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System
Troubleshooting
Guide
Abbott Laboratories
Abbott Park, IL 60064
94816-107—November 2004
©1998, 2004 Abbott Laboratories
AEROSET is a Registered Trademark of
Abbott Laboratories
PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Not for Customer Distribution
2
AEROSET
®
System Troubleshooting Guide
94816-107—November 2004
NOTES
PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Not for Customer Distribution
AEROSET
®
System Troubleshooting Guide 3
94816-107—November 2004
Revision Status
Document Control
Number(s)
Revision Date Section(s)
Revised
Pages Revised and
Added
30-0897/R1 9/98 Original Issue Original Issue
30-1762/R2 1/00 All Sections All Pages
94816-101 6/01 All Sections All Pages
94816-102 4/02 All Sections All Pages
94816-103 6/02 All Sections All Pages
94816-104 2/03 All Sections All Pages
94816-105 6/03 All Sections All Pages
94816-106 12/03 All Sections All Pages
94816-107 11/04 All Sections All Pages
PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Not for Customer Distribution
4
AEROSET
®
System Troubleshooting Guide
94816-107—November 2004
Highlights of Changes from Previous AEROSET System
Troubleshooting Guide (94819-106)
NOTE: This section is intended as a guide to highlight
major and significant changes to this version of the
AEROSET System Troubleshooting Guide, Part
Number 94816-107. It is NOT intended to be a
comprehensive description of all changes to the guide
and/or AEROSET System functionality, hardware, and
reagent applications.
Overview
• The organization of the Assays/Reagents section of the
AEROSET System Troubleshooting Guide was updated;
it is now divided into General Information and
Assay-specific Information subsections.
1. If troubleshooting information for a specific assay is
available, it is listed alphabetically in Assay-specific
Information. If an assay-specific subsection does not
exist, no additional troubleshooting information is
currently available.
2. Previously, some assays, e.g., MULTIGENT
®
assays,
included Assay-specific Questions sections. These
Question and Answer sections were expanded and
renamed Frequently Asked Questions (FAQ).
• The Question and Answer format of some sections in the
Troubleshooting Guide was eliminated, with the
exception of assay-specific Frequently Asked Questions
(FAQ).
• Procedures to verify Limit of Detection (LOD) and Limit of
Quantitation (LOQ) were consolidated into one
subsection, Verification Procedures in Assays/Reagents,
General Information.
• Assay-specific cross reactivity information for Drugs of
Abuse (DOA) assays is now located in Assay-specific
Information.
PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Not for Customer Distribution
AEROSET
®
System Troubleshooting Guide 5
94816-107—November 2004
• Some information previously included in the
Troubleshooting Guide was eliminated because it
duplicated information that is readily available to
customers in other secondary labeling, e.g., Abbott
Clinical Chemistry Package inserts or the AEROSET
System Operations Manual. Major sections that were
eliminated include:
1. Specific SmartWashâ„¢ parameters
2. Specific method comparison, interference, and limit
of detection information for DOA assays
3. Specimen collection requirements for MULTIGENT
®
assays
Specific Changes and/or New Information
• Mercury warning symbol and information added.
• New information for the C-Reactive Protein and
Rheumatoid Factor assays added to Assays/Reagents,
Assay-specific Information.
• Information for the MULTIGENT Microalbumin assay
added to Assays/Reagents, Assay-specific Information.
The chemical reaction for MULTIGENT Microalbumin
added to Chemical Reactions for Clinical Chemistry Assays.
• New information for the Specific Proteins assays added to
both the Assays/Reagents, General Information and
Assays/Reagents, Assay-specific Information sections.
• Product information for Abbott Clinical Chemistry
calibrators added.
• A list of applicable assays for each control was added to the
Bio-Rad Control Products information table.
• A general Specimen Collection and Handling section was
created by consolidating various assay-specific
information in the previous Troubleshooting Guide.
• Additional information for the Therapeutic Drug
Monitoring (TDM) assays, including Frequently Asked
Questions (FAQ), added to Assays/Reagents, General
Information.
• CK assay—explanation of issues with FlexRate™ linearity.
PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Not for Customer Distribution
6
AEROSET
®
System Troubleshooting Guide
94816-107—November 2004
• Magnesium assay—new assay-specific information added
to describe necessary parameter edits when converting
units from mEq/L to mg/dL.
• Software section—new screen graphics with software
version 1.03ER000. This includes:
– SYSTEM CONFIGURATION screen
– PAGE SETUP screen (Form 1 and Form 2)
– Log On screens (two)
– Assay Configuration screen, Rerun Rules page
– MAINTENANCE UTILITIES screen, SW Info page
– MAINTENANCE UTILITIES screen, Sampling page
– Pressure Monitor screen
•Updated Unit Configuration screen default settings in
System Configuration.
PROPRIETARY INFORMATION
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AEROSET
®
System Troubleshooting Guide 7
94816-107—November 2004
Table of Contents
Revision Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Highlights of Changes from Previous AEROSET System
Troubleshooting Guide (94819-106) . . . . . . . . . . . . . . . . . . 4
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Specific Changes and/or New Information . . . . . . . . . . . 5
Table of Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Proprietary Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Pictorial Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Troubleshooting Guide Usage Disclaimers . . . . . . . . . . . . . . 16
Master Table of Contents/Index Disclaimer . . . . . . . . . . . . . 17
Trademark Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Assays/Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Assay Configuration/Installation . . . . . . . . . . . . . . . . . . . . . 21
Drugs of Abuse (DOA) Assays . . . . . . . . . . . . . . . . . . . . . 21
Cutoff Calibrator Values . . . . . . . . . . . . . . . . . . . . . 21
Qualitative Assay Configuration . . . . . . . . . . . . . . . 22
Print Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Factor Mode—Numeric Results . . . . . . . . . . . . 23
Example of Factor Mode—Numeric Results
Printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Factor Mode—POS/NEG Results . . . . . . . . . . . 26
Example of Factor Mode—POS/NEG Results
Printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Absorbance Mode . . . . . . . . . . . . . . . . . . . . . . . 29
Example of Absorbance Mode Results
Printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Summary of Print Options . . . . . . . . . . . . . . . . 32
ICTâ„¢ Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
I-Index—Calibrator/Control Position 42 . . . . . . . . 32
Biohazardous Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Mercury Warning Symbol . . . . . . . . . . . . . . . . . . . . . . . . 33
Calculated Assay Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Recalculating Calculated Assay Results . . . . . . . . . . . . . 34
Calibration Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Drugs of Abuse (DOA) Assays . . . . . . . . . . . . . . . . . . . . . 35
Ethanol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Qualitative Assays. . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Enzyme Factor Calculation . . . . . . . . . . . . . . . . . . . 37
Use Cal Factor From . . . . . . . . . . . . . . . . . . . . . . . . 38
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8
AEROSET
®
System Troubleshooting Guide
94816-107—November 2004
Calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Multiconstituent Calibrator (MCC), LN 1E65 . . . . . . . . .39
Product Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Chemical Reactions for Clinical Chemistry Assays . . . . . . . .42
Drugs of Abuse (DOA) Assays . . . . . . . . . . . . . . . . . . . . . . . . .60
Assay Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
Cross Reactivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
Method Comparison . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
MULTIGENT
®
Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66
Manufacturer Information . . . . . . . . . . . . . . . . . . . . . . . .66
Plasma Claims for Gel Barrier Tubes . . . . . . . . . . . . . . . . . . .67
Proficiency Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68
AAB Reagent Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68
CAP Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69
Serum Survey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69
Urine Survey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71
CSF Survey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71
Immunology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71
Therapeutic Drug Monitoring . . . . . . . . . . . . . . . . . .72
Urine Drug Testing (Drugs of Abuse) . . . . . . . . . . . .72
Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73
Bio-Rad Control Products . . . . . . . . . . . . . . . . . . . . . . . . .73
Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . .76
Bio-Rad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76
Biochemical Diagnostics, Inc. . . . . . . . . . . . . . . . . . .76
Establishing Quality Control Limits . . . . . . . . . . . . . . . .77
Temporary Quality Control Limits . . . . . . . . . . . . . .77
Permanent Control Limits . . . . . . . . . . . . . . . . . . . .78
Temporary Control Limits Worksheet . . . . . . . . . . .79
Reagent Test Count Tracking . . . . . . . . . . . . . . . . . . . . . . . . .80
Reagent Test Counts . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80
Sample Blanking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81
Self Blank vs. Non-Self Blank . . . . . . . . . . . . . . . . . . . . . .81
Self Blank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81
Non-Self Blank . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81
Sample Interference Indices . . . . . . . . . . . . . . . . . . . . . . . . . .82
SmartWashâ„¢ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
SmartWash (Reagent Carryover) When Moving A and
B-Line Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
SmartWash Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . .84
SmartWash for Non-Abbott Reagent Applications . . . . . .84
Specific Proteins Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85
Imprecision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85
Bar Code Read Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . .85
Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . . .86
PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
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AEROSET
®
System Troubleshooting Guide 9
94816-107—November 2004
Specimen Collection and Handling . . . . . . . . . . . . . . . . . . . 88
Therapeutic Drug Monitoring (TDM) Assays . . . . . . . . . . . . 89
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Troubleshooting Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . . . 90
Verification Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Confirming the Limit of Detection (LOD) . . . . . . . 92
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Limit of Detection for Abbott Assays Data Sheet . . 94
Limit of Detection for Abbott Assays Data
Sheet Example . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Confirming the Limit of Quantitation (LOQ) . . . . 96
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Limit of Quantitation for Abbott Assays Data
Sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Limit of Quantitation for Abbott Assays Data
Sheet Example . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Assay-specific Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Acid Phosphatase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Method Comparison . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Albumin BCG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Observed Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Alkaline Phosphatase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Observed Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
ALT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Ammonium Heparin Tube Not Acceptable . . . . . . . . . 104
ALT/AST Activated Versus ALT/AST . . . . . . . . . . . . . . . . . . 104
Differences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
ALT Activated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Ammonium Heparin Tube Not Acceptable . . . . . . . . . 104
Amphetamine/Methamphetamine . . . . . . . . . . . . . . . . . . 105
Cross Reactivity Testing Performed on the AEROSET
System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Amylase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Interference Information . . . . . . . . . . . . . . . . . . . . . . . 106
Apolipoprotein A1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Apolipoprotein B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
AST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Ammonium Heparin Tube Not Acceptable . . . . . . . . . 109
AST Activated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Ammonium Heparin Tube Not Acceptable . . . . . . . . . 109
Observed Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
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AEROSET
®
System Troubleshooting Guide
94816-107—November 2004
Barbiturates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110
Cross Reactivity Testing Performed on the AEROSET
System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110
Benzodiazepines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .112
Cross Reactivity Testing Performed on the AEROSET
System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .112
Calcium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .114
Observed Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . .114
Cannabinoids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115
Cross Reactivity Testing Performed on the AEROSET
System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115
Troubleshooting Imprecision . . . . . . . . . . . . . . . . . . . . .116
Cocaine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .117
Cross Reactivity Testing Performed on the AEROSET
System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .117
Complement C3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .119
Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . .119
Complement C4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .120
Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . .120
C-Reactive Protein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .121
Standard Material Recovery . . . . . . . . . . . . . . . . . . . . . .121
Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . .121
Creatine Kinase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125
Digoxin (MULTIGENT
®
) . . . . . . . . . . . . . . . . . . . . . . . . . . .125
Spironolactone/Canrenone Interference Results . . . . . .125
Cross Reactivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .126
Sample Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127
Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . .127
Direct LDL (MULTIGENT) . . . . . . . . . . . . . . . . . . . . . . . . . .128
Sample Storage and Stability . . . . . . . . . . . . . . . . . . . . .128
Reagent Storage and Stability . . . . . . . . . . . . . . . . . . . . .128
Calibrator Storage and Stability . . . . . . . . . . . . . . . . . . .128
Linearity Verifiers (80-5953-00, 2 x 3 mL) . . . . . . . . . . .129
Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . .131
Observed Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . .131
Ethanol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .132
Specificity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .132
GGT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .132
Observed Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . .132
Haptoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .133
Observed Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . .133
PROPRIETARY INFORMATION
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AEROSET
®
System Troubleshooting Guide 11
94816-107—November 2004
Hemoglobin A
1c
(MULTIGENT
®
) . . . . . . . . . . . . . . . . . . . . 134
Reaction Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
Pretreatment (Hemolysate Preparation) . . . . . . . . . . . . 135
Accuracy by Recovery of Standards . . . . . . . . . . . . . . . 136
Hemoglobin Denaturant Storage Conditions . . . . . . . 137
Sample Mixing (Vortex Mixing vs. Pipet Mixing) . . . . 137
Vortex Mix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Pipet Mix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
Interference Information . . . . . . . . . . . . . . . . . . . . . . . 139
Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . . 141
ICTâ„¢ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
L and H (Reference Range) Result Flags Display with
No Result when Error Log Message 351 or 352 Is
Generated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Immunoglobulin A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
Immunoglobulin G . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Immunoglobulin M . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
Iron . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
Interference Information . . . . . . . . . . . . . . . . . . . . . . . 148
Magnesium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
Units Conversion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
Methadone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
Cross Reactivity Testing Performed on the AEROSET
System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
Microalbumin (MULTIGENT) . . . . . . . . . . . . . . . . . . . . . . . 152
Specimen Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152
Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . . 152
Opiates 300 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
Cross Reactivity Testing Performed on the AEROSET
System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
Opiates 2,000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Cross Reactivity Testing Performed on the AEROSET
System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Phencyclidine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
Cross Reactivity Testing Performed on the AEROSET
System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
Prealbumin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
Propoxyphene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
Cross Reactivity Testing Performed on the AEROSET
System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Not for Customer Distribution
12
AEROSET
®
System Troubleshooting Guide
94816-107—November 2004
Rheumatoid Factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .162
Standard Material Recovery . . . . . . . . . . . . . . . . . . . . . .162
Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . .163
Total Bilirubin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .167
Observed Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . .167
Total Protein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .167
Interference Information . . . . . . . . . . . . . . . . . . . . . . . .167
Transferrin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .168
Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . .168
Valproic Acid (MULTIGENT
®
) . . . . . . . . . . . . . . . . . . . . . . .169
Accuracy by Recovery . . . . . . . . . . . . . . . . . . . . . . . . . . .169
Interference Information . . . . . . . . . . . . . . . . . . . . . . . .169
Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . .170
Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171
Color Coding on the AEROSET System . . . . . . . . . . . . . . . .173
Exporting Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .174
Exported Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .174
Exported Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .174
Host Interface Trace Log . . . . . . . . . . . . . . . . . . . . . . . . . . . .175
Observed Problems—Software . . . . . . . . . . . . . . . . . . . . . . .176
QUALITY Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .178
Interval QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .178
QC Rounding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .178
QC Statistics—Decimal Places . . . . . . . . . . . . . . . . . . . .179
Rounding of Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . .180
Sample Sequence/Smart Sampling . . . . . . . . . . . . . . . . . . . .180
Screen Hierarchy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .181
Action Area of the Main Display . . . . . . . . . . . . . . . . . .181
Information Access Area of the Main Display . . . . . . . .182
Screen Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .183
Main Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .183
REAGENTS Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .183
REAGENTS (Supply Center Segment) Screen . . . . . . . . .184
Reagent Supply Center Segment Details Screen . . . . . . .184
DATABASE Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .185
Search Dialog Window . . . . . . . . . . . . . . . . . . . . . . . . . .185
Patient Demographics Dialog Window . . . . . . . . . . . . .185
Print Options Dialog Window—Order List/Loadlist . . .186
Order Samples Screen . . . . . . . . . . . . . . . . . . . . . . . . . . .186
PAGE SETUP Screen (Form 1) . . . . . . . . . . . . . . . . . . . . .187
Form 1 Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .187
PAGE SETUP Screen (Form 2) . . . . . . . . . . . . . . . . . . . . .188
Define Free Text Screen . . . . . . . . . . . . . . . . . . . . . . . . .188
Form 2 Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .189
On-line Data Transfer Dialog Window . . . . . . . . . . . . . .189
PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Not for Customer Distribution
AEROSET
®
System Troubleshooting Guide 13
94816-107—November 2004
RESULT Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190
RESULT Screen—Viewing Rerun Result . . . . . . . . . . . . 190
Reaction Graph Screen—Error Code . . . . . . . . . . . . . . 191
Reaction Graph Screen—Rate Assay . . . . . . . . . . . . . . . 191
Reaction Graph Screen—End-point Assay . . . . . . . . . . 192
Absorbance Data Screen . . . . . . . . . . . . . . . . . . . . . . . . 192
DATABASE Screen, Accept Results Dialog Window . . . 192
CALIBRATOR/CONTROL Screen . . . . . . . . . . . . . . . . . 193
CALIBRATOR/CONTROL Screen—Set 1 . . . . . . . . . . . . 193
Position Dialog Window . . . . . . . . . . . . . . . . . . . . . . . . 194
CALIBRATION SUMMARY Screen . . . . . . . . . . . . . . . . 194
Calibration Details Screen . . . . . . . . . . . . . . . . . . . . . . 195
QC SUMMARY Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 195
Levey-Jennings Graph Screen . . . . . . . . . . . . . . . . . . . . 196
Print Options (QC) Dialog Window . . . . . . . . . . . . . . . 196
Levey-Jennings Graph Report . . . . . . . . . . . . . . . . . . . . 197
QC Details Dialog Window . . . . . . . . . . . . . . . . . . . . . 197
QC Data List Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
ASSAYS Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198
ASSAY STATUS Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 198
Assay Configuration Screen, Outline Page . . . . . . . . . . 199
Assay Configuration Screen, Base Page
(End-point Assay) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199
Assay Configuration Screen, Base Page (Rate Assay) . . 200
Assay Configuration Screen, Calibration Page (Linear
Calibration Mode) . . . . . . . . . . . . . . . . . . . . . . . . . . . 200
Assay Configuration Screen, SmartWashâ„¢ Page . . . . . 201
Assay Configuration Screen, Rerun Rules Page . . . . . . 201
RUN OPTIONS Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 202
SYSTEM CONFIGURATION Screen . . . . . . . . . . . . . . . . 202
SELECT ASSAYS FOR STAT Screen . . . . . . . . . . . . . . . . . 203
Pause Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
Unpause Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204
START UP OPTIONS Screen . . . . . . . . . . . . . . . . . . . . . 204
SHUTDOWN OPTIONS Screen . . . . . . . . . . . . . . . . . . . 205
ERROR LOG Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
MAINTENANCE UTILITIES Screen, System Page . . . . . 206
MAINTENANCE UTILITIES Screen, SCC Page . . . . . . . 206
MAINTENANCE UTILITIES Screen, Sampling Page . . . 207
Pressure Monitor Screen . . . . . . . . . . . . . . . . . . . . . . . . 207
MAINTENANCE UTILITIES Screen, Rgt Area 1 Page . . 208
MAINTENANCE UTILITIES Screen, Rgt Area 2 Page . . 208
MAINTENANCE UTILITIES Screen, Rxn Area Page . . . 209
Cuvette Blank Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 209
Cuvette Integrity Check Screen . . . . . . . . . . . . . . . . . . 210
PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Not for Customer Distribution
14
AEROSET
®
System Troubleshooting Guide
94816-107—November 2004
MAINTENANCE UTILITIES Screen, SW Info Page . . . . .210
Printer A Configuration Window . . . . . . . . . . . . . . . . . .210
ONLINE (HOST) CONFIGURATION Dialog Window . .211
Run Progress Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .211
Log On Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .211
User Alert Dialog Window . . . . . . . . . . . . . . . . . . . . . . .211
System Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . .212
FAC Limit % Field—Configuration . . . . . . . . . . . . . . . .212
System Configuration Software Disk v3.0 . . . . . . . . . . .213
Unit Configuration Default Screen . . . . . . . . . . . . . . . .215
Unit Configuration Screen, Default View Page 2
(Software Version 1.03ER000) . . . . . . . . . . . . . . .216
Startup/Shutdown Setting Default Screens . . . . . . . . . .217
User Codes/Passwords . . . . . . . . . . . . . . . . . . . . . . . . . . . . .219
Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221
CPU Used with the AEROSET System . . . . . . . . . . . . . . . . .223
Cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .225
Cuvette Volumes—Minimum and Maximum . . . . . . . .225
Cuvette Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .225
Cuvette Identification . . . . . . . . . . . . . . . . . . . . . . . . . .225
GPIB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .226
ICTâ„¢ Warranty Information . . . . . . . . . . . . . . . . . . . . . . . .226
Noise Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .226
Observed Problems—Hardware . . . . . . . . . . . . . . . . . . . . . .227
Serial Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .230
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .231
Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .231
USP Purified and WFI Requirements . . . . . . . . . . .231
Verification Procedures/Adjustments/Alignments . . . . . . .232
Lamp Gain and A/D Check . . . . . . . . . . . . . . . . . . . . . .232
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . .232
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .232
Reagent Arm Adjustment . . . . . . . . . . . . . . . . . . . . . . . .234
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . .234
R1A Probe Horizontal Adjustment . . . . . . . . . . . . .234
Reagent Carousel Alignment . . . . . . . . . . . . . . . . .237
R1A Probe Cuvette Alignment . . . . . . . . . . . . . . . .239
R1A Probe Wash Cup Alignment . . . . . . . . . . . . . .242
PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Not for Customer Distribution
AEROSET
®
System Troubleshooting Guide 15
94816-107—November 2004
Troubleshooting Flowcharts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 245
Abbott Assay—Basic Assay Troubleshooting . . . . . . . . . . . 247
Assay Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . 248
Instrument Troubleshooting . . . . . . . . . . . . . . . . . . . . 248
Non-Abbott Assay—Basic Assay Troubleshooting . . . . . . . 250
Confirmation of Assay Parameter Settings (Illegal
Configuration) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
Erratic Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253
QC Out of Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 254
Calibration Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 257
ICTâ„¢ Failed Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . 259
Bubbles in ICT Module Tubing . . . . . . . . . . . . . . . . . . . . . 261
LIS/Communication Problems . . . . . . . . . . . . . . . . . . . . . . 262
Water Issue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 264
PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Not for Customer Distribution
16
AEROSET
®
System Troubleshooting Guide
94816-107—November 2004
Proprietary Statement
Copyright 1998, 2004, Abbott Laboratories, Abbott Park,
Illinois. All rights reserved. No part of this document may be
reproduced, stored, or transmitted in any form or by any
means electronic, mechanical, photocopied, recorded, or
otherwise without the prior written permission of Abbott
Laboratories.
Pictorial Disclaimer
All samples (printouts, graphics, displays, screens, etc.)
contained in the AEROSET System Troubleshooting Guide
are for information and illustration purposes only and shall
not be used for clinical or maintenance evaluations. Data
shown in sample printouts and screens do not reflect actual
patient names or test results. Abbott Laboratories makes no
representations or warranties about the accuracy and
reliability of the information in the graphics.
Troubleshooting Guide Usage Disclaimers
Information contained in this document was developed for
use by trained Abbott Laboratories Field Service personnel, or
by other persons knowledgeable or experienced with
operation and service of the AEROSET System. The
information should be used under direct supervision and
cooperation with Abbott Laboratories technical sales and
service representatives.
In no event shall Abbott Laboratories or its affiliates be liable
for any damages or losses incurred in connection with, or
arising from use of information in this document by persons
not fully trained by Abbott Laboratories as technical sales and
service representatives. This limitation shall not apply to those
persons knowledgeable or experienced with operation and
service of the AEROSET System, who use this information
under direct supervision of Abbott Laboratories technical sales
and service representatives.
Any product information in this guide should be used in
conjunction with the latest version of the AEROSET System
Operations Manual, Operations Manual Addendum, or
Product Information Letter. If any discrepancies in
information exist within this guide or any other, the latest
version of the Operations Manual, Operations Manual
Addendum, or Product Information Letter takes precedence.
PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Not for Customer Distribution
AEROSET
®
System Troubleshooting Guide 17
94816-107—November 2004
Master Table of Contents/Index Disclaimer
Incremental manual updates may cause the Master Table of
Contents or Master Index page numbering to change.
Trademark Statements
All Abbott Laboratories product names and trademarks are
owned by or licensed to Abbott Laboratories, its subsidiaries,
or affiliates. No use of any Abbott trademark, trade name,
trade dress, or product name may be made without the prior
written authorization of Abbott Laboratories, except to
identify the product or services of Abbott Laboratories. All
other trademarks, brands, product names, and trade names are
the property of their respective companies. All rights reserved.
Except as permitted above, no license or right, express or
implied, is granted to any person under any patent, trademark,
or other proprietary right of Abbott Laboratories.
c
8000, AEROSET, ARCHITECT, AxSYM, IMx, MULTIGENT,
Nembutal, and TDx are registered trademarks of Abbott
Laboratories.
FastTrack, FlexRate, ICT, and SmartWash are trademarks of
Abbott Laboratories.
PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Not for Customer Distribution
18
AEROSET
®
System Troubleshooting Guide
94816-107—November 2004
NOTES
AEROSET
®
System Troubleshooting Guide 19
94816-107—November 2004
Assays/Reagents
Assays/Reagents
PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Assays/Reagents Not for Customer Distribution
20
AEROSET
®
System Troubleshooting Guide
94816-107—November 2004
NOTES
/
