DCIM-B01.840.10.01.02 Immulite Com Lis PDF

IMMULITE® & IMMULITE 1000

Troubleshooting Guide

Document Number: 600858

Revision A
Date: January 2007
Copyright © 2007 by Siemens Medical Solutions Diagnostics. All rights reserved.

Copyright © 2007 by Siemens Medical Solutions Diagnostics. 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 Siemens Medical Solutions Diagnostics except
that you may make one copy of the program CD solely for back-up purposes.
IMMULITE® is a registered trademark of Siemens Medical Solutions Diagnostics.

All other products mentioned are trademarks of their respective companies.
Siemens Medical Solutions Diagnostics

Certificate No: UQA0113493
Siemens Diagnostics' quality products are manufactured under a quality

system that is registered to ISO 13485:2003.
ii 600858-A IMMULITE & IMMULITE 1000 Troubleshooting Guide

TABLE OF CONTENTS
GENERAL TROUBLESHOOTING................................................................................. 1
General Troubleshooting Tips .............................................................................................2
Non-Mechanical Troubleshooting........................................................................................3
Did Something Change in the Middle of the Run? .............................................................4
Final Documentation in Clientele.........................................................................................5
CHEMISTRY ..................................................................................................................7
The Immune Reaction ...........................................................................................................8
Sandwich Assay (e.g., hCG, TSH) ....................................................................................8
Competitive Assay (e.g., TT4, E2)...................................................................................10
Chemiluminescence............................................................................................................12
Data Reduction................................................................................................................12
Adjustment Theory ..........................................................................................................13
Interpreting Adjustment Results ......................................................................................13
Calculated Intercept Cutoffs ............................................................................................14
Control Results ................................................................................................................15
One Adjustor Assays ..........................................................................................................16
T3 Uptake, Allergy, and Infectious Disease Assays ........................................................16
Determination of Cut-Off..................................................................................................17
Method Verification Data Review Guidelines....................................................................19
Purpose ...........................................................................................................................19
Introduction......................................................................................................................19
Definitions........................................................................................................................19
Analytical Sensitivity ..........................................................................................................23
Analytical Sensitivity, Functional Sensitivity and Calibration Range ...............................23
CONTROLS ................................................................................................................. 27
Automated QC Evaluation (IMMULITE 1000) ....................................................................28
Automated QC Definitions ...............................................................................................28
Automated QC Flags .......................................................................................................28
Automated QC.................................................................................................................29
CPS/COUNTS .............................................................................................................. 33
Control/Adjustor Problems.................................................................................................34
Control Problem Immediately after an Adjustment ..........................................................34
A Customer Has Problems with Controls not Currently Assayed/Evaluated in DPC QC 34
Adjustor Handling Issues.................................................................................................35
B12 and Folate ................................................................................................................35
IMMULITE & IMMULITE 1000 Troubleshooting Guide 600858-A iii

CPS Troubleshooting..........................................................................................................36
Patterns in Data...............................................................................................................37
CPS Scenarios .....................................................................................................................38
Calculation Error (CPS < 5000) .......................................................................................38
Consistent High Counts...................................................................................................38
Dose Is Lower than Expected..........................................................................................38
Intermittent High Counts..................................................................................................38
Intermittent Low Counts...................................................................................................39
Intermittent Very Low Counts ..........................................................................................39
Low Counts (CPS = 0).....................................................................................................39
Low Counts (CPS = 10 to 100)........................................................................................39
Low Counts (CPS = 100 to 1000)....................................................................................40
Low Counts (CPS = 2000 to 20000)................................................................................40
Low Counts (CPS > 25000, but much less than normal).................................................40
Negative CPS ..................................................................................................................40
DIAGNOSTICS.............................................................................................................41
Running Diagnostics ..........................................................................................................43
Running Diagnostics on the IMMULITE ..........................................................................43
Running Diagnostics on the IMMULITE 1000 .................................................................44
List of Diagnostic Programs...............................................................................................46
APRIME...........................................................................................................................46
ATTURN ..........................................................................................................................46
BCODE............................................................................................................................46
BCODEON ......................................................................................................................47
BCODESPD ....................................................................................................................47
BCODETST .....................................................................................................................48
BKGNDCNT ....................................................................................................................48
BPRIME...........................................................................................................................49
CARBACK .......................................................................................................................49
CARCHECK ....................................................................................................................49
CARPOS .........................................................................................................................49
CARSHAKE.....................................................................................................................49
DARKCNT .......................................................................................................................50
DECON............................................................................................................................50
DECON1..........................................................................................................................50
DISSUB ...........................................................................................................................50
DISWAT...........................................................................................................................51
EMPTYTUB .....................................................................................................................51
LCHAIN ...........................................................................................................................52
LEVCRASH .....................................................................................................................52
LEVFALSE ......................................................................................................................52
LEVSENSR .....................................................................................................................53
LEVSENSS......................................................................................................................53
LUMCHN .........................................................................................................................53
MCARTST .......................................................................................................................54
PIPXPOS.........................................................................................................................54
PMTCOUNT ....................................................................................................................54
iv 600858-A IMMULITE & IMMULITE 1000 Troubleshooting Guide

PRBECLEAN...................................................................................................................54
PRIME .............................................................................................................................55
PROBANGL.....................................................................................................................55
PROBETST .....................................................................................................................55
RBCODE .........................................................................................................................55
REAGENTH.....................................................................................................................56
REAGENTP.....................................................................................................................56
SCHANGE.......................................................................................................................56
SHUTLOAD .....................................................................................................................57
SHUTSPIN ......................................................................................................................57
SHUTTLE ........................................................................................................................57
SOLE1W..........................................................................................................................58
SOLE2S...........................................................................................................................58
SPINCHK.........................................................................................................................58
SPINON...........................................................................................................................58
TEMPS ............................................................................................................................59
V1TEST ...........................................................................................................................59
V2TEST ...........................................................................................................................59
V4TEST ...........................................................................................................................60
WASHSPD ......................................................................................................................60
WATERTPM ....................................................................................................................60
WATERTST.....................................................................................................................61
DISCORDANT RESULTS ............................................................................................ 63

Identifying Discordant Results...........................................................................................64
Definition of a Discordant Result .....................................................................................64
Documenting Discordant Results ....................................................................................65
General Rules ......................................................................................................................66
Discordant Complaints Flow Chart....................................................................................67
ERROR MESSAGES, CAUSES, AND SOLUTIONS................................................... 69

IMMULITE .............................................................................................................................70
IMMULITE 1000 ....................................................................................................................96
HARDWARE .............................................................................................................. 129

Computer Input/Output Views..........................................................................................130
IMMULITE Computer Input/Output Views .....................................................................130
IMMULITE 1000 Computer Input/Output Views ............................................................134
Hand-Held Laser Scanner Symbologies .........................................................................135
IMMULITE/IMMULITE 1000 Laser Scanner Programming ...........................................136
PSC Laser Scanner.......................................................................................................136
PC Communication ...........................................................................................................139
IMMULITE PC Communication Errors...........................................................................139
IMMULITE 1000 PC Communication Errors..................................................................140
IMMULITE & IMMULITE 1000 Troubleshooting Guide 600858-A v

Power..................................................................................................................................141
Power Issues .................................................................................................................141
Troubleshooting Fuses ..................................................................................................141
Printers ...............................................................................................................................142
OKIDATA Microline .......................................................................................................142
Epson (Model LX-300)...................................................................................................143
Citizen (Model GSX190)................................................................................................143
OKIDATA B4200/B4250 ................................................................................................143
IMMULITE 1000 SOFTWARE.................................................................................... 145

Start Menu Options ...........................................................................................................146
Backup Agent ................................................................................................................146
Batch Printing Results ...................................................................................................147
Event Viewer .................................................................................................................148
Export Data....................................................................................................................149
IMMULITE 1000 Executable..........................................................................................149
Kit Configurations ..........................................................................................................149
QC Graph ......................................................................................................................150
Common Procedures ........................................................................................................151
Finding the Current Software Version ...........................................................................151
Locating and Restoring Backups...................................................................................151
Locating Database Files ................................................................................................152
Locating the LIS Log......................................................................................................153
Recovery Mode Procedure............................................................................................153
Restarting the Software after Running Diagnostics.......................................................154
VB (Visual Basic) Errors ................................................................................................154
IMMULITE SOFTWARE............................................................................................. 155

DOS Program Descriptions ..............................................................................................156
BACKDAT......................................................................................................................156
EXPORT........................................................................................................................156
GETDATAT ...................................................................................................................156
KITS (For Internal Use Only) .........................................................................................157
PC and PCSTAT ...........................................................................................................161
STATUS ........................................................................................................................162
WATER..........................................................................................................................163
IMMULITE Database Procedures .....................................................................................165
Repairing a Database....................................................................................................165
Checking the Size of a Database ..................................................................................167
Reducing the Size of a Database ..................................................................................168
Reinstalling a Database.................................................................................................168
Additional IMMULITE Software Information....................................................................170
BACKUP........................................................................................................................170
Date Time Conflict .........................................................................................................170
Deleting Records ...........................................................................................................170
Error 88..........................................................................................................................171
Software Not Responding/Freeze .................................................................................171
vi 600858-A IMMULITE & IMMULITE 1000 Troubleshooting Guide

Common IMMULITE Software Procedures......................................................................172
Control Entry..................................................................................................................172
Editing Records .............................................................................................................172
Long Report Format ......................................................................................................173
Printing Screens or Reports ..........................................................................................174
Searching for Records...................................................................................................174
LIS (LABORATORY INFORMATION SYSTEM) ....................................................... 175

Cable Specs .......................................................................................................................176
IMMULITE LIS ....................................................................................................................177
Configuring the LIS........................................................................................................177
Upload of Results ..........................................................................................................178
Broadcast Download .....................................................................................................178
Host Query ....................................................................................................................179
Possible LIS Errors........................................................................................................179
IMMULITE 1000 LIS ...........................................................................................................181
Host Query ....................................................................................................................183
LIS Troubleshooting..........................................................................................................184
Activating the LIS Log....................................................................................................184
LIS Records .......................................................................................................................185
Header Message Records.............................................................................................185
Patient Information Record............................................................................................185
Order Record.................................................................................................................186
Result Record................................................................................................................187
Query Record ................................................................................................................187
Terminator Record.........................................................................................................188
LOAD PLATFORM & LOAD CHAIN ......................................................................... 189

About the Load Platform & Load Chain ..........................................................................190
Associated Errors .............................................................................................................191
Load Platform & Load Chain Troubleshooting Tips ......................................................192
Load Chain Is not Functioning Properly .........................................................................193
Jam Caused by a Baffle or Other Obstruction...............................................................193
Jam at the Star Wheel ...................................................................................................193
Contaminated Load Chain or Load Platform .................................................................194
Related Diagnostics ..........................................................................................................195
LCHAIN .........................................................................................................................195
IMMULITE & IMMULITE 1000 Troubleshooting Guide 600858-A vii

LOW VOLUME CUSTOMERS ................................................................................... 197
Recommendations for Low Volume Use Customers .....................................................198
Before Operation ...........................................................................................................198
At the End of Operation .................................................................................................198
Additions to Monthly Maintenance.................................................................................198
Reminders for Low Volume Use....................................................................................198
LUMINOMETER......................................................................................................... 199
About the Luminometer ....................................................................................................200
Luminometer Chain Is not Moving...................................................................................202
Shuttle Is Positioned Incorrectly ....................................................................................202
Test Unit Jam ................................................................................................................202
Dislodged Luminometer Chain Baffle ............................................................................202
Related Diagnostics.......................................................................................................203
CALC Errors Due to Non-Washing of Bead ....................................................................204
Troubleshooting Tips .....................................................................................................204
High-Speed Spinner Is Not Spinning Properly ..............................................................204
CALC Errors Due to High/Low CPS Counts....................................................................206
PMT Attenuator Disc Is not Moving ...............................................................................206
Tests Units Remain on the Luminometer Chain.............................................................207
Operator Pressed ALARM MUTE and GO ....................................................................207
MAIN INCUBATION CAROUSEL.............................................................................. 209

About the Main Incubation Carousel ...............................................................................210
Front End Shutdown......................................................................................................211
Sample Cup on the Main Incubation Carousel ..............................................................211
Mispositioned Main Carousel ........................................................................................211
Main Carousel Error ......................................................................................................212
Shuttle Is Jammed Against Main Carousel....................................................................212
Load Chain Is Not Advancing Correctly.........................................................................212
PIPETTOR.................................................................................................................. 215
About the Pipettor .............................................................................................................216
Level Sensing Errors ........................................................................................................217
Reagent Level Sense Error with "Are there caps on the reagent?"...............................217
Loose Probe ..................................................................................................................217
Splashing.......................................................................................................................217
viii 600858-A IMMULITE & IMMULITE 1000 Troubleshooting Guide

Air in the System ...........................................................................................................218
Probe Is Scraping the Reagent Wedge .........................................................................218
Obstruction in the Probe or Tubing.................................................................................221
Improper Probe Cleaning ..............................................................................................221
Blocked Probe ...............................................................................................................221
Probe Tubing .................................................................................................................221
Pipettor Positioning Problems .........................................................................................223
Operator Error ...............................................................................................................223
Probe Tubing .................................................................................................................223
Probe Is Dripping ..............................................................................................................224
A Valve Is not Activating................................................................................................224
Precision Failure ...............................................................................................................225
Poor Sample Reproducibility .........................................................................................225
PRECISION & ACCURACY....................................................................................... 227

Testing for Precision.........................................................................................................228
Precision and Accuracy....................................................................................................229
Possible Causes of Precision Problems........................................................................229
Possible Causes of Accuracy Problems........................................................................230
Precision vs. Accuracy Grid...........................................................................................232
REAGENT CAROUSEL ............................................................................................. 235

About the Reagent Carousel ............................................................................................236
Bad Barcode Reads ..........................................................................................................237
Non-Barcoded Probe Cleaning Wedge .........................................................................237
Wedge Is Incorrectly Placed in the Tray........................................................................237
Obstructed Barcode Label.............................................................................................237
Glossy Barcode Label ...................................................................................................237
Damaged Barcode Label...............................................................................................237
Mispositioned Barcode Label ........................................................................................238
Damaged Reagent Tray ................................................................................................238
Condensation in the Reagent Carousel.........................................................................238
Reagent Level Sense Issues ............................................................................................240
Tests Units Remain after Reagent Is Used Up..............................................................240
Waste in the Reagent Carousel........................................................................................241
Kinked or Clogged Waste Tubing..................................................................................241
Clogged Waste Container Air Filter (IMMULITE Only) ..................................................241
Temperature Issues ..........................................................................................................242
Temperature Controller Status LEDs ............................................................................242
Reagent Carousel Temperature Is too High..................................................................243
IMMULITE & IMMULITE 1000 Troubleshooting Guide 600858-A ix

Bad TED (Thermo Electric Device): High Temp............................................................244
Bad TED (Thermo Electric Device): Low Temp.............................................................244
Short in Thermistor on the Reagent Carousel PCB: Temp Is too High .........................244
Short in Thermistor on the Reagent Carousel PCB: Temp Is too Low ..........................244
SAMPLE & TEST UNIT BARCODE READER .......................................................... 247

About the Sample & Test Unit Barcode Reader .............................................................248
Troubleshooting Tips........................................................................................................250
Contaminated Orange O-Ring Is Dirty or Worn .............................................................251
Contaminated Barcode Idler Assembly .........................................................................251
Motor Issues ..................................................................................................................251
Jam on the Load Chain .....................................................................................................254
Jam at the Barcode Idler Assembly...............................................................................254
SHUTTLE ...................................................................................................................257
About the Shuttle...............................................................................................................258
Shuttle Is Jammed or Not Moving....................................................................................261
Shuttle Is Blocked by a Test Unit...................................................................................261
Broken Shuttle Sensor or Flag ......................................................................................262
SUBSTRATE & WATER PUMPS .............................................................................. 265

About the Substrate & Water Pumps...............................................................................266
Imprecise or Inaccurate Results ......................................................................................267
Inspect Test Units on the Exit Ramp .............................................................................267
Substrate and Water Issues .............................................................................................268
Low Levels of Substrate or Water .................................................................................268
Loose Tubing Fittings ....................................................................................................268
Kinked or Cracked Tubing .............................................................................................268
Substrate Dispense Issues...............................................................................................270
Clogged Substrate Nozzle.............................................................................................270
Clogged Air Filter in the Substrate Spike.......................................................................270
x 600858-A IMMULITE & IMMULITE 1000 Troubleshooting Guide

Defective Substrate Pump.............................................................................................270
Mispositioned Test Unit .................................................................................................270
Water Dispense Issues .....................................................................................................271
Dried Up Water Pump Valve .........................................................................................271
Noisy Solenoid Pump........................................................................................................272
Noisy Water Pump.........................................................................................................272
Noisy Substrate Pump...................................................................................................272
SYRINGE PUMPS...................................................................................................... 273

About the Syringe Pumps.................................................................................................274
Syringe A or B Overload Error .........................................................................................276
Syringe Tips (or Syringe not Seated Properly) ..............................................................276
Bad Dilutor (Motor) ........................................................................................................276
Blocked Probe ...............................................................................................................276
Power Glitch or Interruption...........................................................................................277
Noisy or Squeaky Syringes when Priming......................................................................278
Imprecision Caused by Air ...............................................................................................279
Air in the Water or Probe Wash Bottle...........................................................................279
Clogged End of Line Filters (IMMULITE Only) ..............................................................279
Worn Flair ......................................................................................................................280
Faulty Macro & Micro Valves.........................................................................................280
Syringes Aren't Moving ....................................................................................................281
Loose Syringes..............................................................................................................281
Power Glitch ..................................................................................................................281
Valve Failure ......................................................................................................................282
Probe Wash not Dispensing ..........................................................................................282
TEMPERATURES...................................................................................................... 283
About Temperatures .........................................................................................................284
Luminometer Temperature ............................................................................................284
Main Incubator Carousel Temperature..........................................................................284
Reagent Carousel Temperature ....................................................................................284
System Ambient Temperature.......................................................................................284
Electrical Ambient Temperature ....................................................................................284
Viewing Temperatures ......................................................................................................285
TEMPS ..........................................................................................................................285
Viewing Temperatures within the Software ...................................................................285
Temperature Controller Status LEDs ..............................................................................286
Temperature Controller Status LED Table ....................................................................287
Troubleshooting.............................................................................................................287
IMMULITE & IMMULITE 1000 Troubleshooting Guide 600858-A xi

WATER ...................................................................................................................... 289
Water Quality .....................................................................................................................290
Water Issues Are Suspected ............................................................................................291
Frequently Affected Assays...........................................................................................291
Initial Troubleshooting ...................................................................................................291
Testing the Water Supply .................................................................................................292
Instructions ....................................................................................................................292
WATERTST (IMMULITE) ..............................................................................................293
WATERTPM (IMMULITE) .............................................................................................294
WATERTST (IMMULITE 1000) .....................................................................................295
WATERTPM (IMMULITE 1000) ....................................................................................296
Acceptability Guidelines...................................................................................................297
CPS for All Water Tests.................................................................................................297
WATERTST Guidelines.................................................................................................297
WATERTPM Guidelines ................................................................................................298
Stubborn Contamination................................................................................................298
Instructions for Substrate Decon.....................................................................................299
xii 600858-A IMMULITE & IMMULITE 1000 Troubleshooting Guide

GENERAL TROUBLESHOOTING
General Troubleshooting Tips .............................................................................................2
Non-Mechanical Troubleshooting........................................................................................3
Did Something Change in the Middle of the Run? .............................................................4
Final Documentation in Clientele.........................................................................................5
IMMULITE & IMMULITE 1000 Troubleshooting Guide 600858-A 1

GENERAL TROUBLESHOOTING TIPS
• Get as much information as possible about what occurred before, during, and after the
problem.
IMMULITE Errors
• IMMULITE error messages display on the Instrument Display Panel, monitor, or paper
printout.
• Examples:
"Part A reagent missing" appears on the IMMULITE Display Panel if a reagent wedge
has zero tests remaining and another wedge with the same lot number is not on the
Main Incubation Carousel. It will not print or appear on the monitor or in the error log.
"no reagent for TSH tube at barcode reader" appears on the monitor for one cycle,
prints, and posts to the error log.
• Operators may not see errors on the monitor or the IMMULITE Display Panel since
messages only display for one cycle, or 30-second interval. The IMMULITE and the
computer communicate every 30 seconds.
Note: Generic messages appear on the IMMULITE Display Panel. Specific error messages
appear on the monitor and printout.
IMMULITE 1000 Errors

• IMMULITE 1000 errors appear as message boxes on the screen and in the Event Log.
• To access the Event Log for a particular session:
From the System Status menu, select View Session Event Log.
Only events from the current login session will display.
• To access the historic log in the Event Viewer:
From the start-up screen, select Event Viewer.
Select the Windows Start button, then IMMULITE 1000 followed by Event Viewer.
2 600858-A IMMULITE & IMMULITE 1000 Troubleshooting Guide

NON-MECHANICAL TROUBLESHOOTING
Get specific information when troubleshooting a non-mechanical problem.
1. Which assay(s) is the operator having a problem with?
2. Review assay-specific information.
Special handling requirements for the adjustors or controls
Important notice recently sent with updated control targets
Recent chemistry study about this assay
Sequential, pre-diluted, or pre-treated
Adjustment interval
Check the Assay Update Log
3. When did the problem begin? What is the exact nature of the problem?
4. When was the last adjustment?
Slope and intercept
Adjustor CPS
Compare with the previous adjustment
What were the QC results after the adjustment?
Slope range for the customer's Instrument
How were the adjustors stored and handled?
Note: Open reagent stability is 30 days.
5. What controls were used for this assay?
Lot number
Ranges (DPC or established by the client?)
Range change?
Is this a new lot of control material?
Liquid or lyophilized
Do these controls require special handling?
Storage and handling
How old are the controls (if refrigerated)?
6. Are there problems or trends with other assays?
What were the slopes/intercepts for other assays when the problem occurred?
What were the control results for these other assays, both after the adjustment, and
on the day in question for the problem assay?
Is the same control material used for all assays under discussion?
Were the adjustors stored under the same conditions?
7. When was Instrument maintenance performed, and what was done?
Was any maintenance completed immediately before the problem appeared?
Is there a new water source?
8. What was the previous kit lot number in use in the lab?
Have they skipped a number of kit lots?
Were there important notices/bulletins describing a change made to a kit lot that
was not used in this lab?
What is the software version in use?
Does the assay require the most recent software version?
9. Review the stability data.

DID SOMETHING CHANGE IN THE MIDDLE OF THE RUN?
Instrument Operator Assay
Any error messages? Aliquot or fresh controls today? Read insert for special handling
Display Panel How long has substrate been on Adjustors, controls, patients,
Printout (IMM) the unit? working solutions
Event viewer (I1K) Revised control ranges
Any additional maintenance or
Different Sounds? Look different?
service? Important Notices
Water & Probe Wash
Storage of controls, kits, Technical Bulletins
Volume adjustors, diluents?
Position of bottles (IMM)
Where & how stored?
Bubbles in lines? Compare to stability data
Frost free freezer?
Lines switched
Receiving? Kit release data
Shake test - bubbles of foam in
How long in use?
the water bottle? Biorad QAP data (Unity/Peer)
Within dating?
When filled?
Off-label use?
Replaced?
Cleaned? Was a new wedge added?
When was the kit received?
Syringes – barrel & thumbscrews What QC ranges are on the print
out? When put into use?
Bubbles in syringes
Euro or Hamilton dilutor? New control lot? Expiration Date?
Maintenance of tips Open kit component stability?
Change in control lot?
Probe fitting/Probe bent?
How were the control ranges Change in kit lot?
Check wash spin movement and
established? New kit lot?
speed
How long have the targets been
Wash well – fluid/pink?
in use?
Substrate dispense – spike or filter Adjustment history
Operator experience?
Clogged nozzle Other assays affected?
Was kit barcode rescanned?
Missing or double o-rings on spike?
Water dispense Export data (adjustor/controls)
Check test units fluid level – bead & Review CPS, mean, SD, %CV
sump
Last decon date?
Change in water source?
Steam distilled drinking water?
Macrovalve & microvalve pushed in
and locked? (Hamilton dilutor)
Last time end of line filters changed
(IMMULITE)
Last time inline filters changed
(IMMULITE 1000)

FINAL DOCUMENTATION IN CLIENTELE
The following should be included in the Clientele report:
1. Instrument type
2. Id and Lot Numbers
3. Name, address and phone number
4. Nature of Complaint
5. Dates, Results, and Data
6. Plan of Action
7. Corrective Action
8. Summary: Problem, resolution
9. Proper Coding

CHEMISTRY
The Immune Reaction ...........................................................................................................8
Sandwich Assay (e.g., hCG, TSH) ....................................................................................8
Competitive Assay (e.g., TT4, E2)...................................................................................10
Chemiluminescence............................................................................................................12
Data Reduction................................................................................................................12
Adjustment Theory ..........................................................................................................13
Interpreting Adjustment Results ......................................................................................13
Calculated Intercept Cutoffs ............................................................................................14
Control Results ................................................................................................................15
One Adjustor Assays ..........................................................................................................16
T3 Uptake, Allergy, and Infectious Disease Assays ........................................................16
Determination of Cut-Off..................................................................................................17
Method Verification Data Review Guidelines....................................................................19
Purpose ...........................................................................................................................19
Introduction......................................................................................................................19
Definitions........................................................................................................................19
Analytical Sensitivity ..........................................................................................................23
Analytical Sensitivity, Functional Sensitivity and Calibration Range ...............................23

THE IMMUNE REACTION
Sandwich Assay (e.g., hCG, TSH)

1. A polystyrene bead coated with an excess amount of antibody against a molecule to be
measured (e.g., hCG) is enclosed in a test unit.
2. The reagent wedge contains another antibody against a different area of the molecule to
be measured. Alkaline phosphatase is attached to the reagent antibody (e.g., anti-hCG-
alkaline phosphatase). The alkaline phosphatase is considered the label.
3. Sample and reagent are added to the test unit. During the incubation the molecule being
measured (e.g., hCG) binds to the antibody-coated bead, where it is captured and held.
The antibody from the reagent, which is labeled with the alkaline phosphatase, then
binds to the captured substance (e.g., hCG) being held on the bead.
4. Excess reagent and sample is removed. The test unit is spun at a high speed on its long
axis to eject any liquid out of the tube. Distilled water is injected into the test unit and the
tube is spun again (repeated 4X). After the last spin there will be <2 µL of liquid
remaining.
5. Chemiluminescent Substrate is added. Chemiluminescent substrate is injected into the
test unit and incubated for 10 minutes. During incubation the alkaline phosphatase label
catalyses the substrate and photons of light are released.
6. Photon light output is measured. The test unit is moved in front of Photomultiplier Tube
(PMT) and the photon output is converted to count per second (CPS).
7. Sandwich assays have a direct relationship between CPS and results: The more
molecules (e.g., hCG) present in the patient's sample, the more of it will bind to the bead.
This will then capture more of the second, labeled antibody from the reagent, resulting in
more alkaline phosphatase being bound to the bead. The more alkaline phosphatase on
the bead, the more light produced after substrate is added and the higher the counts for
the sample. A high CPS relates to a higher concentration of target molecules in the
patient's serum (i.e., high hCG result). A low CPS result relates to a lower concentration
of target molecules in the patient's serum (i.e., low hCG result).
Figure 1: Graph of Signal (CPS) vs. Concentration (Dose) for Sandwich Assays

Competitive Assay (e.g., TT4, E2)
1. The polystyrene bead coated with a limited amount of antibody against the molecule
being measured (e.g., TT4) is enclosed in a test unit.
2. The reagent wedge contains molecules analogous to the molecules to be measured. The
reagent analog is labeled with alkaline phosphatase (e.g., TT4-alkaline phosphatase).
There is no second antibody.
3. Sample and reagent are added to the test unit. During incubation the target molecules in
the patient's sample (e.g., TT4) competes with the labeled molecule from the reagent
(e.g., TT4-alkaline phosphatase) for the limited number of antibody binding sites on the
bead.
4. Excess reagent and sample is removed. The test unit is spun at a high speed on its long
axis to eject any liquid from the tube. Distilled water is injected into the test unit and it is
spun again (repeated 4X). After the last wash there will be <2 µL of liquid remaining.
5. Chemiluminescent Substrate is added. Chemiluminescent substrate is injected into the
test unit and incubated for 10 minutes. During incubation the alkaline phosphatase label
catalyses the substrate and photons of light are released.
6. Photons light output measured. The test unit is moved in front of the Photomultiplier Tube
(PMT) and photons output is converted to counts per second (CPS).
7. Competitive assays have an inverse relationship between CPS and result: The more
target molecules (e.g., TT4) present in the patient's sample, the more of it will bind to the
bead. As the patient's target molecules take up antibody binding sites on the bead, fewer
sites remain available for the alkaline phosphatase-labeled substance (e.g., TT4-alkaline
phosphatase) from the reagent. This results in less alkaline phosphatase label bound to
the bead and therefore less light (lower CPS) will be produced. Lower CPS relates to a
higher concentration of the target molecule in the patient's serum (i.e., higher TT4 result).
Higher CPS relates to lower concentration of the target molecules in the patient's serum
(i.e., lower TT4 results).
Figure 2: Graph of Signal (CPS) vs. Concentration (Dose) for Competitive Assays

CHEMILUMINESCENCE
When substrate is added, the alkaline phosphatase bound to the bead will cleave a
phosphate group off of the substrate, causing it to emit photons of light, measured in counts
per second, or CPS.
Data Reduction
Dark Counts
The PMT takes a one second dark count every cycle while the attenuator disk is in the
closed position. This is a background count check. The dark counts should not exceed 300.
The last 10 dark count reads are then averaged (running average).
Readings
The attenuator disk turns to its attenuated position and a decision count is taken. If the
counts are below 10,240, the disk turns to its open (unattenuated) position. If the counts
exceed 10,240, the disk remains in the attenuated position and 12 one-second readings are
taken by the PMT. The average dark counts are subtracted from each reading. The highest
and the lowest counts are dropped and the remaining 10 are averaged.
CAF (Chemiluminescence Attenuation Factor)

When counts are taken with the attenuator filter in place, 99 percent of the light is blocked
from the PMT. This is useful for samples with very high counts, so they can be read without
blinding the PMT. If samples are read with the filter in place, the CPS must be multiplied by
the Instrument’s Chemiluminescence Attenuation Factor (CAF) to correct for the blockage of
light.
PMT Factor
Each PMT is “calibrated” against a light emitting source of known value. A correction factor
is determined for each PMT so that they all produce the same output for this radioactive
source. This is done so that all PMTs give close to the same counts for any given sample.
The average counts for a sample are multiplied by this PMT factor to standardize counts.
Summary of Data Reduction

1. A test unit moves in front of the PMT.
2. A dark count reading is taken and averaged with the nine previous dark counts.
3. An attenuated decision count is taken. The decision is made to read sample with or
without attenuator disk.
4. The PMT takes 12 one-second readings.
5. The average of the last 10 dark counts is then subtracted from each of the 12 readings.
6. The highest and lowest readings are dropped and the remaining 10 are averaged.
7. The mean CPS is multiplied by the PMT factor.
8. If the test unit was read attenuated, the CPS are then multiplied by the CAF.

9. The CPS are then multiplied by the slope of adjustment and the intercept is
added/subtracted.
10. The "adjusted" CPS are then read off the stored master curve to convert CPS to dose.
Adjustment Theory
Refer to Section 8 of the IMMULITE Operator's Manual and Section 13 of the IMMULITE
1000 Operator's Manual.
• A stored master curve was developed in Euro DPC or DPC LA for each kit lot. The curve
is mathematically stored in the kit barcode parameters on the box flap, which is scanned
into the software by the operator. Adjusted CPS are read off of this stored curve to
determine the actual dose of a sample.
• Every Instrument yields somewhat different counts (due to variations of each PMT).
Since the master curve was developed on one system and samples are run on another
system, different counts can be expected. Therefore, we can not use a curve generated
on another Instrument to determine dose unless the two systems are equilibrated. We do
this by adjusting.
• Initial Adjustments account for differences in PMTs. Slope and intercept defines the
relationship between the customer’s Instrument and the master curve Instrument. These
are applied to CPS from the customer’s Instrument to make them equivalent to the
master curve Instrument CPS. At this point they can be read off of the master curve.
• A 10-15 percent variation is allowed between an initial slope and a readjustment slope.
This variation is due to loss of enzyme activity in the liquid reagent.
• The sample CPS is multiplied by the adjustment slope, and the intercept is either added
or subtracted. The counts are then read off of the stored master curve that was scanned
into the database. The counts are then converted to a dose.
Interpreting Adjustment Results

Refer to Section 8 of the IMMULITE Operator's Manual and Section 13 of the IMMULITE
1000 Operator's Manual.
The IMMULITE and IMMULITE 1000 software rejects an adjustment if the CVs between
adjustor replicates exceed the cutoff.
• For competitive assays, the cutoff is 10 percent for low and high adjustors.
• For sandwich assays, the cutoff is 15 percent for the low adjustor, and 10 percent for the
high adjustor.
Adjustment Handling on the IMMULITE
• If one adjustor fails, only that adjustor must be repeated.
Adjustment Handling on the IMMULITE 1000
• If one adjustor level fails, then both adjustor levels need to be repeated.

HOLD Feature
Tests pipetted between adjustor replicates are read at the PMT, but the result is not
calculated this time. Instead, the word HOLD is displayed in the results field and in the
Review screen. When the adjustment in progress completes successfully, the held results
are calculated with the new adjustment. The time of results for these tests is the time the
tests were read at the PMT, not the time the results were calculated. To indicate that these
tests were calculated using the new adjustment, the HADJ flag displays with the result.
If the adjustment in progress fails, the held tests are calculated using the last good
adjustment or master curve. These results are flagged ADJ when appropriate.
Patient Sample Flags

Patient Samples Patient Results Patient Report LIS Report Status LIS Report Flags
Resulted Off Of Screen Column Column
Master Curve ADJ ADJ Def Adj ADJ
Overdue OVDADJ ADJ Adj Due ADJ
Adjustment
Expired Kit ADJ,EXP ADJ,EXP Kit Exp ADJ,Exp
Previous Valid No flag No flag No flag ADJ
Adjustment
Adjustment Criteria
1. Controls: Controls are the primary criteria that customers use to validate adjustment.
2. Slope: There are different criteria for initial slopes vs. slopes of readjustment. Initial
slopes should fall within the expected slope range. The slope range is the average of 10
initial slopes plus or minus 20 percent.
3. Intercept: Intercepts generally conform to the following guidelines; however, situations
may occur where these guidelines are not applicable.
Readjustment Criteria
When readjusting a kit, the slope should only change by +/- 10% of the previous slope for the
kit lot.
Calculated Intercept Cutoffs

Sandwich Assay
A large intercept affects the dose calculation at very low doses. The intercept should be:
• absolute value of the intercept ≤ (Master Curve Low Adjustor CPS x 30%)
Competitive Assay
The intercept should be:
• absolute value of the intercept ≤ (Curve Parameter 1 x 2%)
Note: P1 is found on the Kit Entry Screen

Exceptions (For IMMULITE/IMMULITE 100 Only)
For Estriol, Digoxin and, Phenobarbitol, use Curve Parameter 2 in the above calculation
instead of Curve Parameter 1.
Control Results
• Customers must run controls according to their laboratory standard operating procedures
to monitor system performance. If controls are out of range, based on the laboratory’s
SOPs, it could indicate an assay problem, a control material problem, an operator error,
or an Instrument problem.
• Customers must run controls to evaluate the validity of an adjustment.

ONE ADJUSTOR ASSAYS
T3 Uptake, Allergy, and Infectious Disease Assays

There are two types of assays with one adjustor:
• T3 Uptake and
• Cut-off assays, i.e., infectious disease and allergy.
These assays all have a single calibration point. When the “adjustor” is run, a calibration
curve is actually being run. Because it is a calibration curve, all “adjustments” are accepted.
The only way to judge whether a calibration curve is correct is to run controls.
The IMMULITE 1000 will calculate an adjustor index for a single adjustor assay. The
calculation is as follows:
• Adjustor Index = Adjustor CPS/Kit Barcode Adjustor CPS
It is calculated as a guideline for the validity of the adjustment. Controls are still in the
primary way to judge and adjustment. Controls are run to judge validity. The calibration
cannot fail.
• T3 Uptake = (Calibrator CPS X P2)/Patient CPS
T3 Uptake
Both T3 and T4 in serum are mostly bound to TBG, thyroid binding globulin. Less than one
percent is free. The free form is in equilibrium with the bound form and TBG. It is also in
equilibrium with albumin.
-T4 + TBG -> T4 – TBG
<-
Only the free form of the hormone is biologically active.
In situations where TBG is increased, such as pregnancy, total T4 increases, but the free T4
concentration remains constant. Before the existence of the FT4 assay, a correction to total
T4 values was required to account for the T4 binding capacity of serum (TBG + albumin).
The correction factor is measured by the T3 Uptake assay.
T3 Uptake is an assay that measures the T3 (and therefore T4) binding capacity of serum.
High TBG concentrations result in low uptake numbers. For example, in pregnancy T3
Uptake is 20- 25 percent. Contrarily, low TBG concentration gives rise to high uptake
numbers.
The total T4 is corrected by T3 Uptake to account for different serum binding capacity. This
value is known as FTI (Free Thyroxine Index) or T7.
FTI or T7 = Total T4 x % T Uptake
An elevated T4 due to high TBG will be brought back into the normal range by multiplying by
the low uptake number and vice versa.

T3 Uptake Calculation
T3 Uptake = Calibrator CPS X P2
___________________________________
Patient CPS
Allergy and Infectious Disease Assays

• Allergy and infectious disease assays may be qualitative, semi-quantitative, or
quantitative.
• Quantitative assays have full standard curves and use normal four-parameter logistics
and two-point adjustment. (two adjustors)
• The qualitative and semi-quantitative assays use a single calibrator, and the results are
classified as positive, negative, or possibly indeterminate. The results in such assays are
calculated by comparing the signal obtained for a patient sample to a cut-off signal.
Determination of Cut-Off
The cut-off for an assay is usually measured in one of two ways:
1. Several hundred patients, both positive and negative, whose clinical status has been
established by another method, are assayed on the Instrument. A cut-off is determined
statistically. If the cut-off level is too low, many negative samples will read positive (poor
specificity). If the cut-off level is too high, many positive patients will be negative (poor
sensitivity). The cut-off that is calculated achieves the optimal sensitivity and specificity.
2. An alternate method for choosing the cut-off, used especially for allergy assays, is based
on the variability in signal response seen with a very large number of negative patient
samples.

Qualitative assays have a single adjustor (or calibrator) whose value is assigned based on
its ratio to the cut-off. For example, if the cut-off 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 (100,000/80,000) is required to match the adjustor to the cut-off.
With the IMMULITE/IMMULITE 1000, a single adjustor is supplied with the kit, and the ratio
of the adjustor to the cut-off 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 cut-off.
Sandwich Qualitative Assay

All allergy assays and all but one of the infectious disease qualitative assays are sandwich
assays. For these assays, if the patient CPS > Cut-off, the result is interpreted as positive. If
the patient CPS < Cut-off, the result is interpreted as negative.
Competitive Qualitative Assay

The only competitive qualitative assay is the hepatitis anti-core antigen assay (Anti-HBc). For
this assay, if the patient CPS < Cut-off, the result is interpreted as positive. If the patient CPS
> Cut-off, the result is interpreted as negative.
Indeterminates
For some qualitative assays, an indeterminate zone is defined. This zone is defined as plus
or minus a certain percentage of the cut-off CPS. If an indeterminate region is characterized,
then P2 times the mean adjustor CPS and P3 times the mean adjustor cps will give the
signal above and below the cut-off defining the indeterminate region. The percentage above
and below the cut-off is defined by P2/P1 and P3/P1. If no indeterminate is defined, P2 and
P3 are zero.
Ratios
Control values are now reported only as positive or negative. However, controls can be
monitored more closely by ratio, i.e., how much higher or lower than the cut-off is the control.
Specifically:
• For sandwich assays, RATIO = CPS/Cut-off
• For competitive assays, RATIO = Cut-off/CPS.
The IMMULITE 1000 automatically calculates a ratio for controls. Control ranges are entered
as ratios in the QC/Control Entry screen.
Patient samples can also be reported as qualitative only or qualitative and ratio. The
configuration selection for this can be accessed by selecting Configurations from the Tools
menu, then Report Settings.

METHOD VERIFICATION DATA REVIEW GUIDELINES
Purpose
To outline the review process for method comparison data.
Introduction
The data sent in for review documents the performance of the assay/Instrument at the time
of the study and may be useful to include in the method comparison database. This
database is a library of method comparisons of IMMULITE assays to various other
immunoassay systems that is compiled and administered by DPC Los Angeles Technical
Service.
The data is currently contained in an Excel spreadsheet that may include the following
worksheets:
• intra assay precision: precision study based on data generated in a single run
• inter assay precision: precision study based on data generated over several days
• calibration: study using calibration verifiers to confirm accuracy / reportable range
• sensitivity: study to calculate the analytical sensitivity for an assay
• dilute: study to evaluate dilutional linearity of an assay
• reference range: study to evaluate selected patient results to estimate a reference range
• method comparison: study to compare results obtained by another method to
IMMULITE/IMMULITE 1000 assay
Not all of these worksheets will be present in all data files. They do not all need to be
present. For evaluation purposes a precision study should be included with verification of the
reportable range and usually method comparison data.
Definitions
Reportable Range
• Term used by CLIA (Clinical Laboratory Improvement Act, [USA]) to describe the range
of concentration over which the assay gives accurate, precise results without dilution.
• DPC product documentation refers to this range as the Calibration.
Reference Range
• Range of values seen in a population of healthy individuals.
• Used to be referred to as the "Normal range", though use of that term has fallen out of
favor as too ambiguous.
• Generally defined as the range covered by the central 95 percent of results obtained
from a reference populations of healthy individuals. This means that, by definition, 5
percent of healthy people will have results outside of the range.

Analytical Sensitivity
• The theoretical lowest concentration that an assay can detect.
• More properly called the Detection Limit.
• Generally established by assaying 20 replicates of a true zero concentration sample and
then calculating the mean and SD of the signal (CPS).
• The analytical sensitivity is defined as the dose equivalent to 2 SD away from the mean
signal for a zero sample.
• This indicator of assay performance has little practical usefulness as the precision of the
assay typically become so poor at concentrations greater than the analytical sensitivity
that results are not useful. This is why the lower limit of the calibration range is almost
always at a greater concentration than the analytical sensitivity.
Protocol
• The review of the data should be principally directed at whether or not the data supports
product claims as well as a review for any potential Instrument issues.
• Is the data consistent with our performance claims in the package insert?
• Is the data consistent with current in-house performance of the assay?
• Look at the data and answer these two questions.
Precision Study
• Include a statement of the mean, SD, and % CV for each material tested.
• Then state how it compares to the product claims, e.g., "observed mean was about 4 SD
above expected mean".
Calibration Study
• Include a statement of which calibration verifier concentration(s) did not meet claim for
recovery and by how much they were off.
• Also note whether the problem appeared to be bias (good reproducibility, but at the
wrong concentration) or scatter in the data.
Sensitivity Study
• Include a statement of the calculated sensitivity at 2 SD and 3 SD and what the product
claim is.
Dilution Study
• Include statement of which dilutions did not recover and provide values for expected
value (what we should have gotten) and the actual results.
Reference Range Study
• If a substantial number of values fell out side of the expected reference range, include a
statement of the number of values that were outside the range, include the result most
outside the range.

Method Comparison Study
• Typically method comparison data shows results obtained by the Instrument and another
method.
• The data is usually listed and also presented graphically in two formats.
• One is a scatter plot that compares the results directly and usually includes a calculated
regression line along with the slope and intercept that describe the line.
• The other plot is a bias plot that compares the percent difference between the two
methods to the result obtained by the comparative method. Most all conclusions can be
drawn by looking at the graphs.
Note: If there are less than 20 data pairs, the method comparison study is not usually of
much value so interpret very small data sets with much caution. Results that are reported as
“greater than” or “less than” should not be included. Results from diluted samples should not
be included.
Scatter Plot
• When reviewing the scatter plot there are two basic aspects of the relationship between
the Instrument results and the comparative method that need to be checked, correlation
and bias.
Correlation
• Correlation ONLY describes how scattered the data is compared to the calculated
regression line.
• You can see how scattered the data is on the plot and can also use the calculated
correlation coefficient or “R”.
• If there is a lot of scatter in the data, or the “R” is less than 0.9, mention this in the
summary.
Bias
• Bias describes the numerical difference between the results (i.e., the Instrument result is
twice the comparative method result).
• Bias is best characterized by the regression slope and intercept.
• Always include the slope and intercept in your summary.
• Also check the PI or our current method comparison database to see how the bias in this
study compares to what we may have seen before comparing to the same method. If this
study shows a different bias, mention that in the summary.

Also when looking at the scatter plot, be careful to note whether the regression line seems
overly influenced by a few data points. Often one or more data points at a high concentration
will strongly influence the regression line. This is usually noticeable because the line does
not go through the rest of the data as well as it could. The regression line should go through
the middle of all the data. If it looks as though a few data points are influencing the line, try
temporarily removing them from the scatter plot and the calculation of slope and intercept. If
the line seems to fit the rest of the data better after removing these points, mention this in the
summary and make note of the slope and intercept from this trimmed data as well. This is
often the result of having very few data points at high concentration.
Bias Plot
• The bias plot indicates how the difference between the two methods changes with
concentration.
• Ideally the data points should be scattered closely around the horizontal axis.
• This plot can reinforce what is seen on the scatter plot and is another way to detect data
points that may not be consistent with the rest.
Once the method comparison data has been reviewed, it may be included in the method
comparison database. The decision to include the data will be made by the reviewers on the
“TSR Method Validation Data” e-mail list. The decision will be based on the number of points
in the study, the quality of the results, and the need for another comparison study involving
the comparative method.

ANALYTICAL SENSITIVITY
Analytical Sensitivity, Functional Sensitivity and Calibration Range

There are a number of terms and concepts that relate to defining the lowest concentration
that an IMMULITE/IMMULITE 1000 assay can report. These can often create confusion for
the customer. These terms and concepts are often misunderstood. Definitions for some of
these terms are as follows:
Analytical Sensitivity
This is what is published in the package inserts as Sensitivity. The formal definition is “the
lowest concentration that can be distinguished from background noise.” This value is
determined by assaying replicates (usually 20) of a sample that is known to have zero
concentration of the analyte. Then the CPS from these replicates are used to calculate a
mean and SD. The analytical sensitivity is set as the dose equivalent to the mean plus 2 SD
for immunometric assays and the mean minus 2 SD for competitive assays. This experiment
is often replicated for customers during validation studies, though there is NO regulatory
requirement to do so.
In the clinical lab, analytical sensitivity has little practical value. The basic reason is that for
almost all assays (especially competitive) the imprecision of the assay increases so rapidly
at low concentrations that, well before the analytical sensitivity is reached, the SD is so large
that results are virtually irreproducible and of little clinical value. This phenomenon can best
be seen by looking at a precision profile, which is a graphical representation of how the
precision of an assay changes with concentration. A number of IMMULITE/IMMULITE 1000
package inserts include precision profiles.
The analytical sensitivity does NOT represent the realistic lower limit of effective
performance for assays, though customers often think it does and the package insert often
adds to this confusion. This is why the lower limit of the calibration or reportable range of the
assay, as set in the software, is almost NEVER equal to the analytical sensitivity.
This limitation of the analytical sensitivity is not new, it applies to RIA, IMMULITE/IMMULITE
1000, and all methods by all manufacturers. How it is handled is what varies. The
manufacturer could have the assays report down to this limit and as long as users didn’t run
replicates, they would probably never notice the poor precision. However, DPC chooses not
to do this and instead limits the calibration range to what is the truly useful range of the
assay. The confusion about, and the limited usefulness of, analytical sensitivity for describing
effective assay performance, led to the development of another concept: functional
sensitivity.
Functional Sensitivity

About a decade ago, in reaction to the limited usefulness of analytical sensitivity, a group of
researchers evaluating TSH assays invented the concept of functional sensitivity. The formal
definition is “the lowest concentration at which an assay can report clinically useful results.”
The group arbitrarily defined “clinically useful results” as good accuracy with a day to day CV
of not more than 20 percent. They felt that a CV of 20 percent was the most imprecision that
could be tolerated for the results to be clinically useful. This definition strictly applies only to
TSH, but the 20 percent guideline and the concept has been widely applied to virtually all
other immunoassays. This happened because the concept makes sense and provides the
user with a real world meaningful, objective indication of the useable lower limit of an assay.
This same philosophy is applied to setting the lower limit of the calibration, or reportable,
range for IMMULITE/IMMULITE 1000 assays. The 20 percent CV limit is NOT strictly
applied, but the approach is the same. When developing the assay, we look at the
performance and decide at what concentration the limit of clinical usefulness is reached. This
is what determines the lower limit put in the software and it is almost NEVER equal to the
analytical sensitivity. In fact, for competitive assays especially, there is usually a substantial
difference between the analytical sensitivity and the lower limit in the software.
Calibration Range (Or the Reporting Limits Set in the Software)

The calibration range is defined as the range of concentration that DPC has decided is the
effective range of the assay and will support. This functionally coincides with the CLIA
concept of Reportable Range, which is the range of concentration over which assay
performance is documented as acceptable. There is not a fixed set of criteria that determine
the calibration range. The lower bound of the calibration range is NOT necessarily the
functional sensitivity as defined above, but the concept is the same. During assay
development, it is decided what is the range of concentration over which the assay will work
and that can be supported. This range is then put into the software. There are always
competing demands in setting this range. For marketing purposes the range should be as
broad as possible. This is always balanced by the realities of the chemistry.
Observations
There is NO requirement that the calibration range of an assay encompass reference ranges
published in the literature or even ranges we publish. It gets a little tricky with our own
ranges. When IMMULITE first came out many of the reference ranges were established by
performing method comparison experiments with IMMULITE and Coat-a-Count (CAC). The
slope and intercept from these comparisons were then used to adjust the CAC reference
range to adapt it to IMMULITE use. This made good use of the well established and
documented CAC reference ranges and is a perfectly reasonable way to establish a
reference range (see NCCLS guidelines for establishing reference ranges). However, for a
number of the assays, the CAC assay has better performance at the low end and was able
to measure lower concentrations. As a consequence, the adjusted reference range may
have a lower bound that is below the lower reporting limit of the IMMULITE assay. For a
number of assays (especially fertility) we have been developing IMMULITE specific ranges
by doing large multi-center studies and the PI ranges are being revised as the data becomes
available.

Some doctors get very alarmed by seeing a result of “less than 20” when the reference
range may be reported as five to 30. If the upper limit of the reference range is 30 and all
relevant pathology causes an elevated result (i.e., greater than 30), then a result of “less
than 20” is within the reference range, and, as such, is “normal” and unambiguous. Over the
years there have been many chemistry methods that don’t have lower reporting limits as low
as we all would like. This is not just an immunoassay issue and for sure not just a DPC
issue. It is our role in Technical Service to not lose sight of that and to help the customer not
lose sight of that. Remember that not too long ago the reference range for TSH was
“undetectable to 10” as ALL TSH assays were unable to measure the lower bound of normal.

CONTROLS
Automated QC Evaluation (IMMULITE 1000) ....................................................................28
Automated QC Definitions ...............................................................................................28
Automated QC Flags .......................................................................................................28
Automated QC.................................................................................................................29

AUTOMATED QC EVALUATION (IMMULITE 1000)
Automated QC Definitions
No Automated QC
• QC data is evaluated using the SD and ranges in the Control Data tab on the Control
Entry screen.
• Flags low or high
Single Rule
• QC data is evaluated using the SD and ranges in the Control Data tab on the Control
Entry screen.
• Flags: In Control or Out of Control
Multi Rules
• Uses Westgard Multi Rule configurations to evaluate QC results within and across QC
materials.
Multi Rules with N(x)
• Uses Westgard Multi Rule configurations to evaluate QC results within and across QC
materials.
• Tracks trends over a longer period of time based on the N(x) configuration.
Automated QC Flags
QCNE (QC Not Evaluated)
The number of controls in the run for a particular assay did not match the number of controls
configured for that assay in the QC Rules tab of the Control Entry screen.
Note: A control run is the number of controls the software sees on the Main Incubation
Carousel at the time the first control is read by the PMT.

Troubleshooting
• Check the QC Rules tab of the Control Entry screen for the configured number of
controls.
Figure 3: Control Entry Screen - QC Rules
• The number of controls within a run can be

Three different QC levels
Three reps of one control
Any combination as long as the total number of controls in the run equals the total
number configured for the assay.
In Control & Out of Control
• In Control: The QC run passed all rules evaluated for the assay.
• Out of Control: The QC run failed one or more rules evaluated for the assay.
Automated QC
Multi Rule Evaluation - Within and Across Control Materials
When an assay is configured for Multi Rule evaluation, the IMMULITE 1000 applies the
appropriate series of QC rules to all of the results in a completed QC run for that assay.
Rules are applied both "within" and "across" control materials where appropriate.
Within
• Control results are compared within the same control material across multiple runs (same
level, run on different days).

Across
• Control results are compared across different control material within the same run
(different levels run on the same day).

Multi Rule Descriptions Table
The Multi Rules used by the IMMULITE 1000 are as follows:
Rule Multi Multi Rules Description

Rules (Nx)
1(3s) A single result exceeds the mean by +/- 3 SD. This rule detects
random and systematic errors.
2(2s) Two consecutive results exceed the mean by 2 SD in the same
direction (i.e., both high or both low). This rule detects systematic
errors across and within control materials for an even number of
controls.
R(4s) A range of 4 SD between the lowest and highest consecutive
control measurements in a group. This rule detects random errors
across control materials.
3(1s) Three consecutive results exceed the mean by 1 SD in the same
direction (i.e., all high or all low). This rule detects systematic
errors across and within control materials for an odd number of
controls.
4(1s) Four consecutive results exceed the mean by 1 SD in the same
direction (i.e., all high or all low). This rule detects systematic
errors across and within control materials for an even number of
controls.
2 of At least 2 out of 3 control measurements exceed the mean by 2
3(2s) SD in the same direction (i.e., both high or both low). This rule
detects systematic errors across and within control materials for an
odd number of controls.
7t Seven consecutive results trend in the same direction (i.e.,
progressively higher or lower). This rule detects systematic error
trends within control materials and is used by both Multi Rule
groups.
6x Six, nine, or 12 consecutive results fall on one side of the mean
(i.e., high or low). This N(x) rule detects systematic error trends
9x
across and within control materials for an odd number of controls.
12x
8x Eight, 10, or 12 consecutive results fall on one side of the mean
(i.e., high or low). This N(x) rule detects systematic error trends
10x
across and within control materials for an even number of controls.
12x
Automated QC Evaluation Report

• The Automated QC Evaluation report includes control result data for each QC run of an
assay as well as an indication of overall assay control status.

• If a QC run fails, this report displays detailed information regarding all failed rules, as well
as rules that were not evaluated.
• If QC results are very different (with high Z scores) than the targets, confirm that the
ranges and units were not changed.

CPS/COUNTS
Control/Adjustor Problems.................................................................................................34
Control Problem Immediately after an Adjustment ..........................................................34
A Customer Has Problems with Controls not Currently Assayed/Evaluated in DPC QC 34
Adjustor Handling Issues.................................................................................................35
B12 and Folate ................................................................................................................35
CPS Troubleshooting..........................................................................................................36
Patterns in Data...............................................................................................................37
CPS Scenarios .....................................................................................................................38
Calculation Error (CPS < 5000) .......................................................................................38
Consistent High Counts...................................................................................................38
Dose Is Lower than Expected..........................................................................................38
Intermittent High Counts..................................................................................................38
Intermittent Very Low Counts ..........................................................................................39
Low Counts (CPS = 0).....................................................................................................39
Low Counts (CPS = 10 to 100)........................................................................................39
Low Counts (CPS = 100 to 1000)....................................................................................40
Low Counts (CPS = 2000 to 20000)................................................................................40
Low Counts (CPS > 25000, but much less than normal).................................................40
Negative CPS ..................................................................................................................40

CONTROL/ADJUSTOR PROBLEMS
Control Problem Immediately after an Adjustment

• Is this the first adjustment or a re-adjustment?
• What are the slope and intercept, the slope range, and the previous slope and intercept
for this kit and/or assay?
• Get kit lot and control lot information.
• Get the control ranges being used at the facility. Are they package insert ranges or
established? If established, how?
• Ask about adjustor and control handling: new vs. frozen adjustors, freshly reconstituted
controls vs. frozen aliquots, liquid vs. lyophilized adjustors.
• If using frozen aliquots, check on the freezer. Is it frost-free? If so, it will go through
freeze/thaw cycles, which can affect the stability of controls and adjustors. Also, how
large are the aliquots?
• Check the CPS on controls before and after adjustment. If the CPS values are similar,
readjust. If CPS values are different, run new controls.
• If the slope/intercept are questionable and/or not comparable to the previous adjustment,
try new adjustors, then a new kit.
As a general rule, small molecules are less prone to degradation during storage of
controls/adjustors. Therefore, control or adjustor problems are more important in sandwich
assays. The following assays are affected by unstable analytes (4/2000):
• ACTH
• IPTH
• Prolactin
• C-peptide
A Customer Has Problems with Controls not Currently

Assayed/Evaluated in DPC QC
Proceed with the regular troubleshooting process:
• Get stability data
• Check QC on other assays
• Get adjustment data
• Check if this is a new lot number
• Check QC ranges being used
• Ask when the ranges were established and with how many data points
• Check QAP data if available.
• In addition, the following can be done:
Check important notices/tech bulletins for updates that may affect the customer’s un-
assayed control material.

Send DPC controls to customers to assess if the problem is systematic and not
limited to one control. If the DPC controls come in though, the problem is not solved,
since it must be determine why the unknown control deviated in the first place.
Get the control the customer is using, either from chemistry or from the customer and
have it run here.
If this is not possible, get the customer a control (e.g., a lot BioRad lot available here)
similar to what they are using.
Investigate any reported or assumed shifts with that control to look for similar shifts in
the controls used in QC. The control used for that purpose should be run in a range
close to the range of the affected control and be preferably from the same
manufacturer.
Adjustor Handling Issues

Check current versions of package inserts, important notices, and technical bulletins for
current handling recommendations (4/2000).
Some specific handling requirements:
• PTH: single-use, use on ice
• Ferritin: never freeze
• PRL, DHS: always freeze
B12 and Folate

• If B12 or Folate shows low control results, check the volume used in the sample cup.
• Remember that a dead volume of 250 µl must be used. Using less can lead to
undetected short sampling.
• Also, the Folate working solution can be used with both the B12 and Folate assays.
• However, the B12 working solution cannot be used with the Folate assay.

CPS TROUBLESHOOTING
Constant CPS = water/ probe wash / substrate
Low Counts High Counts Erratic Counts

(something missing) (something added) (imprecision)
0 counts = no PMT, blown F1 No water (exponential Poor substrate delivery (low to
fuse, defective prescaler intercept) normal)
10 – 100 = no test unit No wash/spin Probe and/or Pump
<50 = no substrate Contamination (exp intercept) Syringe tips
100 – 1000 = substrate dispense In water source Bubbles
2,000 – 25,000 counts = In probe or pump Probe bent or loose (low to
normal)
No reagent (counts – 7,000) In wash well
level sense failure, reagent Probe positioning or level sensing
First tube of a run – valve #2
position
No probe wash (carryover =higher)
Adjustor problem (exponential
Residual probe wash (slopes 2
No water or inconsistent volume
– 5) Intercept, for
dispense
competitive assays)
Contamination
Probe wash and water lines
(inhibitors/interference) Substrate contamination
reversed
No sample pipetted
Insufficient spin/wash (intermittent)
Thumbscrew/barrel on small
Test unit storage- if bag is left
syringe
open, moisture can affect bead
Wedge position or cap on and can cause imprecision.
reagent Refrigerated test unit bags should
remain closed until they reach
Film or bubbles in wedge
room temperature.
Film, bubbles in sample cup
Substrate contamination
Adjustment Bad / QC ok = chase reagents, contamination

Adjustment Bad / QC bad = chase adjustors
CPS = (slope) raw counts + intercept (y=mx + b)

ACCURACY PRECISION
How close the average measured value is Repeatability
to the true value
Adjustment Pipetting – syringes

Lot changes Probe
Maintenance / Decon Bubbles
Controls / Control Ranges / Water
Reconstitution/Storage
Valves
Reagent Expiration Dates
Contamination
Attenuation Factor / PMT Factor
Contamination
Patterns in Data
Remember: CPS x slope + intercept (y=mx+b)
• For any given assay, if the slope and intercept of the adjustment are outside the
guidelines, but the control results are acceptable, troubleshoot the reagent.
• For any given assay, if the slope and intercept of adjustment are outside the guidelines,
and the control results are not acceptable, troubleshoot the adjustors.
• For any given assay, if the slope and intercept appear acceptable, and only the middle
control of a three level control is out, troubleshoot the control.
Low CPS
If the CPS values are too low, something is missing. Look for errors in sample or reagent
pipetting, or with substrate dispense.
• Sandwich assay: sample/reagent pipettingÆ substrate
• Competitive assay: reagent pipetting Æ substrate
Low CPS may also be an indicator of problems with the substrate itself. This is easy to
investigate by running a water test to see the CPS of substrate alone.
Contamination can also cause low CPS. Check the location of the water bottle on
IMMULITE/IMMULITE 1000 systems, as well as the water source on both systems. Is it
sitting in the sunlight or under a heating vent?
High CPS
If the CPS values are too high, suspect problems with the spin or with the wash of the bead.
Unbound material is left behind, adding to the CPS.
Contamination can also cause high CPS.
• competitive assay Æ check sample pipetting also

CPS SCENARIOS
Calculation Error (CPS < 5000)

Possible Causes
• Air in fluidics system
• Bubble on sample
• Low substrate
• False level sense
Consistent High Counts

Possible Causes
• Water is contaminated
• Ran out of water
• Substrate is contaminated
• High speed spinner is no longer spinning
• Incorrect PMT factor
Dose Is Lower than Expected

Possible Causes
• Air bubble on top of sample resulting in insufficient sample
• Defective Valve #1 or Valve #4 causing insufficient sample to be aspirated
• Contamination
Intermittent High Counts

Possible Causes
• Test unit did not spin well or not at all. (Check for spinner errors)
• Test unit was "flicked"
• Upper shuttle slide bearing is sticky causing tubes to misalign in spinner or under
substrate nozzle.
• Intermittent problem with wash/water dispenses.
• In sequential assays, water dispense volume is set too greater than 200 µl, allowing the
sump to overflow back onto the bead.

Intermittent Low Counts
Possible Causes
• "Shuttle at luminometer" sensor flag is bent causing test unit to mis-position under
substrate nozzle
• Substrate solenoid has excessive "drawback" causing part of the substrate stream to
dispense off-center
Intermittent Low Counts

Possible Causes
• Level sensor is stopping before reaching sample
• Sample cups are tipping in sampling positions causing probe to mis-position in cup
• Attenuator sensor disk is loose causing attenuator windows to mis-position
• Probe is loose
• Incorrect PMT factor
• Substrate nozzle is partially clogged causing substrate to dispense off-center
Intermittent Very Low Counts

Possible Causes
• Insufficient substrate dispense due to improper seating of the tubing flare in the
connector at the top of the substrate heater.
• Insufficient substrate dispense due to blockage of the nozzle.
Low Counts (CPS = 0)

Possible Causes
• PMT is defective or not connected
• Prescaler is defective
• PMT power supply fuse (F1) is blown
• PMT multiplier factor was never set
Low Counts (CPS = 10 to 100)

Possible Cause
• No tube in front of PMT for one of the following reasons:
Tube fell off shuttle
Luminometer chain has mis-positioned

Possible Cause
• No or little substrate dispensed

Possible Cause
• No reagent pipetted for one of the following reasons:
The wedge being placed into the tray incorrectly
False level sensing
Mis-positioning of the reagent carousel
Bubbles in reagent wedge
Loose probe
Low Counts (CPS > 25000, but much less than normal)
Possible Causes
• Probe wash has gotten into the test unit- either from residual probe wash in water bottle
or faulty V2 causing probe to drip probe wash
• Substrate reservoir is contaminated
• No sample pipetted
Negative CPS
Possible Causes
• Extremely high dark counts (above 1000)
• Blown fuse
• Bad Parity

DIAGNOSTICS
Running Diagnostics ..........................................................................................................43
Running Diagnostics on the IMMULITE ..........................................................................43
Running Diagnostics on the IMMULITE 1000 .................................................................44
List of Diagnostic Programs...............................................................................................46
APRIME...........................................................................................................................46
ATTURN ..........................................................................................................................46
BCODE............................................................................................................................46
BCODEON ......................................................................................................................47
BCODESPD ....................................................................................................................47
BCODETST .....................................................................................................................48
BKGNDCNT ....................................................................................................................48
BPRIME...........................................................................................................................49
CARBACK .......................................................................................................................49
CARCHECK ....................................................................................................................49
CARPOS .........................................................................................................................49
CARSHAKE.....................................................................................................................49
DARKCNT .......................................................................................................................50
DECON............................................................................................................................50
DECON1..........................................................................................................................50
DISSUB ...........................................................................................................................50
DISWAT...........................................................................................................................51
EMPTYTUB .....................................................................................................................51
LCHAIN ...........................................................................................................................52
LEVCRASH .....................................................................................................................52
LEVFALSE ......................................................................................................................52
LEVSENSR .....................................................................................................................53
LEVSENSS......................................................................................................................53
LUMCHN .........................................................................................................................53
MCARTST .......................................................................................................................54
PIPXPOS.........................................................................................................................54
PMTCOUNT ....................................................................................................................54
PRBECLEAN...................................................................................................................54
PRIME .............................................................................................................................55
PROBANGL.....................................................................................................................55
PROBETST .....................................................................................................................55
RBCODE .........................................................................................................................55
REAGENTH.....................................................................................................................56
REAGENTP.....................................................................................................................56
SCHANGE.......................................................................................................................56
SHUTLOAD .....................................................................................................................57
SHUTSPIN ......................................................................................................................57
SHUTTLE ........................................................................................................................57
SOLE1W..........................................................................................................................58
SOLE2S...........................................................................................................................58
SPINCHK.........................................................................................................................58
SPINON...........................................................................................................................58

TEMPS ............................................................................................................................59
V1TEST ...........................................................................................................................59
V2TEST ...........................................................................................................................59
V4TEST ...........................................................................................................................60
WASHSPD ......................................................................................................................60
WATERTPM ....................................................................................................................60
WATERTST.....................................................................................................................61

RUNNING DIAGNOSTICS
Running Diagnostics on the IMMULITE

Notes:
• The Instrument must be in IDLE mode before continuing.
• Ensure the Probe and Shuttle are in their home positions before running diagnostics.
• From the Startup screen, select DIAGNOSTICS.
• Select Download Diagnostic.
• Select or highlight a diagnostic using the arrow keys.
• Press Enter.
• RUN is highlighted. Press Enter.
• Press GO on the IMMULITE Display Panel to start the diagnostic and follow any
prompts.
• Press ALARM MUTE + GO to stop a diagnostic.
• If an external program is needed (such as PC or GETDATAT), press Esc to exit the
diagnostic files.
• Select Exit to DOS at the startup menu.
• At the DOS prompt, type in the external program's name (PC, water, getdatat) and
follow the prompts.

Running Diagnostics on the IMMULITE 1000
Notes:
• The Instrument must be in IDLE mode before continuing.
• Ensure the Probe and Shuttle are in their home positions before running diagnostics.
• Select DIAGNOSTICS from the Startup menu. The Common Diagnostics screen appear.
Note: Select DIAGNOSTICS or SYSTEM CONFIGURATIONS to display other
diagnostic programs.
• Choose a diagnostic and select the RUN button.
• The program will download to the IMMULITE 1000.
• Press GO on the IMMULITE 1000 Display Panel to initiate the diagnostic.
Note: No additional programs are required to run diagnostics on the IMMULITE 1000.
The figures below depicts the diagnostic screens that appear in the IMMULITE 1000
software version 5.8.

Note: The Systems Configurations screen is password-protected. The password is
C1RRUS.

LIST OF DIAGNOSTIC PROGRAMS
• Diagnostics are listed alphabetically.
• Programs that are not used by Technical Service for troubleshooting are not listed.
• Instructions for running a particular diagnostic are the same for the IMMULITE and
IMMULITE 1000 unless otherwise noted.
• Instructions specific to an Instrument appear under one of the following headings:
IMMULITE Instructions
IMMULITE 1000 Instructions
APRIME
• Used to prime the large syringe (Syringe A) for diagnostic evaluation.
• This diagnostic does not stop automatically.
• Error flagging is not turned on.
ATTURN
• Cycles the Attenuator Disk to the home position, attenuated position, and the
unattenuated position.
Instructions
• Visually check the PMT Attenuator Disk motion to verify sensor operation.
• Observe the position of the single sensor notch found on the right side of the
Luminometer cover above the PMT.
• The single sensor notch points to a 9:00 position at home, 5:00 in the attenuated
position, and 1:00 in the unattenuated position.
• The Attenuator Disk should move smoothly as it turns.
BCODE
• Verifies proper functionality of the Sample & Test Unit Barcode Reader.
• A test unit/sample cup holder is read once every two seconds.
• The next text is then indexed in front of the Barcode Reader.
• PC Mode is required to run this diagnostic.
• There is no limit or specific sequence of test units or sample cups.
• The information will appear on the simulation screen following a successful read.
• Bad barcode reads appear as white ghosts.

• Place one sample cup followed by a test unit on the Load Platform.
• The sample cup number and test code with lot number will display following a successful
read.
BCODEON
• Verifies the operation of the Sample & Test Unit Barcode Reader by turning the
sample/test unit barcode reader on and off.
• Used when cleaning the orange o-ring.
Instructions
• Press the GO button on the Instrument Display Panel to toggle the motor on and off.
BCODESPD
• Used to observe or adjust the motor speed of the Sample & Test Unit Barcode Reader.
Instructions
• Load at least four test units or sample cups onto the Load Platform.
• Run the program and observe the motor speed.
• The speed should be 750 to 790 ms/rev for test units, and 730 to 770 ms/revs for sample
cups.
• Press the Pause button until the next test unit advances.
• Each position should not be more than 40 ms/rev of each other.
Note: Consult with Field Service before adjusting the barcode motor speed.
Adjusting the Barcode Motor Speed
• When facing the back of the Instrument, the barcode speed potentiometer is the one
closest to the Water and Probe Wash Bottles.
• To adjust the speed, make slight, incremental turns while running BCODESPD.
• As you turn the potentiometer, the speed increases or decreases on the Instrument
Display Panel.

BCODETST
• Verifies the proper functionality of the Test Unit & Sample Barcode Reader with repeated
readings.
• Automatically advances the next sample cup or test unit.
• Exit to DOS once the program is running.
• Enter PC Mode if the Instrument is running in Standard Mode, or PCSTAT if the
Instrument is in Turbo Mode.
• Test units and sample cups are read 25 times each at the barcode reader.
• Successful reads populate the Main Carousel on the simulation screen.
• The sequence for testing is one sample cup followed by one test unit. Repeat this
sequence if necessary.
• Sample cups are read 25 times by the Barcode Reader.
• Test units are read 25 times.
• The sample cup number, test code, and kit lot number will display following a successful
read.
Notes:
• Bad barcode reads display as "Bad Barcode".
• Sample cups read by the Barcode Reader display with the cup number.
• Test codes and test unit lot numbers display for the first five test units. The remaining 20
test units will display as 'not recognized'.
• "Not recognized" appears on the Instrument Display Panel when a test unit without a
matching kit lot is read by the Barcode Reader.
BKGNDCNT
• This program provides the current background counts for the Instrument's PMT.
• It will alternate moving the attenuator between the attenuated and unattenuated position.
• While at each position, a set of 12 one-second background counts are taken.
• Run Getdatat.
• The Getdatat program provides the actual raw background counts.

BPRIME
• Used to prime the large syringe (Syringe B) for diagnostic evaluation.
• Error checking flag is turned off.
CARBACK
• Useful for removing sample cups from the Main Incubation Carousel.
• This program moves the carousel backwards in single index steps when the Syringe
Prime button is pressed, or indexes continuously by holding the prime button down.
Instructions
• Make sure the Shuttle is in the home position inside the carousel at about 3 o'clock.
• Follow the prompts on the Instrument Display Panel.
• Press the Syringe Prime button to move the carousel backwards (counter-clockwise).
• Rotate the carousel until the test units and/or sample cups are in the pipetting area.
• Manually remove the test units or sample cups.
• The carousel should be completely empty.
CARCHECK
• This program is used to judge the position of the Main Incubator Carousel in relation to
the tube Shuttle.
• It indexes the carousel ring gear one position, moves the Shuttle into the space between
the carousel baffles, pauses for one second, moves the Shuttle back to home and
repeats.
CARPOS
• Checks the indexing of the Main Incubation Carousel.
• Indexes the Carousel Ring Gear one position every second.
CARSHAKE
• Checks the carousel shaking function.
• Momentarily initializes, indexes the carousel one step, moves the Shuttle in the space
between the baffles, and shakes the carousel for a few seconds.
• This diagnostic stops automatically.

DARKCNT
• Provides the current dark counts for the Instrument.
• Moves the attenuator to the home position,
• Takes a set of 12 one second dark counts with the PMT every fifteen seconds.
• Run Getdatat.
• The Getdatat program provides the actual raw background counts.
DECON
• Introduces decontamination material into the fluidics of the Instrument.
• Draws the decontamination fluid into both syringes, one at a time, and then into the water
pump (five times).
• Under no circumstances should bleach be used to decontaminate the system.
Instructions
• Run DECON for at least five minutes.
• Let the system sit for 15 minutes.
• Run DECON1, which stops automatically after 15 minutes.
DECON1
• Must be used after DECON.
• Flushes out the decontamination fluid and replaces it with fresh water.
• Fills each syringe twice and the water pump 10 times.
• This diagnostic stops automatically. (After about 20 minutes.)
DISSUB
• Tests the Substrate Pump dispensing volume.
• Transports five test units from the Load Chain to the substrate fill position.
• Dispenses 200 µl of substrate into each test unit and moves them to the Sample
Collection Tray.
Instructions
• Thoroughly prime the system.
• Place five test units on the Load Platform.
• Check the level of each for consistency.

• The level of substrate should be just above the bead.
• Check if there are any splatters on the side of the test unit. Imprecision can occur if the
Substrate Nozzle is not dispensing straight down.
DISWAT
• Tests the Water Pump dispensing volume.
• Transports five test units from the Load Chain to the water fill position.
• Dispenses 200 µl of water into each test unit and moves them to the Sample Collection
Tray.
Instructions
• The level of water should be just above the bead.
nozzle is not dispensing straight down.
EMPTYTUB
• Used to check the main driving motor movements of the Instrument.
• Also used to evaluate the proper coordination between interfacing driving motors of the
system.
• Useful if a problem at the transfer points is suspected.
• Useful for removing test units from the system in the event of a shutdown while samples
are in process.
Instructions
• Do not run if Sample Cups are on the system.
• Remove all sample cups and test units from the Load Platform before initializing this
diagnostic program.
• The Load Chain, Main Incubation Carousel, Shuttle, and Luminometer all advance in
sequence.
• Any test units that are in the Luminometer will be moved from the Luminometer Chain
onto the Exit Ramp.
• Check for hesitation. The emptying should be synched.
• Also check for missing or dislodged baffles.
Note: EMPTYTUB cannot be used to remove a sample cup from the Main Incubation
Carousel since it moves the components forward.

LCHAIN
• Used to visually check the functionality and positioning of the Load Chain.
• The Load Chain is indexed once every second.
• Run for about a minute.
Instructions
• Verify the smooth movement of the Load Chain.
• Check for missing baffles.
Note: If sample cups are stuck in the Barcode Reader area, this diagnostic will move them
into the Sample Collection Tray.
LEVCRASH
• Test for proper level sensing of the Probe in each of the five sample pipetting positions.
Instructions
• Pipette at least 100 µl of liquid (must be material that will detect a change in capacitance,
i.e., PBS, probe wash, reagent, sample) into five sample cups.
• Place the five sample cups into the five pipetting positions.
• Put an empty wedge in the Reagent Carousel as a visual marker and leave the lid open.
• The Probe will level sense each cup, starting with position five.
• Any failures will trip the jam sensor, which in turn will index the Reagent Carousel one
step.
LEVFALSE
• Tests for false level sensing in the reagent, five sampling positions, and assay dispense
pipetting positions.
• This test does not require any sample cups to run.
• This diagnostic stops automatically. (IMMULITE 1000 Only)
Instructions
• Place an empty wedge on the Reagent Carousel and a sample cup at the furthest point
on the Load Chain as visual markers.
• If the Probe false level senses in the reagent position, the Load Chain advances.
• If it false level senses in any pipetting position, the Reagent Carousel indexes.
• You can also trigger the system to level sense by touching the Probe after its first pause
on the way down.
• Wires and cables can be jiggled to trigger intermittent problems.
• Intermittent problems indicate a problem with the board.
• Otherwise, the Probe may be loose.

• Check the CPS. If the counts are all depressed, a spiral cable issue is a possibility.
LEVSENSR
Note: The Reagent Carousel does not move during this diagnostic.
• Used to check for consistent reagent level sensing.
• Tests dead volume settings at the reagent positions.
Instructions
• Place a wedge containing 1000 µl of reagent in the position on the Main Incubation
Carousel that is underneath the hole of the Reagent Carousel Lid (because the Reagent
Carousel does not move during this diagnostic).
• The diagnostic will repeatedly level sense in the wedge and display the steps left (SL) on
the Instrument Display Panel (should be between 8-12).
• Confirm the Probe is entering the wedge when it level senses.
• If the numbers are not consistent, consult with Field Service. It may be necessary to
adjust the settings using LEVSNADJ in System Configurations.
• Wipe off the Probe with a DI moistened kimwipe after the diagnostic to prevent cross
contamination.
LEVSENSS
• Exercises the level sensor in the sampling positions.
Instructions
• Place a sample cup containing probe wash in the first pipetting position.
• The diagnostic will repeatedly level sense in the sample cup and display the steps left
(SL) on the Instrument Display Panel. The number should be consistent.
• Confirm the Probe is entering the cup, and is centered, when it level senses.
LUMCHN
Caution: Ensure the Shuttle is at the far left home position before running LUMCHN.
• Checks the movement of the Luminometer Chain by indexing it one position every
second.
• Takes 40 seconds to complete a full rotation of the Luminometer Chain.

MCARTST
• Tests the positioning sensor of the Main Incubator Carousel
Instructions
• Watch the Display Panel as the program runs.
• The hole width of each position hole of the ring gear (in steps) will display on the
Instrument Display Panel with each repeated index of the Main Carousel.
• Nominal values are a range of 22–26 for ‘large’ holes.
• Nominal values are a range of 8–12 for ‘small’ tabbed holes.
PIPXPOS
• Moves the Pipettor to each position and lowers it.
Instructions
• Place a wedge in the pipetting position in the Reagent Carousel.
• Place five sample cups in the pipetting positions. The Vanity Panel may have to be
removed when using five test units.
• Check the position of the Probe as it dips into the each pipetting position.
• If the Probe is not centered, the Probe may be bent or positioned incorrectly.
PMTCOUNT
• Activates measurement readings by the PMT.
• Run Getdatat.
PRBECLEAN
• Runs a special enzyme-cutting probe wash routine which is part of daily maintenance.
• A special probe cleaning kit must be used with this diagnostic
Instructions
• Pipette 2 mL of probe cleaning enzyme cleaner into the probe cleaning wedge.
• Place the probe cleaning wedge in Position 1 on the Reagent Carousel.
• Refer to the kit's package insert for more information.

PRIME
• Primes the two syringes and the associated tubing.
• Priming removes excessive air bubbles and allows for accurate dispensing of water and
probe wash.
• Exercises Syringes A and B and Solenoid Valves 1, 2, and 4.
• Error flagging is turned on.
PROBANGL
• Used to evaluate the dispense angle of the Probe.
• The Probe is positioned over the Probe Wash Station and dispenses water.
Instructions
• Check the Probe from the front, sides, and back while it is dispensing.
• The dispense should not be more than 7-10 degrees off center.
• Unscrew the Probe at the fitting at the top of the Pipettor and twist as it dispenses.
• If the spiral of the stream is wide, the Probe is bent (a slight spiral is acceptable)
• Alternatively, remove the Probe and gently roll it on a flat service.
• Clean the Probe with a DI moistened wipe and return the Probe if it is not bent.
• Replace the Probe if it is bent or dispenses at an angle.
Note: Be sure to tighten the fitting when returning/replacing the Probe.
PROBETST
• Used to evaluate the dispense quality of the Probe.
Instructions
• Look for excessive splashing on the Probe Shaft or out of the home well.
• Look for any dripping when the Probe lifts up and momentarily moves to the Wash Well.
• Dripping indicates back pressure or an occlusion inside the Probe or its associated
tubing.
• The depth of Probe in Wash Well may need to be adjusted (Consult with Field Service).
RBCODE
• Tests the Reagent Carousel Barcode Reader with reagents on board.

• The program moves the Reagent Carousel to the Home position and then to each
position while reading reagent wedge barcodes.
• If there is a problem, the reagent wedges on board will not be read consistently and
some will show up as white ghosts on the IMMULITE.
Instructions
• Load reagent wedges onto the Reagent Carousel.
• Use the ALARM MUTE key to extend the pause at each position for a closer evaluation.
REAGENTH
• Used to checks the Reagent Carousel home position sensors.
• Moves and pauses the Reagent Carousel in the home position between positions one
and two in front of the Barcode Reader LED.
Instructions
• Place a reagent wedge in Position 1 of the Reagent Carousel.
• The red LED should project an oval red light between the edge of the wedge and the first
barcode line when the carousel pauses in the Home position.
• Use the ALARM MUTE button to extend the pause at the Home position for a closer
evaluation
REAGENTP
• Used to check the Reagent Carousel Position Sensor at all 12 positions of the Reagent
Carousel.
• Moves the Reagent Carousel to each of the 12 positions.
Instructions
• Remove all reagents from the Reagent Carousel.
• Look directly through the individual notches found around the edge of the carousel.
• Each position should be centered in front of the Barcode Reader LED.
• Use the ALARM MUTE button to extend the pause at each position for a closer
evaluation.
SCHANGE
• Used when removing the Syringes.

• Both Syringes are moved down approximately halfway to allow for the removal of the
Syringes.
Instructions
• After replacing the syringe tips, press GO to return the Syringes to their home positions.
SHUTLOAD
• Allows the operator to evaluate how the Shuttle loads the test unit into the spin position.
Instructions
• Manually load a test unit onto the Main Incubation Carousel, one position before entering
the Shuttle.
• Inspect for proper actuation of the shuttle springs.
• The test unit should fit snugly into the spinner wheels and sit on a straight angle (without
tilting).
• Press GO to have the program eject the test unit for remove.
SHUTSPIN
• Used to evaluate the High-Speed Spinner cycle.
Instructions
• Manually load a test unit with 200 µl of liquid onto the Main Incubation Carousel, one
position before entering the Shuttle.
• The test unit will be taken to the spin position and the High-Speed Spinner motor will
activate for 30 seconds.
• The test unit should lift up slightly and the liquid should quickly clear from the bottom of
the tube.
• The bead should float in the air while the tube is spinning.
• To check the actual spinner speed, use the WASHSPD diagnostic.
SHUTTLE
• Used to check the positioning of the Shuttle.
• The Shuttle is moved from the home position to a neutral Luminometer position.
• Next, the Shuttle is moved to the spinner.
• Then, the Shuttle is moved to the substrate dispense position.
• The cycle is then repeated.

SOLE1W
• Used to check the dispense volume and/or drawback adjustment of the Water Pump.
Instructions
• Remove the thumbscrew holding the Substrate Heater and Water Nozzle in place.
• Lift the Substrate Heater.
• Disconnect the Water Nozzle.
• Hold a beaker under the Water Nozzle.
• Run the SOLE1W diagnostic.
• Use the ALARM MUTE button to pause and control the shots into the cup.
SOLE2S
• Checks the dispense of the substrate pump.
Instructions
• Remove the thumbscrew holding the substrate heater and water nozzle in place.
• Lift the substrate heater and title it backward.
• Hold a beaker under the substrate heater nozzle.
• Run the SOLE2S diagnostic.
SPINCHK
• Allows for a quick visual check that the high-speed spinner motor is working.
• During this test, the test units will be loaded into the spin position and the spinner motor
will turn on for one second.
Instructions
• Manually load as many test units as desired onto the Main Incubation Carousel.
• Manually rotate to one position before entering the Shuttle.
SPINON
• Turns the high-speed spinner motor on or off.
Instructions
• Press the GO button to turn the high-speed spinner motor on and off.

TEMPS
• Use to monitor Instrument temperatures.
• The temperatures are updated every 30 seconds.
V1TEST
• Tests the functionality of the Valve 1 (V1) of the syringe assembly.
• The water should alternately dispense from the "probe" and from the wash well.
• Except for valve throw, the water should never move in the tubing when the water is
dispensing up from the bottom of the wash well.
• If water is moving down the probe when it should not be, this can cause under-aspirating
of reagent and/or sample.
• It can also cause fluid to be drawn into the probe from the home well resulting in
carryover.
Instructions
Note: Consult with Field Service before running this diagnostic.
• Run the V1TEST diagnostic.
• If the valve is not working at all, water will always dispense from the probe.
• If the valve is stuck in the activated position, the water will always come from the wash
well.
• If one of the two diaphragms in the valve is partially clogged, one port will slowly drip
while the other is dispensing.
V2TEST
• Tests the functionality of Valve 2 (V2) of the syringe assembly.
• The water should alternately dispense from the "probe" and the tubing that goes into the
probe wash container.

Instructions
• Remove the tubing from the probe wash bottle and place into an extra container.
• Run the V2TEST diagnostic.
• If the valve is not working at all, the water will always dispense from the probe.
• If the valve is stuck in the activated position, the water will always come from the probe
wash container tubing.
V4TEST
• Tests the functionality of the Valve 4 (V4) of the syringe assembly.
• This program works exactly like V1TEST.
Instructions
• Run V4TEST diagnostic.
• If the valve is not working at all, water will always dispense from the probe.
• If the valve is stuck in the activated position, the water will always come from the wash
well.
WASHSPD
• Tests or allows adjustment of the speed of the High Speed Spinner motor.
Instructions
• Place one test unit on before the Sample Barcode Reader.
• Follow the prompts on the Display Panel.
• Listen for any unusual sounds and watch the speed of the tube.
Note: Consult with Field Service before adjusting the speed. The target speed is 5520. The
speed will appear on the Instrument Display Panel.
WATERTPM
• Used whenever water or substrate contamination is suspected.

• See WATERTPM (IMMULITE) on page 294.
• See WATERTPM (IMMULITE 1000) on page 296.
WATERTST
• Used whenever water or substrate contamination is suspected.
• See WATERTST (IMMULITE) on page 293.
• See WATERTST (IMMULITE 1000) on page 295.

DISCORDANT RESULTS
Identifying Discordant Results...........................................................................................64
Definition of a Discordant Result .....................................................................................64
Documenting Discordant Results ....................................................................................65
General Rules ......................................................................................................................66
Discordant Complaints Flow Chart....................................................................................67

IDENTIFYING DISCORDANT RESULTS
Definition of a Discordant Result

A discordant result occurs when the initial result of a patient sample is questioned or the test
is repeated and the second result:
• differs enough from the initial result to affect clinical interpretation.
• does not agree with the patient's clinical picture.
• is not within the expected precision of the assay.
Additional Information
• A result is considered discordant if the CV between the initial and repeat result exceeds
three times the Package Insert CV. This is equivalent to three Standard Deviations.
• If the questionable result is reproduced when the sample is tested for the second time,
this may indicate a sample-specific issue, e.g., interferences, medications,
patient/sample specific.
Note: Serial dilutions may be helpful to make this determination.

Documenting Discordant Results
Include the following information when documenting discordant results:
1. How did the customer determine the result was discordant?
a. Was it repeated? Other method?
2. Was the result reported to a physician?
a. If yes, was medical treatment administered, changed, or withheld based on the
discordant result?
Note: If medical treatment was administered, changed, or withheld based on the
discordant result, follow your applicable local guidelines for submitting the call for
regulatory review.
3. Data/Instrument Investigation
a. Date/time the 1) discordant occurred and 2) repeat testing was performed
b. Accession number, tube type and size
c. Sample type
d. Adjustment/control data, lots that were in use when the discordant result was
produced
e. Previous adjustment and control data history
f. Determine whether the adjustment and control data from the time of the discordant is
typical of the instrument and of the assay
g. Review the day error log if possible; otherwise review the cumulative error log for the
date and time in question
4. Review the files and consult with Field Service for possible dispatch.
a. Document findings, plan of action, and resolution.
Note: Field Service is dispatched to rule out an Instrument-related cause, verify
Instrument performance, allow the investigation to focus on non-mechanical causes, and
to reassure the customer that the Instrument is functioning.

GENERAL RULES
Symptom Area to Investigate

Sandwich assays with low CPS results System front end, including pipetting, fluidics,
substrate, etc.
Sandwich assays with high CPS results System back end, including processor,
washing, spinning, etc.
Sandwich low CPS, Competitive high CPS Sample volume specific issue
Sequential Sandwich assay with half of the Burkett valves, probe wash getting into sample
normal CPS on adjustors, and results

DISCORDANT COMPLAINTS FLOW CHART

ERROR MESSAGES, CAUSES, AND SOLUTIONS
IMMULITE .............................................................................................................................70
IMMULITE 1000 ....................................................................................................................96

IMMULITE
Error Message Cause Solution Associated
Diagnostics
Adjustor lots between Test Unit lot numbers Re-run the Adjustor (or N/A
replicates don't match are not the same for all Adjustors) using matching
the Adjustor replicates. Test Unit lots.
Adjustor replicates not The Test Codes behind Re-run the Adjustors with N/A
identical an Adjustor sample cup matching replicate Test
are not all the same (i.e. Codes.
not all TSH replicates).
Adjustor result file not The result file could not File deleted-Repeat N/A
found be found. Adjustment
Ambient Elec. Temp High The ambient electronics Clean the intake fan N/A
[nn] temperature reading is filter on the right side
higher than the of the IMMULITE.
acceptable range. Lift the top panel to
allow the electronics
Note: This is not a fatal to cool.
error condition. TEMPS
Check the fan on the
top left side
Note: The temperature
falls back into an
acceptable range within a
short amount of time.
Ambient Temp. High The internal ambient air This problem should N/A
temperature reading is correct itself.
higher than the
Note: The lab
acceptable range. TEMPS
temperature should be
less than 30ºC.
Atten. Factor not set The attenuation factor Check Configurations, LUM
was not set. Config Settings, PMT
Factor
Note: This message
should not be
encountered if the
computer has been
configured correctly.
Atten. Home Error Appears on the LUMINOMETER
IMMULITE Display
Panel if the error
corrects itself.
Note: If the IMMULITE ATTURN
cannot correct the error,
the Instrument
automatically shuts
down and an error
message appears.

Diagnostics
Atten.- Pos. Error. Refer to the explanation Refer to the solution LUMINOMETER
above for the error above for the error
message: Attenuator message: Attenuator
Home Error. Home Error.
Bad barcode last Sample Either: Wipe the label with a LOAD
#nn lint-free towel or PLATFORM
Torn, wrinkled or
wash the label with
dirty barcode labels,
water.
which cause Test
If the barcode is torn
Units not to spin
or wrinkled, discard
smoothly.
the Test Unit or the BCODEON
Dirty Barcode
sample cup holder. BCODESPD
Reader O-rings.
Perform maintenance BCODETST
Barcode Reader
on the barcode drive BCODE
speed is off in one
wheel.
or all positions.
Bad File Name or Number The computer was Press any key to
in Line xx of Module PC yy turned off or reset return to the DOS
at address zz. Hit any Key without following the command line.
to Return to System. proper Log Off At the
procedure. C:\CIRRUS\IMM
prompt, type fixit and
press [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.
Type start and press
[Enter] to return to
the Start-up menu.
Repeat all tests in
progress.
Note: Be sure to shut
down the Analyzer
before choosing RUN
IMMULITE or START
TURBO. See also:
Database Needs
Repair
Bad LIS Checksum Checksum did not match Re-send results to the N/A
(transmission error). LIS.
Bad or Missing Frame Usually indicates a bug Re-send the results to the N/A

Diagnostics
Number in the LIS software; LIS.
however, could be
If the error continues to
caused by a bad
occur, contact software
message (due to line
dept.
noise, etc.).
Bad Parity Error Due to electrical noise The problem will correct N/A
on the power line, itself.
information was sent to
the software and
incorrectly read as a
message.
Calc error Occurs when the system If all results give Calc WATER/
cannot properly error, check to see if SUBSTRATE
calculate a dose. there is enough water PUMPS
and if the syringe
thumbscrews are
tight.
If an individual result
shows this error and
it is a competitive
-DISSUB
assay, the dose may
be too high. Dilute -DISWAT
and rerun specimen.
-SOLE1W
If the results show <
25,000 cps, see Low -SOLE1S
Counts (CPS = 2000
to 20000) on page
40.
Cannot calculate average An invalid value was Turn the IMMULITE N/A
temperature due to error received for a power off for a couple
temperature reading seconds and then on.
because of a Select RUN
temperature controller IMMULITE or START
error or failure. 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 feel hot,
turn the Instrument
off immediately.
Cannot calculate last An invalid value was Refer to solution above N/A
temperature. Delta error received for a for: Cannot calculate
encountered. temperature reading average temperature due
because of a to error
temperature controller
error or failure.

Diagnostics
Cannot communicate with RUN IMMULITE or If RUN IMMULITE was N/A
IMMULITE START TURBO was selected:
selected while the TO SAVE, RUN EXIT
Display Panel showed TO DOS, ENTER PC
something other than the MODE
message: DPC
If START TURBO was
IMMULITE IDLE, Run
selected:
START Program to
begin. TO SAVE, RUN EXIT
TO DOS, ENTER PC
STAT
Ensure the
IMMULITE Display
Panel reads IDLE.
Press ALARM MUTE
and GO and re-load
the software.
Note: Make sure the
power is on and the
RS232 ports are
connected.
Cannot find Order Record A record required for LIS Re-send the test order to N/A
communications is not IMMULITE.
found.
Cannot find record for The IMMULITE sent a Re-run the test using a N/A
result Sample #nn reading to the computer; different sample cup
testCode however, it did not know holder number.
where the result
belonged in the
database and the result
for this Test Unit was
lost.
Cannot find record to The sample cup was Repeat the tests, N/A
place Adjustor [Control] identified as an Adjustor, identifying the Adjustor,
[Verifier] Entry. control, or verifier after control, or verifier to the
passing the Barcode software before the
Note: The error
Reader. sample cup passes the
message will read either
Barcode Reader.
Adjustor, Control, or
Verifier, depending upon
the situation.
Carousel Shut Down This message appears Repeat all tests in MAIN
when the Main Carousel progress after the cause CAROUSEL
is disabled (i.e. when a of the shut-down is
shuttle/carousel jam is determined and

Diagnostics
detected). corrected. -CARBACK
Note: Any tests in the -CARPOS
Luminometer will
continue if possible. -EMPTYTUB
-CARSHAKE
-CARCHECK
Carousel Temp. High The Incubation Carousel The IMMULITE should MAIN
[Low] temperature is above or correct itself. CAROUSEL
below the acceptable
Note: The error Note: All results
range.
message will read either generated during the high
High or Low. or low temperature period
will be flagged on the
printout.
TEMPS
If the component
feels hot, turn the
Instrument off, allow
it to cool.
Check LED Pattern
on Motor/Heater
board
Collection Tray Full The sample collection If the sample LOAD
tray is full or missing. collection tray is full, PLATFORM
remove the sample
Note: An alarm sounds cups from the
and the IMMULITE collection tray and
goes into AutoPAUSE replace the sample
mode. collection tray.
If the sample
collection tray is
missing, replace it.
Follow the
instructions on the
Instrument Display
Panel to continue.
Power down then
back up
Clean sensor flag
<CR> or <LF> Missing in Usually indicates a Inform your LIS provider
LIS Transmission. programming bug in the of this error.
LIS software, but may be
a bad message (e.g. line
noise).
Dark Count High [nn]. The dark count LUMINOMETER
measured exceeds the
maximum acceptable
limit (300 cps).
-DARKCNT
Note: The preceding
sample may have had -BKGNDCNT
very high cps. -PMTCOUNT

Diagnostics
Database needs repair in The computer’s power Press any key to exit N/A
line 0 of module Pcxxx at was turned off or reset to DOS.
address xxxx:yyyy. Hit without following the Type fixit and press
any key to return to the proper log off procedure. [Enter]. "Attempting
system. to repair database is
displayed", followed
by a message
indicating the
damaged files have
been repaired.
Note: This process -FIXIT
can take as long as -CHKDSK
15 minutes, (see
depending on the FSE)
amount of data
stored. -CHKDSK/F
Type start and press -DEFRAG/F
[Enter] to return to
the Start-up menu.
Data lost. Simulation The computer and the Check the RS232 N/A
screen may not be correct. IMMULITE were not cable.
OLD=[xx], NEW=[yy] communicating for more Save run by Exiting
than 32 cycles. Some of to DOS and running
the data was not in PC mode
received; therefore,
reports will be missing.
Date Time conflict The computer's date or Do the following: N/A
time was set earlier than Enter the current date
the date or time and/or time.
recorded with results Re-run the tests.
already generated by the
IMMULITE.
Diluted Samples below Diluted sample is below Re-run sample N/A
curve the detection limit. undiluted.
Record the CPS of
the test
Division by 0 during An invalid or 0 cps Check PMT LUMINOMETER
Adjust testCode caused by either:
invalid parameters or kit
barcodes -PMYCOUNT
mechanical problems -DKCOUNT
Error during Control QC Refer to the explanation Refer to the solution N/A
below for the error below for the error
message: Error during message: Error during
Patient QC. Patient QC.
Error during Patient QC Unforeseen error . N/A

Diagnostics
Error in last request The LIS encountered an Re-send the results N/A
error when processing to the LIS.
the IMMULITE's request If the error continues
for information. to occur, call your LIS
provider.
Fatal Curve Adjust error An unknown error was Check the CPS. N/A
#nn testCode encountered.
Five Replicates used for More than the required No action is necessary. N/A
Curve Adjust. 5th four Test Units were run The software looks for
replicate dropped. behind the Adjustor quadruplicates only;
sample cup. therefore, the fifth Test
Unit is ignored.
Front End Shut Down The Load Chain and Wait for the LOAD
pipettor are disabled IMMULITE to PLATFORM
because an error was complete the tests in
detected in the Load progress.
Chain, pipettor, or Investigate the cause
syringes which the of the problem by
IMMULITE could not checking the -LCHAIN
correct. associated error
messages or looking -PROBANGL
Note: If possible, the for an obstruction.
IMMULITE will continue -PIPXPOS
processing the tests -PROBTEST
currently in progress.
General failure reading Bad disk Format a new disk (type N/A
Drive A format_a:) and try to
perform the backup
(occurs during backup)
procedure again.
Heaters Shut Down 35 The 35 or 39 degree Check Motor/Heater N/A

[39] Degree Error calibration resistor LED’s
cannot be read properly Power Down/Restart
Note: The error Check Fans & Filters
due to a heater
message will read either TEMPS
controller error.
35 or 39.
Heaters Shut Down The incubator carousel Check Motor/Heater N/A

Car. Heater Error heat is not working LED’s
correctly because of a Power Down/Restart
Check Fans & Filters TEMPS
heater controller error or
a thermistor failure.
Heaters shut down cooler Reagent cooling is not Ensure Instrument N/A
working properly has been powered on

Diagnostics
error because of a heater for more than 45 TEMPS
controller error or a minutes.
thermistor failure. Check Motor/Heater
LED’s
Power Down/Restart
Check Fans & Filters
Heaters shut down - Lum The Luminometer Ensure Instrument N/A
heater error heating is not working has been powered on
properly because of a for more than 45
minutes. TEMPS
heater controller error or
thermistor failure. Check Motor/Heater
LED’s
Power Down/Restart
Check Fans & Filters
Heater startup error. Either: Do the following: N/A
Heaters shut down. Turn the IMMULITE
The IMMULITE
components have not off to reset the heater
reached operating timers.
temperature, even Turn the IMMULITE
though it has been 60 on.
minutes since start-up. Check the
temperature after 45
The power to the minutes (by choosing
Instrument was System Status and
interrupted. Temperature and
Dark Counts from
the Primary screen). TEMPS
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.
High and Low Adjustor Different high and low Re-run the Adjustors N/A
Test Codes don't match Adjustor Test Codes. using the correct Adjustor
(i.e. An Adjustor is definition.
defined as TSH and the
high = TSH, but the low
= T4.)

Diagnostics
High [Low] Adjustor's CVs After dropping the high Evaluate the cps of the PIPETTOR
between replicates are > or low Adjustor replicate, replicates:
than nn%. Adjust aborted. which contributes to If the CVs are very
imprecision the most, high (50% or more),
the CVs are still too call Technical
high. Services.
Note: This error can If the CVs are not
only be encountered high, re-run the
only during the Adjustor which
adjustment process. caused the PROBANGL
adjustment to fail,
ensuring there are no PIPXPOS
bubbles on the PROBTST
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 call during Occurs while calculating Get CPSs N/A
Calc. test testCode an illegal math See Also: CALC
operation. ERROR
Illegal function call during An invalid or 0 cps, Get CPSs N/A

Curve Adjust test testCode caused by either: See Also: CALC
Kit Lot nn ERROR
invalid parameters
or kit barcodes
mechanical
problems
“in Progress or resulted, The auto-number feature Operator should not try to N/A
skipping.” was selected, in the LIS auto-number records that
Data Management are closed or are in
screen, for records progress.
already in progress or
resulted.
Index not found in line Broken database Perform the following
zero of module PC 43 steps exactly as written:
Perform “check disk”
program (CHKDSK)
Perform
“defragmentation”
program
(DEFRAG/F)
Type FIXIT.
Insufficient sample Refer to the explanation Refer to the solution for N/A
for the error message: the error message: No
No Sample Pipetted Sample Pipetted Sample
Sample #nn testCode #nn testCode

Diagnostics
Insuf. Reagent Pip. Either: Do the following: REAGENT
not enough reagent Ensure there is CAROUSEL/
is available to sufficient reagent PIPETTOR
complete the test available to complete
a level-sense error all tests.
was encountered Ensure there are no LEVSENSR
a Test Unit and bubbles on the
Reagent Wedge surface of the sample
were mismatched and reagent.
Replace the incorrect
kit component.
Invalid LIS ID LIS error message which Do the following: N/A
occurs when the Sender From the Start-up
ID or Receiver ID is menu, choose LIS
incorrect. PARAMS.
Check that the
Receiver ID matches PROBANGL
the LIS Sender ID PIPXPOS
and that the Sender
ID matches the LIS PROBTST
Receiver ID.
Invalid LIS Password LIS error message which Do the following: N/A
occurs when the Header From the Start-up
Message Password is menu, choose LIS
incorrect. PARAMS.
Check that the
Header Message
Password field shows
the same Header
Message Password
used by the LIS.
Kit not Found testCode Kit The kit parameters were Enter the kit barcodes N/A
Lot nn. Curve Adjust overwritten with those of (using the laser scanner),
aborted. another kit after and re-run the
pipetting. adjustment.
Note: Do not delete a kit
which is currently
running.
Less than 4 replicates. Refer to the explanation Refer to the solution N/A
Adjust aborted. below for: Less than 4 below for the error
replicates, or Adjustor message: Less than 4
results for all levels are replicates, or Adjustor
not yet available. results for all levels are
not yet available.
Less than 4 replicates, or Either: Depending on the cause, N/A
Adjustor results for all A record for one of either:
levels are not yet available the Adjustor Re-run the Adjustor.
replicates was Re-run the Adjustor

Diagnostics
deleted because of which was short the
a pipetting error. required number of
An insufficient replicates.
number of replicates Note: This sample cup
was loaded. must be re-identified and
followed by four Test
Units.
Level Sense Error The IMMULITE has not REAGENT
level-sensed either the CAROUSEL
reagent or the sample.
PIPETTOR
Note: If five Level Sense
errors occur, the
IMMULITE goes into
AutoPAUSE. The error LEVSENSR
messages associated
with the sample cup LEVSENSS
number are recorded in LEVFALSE
the Error Log.
PROBANGL
PIPXPOS
LIS Sent an INVALID ID of Sender ID incorrect. Enter correct Sender N/A
NULL, record not saved ID in LIS PARAMS.
Check with LIS
provider for correct
ID.
LIS Timeout The LIS is not Re-send the results to the N/A
responding to the LIS.
IMMULITE. This can be
caused by:
cable problem
hardware problem
bug in the LIS
software
Load Chain Error. Appears on the Look for source of the LOAD
IMMULITE Display error condition (e.g., PLATFORM
Panel if an error is a sample cup
detected and the incorrectly seated in
IMMULITE is able to the sample cup
correct itself. holder or a crushed
Test Unit)
Note: If the IMMULITE Remove vanity panel
cannot correct the error, and check for loose
the Instrument or popped baffles. LCHAIN
automatically shuts Check for deformed
down the pipetting (front EMPTYTUB
test units
end) operation and a
message indicates this
has occurred. (The
Instrument will continue
to process the tests in
progress.)

Diagnostics
Low and High Adjustor A Test Unit lot matches Remove the Reagent N/A
reagent lots don’t match two different Reagent Wedge which should not
Wedge lots. (i.e. Two be used for the
Reagent Wedge lots are adjustment and re-run
loaded. The first both Adjustors with only
Reagent Wedge is used one reagent lot loaded on
for the low Adjustor 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 Adjustor Two kit lots share the Re-run the Adjustors N/A
Test lots don't match same Reagent Wedge using the correct Test
lot number but have Units (from the kit which
different Test Unit lots; is being adjusted).
therefore, the low and
high Adjustor replicates
are run with different
Test Unit lots.
Low cps sample xx [test The counts for a result Ensure that: PIPETTOR
code] are less than 15,000. there is sufficient
reagent (sample)
available to complete
all tests
there are no bubbles
on the surface of the
liquid
the syringe PROBANGL
thumbscrew is tight PROBETST
Re-run the test for the PIPXPOS
record which has the low
cps. SOLE1W
Check Test units on exit SOLE2S
chute.
WASHSPD
Lum. Chain and Atten. There is a Luminometer Look for the source of the LUMINOMETER
Shut Down. chain jam. jam. Since this is a fatal
error, the IMMULITE will ATTURN
stop. LUMCHN
EMPTYTUB

Diagnostics
Lum. Chain Error. Appears on the Check for Test Units LUMINOMETER
IMMULITE Display (or other
Panel if an error is obstructions, such as
detected and the Luminometer chain
IMMULITE is able to baffles) which may
correct itself. interfere with the
chain movement.
Note: If the IMMULITE Check test unit on
cannot correct the error, exit ramp, rotate LUMCHN
the Instrument counter-clockwise
automatically shuts until it comes out EMPTYTUB
down and a message Check for popped or
indicates this has loose baffles.
occurred. Note: Repeat any
tests which were in
progress.
Lum. Temp. High [Low] The temperature reading The IMMULITE should LUMINOMETER
for the Luminometer is correct itself.
Note: The error
above or below the Note: All results
message will read either
acceptable range. generated during a
High or Low.
high or low
temperature period
-TEMPS
will be flagged on the
printout.
If the component
feels hot, turn the
Instrument off
immediately.
Check Motor/Heater
LED’s
Main Car. Error This message will Do the following: MAIN
appear on the Stop the IMMULITE CAROUSEL
IMMULITE Display (press ALARM
Panel if the error MUTE and GO).
corrects itself. Log off the system.
Note: If the problem Load and run the
cannot be corrected, the CARBACK (or
Instrument automatically CARPOS) diagnostic
shuts down and an error program, then
message indicates this EMPTYTUB
has occurred. This is Press the black
often caused by a Prime button on the
sample cup holder syringe module to
jammed on the carousel index the Incubation
under the drive gear. Carousel
counterclockwise.

Diagnostics
Remove the Test CARBACK
Units from the
carousel as they CARPOS
become accessible in EMPTYTUB
the Load Chain /
Carousel intersection MCARTST for all
area. 60 holes
Remove the sample
cup holder from the
carousel.
Choose RUN
IMMULITE or START
TURBO 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.
Mechanical error Either: Based on the cause, LOAD
encountered (pipetting) This message either: PLATFORM
appears in Determine the cause BCODE
conjunction with of all bad barcode
numerous bad reads and correct if BCODETST
barcode reads. possible. BCODESPD
A problem was Clean O-ring idlers
encountered with Determine the source PIPETTOR
the pipettor. of the pipettor
interference and
PIPXPOS
correct if possible. Do
not use the PROBANGL
IMMULITE until this
problem is corrected. PROBTST
Message received out of The computer missed a The software N/A

sequence, Seq = xx message from the automatically requests
OldSeq = yy IMMULITE. that the message be re-
sent.
Message Too Short Usually indicates a bug Re-send the results N/A
LIS mesg. too short\bad in the LIS software; to the LIS.
frame however, could be If the error continues
caused by a bad to occur, call your LIS
message (due to line provider.
noise, etc.).
Negative Slope calculated! Sample cups were Re-run both levels of N/A
Are the Adjustor levels identified as low and Adjustors, pipetting each
high, but either the level into the correct

Diagnostics
reversed? levels dispensed into the sample cup holder.
cups were in the reverse
order or only one level
was run for both
samples.
nn days since your last The database has not Either: N/A
backup been backed-up in the ignore this message
last 7 or more days. back-up the system
Note: Execution speed
is greatly reduced.
No info on this # The LIS has no Check the LIS to verify N/A
information regarding that the accession
the accession number number has been
sent in the query. assigned.
Non-Turbo kits cannot be Non-Turbo reagent Either:
run while in Turbo Mode. wedges have been Remove all Non-
Please take all non-turbo loaded onto the reagent Turbo Reagent
kits off the reagent carousel while in Turbo Wedges and press
carousel. Mode. GO to continue
running in Turbo
mode.
Log off and choose
RUN IMMULITE to
run the Non-Turbo
kits.
No Patient Record for A record required for LIS Re-send the test order to N/A
Order communications is not IMMULITE.
found.
No place in database for Either: Based on the cause, N/A
Test Code xx result. The sample cup was either:
identified as a Repeat the tests,
control or Adjustor identifying the control
after passing the or Adjustor to the
Barcode Reader. software before the
The date on the sample cup passes
computer is the Barcode Reader.
incorrect. Check the computer's
date and time
No Place in Database to Either: Based on the cause, N/A
Put Tube, Displayed as The Barcode either:
Bad. Reader read a Test Ensure that all
Unit that was not sample cups are
preceded by a loaded ahead of the

Diagnostics
sample cup. Test Units on the
The operator logged Load Platform.
off and on the Press ALARM MUTE
computer while the and GO
Analyzer was still simultaneously, log
operating. off (via the Primary
Screen) and re-run
the tests.
No Reagent for Either: Depending on the cause N/A
approaching testCode A Reagent Wedge is either:
Tube Part [Reagent Part] missing from the Replace the missing
Lot#[lot#] Reagent Carousel Reagent Wedge.
tray. CAUTION: The
The Reagent Wedge Reagent Wedge must
and Test Unit lot be replaced within 5
numbers are minutes or this test
mismatched. result is lost.
Refer to the solution
for the error
message: Reagent
part A missing.
No Reagent for testCode Indicates either: Depending on the cause N/A
tube at the Barcode there is no Reagent either:
Reader Wedge on board Add the correct
matching the Test Reagent Wedge and
Unit just read at the press GO to re-read
Barcode Reader the Reagent
the current Reagent Carousel.
Wedge has Zero Press PAUSE to
Tests Remaining. ignore the message
(The Instrument will and this test will not
go into AutoPAUSE be pipetted.
mode.) Remove all incorrect
Turbo and Non- sample cups and test
Turbo kits are on units that need to be
board at the same run in a different
time. mode (Turbo or Non-
Turbo) and press
GO.
No Reagent for testCode Indicates either: Depending on the cause N/A
tube(s) on the load chain After the Test Unit(s) either:
passed the Barcode Add the correct
Reader, the Reagent Wedge and
Reagent Wedge for press GO to re-read
these tests went to the Reagent
Zero Tests Carousel, or, press
Remaining. PAUSE to ignore the

Diagnostics
The Reagent Wedge message (this test
and Test Unit lot will not be pipetted).
numbers are Refer to the solution
mismatched. for the error
Turbo and Non- message: Reagent
Turbo kits are on part A missing.
board at the same Remove all incorrect
time. sample 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 REAGENT
Sample #nn testCode Not enough reagent record which was CAROUSEL
is left to continue deleted, making sure
testing. there is enough:
Note: The error will sample (above the
be recorded in the required dead
Error Log and on the volume)
printed report. For reagent (above the 1
this Test Unit, the mL dead volume)
report will say: LEVSENSR
Check probe
Record Deleted
Pipetting Error.
It’s a hardware-
related error (as
indicated on the
Instrument Display
Panel) .
No sample cup for Test Either: If there was a bad LOAD
Unit barcode read, wipe PLATFORM
a bad barcode read
the label with a lint-
occurred for the tube
free towel or wash
just before the Test
the label with light
Unit (which may or
detergent.
may not be a
If the barcode is torn
sample cup)
or wrinkled, discard
there are more than
the Test Unit or
five Test Units
sample cup holder.
behind a sample cup
Perform maintenance
there is no sample
on the barcode drive

Diagnostics
cup in front of the wheel. BCODE
Test Unit Repeat the tests.
If there are more than BCODEON
five Test Units, place BCODETST
the correct number of
Test Units behind the BCODSPD
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 If the error was due REAGENT
Sample #nn testCode because an error was to insufficient sample, CAROUSEL
detected. The error can ensure there is
be: adequate sample in
the sample cup and
hardware-related
re-run the test.
due to insufficient
If it is a hardware
sample
error, remove any
If any other messages obstructions and re-
accompanies the No run the tests.
Sample Pipetted Sample
#nn testCode message,
it is a hardware problem.
LEVFALSE
Note: The error will be
recorded in the Error LEVSENSR
Log and on the printed
report. For this Test
Unit, the printed report
will say: Record Deleted
Pipetting Error.
Overflow Error during A variable was set equal Note the exact overflow N/A
Adjust test testCode Kit to a very large number. error message.
Lot nn
Note: This error is
infrequent when the
master curve
parameters are correct
and the IMMULITE is
running properly.

Diagnostics
Overflow error during Either: Check test units on exit N/A
calculation test testCode A variable was set to ramp.
a very large number.
A hardware error
occurred.
The RS232 cable is
loose or
disconnected.
Note: This is an
infrequent error
when the master
curve parameters
are correct and the
IMMULITE is
running properly.
Pause mode; 5 Level The Instrument will go Check if each error was REAGENT
Sense Errors Encountered into AutoPAUSE mode if due to insufficient volume CAROUSEL
the following errors for reagent or sample.
occur 5 times within a
run:
LEVSENSR
Insuf. Reagent Pip.
Not enough sample
error
PC IMMULITE COMM Communication between Check cable N/A

FAILURE the PC and the connections between
IMMULITE has been the IMMULITE and
Check your cable the PC.
interrupted.
connection now! Reset power on both
Resuming normal the PC and the
operation in 15 seconds. IMMULITE and select
RUN IMMULITE or
START TURBO from
the start-up menu.
Reagent Carousel Home This message appears Ensure that the Reagent REAGENT
Error on the IMMULITE Carousel is seated CAROUSEL
Display Panel if the error properly and that nothing
corrects itself. is blocking the sensor
beneath the carousel
Note: If the problem
tray.
cannot be corrected, the
front end of the
REAGENTH
Instrument automatically
shuts down and an error RBCODE
has occurred. Any tests
in progress will continue
to be processed.
Reagent Level Sense Probe level senses Check for cap on REAGENT
Error. above the maximum Reagent Wedge or large CAROUSEL
Are there Caps on the height of liquid. bubble on top of reagent.

Diagnostics
Reagent Vials? LEVSENSR
TIPJAM
Reagent lot# xmit error The correct lot Re-read the reagent N/A
information could not be barcodes.
transmitted to the
IMMULITE.
Reagent pipetted does not Either: Re-run the Adjustors and N/A
match kit. Adjust aborted. Different Reagent enter the correct kit.
Wedge lots were Note: Be sure to use the
pipetted throughout correct kit components.
the two Adjustor
levels.
The kit needing
adjustment does not
correspond to the
Test Units and
Reagent Wedge
used.
Reagent part A missing Either: If the Test Unit and REAGENT
The Test Unit and Reagent Wedge lots are CAROUSEL
Reagent Wedge lots mismatched:
are mismatched. A Check the Reagent
mismatched lot Status or Kit Entry
occurs when the screen for kit
Test Units and component lot
Reagent Wedge numbers.
currently on-board Confirm that the
are not from the actual lot numbers of
same kit lot. Test Units agree with
Note: Pause is the Reagent Wedge
automatically initiated. on-board.
Change either the
The Reagent Wedge
Reagent Wedge or
has not been placed
the Test Units, as
in the Reagent
needed.
Carousel Tray.
Note: Mismatched
The Reagent
Test Units appear as

Diagnostics
barcodes have not white circles on the
been read after the Primary screen.
kit barcodes were Depending on the
scanned into the Kit error condition, these
Entry screen. Test Units may be
Turbo and Non- carried around the
Turbo kits are on Incubation Carousel
board at the same and sent to the
time. sample collection
tray; or, they may be
shuttled directly to
the sample collection
tray.
Otherwise, do the
following (based on the
cause):
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 Refer to the explanation Refer to the solution for REAGENT
for the error message: the error message: CAROUSEL
Reagent Carousel Home Reagent Carousel Home
Error. Error.
RBCODE
REAGENTH
REAGENTP
Reagent Temp High The Reagent Carousel If just powering on REAGENT
temperature is above the system, you must CAROUSEL
22° C due to wait 45 minutes for
the analyzer to reach

Diagnostics
thermoelectric cooler optimal temperatures. TEMPS
failure. Check Motor/Heater
LED’s
Note: Assays can be
performed if the
reagent carousel
temperature is above
22° C, but the
reagents should be
removed from the
carousel and
refrigerated after
pipetting.
Record Deleted [No Either: If there was insufficient REAGENT
Sample] or [No Reagent] The records were sample, do the following: CAROUSEL
Pipetted deleted because of Check the printout or
Note: This message insufficient sample the Error Log for error
prints on the report. or reagent. messages.
The Reagent Wedge Note: The Test Unit
went to Zero Tests will be in the sample
Remaining after the collection tray.
Test Units were read Re-run the test (Re-
by the Barcode loading the reagent
Reader and the and sample if
Reagent Wedge necessary.)
was not replaced For the other two causes LEVSENSR
before the Test listed, re-run the assays. LEVSENSS
Units reached the
carousel.
The second
Reagent Wedge 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 cup # mismatch A communication error N/A
Call Tech Services occurred between the
IMMULITE and the
software.

Diagnostics
Sample tray full or absent The sample collection If this occurs at start-
tray is full or missing. up, ensure the
sample collection tray
Note: An alarm sounds is situated properly.
and the IMMULITE goes If the sample
into AutoPAUSE mode. collection tray is full,
remove the sample
cups from the
collection tray and
replace the sample
collection tray.
If the sample
collection tray is
missing, replace it.
Follow the
instructions on the
Instrument Display
Panel to continue.
Shut-Car Error This message appears Look for the cause of the LUMINOMETER
on the IMMULITE jam (Test Units, a bent
Display Panel if an error shuttle flag, or a baffle
is detected and the that popped off the
IMMULITE is able to Luminometer chain).
correct itself.
Note: If the problem CARBACK
cannot be corrected, the
Instrument automatically MCARTST
shuts down and an error SHUTLOAD
has occurred. SHUTTLE
LUMCHN
Shut-Pos. Error Refer to the explanation Refer to the solution LUMINOMETER
above for the error above for the error
message: Shut-Car. message: Shut Car.
Error. Error.
CARBACK
SHUTLOAD
SHUTSPIN
SHUTTLE
LUMCHN
A main carousel error has This is a fatal error. The Check for anything LUMINOMETER
occurred. Instrument cannot that would interfere
function and with the shuttle
automatically shuts operation (i.e. bent

Diagnostics
down. shuttle flag). CARBACK
Repeat all tests
Note: All tests currently MCARTST
which were in
in progress are lost.
progress. LUMCHN
Steps Left Overflow The IMMULITE sent an N/A

invalid value for
calculating the amount
of reagent remaining.
Substrate Heater failure Substrate Heater did not Check cable connection LUMINOMETER
reach operating temp behind substrate heater.
(37° C) in allowed time.
Substrate Low Level of substrate in Replace substrate LUMINOMETER
reservoir has dropped bottle and press the
below fill-line. gray button on
substrate reservoir to
fill the reservoir to the
fill-line.
Replace substrate
spike.
Syringe A [B] Error A movement error in the Note: This message SYRINGE
Corrected large syringe (A) or the remains on the Display
small syringe (B) was Panel until it is replaced
Note: The error
detected. The message by another message.
message reads A or B.
will appear on the Check to see if a test
IMMULITE Display result was affected:
Panel if the IMMULITE the Test Unit will
was able to correct itself. appear as a white
Note: If the error was circle on the Primary
screen and a Record PRIME
not correctable, the
Instrument automatically Deleted, Pipetting APRIME
shuts down the front Error appears on the
end. An error message results printout. BPRIME
indicates this has Remove syringes and
occurred. run PRIME, APRIME,
and BPRIME.
Syringe communication Either: Check the ribbon SYRINGE

error cable to assure it is
The ribbon cable is
properly connected to
not properly
the board.
connected to the
If GO was pressed
board.
less than one minute
GO was pressed
after Start-up, do the
less than one minute

Diagnostics
after Start-up. The following: PRIME
small syringe then Turn the IMMULITE
fails to acknowledge power off for a APRIME
commands. minute, then on BPRIME
Note: The Test Unit again.
appears on the Wait for the syringes
screen as a white to move to the top of
circle. the plunger and
A hardware failure select RUN
occurred. IMMULITE or START
TURBO from the
Start-up menu.
If a hardware failure
occurred, the system
should correct itself.
Temperature controller The temperature CAUTION: Do not run N/A
failure controller failed. the IMMULITE until the
Instrument is serviced.
TEMPS
Temperature controller not The temperature Do not run the IMMULITE N/A
operating properly controller has failed. until the Instrument is
serviced
TEMPS
Test Unit lots do not match The Test Units being Re-run the Adjustors N/A
kit. Adjust aborted used do not match the using the correct Test
kit to be adjusted. Units.
Tip Jam Error. Are there Indicates that either: Depending on the cause
caps on the reagents? there is no sample either:
caps were left on the Check the sample
reagent volume. If
the probe is not necessary, add more
positioning correctly sample and re-run
the tests. TIPJAM
Remove cap(s) from
the reagent.
Watch the pipettor to
try and determine the
cause of the jam.
Turbo kits cannot be run Turbo reagent wedges Either:
while in Normal Mode. have been loaded onto Remove all Turbo
Please take all turbo kits the reagent carousel Reagent Wedges and
off the reagent carousel. while in Normal Mode. press GO to continue
running in Normal
mode.
Log off and choose
START TURBO to
run the Turbo kits.

Diagnostics
Valve A [B] Error A problem with the valve See Front End Shut
on the large (or small) Down error message.
Note: A or B appears,
syringe was detected. If
depending on the
the IMMULITE cannot
situation.
correct the error, the
front end will shut down.
Note: The tests in
progress will be
completed.
Warning: Part B reagent A sequential assay Replace the missing part
missing. Reagent Wedge is B reagent and press GO
Hit PAUSE to ignore or missing. to read the reagents.
GO to read reags.
X Home Error. Something has Do the following:

interfered with the probe Determine if anything
Note: This message
movement or a (e.g. probe tubing) is
appears on the IMMULITE
hardware error occurred. interfering with the
Display Panel and in the
If the system cannot pipettor movements.
daily Error Log.
correct itself, the Once the Test Units
Instrument automatically in process are
shuts down the front end finished, correct the
(pipetting and Load PROBTST
problem and restart
Chain indexing). An the IMMULITE. PIPXPOS
error message indicates
this occurred.
Note: The Instrument
will continue to process
tests currently in
progress.
X Pos. Error Refer to the explanation Refer to the solution for
for the error message: X the error message: X
Note: Appears on the
Home Error Home Error
IMMULITE Display Panel
and in the daily Error Log. PIPXPOS
Z Home Error Refer to the explanation Refer to the solution for

for the error message: X the error message: X
Note: Appears on the
Home Error Home Error
IMMULITE Display Panel
and in the daily Error Log. LEVSENSR

IMMULITE 1000
Error Number Problem Cause Solution

201 CV Calculation Error The software Explain to customer
encountered an that a valid CV could
unexpected value in the not be calculated.
database Review data with the
customer.
202 Standard Deviation Calculation The software Explain to customer

Error encountered an that a valid SD could
unexpected value in the not be calculated.
database Review data with the
customer.
300 LIS Error: Timeout During The LIS is not Check the cable
Receive responding to the connection.
IMMULITE 1000. This Review LIS log.
can be caused by:
A cable problem
A hardware
problem
An issue with the
LIS software
301 LIS Error: Invalid Frame Usually indicates an Review LIS log.
Number issue with the LIS
software; however, it
could be caused by a
bad message (e.g. due
to line noise, etc.).
302 LIS Error: Invalid Checksum Checksum did not Review LIS log.
match (transmission
error).
303 LIS Error: Missing Control Usually indicates an Review LIS log.
Character. issue with the LIS
software, but may be a
bad message (e.g., line
noise).
304 LIS Error: Invalid Message There are fewer than Review LIS log.
Length five characters in an
incoming ASTM
formatted data
message.
305 LIS Error: Invalid Frame The frame number is Review LIS log.
Sequence not sequential for an
incoming ASTM
formatted data
message.

306 LIS Error: No No communication Check LIS cable for
Acknowledgement from LIS between the IMMULITE secure connection.
1000 and the LIS. Review LIS log.
307 LIS Error: Timeout During The LIS is not Re-sort data in the
Send responding to the LIS worklist.
IMMULITE 1000. This Try resending the
can be caused by: data.
Review LIS log.
A cable problem
A hardware
problem
An issue with the
LIS software
308 LIS Error: Excessive LIS errors There are numerous Review LIS log.
are occurring LIS errors during a
session.
309 LIS Error: Log File Error There was an error Check the LIS
while writing to the Log settings.
File. Test the serial port
by trying a different
cable.
314 LIS Error: Header Message Either: Check the LIS

Not Received settings.
The Header
Compare with the
Message Password
LIS log.
is incorrect.
Test the serial port
OR by trying a different
There is no header cable.
message.
315 LIS Error: Patient Message Not A record required for Review LIS log.
Received LIS communications is
not found.
316 LIS Error: EOT received prior An LIS message was Review LIS log.
to ENQ received out of
sequence when
establishing a
communication session.
317 LIS Error: Invalid LIS Message An invalid message Review LIS log.
type code was
transmitted.
319 LIS Error: Cannot open Serial port is not Check the LIS
communication port. configured properly or settings.
not at all. Test the serial port
by trying a different
cable, or by
changing the port.

452 Unexpected error 452 – No Occurs when an Troubleshoot the
test input file. Call Technical underlying hardware test code being
Service error causes a software used.
communication issue.
453 Serial port already open. There has been a Check the ports and
communication error cable.
with the serial port.
454 Cannot open serial port. There has been a Check the ports and
communication error cable.
with the serial port.
455 Error in data send There has been a Check the Error Log.
communication error. Check the RS232
cable.
456 Error in data receive There has been a Check the Error Log.
communication error. Check the RS232
cable.
457 Error on Comm Event There has been a Check the Error Log.
communication error Check the RS232
cable.
458 Error in debug form. Occurs when an Consult with the SSI
underlying hardware team.
error causes a software
30000 Substrate Low Level of substrate in Check the substrate
reservoir has dropped volume.
below fill-line. Replace the
substrate bottle and
fill the reservoir.
Check the heater
connection.
Prime Substrate
using SOLE2S.
30001 Water and/or Probe Wash is Water and/or probe Re-fill container(s)
Empty. Re-fill container(s) and wash bottle is empty. and press GO on the
press GO. display panel.
30003 Reagent Pipetting Error. Either: Verify there is

Marking Test Unit as Bad sufficient reagent
Not enough reagent
available to
is available to
complete tests.
complete the test.
Check for bubbles
A level-sense error
on the surface of the
was encountered.
sample and reagent.
OR Verify component
A Test Unit and lots and check for
Reagent Wedge mismatch.
were mismatched.

30004 No Reagent Part xxx for Either: Verify correct Test
approaching xxx (assay) test Unit Lot
A Reagent Wedge
unit, lot xxx Verify reagent
is missing from the
wedge volume.
Reagent Carousel
Re-read the reagent
Tray.
carousel.
OR
The Reagent
Wedge and Test
Unit lot numbers
are mismatched.
30008 Shuttle Main Carousel Error The shuttle has not Look for the cause
found the sensor on the of the jam (Test
Main Carousel. Units, a bent Shuttle
flag, or a Baffle that
popped off the
Note: This message Luminometer.
will also appear on the Refer to the Main
Instrument display Carousel section on
panel when the error is page 209.
detected. A notice will
appear on the display
panel if the IMMULITE
1000 is able to correct
itself.
30009 Shuttle Position Error The shuttle has not Look for the cause
found the sensor at the of the jam (Test
Luminometer. Units, a bent Shuttle
flag, or a Baffle that
Note: This message popped off the
will also appear on the Luminometer.
Instrument display Refer to the Main
panel when the error is Carousel section on
detected. A notice will page 209.
itself.

30011 Main Carousel Error The Main Carousel has Refer to the Main
not found a position Carousel module
sensor. section on page 212
for instructions for
Note: This message MCARTST.
will also appear on the
Instrument display
panel when the error is
itself.
30012 Load Chain Error The Load Chain has not Look for the source
found a position sensor. of the error on the
Load Platform (i.e., a
sample cup
Note: This message incorrectly seated in
will also appear on the the sample cup
Instrument display holder or a crushed
panel when the error is Test Unit).
detected. A notice will Refer to the Load
appear on the display Platform section on
panel if the IMMULITE page 189.
itself.
30013 Pipettor Z-direction has Something has Determine if
jammed looking for Home interfered with the anything is
probe movement or a interfering with the
hardware error has Pipettor movements
occurred. (i.e., probe tubing)
Refer to the Pipettor
section on page 215.
Note: This message
Instrument display
itself.

30014 Pipettor X-direction has Refer to the explanation Determine if
jammed for Error Number anything is
30013. interfering with the
Pipettor movements
(i.e., probe tubing)
30015 Pipettor X-direction has Refer to the explanation Determine if
jammed looking for Home. for Error Number anything is
Pipettor movements
30016 Pipettor Z-direction has Refer to the explanation Determine if
jammed looking for Mid-Z. for Error Number anything is
Pipettor movements
30017 Level Sense Error The IMMULITE 1000 Run LEVSENSR
has not level-sensed (Reagent).
either the reagent or the Run LEVSENSS
sample. (Sample).
Check the Probe
Note: If five Level fitting.
Sense errors occur, the Wipe the probe shaft
IMMULITE 1000 goes with a DI moistened
into AutoPAUSE See pad.
also, Error Number
30044.
30018 Tip Jam Error Indicates that: Check the sample

volume (add more
There is no sample.
sample and re-run
Caps were left on
the tests).
the reagent.
Remove the caps
OR from the reagents.
The probe is not Determine where the
positioning Pipettor is jamming.
correctly. Run the Probe Angle
diagnostic to assure
probe integrity.
If the problem
persists, consult with
SSE.

30019 Large Syringe Error A movement error in Check and tighten
the large syringe was the syringe.
detected. Reseat syringe.
Change the syringe
Note: This message tip.
Instrument display
itself.
30020 Small Syringe Error A movement error in Check and tighten
the small syringe was the syringe.
detected. Reseat syringe.
Change the syringe
Note: This message tip.
Instrument display
itself.
30021 Reagent Carousel has jammed Reagent Carousel has Verify the Reagent
looking for Home. not found the Home Carousel is seated
Sensor. properly and nothing
is blocking the
sensor beneath the
Note: This message Carousel Tray.
will also appear on the Check the bottom of
Instrument display the Carousel Tray
panel when the error is for a bent tab.
detected. A notice will If bent, the
appear on the display Reagent Carousel
panel if the IMMULITE must be replaced.
1000 is able to correct Consult with
itself.
Field Service.
Run REAGENTH
and REAGENTP.

30022 Reagent Carousel has Reagent Carousel has Verify the wedges
jammed. not found a position are seated properly.
sensor. Check for an
obstruction.
Note: This message

Instrument display
itself.
30023 Luminometer Chain Error – If this error occurs, the Refer to the
Tests currently running may be Luminometer Chain has Luminometer section
invalid. Call Technical Service jammed and may be on page 199.
mis-positioned. Tests Consult with Field
on the Main Carousel Service.
are valid.
30024 High Speed Spinner Error Spinner has If a single occurrence:
malfunctioned. Check the label on
Note: As a result of this the affected Test
error, tubes may not Unit (may be caused
have been washed by a loose label).
properly. If multiple occurrences:
Run WASHSPD.
Consult with Field
Service.
30025 Attenuator Disk has jammed Attenuator Disk has not Consult with Field
looking for Home. found the Home Service.
Sensor. Run ATTEN.
Note: This message

Instrument display
itself.

30026 Attenuator Disk has jammed Attenuator Disk has not Consult with Field
looking for position. found a position sensor. Service.
Run ATTEN.
Note: This message

Instrument display
itself.
30027 No Sample Cup available for A bad barcode read Check the barcode.
Test Unit occurred for the tube Verify the number is
just before the Test Unit test units is not
(which may or may not greater than five.
be a sample cup). Check the integrity
of the barcode label.
There are more than Rerun using a
five Test Units behind a different sample cup
sample cup. holder.
There is no sample cup
in front of the Test Unit.
30028 Sample Collection Tray Full or The sample collection Replace Sample
Absent. tray is full or missing. Collection Tray.
Empty Sample
Collection Tray.
Lift and reseat the
Sample Collection
Tray.
Verify that nothing is
blocking the senor
below the tray
30029 Display Panel Communication Display Panel failure Check the cables.
Error Consult with Field
Service.
30032 No Reagent found for (test There is no Reagent Check for
name) xxx test unit after the Wedge on board component
Barcode Reader. matching the Test Unit mismatch.
just read at the Barcode Check Test Unit Lot.
Reader. Re-index the
Reagent Carousel.
The current Reagent
Wedge has Zero Tests
Remaining (the
Instrument will go into
Auto PAUSE mode).

30034 Main Carousel Indexing Error. Main Carousel has mis- Consult with Field
Instrument has shut down. positioned and missed Service.
Call Technical Service. one of its home Run MCARTST.
sensors. Check for proper
shutdown.
Note: All previously Refer to the Main
resulted tests are valid. Carousel section on
All tests on board are page 209.
invalid.
30035 Large Syringe Valve Error A problem with the Reseat the Macro
valve on the Large Valve.
Syringe was detected. Run the PRIME
diagnostic.
Note: This message Consult with Field
will also appear on the Service.
Instrument display
detected. A notice will Note: This error only
appear on the display posts for Hamilton
panel if the IMMULITE dilutors.
itself.
30036 Small Syringe Valve Error A problem with the Reseat the Micro
valve on the Small Valve.
Syringe was detected. Run the PRIME
diagnostic.
Consult with Field
Note: This message Service.
Instrument display
Note: This error only
posts for Hamilton
dilutors.
itself.
30037 Syringe Communication Error Either: Inspect the
Syringes.
GO was pressed on
Reseat if needed.
the Instrument less
Run PRIME.
than one minute
after Start-up. The
small pipettor
syringe then fails to
acknowledge
commands.
OR
A hardware failure
occurred.
30038 Substrate Heater Failure The Substrate Heater Check connections.
did not reach operating Consult with Field
temperature of 37° C in Service.
allowed time.

30040 Front End Shutdown has Load Chain, Pipettor, Allow tests to
occurred. Instrument will Syringes and Reagent complete.
attempt to complete tests in Carousel have shut Check error log.
progress on Main Carousel down due to a jam in Check for physical
and in the Luminometer one of the following obstruction (e.g.,
Assays requiring additional areas: Load Chain, Z- pipettor, load chain
reagent will be lost. pipettor, X-pipettor, areas)
Main Carousel,
Reagent Carousel or
Syringe Pumps.
Note: If possible, the
Instrument will attempt
to complete tests
currently in progress on
the Main Carousel and
Luminometer Assays
requiring additional
reagent will be lost.
30041 Main Carousel Shut Down. Main Carousel has Allow tests in the
Instrument will attempt to jammed or the pipettor Luminometer to
complete tests in the is stuck in the pipetting complete.
Luminometer. Call Technical position on the Main Check error log.
Service. Carousel. This error Check for
often occurs because a obstruction (e.g.,
sample cup is on the sample cup on Main
Main Carousel. Carouse)l
Refer to the Main
Note: This error will Carousel section on
always occur in page 209.
conjunction with Error
Number 30040.
30042 Fatal Shuttle Error. Instrument The Shuttle is not Tests in progress
has shut down. Call Technical reaching one of its are lost.
Services. positions. The Remove test units.
Instrument cannot Check error log.
complete tests. Check for
obstructions.
Refer to the Shuttle
30043 Luminometer Chain Error or Luminometer Chain or Tests in progress
Attenuator Disk Error. Attenuator Disk jam. are lost.
Instrument has shut down. Remove test units.
Call Technical Services. Check error log.
Check for
obstructions.
Refer to the
Luminometer section
on page 199.
Consult Field
Service.

30044 Five Level Sense Errors The Instrument will go Verify sufficient
encountered – Entering Pause into AutoPAUSE mode sample and reagent
Mode if Error Number 30017 volumes.
occurs five times within Check and secure
a run. the Probe fitting.
30045 Communication Error – The correct lot Re-read the
Reagent Transmit information could not be reagents.
transmitted to the Confirm component
IMMULITE 1000. lots.
30046 Temperature Controller Failure The temperature Check status of

– Invalid Results. Software controller failed due to Temperature LEDs.
program will now shut down. either: Refer to the
Call Technical Service. Temperatures
A brief power
outage
Consult with Field
OR Service.
A hardware failure
30053 Logged onto "Run IMMULITE" RUN IMMULITE was For informational
- Operator selected from the purposes only.
Startup screen. The Result of normal
software starts in operation.
Standard mode.
30054 Logged onto "Run Turbo" - Run Turbo was For informational
Operator selected from the purposes only.
Startup screen. The Result of normal
software starts in Turbo operation.
mode.
30055 Logged Off LOG OFF was For informational
selected. purposes only.
Result of normal
operation.
30057 Communication Error. The computer and the Restart computer.
Simulation screen may not be IMMULITE 1000 were Consult with Field
correct. Call Technical not communicating for Service.
Service. more than 32 cycles.
Some of the data was
Old = xxx New = xxx.
not received; therefore,
reports will be missing.
30058 Software is Running in Either: Do not add any new
Recovery Mode! Test in tests while in
The software has
progress will result. Please recovery mode.
crashed.
remove and replace reagent Verify the correct
OR mode.
carousel prior to loading
additional tests. There has been a Allow the tests in
power outage to the progress are
computer. complete.

30059 Heaters have shut down prior The Luminometer or Check status of
to start-up. Main Carousel heating Temperature LEDs.
is not working properly Refer to the
because of a possible Temperatures
power failure, a heater section on page 283.
controller error or Consult with Field
thermistor failure. Service.
30060 Heaters have shut down due to The 35-degree Check status of
35-degree calibrator error. calibration resistor Temperature LEDs.
cannot be read properly (Refer to the
due to a heater Temperatures
controller error. section on page
283)
Power down for at
least one minute.
Check LEDs again.
30061 Heaters have shut down due to The 39-degree Check status of
39-degree calibrator error. calibration resistor Temperature LEDs.
cannot be read properly Power down for at
due to a heater least one minute.
controller error. Check LEDs again.
30064 Heaters have shut down due to Reagent cooling is not Verify the fan below
a Reagent Carousel working properly the Reagent
temperature error. because of a TED error Carousel is
or a thermistor failure. functioning.
Check status of
Temperature LEDs.
Refer to the
Temperatures
Power down for at
least one minute.
Check LEDs again.
30065 Heaters have shut down due to The Main Carousel Verify the fan below
a Main Carousel temperature heater is not working the Reagent
error. correctly because of a Carousel is
heater controller error functioning.
or a thermistor failure. Check status of
Temperature LEDs.
Refer to the
Temperatures
Power down for at
least one minute.
Check LEDs again.

30066 Heaters have shut down due to The Luminometer Verify the fan below
a Luminometer temperature heating is not working the Reagent
error. properly because of a Carousel is
heater controller error functioning.
or a thermistor failure. Check status of
Temperature LEDs.
Refer to the
Temperatures
Power down for at
least one minute.
Check LEDs again.
30069 Cannot establish The Instrument was not Verify Instrument is
Communication with the in Idle mode while in Idle mode.
IMMULITE – Consult switching from standard Try switching modes
Operator’s Manual or On-line to turbo or vice versa. (verify mode).
Help Check for line noise.
30070 Computer Cannot This message occurs in Verify Instrument is

Communicate with the Diagnostics. The in Idle mode.
Instrument. Instrument was not in Repeat the action
Idle mode while that caused the
downloading a error.
diagnostic program.
30072 Software will not load after The PC attempted 3 Verify Instrument is
three attempts. times to communicate in Idle mode.
and the IMMULITE Repeat the action
1000 did not respond. that caused the
error.
Check the cable.
Consult Field
Service.
30073 IMMULITE 1000 Buffer Empty Communication Error. Power down.
Timeout. Call Technical If the error reoccurs,
Service. consult Field
Service.
30076 File.lst or Stat.lst file is Corrupted files. Restore previous
missing. Call Technical backup.
Service. Consult with Field
Service.
30078 The file to be downloaded is Files required for Restore previous
missing. Call Technical Instrument operation backup.
Service. are missing. Consult with Field
Service.
30079 The configuration file is The configuration file to Is the modem line
missing. Call Technical be downloaded is available to dial in?
Service. missing. Consult with Field
Service.

30080 Multiple configuration files Duplicate configuration Cannot run until
exist. Call Technical Services. files are present. extra config files are
removed.
Note: This message Is the modem
should not be available to dial in?
encountered if the Consult with Field
computer has been Service.
30081 Attenuation Factor is out of The attenuation factor Verify CAF factor in
range. Call Technical Service. was not set. kits.
Consult with Field
should not be
encountered if the
computer has been
30082 PMT Multiplier is out of range. The PMT is out of Verify PMT factor in
Call Technical Service range. kits.
Consult with Field
should not be
encountered if the
computer has been
30083 There were no files list in xxx No files are listed in Consult with Field
(file name) either the .1st directory Service.
or the stat.1st directory. May correct w/
Restore.
30100 Unexpected error 30100. Call Occurs when an Check the Error Log.
Technical Service. underlying hardware Consult with Field
error causes a software Service.
Technical Service underlying hardware Consult with Field
30102 Kit not found. The kit parameters Verify that the
were overwritten with operator did not
those of another kit delete a kit that is
after pipetting. currently running.
Rescan the kit.
Reread reagents.
May need to rerun
tests.

30110 Adjustor algorithm for test not Database error Cross reference kit
found – xxx (assay name). occurred. parameters with the
kit release.
30111 Kit Information Deleted. Kit information was Verify that the
Master Curve not available. deleted. operator did not
delete a kit that is
currently running.
Rescan the kit.
Reread reagents.
May need to rerun
tests.
30115 Test Unit Lots do not match kit. The Test Units being Troubleshoot for
used do not match the mismatching kit
kit to be adjusted. components.
30116 Either High or Low Adjustor The second adjustor is Re-run both
level missing. Adjustment not on board the adjustors.
Aborted. Instrument.
30117 Adjustor Record not found in The result file could not Verify the kit is
Database be found. scanned.
Verify kit barcode
information.
30120 Low CPS, Sample #xxx (test Refer to pages 11-10 Use CPS to
name) xxx and 11-11. troubleshoot (e.g.,
Calc Errors).

30121 Adjustment does not meet After dropping an Check CV criteria
acceptance criteria. adjustor replicate, the Sandwich:
Adjustment Aborted. CVs are still outside Low adj < 15%
specifications. High adj < 10%
Note: This error can Competitive:
only be encountered Low adj < 10%
during the adjustment High adj < 10%
process. Check for bubbles in
the sample and
reagent.
Rerun the
adjustment.
30124 Manual Dilution Not Allowed. Manual dilution is not Onboard dilution
allowed on this assay. required.
Verify the diluent
wedge is onboard.
Verify the proper
dilution procedure is
being used, i.e.,
correct sequence,
dilution cup holder.
30130 High and Low Adjustors Sample cups were Result of normal
Reversed. Slope and Intercept identified as low and operation.
Recalculated – xxx (assay high, but either the Adjustor materials
name). levels dispensed into were reversed in
the cups were in the sample cups.
reverse order or only Validate adjustment
one level was run for as usual.
both samples.
30131 Adjustment Complete A kit adjustment has For informational
completed on the purposes only.
Instrument. Result of normal
operation.
30140 Dark Count High xxx The dark count Check the error log.
measured exceeds the For multiple
maximum acceptable occurrences, consult
limit (300 CPS). with Field Service.
For a single
Note: The preceding occurrence, rerun
sample may have had the test.
very high CPS.

30141 No place to put answer Database error Check the record.
Was the record
deleted?
30142 Calculation Error. Unable to The IMMULITE 1000 Review CPS for
calculate result for test xxx. encountered an error results.
while calculating test Is this a single
results. This error may occurrence or
be caused by the multiple assays?
following: Check the water
volume.
A hardware error Check for bubbles in
occurred. the syringes.
Invalid parameters or kit
barcodes.
Note: This is an
infrequent error when
the master curve
parameters are correct
and the IMMULITE
1000 is running
properly.
30143 Calculation Error during A calculation error Review CPS.
Adjustment. Adjustment occurred during Check the water
aborted. adjustment. volume.
Check for bubbles in
the syringes.
30144 ***SEQNUMBEROVERWRITE The software attempted Get files, e.g., DB,
to overwrite a sample error log.
record with a previously Consult with TS
assigned sequence Software
number. Investigations.
30145 Dark Count High results Dark counts exceed Check CPS for
invalid. Call Technical Service. acceptable high previous test unit.
number. Results are For multiple
invalid. occurrences, check
dark counts (from
the System Status
menu)
30146 FATAL CURVE ADJUST Kit information is Re-scan the kit
ERROR – Assay information incorrect in the barcode.
incorrect in Kit Database xxx database. Enter barcode info
(assay name) xxx (kit lot) manually.
Readjust the kit.
30150 Dilution not allowed for this On-board dilution of this Dilution must be
assay or sample type assay or sample is not performed manually.
allowed.
30151 Dilution Required Dilution is required for Re-run tests using
this assay. on-board dilution
sequence.
Need diluent wedge
and dilution cup
holder.

30789 Report Writer Error. Report An unexpected error Attempt to reprint
cannot be printed. occurred while the the report.
IMMULITE 1000
software was
attempting to print a
report.
30800 Edit Chartable Report Error. An unexpected error Verify Instrument is
Cannot open Report for editing occurred while the not printing at the
IMMULITE 1000 time of editing.
software was Attempt to edit the
attempting to open a report again.
chartable report.
30801 Report error. An unexpected error Attempt to reprint
occurred while the the report.
IMMULITE 1000
software was
attempting to print a
report.
31200 Unexpected error 31200. Call Occurs when an Review the Event
Technical Service. underlying hardware Log and
error causes a software troubleshoot
communication issue. accordingly.
Consult with Field
Service.
31201 Turbo kits cannot be run while Turbo Reagent Wedges Verify the Instrument
in RUN IMMULITE mode. have been loaded onto is in Standard mode.
Please remove all Turbo kits the Reagent Carousel
from the Reagent Carousel. while in Standard
mode.
31202 IMMULITE kits cannot be run Non-Turbo Reagent Verify the Instrument
while in Turbo mode. Please Wedges have been is in Turbo mode.
remove all IMMULITE Kits loaded onto the
from the Reagent Carousel. Reagent Carousel while
in Turbo Mode
31203 No Sample Cup for Test Unit Either: Check the event log
for bad barcode
A bad barcode read reads.
occurred for the tube Verify a sample cup
just before the Test Unit was in front of the
(which may or may not Test Unit.
be a sample cup). Refer to the Sample
OR and Test Unit
Barcode Reader
There is no sample cup section on page 247.
in front of the Test Unit.
31204 Mechanical Pipetting Error Mechanical Pipettor Check the event log
Jam. for errors.

31205 No Sample Pipetted. Sample No sample was pipetted Verify sufficient
# xxx (test name) xxx. because an error was sample volume is
detected. The error being used and re-
may be: run the test.
Hardware related
Due to insufficient
sample
Note: If any other error
message accompanies
this one, it is a
hardware problem.
31206 No Reagent Pipetted A tip jam has occurred Verify the reagent
during pipetting. volume.
Check the error log
A false level sense has for associated
occurred. errors.
Not enough reagent is Refer to the Pipettor
left to continue testing. section on page 215.
Error Number 31222
will also occur.
It is a hardware-related
error (as indicated on
the Instrument Display
Panel).
31207 Unexpected error 31207. Call Occurs when an Review the event log
Technical Service. underlying hardware and troubleshoot
error causes a software accordingly.
communication issue. Consult with Field
Service.
31208 Assay not found An assay is not in the Verify the software
volume table. version.
Upgrade to the
current version if
necessary.
31209 Kit Component Mismatch. Occurs when an Verify that the
Repeat failed adjustor level. underlying hardware correct tests units
error causes a software were used.
communication issue. Rerun the
adjustment.
Service.

31211 Test Unit limit has been The allowable number Re-run test(s) with
exceeded of test units has been the acceptable limit
exceeded. of test units.
Note: A maximum of 5
Test Units can follow a
sample cup for a normal
run. A maximum of 4
Test Units can follow a
dilution cup.
31212 Tip Jam in dilution cup Indicates that: Verify the correct
cup insert is used.
There was an error Check the event log.
creating the dilution in Check the Pipettor.
the previous cycle. Refer to the Pipettor
There is no sample cup section on page 215.
in the dilution cup
holder.
OR
The probe is not
positioning correctly.
31213 Dilution is not allowed for xxx. An on-board dilution Re-run assay
was requested for an performing a manual
assay that does not dilution.
allow dilution on board.
31214 Dilution not made for xxx. An on-board dilution Replace the diluent
was requested and a wedge.
diluent wedge not on-
board.
31215 Improper placement of dilution Cups are out of Re-run in proper
cup on Load Chain (Sequence: sequence. sequence.
Sample Cup, Dilution Cup, Note: Dilutions must be
Space, Assay, Assay, Assay, run as follows: Sample
Assay). Cup, Dilution Cup,
Empty Space, Up to four
Test Units.
31216 BAD BARCODE. LAST The error may be Check the event log.
Sample Cup read: xxx caused by one or more Verify the sample
of the following: integrity of the
barcode on the
Torn, wrinkled or dirty sample cup holder.
barcode labels, which Refer to the Sample
cause Test Units not to and Test Unit
spin smoothly. Barcode Reader
Dirty Barcode Reader section on page 247.
O-rings.
Barcode Reader speed
is off in one or all
positions.

31217 No Diluent for approaching xxx Either: Verify the diluent
(assay name) wedge is onboard.
A Diluent Wedge is Verify that the
missing from the wedge is not empty.
Reagent Carousel Tray.
Note: The Diluent
OR Wedge must be
replaced within five
The Diluent Wedge and
minutes or this test
Test Unit lot numbers result is lost.
are mismatched.
communication error. Consult with Field
Service.
31219 Does not match any reagent. Occurs during pipetting Verify the correct
when the proper reagent lot is on
reagent is not on-board board.
or if the probe tip jams Check the event log.
on a reagent lid.
31220 Reagent Level Sense Error Probe level senses Check for cap on
above the maximum Reagent Wedge or
height of liquid. bubbles on top of
reagent.
Check the reagent
volume.
Service.
31222 Reagent Volume Low or Empty The volume in a Replace Reagent
Reagent Wedge is low Wedge.
or empty. Note: Error will start
posting when there are
Error Number 31206
10 tests left in the
will also occur.
wedge.
31224 No Reagent Wedge Found for Occurs when the proper Verify reagent
Assay. regent wedge for an wedge lot number.
assay is not on-board
the Instrument or if
there was an error
reading the barcode for
that reagent.
31225 Expired Kit An expired kit was Verify kit expiration
scanned. date.

31226 Adjustment Overdue Kit adjustment is Readjust kit.
overdue. Check kit release (it
may have been
modified).
Check for important
notice.
31227 Kit Never Adjusted Adjustors for kit were Adjust the kit.
never run.
31230 Five Replicates detected for More than the required No action is
adjustor level. Fifth Replicate four Test Units were run necessary.
dropped. behind the adjustor
sample cup.
31231 Less than 4 replicates This error can be Re-run the failed
detected. Repeat failed caused by: adjustor level.
adjustor level. Check for a ghost,
A record or one of the bad barcode reads,
adjustor replicates was or pipettor errors.
deleted because of a Check the event log.
pipetting error.
An insufficient number
of replicates were
loaded.
31232 Kit Components not matched. This error can be Verify the
Repeat failed adjustor level. caused by the following: component lot
numbers using the
Test Unit lot numbers Kit screen.
are not the same for all
the adjustor replicates.
The Test Codes behind
an adjustor sample cup
are not all the same
(i.e. not all TSH
replicates).
Different Reagent
Wedge lots were
pipetted throughout the
two adjustor levels (this
occurs if two kits share
common test unit lots).
The kit was adjusted
using the incorrect kit
components.
31233 Communication Error: Control side is not in Allow the run to
Simulation Screen may not be sync with User side. complete.
correct. Call Technical Service. Log off and log back
on.

31234 Sample or Dilution Cup on The software has Allow tests in the
Main Carousel. detected that a sample Luminometer to
or dilution cup has complete.
entered the Main Run CARBACK to
Carousel. remove the cup.
Run EMPTYTUB
31235 Replicate error at pipetting One of the adjustor Repeat the adjustor
position. Repeat failed sample replicates has level.
adjustor level. failed due to a pipetting Verify there is
error. This adjustor sufficient volume.
sample will not result. Verify that the
correct A and B
adjustors were
ordered (not 2 As or
2 Bs)
31237 Dilution Code – Sample Cup A dilution cup passed For informational
the barcode reader. purposes only.
31238 Sample cup number A sample cup passed For informational

the barcode reader. purposes only.
31250 Reagent Temperature High The Reagent Carousel If just powering up

xxx° C. temperature is above the system, you
22° C. must wait 45
minutes for the
system to reach
optimal
temperatures.
Remove the
Reagent Carousel
and check for fluid.
Verify the LED
sequence (See the
Temperatures on
page 243 section.)
Check the fans.
Power off, on and
monitor.
Consult with Field
Service.
31251 Ambient Temperature High The internal ambient air Check lab
xxx° C. temperature reading is temperature.
higher than the
acceptable range.
Note: This is not a fatal

error condition.

31252 Ambient Electrical The ambient electronics Clean intake fan
Temperature High xxx° C. temperature reading is filter on the right side
higher than the of the IMMULITE
acceptable range. 1000.
If the problem
persists, consult with
Note: This is not a fatal Field Service.
error condition.
31253 Luminometer Temperature The temperature View Temperatures
HIGH! reading for the (in Tools)
Luminometer is above Check the ambient
the acceptable range. lab temperature.
Check status of
Temperature LEDs.
Refer to the
Temperatures
Run the TEMPS
diagnostic.
Consult with Field
Service.
31254 Luminometer Temperature The temperature View Temperatures
LOW! reading for the (in Tools)
Luminometer is below Check the ambient
the acceptable range. lab temperature.
Check status of
Temperature LEDs.
Refer to the
Temperatures
Run the TEMPS
diagnostic.
Consult with Field
Service.
31255 Main Carousel Temperature The Incubation View Temperatures

HIGH! Carousel temperature is (in Tools)
above the acceptable Check the ambient
range. lab temperature.
Check status of
Temperature LEDs.
Refer to the
Temperatures
Run the TEMPS
diagnostic.
Consult with Field
Service.

31256 Main Carousel Temperature The Incubation Check the
LOW! Carousel temperature is Temperatures (in
below the acceptable Tools)
range. Check the ambient
lab temperature.
Check status of
Temperature LEDs.
Refer to the
Temperatures
Run the TEMPS
diagnostic.
Consult with Field
Service.
31260 Cannot Calculate Last An invalid value was Check the
Temperature. Delta Error received for a Temperatures (in
Encountered. temperature reading Tools)
because of a Shutdown the
temperature controller Instrument for 1-2
error or failure. minutes.
Turn on the
Instrument.
Run the TEMPS
diagnostic to
monitor.
Consult with Field
Service.
31261 Cannot Calculate Average An invalid value was Check the
Temperature due to Error. received for a Temperatures (in
temperature reading Tools)
Turn on the
Instrument.
Run the TEMPS
diagnostic to
monitor.
Consult with Field
Service.
31262 Cannot calculate Luminometer An invalid value was Check the
temperature due to error. received for a Temperatures (in
temperature reading Tools)
because of a hardware Shutdown the
failure. Instrument for 1-2
minutes.
Turn on the
Instrument.
Run the TEMPS
diagnostic to
monitor.
Consult with Field
Service.

31263 Cannot Calculate Main An invalid value was Check the
Carousel Temperature due to received for a Temperatures (in
error. temperature reading Tools)
Turn on the
Instrument.
Run the TEMPS
diagnostic to
monitor.
Consult with Field
Service.
31264 Communication Error: Invalid There has been a Investigate and
Sample Number communication error resolve the
between the Instrument communication
and the PC. Results for issue.
this sample will not Rerun the test.
post.
Service.
31410 Error occurred while importing There is an issue with Re-import the
worklist – Duplicate key an imported worklist. worklist.
Consult with Field
Service.
31420 LIS Error: LIS In Session Occurs when the Send Send/re-send again.
or Re-send button is
pressed in the LIS Data
Management screen
while the PC is
communicating with the
LIS.
31421 LIS Error: No Results Selected Tagged records are not Tag the record.
found in the database. Send/resend.
31422 LIS Error: LIS Unavailable The LIS is not Check the Event
responding to the Log.
IMMULITE 1000. This Check the LIS cable.
can be caused by: Verify the LIS is
active.
A cable problem
A hardware problem
An issue with the LIS
software

31423 LIS Error: Terminator Code There is a terminator Activate the LIS
Error code error. diagnostic
(Configurations).
Log off to activate
the change.
Duplicate the
problem.
Transfer and review
the LIS log.
See LIS
Troubleshooting on
page 184 for more
information.
31424 LIS Error: LIS Terminator Code The terminator code is Activate the LIS
Invalid invalid. diagnostic
(Configurations).
Log off to activate
the change.
Duplicate the
problem.
Transfer and review
the LIS log.
See LIS
Troubleshooting on
page 184 for more
information.
31425 LIS Error: Password Error Occurs when the Activate the LIS
Header Message diagnostic
Password is incorrect. (Configurations).
Log off to activate
the change.
Duplicate the
problem.
Transfer and review
the LIS log.
See LIS
Troubleshooting on
page 184 for more
information.
31426 LIS Error: Sender ID Error Occurs when the Activate the LIS
Receiver ID is incorrect. diagnostic
(Configurations).
Log off to activate
the change.
Duplicate the
problem.
Transfer and review
the LIS log.
See LIS
Troubleshooting on
page 184 for more
information.

31427 LIS Error: Receiver ID Error The Receiver ID sent Activate the LIS
from the LIS does not diagnostic
match the Sender ID (Configurations).
specified in the Log off to activate
IMMULITE LIS the change.
configuration. Duplicate the
problem.
Transfer and review
the LIS log.
See LIS
Troubleshooting on
page 184 for more
information.
31428 LIS Error: Patient ID Missing The LIS is missing a Activate the LIS
patient ID. diagnostic
(Configurations).
Log off to activate
the change.
Duplicate the
problem.
Transfer and review
the LIS log.
See LIS
Troubleshooting on
page 184 for more
information.
31429 LIS Error: Patient ID exceeded The Patient ID has Activate the LIS
20 characters. exceeded the allowable diagnostic
number of characters. (Configurations).
Log off to activate
the change.
Duplicate the
problem.
Transfer and review
the LIS log.
See LIS
Troubleshooting on
page 184 for more
information.
31430 LIS Error: Accession Number The accession number Activate the LIS
Missing. is missing. diagnostic
(Configurations).
Log off to activate
the change.
Duplicate the
problem.
Transfer and review
the LIS log.
See LIS
Troubleshooting on
page 184 for more
information.

31431 LIS Error: Accession Number The accession number Verify that the
exceeded 20 characters. has exceeded the accession number is
allowable number of less than 20
characters. characters.
31433 LIS Error: No Control Record Control information is Enter control

Found not in the database. information on the
Control Entry tab on
the Worklist screen.
Re-download the
control sample from
the LIS.
31435 LIS Error: Invalid Control Data Control data is in an Activate the LIS
invalid format. diagnostic
(Configurations).
Log off to activate
the change.
Duplicate the
problem.
Transfer and review
the LIS log.
See LIS
Troubleshooting on
page 184 for more
information.
31437 LIS Error: LIS Unavailable in Occurs when an Cannot run the
Test Mode. underlying hardware or Instrument in Test
configuration error mode.
causes a software Run LIVE mode
communication issue. (must be done by
the LIS provider).
31438 LIS Error: Unsuccessful Send Communication Error Attempt to re-send
results.
If the issue persists,
review the LIS log.
See LIS
Troubleshooting on
page 184 for more
information.
Technical Service. underlying hardware or and troubleshoot
configuration error accordingly.
causes a software Consult with Field
communication issue. Service.

31440 LIS Error: Query Failure The LIS encountered Initiate another
an error when query to the LIS.
processing the Check the LIS
IMMULITE 1000’s settings in
request for information. Configurations and
verify the mode.
If the issue persists,
review the LIS log.
See LIS
Troubleshooting on
page 184 for more
information.
31500 Data Export Error An error occurred Attempt to export
during data export. again.
Data will not export as Check for database
expected. errors.
31510 Form reagent error An unexpected error Select reagents on

occurred while the the Home screen.
software was displaying Re-read the
the Reagent screen. reagents.
31511 Print Error. The software has Check the printer.

encountered an Reprint.
unexpected error while
printing.
31520 LIS Error: Query IMMULITE 1000 LIS Check the LIS
Communication Error software is not configurations.
responding. LIS
Configuration
parameters may have
changed.
31530 Unexpected Error 31530. Call While calculating an Review the event log
Technical Service. adjustment, the and troubleshoot
software has accordingly.
encountered an Consult with Field
unexpected error. Service.

31590 LIS Error 31590. Call The software has Attempt to resend.
Technical Service. encountered an Transfer and Review
unexpected error during the LIS Log.
LIS Send, Resend or See LIS
Auto-send processing. Troubleshooting on
page 184 for more
information.
31591 LIS Error 31591. Call The software has Transfer and Review
Technical Service. encountered an the LIS Log.
unexpected an See LIS
unexpected error during Troubleshooting on
LIS Order Match page 184 for more
processing. information.
31600 Form Home error An unexpected error Refresh the Home

occurred while the screen (Move to a
software was displaying different screen then
the Home screen. back to Home).
31700 Batch Print Error An unexpected error Reprint the batch.

occurred while the
software was
attempting to print
reports with the Batch
Print utility.
31800 Software error during An unexpected error Manually review the
automated QC rule evaluation. occurred while the QC results or rerun
Control run for the following software was QC.
test requires manual review: performing an
automated QC
evaluation.
31801 Control run has failed One or more control Result of normal
automated QC single rule results have failed operation.
evaluation. Following test is automated QC Single Follow lab protocol
out of control: Rule evaluation. regarding out of
control QC.
31802 Control run has failed One or more control Result of normal
automated QC multirule results have failed operation.
evaluation. Following test is automated QC Multi Follow lab protocol
out of control: Rule evaluation. regarding out of
control QC.
31803 Too few control results for A control run completed Re-run the correct
automated QC multirule with fewer than the number of controls
evaluation. Control run for configured number of for the specified test.
following test requires manual required results for
review: automated QC Multi
Rule evaluation.
31804 Too many control results for A control run completed Re-run the correct
automated QC multirule with more than the number of controls
evaluation. Control run for configured number of for the specified test.
following tests requires manual required results for
review: automated QC Multi
Rule evaluation.

31805 Automated QC turned on for Verify that the lab
the following test: wants Automated
QC for this assay.
Review multi-rule
setup.
31806 Automated QC turned off for Explain that
the following test: automated multi-rule
was turned off.
31807 Automated QC evaluation type Multi-rule
changed for the following test: configurations were
changed.
Review changes
with the operator.
31810 Unexpected Error 31810. Call An unexpected error Refresh the Control
Technical Services. occurred while the Entry screen by
software was displaying moving to a different
the Control Entry screen, then back to
screen. Control Entry.
31900 Unexpected Error 31900. Call An unexpected error Refresh the Kits
Technical Services. occurred while the screen by moving to
software was displaying a different screen,
the Kits screen. then back to Kits.

HARDWARE
Computer Input/Output Views..........................................................................................130
IMMULITE Computer Input/Output Views .....................................................................130
IMMULITE 1000 Computer Input/Output Views ............................................................134
Hand-Held Laser Scanner Symbologies .........................................................................135
IMMULITE/IMMULITE 1000 Laser Scanner Programming ...........................................136
PSC Laser Scanner.......................................................................................................136
PC Communication ...........................................................................................................139
IMMULITE PC Communication Errors...........................................................................139
IMMULITE 1000 PC Communication Errors..................................................................140
Power..................................................................................................................................141
Power Issues .................................................................................................................141
Printers ...............................................................................................................................142
OKIDATA Microline .......................................................................................................142
Epson (Model LX-300)...................................................................................................143
Citizen (Model GSX190)................................................................................................143
OKIDATA B4200/B4250 ................................................................................................143

COMPUTER INPUT/OUTPUT VIEWS
IMMULITE Computer Input/Output Views

The following pages contain photos of the IMMULITE computer's input and output panels
(back panel). The configurations and positions of the jacks are different depending on the
brand and model of the computer. Currently, there are a variety of brands and models in the
field.
Compaq Deskpro

Compaq Proline A 4/33S
IBM 300 GL

Linden Group Newer Computer
IBM 433/DP

Linden Group

IMMULITE 1000 Computer Input/Output Views
Note: The phone line is incorrectly connected to the network port (connector to the right of
trackball). The external modem that comes with the Instrument must be connected to the
phone line. Then connect the modem with the power and communications RS 232 cables
that are supplied. The Remote Diagnostics port next to the LIS port should also be used.

HAND-HELD LASER SCANNER SYMBOLOGIES
By default, the following symbologies are enabled for IMMULITE/IMMULITE 1000 hand-held
laser scanners:
• EAN/JAN (8 or 13) digit
• UPC with 2 or 5 Digit Supplement disabled
• Code 39
• Code 128
The following symbologies can be enabled by scanning the appropriate code in the
symbology section of the PSC User's Guide for the Handheld Laser Scanner:
• Interleave 2 of 5
• Standard 2 of 5
• UPC A
• UPC E
• Code 93
• Codabar
• Code 11
• MSI/Plessy
Note: The hand-held scanner can be programmed at any screen in the software.

IMMULITE/IMMULITE 1000 Laser Scanner Programming
PSC Laser Scanner

Follow these steps to program the IMMULITE/IMMULITE 1000 PSC Laser Scanner:
Note: Verify that the scanner is on and active by ensuring that the yellow light on the back of
the scanner is lit. When the laser is on, the green light illuminates to indicate a successful
scan.
The following sounds occur after successful scans of the barcodes below:
• Steps 1 through 3: A low beep followed by a high chirp
• Steps 4 though 7: A low beep
• Step 7: A low beep for the first five scans and a high chirp on the last scan.
Note: The barcode labels shown below were generated through barcode software.
Reproduction through copying or faxing should not be performed.
1. Scan the "Wedge Mode Enable" barcode (Hex Equivalent is CE):

(Page 62 of old Bar Code manual, "REV.B"; page 46 of new Bar code manual, "REV.B-
2/97")
2. Scan the "Reset to Default" barcode (Hex Equivalent is ZA):

(Page 63 of old Bar Code manual, "REV.B"; page 46 of new Bar Code manual, "REV.B-
2/97")
3. Scan the "PC-AT, PS/2 and 50/60/80" barcode (Hex Equivalent is CF):
2/97")

4. Scan the "Enter Postamble" barcode (Hex Equivalent is LB):
2/97")
5. Scan the "Postamble 1" barcode (Hex Equivalent is 0):
6. Scan the "Postamble 2" barcode (Hex Equivalent is D):
7. Scan the "Postamble 3" barcode six times (Hex Equivalent is 0):
8. IMMULITE Only: Scan the "Confirmation" barcode and verify "01234567" appears. Exit
to DOS. At the DOS prompt, scan in the confirmation barcode. An error "Bad command
or file name" will post. This is normal since DOS does not know what to do with this
information.
Welsh Allyn Scanner

If necessary, reset the scanner by scanning in two barcodes:
• a 'Factory Default Settings' compatible barcode
• an additional 'Add CR (carriage return) suffix' setting command.
These barcodes are also found in the manufacturer's Operator Manual page 11-1 (Rev. D
manual), or on page 12-1 (Rev. E manual).
The following Instruments need to be reset:
• K4575 through K4755.

For all systems beyond this number range, the firmware correction is set before shipping.

PC COMMUNICATION
IMMULITE PC Communication Errors

Common Causes
Note: If the error is self-correcting, the following will display:

• "PC IMMULITE COMM FAILURE. Check your cable connections now. Resuming
normal operation in 15 seconds."
The common causes of PC Communications Errors are:
• Paper jam during a run.
• Printer is off-line, paused, or off.
• Electrical noise in the lines because the Instrument is close to other large equipment (i.e.,
refrigerators, centrifuges etc.).
• Cable connections are loose
• The Instrument is plugged into an outlet with another electrical device. Verify that the
IMMULITE is plugged into its own separate dedicated outlet.
• The database is too large. See Reducing the Size of a Database on page 168 for more
information.
• Drop-down menu is open on the Primary screen when tests are resulting at the PMT.
Select [Esc] to close the menu.
If a PC Comm error occurs and the screen freezes (won't respond to the keyboard):
1. Press CTL+ALT+DEL to escape out of the software (soft boot).
Note: If the software does not respond, turn off the computer by holding the on/off switch
for 10 seconds to reset the computer.
2. Exit to DOS
3. Type FIXIT. FIXIT will delete open demographic records (all tests with open records
must be repeated.)
4. Type PC (standard mode) or PCSTAT (for turbo mode).
5. Answer the usual start-up questions
6. If you get "Cannot communicate with Immulite, Do you wish to continue?" answer Y for
yes.
7. At the end of the run, reprint the records.
8. Log off.
9. Download Standard or Turbo mode.
There is a 50/50 chance to save the run. After logging back onto the primary screen, have
the operator search in PATIENT ENTRY (press F1) for sample cup that is onboard.
• If they see "Assay in Progress", at least some of the results were salvaged.

• If they see "Record Not Found", the run is gone.
Saving the run depends on where the database was broken. They may lose tests between
the time of the PC Comm error and logging back onto the Primary screen. Time is the critical
factor in this case. The chances of losing the run are greater when you reboot the system.
Operators may be kicked out to DOS in the middle of a run. Attempt to salvage the run by
running in PC or PCSTAT as described in steps 4-6 above. Although this may not work,
always attempt it.
Note: PC mode is a simulation and the primary screen will NOT reflect the actual position of
the samples on the system. Also, while in the PC mode, operators should finish their current
run only and not load any new samples on the system. Once the samples in progress result,
log off, restart the software, and run any remaining samples.
Error 88
• Usually occurs when scanning in a kit (the kit must be rescanned).
• If the software automatically reverts to DOS during a run and the message "Error 88"
appears on the computer monitor, the database is broken.
• Performing FIXIT should correct the problem.
• However, the error is "fatal," i.e., the run is almost always lost.
• If FIXIT does not resolve the error, consult with Field Service.
IMMULITE 1000 PC Communication Errors

If RUN IMMULITE or RUN TURBO was selected immediately after exiting Diagnostics,
ghost records or other software issues may occur (i.e., PC Communication errors).
To avoid these issues:
1. Exit diagnostics.
2. Select SHUTDOWN from the Startup screen to return to the Desktop.
3. Ensure IDLE appears on the Instrument Display Panel.
4. Double-click the IMMULITE 1000 icon.
5. Select RUN IMMULITE or RUN TURBO.
6. Verify that the files download during initialization.

POWER
Power Issues
Ask the following questions if a customer has a problem with power:
• Is a UPS or line conditioner being used?
• Were there any power glitches/electrical storms/lights flicker?
• Is the Instrument plugged in?
• Are any LED lights on? Which ones? Also check the four LEDs in the electronics area
and also the Sample Barcode Reader and Reagent Barcode Reader.
• If the Instrument Display Panel is blank after downloading the software and following the
prompts, check the rainbow-colored ribbon cable connections in back of the display
panel.
• If the LED lights on the back of the Instrument are not illuminated, a fuse may have
blown.
Troubleshooting Fuses
Use the following guidelines to determine if a fuse is blown.
Note: Perform common troubleshooting before changing fuses.
The PC Indicates a Problem Communicating with the IMMULITE
• The fuse for the IC logic power supply (F2) is blown.
• The IC logic power supply is defective.
No Motors Are Moving, nor Is the Main Cooling Fan Moving
• The fuse for the heater/motor power supply (F3) is blown.
• The heater/motor power supply is defective.
The CPS of the Test Units Are Zero
• The fuse for the PMT power supply (F1) is blown.
• The PMT power supply is defective.
The Fans Are Not Moving and the F4/F5 LED is off
• Replace the F4/F5 fuse.
• The F5 fuse is only used internationally.
No Power from All of the Individual Supplies
• Main input fuse is blown.
• The input filters/fuse holder is defective.
• The Instrument's power cord is defective.
• The power switch is defective.
• The UPS (if available) may be off, defective, or needs to be charged or reset.

PRINTERS
OKIDATA Microline
Note: The OKIDATA Microline manual is available in Troubleshooter.
Front Panel
Descriptions of Front Panel Lights
LED Status, Function

On: Printer is on line
Off: Printer is off line
Flashing: Flashes with ALARM light to indicate a fault has been
detected
On, SELECT is off: Out of paper
On, SELECT is flashing: Auto diagnostics detected an error
Flashing, SELECT is on: Printer is overheated. Normal print
operation will resume after the printer cools.
On: Printer is on.
Off: Printer is off.
Indicates which character pitch in characters per inch (cpi) is

engaged.
Indicates which print mode is engaged.

NLG = Near letter quality
UTILITY = Draft mode.
HSD = High speed draft mode, or SSD (super speed draft) if 12
cpi is selected.

Epson (Model LX-300)
Be certain the printer is not in PAUSE. PC communication errors occur if the printer is
paused. Press "pause" again and results will print.
Problem: The printer starts printing double-spaced lines. Restore to single space by
changing the Auto Line Feed feature on the printer:
• Turn off the printer.
• While holding the FONT button, turn on the printer.
• Current language settings are printed (release the FONT button when the printing starts).
• Press LF/FF to keep the language in English and prints the table of current settings.
• Press LF/FF again to enter the settings table.
• Look at FONT light 1, FONT light 2, and the Pause light (these indicate the status of a
setting).
• Press the FONT button until three lights show the following display: blinking, blinking, off.
• Press the Pause button to show the current condition of this setting (all three lights are
probably on, which indicates this feature is armed).
• Turn off this feature by pressing the FONT button so that all three lights go out.
• Turn off the printer to save settings.
Citizen (Model GSX190)

If the printer is off-line while results or error messages are trying to be sent, you will get PC
communication errors.
OKIDATA B4200/B4250
• Jams can be caused by improper paper size or paper thickness. Thin paper provides
optimal performance.
• Ensure the top cover of the printer is closed.
• If the jam light is flashing or printer rollers are continuously turning, the printer buffer may
be full. Turn off the printer and disconnect the wide data and power cables. Delete ALL
print jobs from the Windows print buffer. Plug the cables back into the printer and turn on
the printer. Print a test page.
• The jam light can also be caused by "low paper". The paper tray has a tab on the rear
that pushes the paper against the front of the tray. There is a paper sensor at the front
end of the tray. If paper does not touch this sensor, the printer does not acknowledge
that the printer tray is full.
• Other jams can be solved by resetting the toner count. See Resetting Toner Sequence
on page 144.
• If jam light persists, the printer may require a new printer toner cartridge.

• Ensure the rear tray is fully seated. Instruct the customer to pull the tray up, and push it
back down until a solid click is heard.
• The last case scenario is to ship a new printer. Discuss this last option with TSS before
proceeding.
Note: If the account has an HP printer, they must continue with HP upgrades. Sending an
Okidata will require a service visit for fuse retrofit.
Resetting Toner Sequence

The procedure for resetting toner sequence is used if the printer mistakenly perceives that
the toner cartridge is low. The following procedure can fool the printer into thinking a new
toner was installed:
1. Turn off printer.
2. Open the front (top) cover
3. Hold down the button near the LEDs, i.e., the button with two dashes ( // ).
4. While holding down the // button, turn on the printer. Lights should blink on and off for
about six seconds. If the jam light is no longer lit, the printer jam is not related to a low
toner problem. This requires further diagnosis.
5. While continuing to hold down the // button, turn off the printer.
6. Close the cover, and turn on the printer.

IMMULITE 1000 SOFTWARE
Start Menu Options ...........................................................................................................146
Backup Agent ................................................................................................................146
Batch Printing Results ...................................................................................................147
Event Viewer .................................................................................................................148
Export Data....................................................................................................................149
IMMULITE 1000 Executable..........................................................................................149
Kit Configurations ..........................................................................................................149
QC Graph ......................................................................................................................150
Common Procedures ........................................................................................................151
Finding the Current Software Version ...........................................................................151
Locating and Restoring Backups...................................................................................151
Locating Database Files ................................................................................................152
Recovery Mode Procedure............................................................................................153
Restarting the Software after Running Diagnostics.......................................................154
VB (Visual Basic) Errors ................................................................................................154

START MENU OPTIONS
• If the Instrument software is running, press the ALT and TAB buttons simultaneously to
access the Start menu.
• Click the Start button and highlight IMMULITE 1000 to access the Backup Agent, Batch
Print Results, Event Viewer, Export Data, IMMULITE 1000 software, Kits, and QC
Graphs.
Backup Agent
The Backup Agent is used to backup records, configure the amount of time records are
retained in the database, and set the number of backups to keep on file.
1. Select the Start button at the lower left corner of the screen.
Note: If the Instrument software is running, press the ALT and TAB buttons
simultaneously to access the Start menu.
2. Select IMMULITE 1000, then select Backup Agent.
3. Select the Settings tab to configure the Backup Agent.

The factory settings are as follows:
Patients: 62 days (max = 999)
Controls, Adjustors, and Verifiers: 366 days (max = 999)
Messages: 10 days (max = 999)
Errors/Events: 90 days (max = 999)
Maximum Backups: 5
4. To change the default values, enter the Days to Retain Records in the Database in the
Patients or Controls, Adjustors, or Verifiers fields.
5. Enter the number of backups to save on the hard drive in the Maximum Backups field.
6. Select SAVE to accept the changes or CANCEL to cancel the changes.
7. Select EXIT to close the Backup Agent and return to the Windows desktop.
Note: Some patient data will be deleted from the database (depending on the number of
days that are saved) when the next automatic backup occurs at log off.
Batch Printing Results

To access the Batch Print screen, perform the following:
2. Select IMMULITE 1000, then Batch Print Results.

3. Select the DATE AND TIME button to choose a date range.
4. Select a sample type (patients, controls, adjustors, verifiers) in the Result Type field.
5. Select the PRINT button. A prompt displays the number of selected samples to print.
6. Select the OK button at the prompt. The results will print in the format (long or short) that
was configured on the Report Settings page in the Configurations window.
Note: If no results meet the selection criteria, No samples match selection
criteria displays.
Event Viewer
2. Select IMMULITE 1000, then Event Viewer.
The historic error log by default is set to save 90 days of events.
Detailed errors can be accessed by double-clicking the Normal option. The password
is C1RRUS.

Export Data
2. Select IMMULITE 1000, then Export Results.
Note: Alternatively, results can be exported while running the IMMULITE 1000 software.
Under System Status, select EXPORT RESULTS and follow steps 3 through 8 below.
3. Select DATE AND TIME.

4. Choose the Data Type (All, Patient, Adjustor, Control Verifier).
5. Select the Export Method (Screen, File, Printer).
6. Choose to sort the data by selecting PATIENT NAME or ACCESSION #.
7. Select a Field Delimiter.
Tab: separates the data with labs
Comma: separates the data with commas
8. Select the Perform Export button to start the data export.
IMMULITE 1000 Executable

2. Select IMMULITE 1000, then IMMULITE 1000 to launch the software.
Kit Configurations

2. Select IMMULITE 1000, then Kits.
3. The password is KITS. Choose one of the following options:
Configurations: For PMT and CAF factors.
Kit Parameters
Test Parameters: To change assay and max ranges.
Test Parameters
• To customize reportable units, modify the Alternate Units and Multiplier for Alternate
Units fields.
• To customize the reportable range, modify the Assay Min and Assay Max fields, which
define the calibration range of the assay.
• The User Assay Low and the User Assay High default to the Assay Min and Assay
Max.
Note: Changing the Assay Min or Assay Max constitutes off label use.
QC Graph
2. Select IMMULITE 1000, then QC Graph to access the Levey-Jennings graphs without
entering the running software.

COMMON PROCEDURES
Finding the Current Software Version

There are three ways to find the current IMMULITE 1000 software version.
1. From the HELP menu, select About.
2. The software version is displayed on the Startup screen.

3. The software version is in the installation log. Follow the procedure below to access this
file:
a. Right-click the Start button.
b. Select Explore.
c. Locate and double-click the IMMULITE 1000 file folder.
d. Double-click the Logs sub-folder.
e. Open the DPCInstall.log file.
f. Scroll to the end to find the current software version.
g. Verify that the installation was successful and complete.
Locating and Restoring Backups

Locating Backup Archives
1. Right-click the Start button.
2. Select Explore.

3. Navigate to C:\IMMULITE 1000\Backup\Retains.
Restoring from a Backup

Any new data from the date of the backup to the current date will be lost during restoration.
2. Select Explore.
3. Navigate to C:\IMMULITE 1000\Backup\Retains.
4. Select and copy the backup file to be used.

5. Paste the backup into C:\Immulite 1000\databases.
6. Rename the current Immulite1k.mdb to OldImmulite1K.mdb.
7. Rename the backup to Immulite1k.mdb.
8. Go into RUN mode to verify the functionality.
Note: If this does not resolve the error condition, consult with Field Service. There may be
an issue with the language database file. If this is the case, Language.mdb will have to
copied and renamed using the procedure above.
Locating Database Files

2. Select Explore.

3. Navigate to C:\IMMULITE 1000\Backup\Databases.
4. Locate the Errorlog.mdb and Immulite1K.mdb files.
Locating the LIS Log

2. Select Explore.
3. Navigate to C:\IMMULITE 1000\Logs.
Recovery Mode Procedure

• Available in case the IMMULITE 1000 software unexpectedly closes and returns to the
Windows desktop.
• Allows the operator to re-start the IMMULITE 1000 software.
• Tests in-progress will continue until completed.
• Software shutdowns may occur due to communication errors or Windows 2000 operating
software errors.
• If a software shutdown occurs, the Instrument will remain in RUN mode.
Instructions
1. Press the PAUSE button on the Instrument Display Panel.
2. Double-click the IMMULITE 1000 icon on the Windows desktop to display the Start-up
screen.
3. Select RUN IMMULITE or RUN TURBO, as applicable.
4. Select the OK button. A white message box will appear immediately with Event Number
30058: "Software is running in Recovery mode. Tests in progress will result. Please
remove and replace reagent carousel prior to loading additional tests."
5. Press the GO button on the display panel to re-read the Reagent Carousel. Although test
units in progress will not display on the Home screen, they will complete and produce
valid results. The results will be visible in the scrolling result box on the Home screen,
and will automatically print.
IMPORTANT: Do not add any new samples while in Recovery mode.

6. Once tests are in progress, log off the software and return to the desktop.
8. Select RUN IMMULITE or RUN TURBO to initialize the software.
Restarting the Software after Running Diagnostics

Always restart the IMMULITE 1000 software after running diagnostics.
1. Exit to the desktop.
3. Select Run IMMULITE or Run Turbo.
Note: Failure to exit to the desktop may cause PC Comm Errors.
VB (Visual Basic) Errors

In rare occurrences, VB errors may occur.
• Document all of the details surrounding the error, (e.g., current screen,
commands/functions being performed by the operator, software version, etc.)
• Contact Software.
• If a software investigation is needed, copy and transfer the following files which are
located in C:\Immulite 1000\Databases:
Immulite1K.mdb
Errorlog.mdb

IMMULITE SOFTWARE
DOS Program Descriptions ..............................................................................................156
BACKDAT......................................................................................................................156
EXPORT........................................................................................................................156
GETDATAT ...................................................................................................................156
KITS (For Internal Use Only) .........................................................................................157
PC and PCSTAT ...........................................................................................................161
STATUS ........................................................................................................................162
WATER..........................................................................................................................163
IMMULITE Database Procedures .....................................................................................165
Repairing a Database....................................................................................................165
Checking the Size of a Database ..................................................................................167
Reducing the Size of a Database ..................................................................................168
Reinstalling a Database.................................................................................................168
Additional IMMULITE Software Information....................................................................170
BACKUP........................................................................................................................170
Date Time Conflict .........................................................................................................170
Deleting Records ...........................................................................................................170
Error 88..........................................................................................................................171
Software Not Responding/Freeze .................................................................................171
Common IMMULITE Software Procedures......................................................................172
Control Entry..................................................................................................................172
Editing Records .............................................................................................................172
Long Report Format ......................................................................................................173
Printing Screens or Reports ..........................................................................................174
Searching for Records...................................................................................................174

DOS PROGRAM DESCRIPTIONS
BACKDAT
• BACKDAT must be performed before the daily backup.
• This feature allows the customer to copy the patient database and troubleshooting
messages to a floppy disk.
Instructions
1. To copy a database, exit to DOS.
2. Insert a new formatted floppy disk into the drive.
3. Type BACKDAT.
EXPORT
• This program allows the operator to view, print, or archive data to a floppy disk for
troubleshooting or report consolidation purposes.
• Patient, adjustors, and calibration verification data is retained by the database for 31
days.
• Control data is retained for six months.
Instructions
1. From the Start-Up menu, select EXIT TO DOS.
2. Type EXPORT and press [Enter].
3. Enter any three characters to name the file or press [Enter].
4. Select the start and end dates and times for data collection. Remember, only 31 calendar
days of data is in the database.
Select the test type (or press [Enter] to default to ALL) and the type of data to be
viewed (or press [Enter] to default to ALL).
You can print all data types at once by selecting ALL, or print each one individually
(Two or three data types cannot be selected at once).
5. A box appears, summarizing your choices. Print the data, send the information to the
display, or export it to a disk in drive a or b (drive c is not recommended).
6. Once data is generated, answer Y or N to "Do you wish to continue getting data from this
file?" If no, type START at the DOS prompt and press [Enter].
7. Open the data in Excel (or other spreadsheet programs) on a PC that is not connected to
the IMMULITE.
Note: If a customer wishes to store data for future reference, export monthly to a floppy.
GETDATAT
• Data collection program used to obtain raw CPS data from the Luminometer.

Note: This program must be started after the diagnostic program was loaded and before
the tube is read by the PMT.
Instructions
1. After the diagnostic program begins running (after pressing GO on the IMMULITE), press
[Esc].
2. From the Start-up menu, select EXIT TO DOS.
3. Type getdatat and press [Enter]. A menu appears.
4. Press [P] to turn on the printer (if a printout is needed).
Note: Make sure the printer is on-line, not in pause, and loaded with paper.
5. Press [S] to "collect and store" the data.
6. Respond to the next three questions by pressing [Enter] after each. Name the file for
future reference (optional).
7. Once all counts print, stop the IMMULITE by pressing ALARM MUTE+GO on the
IMMULITE Display Panel.
8. Press [Esc] and then [Q] to quit the data collection program.
KITS (For Internal Use Only)

IMPORTANT: The KITS program is for internal use only. Any changes should be made by
a TSR. If a TSR is unavailable, consult with a Tech Service Supervisor before changing any
information in this area. Document any changes in clientele.
• The KITS program is used to enter assay and kit lot specific information into the
software.
• It is also where the CAF, PMT factor, and dark count limits are entered for that
Instrument.
Instructions
To access the Kits program, follow the steps below:
1. From the Start-Up menu, select Exit to DOS.
2. At the prompt type KITS.
3. Enter KITS at the password prompt.
IMPORTANT: Do not share this password with customers unless management approval
was obtained.

The Kits menu screen is then displayed:
KIT PARAMS
• The parameters represent the lot information, curve parameters, and most current
adjustment information.
• The Conc. Low and Conc. High fields provide the actual dose for the low and high
adjustor.
• Use the PAGE UP and PAGE DOWN keys to scroll through the kits. The kits included in
this menu reflect the assays and kit lots currently scanned in by the operator.

QUICK KITS
• QUICK Kits is a summary of the lot numbers and curve parameters for a kit lot. Use
PAGE UP and PAGE DOWN to scroll through the entered kit lots:

TEST PARAMS (Test Parameters)
Note: Changes made to the KITS screen will be overwritten when the software is upgraded.
When changes are made, use F10 or the Print Screen key to print a copy of the screen for
future reference.
Descriptions of Fields in Test Parameters
• Number of test and Name of test
• DPC's Default units: the default and alternate units, including the report multiplier.
The Units Being Reported field is below DPC's Default Units.
Note: If units are used that are not available in the software, the multiplier factor should
be changed accordingly.
• Days between Curve Adjust: adjustment frequency
• Lower bound for answer and Upper bound for answer: Reportable range for that
assay. Fields can be edited by the customer provided they validate.
Note: Any change to the KITS screen is off-label and not supported by DPC. Inform the TSR
and follow the Tech Service Guidelines for reporting this change.
• User assay low and User assay high: patient reference ranges. These values default to
the lower bound for answer and upper bound for answer. Customers can change these
values in Start-Up Menu/Configurations/Assay Settings, and would not have to access
KITS to do so.
• Sig Digits 1=TSH 2=Other: the number of places to the right of the decimal place.
The following fields are defined in the kit barcode and should not be changed.
• Reagent1 Volume in ul's, Reagent2 Volume in ul's, Reagent3 Volume in ul's

• Formula: assay format and the equation used to define the stored master curve.
• Color Number: the color key listed at the bottom of the page and reflects the color
assigned to that assay.
• Number of Reagents used for the assay are listed.
• Low Adjustor CV Limit and High Adjustor CV Limit: the limits the software will use
after an adjustment when comparing the 4 adjustor replicates.
Sandwich assays: Low adj CV < 15% & High adj CV < 10%
Competitive assays: Low/High adj assays < 10%
ATTEN FACTOR
• The Kits menu screen is displayed, as shown below:
• This value is determined, entered, and verified by manufacturing personnel. If you

access this screen, you must re-type the factor in before exiting. Be certain to enter the
correct factor so as not to affect sample results.
MULT. PMT
• The PMT multiplier is entered in this screen.
• This value is determined, entered, and verified by manufacturing personnel. If you

access this screen, you must re-enter the factor before exiting. Be certain to enter the
correct factor so as not to affect sample results.
DARKLIMIT
• The PMT dark limit is entered in the DARK LIMIT screen:
• The current limit for all Instruments is 300.
PC and PCSTAT
• The PC program must be used to retrieve information from certain diagnostic programs
(e.g., results from the Barcode Reader).
• PC is also used to test the database.

• The PC program allows access to a "simulated primary screen" for diagnostic purposes.
• This screen is not to be used for running actual tests, except in Recovery mode.
• The PCSTAT program should not be used except for the rare circumstance listed in the
following note.
Note: Communication may be lost ("PC Communication Failure") during a run.
If the IMMULITE is still running normally, the PC program may be used to allow the run in
progress to complete. If a TURBO chemistry run is in progress, the user must use the
PCSTAT program. Care must be taken to use the correct program (PC or PCSTAT)
depending on the assay run in progress. Otherwise the display and indexing of the
Instrument motions may be incorrect and "mis-matched."
Instructions
1. Determine if the Instrument is in Standard or Turbo mode.
2. After the diagnostic program begins running (after pressing GO on the IMMULITE), press
[Esc].
3. From the Start-up menu, select EXIT TO DOS.
4. Type pc or pcstat and press [Enter].
Note: If "Database needs repair" appears on the monitor, see Repairing a Database on
page 165 for more information.
5. Respond to the questions displayed by pressing [Enter] three times.
6. When the following message appears:
Cannot communicate with the IMMULITE.
Continue running? Y/N
7. Choose [Y] for yes.
Note: Test units will no longer be viewed on the simulation screen in PC mode.
8. To exit, select Log Off and Log Off System.
Note: Do not place new tests on the Instrument until all tests have completed in PC
mode. The operator must log off of the running software and then download Run
IMMULITE again. Then add new tests. Reprint any records AFTER the run is complete,
and before logging off of PC or PCSTAT mode.
STATUS
• This is the cumulative error log beginning with the first use of the IMMULITE.
• If the database is replaced, the error log will not include any errors before the
replacement date.
Viewing the Cumulative Error Log
1. From the Startup menu, exit to DOS.
2. Type Status and press <Enter>.
3. Press Page Up or Page Down to view errors.

4. To get the most current data, press CTRL and Page Down.
Printing the Cumulative Error Log
Note: Since the status log can be quite large, printing the entire log is not recommended.
1. Use CTRL + Page Down to get the most current data.
2. Use the up and down arrow keys to go to the first line to be printed.
3. Press F4.
4. Use the arrow keys to highlight data and press F3 to print the marked sections.
5. Selecting F4 again will de-select the area.
Note: The status log also contains slopes and intercepts for all adjustments.
WATER
• WATER is the data collection program for WATERTPM and WATERTST.
• WATER can be used to print data, but not to save it.
• This program subtracts the substrate blank reading from each test unit and takes into
account the PMT factor.
• Divide the substrate alone CPS by the PMT multiplier to get the actual CPS.
• GETDATAT provides the actual CPS since it doesn't take the PMT multiplier into
account. In addition, GETDATAT saves the data for FSE access.
Instructions
1. Verify that the printer is powered on and on-line. Tests will not run if the printer is off or
paused.
2. Once WATERTST or WATERTPM is loaded in the diagnostics menu and the test units
start moving, press [Esc] and exit to DOS.
3. At the DOS prompt, type WATER and press [ENTER]. A box will post. Select Watertst
or Watertpm.
Note: This must be done within 10 minutes of starting the program. Otherwise, the test
must be repeated because the data will be lost.
4. A "Waiting for data" message appears and results post in about 10 minutes.
5. Once the readings complete and print, press [Esc] to exit to DOS and START to return
to the IMMULITE Start-Up menu.
Interpretation of Data
The guidelines for acceptable water tests are listed below.
1. For all water tests, the cps for each Test Unit should be:
> 4,500 cps and < 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
For either outcome, perform the test again to confirm the results.
If the cps is consistently outside the 4,500 cps to 9,000 cps range, call Technical
Service.
1. For WATERTST, refer to the last line printed with 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. It could also be pH related.
Check pH (if possible). If the value of XXX above is above 2000 cps, DO NOT use this
water source on the system. Find a new water source and test this new source.
CAUTION: If this water source was used, the system must be decontaminated.
2. For WATERTPM, refer to the last two lines printed with results:
Probe Water – Substrate Only = XXX cps
Pump Water – Substrate Only = XXX cps
If the value of XXX for either equation 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. Visually check all test units to determine if the liquid level is equally
distributed between 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
Service.

IMMULITE DATABASE PROCEDURES
Repairing a Database
Ask the client these questions before repairing a database:
• Was there a power outage?
• Is the printer on?
• Was the IMMULITE improperly shut down?
• Is there a recurring software error of any kind?
• Find the software version above the Start-up Menu options.
In the event of a database error, perform the following steps in order, and consult Field
Service when prompted. Always follow the first five steps after a database error.
1. FIXIT: This program attempts to repair the database.

a. Choose Exit to DOS from the Start-up Menu.
b. At the <C:\CIRRUS\IMM> prompt, type FIXIT and press <Enter>.
c. If the program does not complete, consult Field Service.
d. If the program is successful, proceed to Step 2. When complete, the message "repair
successful" appears.
2. CHKDSK: This is an older version of SCANDISK, a utility that detects and repairs hard
drive errors. Run after FIXIT.
a. At the <C:\CIRRUS\IMM> prompt, type CHKDSK and press <Enter>.
b. Note if any files are damaged.
c. Type CHKDSK/F to fix any errors.
d. If Field Service suggests performing a SCANDISK, proceed to Step 3; otherwise,
continue to Step 4.
3. SCANDISK: This utility detects and repairs hard drive errors.

a. At the <C:\CIRRUS\IMM> prompt, type SCANDISK. (The initial scan takes a few
seconds.)
b. The following message appears: "ScanDisk has finished testing the file structure of
drive C...Do you want to perform a surface scan now?"
c. Select YES by toggling the arrow keys and pressing <Enter>.
d. Watch the scan until three rows of highlighted clusters appear at the top of the screen
(approximately 20% complete).
e. Select Exit.

Note: Consult Field Service if any clusters appear with a "B" in the box (these are bad
clusters). The message "Scandisk did not finish examining drive C" appears.
f. Select VIEW LOG to see results of the scan. If desired, save the results by following
the prompts.
g. If no problems are detected, choose EXIT.
h. Proceed to Step 4.
Note: If problems are detected, consult Field Service.
4. DEFRAG/F: This program condenses the data on the hard drive for maximum efficiency
and performance. The program takes seconds to complete.
a. At the <C:\CIRRUS\IMM> prompt, type DEFRAG/F.
b. C: drive will be highlighted. Press <Enter>.
c. When finished, the program returns to <C:\CIRRUS\IMM>. If a bad command or file
name error appears, verify what the client typed.
d. Proceed to Step 5.
Note: Although this is rare, the client may have an older version of DOS that does not
contain this utility.
5. PC: This is the fastest way to test the software. The PC program is a parallel program to
the running IMMULITE software. See PC and PC Stat on page 161 for more information.
a. Type PC and press <Enter>.
b. Answer the questions by pressing <Enter> three times.
c. Answer "Continue Running?" by pressing Y for yes.
d. If the PC program allows entry into the Primary screen, select LOG OFF, LOG OFF
SYSTEM, and type START at the <C:\CIRRUS\IMM> prompt. The Start-up Menu
appears.
e. Download Run Immulite (the running software). If no errors occur during this step, the
client may return to running.
Note: You can not run in PC mode when testing the integrity of the database. Not all the
files are downloaded in PC mode.
If the error continues:
6. FIXDB: This program enables the IMMULITE to use the copy of the main database that
is generated every time the operator logs off the Instrument.
a. If an error occurs while in PC mode or in the Run Immulite program, exit to DOS.
b. Type FIXDB, and press <Enter>. The message "Copy Complete" appears, and you
will be returned to the <C:\CIRRUS\IMM> prompt.

c. Proceed to Step 5 and run PC.
d. If no errors occur, proceed to the Start-up menu and select RUN IMMULITE.
If the error continues:
7. RESTORE: This program restores the database.

Note: Perform this procedure only if the errors began a day or two ago. Any errors that
have occurred for days or weeks will be on the backup disk. Proceed to the database
replacement procedure.
a. If an error occurs after FIXDB, ask the operator to perform the Restore function from
the last valid backup.
b. Perform the Export function in DOS. (Any data from the date of the last backup until
today must be printed out through Export.)
c. Perform the Restore function from the Start-up Menu.
d. Proceed to Step 5 to test the software.
8. If an error occurs after performing the Restore function, consult a Field Service Specialist
for assistance while reinstalling the database.
Checking the Size of a Database

A large database can slow the software, generate software errors, and produce the need for
more than one floppy disk per backup procedure. Perform the following procedure to check
the database size:
1. Exit to DOS.
2. Type KITS at the <C:\CIRRUS\IMM> prompt.
3. Password KITS.
4. Type a small letter e to exit this directory.
5. Enter the PC directory.
6. Type: DIR_*.ism (Replace the underscore with a blank space before continuing).
7. Press Enter to view the following databases:
CNF
Dbase
QC list
8. Write down the number beside each database and consult Field Service.
9. If Field Service suggests reducing the size of the database, continue to the next section.
Note: If multiple config (.CNF) tables exist, consult with Field Service to delete.

Reducing the Size of a Database
Consult a Field Service Specialist before continuing with this procedure.
1. Exit to DOS.
2. At the <C:\CIRRUS\IMM> prompt, type DATE and set the date two weeks ahead of
today's date.
3. Type START to exit.
4. Backup the database See BACKUP on page 170.
5. Exit to DOS.
6. At the <C:\CIRRUS\IMM> prompt, type DATE and re-set the date to today's date.
7. Follow the procedure for Checking the Database Size on page 167 before continuing.
8. Consult Field Service regarding the databases.
9. If the databases are small enough, perform a DEFRAG/F.
Reinstalling a Database
Software Version 4.13 can be used to reinstall a database. The configuration table is not
affected by a reinstallation.
IMPORTANT: The account must be informed that the following information will be deleted
when reinstalling a database. If the account has a lot of assays, consider sending a TSR
since all kits must be rescanned and readjusted.
Since the following information will be deleted, the account should print it before reinstalling
a database.
• All QC data (EXPORT may be used)
• Ranges for all QC materials (Start-up Menu, QC)
• All reference ranges and units on all assays (Start-up Menu, Configurations, Assay
Settings)
• Attenuation Factor (CAF), Multi PMT factors (DOS, KITS, Password KITS, type in factor
number to exit screens. Record the factor number for CAF and PMT.)
• LIS configuration information (Start-up Menu, LIS Parameters, password CONNECT)
• Report format for long reports (Start-up Menu, Configurations, report Format)
Instructions
Follow the procedure below to reinstall a database using software version 4.13:
Note: ALWAYS consult Field Service before beginning.
1. Put Disk #1 into the disk drive.
2. Type A:Install_A_New (Replace the underscores with blank spaces before continuing).
Note: There should not be a space between A: and Install.
3. Press <Enter>. The program will alert you that existing data will be erased.

4. Enter Y to proceed.
5. Insert Disk #2 when requested.
6. Moving forward, use a new disk when performing backups.

ADDITIONAL IMMULITE SOFTWARE INFORMATION
BACKUP
This program removes all patient, adjustor and control data older than 31 calendar days and
compresses the database.
• Ask the client to choose Backup from the Start-up menu.
• The following files are saved on a floppy disk: error log, patient database, QC database,
and configuration files.
• The most efficient method of performing backup is to utilize two floppy disks, one for
every other day. This ensures at least one good backup disk in case the database is
corrupted.
Perform the following procedure if a "fatal error" occurs during the backup procedure:
• Exit to DOS, type PC, and press Enter three times. The Primary screen appears.
If there were no errors during this process:
1. Log off.
2. Type START at the <C:\CIRRUS\IMM> prompt.
3. Select RUN IMMULITE.
4. Answer the questions.
5. Log off.
6. Perform a Backup onto a new disk. (Save the old backup disk and label as such.)
If there were errors during this process, exit to DOS and do the following:.
• FIXIT
• CHKDSK
• SCANDISK
• DEFRAG/F
• Perform a backup onto a new disk.
• If additional problems occur, consult Field Service.
Date Time Conflict

• Date/time conflict can occur if the date is set earlier than the date of the last resulted
specimen.
• If a customer is experiencing a date/time conflict, consult with Field Service for the proper
course of action. Each situation is handled on a case by case basis.
Deleting Records
• Records will automatically be deleted if an associated result is not posted before
midnight.

• Upon log-off, if there are records that have no answers, the following prompt appears:
"Do you want to delete records without answers?" Answering Yes will delete those
records.
• If an error was made when identifying a sample cup, the record can be edited but not
deleted until either log-off, or midnight, as described above. There is no other way to
delete records.
Error 88
• Usually occurs when scanning in a kit (the kit must be rescanned).
• If the software automatically reverts to DOS during a run and the message "Error 88"
appears on the computer monitor, the database is broken.
• Performing FIXIT should correct the problem.
• However, the error is "fatal," i.e., the run is almost always lost.
• If FIXIT does not resolve the error, consult with Field Service.
Software Not Responding/Freeze

If the software is not responding, ensure that the Num Lock button on the keyboard is lit
indicating that the keyboard is working properly. If the button is lit and samples are being
processed, ask the client to perform the following steps in an attempt to save the run:
1. Press Ctrl+Alt+Delete to boot the system.
2. Exit to DOS.
3. Type PC if the Instrument is in Standard mode, or PC STAT if the Instrument is in Turbo
mode.
4. PC or PCSTAT allows tests in progress to finish. DO NOT load additional samples on the
Instrument.
5. If these steps do not solve the problem, obtain the client's software version and consult
Field Service.

COMMON IMMULITE SOFTWARE PROCEDURES
Control Entry
Up to 25 different controls can be identified to the system in the Control Entry screen.
Checking Existing Control Ranges
• Go into Data Entry, Patient Entry and use Page Up and Page Down to locate the cup
with the control. The range of the control will appear on that screen along with "ASSAY
IN PROGRESS".
• Run the control for the assay in question. The entered range will display at the top of the
control report printout.
Changing or Editing Control Information
• If you need to edit any information in the Control Identification screen, you must re-enter
all test codes and levels for that assay.
• If a control is running and went through the barcode reader, changes made to the control
identification will not be applied to that control. The changes, however, will then be
applied to any controls subsequently run (provided they went through the barcode reader
after the changes were made).
Entering Control Ranges for Qualitative Assays
When entering control information for qualitative assays designate:
• negative controls: low limit: 1, high limit: 1
• positive controls: low limit: 3, high limit: 3
• indeterminate controls: low limit: 2, high limit: 2
Editing Records
If an error was made while entering patient information, or if information needs to be added
to a patient record, the record can be edited at any time before the sample is read at the
PMT.
Note: When editing a closed record, the changes can only be printed, not saved to the
database.
1. Go into the Worklist or Patient Entry screen.
Note: In Patient Entry you cannot edit any information in the purple edit box.
2. Type in the sample cup number
3. Press Enter. The purple and yellow edit box appears displaying the existing record for
the sample cup number.
4. At the prompt, select the record to edit or create a new patient.
5. In Worklist Entry screen, edit the accession number in the purple box (notice the field is
blue, meaning it is available).

6. To edit any other information, press Enter and the record is displayed on the first line,
allowing you to edit accession number, name, or dilution factor.
Note: If the Skip last name option is selected and active, you can not edit any other
information. The accession number field will be accessible in the purple edit box, but
upon hitting enter, the record will be dropped back into the worklist. At this point, the
name or dilution factor can not be changed. Turn the skip name option off by hitting F1
and re-type the sample cup number).
7. Type the sample cup number.
8. Press Enter.
9. Select the appropriate record or highlight create new patient, and
10. Press Enter to bring that record up. The existing information appears. You can change or
enter new information.
Note: If a patient's information is incorrect, only create a new record if you are going to
run the same sample cup more than once.
Long Report Format

Use the memory joggers at the bottom of the screen to guide you in customizing the long
report.
Remember:
• Fields cannot be created.
• The existing fields correspond to the available fields in the Patient Entry screen.
• You cannot alter the Patient Entry screen, therefore, if you try to create a new field in
Long Report Format there will be no place to input that data in Patient Entry.
• Fields can be deleted or moved (the field will still appear in patient entry but not on the
long report).
• When moving a field, the corresponding result field must also be moved.
• Anything typed into the screen (which appears in white text) will print on every report,
including text, characters, and lines.
• Customers can add the name of their facility to their long reports by deleting "your Town
Hospital" and typing their name and address at the top of the page.
• The "Change Name" option in the configurations menu ONLY changes the name that
appears in the IMMULITE operating software header, not on reports.
Note: ALT + R restores the default values and deletes all changes that were made.

Printing Screens or Reports
Never print the Primary Screen of the IMMULITE software because it prints in code, not
graphics. Since the screen is updated every cycle, it will reprint the code every 31 or 45
seconds (Run IMMULITE or Turbo mode respectively), until the run is completed, thus
interfering with report/error printing.
Use the following keys to print:
F10
• Prints the screens in the operating software
• Can print a worklist but each page prints individually with heading information
• Prints Levey-Jennings plots when not in the IMMULITE software
F3 (Only works in the Data Entry/Worklist Entry screen)
• Prints the entire worklist
Print Screen Key
• prints other DOS based screens when not in the IMMULITE software
Note: A bug exists in DOS where screens are not always consistently printed using the
Print Screen key. Partial printing of a page may result.
If Samples Are Running on the Instrument:
• The software will not allow you to "print reports not printed today" or "print reports by date
and time" (SYSTEM STATUS: SELECT REPORTS).
• The software generates "PC Communication Errors" while printing screens. See
IMMULITE PC Communication Errors on page 139 for more information.
Searching for Records

• You can search from the DATA ENTRY: PATIENT ENTRY screen and HISTORY
REVIEW: PATIENT REVIEW for patient records only
• To search for patient results by sample cup number, accession number, and patient last
name only, type the information in the respective field, leave the cursor in that field, then
press F1. If the cursor is not in the field of search, you will get a message.
Note: You cannot search for adjustors and controls. Scroll through the records using
Page Up and Page Down to find adjustor and control records.

LIS (LABORATORY INFORMATION SYSTEM)
Cable Specs .......................................................................................................................176
IMMULITE LIS ....................................................................................................................177
Host Query ....................................................................................................................179
Possible LIS Errors........................................................................................................179
IMMULITE 1000 LIS ...........................................................................................................181
Host Query ....................................................................................................................183
LIS Troubleshooting..........................................................................................................184
Activating the LIS Log....................................................................................................184
LIS Records .......................................................................................................................185
Header Message Records.............................................................................................185
Patient Information Record............................................................................................185
Order Record.................................................................................................................186
Result Record................................................................................................................187
Query Record ................................................................................................................187
Terminator Record.........................................................................................................188

CABLE SPECS
• The IMMULITE LIS serial port is COM2.
• The IMMULITE 1000 LIS serial port is COM4.
• Both ports are DB9M (9 pin male). The cable connector needs to be 9-pin female.
• IMMULITE LIS cable wiring reference is ASTM E1381 (5.2.4.2).
• The LIS vendor supplies the cable.
DB9 Connector
Contact Number EIA Circuit Description Instrument Computer (LIS)
2 BB Received Data Input Output
3 BA Transmitted Data Output Input
5 AB Signal Ground ... ...
DB25 Connector (Possibly on older IMMULITEs)

Contact Number EIA Circuit Description Instrument Computer (LIS)
1 ... Shield ... No Connection
2 BA Transmitted Data Output Input
3 BB Received Data Input Output
7 AB Signal Ground ... ...

IMMULITE LIS
• The LIS feature allows results to be uploaded to a host (LIS) computer system.
• The IMMULITE can accept broadcast downloads of work orders from the LIS and send
individual requests for work orders to the LIS via the host query function.
• The industry reference is ASTM 1394-Standard Specification for Low-Level Protocol to
Transfer Messages Between Clinical Laboratory Instruments and Computer Systems.
• See Cable Specs on page 176 for information about cabling.
Configuring the LIS

1. From the LIS parameters, select LIS PARAMS. The password is connect.
2. Use the table below to configure the system:
Uni-directional Bi-directional
Activate the LIS feature? YES YES
Activate Host Query? NO NO
Activate Uni directional Mode? YES NO
Enter Header Message Password
Enter Receiver ID Provided by LIS Vendor. If not, leave blank.
Enter Sender ID
Enter Baud Rate Most common choice is 9600 (Highest speed)
Parity, Data Bits, Stop Bits Parity is NONE
Data Bits is 8.
Stop Bits is 1.

Upload of Results
The operator tags and sends results from the Data Management screen.
• Autosend is not available
• Results can be sent only once; there is no resend feature.
• There is no capability to transmit controls.
• <F4> tags all results
• <F5> tags only one result. <F5> also untags tagged results.
• <F1> sends the results to the LIS.
• The results in the LIS Data Management screen can be printed by pressing <F3>.
Note: If the system is Uni-directional, accession numbers MUST be entered from the
Worklist Entry screen, or results will not be sent to the LIS.
Broadcast Download
The LIS can download a group of work orders for various specimens. In the LIS Data
Management screen, the operator can assign sample cup numbers individually or have the
IMMULITE automatically number the work orders.
1. Using the arrow keys, select the sample where the numbering process should begin.
2. Press <F2> and type the starting number. Sample cup numbers are assigned in
numerical order
3. Sample cup numbers can also be assigned to accession numbers on the Worklist Entry
screen.

Host Query
1. Customers can use the hand-held laser scanner to scan barcoded tubes. See the hand-
held laser scanner manual if the scanner needs to be programmed to read a certain
symbology.
2. The accession number must be entered from the Worklist Entry screen or patient results
will not be sent to the LIS.
3. After the accession number is scanned in, the Instrument will query the LIS to determine
what tests (work orders) need to be run.
4. A record not found error can indicate a programming bug in the LIS.
5. Request the LIS vendor's data stream and examine the terminator message for
terminator codes.
Possible LIS Errors

Invalid ID
• This is the most common error.
• The Sender ID and Receiver ID are incorrect in the header message.
• Try reversing the Sender ID and Receiver IDs in IMMULITE LIS PARAMS.
Invalid Password
• The password is incorrect in the header message.
• Entering the proper password in the LIS PARAMS.
• This password is assigned by the LIS vendor.
Note: Some LIS vendors do not use a password. This field may be left blank.
Bad or Missing Frame Number
• The frame number in the message is invalid.
• Usually indicates a programming bug in the LIS software, but may be a bad message
caused by noise on the line (cable).
• See ASTM 1394 Logical layer section 6.3.2 for further detail.
Invalid Sequence Number
• The sequence number in the message is invalid.
(line noise).
• See ASTM 1394 section 6.6.7 for further detail.
Message Too Short
• Data within the message was dropped or not sent.
(line noise.)
LIS Timeout
• The LIS is not responding to the IMMULITE. The problem is usually with the LIS.

• Check that the cable is connected properly; the LIS Vendor should check they have
provided the correct cable.
• This may also be a hardware related communication or programming problem in the LIS
software.
• The LIS will not show anything when the IMMULITE gives this error. The error means the
IMMULITE is attempting to send and the LIS gives no acknowledgement.
• On rare occasions, a bad communication port on the IMMULITE computer can cause this
issue. The LIS Test cable p/n 400245 or LIS Test cable/Software kit (LIS Comm program
and Instructions) p/n 400843 could be sent to the account to check the communication
port. Field service engineers can check the communication port on-site.
<CR> or <LF> Missing in LIS Transmission
(line noise).
Error in Last Request
• This is a response from the LIS stating the that LIS encountered an error during the
IMMULITE's request for information.
No Info on This #
• A response from the LIS to a Query message. The LIS has no information for the sample
(accession #).

IMMULITE 1000 LIS
The IMMULITE 1000 system can be configured to automatically send data to the LIS.
Several features that are not available on the IMMULITE are available on the IMMULITE
1000. They are:
• Autosend results
• Re-send results
• Receive test orders for control samples
• Send (autosend) control sample results
• The IMMULITE 1000 can be configured for European numbers: 1.200,34. If configured
for European numbers, the dose in the result record will be in the European number
configuration.
• See Cable Specs on page 176 for information about cabling.
Configuring the LIS

Use the LIS Configuration window to configure the system to communicate with the LIS.
1. From the Tools menu, select Configurations.
2. Select the LIS Parameters button.
3. Enter connect in the Password field.
4. In the LIS Host Query Mode box, select the type of interface used for communication
between the IMMULITE 1000 and the LIS.
5. Enter the Password, Receiver ID, and Sender ID provided by the LIS provider.
Otherwise, leave blank.
6. Enter the Baud Rate provided by the LIS. Acceptable entries are 1200, 2400, 9600.
7. Enter N81 in the COM Parameters field.
8. Set the Serial Port to 4.
9. The Diagnostics option should not be checked.
10. Select the SAVE button.

Note: The IMMULITE 1000 software must be rebooted for any saved changes to take
effect.
Communication Modes
The IMMULITE 1000 can be configured to interface with the LIS. The three communication
modes are:
• Uni-Directional: Communication is one-way from the Instrument to the LIS.
Note: The patient accession number is mandatory for results to be uploaded to the LIS.
• Bi-Directional: Communication is two-way between the Instrument and the LIS. An LIS
worklist is generated once a download from the host computer to the Instrument is
initiated.
Note: The LIS must be configured to communicate with Instrument
• Bi-Directional Query: Allows the operator to request information for a single patient
accession number. The Instrument will communicate with the LIS to request for the
single sample.
Upload of Results
To manually send results to the LIS:
• Select the TAG ALL button to tag all resulted records or tag individual results by
highlighting the desired results.

• Send the results by selecting the SEND button. The following message appears:
Number of Records Tagged to be sent to the LIS =2.
• Select OK.
To resend data to the LIS:
• Select HIDE SENT button. The button toggles changes to show SHOW SENT. This
enables previously sent results to appear.
• Individually tag all results to be sent or select the TAG ALL button.
• Select the RE-SEND button to retransmit the results to the LIS.
To review LIS Results:
• Select the LIS button on the toolbar.
• Select the DATE and TIME.
• Select an option in the Sort By field to sort LIS data.
• Select a time frame option.
• Select OK to proceed.
To print LIS Results:
• Select the LIS button on the toolbar.
• Select PRINT LIST button to print currently displayed LIS data. To print previously
displayed data, follow the steps in Reviewing LIS Results section.
Broadcast Download
The LIS can download a group of work orders for various specimens. There are two ways to
assign sample cup numbers to downloaded LIS records:
• Use the AUTO NUMBER feature on the Worklist Display screen.
• Manually enter the numbers on the Worklist Entry screen.
Host Query
1. Customers can use the hand-held laser scanner to scan barcoded tubes. See the hand-
held laser scanner manual if the scanner needs to be programmed to read a certain
symbology.
2. The accession number must be entered from the Worklist Entry screen or patient results
will not be sent to the LIS.
3. After the accession number is scanned in, the Instrument will query the LIS to determine
what tests (work orders) need to be run.
4. A record not found error can indicate a programming bug in the LIS.
5. Request the LIS vendor's data stream and examine the terminator message for
terminator codes.

LIS TROUBLESHOOTING
Activating the LIS Log

The LIS Configuration window is used to activate the LIS Log.
1. From the Tools menu, select Configurations.
2. Select the LIS Parameters button.
3. Enter connect in the Password field.
4. Select Diagnostics to enable a log of the communication between the IMMULITE 1000
and the LIS for troubleshooting. The LIS log should be disabled during normal operation.
5. Select the SAVE button.
Note: The IMMULITE 1000 software must be rebooted for any saved changes to take effect.
Locating the LIS Log

2. Select Explore.
3. Locate and open the IMMULITE 1000 file folder.
4. Open the Logs sub-folder.
5. Copy, zip and transfer.

LIS RECORDS
Header Message Records

Example:
<STX>1H|\^&||DPC|IMMULITE|111 CanfieldÂve^ Flanders^New^Jersey^07836||973-927-
2828|N81|LIS||P|1|20000324143456□58
Five Required Fields:

• Field 1: record types definition
• Field 2: delimiter definition,
• Field 4: password,
• Field 5: sender ID,
• Field 10: receiver ID
• (7.1.4) Access Password: The specifications now state:
Configurable in LIS parameters screen; maximum of 15 characters.
• (7.1.5) Sender Name or ID:
• (7.1.9) COM Parameters: If an LIS provider leaves this field blank, the IMMULITE 1000
will hard code "N81", but if the LIS provider puts "8N1" in this field, the communication
will not work
• (7.1.10) Receiver ID:
Patient Information Record

Example
2P|4|C00063242|||JONES^MARY||||||||□3A
Required Fields
• Field 2: sequence definition
• Field 3: practice assigned patient ID

• (8.1.6) Patient Name field:
Includes example of name for Control sample

First 2 characters: ~C
Next 6 characters: Control Name
Next 3 characters: Control Lot
Next 6 characters: Expiration Date as YYYYMM
Last 1 character: Control Level
Note: The LIS can download tests for a control sample but not adjustors or verifiers.
• (8.1.15) Special Field 1 is not supported. This field should not be used by an LIS
provider.
Order Record
Example
3O|1|7522275250||^^ÂTG|R||||||||Normal|||||||||||C0282□29
Required Fields
• Field 1: record types definitions,
• Field 2: sequence number,
• Field 3: accession #(specimen ID),
• Field 5: universal test ID
• (9.4.3) Specimen ID field supports an accession number for a control as:
First 2 characters: ~C
Next 6 characters: Control Name
Next 3 characters: Control Lot
Next 6 characters: Expiration Date as YYYYMM
Last 1 character: Control Level
Note: The LIS can download tests for a control sample but not adjustors or verifiers.
• Fields 9.4.19, 9.4.21 and 9.4.22 are not supported and should not be used by an LIS
provider.

Result Record
Example
4R|1|^^ÂTG|<20.0|IU/mL|20.0\20.0^100\3000|<|N|F|||20000324013221|20000324024207|
C0282
Required Field
• Field 2: sequence number
• Field 3: test code
• Field 4: result
• Field 5: units
• Field 7: result abnormal flags
• Field 9: results status
• No changes in Test ID, Units, or Result Abnormal Flags.
• (10.1.9) Results Status field.
IMMULITE: This is always an F for final results.
IMMULITE 1000: This is an F when the result is sent for the first time and will be an
R (resent) if the result was resent.
Query Record
Example
2Q|1|^75240623832||ALL||||||||O□54
Required Fields
• Field 1 - record types definition,
• Field 3 - Specimen Accession number,#.
• Field 5 - Universal Test ID,
• Field 13, Request information status code (Requests orders and demographics.)
• Requests ALL tests for an accession number.

Terminator Record
Example
3L|1|F
Required Fields
• Field 1: Record Types Definition
• Field 2: Sequence number
• Field 3: Termination code (Third field required with response to query)
Terminator codes are F and N.
Use terminator I to indicate no test orders for the queried accession number.

LOAD PLATFORM & LOAD CHAIN
About the Load Platform & Load Chain ..........................................................................190
Load Platform & Load Chain Troubleshooting Tips ......................................................192
Load Chain Is not Functioning Properly .........................................................................193
Jam at the Star Wheel ...................................................................................................193
Contaminated Load Chain or Load Platform .................................................................194
Related Diagnostics ..........................................................................................................195
LCHAIN .........................................................................................................................195

ABOUT THE LOAD PLATFORM & LOAD CHAIN
The Load Chain transports:

• Samples cups and test units from the loading area to the Sample & Test Unit Barcode
Reader and pipetting station
• Sample cups to the Sample Collection Tray
• Test units onto the Main Incubation Carousel.

ASSOCIATED ERRORS
Load Chain Error
• Appears on the Instrument Display Panel if an error was detected and self-corrected.
• If the Instrument was unable to correct itself, a Front-End Shutdown occurs.
Front-End Shutdown Error
• The Load Chain and Pipettor were stopped because of an error or jam in the Load Chain,
Pipettor, or Syringes that could not be corrected.
• Tests already on the Main Incubation Carousel and in the Luminometer will to continue to
be processed if the Shuttle and the Luminometer Chain are operating correctly.
• Samples will be lost if the jam affected the Main Incubation Carousel or the Luminometer.
• New samples will not be pipetted.
• The second reagent for a sequential assay will not be pipetted.

LOAD PLATFORM & LOAD CHAIN TROUBLESHOOTING TIPS
Note: Before manually moving any parts of the Instrument, verify that the Probe is not inside
a sample cup or a test unit. Ensure the Instrument is Idle and manually lift the Probe and
place it in the Wash Station to prevent damage.
• Perform a visual inspection to locate the cause of the problem.
• It may be necessary to move the Vanity Panel and inspect for a raised or popped baffle,
or other obstruction.
To remove the Vanity Panel, loosen the screws (do not remove them) and lift the
Vanity Panel straight up.
Do not pull the Probe Tubing when lifting the Vanity Panel.
• Check the Sample Collection Tray. If the Sample Collection Tray if full or missing, the
Load Chain will stop moving.
• Run LCHAIN to verify the smooth movement of the Load Chain.

LOAD CHAIN IS NOT FUNCTIONING PROPERLY
Jam Caused by a Baffle or Other Obstruction

• A loose or dislodged baffle can cause the Load Chain to jam.
• Obstructions can occur if sample cup holders or test units tip, or if incorrect sample cup
types are placed in the sample cup holders.
• A jam on the Load Chain can also block the movement of the Main Incubation Carousel.
Troubleshooting
• Visually inspect the Load Chain and the Barcode Idler Assembly to locate the cause of
the jam.
• If necessary, remove the Vanity Panel to locate the problem. When doing this, do not
remove the screws. Simply loosen the screws so the Vanity Panel lifts straight up.
• If a baffle popped, remove the Vanity Panel and use the Star Wheel to manually rotate
the Load Chain so that the area without the baffle is on one of the corners in the platform.
This gives the Load Chain more support and stability while the baffle is snapped into
place.
• If a sample cup caused the jam, determine if the account uses disposable cups that are
not made by DPC. Non-DPC sample cups may sit higher and could jam the idler.
• If a test unit caused the jam as it made the right turn, determine if the test unit is
malformed or partially crushed.
Note: The motors on the Instrument do not have enough torque or force to crush a test unit.
Jam at the Star Wheel

Troubleshooting
Note: It may be necessary to remove the Vanity Panel to locate the problem. When doing
this, do not remove the screws. Simply loosen the screws so the Vanity Panel lifts straight
up. Do not pull the Probe Tubing when lifting the Vanity Panel.
• Determine if the Star Wheel at the entrance of the Sample Collection Tray is jammed,
stiff, or misaligned.
• Is there a sample cup or test unit tipped at the Star Wheel?
• Did the operator attempt to remove a jammed sample cup from the Star Wheel.
• Check for a raised or dislodged Baffle.

Contaminated Load Chain or Load Platform
Excessive spillage of sample onto the Load Chain can prevent the links from flowing
smoothly.
Troubleshooting
• Is the Load Chain or Load Platform sticky?
• Was serum spilled?
• Determine when the Load Platform was previously decontaminated.
• If necessary, decontaminate the Load Platform, Sample Collection Tray, and the Barcode
Idler Assembly using surface disinfectant and a damp cloth.
Note: Do not use bleach solutions on the Instrument.

RELATED DIAGNOSTICS
LCHAIN
Instructions

LOW VOLUME CUSTOMERS
Recommendations for Low Volume Use Customers .....................................................198
Before Operation ...........................................................................................................198
At the End of Operation .................................................................................................198
Additions to Monthly Maintenance.................................................................................198
Reminders for Low Volume Use....................................................................................198

RECOMMENDATIONS FOR LOW VOLUME USE CUSTOMERS
Notes:
• This section is based on the IMMULITE 1000 Operator Note 0003 (October 4, 2005).
Perform these procedures to minimize the occurrence of microbial growth or
contamination if the Instrument has not, or will not be utilized for approximately one
week.
• If the Instrument was sitting for an extended period of time, a DECON is recommended.
Before Operation
If the system has not been used for approximately one week:
• Fill a clean Water Bottle with fresh distilled water. Do not empty and refill a Water Bottle
that was sitting unused with water in it during the inactive period.
• Flush the system with fresh distilled water using DECON1.
At the End of Operation

If the system will not be used for approximately one week:
• Remove the Water Bottle, rinse with 70% isopropyl alcohol, and invert to dry.
• Place Water Bottle Straws in a second clean dry Water Bottle. Ensure that the tubings
and the end of line filters do not come in contact with anything other than the Water
Bottles.
Additions to Monthly Maintenance

In addition to regular monthly maintenance:
• Decontaminate the system with fresh probe wash.
Reminders for Low Volume Use

• Carefully follow the Package Insert recommendations for the storage of reagents,
adjustors, and control materials.
• Once the cap is fully seated on a reagent wedge, wrap the cap with Parafilm or a similar
material to help ensure the reagent integrity while reagents are not being used.
• Do not place the reagent wedge on the system unless the test that uses the wedge will
be run that day. Leave the reagent wedge capped in the refrigerator.
• Store distilled water away from direct sunlight. Exposing water to direct sunlight during
storage tends to promote microbial growth.

LUMINOMETER
About the Luminometer ....................................................................................................200
Luminometer Chain Is not Moving...................................................................................202
Shuttle Is Positioned Incorrectly ....................................................................................202
Test Unit Jam ................................................................................................................202
CALC Errors Due to Non-Washing of Bead ....................................................................204
Troubleshooting Tips .....................................................................................................204
High-Speed Spinner Is Not Spinning Properly ..............................................................204
CALC Errors Due to High/Low CPS Counts....................................................................206
PMT Attenuator Disc Is not Moving ...............................................................................206
Tests Units Remain on the Luminometer Chain.............................................................207
Operator Pressed ALARM MUTE and GO ....................................................................207

ABOUT THE LUMINOMETER
• Houses the Photomultiplier Tube (PMT) and the Luminometer Chain.

• Maintains an incubation temperature of 37° C, +/- 0.2.
• Each test unit that passes through the Luminometer is incubated for 10 minutes after
substrate is added (in Standard Mode).
• After incubation, 12 one-second reads are taken.
• The high and low readings are discarded and the remaining 10 are averaged.
• At high CPS, the PMT is attenuated for increased photon counting range (the cut-off is
approximately 1 million counts).

ASSOCIATED ERRORS
Lum Chain and Attenuator Shut Down
• This is a fatal error so the Instrument will stop.
• Investigate all related positions and alignments.
Lum Chain Error
• If the Instrument cannot correct the error, the Instrument automatically shuts down and a
message indicates that this has occurred.
• Repeat any tests in progress.
Shut-Car & Shut-Pos Errors
• Check all related movements and critical alignments of the area.

LUMINOMETER CHAIN IS NOT MOVING
Note: If a jam is suspected, look for the cause of the jam before continuing.
Shuttle Is Positioned Incorrectly

The Shuttle is not positioned correctly and is interfering with the Luminometer Chain.
Troubleshooting
• Manually home the Shuttle to the left.
• Jiggle the Main Carousel if the Shuttle does not move to the left.
• Check for an obstruction, e.g., a fallen test unit or baffle.
Note: If necessary, remove the Vanity Panel to locate the problem. When doing this, do not
Test Unit Jam

A test unit has become jammed inside the Luminometer, thus jamming the Luminometer
Chain.
Troubleshooting
• Put the Instrument in Idle.
• Manually move the Shuttle to the left until the Shuttle's opening straddles the L-shaped
side of the Luminometer Chain.
• Push a test unit up the Exit Ramp into the Luminometer Chain.
• Manually move the Luminometer Chain counter-clockwise until the test unit comes into
view.
• The Shuttle may need to be moved to the right or the test unit will not come out.
• Remove the test unit.
Dislodged Luminometer Chain Baffle

A baffle in the Luminometer Chain became dislodged and is interfering with the chain or the
Shuttle.
Troubleshooting
Note: Make sure the Instrument Display Panel says IDLE before manually moving any parts
on the Instrument.
• Manually move the Luminometer Chain counter-clockwise.
• Inspect the chain for missing or popped baffles as you rotate the chain.

• Rotate the Luminometer Chain so the area without the baffle is on one of the corners in
the platform. This gives the chain more support and stability.
• Snap the baffle back on the Luminometer Chain.
• Push any raised baffles down even with the remaining baffles on the Luminometer Chain.
Related Diagnostics
LUMCHN
second.

CALC ERRORS DUE TO NON-WASHING OF BEAD
Troubleshooting Tips
Rule out other causes before troubleshooting the High-Speed Spinner.
• Is this a one time occurrence?
If so, inspect the test unit's label.
• Is the label loose?
• Visually check the consumables.
• Rule out the sample by rerunning the sample in between two controls.
If the problem is intermittent and the sample is ruled out, monitor the issue.
• If the problem persists, inspect the test units on the Exit Ramp.
High-Speed Spinner Is Not Spinning Properly

Possible Causes
• Failed motor and/or motor drive circuitry.
• The motor cable is not plugged in.
• The stainless steel motor coupling is loose.
• The o-rings are worn or missing allowing slippage.
Troubleshooting
• Check the level and color of fluid in the sump chambers of the test units on the Exit
Ramp.
• The fluid (representing substrate only) should be clear, not yellow or cloudy, and the
meniscus should just be touching the bead.
• If the level is too high, or if the liquid is cloudy or contains color, the incubation mixture
was not properly spun out.
• This could be caused by a High-Speed Spinner failure.
• Peel back the test unit label and look at the level of fluid in the sump. Assays of the same
type should have identical sump fluid levels.
• The level in the sump should be one-half to three-fourths full, depending on the assay.
• If not, it could be a High-Speed Spinner failure.
• If the High-Speed Spinner is functioning correctly, refer to Imprecise or Inaccurate
Results on page 267 in the Water and Substrate Pumps section.
Related Diagnostics
SHUTSPIN
• Used to evaluate the High-Speed Spinner cycle.

Instructions
• Manually load a test unit with 200 µl of liquid onto the Main Incubation Carousel, one
position before entering the Shuttle.
• The test unit will be taken to the spin position and the High-Speed Spinner motor will
activate for 30 seconds.
• The test unit should lift up slightly and the liquid should quickly clear from the bottom of
the tube.
• The bead should float in the air while the tube is spinning.
• To check the actual spinner speed, use the WASHSPD diagnostic.
WASHSPD
• Tests or allows adjustment of the speed of the High Speed Spinner motor.
Instructions
• Place one test unit on before the Sample Barcode Reader.
• Follow the prompts on the Display Panel.
• Listen for any unusual sounds and watch the speed of the tube.
Note: Consult with Field Service before adjusting the speed. The target speed is 5520. The
speed will appear on the Instrument Display Panel.

CALC ERRORS DUE TO HIGH/LOW CPS COUNTS
PMT Attenuator Disc Is not Moving

Possible Causes
• The attenuator parameters in the configuration table are incorrect.
• Failed motor and/or motor drive circuitry.
• Loose belt or associated components.
• The associated bearings inside the cover have seized.
Related Diagnostics
ATTURN
• Cycles the Attenuator Disk to the home position, attenuated position, and the
unattenuated position.
Instructions
• Visually check the PMT Attenuator Disk motion to verify sensor operation.
• Observe the position of the single sensor notch found on the right side of the
Luminometer cover above the PMT.
• The single sensor notch points to a 9:00 position at home, 5:00 in the attenuated
position, and 1:00 in the unattenuated position.
• The Attenuator Disk should move smoothly as it turns.

TESTS UNITS REMAIN ON THE LUMINOMETER CHAIN
Operator Pressed ALARM MUTE and GO

The operator pushed ALARM MUTE and GO after a front-end shutdown. The Instrument
shuts down immediately leaving all test units on the Instrument.
Troubleshooting
• The run is lost.
Related Diagnostics
LUMCHN
second.
EMPTYTUB
system.
are in process.
Instructions
diagnostic program.
sequence.
onto the Exit Ramp.

MAIN INCUBATION CAROUSEL
About the Main Incubation Carousel ...............................................................................210
Front End Shutdown......................................................................................................211
Sample Cup on the Main Incubation Carousel ..............................................................211
Main Carousel Error ......................................................................................................212
Load Chain Is Not Advancing Correctly.........................................................................212

ABOUT THE MAIN INCUBATION CAROUSEL
• Mixes and incubates assay test units for 30 or 60 minutes until the Shuttle moves them
into the Luminometer for further processing.

ASSOCIATED ERRORS
Front End Shutdown

Note: Always check the error log to determine what caused the error and when it occurred.
Troubleshooting
• If it occurred at startup, then an improper shutdown is possibly to blame. Inquire and
correct the shutdown procedure.
• If it occurred during a run, allow the tests in progress to finish (if possible).
• Log off the software.
• Continue troubleshooting.
Sample Cup on the Main Incubation Carousel

A sample cup holder made its way onto the Main Incubation Carousel causing a fatal error or
front-end shutdown.
Note: Eight bad barcode reads in a row will allow the eighth tube, whether a sample cup or
test unit, onto the Main Incubation Carousel. If there is a high frequency of bad barcode
reads in the error log, refer to the Sample/Test Unit Barcode Reader section on page 247.
Troubleshooting
• Ask the operator to account for all sample cup holders.
• If a cup cannot be located in the sample cup rack or the Sample Collection Tray, it may
be on the carousel.
• Examine the Main Incubation Carousel to find the sample cup.
• The sample cup may be stuck in the gear area (at the 1 o'clock position).
• Press ALARM MUTE and GO to stop the Instrument. The run is lost once the operator
presses ALARM MUTE and GO.
• The Instrument Display Panel should read that the Instrument is IDLE. (Parts of the
Instrument can now be moved freely.)
• Alternatively, run CARBACK to remove the sample cup.
• Run EMPTYTUB to remove test units that remain in the Luminometer.
IMMULITE 1000 Note: Multiple, incorrect dilution sequences loaded consecutively will cause
a sample cup to enter the Main Incubation Carousel.
Mispositioned Main Carousel

• A Main Carousel Position error can occur if the Main Incubation Carousel interferes with
the operation of the Shuttle.

Troubleshooting
• Let any tests in progress finish (if possible).
• Move the Main Incubation Carousel back and forth to allow the Shuttle to return to the
home position.
• Run SHUTTLE and EMPTYTUB to verify that the Instrument is performing properly.
• If the error continues, the Main Carousel Sensor may not be seeing the holes in the
carousel.
• Consult with Field Service.
Main Carousel Error

A Main Carousel error will cause the Instrument to stop. However, a mechanical issue is not
the cause.
Troubleshooting
• Run MCARTST in System Configs to check the hole sizes on the Main Carousel.
• Instruct the operator to record the numbers on the Display Panel as the Main Carousel
indexes.
• Nominal values are 22-26 for large holes, and 8-12 for small holes.
• Consult with Field Service to rule out dirt in the holes or Main Carousel sensor.
• Spraying compressed air on the Main Carousel sensor holes may remove the dust or
dirt.
Shuttle Is Jammed Against Main Carousel

Troubleshooting
• Manually move the Shuttle to the left (home position).
• The Main Incubation Carousel may need to be moved slightly to disengage the Shuttle.
• If you are having difficulty moving the Main Incubation Carousel, a sample cup may be
on the carousel. See Sample Cup on the Carousel on page 211.
• Otherwise, the Main Incubation Carousel may be mispositioned.
Load Chain Is Not Advancing Correctly

A Main Carousel position error can occur if the Load Chain is not functioning properly.

Load Platform & Load Chain Troubleshooting Tips
Note: Before manually moving any parts of the Instrument, verify that the Probe is not inside
a sample cup or a test unit. Ensure the Instrument is Idle and manually lift the Probe and
place it in the Wash Station to prevent damage.
• Perform a visual inspection to locate the cause of the problem.
• It may be necessary to move the Vanity Panel and inspect for a raised or popped baffle,
or other obstruction.
To remove the Vanity Panel, loosen the screws (do not remove them) and lift the
Vanity Panel straight up.
Do not pull the Probe Tubing when lifting the Vanity Panel.
• Check the Sample Collection Tray. If the Sample Collection Tray if full or missing, the
Load Chain will stop moving.
• Run LCHAIN to verify the smooth movement of the Load Chain.
Related Diagnostics
CARBACK
• Useful for removing sample cups from the Main Incubation Carousel.
• This program moves the carousel backwards in single index steps when the Syringe
Prime button is pressed, or indexes continuously by holding the prime button down.
Instructions
• Make sure the Shuttle is in the home position inside the carousel at about 3 o'clock.
• Follow the prompts on the Instrument Display Panel.
• Press the Syringe Prime button to move the carousel backwards (counter-clockwise).
• Rotate the carousel until the test units and/or sample cups are in the pipetting area.
• Manually remove the test units or sample cups.
• The carousel should be completely empty.
EMPTYTUB
system.
are in process.
Instructions

diagnostic program.
sequence.
onto the Exit Ramp.
LCHAIN
Instructions
MCARTST
• Tests the positioning sensor of the Main Incubator Carousel
Instructions
• Watch the Display Panel as the program runs.
• The hole width of each position hole of the ring gear (in steps) will display on the
Instrument Display Panel with each repeated index of the Main Carousel.
• Nominal values are a range of 22–26 for ‘large’ holes.
• Nominal values are a range of 8–12 for ‘small’ tabbed holes.
SHUTTLE

PIPETTOR
About the Pipettor .............................................................................................................216
Level Sensing Errors ........................................................................................................217
Loose Probe ..................................................................................................................217
Splashing.......................................................................................................................217
Air in the System ...........................................................................................................218
Probe Is Scraping the Reagent Wedge .........................................................................218
Obstruction in the Probe or Tubing.................................................................................221
Improper Probe Cleaning ..............................................................................................221
Blocked Probe ...............................................................................................................221
Probe Tubing .................................................................................................................221
Pipettor Positioning Problems .........................................................................................223
Operator Error ...............................................................................................................223
Probe Tubing .................................................................................................................223
Probe Is Dripping ..............................................................................................................224
A Valve Is not Activating................................................................................................224
Precision Failure ...............................................................................................................225
Poor Sample Reproducibility .........................................................................................225

ABOUT THE PIPETTOR
• Transfers liquid from the reagent wedge and sample cup into the test unit.
• The Probe consists of a stainless steel shaft with an inner core of Teflon tubing.

LEVEL SENSING ERRORS
Note: Five level sense errors in a run will put the system into Auto Pause. Check the error
log for associated errors.
Reagent Level Sense Error with "Are there caps on the reagent?"
Note: If this situation occurs, "Reagent Level Sense Error. Are there caps on the reagent"
appears on the Instrument Display Panel.
The level sensor sensed reagent at an elevation > 150 tests left. Determine if:
• Caps are on the reagents (about 220 tests remaining)
• Bubble on the mouth of the wedge (about 180 tests remaining)
• The wedge is mis-positioned (about 180 tests remaining).
• Reagent is brand new (about 150 tests remaining)
• The reagent was topped off with leftover reagent.
• The Probe is coming in contact with something, e.g., plastic strands from the cover or
wedge opening.
• The Probe is loose.
• Liquid is splashing onto the lower Probe Arm.
• The Probe is scraping the reagent wedge.
• If buildup is suspected, follow the instructions below for cleaning the Probe.
Troubleshooting
• Remove the Probe and clean with a DI moistened kimwipe. This removes any buildup.
• Allow the Probe to dry.
• Wipe off the underside of the lower arm and allow it to dry.
• If the problem persists, continue troubleshooting.
Loose Probe
The fitting at the top of the Probe Block is loose.
Troubleshooting
• Tighten the fitting at the top of the Probe Block.
Splashing
Splashing can occur if the:
• Probe is dispensing at an angle.
• Pipettor is not centered in the home well.

• Depth of Pipettor is incorrectly set in the home well.
• Probe dispense velocity is too great.
Troubleshooting
• Check if the Probe is dispensing at an angle using the PROBANGL diagnostic.
• Check the dispense quality of the Probe using the PROBETST diagnostic.
• Is water splashing during rinsing or washing?
• Is the Probe centered in the home well?
• Check for air in the system.
Air in the System

Excessive air can cause splashing.
Troubleshooting
• Prime the system manually or with the PRIME diagnostic to remove air from the system.
Probe Is Scraping the Reagent Wedge

Troubleshooting
• Determine if the Probe is scraping the reagent wedge close to or away from the operator.
• Consult with Field Service to modify configurations.
Related Diagnostics
PROBANGL
Instructions

PROBETST
• Used to evaluate the dispense quality of the Probe.
Instructions
• Look for excessive splashing on the Probe Shaft or out of the home well.
• Look for any dripping when the Probe lifts up and momentarily moves to the Wash Well.
• Dripping indicates back pressure or an occlusion inside the Probe or its associated
tubing.
• The depth of Probe in Wash Well may need to be adjusted (Consult with Field Service).
LEVFALSE
• Tests for false level sensing in the reagent, five sampling positions, and assay dispense
pipetting positions.
• This test does not require any sample cups to run.
• This diagnostic stops automatically. (IMMULITE 1000 Only)
Instructions
• Place an empty wedge on the Reagent Carousel and a sample cup at the furthest point
on the Load Chain as visual markers.
• If the Probe false level senses in the reagent position, the Load Chain advances.
• If it false level senses in any pipetting position, the Reagent Carousel indexes.
• You can also trigger the system to level sense by touching the Probe after its first pause
on the way down.
• Wires and cables can be jiggled to trigger intermittent problems.
• Intermittent problems indicate a problem with the board.
• Otherwise, the Probe may be loose.
• Check the CPS. If the counts are all depressed, a spiral cable issue is a possibility.
LEVSENSS
• Exercises the level sensor in the sampling positions.
Instructions
• Place a sample cup containing probe wash in the first pipetting position.
• The diagnostic will repeatedly level sense in the sample cup and display the steps left
(SL) on the Instrument Display Panel. The number should be consistent.
• Confirm the Probe is entering the cup, and is centered, when it level senses.
LEVSENSR
Note: The Reagent Carousel does not move during this diagnostic.

• Used to check for consistent reagent level sensing.
• Tests dead volume settings at the reagent positions.
Instructions
• Place a wedge containing 1000 µl of reagent in the position on the Main Incubation
Carousel that is underneath the hole of the Reagent Carousel Lid (because the Reagent
Carousel does not move during this diagnostic).
• The diagnostic will repeatedly level sense in the wedge and display the steps left (SL) on
the Instrument Display Panel (should be between 8-12).
• Confirm the Probe is entering the wedge when it level senses.
• Wipe off the Probe with a DI moistened kimwipe after the diagnostic to prevent cross
contamination.
LEVCRASH
• Test for proper level sensing of the Probe in each of the five sample pipetting positions.
Instructions
• Pipette at least 100 µl of liquid (must be material that will detect a change in capacitance,
i.e., PBS, probe wash, reagent, sample) into five sample cups.
• Place the five sample cups into the five pipetting positions.
• Put an empty wedge in the Reagent Carousel as a visual marker and leave the lid open.
• The Probe will level sense each cup, starting with position five.
• Any failures will trip the jam sensor, which in turn will index the Reagent Carousel one
step.
PIPXPOS
Instructions
Note: Wipe the Probe Tip with a DI moistened wipe after completing the diagnostics.

OBSTRUCTION IN THE PROBE OR TUBING
Improper Probe Cleaning

Buildup or contamination exists because the Probe is not cleaned on a daily basis.
Troubleshooting
• Determine if the customer performs a Daily Probe Cleaning.
• Check if fresh solution is used daily.
• Run the PRBCLEAN diagnostic if necessary.
Blocked Probe
An obstruction may cause the Probe to dispense off center.
Troubleshooting
Note: Never attempt to remove a blockage by inserting a stylet or any other object into the
Probe.
• Check dispense angle using the PROBANGL diagnostic.
• Run PRIME to check for an obstruction.
The 5000 µl Syringe stops for one second during dispense to switch valves.
At that moment water should come out in drips.
If not, this indicates the release of back pressure from the fluidics due to an
obstruction in the Probe or tubing, or the presence of air.
• Replace the Probe if the Probe is blocked.
Probe Tubing
Probe tubing has too much or not enough slack, which causes it to get caught on something
or prevents it from reaching all positions.
Troubleshooting
• Check that the Probe tubing has the correct tension.
• The Probe tubing clips into the notch at the top of the Vanity Panel.
• Tubing should flex over itself without pinching, kinking or knotting.
• Rotate the Pipettor to all positions while the Instrument is idle and observe tubing.
• Remove kinks if necessary.
• Run PIPXPOS and observe.

Related Diagnostics
PROBANGL
Instructions

PIPETTOR POSITIONING PROBLEMS
Operator Error
Troubleshooting
• The operator may have tried to open the Reagent Carousel Lid or change reagents while
the Probe was in motion.
Probe Tubing
Probe tubing has too much or not enough slack, which causes it to get caught on something
or prevents it from reaching all positions.
Troubleshooting
Related Diagnostics
PIPXPOS
Instructions

PROBE IS DRIPPING
A Valve Is not Activating

Troubleshooting
• Consult with Field Service if a valve issue is suspected.

PRECISION FAILURE
Poor Sample Reproducibility

Troubleshooting
• Check the dispense angle using PROBANGL.
• Check the quality of the Probe using PROBETST.

PRECISION & ACCURACY
Testing for Precision.........................................................................................................228
Precision and Accuracy....................................................................................................229
Possible Causes of Precision Problems........................................................................229
Possible Causes of Accuracy Problems........................................................................230
Precision vs. Accuracy Grid...........................................................................................232

TESTING FOR PRECISION
To test for precision when a wash issue is suspected:
• Use the TSH low adjustor, the TSH 0 calibrator, or the IMMULITE/IMMULITE 1000 TSH
sample diluent.
• Any deficiency in the wash will show up immediately.
• Typically, the precision of a 0 runs around 7%CV.
• Pipetting imprecision (microvalve, thumbscrew, air bubbles) will not necessarily affect the
precision of a zero sample in a sandwich assay.
To test for pipetting imprecision
• Use an assay, preferably a sandwich assay rather than a competitive assay, with low
sample volume (e.g., HCG has a 5 µl sample volume).
• Run replicates of control with concentration in a range usually yielding good precision.
• HCG high adjustor is recommended rather than low adjustor or diluent, since the CPS for
zero are independent of sample volume.
To test the precision of a specific assay and compare it with that assay’s current
performance
• Run a sufficient number of replicates (typically 20) and compare to kit release precision.
• If necessary, initiate a study in chemistry to test the precision.
• Check the CV% of adjustor replicates for the assay(s) in question and for several other
assays. This will provide an overall precision check on the Instrument even before any
specific precision testing is done.

PRECISION AND ACCURACY
• Imprecision: When the difference in CPS (CV) between replicates is greater than
expected.
• Inaccuracy: When the level of CPS generated is incorrect, therefore the dose is
incorrect.
Possible Causes of Precision Problems

General Imprecision CPS Higher or Lower than expected
All Assays Affected
• Bubbles in Small Syringe
• Worn small Syringe Tip
• Poor X pipettor alignment of Probe in sampling cups
• Loose or bent Probe
• Intermittent Valve failure
• Partially clogged Substrate Nozzle
• Poor alignment of test unit under Substrate Nozzle
• Inconsistent volume of water dispensed
• Intermittent High-Speed Spinner problems (i.e., inconsistent wash speed)
• Loose syringe thumbscrew or barrel
CPS Higher than Expected

All Assays Affected
• Sticky upper shuttle slide bearing
• Worn High-Speed Spinner o-rings
• The pressure on the tube in the Shuttle is not set properly
• Test units not aligned with entrance to Luminometer (tube flick)
• Inconsistent spinning of High-Speed Spinner motor
• Alkaline phosphatase contamination (water and/or system)
CPS Lower than Expected

All Assays Affected
• Attenuator sensor disk set screws loose
• Reagent Carousel tray platter set screws loose
• Inconsistent level sensing failures
• Probe is loose in Pipettor Arm

• Probe is bent
• Probe wash has gotten into the test unit, either from residual probe wash in Water Bottle,
a faulty V2 causing Probe to drip probe wash, or not following a DECON with DECON1
to thoroughly rinse probe wash
• Small Syringe Tip is worn
CPS Lower than Expected

Only Specific Assays Affected
• Sample cups tipping while in sampling position (tube guides too close)
Possible Causes of Accuracy Problems

CPS Higher or Lower than expected
All Assays Affected
• Substrate contamination
• Worn Syringe Tips
• Incorrect PMT Multiplier
• Loose Syringe thumb screws
• Incorrectly prepared or handled control material
• System/H20 contamination
• Loose Probe
CPS Higher than Expected

All Assays Affected
• No water dispensed from the injector pump
CPS Lower than expected

All Assays Affected
• No substrate dispensed
• Consistent valve failure
• Non functional PMT
• Consistent level sensing failures

CPS inaccurate at High CPS end of Range
All Assays Affected
High End of Sandwich assay working range
Low end of Competitive assay working range
• Incorrect Attenuation Factor
CPS Lower or Higher than expected

• Bad Adjustment
• Poor X pipettor alignment of probe in sample cups
CPS Lower than expected

• Reagent carousel tray platter set screws loose
CPS Higher than expected at

Low CPS end of Range
Low End of Sandwich assay working range
High end of Competitive assay working range
• Water contamination
• Inconsistent spinning of High-Speed Spinner motor
In All Cases...
• If problem is assay specific, examine what is different about the assay that is having the
problem from the assays that are fine.
• Find out when the problem started and what, if anything, has changed such as:
New water source
New kit lot
Recent service performed on Instrument
Software change
Change in primary operator

Precision vs. Accuracy Grid
Is the problem accuracy or precision?
• Imprecision: When the differences in CPS (CV) between replicates are higher than
expected.
• Inaccuracy: When the level of the CPS between replicates is incorrect.
To read the chart below:
• CPS Higher or Lower Than Expected: Determine if the CPS are higher or lower than
expected. There are two rows for each scenario.
• High or Low CPS End Is Affected: Determine if the high CPS or low CPS end of the
assay is affected. There are two rows for each scenario. This will narrow your final
choices to two possible boxes.
• Assays Affected: Determine if all assays or specific assays are affected. This will
reduce your search to one final numbered box. Refer to the Possible Causes of
Accuracy Problems and Possible Causes of Precision Problems for more
information.
Possible Precision and Accuracy Areas

CPS Higher or Lower All Specific High or Low CPS End
Than Expected Assays Assays Is Affected
Affected Affected
CPS Higher Than Expected 1 5 High CPS End of Assay
CPS Higher Than Expected 2 6 Low CPS End of Assay
CPS Lower Than Expected 3 7 High CPS End of Assay
CPS Lower Than Expected 4 8 Low CPS End of Assay
• If the problem is assay specific, examine what is different about the assay that is having
the problem from the assays that are fine.
• Find out when the problem started and what, if anything, has changed such as:
New water source
New kit lot
Recent service performed on Instrument
Software change
Change in primary operator

Cause Box Number
Bad Adjustment 5, 6, 7, 8
Water contamination 2, 6
Substrate contamination 1, 2, 3, 4

Incorrect Attenuation Factor 1, 3
Incorrect PMT Multiplier 1, 2, 3, 4
Incorrectly prepared or handled control material 1, 2, 3, 4
No water dispensed 1, 2
No substrate dispensed 3, 4
Consistent valve failure 4
Worn Syringe Tips 1, 2, 3, 4
Non-functional PMT 3, 4
Loose Syringe thumb screws 1, 2, 3, 4
Reagent Carousel tray platter set screws loose 7, 8
Poor X Pipettor alignment of Probe in sample cups 5, 6, 7, 8
Consistent level sensing failures 3, 4
Possible Causes of Precision Problems

Cause Box Number
Inconsistent level sensing failures 3, 4
Partially clogged Substrate Nozzle 1,2
Inconsistent spinning of High-Speed Spinner motor 1,2
Poor alignment of test unit under Substrate Nozzle 1, 2
Inconsistent volume of substrate dispensed 3, 4
Inconsistent volume of water dispensed 1, 2
Sticky upper Shuttle slide bearing 1,2
Probe is loose in Pipettor Arm 3, 4
Attenuator sensor disk set screws loose 3, 4
Worn high speed spinner o-rings 1,2
Tube pressure 1,2
Test units not aligned with entrance to Luminometer (tube flick) 1,2
Intermittent valve failure 1, 2, 3, 4
Sample cups tipping while in sampling position (tube guides too close) 7,8

REAGENT CAROUSEL
About the Reagent Carousel ............................................................................................236
Non-Barcoded Probe Cleaning Wedge .........................................................................237
Wedge Is Incorrectly Placed in the Tray........................................................................237
Obstructed Barcode Label.............................................................................................237
Glossy Barcode Label ...................................................................................................237
Damaged Barcode Label...............................................................................................237
Mispositioned Barcode Label ........................................................................................238
Damaged Reagent Tray ................................................................................................238
Condensation in the Reagent Carousel.........................................................................238
Reagent Level Sense Issues ............................................................................................240
Tests Units Remain after Reagent Is Used Up..............................................................240
Waste in the Reagent Carousel........................................................................................241
Kinked or Clogged Waste Tubing..................................................................................241
Clogged Waste Container Air Filter (IMMULITE Only) ..................................................241
Temperature Issues ..........................................................................................................242
Temperature Controller Status LEDs ............................................................................242
Reagent Carousel Temperature Is too High..................................................................243
Bad TED (Thermo Electric Device): High Temp............................................................244
Bad TED (Thermo Electric Device): Low Temp.............................................................244
Short in Thermistor on the Reagent Carousel PCB: Temp Is too High .........................244
Short in Thermistor on the Reagent Carousel PCB: Temp Is too Low ..........................244

ABOUT THE REAGENT CAROUSEL
• Includes a cooling chamber and barcode reader for the reagent wedges.
• Cooled to 16 ° C.
• Begins to cool after the Main Carousel and Luminometer exceed 35 ° C.
• An alarm activates when the temperature is 22 ° C or greater.
• The barcode scanner mounted at the side of the chamber reads the reagent wedge
barcodes as the Reagent Carousel rotates.
• The chamber also includes a reagent tray that the wedges clip into.

BAD BARCODE READS
Non-Barcoded Probe Cleaning Wedge

There may be a probe cleaning wedge on the Reagent Carousel. These wedges are not
barcoded and will appear as ghosts on the primary screen on the IMMULITE.
IMMULITE 1000 Note: Bad barcode reads of reagent wedges do not appear as ghosts on
the Reagent Display on the Home screen.
Troubleshooting
• Pause the Instrument.
• Remove the unwanted wedge and reread the Reagent Carousel.
Wedge Is Incorrectly Placed in the Tray

Troubleshooting
• Reposition the reagent wedge (back notch in first and snap the front into the tray)
• Be sure the wedge is not straddling the tray dividers.
Obstructed Barcode Label

Wedges may have condensation or other debris (e.g., spilled reagent or serum, powder from
gloves) on the barcode labels.
Troubleshooting
• Put the Instrument into pause.
• Use a kimwipe to wipe the barcode labels on the wedges.
Glossy Barcode Label

Troubleshooting
• Lightly go over the barcode with a pencil eraser to dull the paper.
Note: Pen or ink erasers are too abrasive.
Damaged Barcode Label

Reagent wedge barcode labels may be damaged or have stray markings from dating
information by operator.
Troubleshooting
• Get the Kit Lot and Reagent Lot information.

• If the wedge barcode is damaged, the Instrument will probably never read it.
• The TSS should consider replacing the wedge.
• The customer should try another wedge that does not appear damaged and verify that it
reads.
Mispositioned Barcode Label

Barcode labels are mispositioned on reagent wedge.
Troubleshooting
• It may be possible to peel off the label and reposition it.
• If not, photocopy the barcode and use clear tape to attach it to the reagent wedge.
• Align it on the wedge (down and to the right) so it is within the window of the reagent
carousel barcode reader.
• Use the plus (+) signs on the edge of the label as guide marks. They should line up with
the spines of the reagent.
Damaged Reagent Tray

Troubleshooting
• Visually check the Reagent Tray. Was it dropped?
• Check the inner-ring (home position) and the outer-ring (12 positions) underneath the
Reagent Tray.
• The customer can try to bend back the notch that appears to be bent.
• The Reagent Tray will need to be replaced to prevent sensor wear.
Condensation in the Reagent Carousel

Humidity in the lab may cause intermittent bad barcode reads.
Troubleshooting
• Wipe the Reagent Carousel with a paper towel to get ride of excess moisture.
• If the high humidity persists, it is possible to put the desiccants from the test unit bags
into the Reagent Carousel.
Related Diagnostics
Run these diagnostics once other issues have been ruled out.
REAGENTH
• Used to checks the Reagent Carousel home position sensors.
• Moves and pauses the Reagent Carousel in the home position between positions one
and two in front of the Barcode Reader LED.

Instructions
• Place a reagent wedge in Position 1 of the Reagent Carousel.
• The red LED should project an oval red light between the edge of the wedge and the first
barcode line when the carousel pauses in the Home position.
• Use the ALARM MUTE button to extend the pause at the Home position for a closer
evaluation
REAGENTP
• Used to check the Reagent Carousel Position Sensor at all 12 positions of the Reagent
Carousel.
• Moves the Reagent Carousel to each of the 12 positions.
Instructions
• Remove all reagents from the Reagent Carousel.
• Look directly through the individual notches found around the edge of the carousel.
• Each position should be centered in front of the Barcode Reader LED.
• Use the ALARM MUTE button to extend the pause at each position for a closer
evaluation.
RBCODE
• Tests the Reagent Carousel Barcode Reader with reagents on board.
• The program moves the Reagent Carousel to the Home position and then to each
position while reading reagent wedge barcodes.
• If there is a problem, the reagent wedges on board will not be read consistently and
some will show up as white ghosts on the IMMULITE.
Instructions
• Load reagent wedges onto the Reagent Carousel.
• Use the ALARM MUTE key to extend the pause at each position for a closer evaluation.
IMMULITE 1000 Note: Bad barcode reads of reagent wedges do not appear as ghosts on
the reagent display on the primary screen.

REAGENT LEVEL SENSE ISSUES
Reagent Level Sense Error with "Are there caps on the reagent?"
Note: If this situation occurs, "Reagent Level Sense Error. Are there caps on the reagent"
appears on the Instrument Display Panel.
The level sensor sensed reagent at an elevation > 150 tests left. Determine if:
• Caps are on the reagents (about 220 tests remaining)
• Bubble on the mouth of the wedge (about 180 tests remaining)
• The wedge is mis-positioned (about 180 tests remaining).
• Reagent is brand new (about 150 tests remaining)
• The reagent was topped off with leftover reagent.
• The Probe is coming in contact with something, e.g., plastic strands from the cover or
wedge opening.
• The Probe is loose.
• Liquid is splashing onto the lower Probe Arm.
• The Probe is scraping the reagent wedge.
• If buildup is suspected, follow the instructions below for cleaning the Probe.
Troubleshooting
• Remove the Probe and clean with a DI moistened kimwipe. This removes any buildup.
• Allow the Probe to dry.
• Wipe off the underside of the lower arm and allow it to dry.
• If the problem persists, continue troubleshooting.
Tests Units Remain after Reagent Is Used Up

• Operator removes reagent when trying to remove air bubbles from the reagent.
• Ambient humidity may be excessively low.
• Configuration table entry incorrect.

WASTE IN THE REAGENT CAROUSEL
Note: Consult with Field Service immediately if there is a pool of waste in the Reagent
Carousel.
Kinked or Clogged Waste Tubing

• Waste tubing has kinked causing liquid to back up into the Reagent Carousel.
• Waste connector is clogged.
Troubleshooting
• Remove any kinks.
• Empty the waste bottle.
Note: It may be necessary to remove the front panel to see the Waste Connector. The
screws are inside the chassis of the IMMULITE, and outside on the front panel of the
IMMULITE 1000.
Clogged Waste Container Air Filter (IMMULITE Only)

Clogged filter causes a pressure build up preventing liquid from flowing into the waste
container.
Troubleshooting
• Remove or replace the air filter.

TEMPERATURE ISSUES
Temperature Controller Status LEDs

Four LEDs are located on the Motor/Heater PCB in the back of the Instrument. Always refer
to the Temperature Controller Status LED Table on page 243 when troubleshooting
temperature errors.
Normal Sequence of LEDs from Left to Right
• L4 (TED cooler): On/Off
When cooling, the light is on.
When the desired temperature is reached, the LED is off.
• L3 (Luminometer Heater): Blinking (5 Hz)

Light is steady at first heat to 35C.
As the temperature increases, the on time of the LED decreases until it reaches the
desired temperature of 37C.
Once that temperature is attained, the on/off time is equal.
Blinks at a rate of 5 times per second.
• L2 (Carousel Heater): Blinking (5 Hz)

Light is steady at first to heat to 35C.
• L1 (Time Hack): Blinking Low (1 Hz)

The control microprocessor LED, called the time hack, indicates the microprocessor
is active.
Blinks at a rate of 1 time per second.
This LED indicates that the temperature control circuitry is functional.
L1 must be blinking or the other LEDs and displayed temperatures are invalid.

Temperature Controller Status LED Table
L4 L3 L2 L1
TED (Cooler) Lum Heater Carousel Heater Time Hack
ON Temp is above Lum temp is Car temp is Microprocessor
16.5°C below 35°C. below 35°C. had a fatal error.
The status of all
other LEDs and
temperature
readings on the
screen are
invalid.
OFF Temp is above Lum temp is Car temp is Microprocessor
16.5°C above 39°C. above 39°C. had a fatal error.
Cooler has shut A full A Full The status of all
down due to a Temperature Temperature other LEDs and
Heater or Cooler Controller Controller temperature
Temp error. Shutdown has Shutdown has readings on the
Lum and/or occurred. occurred. screen are
Carousel have invalid.
not reach 35°C
Blinking Heaters and Heaters and Heaters and Microprocessor
@ 1 Hz Cooler have shut Cooler have shut Coolers have is functional and
down due to down due to a shutdown due to the CPU and
Cooler Temp Lum Temp High Car Temp High Motor Driver
error. error. error. PCBs are
A Full A Full communicating.
Temperature Temperature
Controller Controller
Shutdown has Shutdown has
occurred. occurred.
Blinking N/A Lum temp is Car temp is N/A
@ 5 Hz above 35°C and above 35°C and
below 39°C. below 39°C.
Troubleshooting
• Power off the Instrument for 1-2 minutes (doing this will reset the board).
• Turn on the Instrument and monitor the temperatures for 15 minutes.
• Call customer 30 to 45 minutes later for an update.
Note: The Instrument must be in RUN mode when using System Status | Temps | Dark
Counts. Otherwise, the current temperature reading does not be display. If the Instrument is
not in RUN, use the TEMPS diagnostic. (IMMULITE Only: Exit to DOS, run GETDATAT.)
Reagent Carousel Temperature Is too High

• Reagent Carousel Lid was open for an extended period of time.
• TED is defective (see below).
• TED connector is corroded.
• Exhaust fan is not working.

Bad TED (Thermo Electric Device): High Temp
• System Status | Temps | Dark Counts: Specification is 16 ° C.
• Alarm will sound if > 22 ° C.
• If temperature displayed is 22 - 30 ° C, problem is most likely a bad TED.
Troubleshooting
• If the TED is bad, the system can run with a small ice pack in the Reagent Carousel or by
pipetting the necessary tests and returning the reagent wedges to the refrigerator.
• A field service visit is required to replace the TED.
Bad TED (Thermo Electric Device): Low Temp

• If temperature displayed is < 15 ° C (but not 11.6 °), the TED is stuck on and is not
turning off when the desired temperature is reached.
• The system will shutdown because of the error. (There could also be a problem with the
drive circuitry on the motor/heater PCB.)
Troubleshooting
• A field service visit is required to replace the TED.
Short in Thermistor on the Reagent Carousel PCB: Temp Is too High

• Alarm will sound if >22 ° C.
• If temperature displayed is from 40 – 49 ° C, the temperature display is not correct and
the problem is the thermistor on the Reagent Carousel PCB.
Troubleshooting
• Turn on the Instrument and monitor for 15 minutes.
• Consult with Field Service if the temperature does not stabilize.
• A field service visit is required to address the short in the thermistor.
Short in Thermistor on the Reagent Carousel PCB: Temp Is too Low

• If the temperature is 11.6 ° C, the thermistor is disconnected or electrically open.
Troubleshooting
• Turn on the Instrument and monitor for 15 minutes.
• Consult with Field Service if the temperature does not stabilize.
• A field service visit is required to address the short in the thermistor.

SAMPLE & TEST UNIT BARCODE READER
About the Sample & Test Unit Barcode Reader .............................................................248
Contaminated Orange O-Ring Is Dirty or Worn .............................................................251
Contaminated Barcode Idler Assembly .........................................................................251
Motor Issues ..................................................................................................................251
Jam on the Load Chain .....................................................................................................254
Jam at the Barcode Idler Assembly...............................................................................254

ABOUT THE SAMPLE & TEST UNIT BARCODE READER
• Rotates, reads, and decodes barcodes on sample cups and test units.
• Based on the barcode information, the sample cup or test unit is routed to the sample
pipetting area or the Main Incubation Carousel.

ASSOCIATED ERRORS
Bad Barcode Read: Last Sample #
• A sample cup was not read at the Barcode Reader.
• The last sample cup number that was successfully read will be displayed.
• A sample cup or test unit will appear as a ghost on the primary screen and will go directly
to the Sample Collection Tray, not the Main Incubation Carousel.
No Sample Cup for Test Unit
• This occurs for any test units following the sample cup that was not read by the Barcode
Reader.
• This error will continue until another sample cup is read.

TROUBLESHOOTING TIPS
Determine if Bad Barcode Reads are on sample cups, test units, or both.
Sample Cups Only
• Is it always the same sample cup holder number?
• Try cleaning the cups with a lint-free cloth dampened with water.
• Check the quality of the labels. Are they torn, scratched, marked up, smudged, or
smeared?
• Do not soak the labels because they will peel off the sample cup holder.
Test Units Only
• Is the problem only seen with one assay type or lot #, or one particular bag of test units?
• Is this a new lot #?
Sample Cups and Test Units
• Determine the last time the o-ring and barcode idler assembly were cleaned, and what
was used to clean them (alcohol should not be used).
• Ask if the operator wears powder gloves. Powder from the gloves may get onto the
barcode reader LEDs and o-rings.
Note: If a mechanical issue is suspected, see Bad Barcode Reads on page 251.

BAD BARCODE READS
Contaminated Orange O-Ring Is Dirty or Worn

Troubleshooting
• Clean the orange o-ring with water and a lint-free cloth while running the BCODEON
diagnostic.
• Dry all areas thoroughly.
• Verify that the orange o-ring rotates freely and is not worn or damaged.
Contaminated Barcode Idler Assembly

Troubleshooting
• Clean the four concave idler assembly positions (including the small o-rings and
spindles) with water and a lint-free cloth.
• Thoroughly dry all areas.
• Verify that the two black o-rings are present and that they are positioned properly and
rotate freely.
• Consult with Field Service if either of the o-rings is missing.
Motor Issues
Troubleshooting
• Observe sample cup holders and test units as they rotate in the Barcode Reader.
• It should take 1 to 1.5 turns to read a barcode.
• Four revolutions or more could indicate a bad motor.
• In addition, bad barcode read can occur if the motor speed is too slow or too fast.
Related Diagnostics
BCODE
• Verifies proper functionality of the Sample & Test Unit Barcode Reader.
• A test unit/sample cup holder is read once every two seconds.
• The next text is then indexed in front of the Barcode Reader.
• PC Mode is required to run this diagnostic.
• There is no limit or specific sequence of test units or sample cups.
• The information will appear on the simulation screen following a successful read.

• Place one sample cup followed by a test unit on the Load Platform.
• The sample cup number and test code with lot number will display following a successful
read.
IMMULITE 1000 Note: "Not recognized" appears on the Instrument Display Panel when a
test unit without a matching kit lot is read by the Barcode Reader.
BCODEON
• Verifies the operation of the Sample & Test Unit Barcode Reader by turning the
sample/test unit barcode reader on and off.
• Used when cleaning the orange o-ring.
Instructions
• Press the GO button on the Instrument Display Panel to toggle the motor on and off.
BCODESPD
• Used to observe or adjust the motor speed of the Sample & Test Unit Barcode Reader.
Instructions
• Load at least four test units or sample cups onto the Load Platform.
• Run the program and observe the motor speed.
• The speed should be 750 to 790 ms/rev for test units, and 730 to 770 ms/revs for sample
cups.
• Press the Pause button until the next test unit advances.
• Each position should not be more than 40 ms/rev of each other.
Note: Consult with Field Service before adjusting the barcode motor speed.
Adjusting the Barcode Motor Speed
• When facing the back of the Instrument, the barcode speed potentiometer is the one
closest to the Water and Probe Wash Bottles.
• To adjust the speed, make slight, incremental turns while running BCODESPD.
• As you turn the potentiometer, the speed increases or decreases on the Instrument
Display Panel.

BCODETST
• Verifies the proper functionality of the Test Unit & Sample Barcode Reader with repeated
readings.
• Automatically advances the next sample cup or test unit.
• Test units and sample cups are read 25 times each at the barcode reader.
• Successful reads populate the Main Carousel on the simulation screen.
• The sequence for testing is one sample cup followed by one test unit. Repeat this
sequence if necessary.
• Sample cups are read 25 times by the Barcode Reader.
• Test units are read 25 times.
• The sample cup number, test code, and kit lot number will display following a successful
read.
Notes:
• Bad barcode reads display as "Bad Barcode".
• Sample cups read by the Barcode Reader display with the cup number.
• Test codes and test unit lot numbers display for the first five test units. The remaining 20
test units will display as 'not recognized'.
• "Not recognized" appears on the Instrument Display Panel when a test unit without a
matching kit lot is read by the Barcode Reader.

JAM ON THE LOAD CHAIN
Jam at the Barcode Idler Assembly

A jam at the Barcode Idler Assembly can result from a slight raised baffle, a malformed or
crushed test unit, or a non-DPC sample cup.
Troubleshooting
• Identify the cause of the jam by visually inspecting the Barcode Idler Assembly.
• If a baffle or sample cup caused the jam, see Jam Caused by a Baffle or Other
Obstruction on page 193.
Jam Caused by a Baffle or Other Obstruction

• A loose or dislodged baffle can cause the Load Chain to jam.
• Obstructions can occur if sample cup holders or test units tip, or if incorrect sample cup
types are placed in the sample cup holders.
• A jam on the Load Chain can also block the movement of the Main Incubation Carousel.
Troubleshooting
• Visually inspect the Load Chain and the Barcode Idler Assembly to locate the cause of
the jam.
• If a baffle popped, remove the Vanity Panel and use the Star Wheel to manually rotate
the Load Chain so that the area without the baffle is on one of the corners in the platform.
This gives the Load Chain more support and stability while the baffle is snapped into
place.
• If a sample cup caused the jam, determine if the account uses disposable cups that are
not made by DPC. Non-DPC sample cups may sit higher and could jam the idler.
• If a test unit caused the jam as it made the right turn, determine if the test unit is
malformed or partially crushed.
Note: The motors on the Instrument do not have enough torque or force to crush a test unit.
Related Diagnostics
LCHAIN

Instructions

SHUTTLE
About the Shuttle...............................................................................................................258
Shuttle Is Jammed or Not Moving....................................................................................261
Shuttle Is Blocked by a Test Unit...................................................................................261
Broken Shuttle Sensor or Flag ......................................................................................262

ABOUT THE SHUTTLE
• The Shuttle transfers the test unit from the Main Incubation Carousel to the Wash Station
and the Luminometer Chain.

ASSOCIATED ERRORS
Shuttle-Main Carousel Error
• The Shuttle did not find the home position sensor at the Main Carousel.
Shuttle Position Error
• The Shuttle at the Luminometer position is not found.
Note: Either message will appear on the Instrument Display Panel when the error is
detected. If the problem cannot self-correct, a shut down will occur.

TROUBLESHOOTING TIPS
Perform a Visual Inspection
• Remove the Vanity Panel and inspect the Shuttle and related components to determine
the cause of the problem.
• The Shuttle home position is to the left.
• If the customer can't find the Shuttle, run the SHUTTLE diagnostic.
• Check the movement of the Shuttle. If it won't move, look for a popped baffle or jammed
test unit.

SHUTTLE IS JAMMED OR NOT MOVING
Dislodged Luminometer Chain Baffle

A baffle in the Luminometer Chain is dislodged and is interfering with the chain or Shuttle.
Troubleshooting
Note: Make sure the Instrument Display Panel says IDLE before manually moving any parts
on the Instrument.
• Manually move the Luminometer Chain counter-clockwise.
• Inspect the chain for missing or popped baffles as you rotate the chain.
• Rotate the Luminometer Chain so that the area without the baffle is on one of the corners
in the platform. This gives the chain more support and stability while the baffle is
snapped into place.
• Snap the baffle back on the Luminometer Chain.
• Push any raised baffles down even with the remaining baffles on the Luminometer Chain.
Shuttle Is Blocked by a Test Unit

A test unit has fallen or tilted and is blocking the Shuttle.
Troubleshooting
• Perform a visual inspection.
• If the test unit fell, test the transfer points to determine what caused the problem.
• Chances are that an improper transfer caused the block.
• Otherwise, check the tension of the Shuttle baffles if the test unit is tilted.
Shuttle Is Jammed Against Main Carousel

Troubleshooting
• Manually move the Shuttle to the left (home position).
• The Main Incubation Carousel may need to be moved slightly to disengage the Shuttle.
• If you are having difficulty moving the Main Incubation Carousel, a sample cup may be
on the carousel. See Sample Cup on the Carousel on page 211.
• Otherwise, the Main Incubation Carousel may be mispositioned.

Mispositioned Main Carousel
• A Main Carousel Position error can occur if the Main Incubation Carousel interferes with
the operation of the Shuttle.
Troubleshooting
• Let any tests in progress finish (if possible).
• Move the Main Incubation Carousel back and forth to allow the Shuttle to return to the
home position.
• Run SHUTTLE and EMPTYTUB to verify that the Instrument is performing properly.
• If the error continues, the Main Carousel Sensor may not be seeing the holes in the
carousel.
Broken Shuttle Sensor or Flag

A tube fell into the path of the shuttle and broke the shuttle sensor flag.
Troubleshooting
• Run SHUTTLE.
• There are two flags for the optosensors:
Larger Flag (Position Sensor): If this flag is broken, the Shuttle keeps trying to
move to the right. The Shuttle may jerk or bang.
Smaller Flag (Home Sensor): The Shuttle keeps trying to move to the left. The
Shuttle may jerk or bang.
Related Diagnostics
SHUTTLE
SHUTLOAD
• Allows the operator to evaluate how the Shuttle loads the test unit into the spin position.
Instructions
• Manually load a test unit onto the Main Incubation Carousel, one position before entering
the Shuttle.
• Inspect for proper actuation of the shuttle springs.

• The test unit should fit snugly into the spinner wheels and sit on a straight angle (without
tilting).
• Press GO to have the program eject the test unit for remove.
EMPTYTUB
system.
are in process.
Instructions
diagnostic program.
sequence.
onto the Exit Ramp.

SUBSTRATE & WATER PUMPS
About the Substrate & Water Pumps...............................................................................266
Imprecise or Inaccurate Results ......................................................................................267
Inspect Test Units on the Exit Ramp .............................................................................267
Substrate and Water Issues .............................................................................................268
Low Levels of Substrate or Water .................................................................................268
Substrate Dispense Issues...............................................................................................270
Clogged Substrate Nozzle.............................................................................................270
Clogged Air Filter in the Substrate Spike.......................................................................270
Defective Substrate Pump.............................................................................................270
Mispositioned Test Unit .................................................................................................270
Water Dispense Issues .....................................................................................................271
Dried Up Water Pump Valve .........................................................................................271
Noisy Solenoid Pump........................................................................................................272
Noisy Water Pump.........................................................................................................272
Noisy Substrate Pump...................................................................................................272

ABOUT THE SUBSTRATE & WATER PUMPS
• Automatically pumps water into the test unit during the spin/wash cycle.
• The test unit the moves under the Substrate Heater and substrate is added.
• The solenoid pumps are interfaced with Motherboard # 1.
• The pumps dispense 200 µl of water and substrate.
• Facing the Instrument: the solenoid pump is located on the right hand side, behind the
Load Platform, to the right of the substrate housing.
• IMMULITE: Solenoid Pumps/LAPs
• IMMULITE 1000: Linear Actuator Pumps (LAPs)

IMPRECISE OR INACCURATE RESULTS
Inspect Test Units on the Exit Ramp

Imprecise or inaccurate results can be caused if an incorrect amount of water or substrate is
dispensed.
• Imprecision: When the differences in CPS (CV) between replicates is greater than
expected.
• Inaccuracy: When the level of CPS generated is incorrect, therefore the result is
incorrect.
Troubleshooting Substrate
• Check the level and color of fluid in the sump chambers of the test units on the Exit
Ramp.
• The fluid (representing substrate only) should be clear, not yellow or cloudy, and the
meniscus should just be touching the bead.
• If the level is incorrect, it could be due to a substrate dispense problem or a bad spin.
Check for errors in the log or printer.
Note: Insufficient substrate dispense will cause low CPS
Troubleshooting Water
• Peel back the test unit label and look at the level of fluid in the sump. Assays of the same
type should have identical sump fluid levels.
• The level in the sump should be one-half to three-fourths full, depending on the assay.
• If the level is incorrect, it could be due to a water dispense problem or a bad spin. See
High-Speed Spinner Is Not Spinning Properly on page 204. Check for errors in the log or
printer.
Note: Insufficient water dispense will cause high CPS
Note: If substrate and water dispense volumes are correct, refer to the Syringe section on
page 273 or the Luminometer section on page 199 to troubleshoot other related issues.

SUBSTRATE AND WATER ISSUES
Note: The following issues can be caused by either insufficient water or substrate unless
otherwise noted.
Low Levels of Substrate or Water

Troubleshooting
• Check the Water Bottle volume.
• Fill the Substrate Reservoir or replace the Substrate Bottle.
• Prime the Water and Substrate Pumps.
Loose Tubing Fittings

Troubleshooting
• Check for leaks around the fittings and tubings (including the fitting on the Water Pump).
• Verify that all fittings are secure.
Note: Secure means not too tight (can strip a fitting) or too loose.
Kinked or Cracked Tubing

Troubleshooting
• Inspect the tubing and remove any kinks.
• Look for any cracks or leaks in the tubing.
• Check for creases which may indicate it is being crushed by the cover.
• Replace the tubing if necessary.
• Check flares to verify seal.
Related Diagnostics
DISSUB
• Tests the Substrate Pump dispensing volume.
• Transports five test units from the Load Chain to the substrate fill position.
• Dispenses 200 µl substrate into each test unit and moves them to the Sample Collection
Tray.
Instructions
• Place five test units on the Load Platform.

• The level of substrate should be just above the bead.
Substrate Nozzle is not dispensing straight down.
DISWAT
• Tests the Water Pump dispensing volume.
• Transports five test units from the Load Chain to the water fill position.
• Dispenses 200 µl of water into each test unit and moves them to the Sample Collection
Tray.
Instructions
• The level of water should be just above the bead.
nozzle is not dispensing straight down.

SUBSTRATE DISPENSE ISSUES
Clogged Substrate Nozzle

A clogged Substrate Nozzle can prevent the correct amount of substrate from dispensing
causing low CPS.
Troubleshooting
• Hold the Substrate Nozzle over an empty beaker.
• Check for white precipitate, remove with a kimwipe if present, and prime into a beaker
using the SOLE2S diagnostic.
• Inspect the Substrate Nozzle. Is it dispensing at an angle?
Clogged Air Filter in the Substrate Spike

A clogged air filter in the Substrate Spike will prevent the proper amount from dispensing.
Troubleshooting
• Look at the float.
• If it is at the top, remove the Substrate bottle until the float is lower.
• If it overflows, replace the Substrate Spike.
Note: Normal fluid expansion due to temperature and atmospheric pressure changes may
cause the float to rise above the fill line.
Defective Substrate Pump

Substrate or water is not being dispensed due to a defective pump or substrate is used up
too quickly.
Troubleshooting
• Check for leaks around the pump and red fittings.
• If nothing is leaking, let the Substrate Heater/Nozzle sit overnight over an empty beaker.
• If liquid leaks out overnight, the pump is not holding.
Mispositioned Test Unit

Troubleshooting
• If test units are not aligned under the Substrate Nozzle, consult with Field Service.

WATER DISPENSE ISSUES
Dried Up Water Pump Valve

Water is not being dispensed because the Water Pump Valve dried up to infrequent use of
the Instrument
Troubleshooting
• Verify the fittings on the pump are secure.
• Submerge the Water Nozzle into a clean beaker of fresh and clean distilled water and
run SOLE1W.
• This wets the valve and creates a good seal to get the water to pump through
consistently.
Note: You may have to elevate the Water Bottle to help the water flow to the pump.
Related Diagnostics
SOLE1W
• Used to check the dispense volume and/or drawback adjustment of the Water Pump.
Instructions
• Remove the thumbscrew holding the Substrate Heater and Water Nozzle in place.
• Lift the Substrate Heater.
• Disconnect the Water Nozzle.
• Hold a beaker under the Water Nozzle.
• Run the SOLE1W diagnostic.

NOISY SOLENOID PUMP
Note: A clicking noise indicates a dried valve/pump.
Noisy Water Pump

IMMULITE Note: If the Water Pump is not priming, raise the Water Bottle above the
Instrument to allow gravity to assist.
Troubleshooting
At startup:
• Check the Water Bottle. It may be empty.
• Check the fittings. Water may not be pumping because of an air leak.
• Check the seating of the tubing flare in the pump fitting.
• Run SOLE1W.
• Run DISWAT.
• The End of Line Filters (IMMULITE) or the Inline Filters (IMMULITE 1000) may need to
be replaced.
Noisy Substrate Pump

Troubleshooting
• The Substrate Spike may be clogged. Replace the Substrate Spike if necessary.
• Check the maintenance schedule.
• Run SOLE2S.
• Run DISSUB.

SYRINGE PUMPS
About the Syringe Pumps.................................................................................................274
Syringe A or B Overload Error .........................................................................................276
Bad Dilutor (Motor) ........................................................................................................276
Blocked Probe ...............................................................................................................276
Power Glitch or Interruption...........................................................................................277
Noisy or Squeaky Syringes when Priming......................................................................278
Imprecision Caused by Air ...............................................................................................279
Air in the Water or Probe Wash Bottle...........................................................................279
Clogged End of Line Filters (IMMULITE Only) ..............................................................279
Worn Flair ......................................................................................................................280
Faulty Macro & Micro Valves.........................................................................................280
Syringes Aren't Moving ....................................................................................................281
Loose Syringes..............................................................................................................281
Power Glitch ..................................................................................................................281
Valve Failure ......................................................................................................................282
Probe Wash not Dispensing ..........................................................................................282

ABOUT THE SYRINGE PUMPS

Left (Large) - Syringe A
• 5000 µL
• Pumps probe wash and water through Probe and Wash Well Station.
Right (Small) - Syringe B
• 250 µL
• Precision Syringe aspirates and subsequently delivers reagent, serum sample, and water
(distilled from external Water Bottle) to the test unit.

SYRINGE A OR B OVERLOAD ERROR
Note: May be caused by a bad Syringe Tip, bad Syringe, or bad Dilutor (motor).
Syringe Tips (or Syringe not Seated Properly)

Syringe Tips may be off the plunger and stuck in the barrel, or worn. This could be the cause
of poor maintenance.
Troubleshooting
• Reseat the Syringe.
• For older Instruments, determine if the Syringe Tips are current.
• Determine when the Syringe Tips were replaced.
• Verify that they are seated properly in the Syringes.
• If necessary, replace Syringe Tips using the SCHANGE diagnostic.
• It may be necessary to replace the entire Syringe.
Bad Dilutor (Motor)

Troubleshooting
• Remove the Syringe and run the PRIME diagnostic.
If the error persists and the Syringe is removed, it may be an issue with the motor.
Consult Field Service.
If the error ceases, replace the Syringe Tip or the Syringe.
Note: Do not run PRIME if the Syringe is removed with the Euro style dilutor. Doing so will
cause a jam.
Blocked Probe
An obstruction may cause the Probe to dispense off center.
Troubleshooting
Note: Never attempt to remove a blockage by inserting a stylet or any other object into the
Probe.
• Check dispense angle using the PROBANGL diagnostic.
• Run PRIME to check for an obstruction.
The 5000 µl Syringe stops for one second during dispense to switch valves.
At that moment water should come out in drips.
If not, this indicates the release of back pressure from the fluidics due to an
obstruction in the Probe or tubing, or the presence of air.
• Replace the Probe if the Probe is blocked.

Power Glitch or Interruption
Note: If the Dilutor, Syringe, and Probe were ruled out, the syringe overload error may be
caused by a power glitch (uncommon).
Troubleshooting
• Power the Instrument off for 10 seconds, then on.
• Run the PRIME diagnostic to see if the errors continue to occur.

NOISY OR SQUEAKY SYRINGES WHEN PRIMING
Troubleshooting
• Determine if the Syringe Tips were changed recently.
• If so, exercise the Syringes. Replace the Syringe Tips and run PRIME.
• If the squeaking continues:
Remove the Syringes.
Run PRIME with the Syringes removed. Do not do this with the Euro-style Dilutor. It
will jam.
If the noise disappears, the Syringes are probably causing the squeaking.
If the noise continues, the Dilutor Module is probably the cause. Troubleshoot the
Dilutor Module.

IMPRECISION CAUSED BY AIR
Note: Forward-moving bubbles indicate an air leak. If the bubbles are dancing, a blockage
may be to blame.
Air in the Water or Probe Wash Bottle

Air bubbles will appear if the Water or Probe Wash Bottle is empty, the tubing inside the
bottles is not under liquid level, or a fitting is loose.
Troubleshooting
• Ensure the Water and Probe Wash Bottles have enough liquid in them.
• IMMULITE:
Ensure that the fittings are secure on the bottles.
Check if the white air filter plug is missing from one or both of the lids.
Next, put the lines directly into the bottles and run PRIME.
If the bubbles disappear, the end of line filters may be clogged.
Replace the End of Line filters.
• IMMULITE 1000:
Verify that the tubing connectors are securely snapped into the caps.
Use the PRIME diagnostic to remove any air from the lines.
Loose Tubing Fittings

Troubleshooting
• Check for leaks around the fittings and tubings (including the fitting on the Water Pump).
• Verify that all fittings are secure.
Note: Secure means not too tight (can strip a fitting) or too loose.
Clogged End of Line Filters (IMMULITE Only)

Troubleshooting
• Remove the filters.
• If the bubbles stop, replace the end of line filters.
• Prime for 10 minutes to saturate the new filters.
Syringe Tips (or Syringe not Seated Properly)

Syringe Tips may be off the plunger and stuck in the barrel, or worn. This could be the cause
of poor maintenance.
Troubleshooting
• Reseat the Syringe.

• For older Instruments, determine if the Syringe Tips are current.
• Determine when the Syringe Tips were replaced.
• Verify that they are seated properly in the Syringes.
• If necessary, replace Syringe Tips using the SCHANGE diagnostic.
• It may be necessary to replace the entire Syringe.
Kinked or Cracked Tubing

Troubleshooting
• Inspect the tubing and remove any kinks.
• Look for any cracks or leaks in the tubing.
• Check for creases which may indicate it is being crushed by the cover.
• Replace the tubing if necessary.
• Check flares to verify seal.
Worn Flair
A flair at the ends of the tubing may be worn.
Troubleshooting
• The account can replace the tubing.
Faulty Macro & Micro Valves

Troubleshooting
• To check the Valves, verify there is not any space between the valve and the back of the
Dilutor. Valves should sit flush against the Dilutor.
• If necessary, push the valve against the Dilutor.
• Run the PRIME diagnostic
Note: Macro and Micro Valves may attach by a lever on the older style of the Hamilton
Pump Assembly.
• Reseat the Macro and Micro Valve blocks by releasing the lever on the bottom of
each valve.
• Push the valve in to reseat and relock the lever.

SYRINGES AREN'T MOVING
Loose Syringes
Syringes were not tightened or screwed in correctly.
Troubleshooting
• Verify the Syringes are secure.
• Run PRIME to verify there is power.
Power Glitch
A power interruption disrupted communication between the CPU and the Dilutor (pump)
assembly, or the logic board is confused.
Troubleshooting
• Run PRIME.
• Turn the power off for one minute. Then run PRIME again.

VALVE FAILURE
Probe Wash not Dispensing

Valve #2 is not activating, the filter is clogged, or air is leaking into the system.
Troubleshooting
• Check if the tubings or fittings are leaking.
• Check the Large Syringe for bubbles or an air slug.
• Place the tubing lines directly into the bottle and see if the problem persists. (IMMULITE
only)
• Replace the filters.
Note: Very low CPS could be caused by probe wash leaking into the system, which is
caused by Valve 2 failure. Consult with Field Service if this is suspected.

TEMPERATURES
About Temperatures .........................................................................................................284
Luminometer Temperature ............................................................................................284
Main Incubator Carousel Temperature..........................................................................284
Reagent Carousel Temperature ....................................................................................284
System Ambient Temperature.......................................................................................284
Electrical Ambient Temperature ....................................................................................284
Viewing Temperatures ......................................................................................................285
TEMPS ..........................................................................................................................285
Viewing Temperatures within the Software ...................................................................285
Temperature Controller Status LEDs ..............................................................................286
Temperature Controller Status LED Table ....................................................................287
Troubleshooting.............................................................................................................287

ABOUT TEMPERATURES
Temperatures controlled areas of the Instrument:
• Luminometer (Heated)
• Main Incubation Carousel (Heated)
• Reagent Carousel (Cooled)
Two other areas are monitored:
• System Ambient Temperature
• Electrical Ambient Temperature
Luminometer Temperature
• Specification: 36.9 to 37.1 degrees C
• Can take up to 45 minutes to reach this specification when the Instrument is powered on.
• The alarm will be activated below 36.8 and above 37.2 degrees C.
Main Incubator Carousel Temperature

• Specification: 36.5 to 37.5 ° C
• The alarm will be activated below 36 and above 38 ° C.
Reagent Carousel Temperature

• Specifications: 15.5 to 17 ° C.
• Will not begin to cool until the Luminometer and incubator are above 35 ° C.
• The alarm will be activated above 22 ° C.
System Ambient Temperature

• This is the temperature of the Instrument when the main cover is closed.
• The temperature at which an alarm will be activated is above 34 ° C.
Electrical Ambient Temperature

• This is the temperature of the area in which the main PCBs are located.
• The temperature at which an alarm will be activated is 40 ° C.
Note: Extreme temperature conditions can affect Instrument performance.

VIEWING TEMPERATURES
There are two ways to view temperatures on the IMMULITE and the IMMULITE 1000.
• Use the TEMPS diagnostic
• Access temperatures from the System Status menu within the software.
TEMPS
• Used to monitor Instrument temperatures.
• The temperatures are updated every 30 seconds.
• Run Getdatat or enter PC mode if the Instrument is running in Standard Mode, or
PCSTAT if the Instrument is in Turbo Mode.
• Press the Space Bar to update the temperatures.
Viewing Temperatures within the Software
IMMULITE IMMULITE 1000

Select System Status, Temps/Dark Counts. From the System Status menu, select
Temps/PMT Counts
The latest temperature data will be displayed if Press GO on the Instrument to ensure the
the Instrument is in RUN mode. temperatures display.
Note: Temperatures will not be sent until daily startup is completed and the Display Panel reads,
"DPC IMMULITE RUNNING."
Press <Space Bar> to update the screen. New Temperatures update automatically every 30
temperatures are sent every 30 seconds. seconds.
The average temperature on the screen is the average of the last ten readings. Therefore, unless the
Instrument has been running for five minutes, no data will be displayed.
Note: On rare occasions, a Delta Error may
occur. This indicates that the IMMULITE
software has no temperature information or the
temperature data is not current and a message
is needed from the Instrument. Press <Esc> and
view the repeat the procedure beginning with
step one.

TEMPERATURE CONTROLLER STATUS LEDS
Four LEDs are located on the Motor/Heater PCB in the back of the Instrument. Always refer
to the Temperature Controller Status LED Table on page 243 when troubleshooting
temperature errors.
Normal Sequence of LEDs from Left to Right
• L4 (TED cooler): On/Off
When cooling, the light is on.
When the desired temperature is reached, the LED is off.
• L3 (Luminometer Heater): Blinking (5 Hz)

Light is steady at first heat to 35C.
• L2 (Carousel Heater): Blinking (5 Hz)

Light is steady at first to heat to 35C.
• L1 (Time Hack): Blinking Low (1 Hz)

The control microprocessor LED, called the time hack, indicates the microprocessor
is active.
Blinks at a rate of 1 time per second.
This LED indicates that the temperature control circuitry is functional.
L1 must be blinking or the other LEDs and displayed temperatures are invalid.

Temperature Controller Status LED Table
L4 L3 L2 L1
TED (Cooler) Lum Heater Carousel Heater Time Hack
ON Temp is above Lum temp is Car temp is Microprocessor
16.5°C below 35°C. below 35°C. had a fatal error.
The status of all
other LEDs and
temperature
readings on the
screen are
invalid.
OFF Temp is above Lum temp is Car temp is Microprocessor
16.5°C above 39°C. above 39°C. had a fatal error.
Cooler has shut A full A Full The status of all
down due to a Temperature Temperature other LEDs and
Heater or Cooler Controller Controller temperature
Temp error. Shutdown has Shutdown has readings on the
Lum and/or occurred. occurred. screen are
Carousel have invalid.
not reach 35°C
Blinking Heaters and Heaters and Heaters and Microprocessor
@ 1 Hz Cooler have shut Cooler have shut Coolers have is functional and
down due to down due to a shutdown due to the CPU and
Cooler Temp Lum Temp High Car Temp High Motor Driver
error. error. error. PCBs are
A Full A Full communicating.
Temperature Temperature
Controller Controller
Shutdown has Shutdown has
occurred. occurred.
Blinking N/A Lum temp is Car temp is N/A
@ 5 Hz above 35°C and above 35°C and
below 39°C. below 39°C.
Troubleshooting
• Turn on the Instrument and monitor the temperatures for 15 minutes.
• Call customer 30 to 45 minutes later for an update.

WATER
Water Quality .....................................................................................................................290
Water Issues Are Suspected ............................................................................................291
Frequently Affected Assays...........................................................................................291
Initial Troubleshooting ...................................................................................................291
Testing the Water Supply .................................................................................................292
Instructions ....................................................................................................................292
WATERTST (IMMULITE) ..............................................................................................293
WATERTPM (IMMULITE) .............................................................................................294
WATERTST (IMMULITE 1000) .....................................................................................295
WATERTPM (IMMULITE 1000) ....................................................................................296
Acceptability Guidelines...................................................................................................297
CPS for All Water Tests.................................................................................................297
WATERTST Guidelines.................................................................................................297
WATERTPM Guidelines ................................................................................................298
Stubborn Contamination................................................................................................298
Instructions for Substrate Decon.....................................................................................299

WATER QUALITY
Some of this information was adapted from IMMULITE Operator Note 0009 and IMMULITE
1000 Operator Note 0002 (August 2, 2004).
Note: See the IMMULITE Systems Water Quality InfoBulletin (July 25, 2001) for detailed
information about water quality.
Water Requirements
• The Instrument requires distilled or de-ionized water of consistent quality.
• Water used should meet NCCLS Type 1 reagent water standards at the time of
preparation. According to NCCLS, the specs for Type I water are:
Resistivity: >10 Megohm-cm measured in-line in the water treatment system
Microbial: <10 CFU/ml
Silicate content: 0.05 mg/L
Water must be passed through 0.22 um filter to remove particulates
Water is generally treated with activated carbon to remove organics
• 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.
• In addition, Instruments require a pH greater than 5.5.
Testing for Contamination
The substrate used on the Instrument is sensitive to the presence of alkaline phosphatase
resulting from microbial contamination of the water or of the containers used to store or
transport the water.
• Before using any water on the Instrument, it should be tested for alkaline phosphatase
contamination.
• See Testing the Water Supply on page 292 for more information.
Precautions
High quality reagent water can become contaminated with alkaline phosphatase during
storage and transport. To ensure water quality, DPC makes the following recommendations:
• Keep commercial water systems properly cleaned and maintained.
• Do not use water from a commercial water system during maintenance of the water
system. After maintenance, verify water quality and test the water for alkaline
phosphatase contamination before using it on an Instrument.
• Verify and maintain cleanliness of storage containers, transfer containers, spigots, hoses,
or other plumbing used to transfer water from its source to the Instrument.
• Do not store water in containers for long periods of time. Fill the water bottles directly
from the water system if possible.
• Avoid prolonged exposure of containers/bottles to direct sunlight or heat.
• Maintain the cleanliness of the containers on the system.

WATER ISSUES ARE SUSPECTED
Frequently Affected Assays

Water issues can affect some assays, but not all of them. Frequently affected assays are:
• hCG
• Progesterone
• ATG
• Testosterone
• TSH
• Folate
• PTH
• PSA
• E2
• Vitamin B12
• ATA
Initial Troubleshooting
If water issues are suspected, determine the following:
• Was anything done recently to the water system?
• If a main filtration system is used, were the filters changed recently?
• Is monthly maintenance current?
• When was the last WATERTST and WATERTPM performed? If the results are recent
(less than a couple of days old), review them to determine if they are acceptable.
• When was the last DECON performed?
• Is a transport bottle used? If so, when was the last time it was decontaminated?
• Is the spigot contaminated?
• Is the water bottle in direct sunshine?
• Are gloves being worn? Always wear gloves when dealing with fluidics.

TESTING THE WATER SUPPLY
Note: Step-by-step instructions for the diagnostics referenced in the procedure below are
located on the following pages:
IMMULITE: WATERTST on page 293 and WATERTPM on page 294
IMMULITE 1000: WATERTST on page 295 and WATERTPM on page 296
Instructions
Note: Verify that new water test units are being used. Water test units are designed for one-
time use only.
1. Run WATERTST. Acceptable WATERTSTs do not guarantee water is optimal since
WATERTST only tests for Alkaline Phosphatase contamination.
2. If the WATERTST meets the guidelines:
Perform a DECON followed by WATERTPM.
Note: Do not use Alcohol to decontaminate the following: An IMMULITE or IMMULITE
1000 system with Euro Dilutors.
3. Review the results and determine if they are acceptable. See Acceptability Guidelines on
page 297 for more information.
Note: If a customer is using the GETDATAT program, the IMMULITE water test results
must be manually multiplied by the PMT factor of the Instrument. If a customer is using
the WATER program, the water test results have been multiplied by the PMT factor in the
software. The printed water test results reflect this.
4. If the water test results are acceptable and issues still exist, prime the Water and
Substrate Pumps and try the following:
Fresh controls
Adjustment with fresh adjustors
New kit
Note: If the results for Substrate Only are elevated for WATERTST and WATERTPM,
see Instructions for Substrate Decon on page 299.
5. If suggestions in step 4 do not work, a new water source should be considered. Any new
water source must be tested with WATERTST.
Note: Reintroducing bad water into a clean system allows the problem to persist.

WATERTST (IMMULITE)
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.
Note: A Test Failed Error occurs when an insufficient amount of water test units have
been placed on the load chain for the corresponding water test. (WATERTST requires
two water test units, and WATERTPM requires four 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.
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. 200 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.
11. Once the Test Units start moving on the Load Chain, press [Esc] and choose EXIT TO
DOS.
12. At the DOS prompt, type water and press [Enter].
13. 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.
14. Once the readings print, press [Esc] to exit.
15. Type start and press [Enter] to return to the IMMULITE Start-up menu.
16. Refer to the Acceptability Guidelines on page 297 to determine the outcome of this test.

WATERTPM (IMMULITE)
1. Ensure the printer is online.
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.
Note: Before priming, position Substrate Nozzle over empty container.
3. Select four new and empty water test units. Do not pipette any water into the test units.
4. Place the four empty water test units on the Load Platform.
5. Select DIAGNOSTICS from the next menu and press [Enter].
6. Use the arrow keys to select WATERTPM and press [Enter].
7. When the download is complete, press [Enter].
8. Press GO on the IMMULITE display panel when prompted. The IMMULITE begins the
WATERTPM diagnostic program.
9. 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.
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]. The following screen appears:
12. 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.
13. 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.
14. Type start and press [Enter] to return to the IMMULITE Start-up menu.

WATERTST (IMMULITE 1000)
1. Check to make sure the daily maintenance has been done and the substrate line has
been sufficiently primed.
2. Select two empty water Test Units.
3. Manually pipette 50 µL of water directly from the source into the first Test Unit only.
4. 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).
5. Select the DIAGNOSTICS button on the Start-up screen to access the Common
Diagnostics screen.
Note: The IMMULITE 1000 must be in Idle mode to run diagnostics.
6. Select the WATERTST button and select the RUN button to initialize the diagnostic
program.
7. Press GO (on the Instrument Display Panel) when instructed to do so. Substrate is
dispensed into the Test Units. The Test Units are then moved into the Luminometer and
incubated for 10 minutes.
8. Select the VIEW button.
Note: This screen must be displayed when water test units are at the PMT. Otherwise,
results will not display.
9. After the results display, select the Save Data button to launch the Save As dialog box to
save the results as a file.
10. Select the Retrieve Data button to view a previously saved Water TST file.
11. Select the Print Screen button to print the screen.
12. Select the EXIT button to return to the Water TST screen.

WATERTPM (IMMULITE 1000)
1. Check to make sure daily maintenance has been done and the substrate line was
sufficiently primed.
2. Select four empty water Test Units. Do not pipette water into any of the Test Units.
3. Load all four water Test Units onto the Load Chain.
4. From the Start-up screen, choose DIAGNOSTICS to view the Common Diagnostics
screen.
5. Select the WATERTPM button and select the RUN button to initialize the program.
6. Press GO (on the Instrument Display Panel) when instructed to do so.
The following processes occur:
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.
Substrate is added to the first, third, and fourth Test Units.
The Test Units are incubated in the Luminometer for 10 minutes and readings are
taken.
7. Select the VIEW button.
Note: This screen must be displayed when water test units are at the PMT. Otherwise,
results will not display.
8. After the results display, select the Save Data button to save the results.
9. Select the Retrieve Data button to view a previously saved Water TPM file.
10. Select the Print Screen button to print the screen.
11. Select the EXIT button to return to the Water TPM Screen.
Note: The first result is for the water from the probe, the second is for the water from the
wash station, and the third is for the Test Unit containing substrate.
12. Select the CLOSE button to return to the Start-up screen.

ACCEPTABILITY GUIDELINES
Note: If the results for Substrate Only are elevated for WATERTST and WATERTPM, see
Instructions for Substrate Decon on page 299.
CPS for All Water Tests

For all water tests, the CPS for each test unit should be >4,500 CPS and <9,000 CPS.
• If the CPS is <4500:
Substrate volume was insufficient.
Too much water was added. Confirm the operator measured the water (50 µl)
properly.
• If the CPS is >9000, Alkaline phosphatase contamination is likely.
Perform DECON with 0.1M NaOH or probe wash.
After DECON, if water tests results do drop but remain higher than 9000 CPS,
decontaminate a second time to ensure that the contamination was completely
removed. In addition, soak the water and substrate nozzles in alcohol.
Notes:
• If CPS remains slightly above 9000 CPS after performing two DECONs, the
instrument may not be contaminated.
• Verify previous water test results because the results may be normal for this system.
• Soak water and substrate nozzles in 70% isopropyl alcohol for 5-10 minutes.
WATERTST Guidelines
For WATERTST, refer to the last printed line of results:
External water source - Substrate only = XXX CPS

• If CPS 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. Verify substrate is dispensing properly. Prime the
Substrate Pump and repeat WATERTST.
Check both test units to determine if they contain enough substrate.
Check the water pH if possible.
• If the CPS is above 2000 CPS
The water source may be the issue.
Find a new water source and test the new source.
Be aware that pH also affects this.
If a new water source was used, the system must be decontaminated using the new
water source.

WATERTPM Guidelines
For WATERTPM, refer to the last two lines of printed results:
Probe water - substrate only = XXX CPS

Pump water - substrate only = XXX CPS
• If the CPS for either equation 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. Verify the substrate dispense volume. Prime and repeat
WATERTPM.
Visually check all test units to determine if the liquid level is equally distributed
between the test units.
• If the CPS above is above 2000 CPS:
Perform the test again to confirm these results.
Then decontaminate the system with 0.1M NaOH or probe wash.
Stubborn Contamination
For contamination issues that cannot be resolved after multiple decons, and if pump water
minus substrate is greater than 2000:
• Perform a DECON with 0.1M NaOH.
• While DECON is running, press and hold the Prime button on the water pump to extend
the bellows in the pump.
Note: Alternatively, tape the prime button down instead of pressing and holding it.
• Allow to sit for 30 minutes.
• Soak water and substrate nozzles in alcohol for 15 minutes.
Note: If probe water minus substrate only is greater than 2000 after multiple DECON
attempts (not historically typical), replace the probe.

INSTRUCTIONS FOR SUBSTRATE DECON
When performing WATERTPM, if substrate only CPS are >10,000, then substrate decon
should be performed. Verify that new water test units were used.
IMPORTANT: Consult with Field Service before performing a substrate decon.
1. Before beginning, verify that the customer has one bottle of 0.1M NaOH and two brown
bottles of DI water on hand.
2. Home the Shuttle to the left.
3. Remove the substrate bottle and discard if older than 30 days.
4. Replace the Substrate Spike.
5. Run SOLE2S to empty the substrate reservoir.
Note: Make sure shuttle is in the “home” position before starting Decon.
6. Place the bottle containing NaOH on spike.
7. Fill reservoir using gray prime button. The float should be about ¾ of the way up.
8. Prime using SOLE2S.
9. Stop SOLE2S and let NaOH sit for 20 minutes
10. Run SOLE2S to empty the remaining NaOH in the bottle.
11. When the substrate bottle is empty, replace with bottle of DI water.
12. Prime using SOLE2S until empty.
13. When empty, place the second bottle of DI water on spike and run SOLE2S until empty
to rinse thoroughly.
14. Place a new bottle of substrate on spike. Fill reservoir using SOLE2S.
15. Run WATERTPM to check the substrate CPS.
16. Run controls and determine if readjustment is necessary.

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What troubleshooting steps are described for high substrate CPS values during a WATERTPM test?

What troubleshooting steps are described for high substrate CPS values during a WATERTPM test?

What are the guidelines provided for interpreting WATERTPM test results?

What are the guidelines provided for interpreting WATERTPM test results?

IMMULITE® & IMMULITE 1000

Document Number: 600858

Copyright © 2007 by Siemens Medical Solutions Diagnostics. All rights reserved.

IMMULITE® is a registered trademark of Siemens Medical Solutions Diagnostics.

Siemens Medical Solutions Diagnostics

Siemens Diagnostics' quality products are manufactured under a quality

ii 600858-A IMMULITE & IMMULITE 1000 Troubleshooting Guide

IMMULITE & IMMULITE 1000 Troubleshooting Guide 600858-A iii

iv 600858-A IMMULITE & IMMULITE 1000 Troubleshooting Guide

DISCORDANT RESULTS ............................................................................................ 63

ERROR MESSAGES, CAUSES, AND SOLUTIONS................................................... 69

HARDWARE .............................................................................................................. 129

IMMULITE & IMMULITE 1000 Troubleshooting Guide 600858-A v

IMMULITE 1000 SOFTWARE.................................................................................... 145

IMMULITE SOFTWARE............................................................................................. 155

vi 600858-A IMMULITE & IMMULITE 1000 Troubleshooting Guide

LIS (LABORATORY INFORMATION SYSTEM) ....................................................... 175

LOAD PLATFORM & LOAD CHAIN ......................................................................... 189

IMMULITE & IMMULITE 1000 Troubleshooting Guide 600858-A vii

MAIN INCUBATION CAROUSEL.............................................................................. 209

viii 600858-A IMMULITE & IMMULITE 1000 Troubleshooting Guide

PRECISION & ACCURACY....................................................................................... 227

REAGENT CAROUSEL ............................................................................................. 235

IMMULITE & IMMULITE 1000 Troubleshooting Guide 600858-A ix

SAMPLE & TEST UNIT BARCODE READER .......................................................... 247

SUBSTRATE & WATER PUMPS .............................................................................. 265

x 600858-A IMMULITE & IMMULITE 1000 Troubleshooting Guide

SYRINGE PUMPS...................................................................................................... 273

IMMULITE & IMMULITE 1000 Troubleshooting Guide 600858-A xi

xii 600858-A IMMULITE & IMMULITE 1000 Troubleshooting Guide

IMMULITE & IMMULITE 1000 Troubleshooting Guide 600858-A 1

IMMULITE 1000 Errors

2 600858-A IMMULITE & IMMULITE 1000 Troubleshooting Guide

IMMULITE & IMMULITE 1000 Troubleshooting Guide 600858-A 3

4 600858-A IMMULITE & IMMULITE 1000 Troubleshooting Guide

IMMULITE & IMMULITE 1000 Troubleshooting Guide 600858-A 5

IMMULITE & IMMULITE 1000 Troubleshooting Guide 600858-A 7

Sandwich Assay (e.g., hCG, TSH)

8 600858-A IMMULITE & IMMULITE 1000 Troubleshooting Guide

10 600858-A IMMULITE & IMMULITE 1000 Troubleshooting Guide

CAF (Chemiluminescence Attenuation Factor)

Summary of Data Reduction

12 600858-A IMMULITE & IMMULITE 1000 Troubleshooting Guide

Interpreting Adjustment Results

IMMULITE & IMMULITE 1000 Troubleshooting Guide 600858-A 13

Patient Sample Flags

Calculated Intercept Cutoffs

14 600858-A IMMULITE & IMMULITE 1000 Troubleshooting Guide

IMMULITE & IMMULITE 1000 Troubleshooting Guide 600858-A 15

T3 Uptake, Allergy, and Infectious Disease Assays

16 600858-A IMMULITE & IMMULITE 1000 Troubleshooting Guide

Allergy and Infectious Disease Assays

IMMULITE & IMMULITE 1000 Troubleshooting Guide 600858-A 17

Sandwich Qualitative Assay

Competitive Qualitative Assay