panel to continue.
When the PROBWASH diagnostic is complete, the
PROBANGL diagnostic downloads automatically. The
message Press Go to perform PROBE ANGLE
appears on the Display panel.
Press GO on the IMMULITE display panel to run the
PROBANGL diagnostic. Ensure the probe dispenses water
in a straight and steady stream.
Note: If the probe dispenses water at an angle, please contact
DPC Technical Service.
After 10 priming cycles, the probe angle test will stop
automatically, and DPC IMMULITE Idle Select
RUN IMMULITE to begin appears on the Display
Panel.
Remove the Probe Cleaning Wedge, discard the remaining
Probe Cleaning Solution, and rinse the wedge with distilled
water. Store the vial and wedge in the Probe Cleaning Kit
for future use.
Press [Esc] to return to the Start-up menu.
Select RUN IMMULITE or START TURBO to resume
normal operation.

Weekly On a weekly basis, perform the following:
Maintenance
Remove the fan filter on the right side of the instrument. If the fan filter
is dirty, clean it with mild soap and water.
Dry the fan filter and reinstall.
Every Two Cleaning the water bottle helps to prevent the growth of algae or bacteria.
Weeks These procedures should be performed every two weeks. However, spills
should be cleaned immediately.
Cleaning Water To prevent the growth of algae or bacteria, rinse the water bottle and cap
Bottle with 70% isopropyl alcohol and rinse thoroughly with distilled water. After
replacing the bottle, ensure the blue cap and line connect to the (blue) water
bottle.
Note: To prevent the lines from emptying, keep them elevated.

Monthly Monthly maintenance items are listed below and explained in the
Maintenance instructions that follow:
Clean probe wash bottle
Replace end-of-line filters
Clean the Load Platform, Sample Collection Tray, and sample pipetting
area (if necessary)
Change substrate spike
Change small syringe tip
System Decontamination
Test the water for contamination
Cleaning Probe To prevent the growth of algae or bacteria, clean the probe wash bottle and
Wash Bottle cap with 70% isopropyl alcohol followed by distilled water. After replacing
the bottle, ensure the yellow cap and line connect to the (yellow) probe
wash bottle.
Note: To prevent the lines from emptying, keep them elevated.
Replacing End- Using a lint-free tissue, replace the End-of-Line Filters on the probe wash
of-Line Filters and distilled water filters. Ensure that the new filters are snug but not too
tight.
Cleaning Load If necessary, decontaminate these areas using Surface Disinfectant and a
Platform, damp cloth. The Surface Disinfectant is available from DPC (Catalog
Sample Number: IG20).
Collection Tray,
and Sample
Pipetting Area
CAUTION: Do not use bleach solutions on IMMULITE surfaces.

Replacing the To replace the substrate spike, follow the instructions below:
Substrate Spike
1. Remove the substrate bottle by pulling it upward.
2. Remove the two screws on either side of the spike using a phillips-head
screwdriver (see Figure 51).
3. Remove the substrate vial support assembly.
4. Grasp the spike and remove it from the manifold block.
CAUTION: The O-ring may stick to the bottom of the vial support
assembly. If this occurs, be sure to remove it. (Normally, it rests on the
spike tip.) Do not use metal tools. Metal interferes with substrate
activity. Instead, use plastic tools to remove the O-ring.
5. Remove the new spike from its sterile packaging.

6. Remove the blue fitting from the base of the spike.
Note: Keep the tip guard on and do not touch the tip of the spike, since
this could cause contamination.
7. Reseat the spike in the manifold block by positioning the air filter arm of
the spike into the cutout in the manifold block.
8. Remove the tip guard and place a new O-ring on the spike tip.
9. Reposition the vial support, aligning the screw holes.
10. Re-tighten the screws.
11. Replace the substrate bottle.

Figure 51
The Substrate Spike

Changing the To change the small syringe tip, follow the instructions below:
Small Syringe
Tip IMPORTANT: To prevent contamination, gloves must be worn while
handling the syringes and Teflon tips.
1. From the Start-up menu, select DIAGNOSTICS and press [Enter].

2. Select DIAGNOSTICS again and press [Enter].
2. Use the arrow keys to select the SCHANGE program and press [Enter].
3. After the file has downloaded, press [Enter].
4. Remove the Sample Collection Tray.
Note: Refer to Section 4: Routine Operation to identify the syringe

assembly on the IMMULITE.
5. Loosen the thumbscrew beneath the small syringe.

6. Press GO (on the IMMULITE) when instructed to do so. The syringes
will move partially down and stop.
7. Unscrew the syringe from the leur lock and withdraw the plunger from
the syringe barrel.
8. Using a lint-free wipe, firmly grasp the small syringe tip, carefully twist,
and pull the tip simultaneously to remove it, exposing the metal tip of the
plunger.
9. Place a lint-free wipe on a flat surface. Press a new Teflon tip onto the
syringe plunger by pressing it onto the lint-free wipe. Ensure that the tip
is seated evenly on the plunger by carefully applying even pressure to
the tip.
CAUTION: Since the syringe plunger bends easily, carefully apply

even pressure when re-seating the tip.
10. Rinse the syringe barrel with distilled water and re-assemble the syringe.
11. Re-tighten the syringe evenly into the microvalve by turning
counterclockwise until it is finger-tight.
12. Press GO (on the IMMULITE) to move the syringes to the home
position.

13. Once the syringes are in the home position, re-tighten the thumbscrew
into the base of the small syringe plunger.
14. Press the ALARM MUTE and GO buttons (on the IMMULITE display
panel) simultaneously to clear the diagnostic program from the
instrument display panel.
15. Using the Prime diagnostic program, prime the syringe for 10 to 15
minutes to ensure all air is removed. In addition, the priming will coat
the internal surface of the syringe barrel with Teflon®. This teflon-
coating process is necessary to assure precision.
From the Start-up menu, select DIAGNOSTICS and press [Enter].
Select DIAGNOSTICS again and press [Enter].
Use the arrow keys to select PRIME and press [Enter].
When downloading is complete, press [Enter].
Press GO on the IMMULITE display panel to begin priming the
syringes
16. After 10 minutes, press ALARM MUTE and GO simultaneously on the
IMMULITE display panel to stop the priming program.
Note: Priming is done automatically, by running a diagnostic program.

Always prime the syringes with liquid in the barrels. Priming a dry
syringe damages the Teflon tip.
17. Press [Esc] to return to the Start-up menu.

18. Select RUN IMMULITE or START TURBO to resume normal
operation.
Testing the Upon installation of the IMMULITE Analyzer, the laboratory-distilled water
Water Supply supply will be tested for alkaline phosphatase contamination. Contamination
can affect the IMMULITE’s performance by altering the matrix during the
immunological reaction, or by increasing the post-wash counts per second
(cps). It is recommended that the water supply be tested at least once a
month or whenever contamination is suspected.
Room temperature distilled water must be used in the IMMULITE water
reservoir. The water test procedure involves using two IMMULITE
diagnostic programs:
WATERTST
WATERTPM

Use the Water Test Kit (catalog number: LKWT) in conjunction with these
diagnostic programs to perform the water tests. Refer to the following pages
for instructions on using the WATERTST and WATERTPM diagnostic
programs and for evaluating their results.
WATERTST
The WATERTST diagnostic program tests the water from any source. Water
should be tested before priming water from a new source through the
IMMULITE system or when contamination of the water source is suspected.
The procedure may also detect any contamination present in the water bottle.
1. Ensure the printer is on-line.
2. Prime the Substrate Nozzle using the SOLE2S diagnostic program, to
ensure that it is dispensing properly.
Note: Before priming, position Substrate Nozzle over empty container.
3. Select two new and empty water Test Units.

4. Manually pipette 50 µL of water directly from the source or from the
water in the water bottle into the first Test Unit only. Place this Test
Unit onto the load platform followed by an empty Test Unit.
5. Load both Test Units onto the Load Chain. Place the Test Unit
containing the water at the beginning of the Load Chain (so it enters the
Barcode Reader first).
6. From the Start-up menu, choose DIAGNOSTICS and press [Enter].
7. Select DIAGNOSTICS from the next menu and press [Enter].
8. Use the arrow keys to select WATERTST, and press [Enter] to
download the file.
9. When downloading is complete, press [Enter].
10. Press GO on the IMMULITE display panel when prompted. The
IMMULITE begins the WATERTST diagnostic program. Two hundred
µl of substrate is dispensed into each Test Unit. The Test Units are then
moved into the Luminometer, incubated for 10 minutes, and read by the
PMT.
10. Once the Test Units start moving on the Load Chain, press [Esc] and
choose EXIT TO DOS.
11. At the DOS prompt, type water and press [Enter].

Note: It is suggested that new water Test Units are used to test the
water supply.
12. Type [1] to select the WATERTST and press [Enter].

The screen will post a “Waiting for data…” message. In approximately
10 minutes, the first Test Unit will be read by the PMT.
13. Once the readings print, press [Esc] to exit.
14. Type start and press [Enter] to return to the IMMULITE Start-up
menu.
15. Refer to Acceptance Criteria on page 6-16 to determine the outcome of
this test.
WATERTPM
The WATERTPM diagnostic program tests the water dispensed from the
probe and the Wash/Spin Station. Use this procedure when contamination
within the system is suspected (after ruling out contamination from both the
source water and the water bottle).
1. Ensure that the printer is on-line.
2. Prime the Substrate Nozzle using the SOLE2S diagnostic program and
the Water Nozzle using the SOLE1W diagnostic program, to ensure that
they are dispensing properly.

3. Select four new and empty water Test Units. Do not pipette any water
into the Test Units.
4. Place the four water Test Units onto the Load Platform.
7. Use the arrow keys to select WATERTPM and press [Enter].
8. When the download is complete, press [Enter].
9. Press GO on the IMMULITE display panel when prompted. The
IMMULITE begins the WATERTPM diagnostic program.
The following process occurs:
Water from the probe is pipetted into the first Test Unit.
Water from the wash line is dispensed into the second Test Unit.
Water from the second Test Unit is pipetted into the third Test Unit.
200 µl of substrate is added to the first, third, and fourth Test Units.
After a 10-minute incubation in the Luminometer, readings for each
Test Unit are taken by the PMT.
9. Once the Test Units start moving on the Load Chain, press [Esc] and
choose EXIT TO DOS.
10. At the DOS prompt, type water and press [Enter]. The following
screen appears:

11. Type [2] to select WATERTPM and press [Enter].
The screen will post a “Waiting for data…” message. In approximately
10 minutes, the first Test Unit will be read by the PMT.
12. Once the readings print, press [Esc] to exit to DOS.
Note: The first result is for the water from the probe, the second is for
the water from the Wash/Spin station, and the third is for the Test Unit
containing substrate.
13. Type start and press [Enter] to return to the IMMULITE Start-up
menu.
14. Refer to Acceptance Criteria to determine the outcome of this test.
Acceptance Criteria
The criteria for acceptable water tests are listed below.
Note: See Figure 52 and Figure 53 for examples of acceptable test

results.
1. For all water tests, the cps for each Test Unit should be in the range of
4,500 – 9,000 cps.
If the cps are . . . It is possible that . . .
< 4,500 the substrate volume was insufficient
> 9,000 alkaline phosphatase contamination is possible
In either case, perform the test again to confirm the results.

If the water test results drop below 9000 cps, use an upper limit of
9000 cps to judge whether your IMMULITE is contaminated.
If the water test results drop but remain higher than 9000 cps,
decontaminate again to ensure that the contamination was completely
removed.

If the water test results do not drop and they remain above 9000 cps,
the instrument is one of a small number of instruments that exceed
9000 cps but is not contaminated. In such a case, average the CPS of
several successive water tests. Calculate the mean and SD of those
tests and use the mean and 2.5 SD as the maximum limit.
If the cps is consistently outside the 4,500 cps to 9,000 cps range,
call Technical Services.
2. For WATERTST, refer to last line of results:
External water source – Substrate Only = XXX cps
If the value of XXX above is lower than –650 cps, insufficient substrate
may have been dispensed into one of the Test Units. This could be due
to a clogged nozzle. Check both Test Units to determine if they contain
enough substrate. If the value of XXX above is above 2000 cps, DO
NOT use this water source on the IMMULITE Analyzer. Locate a new
water source, and test this new source.
CAUTION: If this water source was used, the system must be

decontaminated.
3. For WATERTPM, refer to the last two lines of results:

Probe Water – Substrate Only = XXX cps
Pump Water – Substrate Only = XXX cps
If the value of XXX for either equation is lower than –650 cps,
insufficient substrate may have been dispensed into one of the Test
Units. This could be due to a clogged nozzle. Visually check all Test
Units to determine if the liquid level is equally distributed among the
Test Units. If the value of XXX above is above 2000 cps, perform the
test again to confirm these results. Decontaminate the system and/or call
Technical Services.

Sample of Acceptable Water Test Results
Acceptable test results for WATERTPM and WATERTST tests are shown
below.
Figure 52
Sample of Acceptable Water Test (WATERTST)
External water source = 6000 cps

Substrate Only = 5900 cps
External water source – Substrate Only = 100 cps
Figure 53
Sample of Acceptable Water Test (WATERTPM)
Probe Water = 6000 cps

Water dispensed from the pump = 5800 cps
Substrate Only = 5900 cps
Probe Water – Substrate Only = 100 cps

Pump Water – Substrate Only = -100 cps
If the system is contaminated, decontaminate the system using the following

procedure.
System If contamination of the system is suspected, perform water testing
Decontamination followed by the system decontamination procedure. Otherwise, perform
system decontamination monthly.
1. Place the IMMULITE in idle by pressing ALARM MUTE and GO

simultaneously.
2. Obtain the following supplies:
Probe wash (Part No. LPWS2)
End-of-Line filters (Part No. 10-500499)
Gloves
Sterile cotton swabs (Q-Tips)

3. Empty the liquid waste from the waste container.
4. Remove and discard the End-of-Line filters from the water bottle.
5. Remove, empty, and set aside the water container.
6. Place at least 300 mL of diluted probe wash (10X dilution) into another
clean container.
Caution: Do not use the water container for this procedure. Rather, use
another clean container.
7. Place the water lines into the clean container with the fresh probe wash
solution.
8. From the Start-up menu, choose DIAGNOSTICS and press [Enter].
10. Using the arrow keys to select DECON and press [Enter] to download
the file.
11. When the download is complete, press [Enter].
12. Press GO on the IMMULITE display panel when prompted.
13. Run the program for five minutes to ensure the probe wash has
thoroughly penetrated the system.
14. Press ALARM MUTE and GO simultaneously to stop the DECON
program.
15. Allow the system to sit for fifteen minutes. During this time, continue
with steps 16 and 17.
16. Place 100mL of 70% isopropyl alcohol into the original water container.
Place the water lines into the original water container and tighten the
cap. Shake well to ensure the alcohol contacts all surfaces in the
container, including the cap.
17. Discard the alcohol and rinse the water container and cap with distilled
water at least five times (with the cap on) to ensure all surfaces have
been thoroughly rinsed.
18. Install new water End-of Line filters.
Note: Un-powdered gloves must be worn when handling the new filters
since direct contact with the skin may contaminate the filters.

19. Refill the water container with fresh distilled water.
Note: Prior to filling the container, the water must be tested using the
WATERTST diagnostic program.
20. Using a sterile cotton swab moistened with 70% isopropyl alcohol, wipe
the accessible surface of the wash station to help remove any growth.
21. After 15 minutes, run the DECON1 diagnostic program with fresh
distilled water. Prior to running the DECON1 program, ensure at least
300 mL of reconstituted Probe Wash is available in the Probe Wash
bottle and the Probe Wash bottle is connected to the Probe Wash line.
Select DECON1 and press [Enter].

When the program has downloaded, press [Enter] again.
Press GO on the IMMULITE display panel when prompted.
When the program is finished (approximately fifteen minutes) the system
is ready to process assays.
22. Re-test the system for contamination using the WATERTPM diagnostic
program.
23. If the cps does not fall within the ranges described in the Acceptance
Criteria section, call DPC Technical Service for assistance.

Semi-annual Before performing semi-annual maintenance, refer to Section 4: Routine
Maintenance Operation to identify the pump assembly on the IMMULITE.
Changing the Follow the instructions below to change the large syringe tip:
Large Syringe
Tip
Note: To prevent decontamination, wear gloves while handling

syringes and Teflon tips.
3. Use the arrow keys to select the SCHANGE program and press [Enter].
4. After the file has downloaded, press [Enter].
5. Remove the Sample Collection Tray.
6. Loosen the thumbscrew beneath the Large Syringe.
7. Press GO (on the IMMULITE display panel) when instructed to do so.
The syringes will move approximately halfway down and stop.
8. Unscrew the syringe from the luer lock valve, and withdraw the plunger
from the syringe barrel.
9. Remove the large syringe tip by:
Carefully slice the tip with a laboratory knife to expose the metal tip
of the plunger, remove the remainder of the tip and the O-ring
located inside the tip.
10. Replace the O-ring.
11. Place a lint-free wipe on a flat surface. Press a new Teflon tip onto the
syringe plunger by pressing it onto the lint-free wipe. Ensure that the tip
is seated evenly on the plunger by carefully applying even pressure to
the tip.
12. Wet the large syringe tip with probe wash.
13. Rinse the syringe plunger with distilled water and re-assemble the
syringe.

14. Re-tighten the syringe evenly into the luer lock valve by turning
counterclockwise until it is finger-tight.
15. Press GO on the IMMULITE display panel to move the syringe to the
home position.
16. Once the syringes are in the home position, re-tighten the thumbscrew
into the base of the large syringe plunger.
17. Press the ALARM MUTE and GO buttons simultaneously on the
IMMULITE display panel to clear the diagnostic program.
18. Using the PRIME diagnostic program, prime the syringes for 10 to 15
minutes to ensure all air is removed.
Note: Priming coats the internal surface of the syringe barrel with
Teflon, which is necessary to assure precision.
Note: Always prime the syringes with liquid in the syringes. Priming a
dry syringe damages the Teflon tip.
From the Start-up menu, select DIAGNOSTICS and press [Enter].

Select DIAGNOSTICS again and press [Enter].
Use the arrow keys to select PRIME and press [Enter].
When downloading is complete, press [Enter].
Press GO on the IMMULITE display panel to begin priming the
syringes.
After 10 minutes, press ALARM MUTE and GO on the
IMMULITE display panel to stop the priming program.
operation.

As Needed The maintenance items listed and described below are performed on an as
Maintenance needed basis or when requested by a Technical Service Representative.
Cleaning the Sample Barcode Reader Drive Wheel O-ring

Changing the Pipetting Probe
Replacing fuses
Cleaning Follow the instructions below to clean the Sample Barcode Drive Wheel
Barcode Drive O-ring:
Wheel O-ring
2. Use the arrow keys to select the BCODEON program and press [Enter].
3. After the file downloads, press [Enter] again.
4. Press GO (on the IMMULITE) to start the program.
5. Dampen a lint-free tissue or a cotton swab with distilled water, and hold
it gently against the rotating orange O-ring on the sample cup holder/
Test Unit barcode drive wheel for two to three full revolutions.
6. Press ALARM MUTE and GO (on the IMMULITE) simultaneously to
stop the program.
operation.

Changing the Follow the instructions below to change the pipetting probe.
Pipetting Probe
1. Disconnect the Teflon fitting for the probe tubing at the circular T-
junction.
2. Un-screw the ferrule located on top of the probe block (see Figure 54)
and remove the probe.
3. Insert the probe vertically down through the block and the support arm.
Note: Care must be taken not to damage the tip when inserting it
through the bottom hole in the probe block.
4. Carefully thread the probe tubing through the notch in the black vanity
panel. Allow only enough tubing in front of the vanity panel to reach all
pipetting positions without stretching. The remainder of the tubing
should hang behind the vanity panel. Place the brown O-ring on the
probe tubing directly behind the notch. This ensures that the proper
amount of tubing stays in front of and behind the vanity panel.
5. Finger-tighten the ferrule located on top of the probe block (see Figure
54).
CAUTION: Be careful not to bend the level-sense cable.
6. Connect the Teflon fitting for the probe tubing at the circular T-junction.

Figure 54
Pipette Probe Replacement
Replacing Fuses The fuses are located on the right side of the Analyzer, near the power
connection socket (see Figure 4 in Section 1: Introduction).
Note: If the IMMULITE Display Panel is blank, try selecting RUN

IMMULITE or START TURBO from the Start-up menu before replacing
fuses.
Follow the instructions below to replace the fuses.

1. Turn the power switch off and unplug the power cord on the right side of
the instrument.
2. For F1, F2, or F3 fuse replacements, press and turn the black fuse cover
counter clockwise to remove the fuse (see the diagram below).
SE
F4 - F5
FU S E
E FU
F1 FU S
SE
FU S E
E FU
F2 FU S
SE
FU S E
E FU
F3
FU S
Pry off plastic cover here to access F4 and F5 screws
NOTE: DO NOT REMOVE ANY SCREWS.

3. Replace with the correct fuse according to the table below:
Fuse For 110 VAC, use: For 220 VAC, use:

F1 ½-amp time-delay fuse ¼-amp time-delay fuse
(901535-02) (901535-01)
F2 2-amp time-delay fuse 1-amp time-delay fuse
(900236-09) (900236-06)
(900236-14) (900236-11)
(900236-15) (900756-16)
F5 – 4-amp time-delay fuse
(900756-16)
Note: When installing a fuse, press on the black fuse cover and turn
clockwise. Make sure the fuse cover is secure.
4. For the main (F4) fuse in 110 VAC units, gently pry the fuse out of the
holder and replace it with a 6-amp time-delay fuse.
Note: In 220 VAC units, there are two fuses (F4 and F5). Both of these
are 4-amp fuses.
5. Replace the safety cover, and reconnect the power cord.

Section 7: Diagnostics
Introduction Diagnostic programs are used to test particular components of the

IMMULITE System. When the cursor is positioned on the diagnostic
program name, a description of the program appears at the bottom of the
screen. Refer to the table on page 7-5 for a more detailed description of
each program.
Note: Refer to Section 11: Troubleshooting for troubleshooting

information, including a list of error messages.

Running To load and run the diagnostic programs, follow the steps below:
Diagnostic
Programs
1. From the Start-up Menu, select DIAGNOSTICS.
Note: The IMMULITE must be in Idle.
2. Select DIAGNOSTICS and press [Enter].
A list of the various diagnostic programs appears (listed alphabetically).
Figure 55
Diagnostic Files Screen

Note: Some diagnostics are intended for Field Service Engineers only.
These diagnostics are not described in the table on page 7-5. Additional
diagnostic programs may become available with future software
updates.
3. Select the desired diagnostic program by pressing the arrow keys to

select the program name and press [Enter].
4. When the loading is complete, press [Enter] again.
5. Press GO (on the IMMULITE) when instructed to do so.
6. If necessary, press and hold the ALARM MUTE button until all motion
stops, and, while still holding the ALARM MUTE button, press GO to
stop the program.
Note: Some routines stop automatically at the end of the program

cycle, while others repeat until the ALARM MUTE and GO buttons
are pressed simultaneously. The table beginning on page 7-5 states
whether or not the operator needs to stop the program.
7. To load another program, clear the first one by pressing ALARM

MUTE and GO simultaneously.
Note: If the first program is not cleared before loading another, the
following message appears:
IMMULITE cannot communicate ...
Programs can be downloaded when a blank screen or the following
message appears:
DPC IMMULITE IDLE
8. Some diagnostic programs require additional programs to be run

(GETDATAT, PC or WATER). Refer to the table on page 7-5 to
determine if one of these programs is required. Refer to the following
page for information on Running GETDATAT or Running PC. Refer
to Testing the Water Supply in Section 6: Routine Maintenance for
instructions on using the WATER program.

Running Some diagnostic programs require obtaining cps from the Luminometer via
GETDATAT a data collection program called GETDATAT. This program must be
started after the diagnostic program has been loaded and before the tube is
counted by the PMT. To run the GETDATAT program, follow the steps
below:
1. After the diagnostic program begins running (after pressing GO on the
IMMULITE), press [Esc].
3. Type getdatat and press [Enter].
A menu appears.
4. Press [P] to turn on the printer.
Note: Make sure the printer is on-line.
5. Press [S] to collect and store the data.
6. Respond to the next three questions by pressing [Enter] after each.
7. A blank screen appears with the message Press [Esc] to Quit at the
lower right corner. Do not press Quit until all printing has stopped.
8. Once all the counts have been printed, stop the IMMULITE by pressing
ALARM MUTE and GO (on the IMMULITE).
9. Press [Esc] and [Q] to quit the data collection program.
Running PC Some diagnostic programs require that certain information be displayed (i.e.
results from the Barcode Reader) using the PC program. To run the PC
program, follow the steps below:
1. After the diagnostic program begins running (after pressing GO on the
IMMULITE), press [Esc].
3. Type pc and press [Enter].
4. Respond to the questions displayed by pressing [Enter] three times.
5. When the message appears, choose [Y] for yes:
Cannot communicate with the IMMULITE.
Continue running? Y/N
6. To exit, select Log Off and Log Off System.

Diagnostic The table below describes the diagnostic programs in detail, including
Programs whether or not they stop automatically, or if another program (PC or
GETDATAT) is required.
The programs are listed alphabetically on the Diagnostics screen; however,
they are listed by module in the table below:
Other
Module Program Function Auto Program
Stop Required
Load Platform BCODE Carries Test Units into the Barcode Reader to No PC
be read one time each, and then into the
sample tray for retrieval.
Notes: The Test Units are processed at a rate
of approximately one every 2 seconds.
BCODEON Turns the barcode motor on and off by No None
pressing GO.
BCODESPD Displays, in milliseconds, the Test Unit No None
Barcode Reader motor speed after a Test Unit
is placed on the Load Platform and the
directions on the IMMULITE Display Panel
are followed.
BCODETST Advances the Test Unit or sample cups from No PC
the Load Platform to the Barcode Reader and
reads each one 25 times.
LCHAIN Indexes the Load Chain one position every No None
second.
Reagent LEVCRASH Repeatedly level-senses sample in each Yes None
Carousel and sampling position and if a probe crash occurs,
Pipettor stops the test completely and displays “Test
Failed”.
LEVFALSE Repeatedly level-senses at empty reagent and Yes None
sample positions and if a false trigger is
encountered, displays “Test Failed”.
LEVSENSR Moves the X pipettor to the reagent. No None
Repeatedly level-senses.
Displays the number of steps left before
reaching maximum travel.

Other
Stop Required
LEVESENSS Moves the X pipettor to the first sample No None
pipetting position.
Repeatedly level-senses.
Displays the number of steps left before
reaching maximum travel.
PIPXPOS Moves the X pipettor to each position, No None
starting with the home position, and lowers
the Z pipettor into each position.
Note: This program is used to check the X
pipettor positioning.
PROBANGL Positions the probe and dispenses liquid, No None
checking that the probe is dispensing straight
down.
PROBETST Repeatedly positions the probe in the home No No
well to dispense fluid. Tests the integrity of
the probe dispense at the wash station.
RBCODE Repeatedly reads the Reagent Wedge No PC
barcode.
REAGENTH Moves and pauses the Reagent Carousel tray No None
in the home position.
REAGENTP Moves the Reagent Carousel to each of its 12 No None
positions.
UPDOWNA Moves the Z pipettor between the home No None
position and Test Unit dispense depth at
the Test Unit dispense X position.
Cycles the Z pipettor up to the home
sensor and down to the pipetting depth.
UPDOWNH Moves the Z pipettor between the home No None
position and blind hole depth at the blind
hole X position.
UPDOWNW Moves the Z pipettor between the home No None
position and wash well depth at the wash
well X position.
Syringe Pump APRIME Primes only the 5000 µL (A) syringe. No None

Other
Stop Required
Assembly BPRIME Primes only the 250 µl (B) syringe. No None
PRIME Repeatedly primes the two syringes and their No None
tubing.
V1TEST Moves the probe to the wash station No None
alternately dispensing through the probe and
the fresh water well.
Note: The dispensing alternates between
each outlet.
V2TEST Alternates dispensing between the probe and Yes None
the probe wash line.
Note: The line must be removed from the
probe wash reservoir following the
instructions on the Immulite display panel.
V4TEST Moves the probe to the wash station No None
alternately dispensing through the probe and
the fresh water well.
Note: The dispensing alternates between
each outlet.
Water and DISSUB Transports five Test Units from the Load Yes None
Substrate Platform to the substrate dispense
Pumps position.
Dispenses substrate into these Test Units
and moves them to the sample collection
tray.
DISWAT Transports five Test Units from the Load Yes None
Platform to the wash-water dispense
position.
Dispenses water into the five Test Units
and moves them to the sample collection
tray.
SOLE1W Initializes the shuttle to the home No None
position.
Repeatedly dispenses 200 µL of water
from the water pump.
SOLE2S Initializes the shuttle to the home No None
position.
Repeatedly dispenses 200 µL of substrate
from the substrate pump.

Other
Stop Required
Main Carousel CARBACK Moves the Main Carousel backward while the No None
PRIME button is pressed.
Note: The carousel will continue to move
backwards while the button is held down.
CARPOS Moves the Incubation Carousel from position No None
to position.
CARCHECK Indexes the carousel one position. No None
Moves the shuttle into the space between
the carousel baffles and pauses for 1
second.
Moves the shuttle back to the home
position.
Repeats the above process.
Note: Can be used to check each position.
CARSHAKE Shakes the Incubation Carousel with the Press Go None
shuttle in the wash position for six seconds. to end
Luminometer ATTENT4 Moves the Test Unit off the Incubation No None
and Shuttle Carousel
Washes the Test Unit
Adds substrate
Moves the Test Unit to the
photomultiplier tube (PMT) every 30
seconds where two sets of 12-second
counts (both attenuated and unattenuated)
for each tube are taken.
ATTURN Moves the attenuator disk to the home No None
position, attenuated position, and
unattenuated position.
Repeats this process.
Note: This is useful when verifying the
attenuator sensor operation.
BKGNDCNT Alternately rotates the attenuator disk to the No GETDATAT

attenuated and unattenuated positions and
activates a reading by the PMT.

Other
Stop Required
DARKCNT Rotates the attenuator disk to the home No GETDATAT
position and activates readings by the PMT.
LUMCHN Indexes the Luminometer chain one position No None
every second.
LUMTEST4 Moves four Test Units off the carousel. Yes GETDATAT
Moves the Test Units into the PMT.
Alternately takes ten attenuated and ten
unattenuated readings of each Test Unit.
LUMTEST5 Moves one Test Unit off the Main Yes GETDATAT
Carousel.
Moves the Test Unit quickly to the PMT.
Allows the sample to warm in front of the
PMT for 10 minutes.
Alternately takes attenuated and
unattenuated readings of that Test Unit
for the next 60 minutes.
Note: This is a test of the PMT's stationary
reading precision.
PMTCOUNT Activates measurement readings by the PMT. No GETDATAT
SHUTLOAD Indexes the Main Carousel one position. Press Go None
to end
Moves the shuttle to the high-speed spin
position.
Note: This is used to check the pressure
exerted on the Test Units in this position.
SHUTSPIN Indexes the Main Carousel one position. Press Go None
to end
Moves the shuttle to the high-speed
position.
Activates the High-speed Spin motor.
Note: This is used to manually measure the
high-speed spinner speed (in revolutions per
minute).
SHUTTLE Indexes the shuttle to each of its positions. No None
SPINCHK Moves a tube off the Main Carousel and spins No None
it for one second.
SPINON Turns the High-speed Spinner on and off by No None
pressing GO.

Other
Stop Required
WASHSPD Transfers a Test Unit from the Load Platform No None
(before entering the Barcode Reader) into the
High-speed Spinner and displays the spin
speed on the Display Panel.
Maintenance BCODEON Turns the barcode motor on and off by No None
pressing GO.
BCODESPD Displays the Test Unit Barcode Reader motor No None

speed after a Test Unit is placed on the Load
Platform and the directions on the
IMMULITE Display Panel are followed.
DECON Rinses probe wash (10X dilution) through the No None
system.
DECON1 Rinses water through the fluidics system after Yes None
the mechanisms are decontaminated with
probe wash (10X dilution).
Note: The program automatically stops once
260 mL of water passes through the syringes
and 50 mL of water is drawn through the
water solenoid. The program requires at least
300 mL of reconstituted Probe Wash in the
Probe Wash Bottle and the Probe Wash Bottle
must be connected to the Probe Wash line
prior to running.
EMPTYTUB Advances Test Units from the Load Chain No None
through the entire system.
PRIME Repeatedly primes the two syringes and their No None

tubing.
PROBWASH Rinses the special probe cleaning solution No None

through the probe.
Rinses the probe with water to flush.
SCHANGE Moves both syringe arms down halfway. Yes None
Note: This is done so one or both syringe
plungers can be removed. When GO is
pressed, the syringes return to the home
position.

Other
Stop Required
SOLE1W Initializes the shuttle to the home No None
position.
Repeatedly dispenses 200 µL of water
from the water pump.
SOLE2S Initializes the shuttle to the home No None
position.
Repeatedly dispenses 200 µL of substrate
from the substrate pump.
WATERTPM Moves four water Test Units from the Yes WATER
Load Platform around the Main Carousel.
Dispenses water from the probe into the
first Test Unit.
Dispenses water from the wash line into
the second Test Unit.
Pipettes water from the second Test Unit
into the third.
Dispenses substrate into the first, third,
and fourth Test Units and moves the
second Test Unit to the load chain.
Incubates the Test Units in the
Luminometer for ten minutes.
Measures cps.
Note: The cps is used to determine whether
the probe and wash water are contaminated.
For the complete procedure, refer to Section
6: Routine Maintenance.
WATERTST Moves two water Test Units from the Yes WATER
Load Platform around the Main Carousel.
Dispenses substrate into each Test Unit.
Measures cps.
Note: The cps is used to evaluate the water
from any source in the IMMULITE. For the
complete procedure, refer to Section 6:
Routine Maintenance.
Miscellaneous TEMPS Transmits temperature data to the Personal No PC
Computer.

Section 8: Data Reduction and the Chemiluminescent
Reaction
Introduction This section explains the theory behind the IMMULITE system operation.
Internal This section provides a step-by-step description of the internal calculations

Calculations performed by the IMMULITE System when determining test results.
1. Since some of the IMMULITE assays are ultra sensitive and can produce
up to several hundred million counts per second (cps), the IMMULITE
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 unfiltered position
The IMMULITE's attenuator disk restricts the number of photons
entering the PMT, ensuring an accurate count, even if the actual cps are
so high that they exceed the PMT's linear range.
2. For each sample, the IMMULITE first takes a one-second reading (dark
count) in the closed position and then a one-second reading (decision
count) in the attenuated position.
Note: To view the dark counts, select System Status and Temps/Dark
Counts.
If the one-second attenuated reading (decision count) is less than 10,240

cps, the attenuator disk moves to the open position; otherwise, the
attenuator disk remains in the attenuated position while the readings are
taken.
3. Dark counts are calculated by averaging the last ten readings in the
closed position. This average is subtracted from each of the twelve
sample readings.
Note: A dark count measurement is taken every 30 seconds, whether or

not there is a Test Unit in the read position.

4. Next, the IMMULITE takes twelve one-second readings of the sample
and returns the attenuator disk to the closed position.
5. To ensure that the final averaged counts are representative, the highest
and the lowest of the twelve individual readings are dropped, and the
“trimmed” mean (the mean of the remaining ten readings) is calculated.
The mean of counts, after correction through adjustment, is used to
calculate results in terms of dose (analyte concentration) from the master
curve.
6. If the counts were measured in the attenuated position, the trimmed mean
of the ten individual readings is multiplied by the instrument-specific
attenuation factor to yield the total unattenuated counts per second (cps).
cps (unattenuated)= cps(attenuated) x attenuation
factor
7. To determine analyte concentrations, the IMMULITE software refers to

lot-specific master curve parameters that were entered into the system
via the kit barcodes.

Master The IMMULITE calibration method employs a stored master curve in
Curve conjunction with a two-point adjustment procedure. This section provides
Generation / an overview of this calibration method.
Two-Point
Adjustment
Calibration The IMMULITE and its stable reagent system make it unnecessary to run a
Overview standard curve every day. The specific IMMULITE features which make
running a daily standard curve unnecessary include:
Reproducible pipetting
Precise timing
Controlled temperature environment
Extended reagent stability
Instead, analyte concentration is determined by a stored master curve. This
kind of standard curve is generated by the manufacturer for each lot of
reagents and provided as a “master curve.” Adjustors are then used to
correlate the counts per second (cps) of the customer’s instrument to the cps
of the instrument used by the manufacturer to generate the master curve.
Master Curve IMMULITE master curves for each lot of reagents are generated on a single
Generation instrument by running numerous replicates of each standard, using a set of
standards spanning the range of the assay. The number of standards varies
with the analyte and ranges from six for Total T4 (range 1-24 µg/dL) to
fifteen for TSH (range 0.002 - 75 µIU/mL). The standard replicates are
collected in multiple runs (in random order) over several days. Replicates of
a low and high Adjustor are included in every run.
IMMULITE uses the well-established four-parameter logistic approach to
calculate the standard master curve. A computer algorithm fits the best curve
to the data using accepted curve-fitting procedures. IMMULITE uses two
different forms of the equation:
A competitive assay equation
An immunometric (sandwich) assay equation
These equations are shown and described below.
The stored master curve is an equation of the line which best fits the master
curve data. The form of the equation is constant and is permanently stored in
the software assay information.

Note: The numerical values for the four equation parameters vary from
reagent lot to reagent lot. These values are encoded in the kit bar code label.
The cps of the low and high Adjustors that was observed when the master
curve was generated is also encoded in the kit barcode label.
Competitive Assay Equation

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
Sandwich Assay Equation

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
Two-Point To calculate the dose of unknowns directly from the stored master curve, the
Adjustment signal (cps) on a laboratory instrument must match the signal of the master
curve instrument. Because no two photomultiplier tubes (PMT) give exactly
the same level of cps for the same photon input, the signal of each laboratory
instrument must be adjusted to equal that of the master curve instrument
using the two-point adjustment process.
If a full standard curve were run on both the master curve and the customer
instruments, the plot of the cps (master instrument vs. customer instrument)
would be a straight line. For example, possible data for an assay with six
standards is shown in the table below.

Standard Master Curve Instrument Customer Instrument cps
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 data is plotted in the graph below:
Figure 56
cps graph (Master Instrument vs. Customer Instrument)
30,000
(F)
MASTER INSTRUMENT CPS
25,000
20,000
(thousands)
15,000
(E)
10,000
(D)
5,000
(C)
0
0 5,000 10,000 15,000 20,000
CUSTOMER INSTRUMENT CPS (thousands)

Since the relationship between the laboratory instrument and the master
curve signals is a straight line, only two points are required to determine the
line. The two Adjustors define these two points. 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 this line are calculated. Using the equation below, the slope
and intercept are then used to transform the cps for an unknown to the cps
that would have been observed if the sample were run on the master curve
instrument.
Master Curve cps = cpsunknown x Slope + Intercept
The transformed cps can now be used to calculate dose directly from the
master curve.
The purpose of the initial customer adjustment of a new kit lot is to correlate
the cps of the customer’s instrument to that of the master curve instrument at
the time of kit manufacture. Readjustments compensate for changes in the
reagent enzyme activity over time.
Judging The guidelines described below should be used to help interpret whether an
Adjustment adjustment is successful. The guidelines are listed in order of importance.
Validity
1. Controls run immediately following an adjustment
2. The slope of an adjustment
3. The intercept of an adjustment
Controls Run Immediately Following an Adjustment

Quality control samples must be run immediately following an adjustment.
The results obtained with these samples should be within acceptable limits as
established by the laboratory. This is the primary means of validating an
adjustment.
The Adjustment Slope for an Initial Adjustment

The initial adjustment slope generally falls within ± 20% of the mean slope
for the instrument. An initial adjustment refers to the first slope generated on
a new kit lot.
The mean slope must be calculated by the operator. It is the average of at
least ten initial slopes of adjustment, on a single instrument, using either:

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: When fewer than ten adjustments have been run a mean can still be
calculated using the total completed. This mean should be regarded as
preliminary and must be recalculated when at least ten adjustments are
actually completed.

For example, given the following data:
Kit Lot Slope

COR 109 0.94
E2 110 1.13
E2 110 0.98
E2 110 1.09
TSH 110 1.07
TSH 125 0.84
TSH 127 0.89
T4 127 0.94
T4 117 1.06
TU 113 No slope calculated for TU (single
adjustor assay)
T3 115 0.85
FT4 112 0.75
In this example, the mean slope is:

Mean = 0.96
The expected deviation from the mean is calculated as follows:
Deviation = Mean x 0.2 = 0.96 x 0.2 =0.19
The guideline range for a slope is calculated as follows:
Range = Mean +/- Deviation
High Limit = Mean + Deviation =0.96 + 0.19 = 1.15

Low Limit = Mean – Deviation=0.96 – 0.19 = 0.77
The guideline range for slope is:

0.77 to 1.15

The graphic below is a visual presentation of example slopes and how they
can be interpreted.
A In this example the slope is 1.2 or 0.75; the adjustment is likely valid.
Verify that the quality control sample results are close to the expected
mean.
B In this example, the slope is 1.3 or 0.6; the adjustment may still be
valid depending on several factors. If the QC results are close to the
expected mean and the slope for the assay has historically been near
the limit of the slope range, the adjustment is likely valid.
C In this example, a slope less than 0.5 or above 2.0 indicates a problem
and the adjustment is not valid.
Intercept of Adjustment:
Adjustment intercepts are generally below a threshold based on the expected

cps for a zero concentration sample. This threshold is calculated differently
for Immunometric (sandwich) and Competitive assays using the kit
parameters shown below.

Figure 57
Kit Entry Screen
Immunometric
Competitive assays use the
assays use the low adjustor CPS
P1 value value
Immunometric (Sandwich) Assay

A large intercept affects the results but only at very low concentrations. The
best method to validate an adjustment is to run QC samples with low
concentrations. If no QC samples are available at these low concentrations,
the adjustment intercept may be used to validate the adjustment as follows:
Generally the absolute value of the intercept falls below the low Adjustor cps
of the master curve x 30%.
The low Adjustor cps refers to the Adjustor cps information found on the Kit
Entry screen or the adjustment printout. Do not refer to the observed cps
measured for the low adjustor.
For example:
cps of low Adjustor = 84,356
Acceptable intercept: 84,356 x 0.30 = 25,307
The guideline maximum intercept is 25,307.

The graphic below is a visual presentation of some example intercepts and
how they can be interpreted.
A In this example the intercept is 27,000 cps; the adjustment is likely

valid. This intercept would be acceptable unless a significant bias
was noted on the QC samples.
B In this example the intercept is 30,000 cps; the adjustment may still
be valid depending on several factors. This intercept would be
acceptable if the QC results are close to the expected mean and the
intercept for the assay has historically been near the limit
C In this example the intercept exceeding 50,000 cps may indicate a
problem and the adjustment may not be valid. A QC sample targeted
at the lower limit of the assay can be used to validate the adjustment
Intercept of Adjustment for a Competitive Assay

The absolute value of the intercept generally falls below 2% of curve
parameter 1 (P1). P1 is found on the Kit Entry screen.
Note: Curve parameter 2 is used for the following three assays: Digoxin,
Phenobarbital, and Unconjugated Estriol. Interpretation of validity remains
the same regardless of which curve parameter is used to determine the
intercept limit.
For example,
P1 = 61,500,000
Acceptable intercept: 61,500,000 x .02 = 1,230,000

The graphic below is a visual presentation of some example intercepts and
how they can be interpreted.
A In this example the intercept is 1,500,000 cps; the adjustment is

likely valid. This intercept would be acceptable unless a significant
bias was noted on the QC samples.
B In this example the intercept is 1,700,000 cps; the adjustment may
still be valid depending on several factors. This intercept would be
acceptable if the QC results are close to the expected mean and the
intercept for the assay has historically been near the limit
C In this example the intercept exceeding 2,000,000 may indicate a
problem and the adjustment may not be valid. A QC sample targeted
at the upper limit of the assay can be used to validate the adjustment
Summary
1. Controls run immediately following an adjustment should be within
acceptable limits.
2. The slope of an adjustment should fall within ± 20% of the mean slope
for the instrument.
3. The intercept of an adjustment generally falls below a maximum
calculated intercept limit.
Using the combination of these guidelines, if an adjustment does not appear
to be valid, readjustment may be necessary.

Readjustment Every assay must be periodically readjusted 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
The intercepts of readjustments should be judged according to the same
guidelines discussed previously.
Master Cutoff In qualitative assays, the results are classified as non-reactive or reactive,
Generation or indeterminate. The results in such assays are calculated by comparing
for Qualita- the signal obtained for a patient sample, to a cut-off signal.
tive Assays
For sandwich assays:
If patient cps > cutoff, the result is reactive
If patient cps < cutoff, the result is non-reactive
For competitive assays:
If patient cps < cutoff, the result is reactive
If patient cps > cutoff, the result is non-reactive
Where an indeterminate region is defined, it is usually a percentage above
and below the cutoff. For example:
If the percentage = 10% cutoff, then . . .
0.9 x cutoff < Indeterminate < 1.1 x cut-off
Measuring the The cutoff for an assay is usually measured in one of two ways:
Cutoff for an
Assay
Several hundred patients, both reactive and non-reactive whose clinical
status has been established by another method, are assayed on the
IMMULITE. A cutoff is determined statistically. If the cutoff level is set
too low, many truly non-reactive samples will read reactive (poor
specificity). If the cutoff level is too high, many truly reactive patients
will be non-reactive (poor sensitivity). A cutoff is calculated which
achieves the optimal sensitivity and specificity.

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) whose value is
assigned based on its ratio to the cutoff. 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 multiplier of 1.25 (100000/80000) is
required to match the adjustor to the cutoff.
With the IMMULITE, a single adjustor is supplied with the kit, and the ratio
of the adjustor to the cutoff value is supplied on the kit barcode label as P1.
At adjustment, the average cps of the adjustor is multiplied by P1 to
determine the customer cutoff. 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 and
P3/P1. If no indeterminate is defined, P2 and P3 are 0.

The This section provides a brief overview of the chemiluminescent reaction
Chemilu- used in the IMMULITE system.
minescent
Reaction
First, the alkaline phosphatase conjugate (reagent) is bound to the bead
(within the Test Unit) during the immunological reaction. The amount of
alkaline phosphatase captured is directly proportional (for a sandwich assay),
or inversely proportional (for a competitive assay) to the concentration of the
analyte in the patient sample.
Once the Test Unit is washed, a luminogenic substrate is added to the Test
Unit and it is moved onto the Luminometer chain.
Ten minutes later, the Test Unit arrives in front of the photomultiplier tube
(PMT), where the light generated by the luminogenic reaction is measured.
Unlike chemiluminescent reactions involving acridinium esters (which
produce a flash of light) the enzyme-amplified reaction in the IMMULITE
System produces a prolonged glow, as indicated in the figure below.
Figure 58
IMMULITE Enzyme-Amplified Luminescence
Signal (CPS)
Time
In the luminogenic reaction (Figure 59), the substrate (an adamantyl

dioxetane phosphate1) is dephosphorylated into an unstable anion
intermediate by the alkaline phosphatase conjugate captured on the bead.
1
*LUMIGEN® PPD: 4-methoxy-4-(3-phosphatephenyl)-spiro-(1,2-dioxetane-3,2´-adamantane). LUMIGEN® is a
registered trademark of LUMIGEN, Inc., Southfield, MI.

The unstable intermediate emits a photon upon decomposition. 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.
Figure 59
The IMMULITE Chemiluminescent Substrate
O O
OCH3
DIOXETANE PHOSPHATE
(STABLE)
OPO3
ALKALINE PHOSPHATASE LABEL
O O
OCH3
UNSTABLE DIOXETANE
OCH3
O
O
LIGHT (hv)

Section 9: Assay Types
Introduction This section covers the different assay types and how they effect
IMMULITE operation.
Assay Type The table below describes different types of assays.

Table
Assay Type Example Description

One-cycle Total T4 Test Unit stays on the main Incubation Carousel for one
revolution (30 minutes) before being washed.
Two-cycle Third- Test Unit remains on the Incubation Carousel for two
Generation TSH revolutions (60 minutes) before being washed.
Notes: In the second cycle, the assay crosses the
intersection of the Load Chain. The Load Chain
automatically pauses until there is space on the carousel
for the additional Test Units to proceed.
Test Unit appears on the Primary screen as a colored
circle surrounded by a white ring during its first
incubation cycle. When the second incubation cycle
begins, the white ring disappears.
Sequential Progesterone Note: These assays are two-cycle.
There are two Reagent Wedges designated as
components A and B on the Reagent Status display.
Immune reaction components are pipetted at different
times. Incubation with reagent A takes place during the
first cycle. Incubation with reagent B takes place during
the second cycle. A wash step between the cycles may
be included.
Note: When the Reagent Carousel is read, the operator is
alerted if any of the required components are missing.
Immunometric Third- Note: These assays can be one-cycle or two-cycle.
(Sandwich) Generation TSH
The unlabeled antigen binds to the immobilized antibody
and is measured (in terms of quantity) after the labeled
antibody is added.

Assay Type Example Description
Competitive Total T4 Note: These assays can be one-cycle or two-cycle.
The labeled antigen and the unlabeled antigen compete
for binding sites on the antibody-coated bead. Under
these conditions, the antibody bound labeled antigen is
inversely proportional to the concentration of the
unlabeled antigen.

Section 10: The On-line Tutorial
Introduction The On-Line Tutorial (or IMMULITE® On-Line Reference Software)

includes explanatory text, drawings, photo-quality images of the
IMMULITE System, and computer animation of various critical system
functions. Overall, it constitutes an interactive environment for:
Reviewing the IMMULITE operating software, instrument operation, and
assay chemistry
Training secondary instrument operators
Performing routine maintenance and diagnostic procedures
Troubleshooting the system components
The tutorial is a mouse-driven program with a graphical user interface, which
allows fast and easy access to information without searching through long
menus or using the keyboard. More information regarding system
components and concepts can be accessed by selecting the desired item using
the mouse.

Using the This section describes how to:
Tutorial
Start the tutorial
Navigate through the tutorial
Exit the tutorial
Starting the The tutorial can be accessed from either the Start-up menu or the DOS
Tutorial prompt.
From the DOS prompt, type “tutorme” and press [Enter].
From the Start-up menu, select Tutorial.
Navigating The tutorial allows the operator to access information using either the
mouse or the keyboard. When the operator moves the pointer and clicks on
an area of interest, the system presents more information on that subject.
Mouse
To use the mouse, move the mouse to point to the item of interest and click
on the item by pressing one of the mouse buttons.
Keyboard
The cursor (or pointer) can also be moved using the arrow keys. After
moving the cursor, select the item by pressing either the Insert or the Delete
key.
Exiting the To exit the tutorial software:

Tutorial
1. Return to either the Main Menu or the Checklist screen
2. Either click the Exit button or press [F12].
To run the IMMULITE operating software after exiting the tutorial, type
start and press [Enter] at the DOS prompt.
CAUTION: Always leave the tutorial by selecting the Exit button or by

pressing [F12]. If you exit the program by any other means, or if a software
error causes the program to stop, reboot the system by turning the computer
off, waiting ten seconds, and turning it back on.

Tutorial The tutorials main menu options include:
Main Menu
Instrument
Software
Chemistry
Checklist
Index
Exit
The Instrument, Software, and Chemistry menu options include a general
overview and access to more detailed information.
To select a menu option, use the mouse to move the pointer to the desired
item and click (by pressing one of the mouse buttons).
Instrument After selecting Instrument, a photo view of the IMMULITE appears, with
the lid raised and all the working components labeled. If the operator
selects an individual part or module, an explanation of its function displays.
Pointing to and clicking on the boxes contained in the explanation allows
the operator to access more information, including troubleshooting and
maintenance assistance.
Each instrument module screen displays a photo view of the instrument along
with a circled, close-up view of the selected module. The primary module
parts are identified. Some module screens include animation to illustrate
module functions.
A general description of an instrument module contains “hot” buttons that
connect with other module descriptions. A larger photo view or drawing
may also be selected. The operator may return to the Instrument Menu or the
Main Menu by clicking on that option.
Software Select Software to view examples of the IMMULITE operating software

screens.
Software Overview accesses the IMMULITE Primary screen, which
contains information regarding samples, tests, and reagents on the
instrument. If an operator selects a Main Menu option from the Primary
screen, a sub-menu for each option appears.

Chemistry The Chemistry selection provides information about IMMULITE's
enzyme-enhanced chemiluminescence, master curve generation, two-point
adjustment, and the internal calculations that are used to determine the final
patient result. The operator may select the overview or more detailed
information on each topic.
Checklist The Checklist selection accesses the steps required to run the IMMULITE
during an average day, including start-up, running, and shutdown activities.
The operator may select the overview or more detailed information on each
topic.
Index The Index provides a listing, by category, of all topics contained in the
IMMULITE On-Line Reference Software.
For information regarding a specific topic or question, select Index and click
on the desired topic.
Exit This option is used to exit the On-Line Tutorial. For instructions, see
Exiting the Tutorial on page 10-2.

Section 11: Troubleshooting
Overview This section is designed to help the operator diagnose and fix
problems. It is organized into three categories:
Problems and Solutions
Error Messages and Solutions
Fixing or Restoring a Database
The table below indicates where to look for a particular problem.
Category Refer to when:

Problem/Solution The problem is known.
Error Messages An error message appears at the bottom of
the computer screen or on the IMMULITE
Display Panel.
Note: Error messages are also printed as
they occur.

Problems / The Problems and Solutions are categorized by problem type into one of
Solutions four tables:
Instrument
Imprecision
Results
Miscellaneous
Each table shows the cause and solution for the problems described.
Instrument The table below shows causes and solutions for various instrument
Problems problems.
Problem Cause Solution

The IMMULITE Display The power to the system has been Select RUN IMMULITE or
Panel is blank, but the power is interrupted. START TURBO from the Start-
on. up menu.
The IMMULITE System is not The Instrument’s On/Off switch is Turn the IMMULITE On/Off
on. off or the power cable is loose. switch on and make sure the
power cable is properly
connected.
The uninterruptible power supply Turn on or plug in the UPS or
(UPS) or Line Conditioner is not Line Conditioner.
turned on or plugged in.
The main fuse is blown (F4 or F5). Replace the main fuse. Refer to
procedure to replace fuses in
Section 6: Routine
Maintenance.
The F2 or F3 fuses are blown. Refer to procedure to replace
fuses in Section 6: Routine
Maintenance.
All IMMULITE motors are not The F2 or F3 fuses are blown. Refer to procedure to replace
working or energized. fuses in Section 6: Routine
Maintenance.
Instrument is in AutoPAUSE The Reagent Carousel tray was Replace or reposition the
mode. removed. Reagent Carousel tray.
The Sample Collection Tray is full Remove sample cup holders from
or absent. the collection tray: replace or
reposition the collection tray.

Instrument is in AutoPAUSE A pipettor level-sense error Determine the cause of the
mode. (Continued) occurred for the fifth time during level-sense errors by:
that run.
• Watching the probe
pipette to determine if
the probe is false
triggering (stopping
short of the liquid)
• Looking for the error
messages indicating that
no sample or reagent was
pipetted. Refer to the
instructions under
Diagnostic Programs in
Section 7: Diagnostics
to verify the level-sense
error using LEVCRASH
or LEVFALSE.
Re-run the tests.
Note: For further assistance,
call DPC Technical Service.
A lot mismatch was detected at the Load a Reagent Wedge lot
Barcode Reader. compatible with the Test Unit lot
or press PAUSE to ignore.
Both Turbo and Non-Turbo If running in Turbo Mode,
Reagent Wedges have been loaded
Remove all Non-Turbo
onto the reagent carousel.
Reagent Wedges and press
GO to continue.
If running in Standard (Non-
Turbo) Mode,
Remove all Turbo Reagent
Wedges and press GO to
continue.
The Reagent Wedge went to 0 Replace the Reagent Wedge
tests remaining. of the appropriate lot. In
most cases, the Test Unit
appears as a white circle,
indicating that pipetting did
not occur.
Note: The Test Unit is
deposited in the Sample
Collection Tray, and can be
retrieved from the tray.

The substrate reservoir is low. Replace the substrate bottle,
prime the reservoir, and press
GO.
Instrument is in AutoPAUSE A reagent is in the reagent carousel Enter the appropriate kit barcode
mode (Continued). but the kit barcode information has information in the kit entry
not been entered into the system. screen.
Bubbles persistently stick to The syringe tip is worn. Perform the following:
the teflon plunger or the
Completely loosen the
syringe barrel and cannot be
thumbscrew under the small
removed by priming.
syringe.
Press the Prime button.
As the thumbscrew moves
away from the plunger,
manually move the plunger
up and down to break the
bubble.
Re-tighten the thumbscrew
and prime again.
If the tip is worn, replace it.
Refer to the Changing the
Small Syringe Tip
procedure in Section 6:
During the start-up procedure, Either: Press ALARM MUTE and
only part of the initialization GO simultaneously.
RUN IMMULITE or START
procedure is completed. It
TURBO was selected before Turn the IMMULITE power
appears to stall at the
IMMULITE priming the syringe barrels finished off, and then on (after
syringes display message. moving to the tops of the waiting 10 seconds).
syringes.
Wait 30 seconds or until the
There was a problem with the syringe barrels have finished
power supplied to the moving to the tops of the
instrument. syringes.
Select RUN IMMULITE or
START TURBO.

Result Problems The table below shows causes and solutions for various problems regarding
IMMULITE results.

Some sample cup results are Either the barcodes were Check the printout or the Error Log
missing. misread or insufficient for error messages.
sample or reagent caused the
Note: The following Note: The Test Unit will be in the
test not to result.
message appears: Sample Collection Tray.
Testcode Record
Deleted [No Sample] Re-run the test (Re-load the reagent
or [No Reagent] and sample if necessary.)
Pipetted
The Reagent Wedge went to Replace the empty Reagent Wedge and
Zero Tests Remaining re-run the assays.
after the Barcode Reader read
the Test Units and the
Reagent Wedge was not
replaced before the Test Units
reached the carousel.
The second Reagent Wedge Replace the missing or empty Reagent
for a sequential assay was Wedge and re-run the assay.
missing or went to Zero
Tests Remaining and
the Reagent Wedge was not
replaced in time to complete
the second step of the assay.
All sample cup results are The sample cup is associated Results are not printed for a sample cup
missing. with both one-cycle and two- until all tests have been completed.
cycle assays.
None of the Test Units Retrieve all the Test Units associated
associated with the sample with this sample cup from the
cup were pipetted, either Sample Collection Tray.
The sample cup holder Remove all Reagent Wedges that do
barcode was misread. not apply to the current “RUN” mode
(Turbo or Non-Turbo).
Insufficient sample was
sensed for the first Test Re-run the sample.
Unit.
Both Turbo and Non-
Turbo Reagent Wedges
have been loaded onto the
reagent carousel.

All sample cup results are The Print Report option is From the System Status menu,
missing (Continued). turned off. choose Select Reports.
Select either the short or long report
format option and print the missing
reports.
The printer was out of paper. If Report Printing is not off, all
missing results are printed when the
printer error is corrected.
If Report Printing is off, retrieve
reports by selecting System Status,
Select Reports, and Print reports
not yet printed today.
There is a paper jam. After clearing the jam, select System
Status and Print by Date and Time.
Results are not printing. Either: Depending on the cause, either:
Report printing was not Turn report printing on by selecting
turned on. System Status and Select Reports
from the Primary menu.
A printer error occurred
during the IMMULITE Correct the printer error by adding
operation. The results are paper, pressing the On-line button,
held until the error is or clearing a paper jam. All results
corrected. generated during the error period will
now print.
Note: The screen displays a message
indicating the system is searching for
records that have not yet printed (even if
there are no records). The keyboard is
disabled during this search.

Imprecision The table below shows causes and solutions for problems regarding
Problems imprecision.

Imprecise results Bubbles on the surface of the Eliminate the bubbles and re-run the
sample and/or the reagent or tests.
bubbles in the small syringe that
come and go with the cycle.
Air leaks Perform the following steps:
Check for air bubbles in the
lines, or water leaking from the
probe or the fittings. If air
bubbles or leaks are found,
make sure the fittings are
finger-tight.
If bubbles are observed entering
the syringes while priming, the
probe wash or water end-of-line
filters may need to be replaced.
Ensure that the probe does not
drip between priming strokes.
Note: Large bubbles in the
syringes during the run may
indicate a valve problem Please
consult DPC Technical Service.
Re-run the tests.
Syringe thumbscrews are loose. Finger-tighten the thumbscrews
for the small and/or large
syringes.
Ensure that the syringe barrels
are tight.
Re-run the tests.

Imprecise results Insufficient substrate or water was Check the following:
(Continued) dispensed.
The substrate reservoir should
be filled to the fill-line. Fill if
necessary.
Low substrate triggers an alarm
and generates a message in the
Error Log if the level is below
the fill-line. Check the Test
Units on the exit ramp to verify
that the beads are just covered
with substrate.
The substrate nozzle should not
be blocked with white
precipitate. Clean if necessary.
The water bottle should not be
empty. Fill if necessary.
Check the sump chamber of the
Test Unit for the presence of
liquid by peeling off the
barcode label.
Re-run the tests.
The teflon syringe tips on one or Replace syringe tips; following
both syringes are worn. instructions for the small and
large syringe tip replacement in
Section 6: Routine
Maintenance.
Re-run the tests.
The Test Units have been exposed In the future, follow the
to humidity or condensation. package insert instructions for
storing and handling Test Units.
Re-run the tests.
The tubing for the probe is looping Pull the tubing through the slot
around the front of the black vanity in the black panel to shorten the
panel as the probe accesses each amount of tubing in front of the
pipetting position. panel (the washer belongs
behind the panel.)
Rotate the tubing so it is able to
move smoothly through all
pipetting positions.
Re-run the tests.

Imprecise results The sample cup contains clots or Filter serum if necessary and repeat
(Continued). other particles. the test.
The probe is bent or loose. Look for a bend in the probe. If
it is bent, replace it following
the instructions under
Changing the Pipetting Probe
in Section 6: Routine
Maintenance.
If the probe is loose, tighten the
nut on top of the probe.
Run the PROBANGL
diagnostic program.
Re-run the tests.
Level-sense errors by the probe. Watch the probe to determine if
the probe is false triggering
(stopping short of the liquid).
Re-run the tests.
The temperature of either the Check results for a TMP error flag
Luminometer or the Main Carousel associated with the sample cup and
is not within acceptable limits. re-run the tests.
Note: All results generated during
the high or low temperature period
will be flagged on the printout.
Erroneous results with A fuse is blown. Refer to the procedure to replace
counts of less than or equal fuses in Section 6: Routine
to 0 CPS. Maintenance.
There was a photomultiplier tube Call DPC Technical Service.
(PMT) or attenuator motor failure.

Erroneous results with Substrate was not dispensed into the Ensure there is no blockage
counts of 50 to 500 CPS Test Unit. in the substrate nozzle.
Run the SOLE2S
Diagnostic program. Look
for bubbles in substrate
bottle in the substrate bottle.
If there are no bubbles,
replace the substrate spike.
Check that substrate is
dispensed when the pump is
primed.
Ensure that substrate is
available in the reservoir
and through the line.
Ensure the substrate and
water nozzles are secured in
place.
Note:
The substrate reservoir should not
be completely filled. If it is full, the
substrate spike must be changed.
A Test Unit was not present where Check for repeated error
it was expected to be (possibly due messages regarding the
to a carousel positioning error). Main Carousel or the
Luminometer chain.
Note: For further assistance, call
DPC Technical Service
Erroneous results with The system ran out of water. Replenish the water supply, prime
counts of 2000 to 25000 the system, and re-run the tests.
CPS.
No reagent was pipetted This CPS level indicates
into the Test Unit because substrate background
of a level-sense error. A counts and points to a lack
false triggering probe of alkaline phosphatase
caused the error. enzyme in the Test Unit.
Refer to LEVCRASH and
Loose thumbscrew or
LEVFALSE diagnostic
syringe barrel.
programs in Section 12:
Detached syringe tip. Diagnostics.
Finger-tighten the
thumbscrews for the small
and/or large syringes. Also,
ensure that the syringe

barrels are tight.
Replace the detached
syringe tip following the
instructions for large and
small syringe tip
replacement in Section 8:
Erroneous results with A reagent carousel positioning Call DPC Technical Service
counts of 2000 to 25000 error.
CPS (Continued).
Wash liquid was not removed from Check the fluid level
the Test Units. around the bead. After
leaving the Luminometer,
the volume should be 200
µL - just covering the bead.
Note: If the liquid covering the

bead is higher than the level
mentioned above and the High-
speed Spinner is not operating
properly, call DPC Technical
Service.
Miscellaneous The table below shows causes and solutions for miscellaneous problems.
Problems

More Test Units remain in a kit Reagent is evaporating because the Discard the remaining Test Units.
than reagent. wedge was left uncapped in the In the future, cap and store
Reagent Carousel. Reagent Wedges in the
refrigerator when assays are not
being run.

Error The table below lists error messages, their cause, and the solution to the
Message / problem. Errors are listed alphabetically.
Solution
Table
Note: Repeated error messages may indicate a serious problem. Write down
the exact error message or print the Error Log and call DPC Technical
Service. (To print the Error Log, choose System Status and View Error
Log from the Primary Screen. Press [F10] to print.)
Error Message Cause Solution

Adjustor lots Test Unit lot numbers are not the Re-run the Adjustor (or Adjustors)
between replicates same for all the Adjustor using matching Test Unit lots.
don't match replicates.
Adjustor replicates The Test Codes behind an Re-run the Adjustors with matching
not identical Adjustor sample cup are not all the replicate Test Codes.
same (i.e. not all TSH replicates).
Adjustor result The result file could not be found. Call DPC Technical Service.
file not found
Ambient Elec. Temp The ambient electronics Clean the intake fan filter
High [nn] temperature reading is higher than on the right side of the
the acceptable range. IMMULITE.
Note: This is not a fatal error
condition.
Note: The lab temperature should
be less than 30° C. The temperature
should fall back into an acceptable
range within a short amount of time.
Ambient Temp. High The internal ambient air This problem should correct itself.
temperature reading is higher than Call DPC Technical Service if the
the acceptable range. error message persists.
Note: This is not a fatal error Note: The lab temperature should
condition. be less than 30ºC.
Atten. Factor not The attenuation factor was not set. Call DPC Technical Service.
set
Note: This message should not be
encountered if the computer has
been configured correctly.

Atten. Home Error Attenuator Disk has not found the If the problem is not correctable, the
Home Sensor. Lum. Chain and Atten.
Shut Down error will occur.
Note: This message will also

appear on the Instrument display
panel when the error is detected.
A notice will appear on the display
panel if the IMMULITE is able to
correct itself.
Atten.-Pos. Error. Attenuator Disk has not found the Refer to the solution above for the
Position Sensor. error message: Attenuator
Home Error.

correct itself.
Bad barcode last Either: Wipe the label with a lint-free
Sample #nn towel or wash the label with water.
Torn, wrinkled or dirty
barcode labels, which cause If the barcode is torn or
Test Units not to spin wrinkled, discard the Test Unit
smoothly. or the sample cup holder.
Dirty Barcode Reader O-rings. Perform maintenance on the
barcode drive wheel (refer to
Barcode Reader speed is off in
Section 6: Routine
one or all positions.
Maintenance).
Run the BCODESPD diagnostic
program.

Bad File Name or The computer was turned off or Press any key to return to the
Number in Line xx reset without following the proper DOS command line.
of Module PC yy at Log Off procedure.
address zz. Hit At the C:\CIRRUS\IMM
any Key to Return prompt, type fixit and press
to System. [Enter].
A message indicating that the
software is attempting to repair
the database will be displayed
until the damage is corrected.
Note: Some data may be lost in
this process.
If the repair is successful, three
messages that state a successful
repair will appear.
Type start and press
[Enter] to return to the Start-up
menu.
Repeat all tests in progress.
Note: Be sure to shut down the
System before choosing RUN
IMMULITE or START
TURBO. Call DPC Technical
Service if the problem persists.
Bad LIS Checksum Checksum did not match Re-download the orders to the
(transmission error). IMMULITE.
Bad or Missing Usually indicates an inconsistency Re-download the orders to the
Frame Number between the IMMULITE LIS IMMULITE.
software and the laboratory LIS
If the error continues to occur, call
software. This may require a
your LIS provider.
change in the laboratory LIS
software.
Bad Parity Error Due to electrical noise on the Problem will usually correct itself.
power line, information was sent
If the problem does repeat, call DPC
to the software and incorrectly
Technical Service.
read as a message.

Calc error Occurs when the system cannot If all results give Calc
properly calculate a dose. error, check to see if there is
enough water and if the syringe
thumbscrews are tight.
If an individual result shows
this error and it is a competitive
assay, the dose may be too high.
Dilute and rerun specimen.
If the results show < 25,000
CPS, refer to page 11-10 for:
Erroneous results with counts of
2,000 to 25,000 CPS.
Cannot calculate An invalid value was received for Select System Status and
average temperature a temperature reading because of a Temps/Dark Counts to view
due to error temperature controller error or instrument temperatures. If the
failure. temperatures are not within
specifications, perform the
following steps:
Turn the IMMULITE power off
for 1 minute and then on.
Select RUN IMMULITE or

START TURBO from the Start-
up menu.
Put the instrument manually
into the pause mode.
Check the temperature after 10

minutes.
Note: If the Luminometer or Main
Carousel feels hot, turn the
instrument off immediately.
Cannot calculate An invalid value was received for Refer to solution above for:
last temperature. a temperature reading because of a
Delta error Cannot calculate average
temperature controller error or temperature due to
encountered.
failure. error.

Cannot communicate RUN IMMULITE or START Ensure the IMMULITE Display
with IMMULITE TURBO was selected while the Panel reads IDLE.
Display Panel showed something Press ALARM MUTE and GO
other than the message: DPC and re-load the software.
IMMULITE IDLE, Run
START Program to begin. Note: Make sure the power is on
and the RS232 ports are connected.
Cannot find Order A record required for LIS Re-send the test order to the
Record communications is not found. IMMULITE.
Cannot find record The IMMULITE sent a reading to Re-run the test using a different
for result Sample the computer; however, it did not sample cup holder number.
#nn testCode know where the result belonged in
the database and the result for this
Test Unit was lost.
Cannot find record The sample cup was identified as Repeat the tests, identifying the
to place Adjustor an Adjustor, control, or verifier Adjustor, control, or verifier to the
[Control] after passing the Barcode Reader. software before the sample cup
[Verifier] Entry.
passes the Barcode Reader.
Note: The error message
will read Adjustor,
Control, or Verifier,
depending upon the
situation.
Carousel Shut Down Main Carousel has jammed or the The Instrument will attempt to
pipettor is stuck in the pipetting complete tests in progress in the
position on the Main Carousel. Luminometer.
This error often occurs because a
Perform the following:
sample cup is on the Main
Carousel. Allow tests in progress to
complete.
Note:
Stop the IMMULITE (press
This error will always occur in
ALARM MUTE and GO).
conjunction with the Front End
Shut Down error. Log off the system.
Run the CARBACK
diagnostic to check for a
sample cup on the Main
Carousel.
Press the black Prime
button on the syringe
module to index the
Incubation Carousel
counterclockwise.
Remove the Test Units from
the carousel as they become

accessible in the Load
Chain/Carousel intersection
area.
Remove the sample cup
holder from the carousel.
Select RUN IMMULITE
or RUN TURBO from the
Start-up menu to repeat the
aborted tests.
Note: Remove the Test Units from
the Load Chain (between the
Barcode Reader and the carousel)
before restarting the tests. For
further assistance, call DPC
Technical Service.
Carousel Temp. High The Incubation Carousel The IMMULITE should correct
[Low] temperature is above or below the itself. If it does not, call DPC
Note: The error message acceptable range. Technical Service.
will read either High or Note: All results generated during
Low. the high or low temperature period
If the component feels hot, turn the
instrument off, allow it to cool, and
Collection Tray The sample collection tray is full If the sample collection tray is
Full or missing. full, remove the sample cups
from the collection tray and
Note: An alarm sounds and the
replace the sample collection
IMMULITE goes into
tray.
AutoPAUSE mode.
If the sample collection tray is
missing, replace it.
Follow the instructions on the
instrument Display Panel to
continue.

<CR> or <LF> Usually indicates an inconsistency Inform your LIS provider of this
Missing in LIS between the IMMULITE LIS error.
Transmission. software and the laboratory LIS
software. This error also may be a
bad message (e.g. line noise).
Dark Count High [nn]. The dark count measured exceeds Call DPC Technical Service.
the maximum acceptable limit
(300 CPS).
Note: The preceding sample may
have had very high CPS.
Database needs The computer’s power was turned Press any key to exit to DOS.
repair in line 0 of off or reset without following the
module Pcxxx at Type fixit and press [Enter].
proper log off procedure.
address xxxx:yyyy. The message: Attempting
Hit any key to to repair database is
return to the displayed, followed by a
system. message indicating the damaged
files have been repaired.
Note: This process can take as
long as 15 minutes, depending
on the amount of data stored.
If the repair is successful, three
messages that state a successful
repair will appear.
Type start and press [Enter]
to return to the Start-up menu.
Data lost. The computer and the IMMULITE Check the RS232 cable.
Simulation screen were not communicating for more
may not be correct. Note: For further assistance,
than 32 cycles. Some of the data
OLD=[xx], NEW=[yy] call DPC Technical Service.
was not received; therefore, reports
will be missing.
Date Time conflict The computer's date or time was Do the following:
set earlier than the date or time
Enter the current date and/or
recorded with results already
time (see Initializing the
generated by the IMMULITE.
Software in Section 4: Routine
Operation).
Re-run the tests.
Diluted Samples Diluted sample is below the Re-run sample undiluted.
below curve detection limit.

Division by 0 The IMMULITE encountered an Call DPC Technical Service.
during Adjust error while calculating test results.
testCode This error may be caused by the
following:
A hardware error occurred.
The RS232 cable is loose
or disconnected.
Invalid parameters or kit
barcodes.
Note: This is an infrequent error
when the master curve parameters
are correct and the IMMULITE is
running properly.
Error during Unexpected Error. Call DPC Technical Service.
Control QC
Error during Unexpected Error. Call DPC Technical Service.
Patient QC
Error in last The LIS encountered an error Re-send the results to the LIS.
request when processing the IMMULITE's
If the error continues to occur, call
request for information.
your LIS provider.
Fatal Curve Adjust An unknown error was Call DPC Technical Service.
error #nn testCode encountered.
Five Replicates More than the required four Test No action is necessary. The
used for Curve Units were run behind the Adjustor software looks for quadruplicates
Adjust. 5th sample cup. only; therefore, the fifth Test Unit is
replicate dropped.
ignored.
Front End Shut Down The Load Chain and pipettor are Wait for the IMMULITE to
disabled because an error was complete the tests in progress.
detected in the Load Chain,
Investigate the cause of the
pipettor, or syringes that the
problem by checking the
IMMULITE could not correct.
associated error messages or
Note: If possible, the IMMULITE looking for an obstruction.
will continue processing the tests
currently in progress.
Heaters Shut Down The 35 or 39-degree calibration Call DPC Technical Service.
35 [39] Degree resistor cannot be read properly
Error due to a heater controller error.
Note: The error message
will read either 35 or 39.

Heaters shut down - The Main Carousel heater is not Call DPC Technical Service.
Car. heater error working correctly because of a
heater controller error or a
thermistor failure.
Heaters shut down - Reagent cooling is not working Call DPC Technical Service.
cooler error properly because of a TED error or
Note: Refrigerate reagents between
a thermistor failure.
2°C and 8°C when not in use.
Heaters shut down - The Luminometer heating is not Call DPC Technical Service.
Lum heater error working properly because of a
heater controller error or
thermistor failure.
Heater startup Either: Do the following:
error. Heaters
shut down. The IMMULITE components Turn the IMMULITE off for 1
have not reached operating minute to reset the heater
temperature, even though it timers.
has been 60 minutes since
Turn the IMMULITE on.
start-up.
Check the temperature after 45
The power to the instrument
minutes (by choosing System
was interrupted.
Status and Temperature and
Dark Counts from the Primary
Screen).
Notes:
The IMMULITE software does not
need to be loaded before the system
warms-up.
Once the IMMULITE has reached
operating temperature, it should be
left on.
If the error message persists, call
High and Low Different high and low Adjustor Re-run the Adjustors using the
Adjustor Test Codes Test Codes. (i.e. An Adjustor is correct Adjustor definition.
don't match defined as TSH and the high =
TSH, but the low = T4.)

High [Low] After dropping the high or low Evaluate the CPS of the replicates:
Adjustor's CVs Adjustor replicate, whichever
between replicates If the CVs are very high (30%
contributes to imprecision the
are > than nn%. or more), call DPC Technical
most; the CVs are still too high.
Adjust aborted. Service.
Note: This error can only be
If the CVs are not high, re-run
encountered during the adjustment
the Adjustor that caused the
process.
adjustment to fail, ensuring
there are no bubbles on the
surface of either the sample or
the reagent.
Note: Another sample cup
must be identified as an
Adjustor and followed by four
Test Units.
Illegal function Occurs while the Instrument Call DPC Technical Service.
call during Calc. software is performing a
test testCode calculation.
Illegal function An invalid or 0 CPS, caused by Call DPC Technical Service.

call during Curve either:
Adjust test
testCode Kit Lot nn Invalid parameters or kit
barcodes
Mechanical problems
“In Progress or The auto-number feature was Operator should not try to auto-
resulted, selected, in the LIS Data number records that are closed or
skipping.” Management screen, for records are in progress.
already in progress or resulted.
Insufficient sample Refer to the explanation for the Refer to the solution for the error
error message: No Sample message: No Sample
Pipetted Sample #nn Pipetted Sample #nn
testCode testCode
Insuf. Reagent Pip. Either: Do the following:
Not enough reagent is Ensure there is sufficient
available to complete the test reagent available to complete all
tests.
A level-sense error was
encountered Ensure there are no bubbles on
the surface of the sample and
A Test Unit and Reagent
reagent.
Wedge were mismatched
Replace the incorrect kit
The cap on the Reagent
component.
Wedge was not removed, thus
causing a tip jam error. Ensure the cap on the Reagent
Wedge is open.

Invalid LIS ID LIS error message that occurs Do the following:
when the Sender ID or Receiver ID
From the Start-up menu, choose
is incorrect.
LIS PARAMS.
Check that the Receiver ID
matches the LIS Sender ID and
that the Sender ID matches the
LIS Receiver ID.
Invalid LIS LIS error message that occurs Do the following:
Password when the Header Message
From the Start-up menu, choose
Password is incorrect.
LIS PARAMS.
Check that the Header
Message Password field shows
the same Header Message
Password used by the LIS.
Kit not Found The kit parameters were Enter the kit barcodes (using the
testCode Kit Lot overwritten with those of another laser scanner), and re-run the
nn. Curve Adjust kit after pipetting. adjustment.
aborted.
Note: Do not delete a kit that is
currently running.
Less than 4 Refer to the explanation below for: Refer to the solution below for the
replicates. Adjust Less than 4 replicates, error message: Less than 4
aborted. or Adjustor results for replicates, or Adjustor
all levels are not yet results for all levels
available. are not yet available.
Less than 4 Either: Depending on the cause, either:
replicates, or
Adjustor results A record for one of the Re-run the Adjustor.
for all levels are Adjustor replicates was deleted
Re-run the Adjustor that was
not yet available because of a pipetting error.
short the required number of
An insufficient number of replicates.
replicates were loaded.
Note: This sample cup must be re-
identified and followed by four Test
Units.

Level Sense Error The IMMULITE has not level- Call DPC Technical Service.
sensed either the reagent or the
sample.
Note: If five Level Sense
errors occur, the IMMULITE goes
into AutoPAUSE. The error
messages associated with the
sample cup number are recorded in
the Error Log.
LIS Sent an INVALID Sender ID incorrect. Enter correct Sender ID in LIS
ID of NULL, record PARAMS. Check with LIS
not saved provider for correct ID.
LIS Timeout The LIS is not responding to the Check the cable connection.
IMMULITE. This can be caused
Re-send the results to the
by:
LIS.
Cable problem
If the error continues to
Hardware problem occur, call DPC Technical
Service.
There may be an inconsistency
between the IMMULITE LIS
software and the laboratory
LIS software. This may require
a change in the laboratory LIS
software.
Load Chain Error. The Load Chain has not found a Look for source of the error
position sensor. condition (i.e. a sample cup
incorrectly seated in the sample cup
holder or a crushed Test Unit) and
call DPC Technical Service for
assistance.
panel if the IMMULITE is able to Note: If the IMMULITE cannot
correct itself. correct the error, the instrument
automatically shuts down the
pipetting (front end) operation and a
message indicates this has occurred.
(The instrument will continue to
process the tests in progress.)
Low and High A Test Unit lot matches two Remove the Reagent Wedge that
Adjustor reagent different Reagent Wedge lots. (i.e. should not be used for the
lots don’t match Two Reagent Wedge lots are adjustment and re-run both
loaded. The first Reagent Wedge Adjustors with only one reagent lot
is used for the low Adjustor loaded on the instrument.
replicates, but there is not enough
reagent for the high Adjustor
replicates, so the second Reagent

Wedge lot is used.)
Low and High Two kit lots share the same Re-run the Adjustors using the
Adjustor Test lots Reagent Wedge lot number but correct Test Units (from the kit
don't match have different Test Unit lots; which is being adjusted).
therefore, the low and high
Adjustor replicates are run with
different Test Unit lots.
Low CPS sample xx The counts for a result are less Refer to the solution listed for the
[test code] than 15,000. Error,
Erroneous results with
counts of 2000 to 25000
CPS.
Lum. Chain and There is a Luminometer Chain or Look for the source of the jam.
Atten. Shut Down. Attenuator Disk jam. Since this is a fatal error, the
IMMULITE will stop.
Note: For further assistance, call
Lum. Chain Error. If this error occurs, the Call DPC Technical Service to
PRESS <ESCAPE> TO Luminometer chain has jammed determine the validity of tests in the
CONTINUE and may be mis-positioned. Tests Luminometer.
on the Main Carousel are valid.
Lum. Temp. High The temperature reading for the The IMMULITE may correct itself.
[Low] Luminometer is above or below If it does not, call DPC Technical
Note: The error message the acceptable range. Service.
will read either High or Note: All results generated during
Low. a high or low temperature period
If the component feels hot, turn the
instrument off immediately and call
Main Car. Error This message will appear on the Do the following:
IMMULITE Display Panel if the
Monitor the Instrument for
error corrects itself.
subsequent Main Carousel
Note: If the problem cannot be errors. In severe cases, the
corrected, the instrument Carousel Shutdown error
automatically shuts down and an will occur. Refer to instructions
error message indicates this has for the Carousel
occurred. A sample cup holder Shutdown error.
jammed on the carousel under the
drive gear often causes this.

Mechanical error Either: Based on the cause, either:
encountered
(pipetting) This message appears in Determine the cause of all bad
conjunction with numerous barcode reads and correct if
bad barcode reads. possible.
A problem was encountered Check seating of probe tube at
with the pipettor. Vanity Panel.
If persistent, call DPC
Technical Service.
Note: The washer belongs behind
the Vanity Panel.
If the problem is not correctable, the
Front End Shut Down Error
will occur.
Message received The computer missed a message The software automatically requests
out of sequence, from the IMMULITE. that the message be re-sent.
Seq = xx
OldSeq = yy If the message persists, call DPC
Technical Service.
Message Too Short Usually indicates an inconsistency Re-send the results to the LIS.
LIS mesg. too between the IMMULITE LIS
short\bad frame If the error continues to occur, call
software and the laboratory LIS
your LIS provider.
software. However, the error also
can be caused by a bad message
(due to line noise, etc.).
Negative Slope Sample cups were identified as low Re-run both levels of Adjustors,
calculated! Are the and high, but either the levels pipetting each level into the correct
Adjustor levels dispensed into the cups were in the sample cup holder.
reversed?
reverse order or only one level was
run for both samples.
nn days since your The database has not been backed- Either:
last backup up in the last 7 or more days.
Ignore this message and backup
Note: Execution speed is greatly the system soon. Refer to the
reduced. Daily Maintenance procedure in
Section 6: Routine
Maintenance.
Back-up the system
No info on this # The LIS has no information Check the LIS to verify that the
regarding the accession number accession number has been
sent in the query. assigned.

Non-Turbo kits Non-Turbo reagent wedges have Either:
cannot be run while been loaded onto the reagent
in Turbo Mode. Remove all Non-Turbo
carousel while in Turbo Mode.
Please take all Reagent Wedges and press
non-turbo kits off GO to continue running in
the reagent Turbo mode.
carousel.
OR
Log off and Choose RUN
IMMULITE to run the
Non-Turbo kits.
No Patient Record A record required for LIS Re-send the test order to the
for Order communications is not found. IMMULITE.
If problem persists, call
your LIS provider.

No place in Either: Based on the cause, either:
database for Test
Code xx result. The sample cup was identified Repeat the tests, identifying the
as a control or Adjustor after control or Adjustor to the
passing the Barcode Reader. software before the sample cup
passes the Barcode Reader.
The date on the computer is
incorrect. Note: If the problem persists,
Check the computer's date and
time (see Initializing the
Software in Section 4: Routine
Operation).
No Place in Either: Based on the cause, either:
Database to Put
Tube, Displayed as The Barcode Reader read a Ensure that all sample cups are
Bad. Test Unit that was not loaded ahead of the Test Units
preceded by a sample cup. on the Load Platform.
The operator logged off and on Press ALARM MUTE and GO
the computer while the System simultaneously, log off (via the
was still operating. Primary Screen) and re-run the
tests.
No Reagent for Either: Depending on the cause either:
approaching
testCode Tube Part A Reagent Wedge is missing Replace the missing Reagent
[Reagent Part] from the Reagent Carousel Wedge.
Lot#[lot#] tray.
CAUTION: The Reagent
The Reagent Wedge and Test Wedge must be replaced within
Unit lot numbers are 5 minutes or this test result is
mismatched. lost.
Refer to the solution for the
error message: Reagent
part A missing.
No Reagent for Indicates either: Depending on the cause either:
testCode tube at
the Barcode Reader There is no Reagent Wedge on Add the correct Reagent Wedge
board matching the Test Unit and press GO to re-read the
just read at the Barcode Reader Reagent Carousel.
The current Reagent Wedge Press PAUSE to ignore the
has Zero Tests message and this test will not be
Remaining. (The pipetted.
instrument will go into
Remove all incorrect sample
AutoPAUSE mode.)
cups and test units that need to
Turbo and Non-Turbo kits are be run in a different mode
on board at the same time. (Turbo or Non-Turbo) and press
GO.

No Reagent for Indicates either: Depending on the cause either:
testCode tube(s) on
the load chain After the Test Unit(s) passed Add the correct Reagent Wedge
the Barcode Reader, the and press GO to re-read the
Reagent Wedge for these tests Reagent Carousel, or press
went to Zero Tests PAUSE to ignore the message
Remaining. (this test will not be pipetted).
The Reagent Wedge and Test Refer to the solution for the
Unit lot numbers are error message: Reagent
mismatched. part A missing.
Turbo and Non-Turbo kits are Remove all incorrect sample
on board at the same time. cups and test units that need to
be run in a different mode
(Turbo or Non-Turbo) and press
GO.
No Reagent Pipetted Either: Re-run the test for the record which
Sample #nn testCode was deleted, ensuring there is
Not enough reagent remains to
enough:
continue testing.
Sample (above the required
Note: The error will be recorded
dead volume)
in the Error Log and on the
printed report. For this Test Unit, Reagent (above the 1 mL dead
the report will say: Record volume)
Deleted Pipetting
Error.
It is a hardware-related error
(as indicated on the instrument
Display Panel).

No sample cup for Either: If there was a bad barcode read:
Test Unit
A bad barcode read occurred Wipe the label with a lint-free
for the tube just before the towel or wash the label with
Test Unit (which may or may light detergent.
not be a sample cup)
If the barcode is torn or
There are more than five Test wrinkled, discard the Test Unit
Units behind a sample cup or sample cup holder.
There is no sample cup in front Perform maintenance on the
of the Test Unit barcode drive wheel (Refer to
Section 6: Routine
Maintenance).
Repeat the tests.
If there are more than five Test
Units, place the correct number of
Test Units behind the sample cup
and re-run the test.
If there is no sample cup in front of
the Test Unit, place a sample cup in
front of the Test Unit and re-run the
test.
No Sample Pipetted No sample was pipetted because If the error was due to insufficient
Sample #nn testCode an error was detected. The error sample, ensure there is adequate
can be: sample in the sample cup and re-run
the test.
Hardware-related
If it is a hardware error, remove any
Due to insufficient sample
obstructions and re-run the tests.
If any other message accompanies
the No Sample Pipetted
Sample #nn testCode
message, it is a hardware problem.
Note: The error will be recorded
in the Error Log and on the printed
report. For this Test Unit, the
printed report will say: Record
Deleted Pipetting Error.
Overflow Error An error occurred while Note the exact overflow error
during Adjust test performing a calculation error. message.
testCode Kit Lot nn
A hardware error occurred. Check the RS232 cable.
The RS232 cable is loose or Call DPC Technical Service.
disconnected.

Overflow error Either: Note the exact overflow error
during calculation message.
test testCode A calculation error occurred.
Check the RS232 cable.
A hardware error occurred.
Call DPC Technical Service.
The RS232 cable is loose or
disconnected.
Pause mode; 5 Level The instrument will go into Call DPC Technical Service if each
Sense Errors AutoPAUSE mode if the following error was not due to insufficient
Encountered errors occur 5 times within a run: volume for reagent or sample.
Insuf. Reagent Pip.
Not enough sample
error
PC IMMULITE COMM Communication between the PC Check cable connections
FAILURE and the IMMULITE has been between the IMMULITE and
Check your cable interrupted. the PC.
connection now!
Reset power on both the PC and
Resuming normal the IMMULITE and select
operation in 15 RUN IMMULITE or START
seconds.
TURBO from the start-up
menu.
Reagent Carousel Reagent Carousel has not found Ensure that the Reagent
Home Error the Home Sensor. Carousel is seated properly
Note: This message will also and nothing is blocking the
appear on the Instrument display sensor beneath the Carousel
panel when the error is detected. Tray.
Check the bottom of the
Carousel Tray for a bent
correct itself.
tab. If bent, call DPC
Technical Service.
Note: If the problem is not
correctable, the Front End
Shut Down error will occur.
Reagent Level Sense Probe level senses above the Check for cap on Reagent Wedge or
Error. maximum height of liquid. large bubble on top of reagent. Call
Are there Caps on DPC Technical Service if error
the Reagent Vials?
persists.
Reagent lot# xmit The correct lot information could Re-read the reagent barcodes. If the
error not be transmitted to the problem persists, call DPC
IMMULITE. Technical Service.

Reagent pipetted Either: Re-run the Adjustors and enter the
does not match kit. correct kit.
Adjust aborted. Different Reagent Wedge lots
were pipetted throughout the Note: Be sure to use the correct kit
two Adjustor levels. components.
The kit needing adjustment
does not correspond to the
Test Units and Reagent Wedge
used.
Reagent part A Either: If the Test Unit and Reagent Wedge
missing lots are mismatched:
The Test Unit and Reagent
Wedge lots are mismatched. Check the Reagent Status or Kit
A mismatched lot occurs when Entry screen for kit component
the Test Units and Reagent lot numbers.
Wedge currently on-board are Confirm that the actual lot
not from the same kit lot. numbers of Test Units agree
with the Reagent Wedge on-
Note: Pause is automatically
board.
initiated.
Change either the Reagent
The Reagent Wedge has not Wedge or the Test Units, as
been placed in the Reagent needed.
Carousel Tray.
Note: Mismatched Test Units
The Reagent barcodes have appear as white circles on the
not been re-read after the kit Primary Screen. Depending on
barcodes were scanned into the the error condition, these Test
Kit Entry screen. Units may be carried around the
Turbo and Non-Turbo kits are Incubation Carousel and sent to
on board at the same time. the sample collection tray; or,
they may be shuttled directly to
A kit was not scanned. the sample collection tray.
Otherwise, do the following (based
on the cause):
Scan the Kit.
Place the Reagent Wedge in the
Reagent Carousel Tray.
Re-read the reagent barcodes.
Remove all incorrect sample
cups and test units that need to
be run in a different mode
(Turbo or Non-Turbo) and press
GO.

Reagent Pos. Error Reagent Carousel has not found Ensure that the Reagent
the Position Sensor. Carousel is seated properly
and nothing is blocking the
sensor beneath the Carousel
Tray.
A notice will appear on the display Check the bottom of the
panel if the IMMULITE is able to Carousel Tray for a bent
correct itself. tab. If bent, call DPC
Technical Service.
correctable, the Front End
Shut Down error occurs.
Reagent Temp High The Reagent Carousel temperature If just powering on the system, you
is above 22° C. must wait 45 minutes for the system
to reach optimal temperatures. Call
DPC Technical Service if the
problem persists.
Reagent temperature Thermoelectric Cooler failure Remove reagents. Call DPC
out of spec after Technical Service if the problem
pipetting persists.
Record Deleted [No Either: If there was insufficient sample, do

Sample] or [No the following:
Reagent] Pipetted The records were deleted
because of insufficient sample Check the printout or the Error
Note: This message prints or reagent. Log for error messages.
on the report.
The Reagent Wedge went to Note: The Test Unit will be in
Zero Tests Remaining the sample collection tray.
after the Barcode Reader read
the Test Units and the Reagent Re-run the test (Re-loading the
Wedge was not replaced reagent and sample if
before the Test Units reached necessary.)
the carousel. For the other two causes listed, re-
The second Reagent Wedge run the assays.
for a sequential assay was
missing or went to Zero
Tests Remaining and the
Reagent Wedge was not
replaced in time to complete
the second step of the assay.

Sample Tray Full or The sample collection tray is full If the sample collection tray is
Absent or missing. full, remove the sample cups
from the collection tray and
Note: An alarm sounds and the
replace the sample collection
IMMULITE goes into
tray.
AutoPAUSE mode.
If the sample collection tray is
missing, replace it.
Follow the instructions on the
instrument Display Panel to
continue.
Sample cup # A communication error occurred Call DPC Technical Service.

mismatch between the IMMULITE and the
Call Tech Services software.
Shut-Car Error The shuttle has not found the Look for the cause of the
sensor on the Main Carousel. jam (Test Units, a bent
shuttle flag or a baffle that
popped off the
Note: This message will also Luminometer Chain).
Notes:
A notice will appear on the display If the problem cannot be corrected,
panel if the IMMULITE is able to the instrument automatically shuts
correct itself. down and the Main Carousel
Error May Have Occurred
error message will occur.
For further assistance, call DPC
Technical Service.
Shut-Pos. Error The shuttle has not found the Look for the cause of the
sensor at the Luminometer. jam (Test Units, a bent
shuttle flag or a baffle that
popped off the
Luminometer Chain).
A notice will appear on the display Notes:
If the problem cannot be corrected,
correct itself.
the instrument automatically shuts
down and the Main Carousel
Error May Have Occurred
error will occur.
For further assistance, call DPC
Technical Service.

Main Carousel Error This is a fatal error. The Check for anything that would
May Have Occurred instrument cannot function and interfere with the shuttle
automatically shuts down. operation (i.e. bent shuttle flag)
and call DPC Technical
Note: All tests currently in
Service.
progress are lost.
Repeat all tests that were in
progress.
Steps Left Overflow The IMMULITE sent an invalid If the problem persists, call DPC
value for calculating the amount of Technical Service.
reagent remaining.
Substrate Heater Substrate Heater did not reach Call DPC Technical Service.
failure operating temp (37° C) in allowed
time.
Substrate Low Level of substrate in reservoir has Replace the substrate bottle
dropped below fill-line. and squeeze the gray button
on the substrate reservoir to
fill the reservoir to the fill-
line.
If problem persists, contact
Syringe A [B] Error A movement error in the large Check to see if a test result
Corrected syringe (A) or the small syringe was affected. An affected
Note: The error message (B) was detected. The message Test Unit will appear as a
reads A or B. will appear on the IMMULITE white circle on the Home
Display Panel if the IMMULITE screen.
was able to correct itself.
If there are affected Test
Units and/or the error was
not correctable, call DPC
Technical Service.
Note: If the error is not correctable,
the Instrument automatically shuts
down the front-end and the Front
End Shut Down error will
occur.

Syringe ACK error Either: If GO was pressed less than one
minute after Start-up, do the
GO was pressed less than one
following:
minute after Start-up. The
small pipettor syringe then Turn the IMMULITE power off
fails to acknowledge for a minute, then on again.
commands. Wait for the syringe barrels to
Note: The Test Unit appears move to the top of the plunger
on the screen as a white circle. and select RUN IMMULITE
or START TURBO from the
A hardware failure occurred. Start-up menu.
Note: If the error message
persists, call DPC Technical
Service.
correctable, the front-end will
shutdown and the Front End
Shut Down error will occur. The
tests in progress will be completed.

Temperature The temperature controller failed Perform the following:
controller failure due to either:
Press PAUSE on the
A brief power outage Display Panel three times to
shut down the Instrument.
OR
Turn the instrument power
A hardware failure
off.
After approximately 2-4
minutes, turn the instrument
power on.
Re-start the software. If the
error re-occurs after
initialization, call DPC
Technical Service.
Temperature The temperature controller failed Perform the following:

controller not due to either:
operating properly Press PAUSE on the
A brief power outage Display Panel three times to
shut down the Instrument.
OR
Turn the instrument power
A hardware failure
off.
After approximately 2-4
minutes, turn the instrument
power on.
Re-start the software. If the
error re-occurs after
initialization, call DPC
Technical Service.
Test Unit lots do The Test Units being used do not Re-run the Adjustors using the
not match kit. match the kit to be adjusted. correct Test Units.
Adjust aborted

Tip Jam Error. Are Indicates that: Depending on the cause either:
there caps on the
reagents? There is no sample Check the sample volume. If
Caps were left on the reagent necessary, add more sample and
re-run the tests.
Or
Remove cap(s) from the
The probe is not positioning
reagent.
correctly
Watch the pipettor to try and
determine the cause of jam.
Perform the Probe Angle
Diagnostic to assure probe
integrity.
Note: Call DPC Technical
Service if the message persists
or if the source of problem is
unclear.
Turbo kits cannot Turbo reagent wedges have been Either:
be run while in loaded onto the reagent carousel
Normal Mode. Please Remove all Turbo Reagent
while in Normal Mode.
take all turbo kits Wedges and press GO to
off the reagent continue running in Normal
carousel. mode.
Log off and Choose
START TURBO to run the
Turbo kits.
Valve A [B] Error A problem with the valve on the If problem persists, call DPC
Note: A or B appears, Large Syringe (A) or Small Technical Service.
depending on the situation. Syringe (B) was detected.
Note: This message will also correctable, the front-end will
appear on the Instrument display shutdown and the Front End
panel when the error is detected. Shut Down error will occur. The
A notice will appear on the display tests in progress will be completed.
panel if the IMMULITE 1000 is
able to correct itself.
Warning: Part B A sequential assay Reagent Wedge Replace the missing part B reagent
reagent missing. is missing. and press GO to read the reagents.
Hit PAUSE to ignore
or GO to read
reags.

X Home Error. Something has interfered with the Perform the following:
Note: This message appears probe movement or a hardware
Determine if anything is
on the IMMULITE Display error has occurred.
interfering with the pipettor
Panel and in the daily Error movements (i.e., probe
Log. tubing).
appear on the Instrument display Once the Test Units in
panel when the error is detected. process are finished, correct
A notice will appear on the display the problem and restart the
panel if the IMMULITE is able to IMMULITE.
correct itself.
Note:
the Front End Shut Down
error will occur. The instrument
will continue to process tests
X Pos. Error Something has interfered with the Perform the following:
Note: Appears on the probe movement or a hardware
IMMULITE Display Panel error has occurred.
and in the daily Error Log. movements (i.e., probe
tubing).
correct itself.
Note:

Z Home Error Something has interfered with the Perform the following:
Note: Appears on the probe movement or a hardware
IMMULITE Display Panel error has occurred.
and in the daily Error Log. movements (i.e., probe
tubing).
correct itself.
Note:
Z Mid Error Something has interfered with the Perform the following:
probe movement or a hardware
error has occurred.
movements (i.e., probe
tubing).
correct itself.
Notes:
If the probe was on the Main
Carousel when the error occurred,
the Main Car.Error will
occur.

Fixing or In the event of a serious system error, the RESTORE function is used to
Restoring a copy the database stored on diskette (during back-up) to the computer's hard
Database drive. Before restoring the database, attempt to fix the database using the
FIXIT program. If FIXIT does not correct the problem, use the Restore
function to restore the database.
CAUTION: The Restore function will delete all data generated since the last
backup.
Running FIXIT Instructions for running the FIXIT program:

2. At the c: prompt, type fixit and press [Enter].
The FIXIT program checks the software for damage and attempts to
correct the problem.
3. When the c: prompt reappears, type start and press [Enter] to return
to the Start-up menu.
Restoring a If FIXIT does not correct the problem, follow the steps below to restore the
Lost or database when it is damaged or lost:
Damaged
Database
1. From the Start-up menu, select BACKUP/RESTORE and press
[Enter].
2. Select RESTORE DATA BASE and press [Enter].

4. Place the disk (containing the database archive) into the disk drive and
press any key to continue.

A message appears, stating that the database is being unpacked. This
process will take 1-3 minutes.
When the restoration is complete, the Start-up menu appears.

Appendix A : System Specification Tables
Output The Output Specification Tables below list the output to be expected from
the IMMULITE system.
Standard Mode:
Item Specification
Time to First Result 42 minutes for a one-cycle assay or 72 minutes
for a two-cycle assay
Turbo Mode:
Item Specification
Time to First Result <15 minutes for a one-cycle assay or
<22 minutes for a two-cycle assay
Luminometer The Luminometer Specification Table below lists characteristics

associated with the Luminometer.
Item Specification
Signal Detection Method Photon-counting photomultiplier
tube
Wavelength of Emitted Light 425 to 500 nm
External Computer Industry Standard Personal
Computer
IMMULITE Operator’s Manual 600032-K A-1

Hardware The Hardware Weight Specification Table below shows the weight of
each piece of hardware.
The dimensions of the IMMULITE System (without the computer) are
40 x 24.75 x 16 inches (or 102 x 63 x 41 cm).
Hardware Weight
IMMULITE System 240 pounds / 109 kg
Computer 64 pounds / 29 kg
Printer 11 pounds / 5 kg
Uninterruptible Power Supply (optional) 69 pounds / 31 kg
Fluid Usage The fluid specifications are listed in the table below:
Approx. Number
Volume Used Volume of Full of Tests Per Full
Fluid Per Test Container Container†
Water∗ 4.1 mL 2000 mL 500
Probe Wash‡ 1.0 mL 1000 mL 1000
Substrate 0.2 mL 105 mL 500
†Number of Tests Per Full Container may vary depending upon amount of priming performed.
∗Volume Used Per Test is based upon a 1-cycle assay. Add 3.4 mL for a 2-cycle (sequential)
assay.
‡Volume Used Per Test is based upon a 1- cycle assay. Add 1 mL for a 2-cycle (sequential)
assay.
British Thermal The IMMULITE generates 920 BTUs/hour.

Unit (BTU)
Specifications
A-2 600032-K IMMULITE Operator’s Manual

EC Declaration of Conformity
according to directive 98/79/EC
We,
DPC Cirrus Inc.
62 Flanders-Bartley Road
Flanders, NJ 07836
a subsidiary of Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, CA 90045-5597
declare under sole responsibility that the following equipment to which this declaration relates, meets the essential
health and safety requirements and is in conformity with the relevant sections of applicable EC standards and other
normative documents. If changes are made to the product which is covered by this declaration of conformity, the
declaration of conformity is no longer valid.
Equipment type: In Vitro Diagnostic Medical Device
Model: IMMULITE
Serial Number: __________
EC Directives: 93/68/EC, 89/392/EC (91/368/EC, 93/44/EC),

73/23/EC, 89/336/EC
Harmonized Standards
Used: EN55011, EN60555-2, EN60555-3, EN50082-1,
EN61000-3-2, EN61000-3-3
National and other IEC 1010-1, IEC 801-2,3,4, IEC 1000-4-2, IEC 1000-4-4,
standards and technical ENV50140, ISO 9001:1994 (BS EN ISO 9001:1994),
specifications: 21CFR, Part 820 FDA cGMP, EN46001: 1996;
ISO 13485: 1996; UL 1262, Laboratory Equipment
Notified body according

to Annex VII: Not Applicable
employed to hold the documentation and evaluate the safety issues of this equipment.
Date/Signature of manufacturer
or responsible party: ______________________________________________________
Title of signatory: Vice President, Regulatory Affairs and Quality Systems___2000
Date/Signature of EU representative
or responsible party: ______________________________________________________
Title of signatory: ______________________________________________________
IMMULITE Operator’s Manual 600032-K A-3

Appendix B : IMMULITE Package Contents
Package The table below lists the items included in the IMMULITE package:
Contents
Installation Items:
Description Quantity
IMMULITE System 1
Computer 1
Monitor 1
Keyboard 1
Keyboard Drawer 1
Printer and Printer Cable 1
Printer Paper 1
Printer Stand 1
IMMULITE / Computer Interface Cord 1
Power Cords 3
Fuses 4
25 Micron Filters 10
Tygon Tubing 5 feet
Male Elbow (½” X ¼”) 1
Uninterruptible Power Supply (UPS) - optional 1
Sample Collection Tray 1
Reagent Carousel Tray 1
Barcode Laser Scanner and Holster 1
Fan Filter 1
IMMULITE Software Disk 1
Database Backup Disk 1
On-line Reference Software and Manual 1
IMMULITE Installation Notes 1
Warranty Card 1
IMMULITE Operator’s Manual 600032-K B-1

Operator Items:
Description Quantity
Water Bottle 1
Probe Wash Bottle 1
Assay Waste Container 1
Liquid Waste Container 1
Sample Cups 1 Bag of 1000
Sample Cup Caps 1 Bag of 1000
Sample Cup Holders 2 Sets of 50
Sample Transfer Racks 1
Sample Transfer Pipettes 500
Test Unit Bag Stand 1
Replacement Syringe Tips 2 sets of 2
Syringe O-Rings 2
Substrate Spike 1
Biohazard Bags 50
Operator's Manual 1
B-2 600032-K IMMULITE Operator’s Manual

Appendix C : Installation Preparations
Overview An authorized DPC Service Representative must install the IMMULITE

System. Before the Service Representative’s arrival, you can make a few
simple preparations to expedite the installation process.
Upon receipt of the IMMULITE System and computer, inspect the shipping
container. If there is any external damage to the container, notify your
shipping department and contact DPC Technical Service.
Choosing a Choose a suitable location for the IMMULITE System in the laboratory,
Location based on the system requirements. The requirements to consider when
choosing a location are listed and described below:
Power
Space
Environmental
Temperature
Power Keep the following power requirements in mind when choosing a location
The power consumption during operation is 700 W for 120 VAC
instruments and 800 W for 220 VAC instruments.
Use a dedicated, grounded power supply line for the IMMULITE System,
printer, and computer.
Each instrument is set at the factory to run on 100 VAC, 110 VAC, 220
VAC or 240 VAC power supply. The orange label near the power supply
(on the right side of the instrument) shows the required voltage.
Note: The frequency can be either 50 or 60 Hz.
We recommend the use of an uninterruptible power supply or line

conditioner, which are available through DPC. To order this item,
contact your DPC representative.
CAUTION: Do not place the system near centrifuges, ultrasound or X-ray

machinery, NMR scanners, or other sources of magnetic fields.
IMMULITE Operator’s Manual 600032-K C-1

Space Keep the following space requirements in mind when choosing a location
The System must be placed on a level surface.
The instrument requires 100 inches (254 cm) of bench space to
accommodate the IMMULITE, computer, and printer.
The bench depth must be at least 21 inches (54 cm).
Any overhead cabinets must be at least 22 inches (56 cm) above the
bench.
The computer can be installed on either side of the IMMULITE System;
however, placing it on the right side is recommended. This will facilitate
easy access to the computer while loading samples.
Temperature Keep the following temperature requirements in mind when choosing a
location for the system:
Ambient temperature should be between 18º and 30ºC
The maximum relative humidity should be 80% for a temperature up to
30° C.
CAUTION: The System should not be placed in direct sunlight or in front

of an air conditioning vent, heat vent, or heat-producing equipment.
Environmental The equipment is designed for safe use under the following conditions:
Specifications
Indoor usage
Altitude up to 2,000 meters
Main supply voltage does not exceed +/- 10% of the nominal voltage
Transient over voltages according to Installation Category II
Pollution Degree 2 in accordance with IEC Standard 664
Water Quality Distilled or de-ionized water of consistent quality is required. Water
Specifications 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 (see Water Testing procedure on page 6-12
of the IMMULITE Operator’s Manual). IMMULITE systems are
sensitive to the presence of alkaline phosphatase resulting from microbial
contamination of the water or 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.
C-2 600032-K IMMULITE Operator’s Manual

Often, high quality reagent water becomes contaminated during storage and
transport. To ensure water quality on the system:
1. Keep commercial water systems appropriately maintained.
1. 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.
2. Maintain cleanliness of storage containers, transfer containers, spigots,
hoses or other plumbing used to transfer water from its source to the
Instrument.
3. 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
IMMULITE Operator’s Manual 600032-K C-3

C-4 600032-K IMMULITE Operator’s Manual
Appendix D : Operational Precautions
Precautions Operational precautions are included throughout this manual. The table
Table below provides a comprehensive list of all the precautions to take for
optimal IMMULITE operation.
Category Precaution
Electrical For reliable performance, the IMMULITE must be on a dedicated 110v
electrical line.
Printer The printer must be attached to the IMMULITE computer and be on-
line during IMMULITE operation.
Note: A pink error box appears on the computer screen when there are
any problems associated with the printer.
Cover The cover keeps the temperature inside the instrument stable. Exercise
the following precautions:
Do not run the IMMULITE with the top cover open.
Do not open the top cover while the IMMULITE is operating.
Reagent Carousel Lid Always press PAUSE before opening the Reagent Carousel lid.
Note: If the Reagent Carousel lid is opened while the IMMULITE is
pipetting, it may create interference that causes the front-end to shut
down. Although the tests in progress will continue, new tests will not
be processed.
Loading Do not load one sample cup holder after another onto the Load Platform.
Note: Each sample cup holder must be followed by a minimum of one
and a maximum of five Test Units.
Fluid Levels Monitor the available volumes of water, probe wash solution, and
substrate. Running out of water or probe wash during operation could
cause loss of the entire run. Refer to the Fluid Usage Table in Appendix
A page A-2.
Substrate Reservoir Do not over-prime the substrate reservoir past the fill-line.
Note: At the fill-line, the reservoir contains 7 mL of substrate. When
the substrate bottle first empties, there is enough substrate in the system
for 35 more tests (or 17 more minutes of continuous testing). An alarm
and an error message indicate the reservoir level has reached 5 mL.
(See the Substrate Low error message.)
IMMULITE Operator’s Manual 600032-K D-1

Category Precaution
Substrate Bottle Do not remove the entire substrate bottle crimp cap. Remove only the
plastic cap.
Substrate Spike Do not touch the substrate spike with your fingers.
Samples Use only serum samples, unless the kit's package insert states otherwise.
Note: When used, EDTA collection tubes must be filled to their
capacity. Failure to do so will result in an excess concentration of EDTA
that will interfere with the assay and cause a false depression of values.
Barcode Labels Do not use Test Units or sample cup holders if the barcode label is
wrinkled, damaged, or removed.
A bad Test Unit barcode appears as a white circle on the Primary
Screen. The Test Unit is advanced into the sample collection tray.
A bad Reagent Wedge barcode is indicated as such on both the Reagent
Status Screen and on the Primary Screen.
Barcode Labels On the Test Units or Reagent Wedges, do not write immediately to the
left or right of the barcode. When making a notation on a Reagent
Wedge, write on an area that is not read by the Barcode Reader and use
a red pen or pencil.
Reagents Use only IMMULITE reagents with the IMMULITE System.
Before using a reagent kit, carefully follow the package insert
instructions supplied with each IMMULITE kit.
Reagent Use IMMULITE reagents are for in vitro diagnostic use only.
Biosafety Some IMMULITE components contain material of human origin which,
when tested by FDA-approved methods, were found to be non-reactive
for hepatitis B surface antigen and for the HIV antibody; however, no
test can guarantee that products derived from human blood will not be
infectious. Be sure to handle all components as if they are capable of
transmitting infection.
Reagent Disposal Sodium azide has been added to some IMMULITE reagent components
as a preservative. When disposing IMMULITE components, flush with
large volumes of water to prevent the buildup of potentially explosive
metal azides in the lead and copper plumbing.
Reagent Storage Kit reagents should be refrigerated.
Note: This rule does not apply to substrate (once it is placed on the
instrument). A substrate bottle remains on the instrument until it is
empty or for 30 days (whichever comes first).
Outdated Reagents Do not use reagents after their expiration dates.
D-2 600032-K IMMULITE Operator’s Manual

Category Precaution
Test Units Remove kits from the refrigerator and allow the Test Units to reach
room temperature before using on the instrument.
To avoid moisture condensation on the beads, do not open Test Unit
bags until they reach room temperature.
The Test Units are packaged in resealable, zip-lock bags with a
desiccant to maintain the bead quality for future use. Ensure that
opened bags are re-sealed tightly to preserve the bead quality.
Substrate The chemiluminescent substrate is light sensitive and should not be
exposed to direct sunlight.
Water Use distilled water, at room temperature, in the external water reservoir.
Exercise caution to prevent bacterial contamination of the water and
liquid lines.
Water should not be exposed to direct sunlight.
Note: The chemiluminescent substrate used in the IMMULITE System
is very sensitive to alkaline phosphatase.
Contamination of these lines can cause high background counts. If
normal precautions are followed, and only distilled water is used,
contamination should not be a problem.
Note: The IMMULITE supply lines are thoroughly cleaned before
installation.
If the water source is changed, perform a water test for alkaline
phosphatase contamination (see Testing the Water Supply in Section
6).
Adjustment Once an adjustment is made, determine if the adjustment is acceptable.
Acceptability (Refer to Judging Adjustment Validity in Section 8)
IMMULITE Operator’s Manual 600032-K D-3

Appendix E : In Vitro Diagnostic Symbols
Symbol Definition
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
IMMULITE Operator’s Manual 600032-K E-1

Symbol Definition
Non-sterile
Do not re-sterilize
Keep away from heat
Keep dry
Protect from heat and radiation
Minimum temperature
Temperature range
Maximum temperature
Control
Negative control
Positive control
Manufacture Date
E-2 600032-K IMMULITE Operator’s Manual

Symbol Definition
Do not use if package is open or damaged
In Vitro Diagnostic device
Manufactured by
Contains sufficient for [X] tests
For Performance Evaluation only
Authorized European Representative
IMMULITE Operator’s Manual 600032-K E-3

Appendix F : Quick Card and Worksheets
Introduction This section includes the IMMULITE Operator's Quick Reference Card and
the following worksheets:
Adjustment Log
Daily, Weekly and As Needed Maintenance Record
Monthly and Semi-annual Maintenance Record
These items can be copied and used as needed.
IMMULITE Operator’s Manual 600032-K F-1

IMMULITE® Operator’s Quick Reference Card
Start-up Note: Patients may be identified any time
before results emerge.
1. Allow Test Units to reach room
temperature.
1. Access Data Entry and Worklist
2. Turn on the computer, monitor and Entry.
printer.
2. Type the sample cup holder number and
3. Select RUN IMMULITE or START press [Enter].
TURBO from the Start-up menu.
3. Enter the barcode ID using the laser
4. Answer the computer's start-up scanner, or manually type the accession
questions. number and/or patient last name.
5. Press GO on the IMMULITE to
initialize the instrument.
Shutting Down
6. Follow the setup instructions on the
IMMULITE Display Panel. 1. Allow the IMMULITE to shut down
automatically (10 minutes after the run
7. Load Reagent Wedges for all tests has finished) or press PAUSE 3 times to
desired and read their barcodes. shut down immediately.
8. Load samples, each followed by 1 to 5 Note: If the instrument is in AutoSTOP
Test Units. mode, press ALARM MUTE and GO
simultaneously on the display panel.
Entering Controls 2. Log off the system by selecting Log Off
Note: Controls must be identified before and Log Off System.
tubes enter the instrument. 3. Back up the system by selecting
BACKUP/RESTORE from the Start-up
1. Access Data Entry and Patient Entry.
menu.
2. Type $ followed by the sample cup
holder number, and press [Enter]. Note: Answer Y to each question.
3. Use the arrow keys to select the proper 4. Clean the probe using the Probe
control. Cleaning Kit and the PROBWASH
diagnostic program.
Entering Adjustors 5. Remove the Probe Cleaning Wedge,
Note: Adjustors must be identified before discard the remaining solution, and rinse
tubes enter the instrument. with distilled water. Store the wedge in
the Probe Cleaning Kit.
1. Access Data Entry and Patient Entry. 6. Press [Esc] to return to the Start-up
2. Type # followed by the sample cup menu and select Exit to DOS.
holder number, and press [Enter]. 7. Turn off the computer.
3. Answer the kit adjustment questions in 8. Cap and refrigerate the Reagent Wedges.
the purple and yellow window.
Entering Patients
F-2 600032-K IMMULITE Operator’s Manual

Adjustment Log
IMMULITE® SYSTEM
Serial Number:
Competitive Assays: CRITERIA

1. QC
Curve Parameter 1 X 2% = calculated intercept 2. SLOPE
3. INTERCEPT-should be less
than calculated intercept
Sandwich Assays:
Master Curve Low Adj. CPS X 30% = calculated intercept
Date Test Kit Lot Slope Intercept Calculated Controls Adj. Tech
Intercept Verified
IMMULITE Operator’s Manual 600032-K F-3

Daily, Weekly, and As Needed IMMULITE® Maintenance Record
Serial # ________________
Daily Maintenance: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Check printer paper
Check volume of water,
wash, and substrate
Empty solid & liquid
waste
Tighten syringes (at
top) & thumbscrews
(under them)
Prime syringes (watch
lines for air)
Check substrate
dispensing nozzle
Prime water and
substrate pumps (watch
lines for air)
Perform system back-
up
Clean the probe/Check
Probe Angle
Operator Initials:
Weekly Maintenance: Week #1 Week #2 Week #3 Week #4 Week #5

Check/clean fan filter
Operator Initials:
Every Two Weeks Maintenance: Date #1 Date #2 Date #3

Clean Water Bottle (check line destinations)
Operator Initials:
As needed Maintenance: Date #1 Date # 2 Date #3 Date #4 Date #5 Date #6

Clean Barcode Reader drive wheel O-ring
Change the Pipetting Probe Supervisor's Signature:
Operator Initials:
IMMULITE Operator's Manual 600032-K F-5

Monthly and Semi-annual IMMULITE® Maintenance Record
Serial #_______________
Monthly Maintenance List JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC
Clean probe wash bottle (check line
destinations)
Replace probe wash and water end-of-line filters

Check Load Platform and Sample Collection
Tray. If necessary, clean with germicide
Change substrate spike
Replace small syringe tip
Decontaminate the System
Test the water supply (watertst and watertpm)
Operator Initials:
Supervisor Initials:
Semi-annual maintenance:
For the year beginning ___________, ______ to the year ending___________,______
month year month year
Semi-annual Maintenance: Replacement Date Replacement Date

#1 #2
Replace large syringe tip or whole plunger assembly
Operator Initials:
Supervisor Initials:

References
1. Babson AL. The DPC Cirrus IMMULITE automated immunoassay

system. J Clin Immunoassay 1991;14:83-8.
2. Babson AL, Olson DR, Palmieri T, Ross AF, Becker DM, Mulqueen PJ.
The IMMULITE assay tube: a new approach to heterogeneous ligand
assay. Clin Chem 1991;37:1521-2.
3. Cembrowski GS, Carey RN. Laboratory quality management. Chicago:
ASCP Press, 1989.
4. Chan DW, editor. Immunoassay: a practical guide. New York:
Academic Press, 1987.
5. Ekins RP. Towards immunoassays of greater sensitivity, specificity and
speed: an overview. In: Albertini A, Ekins RP, editors. Proceedings of
the Third International Conference on Radioimmunoassay, 1981.
Gardone Riviera, Italy: Elsevier, 1981:3-21.
6. Johnson GF. Data reduction techniques for immunoassay. In: Chan
DW, editor. Immunoassay: a practical guide. New York: Academic
Press, 1987:129-47.
7. Nix ABJ, Rowlands RJ, Kemp KW, Wilson DW, Griffiths K. Internal
quality control in clinical chemistry: a teaching review. Statistics in
Medicine 1987;6:425-40.
8. Nix ABJ, Groom GV. A strategy for immunoassay data reduction. In:
Morris BA, Clifford MN, Jackman R, editors. Immunoassays for
veterinary and food analysis -- 1. New York: Elsevier, 1988;199-219.
9. Westgard JO, et al. A multi-rule chart for quality control. Clin Chem
1981;27:493-501.
IMMULITE Operator's Manual 600032-K

IMMULITE Clearance Certificate
Make of Equipment/Item: __________________________________________________________________
Catalog Number: _________________________________________________________________________
Other Distinguishing Features: ______________________________________________________________
Return Authorization Number (contact the Instrument Service department): ___________________________
Customer Information:
Name of Company: _______________________________________________________________________
Full Official Address: _____________________________________________________________________
Telephone Number: _____________________________ Extension: _______________________________
Contact: ______________________________________ Position Held: ____________________________
Signed: _______________________________________ Date: ___________________________________
Check one and explain if appropriate:

This equipment/item has not been in contact with human blood, other potentially infectious body fluids or
pathological samples, or toxic or radioactive materials. It has been cleaned in preparation for inspection,
servicing or repair.
This equipment has been cleaned and decontaminated. The decontamination method is outlined below:
_____________________________________________________________________________________
_____________________________________________________________________________________
This equipment could not be decontaminated. Risk and safety precautions to be adopted are outlined as
follows:
_____________________________________________________________________________________
_____________________________________________________________________________________
Shipping Address (check one):

Within the US: Internationally: Internationally, if authorize
DPC Instrument Systems Division Contact your National Distributor EURO/DPC Ltd.
62 Flanders-Bartley Road Glyn Rhonwy
Flanders, NJ 07836 Llanberis, Gwynedd LL55 4EL
Fax: (973) 927-4101 United Kingdom
Fax: 44 286 871802
Return Shipping Details:
Name of Clearing Agent: __________________________________________________________________
Airport: ________________________________________________________________________________
Address: _______________________________________________________________________________
Contact: ________________________________________________________________________________
IMPORTANT: Please include two copies of this certificate with each instrument; one outside the box with the return
documents, and one inside the box with the instrument. Also, fax a copy of this completed certificate to the destination. DPC
Instrument Systems Division and EURO/DPC Ltd. reserve the right to refuse improperly cleansed equipment.
600032-K IMMULITE Operator’s Manual

LIMITED WARRANTY
LIMITED WARRANTY. DPC 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. DPC 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.
DPC Warrants that the items delivered hereunder are of good material and workmanship, and are free from defects
in design and manufacture. DPC’s 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. DPC shall not be liable for any direct, indirect,
incidental, or consequential damages arising out of possession or use of the items. Racks and Consumables, are not
covered by this Warranty.
CUSTOMER REMEDIES. DPC’s entire liability and your exclusive remedy shall be replacement of the Software
that does not meet DPC’s Limited Warranty and which is returned to DPC. The Limited Warranty is void if failure
of the Software has resulted from accident, abuse, or misapplication.
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”. DPC 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. DPC shall not
be liable for any direct, indirect, incidental, or consequential damages arising out of possession or use of this
product.
WARSOFT-B
IMMULITE Operator’s Manual 600032-H

600032-K IMMULITE Operator’s Manual
INDEX
Barcoded Reagent Wedge, 1-8
A Barcoded Test Units, 1-8
Bi-Directional communications
Acceptable slope
interface, 3-11
Deviation from the mean, 8-8
Bi-Directional Host Query, 3-11
Range, 8-8
Biosafety precautions, D-2
Adjustment Log, F-3
British Thermal Unit, 2-2, A-2, C-2
Adjustment precautions, D-3
BTU, 2-2, A-2, C-2
Adjustment procedure
Identifying an adjustor, 4-20 C
Running adjustors, 4-22
Adjustment validity, 4-29, 8-6 Calculations. See Internal Calculations
Adjustment slope for an initial Calibration
adjustment, 8-6 Judging adjustment validity, 8-6
Control results, 4-29 Master curve generation, 8-3
Intercept, 4-30 Overview, 8-3
Intercept of adjustment for a Readjustment, 8-13
competitive assay, 8-11 Two-point adjustment, 8-4
Intercept of adjustment for an Chemiluminescent Reaction, 8-15
immunometric assay, 8-10 Chemiluminescent Substrate Module, 1-
Slopes, 4-29 11
Adjustment verification, 4-29 Cleaning
Adjustors, 1-8 Probe, 4-38
Assay settings, 3-3 Competitive assay equation, 8-3, 8-4
Assay Types, 9-1 Competitive assays, 9-2
Competitive, 9-2 Component disposal precautions, D-2
One-cycle, 1-16, 9-1 Configuring the Software, 3-1
Sandwich, 9-1 Changing the assay settings, 3-3
Sequential, 9-1 Changing the auto-backup default, 3-
Two-cycle, 1-16, 9-1 10
Assays Selecting a printer, 3-10
Expected ranges, 3-8, 3-9 Setting the facility name, 3-2
Running, 4-18 Setting the LIS parameters, 3-11
Associating sample cups with Adjustor Setting the long report format, 3-5
IDs, 4-22 Control report, 4-27
Auto-Backup default, 3-10 Control results, 4-29, 4-40
AutoPAUSE mode, 4-34 Editing, 4-44
AutoSTOP mode, 4-34 Plotting, 4-41
Printing, 4-41
B Statistical summary, 4-40
Controls, E-2
Backing up the system, 4-36
Identifying, 4-26
BACKUP ON/OFF, 3-10
Running, 4-26, 4-27
BACKUP/RESTORE, 4-37
Cover precautions, D-1
Barcode Information, 1-10
Barcode label precautions, D-2
IMMULITE Operator’s Manual 600032-K Index-1

D H
Daily maintenance, 4-5 Hardware, B-1
Daily Shutdown, 4-35 Hardware weight specifications, A-2
Backing up the system, 4-36
Cleaning the probe, 4-38 I
Logging off, 4-36
Identifying an adjustor, 4-20
Removing / emptying test supplies, 4-
IMMULITE 1000
39
Introduction, 11-11, 11-36, 11-37
Stopping the Instrument, 4-35
IMMULITE Package Contents, B-1
Daily Start-up Procedure, 4-2
Hardware, B-1
Daily maintenance, 4-5
IMMULITE System
Initializing the software, 4-2
How it Works, 1-2
Loading reagents, 4-13
Instrument diagrams, 1-4
Preparing reagents, 4-2
Kit components, 1-7
Dark count, 8-1
Other test supplies, 1-11
Data
Output specifications, 1-16
Plotting, 4-40
Power requirements, 2-1, C-1
Data Reduction and the
Product description, 1-2
Chemiluminescent Reaction
Software overview, 1-13
Internal Calculations, 8-1
Space requirements, 2-2, C-2
Master Curve Generation, 8-3
Temperature requirements, 2-2, C-2
Two-Point Adjustment, 8-3
Test process overview, 1-3
Database
IMMULITE system specifications. See
Lost or damaged, 4-38
System Specification Tables
Decision count, 8-1
IMMULITE® Operator’s Quick
Display Panel Buttons, 11-36
Reference Card, F-2
Immunometric assay equation, 8-3
E
Important notices, 1-10
Editing control results, 4-44 Imprecision problems, 11-7
Editing patient results, 4-49 In Vitro Diagnostic, E-3
Electrical precautions, D-1 Installation Preparations, 2-1, C-1
Environmental Conditions, 2-2, C-2 Choosing a Location, 2-1, C-1
Error Message / Solution Table, 11-12 Upon receipt of the system, 2-1
Expected ranges, 3-8, 3-9 Water requirements, 2-3, C-2
Instrument Overview, 11-36
F Instrument problems, 11-2
Intercept, 4-30
Fixing a database, 11-40
Internal Calculations, 8-1
FIXIT, 11-40
Introduction, 1-1
Fluid level precautions, D-1
IVD, E-3
Fluid specifications, A-2
Fluid usage, 2-2, A-2, C-2
K
Forms
Adjustment Log, F-3 Kit components, 1-7
Adjustors, 1-8
Barcode information, 1-10
Index-2 600032-K IMMULITE Operator’s Manual

Barcoded Reagent Wedge, 1-8 Operational Precautions, D-1
Barcoded Test Units, 1-8 Adjustments, D-3
Important notices, 1-10 Barcode labels, D-2
Package insert, 1-9 Biosafety, D-2
Component disposal, D-2
L Cover, D-1
Electrical, D-1
Levey-Jennings plot, 4-40
Fluid levels, D-1
LIS, 4-36
Loading, D-1
Bi-Directional, 3-11
Printer, D-1
Bi-Directional Host Query, 3-11
Reagent carousel lid, D-1
Uni-Directional, 3-11
Reagent storage, D-2
LIS parameters, 3-11
Reagents, D-2
LIS parameters password, 3-12
Samples, D-2
LIS PARAMS, 3-11
Substrate, D-3
Loading precautions, D-1
Substrate bottle, D-2
Loading reagents, 4-13
Substrate reservoir, D-1
Loading samples, 4-18
Substrate spike, D-2
Location selection, 2-1, C-1
Test units, D-3
Power requirements, 2-1, C-1
Water, D-3
Space requirements, 2-2, C-2
Ordering the IMMULITE, 1-17
Temperature requirements, 2-2, C-2
Output specifications, A-1
Logging off, 4-36
Long report format, 3-5
P
Luminogenic reaction, 8-15
Luminometer specifications, A-1 Package insert, 1-9
Patient results, 4-46
M Editing, 4-49
Plotting, 4-46
Main menu
Printing, 4-47
Quality Control, 4-40
Plotting control results, 4-41
Manual
Plotting patient results, 4-46
Overview, 1-1
Precautions table, D-1
Typographical conventions, 1-1
Primary screen, 1-14
Master curve
Load chain and Main carousel, 1-15
Generation, 8-3
Reagent carousel, 1-15
Stored, 8-3, 8-4
Reagent status, 1-15
Master Curve, 4-20
Results box, 1-16
Calibration, 8-3
Time-to-result indicators, 1-16
Generation, 8-3
Printer precautions, D-1
Master Cutoff Generation for Qualitative
Printer selection, 3-10
Assays, 8-13
Printing, 4-32
Measuring the Cutoff, 8-13
Probe Wash Module, 1-12
Mean slope, 8-6
Problems & Solutions, 11-2
O Problems and solutions
Imprecision, 11-7
One-cycle assays, 1-16, 9-1 Miscellaneous, 11-11

Results, 11-5 Running Adjustors, 4-20
Problems and Solutions Running Assays, 4-18
Instrument, 11-2 Running Controls, 4-26
PROBWASH, 4-38 Running Adjustors, 4-20, 4-22, 4-29
Purchasing the IMMULITE. See Adjustment procedure, 4-20
Ordering the IMMULITE Running Assays, 4-18
Loading a sample, 4-18
Q Removing sample cup holders, 4-18
STAT procedure, 4-19
Quality Control, 4-40
Running Calibration Verifiers, 4-31
Control results, 4-40
Running Controls, 4-26, 4-27
Patient results, 4-46
Identifying controls, 4-26
Quick Card and Worksheets, F-1
Quick Reference Card, F-2
S
R Safety Precautions. See Operational
Precautions
Readjustment, 8-13
Sample
Reagent
Loading, 4-18
Carousel lid precautions, D-1
Precautions, D-2
Precautions, D-2
Volume, 4-18
Preparation, 4-2
Sample cup holder removal, 4-18
Reagent precautions, D-2
Sample volume, 4-23
Reagents
Sandwich assay equation, 8-3, 8-4
Adding or changing, 4-33
Sandwich assays, 9-1
Loading, 4-13
Sequential assays, 9-1
Removing sample cup holders, 4-18
Setting the time and date, 4-4
Report format, 3-5
Shutdown. See Daily Shutdown
REPORT FORMAT
Slope, 4-29
Deleting highlighted text fields, 3-8
Software configuration, 3-1
Entering expected ranges, 3-8
Changing the assay settings, 3-3
Entering new text, 3-5
Changing the auto-backup default, 3-
Modifying existing text, 3-7
10
Moving existing text, 3-7
Selecting a printer, 3-10
Moving highlighted text fields, 3-8
Setting the facility name, 3-2
Positioning expected ranges, 3-9
Setting the LIS parameters, 3-11
Report printing
Setting the long report format, 3-5
Selecting short or long, 4-4
Software initialization, 4-2
Restore function, 11-40
Software overview, 1-13
Restoring a database, 11-40
Software update procedure, 3-1
Result problems, 11-5
Specifications
Results. See Control results or Patient
BTU, 2-2, A-2, C-2
results
Start-up TC procedure. See Daily Start-
Routine Operation, 4-1
up Procedure
Adding or Changing Reagents, 4-33
STAT procedure, 4-19
Daily Shut Down, 4-35
Stored master curve. See Master Curve -
Daily Start-up Procedure, 4-2
Stored
Printing, 4-32

Substrate bottle precautions, D-2 Exiting, 10-2
Substrate precautions, D-3 Main menu, 10-3
Substrate reservoir precautions, D-1 Navigating, 10-2
Substrate spike precautions, D-2 Starting, 10-2
Symbols, E-3 Two-cycle assays, 1-16, 9-1
System Specification Tables, A-1 Two-point adjustment, 8-4
Hardware, A-2 Two-Point Adjustment, 8-3
Luminometer, A-1 Calibration, 8-3
Output, A-1 Judging adjustment validity, 8-6
System Specifications
Fluids, 2-2, A-2, C-2 U
Uni-Directional communications
T
interface, 3-11
Technical Assistance, 1-17 Updating the Software, 3-1
Temperature, E-2
Test unit V
Precautions, D-3
Verifiers
Test units
Running, 4-31
Mismatched, 1-15
Short-sampled, 1-15 W
Troubleshooting, 11-1
Error Message / Solution Table, 11-12 Water precautions, D-3
Overview, 11-1 Water requirements, 2-3, C-2
Problem & Solutions, 11-2
Tutorial, 10-1


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IMMULITE® Automated Immunoassay System

IMMULITE® is a registered trademark of Diagnostic Products Corporation.

Diagnostic Products Corporation

IMMULITE Operator’s Manual 600032-K i

ii 600032-K IMMULITE Operator’s Manual

IMMULITE Operator’s Manual 600032-K iii

APPENDIX E : IN VITRO DIAGNOSTIC SYMBOLS................................................................................E-1

APPENDIX F : QUICK CARD AND WORKSHEETS ................................................................................F-1

iv 600032-K IMMULITE Operator’s Manual

Conventions The following conventions are used throughout this manual.

Item Convention Used

IMMULITE Operator’s Manual 600032-K 1-1

How it Works The IMMULITE System utilizes assay-specific, antibody, or antigen-coated

1-2 600032-K IMMULITE Operator’s Manual

Note: The materials needed to operate the IMMULITE are included in

IMMULITE Operator’s Manual 600032-K 1-3

Note: Reagent changes can be made during instrument operation by

Instrument A diagram of the IMMULITE Display Panel is shown in Figure 2. Figures 3

1-4 600032-K IMMULITE Operator’s Manual

IMMULITE Operator’s Manual 600032-K 1-5

1-6 600032-K IMMULITE Operator’s Manual

IMMULITE Operator’s Manual 600032-K 1-7

Barcoded Test Units

1-8 600032-K IMMULITE Operator’s Manual

IMMULITE Operator’s Manual 600032-K 1-9

1-10 600032-K IMMULITE Operator’s Manual

Note: Each bottle of Chemiluminescent Substrate contains enough material

IMMULITE Operator’s Manual 600032-K 1-11

1-12 600032-K IMMULITE Operator’s Manual

IMMULITE Operator’s Manual 600032-K 1-13

1-14 600032-K IMMULITE Operator’s Manual

IMMULITE Operator’s Manual 600032-K 1-15

1-16 600032-K IMMULITE Operator’s Manual

DPC Instrument Systems Division

Diagnostic Products Corporation

IMMULITE Operator’s Manual 600032-K 1-17

Note: The frequency can be either 50 or 60 Hz.

We recommend the use of an uninterruptible power supply or line

CAUTION: Do not place the system near centrifuges, ultrasound or X-ray

IMMULITE Operator’s Manual 600032-K 2-1

Temperature Keep the following temperature requirements in mind when choosing a

CAUTION: The System should not be placed in direct sunlight or in front

2-2 600032-K IMMULITE Operator’s Manual

IMMULITE Operator’s Manual 600032-K 2-3

IMMULITE Operator’s Manual 600032-K 3-1

3-2 600032-K IMMULITE Operator’s Manual

3. At the prompt, either:

IMMULITE Operator’s Manual 600032-K 3-3

3-4 600032-K IMMULITE Operator’s Manual

Notes: Values must be entered in the units identified in the previous

5. Press [Esc] to exit.

SAVE CHANGES? Y/N

6. Press [Y] to save.

Long report modification processes include:

Entering New Text

IMMULITE Operator’s Manual 600032-K 3-5

Note: To print a copy of the newly configured report, press [F10].

3-6 600032-K IMMULITE Operator’s Manual

Note: Highlighted fields have an alternate background color.

1. From the Start-up menu, select CONFIGURATIONS and press