Abbott AEROSET Troubleshooting Manual

System

Troubleshooting

Guide

Abbott Laboratories

Abbott Park, IL 60064

94816-107—November 2004

AEROSET is a Registered Trademark of

Abbott Laboratories

PROPRIETARY INFORMATION

CONFIDENTIAL MATERIAL

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2

AEROSET

®

System Troubleshooting Guide

94816-107—November 2004

NOTES

PROPRIETARY INFORMATION

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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

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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

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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 SmartWash™ 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

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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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®

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

ICT™ 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

PROPRIETARY INFORMATION

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®

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

SmartWash™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .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

Not for Customer Distribution

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

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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

CONFIDENTIAL MATERIAL

Not for Customer Distribution

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

ICT™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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, SmartWash™ 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

ICT™ 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

ICT™ 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

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

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

PROPRIETARY INFORMATION

CONFIDENTIAL MATERIAL

Assays/Reagents Not for Customer Distribution

20

AEROSET

®

System Troubleshooting Guide

94816-107—November 2004

NOTES

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