Operations Manual: List No. 9D06-05 Volume 1 of 2

Operations Manual
List No. 9D06-05

Volume 1 of 2
Abbott Laboratories ©1998, 2004 Abbott Laboratories

Abbott Park, IL 60064 AEROSET is a Registered Trademark of
200154-101—November 2004 Abbott Laboratories
NOTES
ii AEROSET® System Operations Manual

200154-101—November 2004
Revision Status
Document Revision Section(s) Pages Revised Software

Control Date Revised and Added Version
Number(s)
9D06-01 6/98 Original Issue Original Issue Version

1.00ER001
9D06-02 3/99 All Sections All Pages Version
1.00ER005
94819-101 7/01 Introduction, All Pages Version
Section 9 1.00ER005
94819-102 3/02 All Sections All Pages Version
1.01ER000
(Not Distributed)
94819-103 3/02 Introduction, Master All Pages Version
Table of Contents, 1.00ER005
Section 9, Index
94819-104 5/02 Introduction, Master All Pages Version
Table of Contents, 1.01ER000
Sections 2, 5, 6, 9,
10, Appendix A & B,
Index
94819-105 11/02 Introduction All Pages Version
Section 1 1-5 1.02ER000
Section 2 All Pages (Not Distributed)
Section 4 4-4, 4-10
Section 5 All Pages
Section 6 6-6
Section 9 All Pages
Section 10 All Pages
Glossary Glossary-1
Appendix F F-6
Index All Pages
How to Use This How-4 1.02ER000
Manual
Section 2 2-16, 2-97,
2-111 to 2-113,
2-144, 2-148 to
2-152, 2-154,
2-188, 2-219
AEROSET® System Operations Manual iii

200154-101—November 2004
Document Revision Section(s) Pages Revised Software
Control Date Revised and Added Version
Number(s)
94819-106, 6/03 Section 3 3-16, 3-19, 3-22 Version

Continued Section 5 All Pages 1.02ER000
Section 6 6-8, 6-23
Section 8 8-3, 8-17
Section 9 All Pages
Section 10 All Pages
Appendix A All Pages
Appendix C All Pages
Appendix D All Pages
Appendix E All Pages
Index All Pages
Section 10 1.02ER000
Index
200154-101 11/04 Volume 1, All Pages Version
All Sections 1.03ER000
200155-101 11/04 Volume 2, All Pages Version
All Sections 1.03ER000
iv AEROSET® System Operations Manual

200154-101—November 2004
Highlights of Changes from Previous AEROSET System
Operations Manual, List Number 9D06-04
NOTE: This section is intended as a guide to highlight
major and significant changes to this version of the
AEROSET System Operations Manual, List Number
9D06-05. It is NOT intended to be a comprehensive
description of all changes to the operations manual
and/or AEROSET System functionality and hardware.
As with all previous revisions of the AEROSET System
Operations Manual, it is recommended that all
AEROSET System operators thoroughly review this new
operations manual version.
Overview
Software
The software on your AEROSET System was upgraded to
version 1.03ER000. This manual was revised to be consistent
with software v1.03ER000.
Hardware
The software upgrade also provides functionality to run
optional new hardware features on the AEROSET System:
• Clot Detection system
• Sample Carryover Reduction feature
• Non-bar code labeled sample carriers
Addendum
Applicable information from the AEROSET System
Operations Manual Addendum (Part Number 94727-112,
April 2004) was incorporated into this version of the
operations manual.
AEROSET® System Operations Manual v

200154-101—November 2004
Specific Changes and/or New Information
Section 1, Use or Function

• Information to describe and illustrate the 20 mL reagent
wedge.
• Information to describe the new non-bar code labeled
sample carrier.
• New sections to describe the Lamp Monitoring feature,
and optional Clot Detection system and Sample
Carrryover Reduction feature.
Section 2, Installation and Special Procedures

• New system configuration parameters for several options
on the SYSTEM CONFIGURATION screen, including
changes to the Save by Car’r ID, Sample Bar Codes,
1st Car’r for No-Bcode Samples fields.
• New parameters for allowable sample IDs, manually
configured sample IDs, and use of non-bar code labeled
sample carriers.
• New information about Sample Report Print Format
options and changes to default settings.
• Changes to configuration of assay numbers and panel
numbers.
• New graphics for the Log On screen, SYSTEM
CONFIGURATION screen, and Rerun Rules page of the
Assay Configuration screen (photometric and
potentiometric assays).
• Changes to the functionality of the STAT alert, and system
functionality when configuring calculated assays and
dilutions.
Section 5, Operating Instructions

• New graphic for the Log On screen.
• Improved system functionality with the Reagent Linking
option, and running non-bar code labeled samples,
calculated assays and dilutions.
vi AEROSET® System Operations Manual

200154-101—November 2004
Section 9, Service and Maintenance, Appendix F
The Source Lamp Replacement Procedure is now included with
Quarterly Maintenance to align with Abbott Laboratories’
recommendation for quarterly source lamp replacement.
Section 10, Troubleshooting and Diagnostics

• New information to describe the Optional Clot Detection
feature and Pressure Monitor screen.
• New Result Error Codes, Error Log Messages, and Observed
Problems.
• New troubleshooting information added where needed to
enhance existing error messages and observed problems.
• The ERROR LOG screen description was revised to reflect
updated system functionality and Error Log Message
handling.
• Priority Levels of some Error Log Messages were changed.
AEROSET® System Operations Manual vii

200154-101—November 2004
NOTES
viii AEROSET® System Operations Manual

200154-101—November 2004
Revision Log
Instructions: Use this log as a permanent record to document the revised section(s) which have
been added to this manual.
1. Write the document control number in the first column. This number is in the footer of
each section or tab. Make an entry for each section or tab placed in the manual.
2. Write the revision date, also found in the footer, in the second column.
3. Write the version of the software for the revised pages or sections in the third column.
4. Sign in the fourth column to verify that revised pages have been added to the manual.
5. Record the date that the revised section was incorporated in the fifth column.
Document Revision Software Version Revision Date

Control Number Date (If applicable) Incorporated Incorporated
by
AEROSET® System Operations Manual ix

200154-101—November 2004
Foreword
Congratulations on the purchase of the AEROSET System. The
AEROSET System is a fully automated, random access, clinical
chemistry analyzer for the rapid quantitative analysis of tests
commonly performed in clinical chemistry including
electrolytes. This AEROSET System is designed to automate
your laboratory chemistry testing environment by providing
random access analysis of up to 2,000 tests per hour, using
photometric and potentiometric methodologies. The
AEROSET System has solid state ion-selective electrodes
trademarked as Integrated Chip Technology™ (ICT). This
technology utilizes potentiometric measurement of sodium
(Na+), potassium (K+), and chloride (Cl-).
The AEROSET System is backed by dedicated professionals who
excel in engineering, technical support, and training. Abbott
Laboratories looks forward to assisting you in any way
possible. This service is available by calling your Abbott
Representative.
Customer Support
Contact your local Abbott Representative.
x AEROSET® System Operations Manual

200154-101—November 2004
Proprietary Statement
Copyright 1998, 2004 Abbott Laboratories, Abbott Park,
Illinois. All rights reserved. Printed in the United States of
America. No part of this media may be reproduced, stored,
retrieved, or transmitted in any form or by any means without
the prior written permission of Abbott Laboratories.
The information, documents, and related graphics published
herein (the “Information”) are the sole property of Abbott
Laboratories. Permission to use the Information is granted,
provided that:
• the copyright notice appears on all copies;
• use of the Information is for the operation of Abbott
products by Abbott trained personnel or informational use
only;
• the Information is not modified in any way; and
• no graphics are used separate from accompanying text.
Each person assumes full responsibility and all risks arising
from use of the Information. The Information is presented “as
is” and may include technical inaccuracies or typographical
errors. Abbott Laboratories reserves the right to make
additions, deletions, or modifications to the Information at
any time without any prior notification.
AEROSET System Operations Manual

This AEROSET System Operations Manual should always be
used in conjunction with the latest version of the Operations
Manual Addendum and/or Product Information Letter. If
discrepancies in information exist within training materials or
any other AEROSET materials, this version of the Operations
Manual, along with the Operations Manual Addendum and/or
Product Information Letter takes precedence.
Pictorial Disclaimer
All samples (printouts, graphics, displays, screens, etc.) 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 is not engaged in rendering medical
advice or services.
AEROSET® System Operations Manual xi

200154-101—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.
Warranty Statement
Abbott Laboratories makes no representations or warranties of
any kind or nature with respect to the information. Abbott
Laboratories hereby disclaims all representations and
warranties, whether express or implied, created by law,
contract, or otherwise, including without limitation, any
warranties of merchantability, fitness for a particular purpose,
title or non-infringement. In no event shall Abbott
Laboratories be liable for any damages of any kind or nature,
including, without limitation, direct, indirect, special
(including loss of profit) consequential or incidental damages
arising from or in connection with the existence or use of the
information, regardless of whether Abbott Laboratories has
been advised as to the possibility of such damages.
xii AEROSET® System Operations Manual

200154-101—November 2004
Abbott Instrument Warranty
Abbott Laboratories warrants instruments sold by Abbott
Diagnostics Division to be free from defects in workmanship
and materials during normal use by the original purchaser.
This warranty shall continue for a period of one year,
commencing twenty-one (21) days from the date of shipment
to the original purchaser, or until title is transferred from the
original purchaser, whichever occurs first (the “Warranty
Period”).
If any defects occur during the Warranty Period, contact your
Abbott Customer Service Representative immediately, and be
prepared to furnish information including the serial number,
the model number, and pertinent details concerning the
defect.
This Warranty does not cover defects or malfunctions which:
(1) are not reported to Abbott during the Warranty Period and
within one week of occurrence; (2) result from chemical
decomposition or corrosion; (3) are caused primarily by failure
to comply with any requirement or instruction contained in
the applicable Abbott Operations Manual; or (4) result from
maintenance, repair, or modification performed without
Abbott’s authorization.
Abbott’s liability for all matters arising from the supply,
installation, use, repair and maintenance of the instrument,
whether arising under this Warranty or otherwise, shall be
limited solely to the repair or (at Abbott’s sole discretion)
replacement of the instrument or of components thereof.
Replaced parts shall become the property of Abbott
Laboratories. In no event shall Abbott be liable for injuries
sustained by third parties, consequential damages, and/or lost
profits.
The ICT™ module Warranty is 15,000 samples or two months
post-installation, whichever occurs first.
The AEROSET cuvette warranty is one year post-installation.
THE FOREGOING IS THE SOLE WARRANTY MADE BY
ABBOTT LABORATORIES REGARDING THE INSTRUMENT,
AND ABBOTT SPECIFICALLY DISCLAIMS ALL OTHER
WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING THE
WARRANTIES OF MERCHANTABILITY AND FITNESS IMPLIED
FOR A PARTICULAR PURPOSE.
AEROSET® System Operations Manual xiii

200154-101—November 2004
Instrument Labeling
Symbols Used on Instrument Labeling
The symbols in the following table are used on the
instrument’s labeling.
Key to Symbols Used on Instrument Labeling
For in vitro diagnostic use *Caution or Warning:
List number/Catalog number *Caution or Warning: Electrical shock
Serial number *Caution: Hot surface
Batch code/Lot number Caution: Potential biohazard
Unit *Caution: Class II Laser Product
Item Use by/Expiration date
Quantity Temperature limitation
Size AC input power
Color
DISK Disk
VERSION Version
ASSAY DISK Assay disk
IMPORT DISK Import disk
DRUGS OF ABUSE Drugs of abuse
THERAPEUTIC DRUG MONITORING Therapeutic drug monitoring
SERUM PROTEINS Serum proteins
CONVENTIONAL UNITS Conventional units
SI units
SYSTEM CONFIGURATION SOFTWARE System configuration software
* Symbols have black text with yellow background.
xiv AEROSET® System Operations Manual

200154-101—November 2004
Key to Symbols Used on Instrument Labeling (Continued)
Legal Manufacturer
ABBOTT
MAX-PLANCK-RING 2
65205 WIESBADEN
GERMANY
+49-6122-580
Instrument Labeling
If the following label is on the instrument, the instrument is
CE marked to EMC Directives:
• 89/336/EEC Electromagnetic Compatibility Directive
• 73/23/EEC Low Voltage Directive
If the following label is on the instrument, the instrument is

CE marked for IVD Directive 98/79/EC.
AEROSET® System Operations Manual xv

200154-101—November 2004
Agency Approval
The Abbott AEROSET System has been tested and found to
comply with the following agency standard.
In Vitro Diagnostic Directive 98/79/EC

Legal Manufacturer Abbott Laboratories
Abbott Park, IL 60064
Authorized Representative Abbott
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580
xvi AEROSET® System Operations Manual

200154-101—November 2004
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.
AEROSET, ARCHITECT, and MULTIGENT are registered
trademarks of Abbott Laboratories.
FastTrack is a trademark of Abbott Laboratories.
FlexRate is a trademark of Abbott Laboratories.
ICT or Integrated Chip Technology is a trademark of Abbott
Laboratories.
Line Balance is a trademark of Abbott Laboratories.
OSS or Optimum Sampling Sequence is a trademark of Abbott
Laboratories.
Probe Rebound Technology is a trademark of Abbott
Laboratories.
SmartWash is a trademark of Abbott Laboratories.
AEROSET® System Operations Manual xvii

200154-101—November 2004
NOTES
xviii AEROSET® System Operations Manual

200154-101—November 2004
Master Table of Contents
VOLUME 1
Master Table of Contents . . . . . . . . . . . . . . . . . .Master Table of Contents-1
How to Use This Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . How-1
Section 1. Use or Function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Section 2. Installation Procedures and Special Requirements . . . . . . . 2-1
Section 3. Principles of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Section 4. Performance Characteristics and Specifications . . . . . . . . . 4-1
Section 5. Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Section 6. Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Section 7. Operational Precautions and Limitations. . . . . . . . . . . . . . . . 7-1
Section 8. Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Glossary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Glossary-1
Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index-1
AEROSET® System Operations Manual Master Table of Contents-1

200154-101—November 2004
VOLUME 2
Master Table of Contents . . . . . . . . . . . . . . . . . Master Table of Contents-1
Section 9. Service and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Section 10. Troubleshooting and Diagnostics . . . . . . . . . . . . . . . . . . . . 10-1
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Glossary-1
Appendix A. AEROSET System Math Models. . . . . . . . . . . . . Appendix A-1
Appendix B. AEROSET System Printed Reports . . . . . . . . . . Appendix B-1
Appendix C. AEROSET Accessories and Consumables . . . . Appendix C-1
Appendix D. Sample Interference Indices. . . . . . . . . . . . . . . . Appendix D-1
Appendix E. AEROSET System ICT™ . . . . . . . . . . . . . . . . . . . Appendix E-1
Appendix F. Forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix F-1
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index-1
Master Table of Contents-2 AEROSET® System Operations Manual

200154-101—November 2004
How to Use This Manual
Overview
This section provides information on making the most
productive use of the AEROSET System Operations Manual.
The manual was designed to provide guidance for both new
and experienced operators.
Manual Structure
The manual is tabbed and divided into sections as listed in the
Master Table of Contents.
Primary manual sections begin with the section Table of
Contents and an introductory overview. Task-oriented
information is presented in step-by-step format. Sections
include:
Section 1
• Use or Function—complete description of the AEROSET
System and its components, and an overview of the
software.
Section 2
• Installation Procedures and Special Requirements—
installation of the AEROSET System including:
– System configuration
– Assay configuration
Section 3
• Principles of Operation—brief explanation of the
AEROSET System Operational Theory.
Section 4
• Performance Characteristics and Specifications—
general, physical, electrical, data communication,
bar code reader, and processing specifications of the
AEROSET System.
AEROSET® System Operations Manual How to Use This Manual-1

200154-101—November 2004
Section 5
• Operating Instructions—step-by-step guide to daily
operation of the AEROSET System, including:
– System initialization
– Inventory and loading consumables
– Sample ordering
– Pausing and resuming operation
– Reviewing results
– Validating or deleting results
– Running and reviewing controls
Section 6
• Calibration Procedures—description of procedures used
to calibrate assays and review calibrations on the AEROSET
System.
Section 7
• Operational Precautions and Limitations—conditions
that can affect performance including environmental
requirements, precautions, and limitations of the system
and its components.
Section 8
• Hazards—describes possible biohazard, electrical,
mechanical, chemical, and physical hazards that could
occur when operating the AEROSET System.
Section 9
• Service and Maintenance—details scheduled and
non-scheduled maintenance of the AEROSET System,
including: decontamination; cleaning; adjustments;
verification; and component replacement. Maintenance
schedules are also included.
Section 10
• Troubleshooting and Diagnostics—provides methods
for identifying and responding to Result Error Codes,
Calibration Error Codes, Assay-specific Error Messages,
Error Log Messages, and observed hardware and software
problems.
How to Use This Manual-2 AEROSET® System Operations Manual

200154-101—November 2004
Glossary
• Glossary—contains explanation of words, terms, and
abbreviations used throughout the AEROSET System
Operations Manual.
Appendices
• Appendices—additional supporting material
– Appendix A—AEROSET System Math Models
– Appendix B—AEROSET System Printed Reports
– Appendix C—Accessories and Consumables
– Appendix D—Sample Interference Indices
– Appendix E—AEROSET System ICT™
– Appendix F—Forms
Index
• Comprehensive list of topics discussed in the manual.

200154-101—November 2004
Text Conventions
Descriptions and instructions in this manual are concise and
well-illustrated. Most procedures are explained with numbered
steps. All information related to an activity is generally
included in one location to minimize referencing between
sections. Illustrations appear where they are useful to the
explanation.
Icons
Throughout the text, icons appear where information warrants
special attention.
These icons, when present on the label of the AEROSET System
hardware, refer the operator to the manual for information
about the hazard. Refer to Section 8, Hazards for additional
information.
NOTE: This icon is used to indicate important
information, or information that represents an
exception to conventional methods.
CAUTION: The general CAUTION icon appears
! adjacent to explanations of conditions that could result
in minor injury or interfere with proper functioning of
the system.
WARNING: The general WARNING icon identifies a
! physical, mechanical, or procedural situation which
could result in moderate to severe personal injury.
CAUTION: Hot Surface. The Hot Surface icon labels
an activity or area where hot surfaces are present.
WARNING: Potential Biohazard. The Potential
Biohazard icon labels an activity or area where the
operator may be exposed to potentially infectious
materials.
WARNING: Class II Laser Product. The Class II Laser
Product icon warns against direct viewing into the
light beam or reflections from the light beam generated
by the bar code readers.

200154-101—November 2004
Notation
Screen Buttons and Names
Buttons displayed on the screens, screen names, etc., are
indicated throughout this manual and are described in the
following table.
Description in the Operations

Display on the Screen
Manual
<Reagents>
CALIBRATOR/CONTROL screen
Keyboard Buttons
Description in the Operations

Keyboard Buttons
Manual
[Enter]
Enter
Graphic Conventions
Step-by-step instructions involving Touchscreen and keyboard
sequences are provided throughout the manual with graphics
to illustrate those sequences.
All operators should read and understand the content of this
manual before running the AEROSET System.

200154-101—November 2004
NOTES

200154-101—November 2004
Section 1
Section 1: Use or Function
Use or Function
Section 1 Table of Contents

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Primary Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

System Control Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Covers, Doors, and Panels . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Sampling Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
FastTrack™ Sampler . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Carousel Sampler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Processing Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Sample and Reagent Arms . . . . . . . . . . . . . . . . . . . . . . 1-10
Reagent Supply Centers . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Reaction Carousel Area . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
ICT™ Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
ICT Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Bar Code Readers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Wash System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Local User Interface Control Panel . . . . . . . . . . . . . . . . . . 1-18
LED Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Front Display Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21
Bulk Solution Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-23
Consumables and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25

Consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25
Consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26
Sample Cups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26
Reagent Cartridges and Caps . . . . . . . . . . . . . . . . . . . . 1-27
ICT Sample Diluent . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-28
ICT Calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-28
ICT Cleaning Fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29
ICT Reference Solution . . . . . . . . . . . . . . . . . . . . . . . . . 1-29
Wash Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29
Water Bath Additive . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-30
Calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-30
AEROSET® System Operations Manual Table of Contents-1

200154-101—November 2004
Use or Function Section 1
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31
Sample Carriers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31
End-of-Run Sample Carrier . . . . . . . . . . . . . . . . . . . . . . 1-32
Non-bar Code Labeled Sample Carrier (Optional) . . . . 1-32
Cup/Tube Adapters . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-32
Sample Carrier Trays . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33
Sample Carrier Tray Covers . . . . . . . . . . . . . . . . . . . . . 1-33
Reagent Cartridge Adapters . . . . . . . . . . . . . . . . . . . . . 1-34
Manuals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-34
Special Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-35

SmartWash™ Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-35
OSS™ Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-36
Operation during SmartWash Processing . . . . . . . . . . . 1-36
Clot Detection System (if Installed) . . . . . . . . . . . . . . . . . . 1-37
Lamp Monitoring Feature . . . . . . . . . . . . . . . . . . . . . . . . . 1-37
Sample Carryover Reduction Feature (if Installed) . . . . . . 1-38
Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-39
Screen Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-39
Screen Hierarchy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-40
Action Area of the Main Display . . . . . . . . . . . . . . . . . 1-40
Information Access Area of the Main Display . . . . . . . 1-41
Information Access Area . . . . . . . . . . . . . . . . . . . . . . . . . . 1-42
Action Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-44
Display Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-47
Status Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-47
Run Progress Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-48
Screen Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-49

Touchscreen Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-49
Buttons and Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-49
Tabs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-49
Scroll Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-49
Drop-down List Box . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-50
Combo Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-50
Checkbox . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-50
Single Selection Item . . . . . . . . . . . . . . . . . . . . . . . . . . 1-50
Keyboard Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-51
Table of Contents-2 AEROSET® System Operations Manual

200154-101—November 2004
Section 1 Use or Function
Section 1: Use or Function
Use or Function
Overview
The AEROSET System is a fully automated, random and
continuous access, high throughput clinical chemistry system.
The instrument utilizes a dual pipetting system with
maximum throughput up to 2,000 tests/hour when running
both photometric and potentiometric assays. The AEROSET
System is an open system that accommodates use of
non-Abbott manufactured reagents.
CAUTION: For Abbott applications, assay parameters
! for any previously programmed assay should not be
edited, unless specifically indicated in the assay-specific
package inserts. Incorrect editing of assay parameter
files may affect calculation of results and could produce
erroneous results. Verify edits to assay parameter files
against assay-specific package inserts.
CAUTION: For non-Abbott applications, correct
! implementation of the assay must be verified. Incorrect
implementation could produce erroneous results.
AEROSET® System Operations Manual 1-1

200154-101—November 2004
Use or Function
Use or Function Section 1
NOTES
1-2 AEROSET® System Operations Manual

200154-101—November 2004
Primary Components
Primary components of the AEROSET System include:

• System Control Center
• Analyzer
Analyzer
System Control
125602a
Center
Figure 1.1: Primary Components of the AEROSET System

200154-101—November 2004
Use or Function
Primary Components Section 1
System Control Center

The System Control Center (SCC) controls operation of the
AEROSET Analyzer. It provides user interface, data
management capability, and interface to a Host computer.
Through the System Control Center, orders are received and
results are transferred. The following functions are also
performed:
• Manual entry of patient, control, and calibration orders
• Review patient results, control data, and calibration results
• Set up system and assay configuration
This illustration identifies basic components of the System
Control Center (SCC).
3 4
125620
Figure 1.2: System Control Center

200154-101—November 2004
Use or Function
Section 1 Primary Components
Figure 1.2: System Control Center

Item SCC Component Description
1 Color Touchscreen Color monitor with touch
monitor function
2 Keyboard Standard alphanumeric
3 Computer (CPU) IBM PC/AT compatible
4 Floppy disk drive Used to install assay files,
upgrade system software, and
copy files from the CPU
5 Printer Dot matrix printer
6 Component stand Provides support for the SCC
(optional)
Additional components not illustrated include:
SCC Component Description

GPIB communication cable Transmits all communication
between the SCC and system
Touchpoint Can be used as an alternate
means to perform Touchscreen
functions
Analyzer
The following sample processing activities are performed by
the AEROSET System:
• Identify and dispense samples and reagents
• Mix samples and reagents
• Perform photometric reads
• Measure electrolytes
• Wash cuvettes

200154-101—November 2004
Use or Function
Covers, Doors, and Panels

Top-Main
Cover
Front-Right
Door
Front-Middle
Door
Left-Side Front-Left
Panel 125601a
Door
Figure 1.3: AEROSET System (Front View)
Rear Folding Panel
ICT™ Pump
Access Door
Rear-Right Panel
Right-Side
Rear-Left Panel
Panel 125625a
Figure 1.4: AEROSET System (Rear View)

200154-101—November 2004
Use or Function
Sampling Area
The sampling area of the AEROSET System includes the
FastTrack™ Sampler and Carousel Sampler.
Carousel Sampler
FastTrack Sampler
125603a
Figure 1.5: Sampling Area
FastTrack Sampler
The FastTrack Sampler transports routine patient samples to
the sample arm.
125630
Figure 1.6: FastTrack Sampler

200154-101—November 2004
Use or Function
Sample carriers hold patient samples.
Figure 1.7: Sample Carrier
Sample carriers are loaded in sample carrier trays for loading

on the FastTrack™ Sampler.
125606
Figure 1.8: Sample Carrier Tray
Total sample capacity of the FastTrack Sampler is 200 samples.

• Each sample carrier holds up to five samples.
• Each tray holds up to 10 sample carriers.
• Up to four sample carrier trays can be loaded on the
FastTrack Sampler.

200154-101—November 2004
Use or Function
Carousel Sampler
The Carousel Sampler includes the following:
1. Reserved STAT position
2. Sample Carousel
3. Calibrator/Control (C/C) Carousel
1
2
125607
Figure 1.9: Carousel Sampler
The Reserved STAT position is a single fixed position used

exclusively for STAT patient samples. Samples can be loaded in
a tube or sample cup. Cup/tube adapters must be used when
loading sample cups and tubes with a diameter of 13 mm.
Positive identification using a bar code label is not available in
the Reserved STAT position.
The Sample Carousel has 30 positions for loading routine or
priority patient samples. If priority sampling is configured,
samples in the Carousel Sampler are prioritized over samples
loaded on the FastTrack™ Sampler.
The system can be configured to also use the Sample Carousel
for loading additional calibrators when space is insufficient on
the Calibrator/Control Carousel. Patient samples and
calibrators cannot be loaded and run at the same time on the
Sample Carousel.
Samples can be loaded in tubes and sample cups. Cup/tube
adapters must be used when loading sample cups and tubes
with a diameter of 13 mm. Patient sample tubes can be bar
code labeled for positive identification. Bar codes cannot be
used for calibrator samples.

200154-101—November 2004
Use or Function
The Calibrator/Control (C/C) Carousel has 45 positions for

loading calibrators and controls in sample cups. Carousel
positions are fixed positions configured by the operator in the
system software. Cup/tube adapters are not used on the
Calibrator/Control Carousel.
Processing Area
The processing area includes the following components:
• Sample and reagent arms
• Reagent Supply Centers
• Reaction Carousel area
• ICT™ unit (Integrated Chip Technology) utilized for
potentiometric assays
• Bar code readers
• Wash system
Sample and Reagent Arms

The sample arm has two probes on a single arm to aspirate
sample from either sample cups or tubes. Samples are
dispensed into cuvette pairs on the Reaction Carousel.
125616
Figure 1.10: Sample Arm

200154-101—November 2004
Use or Function
There are two reagent arm mechanisms (R1 and R2) on the
AEROSET System. Both reagent arm mechanisms have two
arms, each with a single probe. This configuration
simultaneously dispenses reagent for two assays.
R1
R2
125623
Figure 1.11: Reagent Arm
The sample and reagent arms are equipped with the Probe
Rebound Technology™ feature, which stops lowering of the
probe when an obstacle is detected.

200154-101—November 2004
Use or Function
Reagent Supply Centers

There are two Reagent Supply Centers on the AEROSET
System, R1 and R2. Each provides refrigerated storage for
56 reagent cartridges. The Reagent Supply Centers and
associated reagent arms are controlled separately to allow each
reagent arm to independently dispense reagent.
R1
R2
125608
Figure 1.12: Reagent Supply Centers

200154-101—November 2004
Use or Function
Reaction Carousel Area

Photometric assay processing occurs on the Reaction Carousel.
The Reaction Carousel includes 15 cuvette segments in a
37°C water bath.
Cuvette
ICT
Mixer Washer
Unit
Unit
Photometer
Read
Position
Reaction R2
Carousel
125609a
Figure 1.13: Reaction Carousel
The Reaction Carousel rotates counterclockwise approximately

¼ turn every 4.5 seconds, and positions reaction cuvettes at
the following locations to process the reaction:
• Sample/dispense
• R1 (reagent) dispense
• R2 (reagent) dispense
• ICT™ (electrolyte) aspiration
• Mixing positions (2)
• Photometric read position
• Diluted sample aspiration

200154-101—November 2004
Use or Function
The mixer unit contains two mixer pairs to mix reaction

components after the first and second reagents are dispensed.
Mixer 2
Mixer 1
125610a
Figure 1.14: Mixer Unit
Each cuvette segment contains 11 cuvette pairs (22 rectangular

glass cuvettes). With 15 cuvette segments, the Reaction
Carousel contains 165 cuvette pairs
(11 cuvette pairs x 15 cuvette segments), for 330 cuvettes
total.
125611
Figure 1.15: Cuvette Segment

200154-101—November 2004
Use or Function
The cuvette washer has eight pairs of nozzles which perform

the following functions:
• Aspirate the sample and reagent mixture to waste
• Wash cuvettes with alkaline and acid wash solutions
• Rinse with water
• Dispense water for the water blank reading
• Dry cuvettes
125612
Figure 1.16: Cuvette Washer

200154-101—November 2004
Use or Function
ICT™ Unit
The AEROSET System utilizes Integrated Chip Technology™
(ICT) ion-selective electrodes to measure potentiometric assays
(electrolytes). The ICT unit rotates into position to aspirate
sample or ICT reference solution to the ICT module. The
AEROSET System simultaneously measures Na+, K+, and/or Cl-
during photometric testing.
125613
Figure 1.17: ICT Unit
ICT Module
The ICT module is an integrated chip containing Na+, K+, and
Cl- electrodes. It is located in the ICT unit.
ICT Module
Sodium
Potassium
Chloride
125673
Figure 1.18: ICT Module

200154-101—November 2004
Use or Function
Bar Code Readers

The AEROSET System has five bar code readers.
4
3
2
2
1
125614
Figure 1.19: Bar Code Readers
Figure 1.19: Bar Code Readers

Item Component Description
1 Sample Carousel Reads bar code labels on sample
tubes
2 Reagent Supply 2D (two dimensional) bar code
Centers 1 & 2 readers read both 1D and 2D bar
code labels on Abbott reagent
cartridges
3 Sample Carrier Reads the sample carrier ID bar code
label
4 FastTrack™ Reads bar code labels on sample
Sampler tubes in the sample carriers
Wash System
The following table lists component and wash solution
information for the wash system.
Component Wash
Reagent and Probes can be washed with DI water
sample probes (Type II), alkaline or acid wash solutions
Reaction cuvettes Washed with DI water (Type II), and
alkaline and acid wash solutions
Mixers Washed with DI water (Type II)

200154-101—November 2004
Use or Function
Local User Interface Control Panel

The Control Panel provides Local User Interface (LUI) for
controlling the FastTrack™ Sampler and Reagent Supply
Centers.
3
3
2
1
125615
Figure 1.20: LUI Control Panel
Figure 1.20: LUI Control Panel

Item Component Description
1 Remove Rack Removes the sample carrier from the
sampler and returns it to the sample
carrier tray
2 Tray Home Homes the carrier handler which
moves the sample carrier in and out
of the FastTrack Sampler. It also
homes the FastTrack Sampler
3 Tray Feed Moves the sample carrier tray one
position, direction indicated by the
arrow
4 R2 and R1 Rotates the Reagent Supply Center
counterclockwise by one segment.
When R2 and R1 are illuminated,
access to the Reagent Supply
Centers is allowed

200154-101—November 2004
Use or Function
LED Indicators
LED (light emitting diode) indicators on the AEROSET System
include:
• Sample Carousel Movement Indicator LED—illuminates
when the Sample Carousel is moving or when sampling
from the carousel is in process.
• STAT Sampling Indicator LED—illuminates when a STAT
sample is being aspirated.
STAT Sampling
Indicator LED
Sample Carousel
Movement
Indicator LED
125617a
Figure 1.21: Carousel Sampler LED Indicators

200154-101—November 2004
Use or Function
• FastTrack™ Sampler Indicator LEDs—include eight Tray

Status LEDs and one Carrier Entry Position LED.
Tray Status
Carrier Entry
Position
125619a
Figure 1.22: FastTrack Sampler LED Indicators
– Tray Status LEDs—indicate presence of a sample

carrier tray on the FastTrack Sampler. The LED to the
right of the tray illuminates blue. When system power
is turned ON and the FastTrack Sampler is ready to
begin movement, the LEDs illuminate orange and
flash. When the FastTrack Sampler is homed or starts
moving, the LEDs stop flashing.
– Carrier Entry Position LED—the LED directly in front
of the sampler is arrow-shaped and illuminates red
when a run is in process.

200154-101—November 2004
Use or Function
Front Display Panel

Indicators on the display panel at the front of the analyzer
indicate the power status and FastTrack™ Sampler status.
5
4
3
2
1 125618
Figure 1.23: Front Display Panel
125647
Figure 1.24: Front Display Panel Indicators

200154-101—November 2004
Use or Function

Indicator Description
1 REFRIG Main Circuit Breaker Switch is ON.
AUTO Rotary Power Control Switch is set to AUTO position.
Required for the system to automatically perform START UP and
SHUTDOWN at configured times.
POWER System is fully powered ON.
Main Circuit Breaker Switch is ON.
Rotary Power Control Switch is set to AUTO or ON.
2 RUN FastTrack™ Sampler is transporting samples.
3 RERUN System is configured for Auto Return of the FastTrack Sampler.
When the end-of-run sample carrier is detected, the indicator is
illuminated and the FastTrack Sampler returns samples for rerun
to the carrier sampler position.
4 REMOVE Sample carrier trays must be removed to allow movement of
additional trays to the carrier sampler position.
5 SET Sample carrier trays may be loaded on the FastTrack Sampler.
Indicator(s) Main Circuit Rotary Power

Power
Illuminated Breaker Control Switch
REFRIG ON OFF Power is supplied to
refrigerators of Reagent
Supply Centers only.
REFRIG ON AUTO System performed
AUTO automatic power OFF or
SHUTDOWN; power is
supplied to refrigerators
of Reagent Supply
Centers only.
REFRIG ON ON System is fully powered
POWER ON; power is supplied to
all components.
REFRIG ON AUTO System is fully powered
AUTO ON; power is supplied to
POWER all components.

200154-101—November 2004
Use or Function
Bulk Solution Area

The front-right door, in the lower area of the analyzer, opens
to a compartment that provides onboard storage of bulk
solutions.
Acid Wash Solution

Alkaline Wash Solution
ICT Reference Solution 125624a
Figure 1.25: Bulk Solution Area
Solution Description
ICT™ Reference Used in electrolyte(s) measurement
Alkaline Wash Diluted by the analyzer then used for
cuvette washing
Acid Wash Diluted by the analyzer then used for
cuvette washing

200154-101—November 2004
Use or Function
NOTES

200154-101—November 2004
Consumables and Accessories
Consumables
AEROSET consumables include:
□ Sample Cups
□ Reagent Cartridges and Caps
□ ICT™ Sample Diluent
□ ICT Calibrators
□ ICT Cleaning Fluid
□ ICT Reference Solution
□ Wash Solutions
□ Water Bath Additive
□ Calibrators
Accessories
AEROSET accessories include:
□ Sample Carriers
□ End-of-Run Sample Carrier
□ Cup/Tube Adapters
□ Sample Carrier Trays
□ Sample Carrier Tray Covers
□ 20 mL Reagent Cartridge Adapters
□ Small Reagent Cartridge Adapters
□ System Operations Manual
□ Package Insert Binder

200154-101—November 2004
Use or Function
Consumables and Accessories Section 1
Consumables
Sample Cups
Sample cups are used to load calibrators, controls, and patient
samples on the AEROSET System. They can be placed on the
Calibrator/Control Carousel, Sample Carousel, Reserved STAT
position, and sample carriers. Volume graduation lines at 1 mL
and 2 mL are useful when filling sample cups, eliminating
need for precision pipetting.
NOTE: Use of AEROSET sample cups is required to
adequately accommodate the AEROSET System sample
probe.
NOTE: Refer to parameters in the assay-specific package
inserts for individual assay sample volume
requirements.
NOTE: Cup/tube adapters are required when loading
sample cups in all positions except those on the
2 mL
1 mL
125638
Figure 1.26: AEROSET Sample Cup

200154-101—November 2004
Use or Function
Section 1 Consumables and Accessories
Reagent Cartridges and Caps

Reagent cartridges are used in Reagent Supply Centers and
contain reagents used during operation. They may also
contain ICT™ sample diluent, diluted wash solutions, and
water bath additive.
There are five types of reagent cartridges:
• Large, white or natural—approximately 90 mL
• Small, white or natural—approximately 55 mL
• 20 mL wedge, white or natural
• 20 mL bottle, natural—only available with some
prepackaged reagents, cannot be ordered separately
• 100 mL, white—only available with some prepackaged
reagents, cannot be ordered separately
Large (90 mL) 100 mL
20 mL Wedge
Small (55 mL) 20 mL Bottle
Figure 1.27: Reagent Cartridges

200154-101—November 2004
Use or Function
ICT™ Sample Diluent

ICT sample diluent is prepackaged in large bar coded reagent
cartridges and is placed in an outer segment of Reagent Supply
Center 1. ICT sample diluent is used to dilute samples for
electrolyte analysis.
125639a
Figure 1.28: ICT Sample Diluent
ICT Calibrators
ICT calibrators (7% bovine serum albumin base) and ICT urine
calibrators (aqueous base) are used to calibrate the ICT
module. Each set contains two levels, low and high. Refer to
the ICT Calibrator Package Inserts for additional
information on calibration.
125627
Figure 1.29: ICT Calibrators

200154-101—November 2004
Use or Function
ICT™ Cleaning Fluid

ICT cleaning fluid is used daily during the START UP and
SHUTDOWN Procedures to clean the ICT module.
125640
Figure 1.30: ICT Cleaning Fluid
ICT Reference Solution

The ICT reference solution container is loaded on a weight
platform behind the front-right door. It is aspirated and
analyzed by the ICT module before and after each sample to
provide a reference concentration for results calculation.
Wash Solutions
Two wash solutions are used on the AEROSET System:
• Alkaline wash solution
• Acid wash solution
The containers are loaded on a weight platform behind the
front-right door. Wash solutions are used by the cuvette
washer to clean cuvettes after sample analysis.
Diluted wash solutions must also be prepared for probe
washing use. Supplies of diluted wash solutions are placed in
the Reagent Supply Centers and on the Calibrator/Control
Carousel.

200154-101—November 2004
Use or Function
Water Bath Additive

Water bath additive is used to minimize bacterial growth in
the water bath. A supply of water bath additive is placed in an
outer segment of Reagent Supply Center 1. It is dispensed into
the water bath when the Change Water In Bath option is
performed during the START UP or SHUTDOWN Procedure.
125642
Figure 1.31: Water Bath Additive
Calibrators
Several types of calibrators are used on the AEROSET System,
both serum and aqueous based materials. Refer to the
assay-specific package inserts to identify calibrators for each
assay.

200154-101—November 2004
Use or Function
Accessories
Sample Carriers
Sample carriers hold tubes and cups loaded on the FastTrack™
Sampler. The carriers have bar code labels for identification by
the system. Each carrier has five positions designed to hold the
following sample container types:
• 16 x 100 mm (10 mL) tubes
• 16 x 75 mm (7 mL) tubes
• 13 x 100 mm (7 mL) tubes, with cup/tube adapters
• 13 x 75 mm (5 mL) tubes, with cup/tube adapters
• AEROSET sample cups, with cup/tube adapters
Tubes can be labeled with bar codes for positive identification.
Although sample cups cannot be labeled with bar codes, a cup
can be placed in a bar code labeled tube for sampling and
identification.
125605a
Figure 1.32: Sample Carrier

200154-101—November 2004
Use or Function
End-of-Run Sample Carrier

The end-of-run sample carrier is a blue carrier labeled with the
number zero (0) that is placed on the FastTrack™ Sampler in
the last position of a run. When the end-of-run carrier is
identified, the FastTrack Sampler stops sampling. If Auto
Return is defined, the analyzer returns the carriers to the
starting position and begins to sample reruns.
Non-bar Code Labeled Sample Carrier (Optional)

The non-bar code labeled sample carrier is a green carrier
labeled with numbers greater than or equal to 9001. The
non-bar code labeled sample carrier is used to run non-bar
code labeled samples or samples with unreadable bar code
labels on the FastTrack Sampler. Refer to System
Configuration (1st Car’r for No-Bcode Smpls) in Section 2,
Installation Procedures and Special Requirements for details.
Cup/Tube Adapters
Cup/tube adapters are used in the sample carriers, Sample
Carousel, and Reserved STAT position when 13 mm diameter
tubes or sample cups are loaded.
125629
Figure 1.33: Cup/Tube Adapter

200154-101—November 2004
Use or Function
Sample Carrier Trays

Sample carrier trays are used to hold sample carriers for
loading on the FastTrack™ Sampler. Each tray holds up to
10 sample carriers.
125606
Figure 1.34: Sample Carrier Tray with Sample Carriers
Sample Carrier Tray Covers

Sample carrier tray covers can be placed on sample carrier trays
to cover open sample containers. The covers are used when
samples are running. There are two types:
• Low—covers short tubes and sample cups
• High—sits higher on the tray to cover tall tubes
125641
Figure 1.35: Carrier Tray Covers

200154-101—November 2004
Use or Function
Reagent Cartridge Adapters

Two types of reagent cartridge adapters are used on the
AEROSET System:
• 20 mL reagent bottle adapters
• Small (55 mL and 20 mL wedge) reagent cartridge adapters
Adapters are used to ensure correct alignment of 20 mL bottles
and small reagent cartridges when placed in the Reagent
Supply Center.
Figure 1.36: Reagent Cartridge Adapters
Manuals
The following manuals are provided for use with the AEROSET
System:
• AEROSET System Operations Manual
A complete reference for operation of the AEROSET
System.
• AEROSET Package Insert Binder
Provides a repository for assay-specific Abbott Clinical
Chemistry Package Inserts for Abbott reagents used with
the AEROSET System.

200154-101—November 2004
Special Features
SmartWash™ Feature
The SmartWash feature provides an additional wash process,
when needed for reagent probes, sample probes, and reaction
cuvettes. It is used to prevent assay-to-assay interference when
specific combinations of assays are tested.
If a known combination of assays results in assay-to-assay
interference, interference can be avoided by configuring the
combination as a SmartWash pair. This executes an additional
wash process between measurement of the assays.
NOTE: SmartWash pair default settings are configured
for Abbott reagents. For alternate reagent applications,
refer to Reagent Carryover in Section 2, Installation
Procedures and Special Requirements.
CAUTION: Changing assay configuration from the
! A-Line to the B-Line (or B to A) may affect reagent
carryover (SmartWash) and test results.
Guidelines to minimize reagent carryover:
1. When an assay is defined on the B-Line, the SmartWash
page only allows selection of a reagent probe wash with
other assays on the B-Line. If the assay is moved to the
A-Line, the assay could be affected by carryover from an
assay on the A-Line. Refer to the Abbott Clinical
Chemistry Package Inserts to define probe washes
needed for A-Line assays.
2. Certain assays should not be configured together on the
same line, because it is not possible to ensure sufficient
washing to eliminate reagent carryover.
Refer to the LIMITATIONS OF THE PROCEDURE section in the
assay-specific package inserts.
NOTE: The OSS™ (Optimum Sampling Sequence)
feature automatically changes the sampling sequence,
so assays configured as SmartWash pairs are not
measured consecutively. If it is not possible to separate
the assays, the SmartWash feature is automatically
activated.

200154-101—November 2004
Use or Function
Special Features Section 1
OSS™ Feature
Throughput of the AEROSET System depends on optimum
usage of reaction cuvettes. When the Smart Sampling option
in System Configuration is ON, the Optimum Sampling
Sequence feature enables the system to maximize throughput.
OSS maximizes processing speed when the SmartWash™
feature is active.
When OSS is enabled, the sampling sequence is rearranged to
minimize the number of empty reaction cuvettes used.
Operation during SmartWash Processing

When the Optimum Sampling Sequence cannot be utilized to
separate SmartWash pairs, the SmartWash feature is executed.
Example: When assays A, B, and C are ordered and a
SmartWash pair A씮B is configured:
OSS Feature Not Used OSS Feature Used

Cycle System Operation Cycle System Operation
1 Sampling for assay A 1 Sampling for assay A
2 Wash 2 Sampling for assay C
(empty cuvettes)
3 Sampling for assay B 3 Sampling for assay B
4 Sampling for assay C

200154-101—November 2004
Use or Function
Section 1 Special Features
Clot Detection System (if Installed)

The Clot Detection system allows the AEROSET to monitor
aspiration for clotted samples. An aspirated clot is detected by
an increase in pressure resulting from an obstruction in the
sample probe. When a sample probe obstruction is detected,
the AEROSET System:
• Discontinues aspiration for the sample in process.
NOTE: The system will attempt to aspirate each
replicate ordered for a sample.
• Generates an Error Log Message to indicate a clot was
detected.
• Generates a Result Error Code and masks results for all
affected tests.
• Moves the sample probe to the wash cup to attempt
removal of the clot.
Contact your Abbott Representative for additional details.
CAUTION: Due to variability in sample/clot viscosity, it
! is possible that a clotted sample will not be detected
with this feature. It is the operator’s responsibility to
verify the condition of each sample before placement
on the instrument.
Lamp Monitoring Feature

As the AEROSET System source lamp ages and begins to
deteriorate, lamp intensity also begins to degrade and slight
reading fluctuations occur. The Lamp Monitoring feature
detects these small fluctuations and the system generates an
appropriate Error Log Message. This feature allows for
troubleshooting and detection of a defective source lamp or
faulty optics system.

200154-101—November 2004
Use or Function
Special Features Section 1
Sample Carryover Reduction Feature (if Installed)

Sample carryover requirements are not the same for all
instruments. The requirements for clinical chemistry analyzers
may be less stringent than for immunoassay analyzers. The
possibility of sample carryover should be considered when
transferring samples that have been processed on one analyzer
to another for additional testing.
The optional Sample Carryover Reduction feature includes a
new wash cup with additional software improvements, which
work together to reduce sample-to-sample carryover on the
AEROSET System. Contact your Abbott Representative for
additional details.

200154-101—November 2004
Software
Screen Layout
After the Log On Procedure is performed, the screen to operate
the AEROSET System displays. The Main Display is divided
into the following areas:
Status
Area
Display
Display Area
Area
Action
Area
Run Progress Area Information Access Area
Figure 1.37: Main Display

200154-101—November 2004
Start
1-40
Action Area of the Main Display
Cancel
Software
Save
RUN OPTIONS SysCfg SmplSeq
QC Rule
Use or Function
RUN OPTIONS SysCfg SmplSeq

QC Rule
Screen Hierarchy
SELECT ASSAYS FOR STAT
START UP OPTIONS
SHUTDOWN OPTIONS
REAGENT SCAN
STOP
Print System
ERROR LOG Beep OFF SCC
ResetErr Sampling
MAINTENANCE
UTILITIES Rgt Area 1
Rgt Area 2
ONLINE
HOST COMMUNICATION Rxn Area
CONFIGURATION
SW Info
Printer
Configuration
Log On
200154-101—November 2004
Section 1
AEROSET® System Operations Manual

Information Access Area of the Main Display Print
C/C Crsl
Set 1
Print Set 2
CALIBRATOR/
Section 1
CONTROL Stored Set 3

All Clear All
Average
CALIBRATION Detail Print
SUMMARY Dates Form1/2
Del Prev Options
FreeText
AEROSET® System Operations Manual

200154-101—November 2004
Print Options Import
Print Page Setup Export
Wizard
Order Order Samples
Clear
Result RESULT
Accept Print
RxnGraph Accept Adjusted/Free/Normal
Rerun Reaction Graph Export
Export Rerun Abs Data
Recalc Edit
Delete ReCalc
View Delete
Add
R1-A
R1-B
R1-C
Report
R1-D
Clear All
R2-A
R2-B
R2-C
Print Print Outline Print
R2-D
All Details Import
Base
QC SUMMARY LJ Graph Datalist Calibration Export
Export Export QC Save
D. Range SmartWash Delete
Delete Rerun Rules
Config
ASSAYS Assay Status Calib Cal Details Print
QC Levey-Jennings Details
Replace Graph Datalist
Status Error Status Export
Software
1-41
Use or Function
Use or Function
Software Section 1
Information Access Area

The following table describes functions of buttons located in
the Information Access Area.
To Access This
Press This Button… Description
Information
Calibrator/ Displays configuration of the Calibrator/Control
Control Carousel Carousel, where expected values are entered.
display and
configuration
Reagent Supply Displays inventory of the Reagent Supply
Centers display Centers. The position where the reagent is located
and configuration and estimated remaining reagent volume can be
viewed, both by number of remaining tests and
%volume.
Calibration Displays current calibration absorbance values
summary and factors for all assays. Data can be saved so a
month’s average displays. It also allows for
deletion of previous calibration curves.
Quality control Displays the QC SUMMARY screen where a
summary summary of QC statistics for all assays and levels
can be viewed. Levey-Jennings graphs and QC
details can also be accessed from this screen.
Database Displays the DATABASE screen, used to create
patient sample orders, view completed results,
view Result Error Codes, and process results
functions.

200154-101—November 2004
Use or Function
Section 1 Software
To Access This
Information
Assays display Displays the ASSAYS screen to enable access to
the ASSAY STATUS screen for each assay. On the
ASSAY STATUS screen, the current calibration
curve, reagent status, and a summary of QC
statistics display. Assay Configuration,
Levey-Jennings Graph, and Calibration Details
screens are also accessed from this screen. The
assay-specific buttons on the ASSAYS screen
display different colors to indicate assay status:
• Pink—reagent is expired or empty, or the
calibration is expired/unusable.
• Yellow—reagent is below the alert level or a
Calibration Error occurred.
• Black—an assay parameter is defined
incorrectly.
• Green—assay is okay.
Select <Status> on the ASSAY STATUS screen for
explanation of the button color change.

200154-101—November 2004
Use or Function
Software Section 1
Action Area
The following table describes functions of buttons located in
the Action Area.
To Perform
This Action
Initiate a run or Displays the RUN OPTIONS screen. On this screen,
perform system types of samples to be run are selected and the run
configuration process initiated. Calibrations and controls are
ordered on this screen, and the SYSTEM
CONFIGURATION screen is also accessed.
Pause the system Displays the RUN OPTIONS screen. On this screen,
during a run the operator can PAUSE the system to temporarily
stop movement of the Reagent 1 probes, sample
probes, Carousel Sampler, and FastTrack™ Sampler.
WARNING: If a diluted sample has been
!dispensed, the sample and R1 reagent arms
may move after the status has changed to
PAUSE. Wait 25 seconds before accessing the
Sample Carousel and Reagent Supply Center 1
areas.
WARNING: The AEROSET System does not
!stop movement of the Reagent 2 probes, ICT™
unit, mixers, or cuvette washers so Assay Read
Times are unaffected.
CAUTION: The system completes dispensing
!and mixing of any sample and reagent already
aspirated. Confirm the PAUSE status in the
System Status Area and confirm the
R1 Indicator on the Local User Interface (LUI)
Control Panel is illuminated before
proceeding.
Order and start a Displays the SELECT ASSAYS FOR STAT screen to
STAT sample order a sample in the Reserved STAT position and
initiate STAT processing.
Initiate the Allows configuration and initiation of START UP
START UP Procedures.
Procedure
Initiate the Allows configuration and initiation of SHUTDOWN
SHUTDOWN Procedures.
Procedure

200154-101—November 2004
Use or Function
Section 1 Software
To Perform
This Action
Scan bar code Initiates a scan of bar codes on reagent cartridges in
labeled reagent the Reagent Supply Centers.
cartridges
Stop the system Stops a run completely, so all movement and
during a run processing ceases. Any samples in progress are not
completed and remain pending. When the run is
reinitiated by selecting <RUN>, these samples are
repipetted.
WARNING: The system attempts to home all
! robotics before movement stops. Before
proceeding, confirm the READY status in the
System Status Area.
Process progress This button is not selected to perform an action.
display Instead, it displays the progress of processes, e.g.,
multiple reports were selected to print, or multiple
samples were sent to the Host computer. This button
displays a green bar and percent completed.
Review the Displays the Error Message Log. The background
Error Log color of the Error Log icon changes to indicate
occurrence of an error and the error level.
• Yellow—low level error
• Pink—medium level error
• Red—high level error
The system can also be configured to generate an
audible alarm when an error occurs.
Perform Displays the MAINTENANCE UTILITIES screens,
Maintenance where the Touchscreen is used to move components
Utilities for maintenance and troubleshooting purposes.
These screens are also accessed to perform software
Backup and Restore Procedures.
Define options Accesses printer options, including clearing of the
for Printer A print buffer and configuration of automatic report
printing.
NOTE: Format of Patient reports is configured
on the DATABASE screen.
Define options Accesses most of the same options as Printer A.
for Printer B

200154-101—November 2004
Use or Function
Software Section 1
To Perform
This Action
Define options Accesses Host interface functions—to enable,
for Host disable, and configure communication with the
interface laboratory Host computer.
connections The Host Communication icon changes to indicate
online status:
• Blue with a slash—the ONLINE
CONFIGURATION screen is configured as offline,
or the Host is not connected.
• Blue and white—Host is online and connected, in
READY status.
• Red and black—Host is online and connected, but
communication is temporarily suspended. To
resume communication, select the Host
Communication icon then select <OK>.
Print a copy of Prints a copy of the screen currently displayed. The
the screen Print Screen function is only allowed when the
when the system status is READY. The Print Screen
icon on the screen is disabled when the system is in
RUN, SAMPLING END, PAUSE, CUVETTE FILL, and
SUSPEND status.
Exit system Exits the system software and returns to the Log On
software screen. The Log On screen is used to SHUTDOWN
system software before powering OFF, or before Log
On with a different password.

200154-101—November 2004
Use or Function
Section 1 Software
Display Area
This area displays information or actions that correspond to
the button selected in the Information Access Area or Action
Area. For example, if <Cal/Control> is selected, the
CALIBRATOR/CONTROL screen appears in the Display Area.
NOTE: Unless the operator exits the displayed screen
before selecting a new option, typically by selecting
<OK>, the new screen overlays the earlier screen.
Status Area
This area displays the system status, date, time, water bath
level, and high-concentration waste full indicator.
Status Area
Status (includes:
READY, RUN, PAUSE,
SAMPLING END, SUSPEND,
CUVETTE FILL, REAGENT
SCAN, STANDBY, START UP,
Date and SHUTDOWN)
Time
High-concentration
Water Bath Level Waste Full Indicator
(Green = OK, Blue = Cold, Pink = Hot) (Visible when full)
Figure 1.38: Status Area of the Main Display

200154-101—November 2004
Use or Function
Software Section 1
Run Progress Area

This area displays the progress of assay analysis. When
measurement is started, a colored bar appears at the left end of
the Run Progress Area, then moves to the right as
measurement continues. When the bar reaches the red mark
in the center of the display, the second reagent, if appropriate,
is dispensed. When the bar reaches the far right, the sample is
complete and results display on the DATABASE screen.
NOTE: The Run Progress Area bar represents
approximately 10 minutes of processing time, divided
into approximately one minute intervals.
Run Progress
Area
Figure 1.39: Run Progress Area of the Main Display
The bar color indicates the sample type currently being

analyzed, listed in order of priority:
Color Sample Type

Green Calibrator
Yellow Control
Pink STAT sample
Gray Patient sample

200154-101—November 2004
Screen Navigation
Several methods to access and display information on

AEROSET System screens are available. As previously described,
use of buttons is one option. This section outlines additional
methods for accessing information and related displays.
CAUTION: After information is entered in a field, there
! is a 30 second time limit for the operator to move to
the next field to accept the entry, e.g., pressing [Tab] on
the keyboard or using the Touchscreen. Failure to move
to the next field within 30 seconds causes the field to
revert to the previous entry.
Touchscreen Operation
Buttons and Icons
Pictures or text display on buttons and icons. When a button
or icon is selected, the frame turns blue or the button changes
color.
Tabs
Some software screens have additional subscreens, known as
pages. Tabs are visible along the upper Display Area, and can
be selected to access the available pages. Page tabs for
subscreens of the Assay Configuration screen are shown.
Scroll Bar
A scroll bar appears on some screens when a list displays, and
indicates additional selections are available. The operator can
touch the scroll bar or use the arrow keys [씮] [씯] on the
keyboard to view all list items. A scroll bar is shown.

200154-101—November 2004
Use or Function
Screen Navigation Section 1
Drop-down List Box

For data entry in a single field, a drop-down list box displays if
two or more pre-configured options are available. The arrow
button to the right of the field, the list box icon, is selected to
display the choices. After a choice is made from the list, select
the return arrow at the bottom to close the list. A drop-down
list box is shown.
Combo Box
The combo box looks like the drop-down list box and also
allows the operator to make selections from the pre-configured
list. However, the combo box has a feature that is different
from the drop-down list box; it also allows keyboard entry to
create new list items.
Checkbox
On screens where checkboxes (聺) display, multiple options
can be selected by touching the box for checkmark placement.
A screen with checkboxes is shown.
Single Selection Item

On screens where single selection items display, only one item
can be selected by touching the circle for checkmark
placement. A single selection item is shown.

200154-101—November 2004
Use or Function
Section 1 Screen Navigation
Keyboard Operation
In addition to Touchscreen operation, the keyboard can also
be used to operate the system software.
Keyboard Operation Result
[Tab] or [Shift] + [Enter] Moves cursor to the next field

[Shift] + [Tab] or Moves cursor to the previous
[Shift] + [Backspace] field
1. Key operation for checkboxes:

• [Space] switches between “Select” (聺) and
“Deselect” (□).
2. Key operation for combo boxes:
• Entry from the keyboard is possible.
• [앗] opens the selection window.
• [ 씮] [앗] moves the cursor to the next item.
• [씯] [앖] moves the cursor to the previous item.
• [Enter] selects the highlighted item and closes the
window.
• [Esc] closes the window.
3. Key operation for drop-down list boxes:
• [앗] opens the selection window.
• [씮] [앗] moves the cursor to the next item.
• [씯] [앖] moves the cursor to the previous item.
• [Enter] selects the highlighted item and closes the
window.
• [Esc] closes the window.
4. Key operation for list screens:
• [씯 ] [앖] [씮] [앗] moves the cursor in the arrow
direction.
• [PageUp] moves the cursor to the item at the same
position on the previous page’s list and the previous
page displays.

200154-101—November 2004
Use or Function
Screen Navigation Section 1
• [PageDown] moves the cursor to the item at the same

position on the next page’s list and the next page
displays.
• [Shift] pressed together with key above selects
multiple items.
• [Home] moves the cursor to the first item of the list
and the first page displays.
• [End] moves the cursor to the last item of the list and
the last page displays.
• [Ctrl] + [Home] moves the cursor to the first item on
the screen.
• [Ctrl] + [End] moves the cursor to the last item on the
screen.
• [Enter] selects the item highlighted by the cursor.
• [Backspace] moves the cursor to the item previously
selected.

200154-101—November 2004
Section 2
Section 2:
Installation Procedures and

Special Requirements

Site and System Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
System Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Checkout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Sample Carrier Label Placement . . . . . . . . . . . . . . . . . . 2-2
Sample Carrier Bar Code Label Placement . . . . . . . . . . . 2-4
Sample Carrier Numeric Code Label Placement . . . . . . . 2-5
AEROSET System Configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

Log On Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Configure Log On Password . . . . . . . . . . . . . . . . . . . . . . 2-8
Delete an Existing User Code . . . . . . . . . . . . . . . . . . . . 2-10
Run Options Configuration . . . . . . . . . . . . . . . . . . . . . . . . 2-11
System Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
System Configuration (1st Car’r for No-Bcode Smpls) . 2-24
QC Rules Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25
MAINTENANCE UTILITIES Screen . . . . . . . . . . . . . . . . . . . 2-28
Automatic Power ON, START UP, and SHUTDOWN . . 2-29
Enabling Automatic Modes . . . . . . . . . . . . . . . . . . 2-29
DATABASE Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31
Panel Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31
Sample Report Forms Configuration . . . . . . . . . . . . . . 2-34
Configure Result Print Format Options . . . . . . . . . 2-37
Configure Page Format Options. . . . . . . . . . . . . . . 2-40
Printing Reference Ranges . . . . . . . . . . . . . . . . . . . . . . . . . 2-43
ASSAYS Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-46
Assay Display Order . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-46
Export Assay Files . . . . . . . . . . . . . . . . . . . . . . . . . 2-46
Delete Assay Files . . . . . . . . . . . . . . . . . . . . . . . . . . 2-48
Import Assay Files . . . . . . . . . . . . . . . . . . . . . . . . . 2-49
Printer Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-52
Printer A and B Configuration . . . . . . . . . . . . . . . . . . . 2-52
Host Communication Icon . . . . . . . . . . . . . . . . . . . . . . . . 2-55
Host Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-55
Host Communication Icon . . . . . . . . . . . . . . . . . . . . . . 2-57

200154-101—November 2004
Installation Procedures and Special Requirements Section 2
Reagent Configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-59

Reagent Supply Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-60
Reagent Cartridges with Bar Code Labels . . . . . . . . . . . . . 2-62
Reagent Cartridges without Bar Code Labels . . . . . . . . . . . 2-64
Concentrated Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-68
Calibrator/Control Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-71
Assay Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-75

Photometric Assay Configuration . . . . . . . . . . . . . . . . . . . 2-76
Photometric Outline Page . . . . . . . . . . . . . . . . . . . . . . 2-78
Quantitative Ranges . . . . . . . . . . . . . . . . . . . . . . . 2-80
Qualitative Ranges . . . . . . . . . . . . . . . . . . . . . . . . 2-84
Photometric Base Page . . . . . . . . . . . . . . . . . . . . . . . . . 2-85
Photometric Calibration Page . . . . . . . . . . . . . . . . . . . 2-96
Photometric QC Page . . . . . . . . . . . . . . . . . . . . . . . . . 2-105
Photometric SmartWash™ Page . . . . . . . . . . . . . . . . . 2-109
Photometric Rerun Rules Page . . . . . . . . . . . . . . . . . . 2-112
Calculated Assay (Ratios) Configuration . . . . . . . . . . . . . 2-114
Calculated Outline Page . . . . . . . . . . . . . . . . . . . . . . . 2-116
Quantitative Ranges . . . . . . . . . . . . . . . . . . . . . . 2-116
Qualitative Ranges . . . . . . . . . . . . . . . . . . . . . . . 2-120
Calculated Base Page . . . . . . . . . . . . . . . . . . . . . . . . . 2-121
Calculated QC Page . . . . . . . . . . . . . . . . . . . . . . . . . . 2-124
Calculated Rerun Rules Page . . . . . . . . . . . . . . . . . . . 2-127
Potentiometric Assay Configuration . . . . . . . . . . . . . . . . 2-129
Potentiometric Outline Page . . . . . . . . . . . . . . . . . . . 2-131
Qualitative Ranges . . . . . . . . . . . . . . . . . . . . . . . 2-135
Potentiometric Base Page . . . . . . . . . . . . . . . . . . . . . . 2-136
Potentiometric Calibration Page . . . . . . . . . . . . . . . . 2-142
Potentiometric QC Page . . . . . . . . . . . . . . . . . . . . . . . 2-145
Potentiometric SmartWash Page . . . . . . . . . . . . . . . . 2-148
Potentiometric Rerun Rules Page . . . . . . . . . . . . . . . . 2-151
Sample Interference Indices Configuration . . . . . . . . . . . 2-153
Reference File Options . . . . . . . . . . . . . . . . . . . . . . . . 2-154
Common Test File . . . . . . . . . . . . . . . . . . . . . . . . 2-154
Extra Test File . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-155
Reference File Configuration . . . . . . . . . . . . . . . . . . . 2-155
Using the Saline Protocol . . . . . . . . . . . . . . . . . . 2-155
Reagent Configuration . . . . . . . . . . . . . . . . . 2-155
Assay Configuration . . . . . . . . . . . . . . . . . . . 2-155
Using ALT or AST . . . . . . . . . . . . . . . . . . . . . . . . 2-156
Sample Interference Index File Configuration . . . . . . 2-157

200154-101—November 2004
Section 2 Installation Procedures and Special Requirements
Sample Interference Indices Outline Page . . . . . . . . . 2-158

Qualitative Ranges . . . . . . . . . . . . . . . . . . . . . . . . 2-162
Sample Interference Indices Base Page . . . . . . . . . . . . 2-163
Sample Interference Indices QC Page . . . . . . . . . . . . . 2-165
Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-168
Confirmation of Assay Parameter Settings . . . . . . . . . . . . 2-169
ASSAY STATUS Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-171
Assay Name Display Area . . . . . . . . . . . . . . . . . . . . . 2-172
Reagent Information Display Area . . . . . . . . . . . . . . . 2-172
Calibration Data Display Area . . . . . . . . . . . . . . . . . . 2-173
Control Data Display Area . . . . . . . . . . . . . . . . . . . . . 2-174
Measurement Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-175

Line Balance™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-176
Sample Blank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-178
Assay Parameter Setting . . . . . . . . . . . . . . . . . . . . . . . 2-180
Color Correction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-183
Type Number Configuration . . . . . . . . . . . . . . . . . . . . . . 2-186
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-186
Example of Volume Correction . . . . . . . . . . . . . 2-186
Dispense Mode R1 . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-187
Dispense Mode R2 . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-188
Diluent Dispense Mode . . . . . . . . . . . . . . . . . . . . . . . 2-189
Prozone Reaction Check . . . . . . . . . . . . . . . . . . . . . . . . . . 2-190
FlexRate™ Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-194
Diluting Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-196
Configuring Sample and Diluent Volumes . . . . . . . . 2-197
Configuring the Diluent . . . . . . . . . . . . . . . . . . . . . . . 2-200
Diluting the Blank/Calibrator . . . . . . . . . . . . . . . . . . . . . 2-203
Diluting a Single Calibrator . . . . . . . . . . . . . . . . . . . . 2-203
Diluting a Multiple Calibrator . . . . . . . . . . . . . . . . . . 2-206
Result Data Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-209

Absorbance Range Limits . . . . . . . . . . . . . . . . . . . . . . . . . 2-210
End-point Absorbance Variation . . . . . . . . . . . . . . . . . . . 2-212
Rate Linearity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-213
Extrapolated Calculation . . . . . . . . . . . . . . . . . . . . . . . . . 2-215

200154-101—November 2004
Installation Procedures and Special Requirements Section 2
Reagent Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-217

Cross-contamination Protocol . . . . . . . . . . . . . . . . . . 2-217
Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-217
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-217
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-218
Interpretation of Results . . . . . . . . . . . . . . . . . . . . . . . 2-221
Implementation and Verification of the SmartWash™
Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-222
Example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-223
Import and Export Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-225

Import Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-226
Export Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-227
Instrument Relocation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-229

Distant Relocation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-229
Local Relocation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-229
Movement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-229
Reinstallation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-229

200154-101—November 2004
Section 2: Installation Procedures and Special Requirements
Site and System Preparation
Before the Abbott Field Service Representative performs

installation, the location of the AEROSET System must be
evaluated to ensure it meets environmental and electrical
requirements. Refer to Section 4, Performance Characteristics and
Specifications for additional information.
System Preparation
The Abbott Field Service Representative unpacks, positions,
and connects the AEROSET System. This includes the
following:
• Unpack the system
• Unpack the accessory kit
• Position the system and its peripherals
NOTE: The AEROSET System should be located
away from direct sunlight.
• Assemble the system
• Connect all cables
• Confirm proper seating and secure connections of all
circuit boards, power supplies, etc.
• Check seating and alignment of all carousels
Checkout
After the AEROSET System is positioned and connected, the
Abbott Field Service Representative performs the following
procedures to confirm satisfactory installation and operation:
• Assay File Installation
• System Verification
When the Abbott Field Service Representative completes these
procedures, the AEROSET System is ready for site-specific
configuration.
NOTE: If any accessories or supplies are missing or in
unsatisfactory condition when unpacked, the Abbott
Representative assists with damage reporting and
replacement.

200154-101—November 2004
Installation Procedures and Special Requirements
Site and System Preparation Section 2
Sample Carrier Label Placement

Each sample carrier must have two labels for sample
identification:
• Sample carrier bar code label—read by the system
• Sample carrier numeric code label—read by the operator
The number on the sample carrier numeric code label must
match the number on the sample carrier bar code label.
CAUTION: It is the operator’s responsibility to verify
! correct label placement.

200154-101—November 2004
Section 2 Site and System Preparation
Matching, adhesive numeric code and bar code labels are

supplied in sheets with the sample carriers. Additional bar
code labels can be ordered separately.
0 2 0 1
0 2 0 2
Sample Carrier Bar Code Labels
0 2 0 3
Sample Carrier Numeric Code Labels

0 2 0 4
0 2 0 5
0 2 0 6
201 202 203 204 205 206 207 208 209 210
211 212 213 214 215 216 217 218 219 220
221 222 223 224 225 226 227 228 229 230
0 2 0 7
231 232 233 234 235 236 237 238 239 240
241 242 243 244 245 246 247 248 249 250
251 252 253 254 255 256 257 258 259 260
0 2 0 8 261 262 263 264 265 266 267 268 269 270
271 272 273 274 275 276 277 278 279 280
281 282 283 284 285 286 287 288 289 290
0 2 0 9 291 292 293 294 295 296 297 298 299 300
0 2 1 0
Figure 2.1: Sample Carrier Bar Code and Numeric Code Labels

200154-101—November 2004
Sample Carrier Bar Code Label Placement

1. Stand the sample carrier upright as shown.
Sample Carrier Bar

Code Label
Rear of Sample
Carrier
Figure 2.2: Applying Sample Carrier Bar Code Label
2. Lay the upper edge of the label over the existing label,
then carefully press down only the upper edge.
3. Apply pressure from the top of the label to the bottom,
being careful to not wrinkle the label.
NOTE: The bar code label must be positioned
properly. Improper positioning could result in bar
code read error messages.
4. Inspect the bar code label for wrinkles and proper
alignment.
5. Firmly press down on the entire label surface to ensure it
is secured.

200154-101—November 2004
Section 2 Site and System Preparation
Sample Carrier Numeric Code Label Placement

1. Stand the sample carrier upright as shown. Ensure the
number on the numeric code label matches that on the
sample carrier bar code label.
Sample Carrier Numeric

Code Label
Front of Sample
Carrier
Figure 2.3: Applying Sample Carrier Numeric Code Label
2. Lay the left edge of the label over the existing label, then
carefully press down only the left edge.
3. Apply pressure from the left edge of the label to the right
edge, being careful to not wrinkle the label.
4. Inspect the label for wrinkles and proper alignment.
5. Firmly press down on the label to ensure it is secured.

200154-101—November 2004
NOTES

200154-101—November 2004
AEROSET System Configuration
Log On Screen
The Log On level determines access to screens and functions.
The ability to “view” or “view and edit” and functionality of
each access level is described in the following table.
user super
System Function View Edit View Edit
Printer A and B NO NO YES YES
configuration
Page setup NO NO YES YES
configuration
System configuration NO NO YES NO
hardware options
(Reagent Bar Codes,
External Robotics,
ICT™)
Clot Detection NO NO YES YES
Host communication NO NO YES YES
configuration
Calibration curve data YES NO YES System
configuration
dependent
Deleting QC YES NO YES YES
Patient demographics NO NO YES System
on the RESULT screen configuration
dependent
Calibrator/Control NO NO YES YES
Carousel configuration
Reagent configuration NO NO YES YES
Assay counts YES NO YES NO

200154-101—November 2004
AEROSET System Configuration Section 2
Configure Log On Password

1. Turn ON the system power. The Log On screen displays.
NOTE: If the system is operational, select the Exit
icon in the lower-right section of the Action Area
of the Main Display to return to the Log On
screen.
Without Optional Clot Detection and With Optional Clot Detection and Sample
Sample Carryover Reduction Installed Carryover Reduction Installed
Figure 2.4: Log On Screen
2. To configure a new user code and password, use one of the

following codes to determine an access level.
Press [Tab] on the

If User Code Is… Keyboard Then Enter This
Password
user user
super super
3. Type the user code. Press [Tab] on the keyboard.

NOTE: Do not press [Enter] after typing the user
code.
4. Type the password. An asterisk (*) displays in the Password
field for each character entered for the password. Press
[Enter] on the keyboard.
NOTE: Both the User Code and Password fields are case
sensitive.

200154-101—November 2004
Section 2 AEROSET System Configuration
5. The USER REGISTRATION dialog window displays.
Figure 2.5: USER REGISTRATION Dialog Window
Configure the new user code and password for future use.
a. Type any character, up to 6, in the User Code field
then press [Tab] on the keyboard.
NOTE: If the code is “user” level, the system
can be initiated by entering only the user code;
a new password does not need to be created.
NOTE: Other user codes can be displayed,
registered, or deleted for only the same access
level.
b. Type any character, up to 6, in the Password field then
press [Enter] on the keyboard. The Add button
displays.
NOTE: An asterisk (*) displays in the Password
field for each character entered for the
password.
c. Select <Add> on the USER REGISTRATION dialog
window.
d. Select <OK>. The Log On screen displays.
6. Type the user code configured in step 5 then press [Tab]
on the keyboard. Type the configured password then press
[Enter]. The Log On process is complete and the
DATABASE screen displays.
NOTE: Up to 50 pairs of user codes and passwords
can be registered for the “user” and “super” levels
combined.

200154-101—November 2004
Delete an Existing User Code

1. Turn ON the system power. The Log On screen displays.
NOTE: If the system is operational, select the Exit
icon in the lower-right section of the Action Area
of the Main Display to return to the Log On
screen.
2. To delete an existing user code and password, use one of

the following codes to open the appropriate access level.
Press [Tab] on the

If User Code Is… Keyboard Then Enter This
Password
user user
super super
3. Type the user code and password to be deleted then press

[Enter] on the keyboard. The Delete button displays.
4. Select <Delete> on the USER REGISTRATION dialog
window.
5. Select <OK> on the Delete User Code dialog window.
6. Select <OK>. The Log On screen displays.

200154-101—November 2004
Run Options Configuration

1. Select <RUN> in the Action Area of the Main Display. The
RUN OPTIONS screen displays.
Figure 2.7: RUN OPTIONS Screen
2. The following parameters are configured on the RUN

OPTIONS screen.
RUN OPTIONS Screen Parameters

Field Description
Priority Patient samples on the Sample Carousel
are prioritized over samples loaded on
the FastTrack™ Sampler when this
option is selected. The default setting is
ON (selected).
Auto Return The system can be configured to
automatically return identified samples
to the sample arm for rerun. When
configured, all reruns are presented to
the sample arm if they are:
• Manually ordered reruns
• Auto Reruns
The default setting is OFF (unselected).

200154-101—November 2004
RUN OPTIONS Screen Parameters (Continued)

Field Description
†
Car’r Allows definition of the carrier numbers
used when ordering samples to run on
the Sample Carousel. Refer to Ordering
Patient Samples on the Sample
Carousel in Section 5, Operating
Instructions. The default settings are:
A = 1000
B = 2000
C = 3000
D = 4000
E = 5000
F = 6000
† The database must be cleared before editing this field.

200154-101—November 2004
System Configuration
1. Select <SysCfg> in the right column of the RUN OPTIONS
screen. The SYSTEM CONFIGURATION screen displays.
Figure 2.8: SYSTEM CONFIGURATION Screen

200154-101—November 2004
2. Configure the following parameters.
SYSTEM CONFIGURATION Screen

Parameters
Field Description
Auto Rerun Allows configuration of the system to
automatically reorder assays for
samples that meet user-defined criteria
(Rerun rules) on an assay-by-assay basis.
To activate the Auto Rerun feature, this
option must be selected and
assay-specific Rerun rules defined on
the Assay Configuration screen.
NOTE: Samples are not
automatically returned to the
sample arm unless the Auto
Return option is selected on the
RUN OPTIONS screen.
Run Suspend Allows configuration of length of time
Time (m) the system waits, in minutes, after a run
is complete. While in SUSPEND status,
an abbreviated run initialization is used
(when the next run is initiated). The
default setting is 10 minutes.
Enable Cal Allows editing of read values (e.g.,
Edits absorbances) for calibrators configured
on the ASSAY STATUS screen. The
default setting is ON.
NOTE: If configured ON, only a
Log On level of “super” can edit
calibrator values.
Smart Allows the system to determine the
Sampling assay sampling order, to maximize
processing speed, and reduce the
number of empty reaction cuvettes.
When this option is ON, the OSS™
feature enables the system to maximize
throughput. The default setting is ON.
* The operator is required to cycle system power after editing
this field.
‡ This field can only be edited by an Abbott Representative.

200154-101—November 2004

Parameters (Continued)
Field Description
Saving Mode Allows the system to pick up the
over-aspiration volume one time for
the same sample when aspirating more
than one test, rather than each time a
test is aspirated. The default setting is
ON.
NOTE: Over-aspiration is an
additional volume of sample
aspirated before the actual
sample volume required for
analysis. This prevents the
sample from being diluted with
system water in the probe. Even
with the Sample Saving Mode
option ON, tests requiring
onboard dilutions or sample
volumes exceeding 15 µL, an
additional 8 µL volume of
sample—the “over-aspiration”
volume—may be aspirated by
each probe. The additional
number of over-aspirations
required for these scenarios is
variable, and can be aspirated
from the current sample and/or
the following sample. When
using tests that meet these
conditions, allow for the
possibility of over-aspiration
volumes when dispensing
sample.
this field.

200154-101—November 2004

Field Description
1st Car’r for Allows configuration to restrict samples
No-Bcode without bar code labels to specific
Smpls sample carriers. This option must be
(samples)† configured to run samples without bar
code labels or with damaged bar code
labels. The default setting is 5000.
NOTE: Refer to System
Configuration (1st Car’r for
No-Bcode Smpls) in this section
for details.
Example: If set to 5000, the system
would only allow samples without bar
code labels to be run in sample carriers
with IDs 5000 or higher.
NOTE: The optional non-bar
code labeled sample carriers are
numbered greater than or equal
to 9001. If using these carriers,
the 1st Car’r for No-Bcode Smpls
field must be set to 9001 or
below.
Cycle time Allows configuration of the length of
(0.1 sec) time, in tenths of seconds, for each
quarter turn of the Reaction Carousel.
The default setting is 45
(x 0.1 sec = 4.5 seconds).
CAUTION: Abbott applications
! were developed using a cycle
time of 4.5 seconds. If this option
is edited, the timing and results
of all assays are affected.
this field.

200154-101—November 2004

Field Description
Save by Car’r When selected, orders are tracked in the
ID*† database by carrier and position. The
default setting is OFF.
CAUTION: When this option is
! selected, the sample ID must be
manually entered to ensure
proper sample identification.
CAUTION: If the Save by Car’r
! ID option is selected (ON), a
manually entered sample ID is
not verified against the patient
bar code label on the tube.
NOTE: If the Save by Car’r ID
option is selected (ON), the
Sample Bar Codes option is
automatically OFF (deselected).
NOTE: Auto Rerun is not
performed on non-bar code
labeled samples, and reruns must
be requested manually.
Alphanumeric Allows configuration for numeric or
Sample ID*† alphanumeric sample IDs. The default
setting is ON.
• When set to OFF, the sample ID is
numeric only and automatically
increments when the Batch Ordering
option is used on the Order Samples
screen. Leading empty spaces are
filled with zeros to complete the
configured ID character field
(configured in the Bar Code
Length-Skip-ID field).
• When set to ON, the sample ID is
alphanumeric, does not
auto-increment, and does not fill
empty spaces with zeros.
this field.

200154-101—November 2004

Field Description
Bar Code The bar code length can range from
Length-Skip- 2 to 20 characters.
ID*† Allows configuration of:
• Bar code length = total length of the
bar code
• Skip = number of characters to skip at
the beginning of the bar code (bar
code information that is not part of
the sample ID)
• ID = number of characters allowed in
the sample ID. The default setting is
20-0-20, which indicates up to
20 characters are in the total length
of the bar code and all are part of the
sample ID.
• To edit the Bar Code Length-Skip-ID
field, the ID must be edited first. This
allows the Skip and Bar Code Length
fields to be edited.
NOTE: The smallest number
which can be configured in the
Bar Code Length and ID fields
is 6.
Auto Order Allows the system to automatically
Calculations* perform configured calculations when
constituent assays are ordered. The
default setting is ON.
Auto Validate* Allows the system to automatically
validate patient results in the database
if no Result Error Codes were generated.
The default setting is OFF.
this field.

200154-101—November 2004

Field Description
Enable Demog. Allows (Log On level of “super” only)
Edits in edits to patient demographics on the
RESULT RESULT screen. The default setting is
ON.
NOTE: The sample ID cannot be
edited.
Characters for Allows operator selection of single
L/H Flags characters for Low and High Result
Flags. The default setting is L and H.
NOTE: These flags display next
to patient samples when below
or above the configured reference
range. These flags also display
next to QC samples when
outside the defined 2 SD range.
Sample Bar Allows configuration that requires the
Codes*† system to match sample bar codes with
the entered sample ID. When selected,
orders are tracked in the database by
sample ID. The default setting is ON.
NOTE: If the Sample Bar Codes
option is deselected (OFF), the
Save by Car’r ID option is
automatically selected (ON).
NOTE: Auto Rerun is not
performed on non-bar code
labeled samples, and reruns must
be requested manually.
Fixed Digits Allows configuration that requires the
same number of characters for every bar
code sample ID. The default setting is
OFF.
this field.

200154-101—November 2004

Field Description
Reagent Bar Allows the system to read reagent bar
Codes‡ code labels. This is initiated by selecting
<RGT SCAN> in the Action Area of the
Main Display. The default setting is ON.
If a reagent cartridge does not have a
bar code label, the reagent position
must be configured by the operator.
Refer to Reagent Configuration in this
section.
Rgt (Reagent) Allows configuration to alert the
Lo Alert (#T) operator when any reagent cartridge
level falls below the defined number of
tests. The alert level applies to all
reagent cartridges. The default setting is
20 tests. This alert can also be
configured on the REAGENTS screen
for an individual reagent cartridge.
Refer to Reagent Configuration in this
section.
External Used with laboratory automation
Robotics*‡ systems. The default setting is OFF.
ICT‡ Enables the system to use the ICT™
module. The default setting is ICT.
Audible Alerts Audible alerts can be configured for the
following conditions:
• Error: Error generated
• Crsl Done: All samples from the
Carousel Sampler were accessed
• Track Done: All samples from the
FastTrack™ Sampler were accessed
• STAT Done: A STAT was sampled
• Suspend: System in SUSPEND status
• Ready: System in READY status
this field.

200154-101—November 2004

Field Description
ScreenSaver Allows configuration of time, in
(min) minutes, the system permits absence of
screen interaction before activating the
screensaver. The default setting is
10 minutes.
NOTE: External screensavers
cannot be loaded on the
AEROSET System.
Sample Clot When selected, sample aspirations are
Detection monitored for the presence of a clot.
System (if CAUTION: Do not select this
Installed) ! option if the Sample Clot
Detection system hardware is not
installed on the AEROSET
System. Failure to comply will
generate an Error Log Message
and change the system status to
PAUSE when a run is initiated.
If a clot or sample probe obstruction is
detected, the system:
• Discontinues aspiration of the sample
in process
NOTE: The system will attempt
to aspirate each replicate ordered
for a sample.
• Generates an Error Log Message to
indicate a clot was detected
• Generates a Result Error Code and
masks results for all affected tests
• Moves the sample probe to the wash
cup to attempt removal of the clot
Wash Count Allows configuration of the number of
for Removing cycles the system performs a sample
Clot (if probe wash to remove a clot from the
Installed) sample probe. The default setting is 2.
this field.

200154-101—November 2004

Field Description
Calibrator (if When selected, the system monitors
Installed) calibrators for the presence of a clot. If
calibrator viscosity is too high and
erroneous clot detection errors are
triggered, this option can be deselected.
Control (if When selected, the system monitors
Installed) controls for the presence of a clot. If
control viscosity is too high and
erroneous clot detection errors are
triggered, this option can be deselected.
SmplSeq Allows override of the system default
(Sampling for assay sampling order.
Sequence) NOTE: System level
requirements to maximize
throughput cannot be
overridden. The following list
indicates these requirements, in
the order of sampling:
– Normal assays/ICT™
– SmartWash™ pairs
– Dilutions
– Assays with sample
volume > 15 µL
The sampling sequence defined is
used in each of the system level
requirements.
• Select <SmplSeq> in the right
column of the SYSTEM
CONFIGURATION screen.
• To add an assay to the sampling
sequence, select the first assay in the
unselected (left) column, then select
<Add> in the right column of the
Sampling Sequence dialog window.
this field.

200154-101—November 2004

Field Description
SmplSeq • In the desired order, repeat the
(Sampling preceding step for all assays.
Sequence), • To remove an assay from the
Continued sampling sequence, select the assay
in the Sampling Sequence column,
then select <Remove> in the right
column of the Sampling Sequence
dialog window.
NOTE: When the Smart
Sampling option is selected,
assays defined in SmplSeq are not
acknowledged unless ICT™
assays are defined in SmplSeq.
This allows ICT samples to be
aspirated first while still using
the Smart Sampling option.
this field.
3. Select <OK> to save the settings.

200154-101—November 2004
System Configuration (1st Car’r for No-Bcode Smpls)

If the Save by Car’r ID option on the SYSTEM
CONFIGURATION screen is selected (聺):
• The Sample Bar Codes option is automatically deselected
and the sample bar code reader is disabled.
• To operate the AEROSET System without bar code labeled
samples, manual entry of a sample ID and carrier/position
is recommended.
When the Sample Bar Codes option on the SYSTEM
CONFIGURATION screen is selected (聺), the AEROSET System
can be configured to run both bar code and non-bar code
labeled samples. Non-bar code labeled sample positions are
configured in the 1st Car’r for No-Bcode Smpls field.
• A non-bar code labeled sample can only be placed in a
carrier number greater than or equal to the number
configured in the 1st Car’r for No-Bcode Smpls field and
manual entry of a sample ID and carrier/position is
required.
NOTE: The optional non-bar code labeled sample
carriers are numbered greater than or equal to
9001. If using these carriers, the 1st Car’r for
No-Bcode Smpls field must be set to 9001 or below.
• A bar code labeled sample can only be placed in a carrier
number less than the number configured in 1st Car’r for
No-Bcode Smpls field.

200154-101—November 2004
QC Rules Configuration
Use the following instructions to configure Westgard rules.
1. Select <QC Rule> in the right column of the SYSTEM
CONFIGURATION screen. The QC Rules dialog window
displays.
2. Select <Default> to use all rules defined in the display
below.
Figure 2.9: QC Rules Dialog Window
a. The following table describes QC rules parameters.
AEROSET Westgard
Description
QC Rule Rule
1-□R-2 12s 1 point outside 2 SD
1-□R-3 13s 1 point outside 3 SD
2-□R-2 22s 2 consecutive points outside
2 SD on the same side of the
mean
2-聺R-4 R4s Range of 2 points greater than
4 SD
4-□R-1 41s 4 consecutive points exceed
1 SD on the same side of the
mean
10-□R-0 10 x 10 consecutive points above or
below the mean
0-□R-0 Generic Operator-defined QC rule.
Rule Generates the Error Log
Message “Westgard Rule
Violation, Additional Rule”.
NOTE: When the checkbox (聺) next to R of the

QC rule is selected, QC values are compared
against each other. If not selected, QC values are
compared against the mean.

200154-101—November 2004
b. The following diagram summarizes how the AEROSET

System implements the QC rules.
Control
Data
1-2 SD
No In-Control Accept Run
Rule Violated
No
Yes
1-3 SD 2-2 SD 2R-4 SD 4-1 SD 10-R0 0-R0

No No No No No
Rule Violated Rule Violated Rule Violated Rule Violated Rule Violated Rule Violated
Yes Yes Yes Yes Yes Yes
Out-of-Control Reject Run
Figure 2.10: QC Rules
First, QC data are checked against the 1-2 SD rule. If

the data are within 2 SD, the data are considered
“in-control” and are not evaluated against the other
QC rules.
NOTE: For other QC rules to be checked when
a value is within 2 SD, the first QC rule
(1-2 SD) must be modified by adding a zero in
the Num field box of this rule. This would
allow QC results to be evaluated against the
other rules.
NOTE: The Westgard rule Error Log Message is
fixed to the error code. For example, if the
1-3 SD was changed to 1-2 SD error code, the
message “Westgard Rule Violation, 1-3 SD” still
prints.

200154-101—November 2004
c. To edit QC rules configuration:
To... Perform
Define the number Enter the desired number in the
of points evaluated left box of the rule.
Disable rule Enter zero in the left box of the
rule so it is not used.
Evaluate the range Select the checkbox (聺) next to R.
between the
number of desired
points
Evaluate points Deselect the checkbox (□) next
against the mean to R.
Define the number Enter the number in the right box
of standard of the rule. An entry of zero
deviations indicates use of the actual mean.
d. Select <OK> on the QC Rules dialog window.

NOTE: The Use QC Rule checkbox (聺) must be
selected on the QC page of each assay
configuration to allow system application of
Westgard rules for that assay.
3. Select <OK> in the upper-right corner of the SYSTEM
CONFIGURATION screen. The Save Settings
confirmation dialog window displays.
4. Select <OK>.

200154-101—November 2004
MAINTENANCE UTILITIES Screen

The AEROSET System can be configured to automatically
power ON and perform START UP or SHUTDOWN without the
operator’s presence.
The system must first be powered OFF and the Rotary Power
Control Switch set to the AUTO position for the Automatic
Power ON, START UP, and SHUTDOWN options to engage.
SHUTDOWN can be initiated by the operator:
• Perform the Power OFF Procedure; refer to Section 5,
Operating Instructions.
• Manually initiate the SHUTDOWN Procedure; refer to
Section 9, Service and Maintenance.
The Rotary Power Control Switch must be set to the AUTO

position. When SHUTDOWN is complete, the system software
starts tracking the time and checking configured options on
the System page of the MAINTENANCE UTILITIES screen. If
an automatic option is configured, the software uses the time
counter to track when the configured options will be
performed.
1. Mode: Power ON—the system will power ON the System
Control Center and the analyzer.
2. Mode: START UP—the system will power ON the System
Control Center and perform selected options of the START
UP Procedure.
3. Mode: SHUTDOWN—the system will power ON the
System Control Center and perform selected options of
the SHUTDOWN Procedure.
CAUTION: Automatic START UP is disabled after a
! power failure. The system MUST be manually initiated.
NOTE: Refer to Perform START UP and Perform

SHUTDOWN in Section 9, Service and Maintenance for
details.

200154-101—November 2004
Automatic Power ON, START UP, and SHUTDOWN
Enabling Automatic Modes

1. Select the Maintenance Utilities icon in the Action Area
of the Main Display. The System page of the
MAINTENANCE UTILITIES screen displays.
Auto
Start Up/Shutdown
Schedule
Figure 2.11: MAINTENANCE UTILITIES Screen, System Page
2. In the Auto Start Up/Shutdown Schedule area, define the

following:
• Time—enter the desired time for Automatic Power
ON, START UP, or SHUTDOWN.
• Mode—select None, Power ON, START UP, or
SHUTDOWN. When None is selected, the Automatic
Power ON function is not activated.
Refer to START UP and SHUTDOWN in Section 5,
Operating Instructions for details.
Example:
To START UP the system at 3:30 pm on Tuesday—
Tue 15 : 30 Start Up

200154-101—November 2004
3. After the automatic ON/OFF schedules are defined, select

<OK> to save the settings.
NOTE: In the following tables, “X” represents
default settings which cannot be edited. Refer to
Section 9, Service and Maintenance for additional
maintenance requirements.
Automatic START UP Options

Option START UP START UP 2 START UP 3
Change Water In Bath X X X
Wash Cuvettes X X X
Wash Probes (and Mixers) with:
• Water X X
• 1% alkaline wash solution X
• 0.5% acid wash solution
Wash ICT™ with:
• ICT cleaning fluid X
• ICT reference solution X X
Drain & Fill IRef Cup X X
Flush Water Lines X X X
Automatic SHUTDOWN Options

SHUTDOWN SHUTDOWN
Option SHUTDOWN
2 3
Change Water In Bath X X X
Wash Cuvettes X X X
Wash Probes (and Mixers) with:
• Water X
• 1% alkaline wash solution X X
Wash ICT with:
• ICT cleaning fluid X
• ICT reference solution X
Drain & Fill IRef Cup X
Clear Database, All Records
NOTE: The system must first be powered OFF and the
Rotary Power Control Switch set to the AUTO position
for the Automatic Power ON, START UP, and
SHUTDOWN options to engage.
200154-101—November 2004
DATABASE Screen
Assay panel configuration and Sample Report forms can be
configured on the DATABASE screen.
Panel Configuration
1. Select <Database> in the Information Access Area of the
Main Display. The DATABASE screen displays.
2. Select <Order> in the right column of the screen. If an
order already exists and is highlighted, the Order Samples
dialog window displays.
Figure 2.12: Order Samples Dialog Window
3. Select <New>. The Order Samples screen displays.
PanelCfg
Figure 2.13: Order Samples Screen

200154-101—November 2004
4. Select <PanelCfg> in the right column of the screen. The

Panel Configuration screen displays.
Panel
Buttons
Figure 2.14: Panel Configuration Screen
5. Select an empty panel button from the bottom two rows

of the screen. This button position selection defines the
panel display order.

200154-101—November 2004
6. On the Panel Configuration screen, configure the

following parameters.
Field Description
Panel # Enter the number, 1 to 9999. The panel
number must not be the same as any assay
number used on the Assay Configuration
screen or any existing panel number.
NOTE: If a panel number is created
using an existing assay number or
panel number, the message “ID#
already used in another file” displays
and the panel number defaults to
zero.
If an existing panel number is edited
using an existing assay number or
panel number, the message “ID#
already used in another file” displays
and the panel number reverts to the
previous number.
NOTE: If a Host (interface) computer
is connected to the system, the panel
number must match that used by the
Host.
Panel Name Enter the panel name, up to 6 characters.
7. Select assays for inclusion in the panel. The selected assay

buttons turn green.
8. When configuration is complete, select <OK> on the
Panel Configuration screen to save the settings.

200154-101—November 2004
Sample Report Forms Configuration

Two printed list formats for orders are available on the
DATABASE screen, Order List and Loadlist.
Two user-definable Sample Report forms are available for
printing sample results, Form 1 and Form 2.
Refer to Printing Results in Section 5, Operating Instructions for
details. Refer to Appendix B, AEROSET System Printed Reports for
sample reports.
NOTE: Default Sample Report forms are loaded on the
System Control Center during system installation. The
following procedure is required only if edits to the
information are needed. Before making edits to
Form 1 or Form 2, export the forms to the hard disk.
Refer to Import and Export Functions in this section.
NOTE: If a new assay is installed, the assay name must
be selected on the PAGE SETUP screen for both Form 1
and Form 2.
NOTE: After making sample edits to Form 1 or Form 2,
select <PRINT> to view an example Sample report.
Verify all fields print correctly and without truncation.
Use the following instructions to configure a Sample Report
form.
2. Select <Print> in the right column of the screen. The Print
Options dialog window displays.
Figure 2.15: Print Options Dialog Window

200154-101—November 2004
3. Select <Page Setup>. The PAGE SETUP screen displays.
Figure 2.16: PAGE SETUP Screen
4. The default form name is Form 1. Proceed to step 5, or

select <Form2> in the right column of the screen to
configure Form 2.
5. Select <Options> in the right column of the PAGE SETUP
screen. The Form Options dialog window displays.
Figure 2.17: Form Options Dialog Window

200154-101—November 2004
Form Options (Sample Report Form)

Field Description
Paper Size Enter the number of columns and rows
for the paper size in use. Default settings
are 80 columns (up to 136) and 66 rows
(up to 148).
NOTE: If additional rows are
required to allow up to 100 assays
to print on the report, edit the
Row field to the appropriate
number.
Multi-print To print the results for more than one
patient per page on Form 2, the
checkbox (聺) below Multi-print is
selected. When selected, the checkbox is
labeled ON. The default setting for
Multi-print is an unselected checkbox
(□) (OFF). Enter the number of columns
per sample. The default setting for
number of columns is 40/40.
Date Format Select the desired date and time format.
(and The default setting is Date and Time
Time Format) (HH:MM). Other options include Date,
Date and Time (HH:MM:SS).
NOTE: The order the date displays
in these fields depends on
configuration of the system date
format (YY/MM/DD, MM/DD/YY,
or DD/MM/YY). The system date
format is configured during system
installation.

200154-101—November 2004
7. Select <OK> on the Form Options dialog window. The

PAGE SETUP screen displays.
Result Print
Format Options
8. Enter the form name, up to 20 characters, in the Form

Name field.
Configure Result Print Format Options

1. Select the checkbox (聺) next to desired result-related
options to be printed on the form:
• Assay Name—up to 6 characters
• Result—up to 6 characters
• Error Code—up to 3 characters
• L/H Flag—1 character
• Units—up to 12 characters
• Ref. Range—up to 15 characters
• Age/Sex Reference Ranges—up to 15 characters
• Enter the Print Start column in the field to the right of
each item. The Print Start column represents a relative
value starting from zero (0).

200154-101—November 2004
Dil/Edit
2. Use the button on the screen to view the following

option:
Dil/Edit—up to 8 characters
NOTE: “Dil 1” or “Dil 2” prints next to the
original result and/or rerun result if this option is
selected, and a dilution is ordered on the Order
Samples screen. “Edit” prints next to an edited
result.

200154-101—November 2004
PAGE SETUP Screen, Result Print Format Options (Default Settings)

Max Character Form 1 Print Form 2 Print
Option
Length* Start Column Start Column
Assay Name 6 6 0
Result 6 15 17
Error Code 3 0 blank
L/H Flag 1 14 12
Units 12 22 24
Ref. Range 15 blank 45
Age/Sex Ref 15 blank 61
Dil/Edit 8 31 35
* This value cannot be edited
Rules for configuring a customized report:

• The Print Start column value entered for each Result Print
Format option must be unique.
• The Print Start column value for each option must not
cause an overlap with another field based on the
maximum character length.
• After making edits, print an example report by selecting
<PRINT> on the PAGE SETUP screen for Form 1 and
Form 2. Verify all fields print correctly and without
truncation.
CAUTION: Failure to comply can result in partial or
! complete truncation of the Result Print Format options
on the AEROSET Sample report.

200154-101—November 2004
Configure Page Format Options
Page Format
Options
1. Select the list box icon to the right of each item column
selection field to display available options.
NOTE: Use the right scroll button to view
additional item columns.
2. Select the desired option to be printed on the form. The
options are described in the following table.
NOTE: Eight items can be configured to print in a
row on the defined paper size.
Page Format Options

Character
Option Prints…
Limit
Sample ID 20 Sample ID assigned to sample
Patient ID 20 Patient ID assigned to sample
Birthdate 8 Patient date of birth
Age 3 Patient age
Sex 4 Patient sex
Last Name 30 Patient last name
First Name 30 Patient first name
Doctor 20 Name of referring physician

200154-101—November 2004
Page Format Options (Continued)

Character
Option Prints…
Limit
Location 20 Name of patient location
Comment 20 Comment regarding patient or
sample, entered on the Patient
Demographics dialog window
Ordered 17 Date and time sample is
D/T ordered
Manual Dil 3 Manual dilution ratio
Operator 8 Name of person who approved
ID the results (Log On entry)
Complete 17 Completion date and time of
D/T sample
C/P 8 Carrier and position number
Current 17 Date and time results are
D/T printed
Orig + 8 Original and rerun results
Rerun
Incomplete 10 Status “Incomplete” at the top
of the form when there are
incomplete results
Master/ 6 Copy status of “Master”
Copy (original) or “Copy”
Equip ID 4 Equipment ID entered into the
system at installation by the
Abbott Representative.
NOTE: The equipment
ID is not the system
serial number. The serial
number is located on a
label on the rear of the
analyzer.
NOTE: <Wizard> is used to access the Print Form

Wizard dialog window, which is not currently in
use.

200154-101—November 2004
PAGE SETUP screen parameters include:
Option Description
Pack When no result is available for the assay, the
blank line is eliminated.
Form Feed Starts printing on the next page.
Form End Marks the end of the print form without
form feeding.
Assay All assays configured on the system are
Names listed. Selecting an assay prints the assay
name and result. The result prints according
to the Result Print Format options
configured.
Free Text Seventy lines of free text, with up to
80 characters, can be entered using the
keyboard.
The following keyboard selections can be used on the

PAGE SETUP screen.
Press the Key(s)… The Result Is

Left/Right Arrow Page format defining area scrolls
horizontally.
Up/Down Arrow When the cursor is at a selection
item, the item is selected.
When the cursor is in a start
column entry field, it moves to the
entry field above or below the
current field.
Page Up/Down Page scrolls vertically.
Insert Item at the cursor position and
subsequent items shift right by
one, making the current cursor
position free for definition.
Delete Item at the cursor position is
deleted and subsequent items shift
left by one.
3. Select <OK> in the upper-right corner of the PAGE SETUP

screen.

200154-101—November 2004
Printing Reference Ranges

The following options for printing reference ranges on Sample
Result reports are available:
• Default reference range (defined as L-Reference-H on the
Outline page of the Assay Configuration screen)
• Age and gender specific reference ranges
• Both reference ranges
• No reference range
The reference range and gender specific reference ranges are

selections for both Form 1 and Form 2; however, only Form 2
with a single column has the space to print these reference
ranges as configured.
Use the following instructions to configure Form 2 with a
reference range and/or age and gender specific reference
ranges.
3. Select <Page Setup>. The PAGE SETUP screen displays.
4. Select <Form2> in the right column of the screen to
configure Form 2.
5. Select the checkbox (聺) next to the Ref. Range and
Age/Sex Ref fields as shown.
6. Type the Print Start column located to the right of the

Ref. Range and Age/Sex Ref fields as follows:
• Ref. Range: 45
• Age/Sex Ref: 61

200154-101—November 2004
7. Select <FreeText> in the right column of the PAGE SETUP

screen. The Define Free Text screen displays.
Figure 2.21: Define Free Text Screen
8. Enter the following free text:

• At Row 23, type REFERENCE RANGE
• At Row 24, type AGE/GENDER RANGE
9. Select <OK> on the Define Free Text screen. The PAGE
SETUP screen displays.

200154-101—November 2004
10. Select the button to move to Row 18 and the

button to view Column 4. Select the list box icon at
Row 18, Column 4 to display the options. Select
Free Text 23 then select the return arrow to close the list.
In Row 18, Column 5 select Free Text 24.
11. Type the Print Start column located to the right of the Free
Text 23 and 24 fields as follows:
• Free Text 23: 45
• Free Text 24: 63
12. Select <OK> in the upper-right corner of the PAGE SETUP
screen to save the settings.

200154-101—November 2004
ASSAYS Screen
The assay display order can be customized on the ASSAYS
screen.
Assay Display Order

Assay display order is defined by the order of installation of
assay files. To customize the assay display order, assay files can
be exported to the Library file on the SCC hard drive, then
imported in the desired order. This function should be
performed before assay calibration to prevent loss of assay
calibration and QC data.
CAUTION: If the assay number is edited, verify the
! following:
• The Use Cal Factor From field for assays that use the
calibration data from the changed assay file is correct.
• Page Set-up configuration of the Sample Report forms
is correct.
Export Assay Files

Assay files can be exported to the Library for storage on the
hard disk. Use the following instructions to export files for
storage.
1. Before performing this procedure, create a template with
the desired assay display order. The assays display on the
Touchscreen monitor in rows of 10, with 100 total
available assay files.
2. Select <Assays> in the Information Access Area of the
Main Display. The ASSAYS screen displays.
3. Select the first assay to export. The assay-specific ASSAY
STATUS screen displays.
4. Select <Config> in the right column of the screen. The
Assay Configuration screen displays.

200154-101—November 2004
5. Select <Export> in the right column of the screen. The

Save Assay Configuration dialog window displays.
Figure 2.23: Save Assay Configuration Dialog Window
6. Select the list box icon next to the Drive field, select the
HARD DISK option, then select the return arrow to close
the list.
7. Enter an assay file name in the File Name field, up to
8 characters. The system will automatically add the
appropriate file extension (.tcn) upon completion of
export function. Document the assay file name used.
8. Select <OK> on the Save Assay Configuration dialog
window. The Save confirmation dialog window displays.
Figure 2.24: Save Confirmation Dialog Window
9. Select <OK>. The assay file transfers to the Library file on

the hard disk.
10. Repeat steps 3 through 9 for all assay files requiring a
change to the display order.
11. Select <OK> in the right column of the Assay
Configuration screen. The Save dialog window displays.
12. Select <OK> again to save the assay parameters.

200154-101—November 2004
Delete Assay Files

After assay files are exported to the Library on the hard disk,
they should be deleted from the ASSAYS screen. Use the
following instructions to delete assay files.
2. Select the first assay for deletion. The assay-specific ASSAY
4. Select <Delete> in the right column of the screen. The
Delete dialog window displays.
Figure 2.25: Delete Dialog Window
5. Select <OK>. The assay is deleted from the system. The

Select Reaction Mode dialog window displays.
Figure 2.26: Select Reaction Mode Dialog Window
6. Select <Cancel>.
7. Repeat steps 1 through 6 for all assays to be deleted.
CAUTION: When an assay file is deleted, all other files
! referencing the deleted assay (e.g., as a Sample Blank,
Use Cal Factor From, etc.) must also be deleted or
edited. Failure to comply will cause the assay button
text for the other assays to be black.

200154-101—November 2004
Import Assay Files

Assay files are imported in the desired order. Use the following
instructions to import files.
2. Select an empty assay button for placement of the desired
assay. The Select Reaction Mode dialog window displays.
3. Select the appropriate Reaction Mode. Refer to the

assay-specific package inserts for the Reaction Mode of the
assay.
4. Select <OK>. The Assay Configuration screen displays.
5. Select <Import> in the right column of the screen. The
Import Assay Configuration dialog window displays.
Figure 2.28: Import Assay Configuration Dialog Window
6. Select the list box icon next to the Drive field, select the
appropriate Drive option in the drop-down list, then select
the return arrow to close the list.
7. Select the list box icon next to File Name, select the file
name, then select the return arrow to close the list.
8. Select <OK> on the Import Assay Configuration dialog
window. The Import confirmation dialog window
displays.

200154-101—November 2004
9. Select <OK>. The assay file transfers to the Assay

Configuration screen.
NOTE: If the assay number of the imported file is
currently in use on the system, the imported assay
number will default to zero. The operator must
enter an unused assay number.
10. Select the Base tab. The Base page displays.
11. Verify the Sample Blank Test field is accurate for the assay
name and number for the assay being imported. If not,
edit the assay name and number by selecting the correct
assay name and number in the drop-down list box of the
Sample Blank Test field.
NOTE: Verify the following items match the new
assay number when used, or that the listed
configuration parameters are reentered:
• The Use Cal Factor From field for assays that
use calibration data from the edited assay file
• Page Set-up configuration of the Sample Report
forms
• Calculated assays that use this edited assay file
• The cuvette section for the SmartWash™ page
for all assays that use this edited assay file
• Calibrator targets and controls on the
CALIBRATOR/CONTROL screen must be
re-entered for the edited assay
• Serum Indices
• Panel configuration
• Sample sequence
• Host assay number configuration
12. Select <OK> or <Save> in the right column of the Assay
Configuration screen. The USER ALERT dialog window
displays.
Figure 2.29: USER ALERT Dialog Window

200154-101—November 2004
13. Select <OK>. The Assay Parameters dialog window

displays.
15. Repeat steps 1 through 14 for each assay, selecting the
button locations that determine the desired assay display
order.
16. When the assay import process is complete, perform a
backup of the assay files. Refer to As Needed Maintenance
Procedures in Section 9, Service and Maintenance for details.
17. If necessary, perform the Library Maintenance Procedure
to delete assay files from the hard disk. Refer to As Needed
Maintenance Procedures in Section 9, Service and
Maintenance for details.

200154-101—November 2004
Printer Icons
Printer configuration on the AEROSET System allows the
operator to:
• Configure Printer A
– Result Printing mode

– Wait time for Multi-print feature
– Enable printing of Calibration, Control, and Patient
reports
• Configure Printer B
– Result Printing mode

– Wait time for Multi-print feature
– Enable printing of Control and Patient reports
Printer A and B Configuration

Printer A should be designated to print Form 1, and Printer B
to print Form 2. Refer to Sample Report Forms
Configuration, described previously in this section.
Use the following instructions to configure Printers A and B.
1. Select the Printer A icon in the lower-right section of the
Action Area of the Main Display. The PRINTER A dialog
window displays.
Figure 2.30: PRINTER A Dialog Window

200154-101—November 2004
2. Select <Config>. The Printer Configuration dialog

window displays.
Figure 2.31: Printer Configuration Dialog Window
Printer Configuration Parameters

Field Description
Result Printing Allows configuration for reports to
Mode print on manual request, for validated
results only, or for all results. The
default setting for Printer A is All and
Printer B is Request.
Wait Time for The multi-report form contains
Multi-print multiple sample reports on a single
Feature (sec) page. The length of time the system
delays before printing a page can be
defined, to avoid delay waiting for a
page to fill. The default setting is
30 seconds for both Printers A and B.
Enable Allows configuration of which reports
Calibration/ are printed. Select the checkbox (聺)
Control/Patient next to the desired option(s). The
Reports default setting is ON (selected) for
each option.
4. Select <OK>. The Save dialog window displays.

NOTE: Repeat steps 1 through 5 to configure Printer B.
NOTE: Printer B configuration does not include the

Enable Calibration Reports option.

200154-101—November 2004
NOTE:
If... Then
Enable Control Reports is Reference ranges printed
selected for Printer B (Form 2) on the report are patient
and reference ranges, not QC
ranges.
the Reference Ranges option on
the PAGE SETUP screen is
selected for Form 2

200154-101—November 2004
Host Communication Icon

Sample information can be communicated through a Host
computer via two methods:
• Host download
• Host query
Refer to Section 5, Operating Instructions for details on Host
computer use. Additional information is available in
AEROSET Host Interface Specifications.
Host Configuration
Use the following instructions to configure the AEROSET
System for Host communication.
1. Select the Host Communication icon in the lower section
of the Action Area of the Main Display. The HOST
COMMUNICATION dialog window displays.
Figure 2.32: HOST COMMUNICATION Dialog Window
2. Select <Config>. The ONLINE CONFIGURATION screen

displays.
Figure 2.33: ONLINE CONFIGURATION Screen

200154-101—November 2004
ONLINE CONFIGURATION (Host Communication)

Parameters
Field Description
Protocol Type The default setting is Offline; other
options include Type 1, Type 1', Type 1",
Type 2, Type 3, Type 4, and Type 5.
NOTE: When a Host system is not
available, the Protocol Type
should be set to Offline.
Result Determines the Release mode of results.
Transmission Options include:
Mode
• Valid (validated results only)
• Request (manual release of results
defined by the operator). All results
selected are sent, including: reruns,
replicates, and results with Result
Error Codes. The default setting is
Request.
• All results are sent, including: reruns,
replicates, and results with Result
Error Codes (as they are completed).
Transmit QC Select the checkbox (聺) if control
Results results will be transmitted. The default
setting is ON (selected).
Use When this setting is:
Transmission • Selected—messages and check digit
Check Digit (check for errors in message
transmission) are accepted. The
default setting is ON (selected).
• Unselected—only messages are
accepted.
Master Enter the minimum time period for
Control Time which the system remains the master.
(sec) The default setting is 6 seconds.

200154-101—November 2004
ONLINE CONFIGURATION (Host Communication)

Field Description
Maximum Enter the time period in which a
Wait Time delayed response to a transmitted
(sec) message can be detected. The default
setting is 6 seconds, with a
0 to 99 second range. However, greater
than 20 seconds is not recommended,
due to negative impact on throughput.
If no response is detected during this
period, an error is generated in the Error
Log.
Transmission Enter the interval, 0 to 99 seconds,
Interval (sec) before the system transmits the next
message. The default setting is
0 seconds.
RS-232C • Select the list box icon for the
Config communications conditions; the
default setting is 8L-1S-NP. Select the
desired option then select the return
arrow to close the list.
• Select the list box icon for the baud
rate; the default setting is 9600. Select
the desired option then select the
return arrow to close the list.
4. Select <OK> in the upper-right corner of the ONLINE

CONFIGURATION screen. The Save Settings
Host Communication Icon

Blue with a slash—the ONLINE CONFIGURATION
screen is configured offline or the Host is not connected
Blue—Host online and connected
Red and black—the Host is online and connected, but

temporarily suspended. To resume communication,
select the Host Communication icon then select
<OK>.

200154-101—November 2004
NOTES

200154-101—November 2004
Reagent Configuration
Reagent cartridges can be loaded in two Reagent Supply

Centers on the AEROSET System. Reagents supplied by Abbott
Laboratories are bar code labeled, so they can be loaded in a
Reagent Supply Center then scanned by the reagent bar code
reader. Reagent location is configured automatically.
Multiple cartridges of the same reagent can be loaded on the
system. (The number of cartridges allowed depends on the
selected Unit Configuration parameter.) The reagent in the
lowest Reagent Supply Center position is used first. The same
reagent name must be entered for all cartridges. If a different
reagent name is entered, the reagent is not used. In addition,
all cartridges must be loaded in the appropriate Reagent
Supply Center segment associated with the A-Line or B-Line
configured in the assay file.
Solutions listed in the following table are already configured.
Segment Position Name

R1-C 10 DILUENT
R1-C 11 AlkW
R1-C 12 AcidW
R1-D 1 CO20051
R1-D 18 DILUENT
R1-D 19 AlkW
R1-D 20 AcidW
R2-C 11 AlkW
R2-C 12 AcidW
R2-D 19 AlkW
R2-D 20 AcidW
Water bath additive and reagents, except those supplied by

Abbott Laboratories, must be manually configured as described
in this section.

200154-101—November 2004
Reagent Configuration Section 2

Reagents for two assays can be aspirated independently from
two separate Reagent Supply Centers by the reagent arms,
which are separately controlled. To improve throughput with
efficient utilization of cuvette pairs, the AEROSET System uses
the Line Balance™ feature to pair assays for each run. The
system aspirates reagents for the two assays, one assay on a
designated A-Line and the other on a designated B-Line, in the
same cycle. The system software pairs assays for each run.
Refer to Assay Configuration in this section for details.
The following table describes the location and capacity of each
segment in the Reagent Supply Center.
Segment Location
A, B, and C Outer section of each Reagent Supply Center.
Each segment holds up to 12 reagent cartridges.
D Inner section of each Reagent Supply Center.
This segment holds up to 20 reagent cartridges.
Reagent Supply Center 2
D C
B
A
D
B
Shaded = A-Line (Outer) A
Unshaded = B-Line (Inner)
Figure 2.34: Location of A-Line and B-Line on the Reagent

Supply Centers

200154-101—November 2004
Section 2 Reagent Configuration
The following table describes placement of reagents in the

Reagent Supply Centers, based on the number of reagents for
the assay.
# of Reagents
Location
for Assay
1 Reagent Supply Center 1
2 First reagent = Reagent Supply Center 1
Second reagent = Reagent Supply Center 2
The following table describes loading locations for reagent

cartridges.
# of Reagents
Line Loading Location
for Assay
1 A-Line R1-A, R1-B, or R1-C
1 B-Line R1-D
2 A-Line First reagent = R1-A, R1-B, or
R1-C
Second reagent = R2-A, R2-B, or
R2-C
2 B-Line First reagent = R1-D
Second reagent = R2-D
NOTE: To determine if Abbott reagents are configured

for the A-Line or B-Line, refer to the assay-specific
ASSAY STATUS screen, Outline page, or select <Print>
on the ASSAYS screen. (If the assay button text is black,
the assay does not print on this report.)

200154-101—November 2004
Reagent Cartridges with Bar Code Labels

When using reagent cartridges with bar code labels supplied by
Abbott Laboratories, perform the following instructions to
configure reagent locations.
1. Follow instructions previously described in Reagent
Supply Centers to determine the loading location.
2. Load the reagent cartridge in the correct Reagent Supply
Center location.
NOTE: Before accessing the Reagent Supply
Centers, verify the R1 and R2 Indicators on the
Local User Interface (LUI) Control Panel are
illuminated.
3. Select <RGT SCAN> in the Action Area of the Main
Display to initiate scanning of the Reagent Supply
Centers. Reagent cartridge information included on the
bar code label is stored on the REAGENTS screen.
NOTE: If a new reagent lot or cartridge is scanned,
an Error Log Message displays. The operator can
order a calibration and load the calibrators. If
automatic calibration is defined for lot or cartridge
change, the Error Log Message indicates the
calibrators should be loaded.
CAUTION: If the previous lot or cartridge of
! reagent was cleared from reagent configuration
before loading a new reagent lot or cartridge, an
Error Log Message is not generated.
NOTE: If any reagent configuration is edited and
saved after the reagent scan is complete, this
reagent becomes manually configured. Refer to
Load Reagents in Section 5, Operating Instructions
for details.

200154-101—November 2004
Figure 2.35: REAGENTS Screen, R1-A Page
4. A reagent-specific Reagent Low (Rgt Lo) Alert can be

configured. Refer to Reagent Cartridges without Bar
Code Labels in this section.

200154-101—November 2004
Reagent Cartridges without Bar Code Labels

Use the following instructions to configure Reagent Supply
Center locations, when:
• Using reagent cartridges for onboard diluents supplied by
Abbott Laboratories
• Using reagent or reagent cartridges not supplied by Abbott
Laboratories
• Configuring Reagent Low (Rgt Lo) Alerts on bar code
labeled reagents
1. Select <Reagents> in the Information Access Area of the
Main Display. The REAGENTS screen displays.
Figure 2.36: REAGENTS Screen
2. The default view is the View page. It displays a summary

of all Reagent Supply Center locations.
NOTE: For a complete inventory of onboard reagents,
select <Report> in the right column of the screen. The
Reagent Report screen displays. The report may be
sorted by position, reagent name, type, expiration date,
or remaining volume (%).

200154-101—November 2004
3. Select the page tab for the Reagent Supply Center where
the reagent cartridge will be placed, e.g., R1-C. The
selected page displays.
Figure 2.37: REAGENTS Screen, R1-C Page
4. Select the button for the number corresponding to the

segment position where the reagent cartridge will be
placed. The Position dialog window displays.
Figure 2.38: R1-A No. 10 Dialog Window
5. Select <Clear> to delete all previous entries if necessary.

The Clear dialog window displays.
6. Select <OK>.
NOTE: When <Clear> is selected, the default
settings for Reagent Type and Cartridge Size
display.

200154-101—November 2004
Reagent Cartridge Parameters

Field Description
Reagent Enter the reagent name, up to 7 characters.
Name This is a required field.
CAUTION: Verify the entered
! reagent name is identical to the
reagent name on the Base and
SmartWash™ pages of the Assay
Configuration screen. If the reagent
name is not identical on the Base
and SmartWash pages, SmartWash
will not occur and erroneous results
could be produced.
Reagent This is a required field. Select from the
Type following options:
R1—Reagent 1
R2—Reagent 2
Diluent—sample diluent
AlkW—onboard diluted alkaline wash
AcidW—onboard diluted acid wash
Dtg—optional detergent as a wash solution
Additive—water bath additive
Cartridge Select the list box icon to display available
Size options. Select the appropriate cartridge
size then select the return arrow to close
the list. This is a required field.
Exp Date Enter the reagent expiration date. When
the expiration date is reached and a reagent
scan is complete, an Error Log Message
displays.
NOTE: The Exp Date field must be
configured to generate an expired
(EXP) Result Error Code and Error
Log Message.
Lot # Enter the lot number.
Cartridge # Enter the cartridge serial number, if
available.

200154-101—November 2004
Reagent Cartridge Parameters (Continued)

Field Description
Rgt Allows configuration of a reagent-specific
(Reagent) alert by %volume or number of tests left.
Lo Alert NOTE: If this option is used, it
overrides the alert configured
through system configuration.
8. Verify all fields are complete and correct. Select <OK> in

the upper-right corner of the Position dialog window. The
Save Reagent dialog window displays.
9. Select <OK> to save the settings. The Reset Reagent
Volume dialog window displays.
10. Select <OK>.
NOTE: The %volume or remaining tests does not
update until fluid is sensed.
11. Repeat steps 3 through 9 to configure additional reagent
cartridge positions.
NOTE: <Export> can be used to copy the reagent
configuration to a floppy disk or the hard drive.
Refer to Import and Export Functions in this
section.
12. Select <OK> in the upper-right corner of the REAGENTS
screen to save all reagent cartridge settings.

200154-101—November 2004
Concentrated Reagents
Volume of the reagent and water must be configured when
using concentrated reagents. Perform the following
instructions to configure reagent and water volume.
2. Select the desired assay button. The ASSAY STATUS
screen displays.
Figure 2.39: Assay Configuration Screen, Base Page

200154-101—November 2004
Concentrated Reagent Parameters

Field Description
Reagent 1/ Select the concentrated reagent name
Reagent 2 configured on the REAGENTS screen.
R.Vol Enter the dispense volume of the
concentrated reagent. Range is 10 to
345 µL.
W.Vol Enter the water volume to be added to the
concentrated reagent. Range is 0 to 345 µL.
The water and reagent volumes entered
determine the dilution ratio.
NOTE: Total volume of sample, reagent, and water

must be at least 160 µL to ensure proper mixing
and provide adequate volume to achieve
photometric reads.
NOTE: The maximum volume of sample, reagent,
and as needed water must not exceed 360 µL.
CAUTION: If the total volume is not adequate,
! patient results could be affected.

200154-101—November 2004
NOTES

200154-101—November 2004
Calibrator/Control Configuration
Up to eight calibrators (C1 to C8) and controls (QC1 to QC8)

can be configured for each assay. Calibrators for Abbott
applications (name and position only) are preconfigured on
the Assay Disk. The operator must define concentrations in
these fields.
1. Select <Cal/Control> in the Information Access Area of

the Main Display. The CALIBRATOR/CONTROL screen
displays. Four carousel configuration displays are accessed
using buttons on the CALIBRATOR/CONTROL screen.
Button Display Description

C/C Crsl Calibrator/Control Numeric buttons on the screen (1 to 45) correspond to
Carousel positions on the Calibrator/Control Carousel.
NOTE: Positions 1 to 37 are available for calibrator
and control configuration. Positions 38 to 45 are
predefined. The predefined positions are
summarized below:
Sample Type Carousel Position
ICT™ Urine Calibrator 38, 39 (I-UrLo, I-UrHi)
ICT Serum Calibrator 40, 41 (I-Lo, I-Hi)
Index (currently not used) 42 (I-Index)
ICT Cleaning Fluid 43 (I-Clean)
Wash solution 44, 45 (AlkW, AcidW)
Set 1 Sample Carousel Buttons on the screen (A-1 to F-5) correspond to
Configuration 1 positions on the Sample Carousel. All positions are
Set 2 Sample Carousel available for calibrator configuration only. When a
Configuration 2 calibration run is initiated, the operator selects the
Sample Carousel configuration to be used. Refer to
Set 3 Sample Carousel Performing a Calibration Run in Section 6, Calibration
Configuration 3 Procedures for information on initiating a calibration run.
NOTE: If automatic calibration options will be used,

calibrators must be defined on the Calibrator/Control
Carousel.

200154-101—November 2004
Calibrator/Control Configuration Section 2
2. Select the button in the right column of the screen

corresponding to the desired carousel configuration.
Figure 2.40: CALIBRATOR/CONTROL Screen,

Calibrator/Control Carousel Configuration
Figure 2.41: CALIBRATOR/CONTROL Screen, Sample

Carousel Configuration

200154-101—November 2004
Section 2 Calibrator/Control Configuration
3. Select the corresponding button for the

Calibrator/Control Carousel position where the calibrator
or control will be defined. The Position dialog window
displays. Configured assay files display in the lower
section of the dialog window.
NOTE: For example, when [2] is pressed on the
keyboard, the Position 2 dialog window displays.
Figure 2.42: Position 2 Dialog Window
NOTE: The position numbers displayed on the

Position dialog window for Set 1, 2, and 3
calibrator configurations are listed in the following
table.
Sample Carousel Position

Set
Positions Numbers
Set 1 A1 to F5 61 to 90
Set 2 A1 to F5 91 to 120
Set 3 A1 to F5 121 to 150
4. Enter the C/C (calibrator or control) name and comment,

up to 8 characters.
5. Enter the calibrator or control target value in the field next
to the appropriate assay.
NOTE: If assay configuration was not performed
before this step, no assays display.

200154-101—November 2004
Calibrator/Control Configuration Section 2
6. Select <OK> in the upper-right corner of the Position

dialog window. The Save Configuration dialog window
displays.
Figure 2.43: Save Configuration Dialog Window
NOTE: When a calibrator value is edited, all

existing calibration curves—current, previous, and
stored—for that assay will become invalid and
flagged with the INV Calibration Error Code. Assay
text on the ASSAYS screen turns yellow or pink
and any result generated from this calibration
curve will have a CAL Result Error Code. It is
necessary to perform a full calibration before
reporting patient results. Calibration curves are
not affected when control means are edited.
CAUTION: Failure to calibrate after editing
! calibrator values could produce erroneous results.
7. Select <OK> to save the settings. The C/C name displays
on the selected button.
Example: .
8. Select <OK> in the upper-right corner of the
CALIBRATOR/CONTROL screen.

200154-101—November 2004
Assay Configuration
Abbott applications are configured in the System Control

Center during system installation. New releases of assay
configuration parameters are loaded in the system by the
operator. The following procedures are required only for
site-specific edits.
NOTE: It is recommended that each laboratory
determine its own reference range, based on its
particular locale and population characteristics to edit
the values appropriately.
Assay file configuration is divided into four categories:
• Photometric
• Calculated
• Potentiometric
• Sample Interference Indices (hemolysis, icterus, and
lipemia)
CAUTION: For Abbott applications, assay parameters
! should not be edited for any preconfigured assay, unless
specifically indicated in the Abbott Clinical
Chemistry Package Inserts provided by Abbott
Laboratories. Incorrect editing of assay parameter files
may affect calculation of results and could produce
erroneous results. Verify edits to assay parameter files
against the Abbott Clinical Chemistry Package
Inserts.
CAUTION: For non-Abbott applications, the operator
! must verify correct implementation of the assay.
Incorrect implementation could produce erroneous
results.

200154-101—November 2004
Assay Configuration Section 2
Photometric Assay Configuration

Use the following instructions to configure photometric
assays.
Figure 2.44: ASSAYS Screen
2. Select an empty assay button. The selection order

determines the assay display order. The Select Reaction
Mode dialog window displays.

200154-101—November 2004
Section 2 Assay Configuration
3. Select the checkbox (聺) next to Photometric then select

<OK> on the dialog window. The Assay Configuration
screen displays.
Figure 2.46: Assay Configuration Screen, Outline Page

200154-101—November 2004
Photometric Outline Page

1. The Outline page view is the default view on the Assay
2. Enter the assay name, up to 6 characters.
3. Enter the assay number, range 1 to 9999. This number
must be unique for each assay.
NOTE: If an assay number is edited using a panel
number or existing assay number, it defaults back
to the original number. If an assay is imported
using an existing number, the assay number will
default to zero and will require entry of a unique
number before the assay will be saved.
CAUTION: Access the Base page before saving the
! assay to verify the Sample Blank Test field was
updated to the new assay number for assays with a
Self Blank test defined.
NOTE: Non-Self Blank assays that use this edited
assay number must be edited to match the new
assay number.
NOTE: If a Host computer is connected to the
system, the assay number must match the one
used by the Host.
4. Indicate if the assay will be run on the A-Line or B-Line.
Refer to Line Balance™ in this section for additional
information.
5.
If... Then
This is a new assay that Proceed to Quantitative Ranges.
did not previously exist
on the system and the
assay # is not in use on
the system

200154-101—November 2004
If... Then
An existing assay 1. Access the Base page of the Assay Configuration
number is edited screen. Verify the Sample Blank Test field on the Base
page for Self Blank assays matches the new assay
number. If not, edit the assay name and number by
selecting the correct assay name and number in the
drop-down list of the Sample Blank Test field.
NOTE: Non-self Blank assays that use this
edited assay number must be edited to match
the new assay number.
2. Select <OK> or <Save>.
3. The USER ALERT dialog window displays.
Figure 2.47: USER ALERT Dialog Window

4. Select <OK>. The Save Assay Parameters dialog
window displays.
Verify the following items match the new assay number

when used, or that the listed configuration parameters
are reentered. Refer to the Assay Number Change
Worksheet in Appendix F, Forms for a guide.
• The Use Cal Factor From field for assays that use
calibration data from the edited assay file
• Page Set-up configuration of the Sample Report forms
• Calculated assays that use this edited assay file
• The cuvette section for the SmartWash™ page for all
assays that use this edited assay file
• Calibrator targets and controls on the
CALIBRATOR/CONTROL screen must be re-entered
for the edited assay
• Serum Indices
• Panel configuration
• Sample sequence
• Host assay number configuration
CAUTION: Configuration parameters described above

! must be verified or edited after assay configuration is
saved.

200154-101—November 2004
Quantitative Ranges
1. If a quantitative result will be reported, select
Quantitative Ranges, the default selection.
A B F C D C F B E
Photometric Assays, Quantitative Ranges

Parameters
Field Description
A. Allows entry of a quantitative result,
up to 6 characters, for reporting
values below the Min (minimum)
value entered. For example, < (Min).
The default setting is blank.
NOTE: Characters entered in
this field replace quantitative
results below the minimum
value entered.

200154-101—November 2004

Field Description
B. Min and Max Values in these fields are used to
Value represent the printable range for a
numerical result, and may be used to
define the reportable range of the
assay. The default setting is 0.
NOTE: These values are not
adjusted by the system for
sample dilutions. When a Max
value is defined, this value
must be multiplied by the
highest dilution factor for any
configured Dil 1, Dil 2, or
manual dilution. There is no
Rerun rule associated with this
value. Use the L-Linear
Range-H fields to define limits
that are automatically
adjusted for the sample
dilution, and for which there
are available Rerun rules (LL
and LH Result Error Codes).
NOTE: Some assays may have
a defined minimum and
maximum value, as well as a
defined minimum and
maximum text field.
C. Panic-L and Values in these fields cause the PVL
Panic-H and PVH Result Error Codes to occur.
This field is user-defined.
D. L-Reference-H Values in these fields represent the
reference range of the assay.
NOTE: Each laboratory should
establish its own reference
range.

200154-101—November 2004

Field Description
E. Allows entry of a quantitative result,
up to 6 characters for reporting
values above the Max (maximum)
value entered. For example, > (Max).
results above the maximum
value entered.
F. L-Linear Values in these fields represent the
Range-H reportable range of an assay, and
cause the LL and LH Result Error
Codes to occur.
NOTE: The Linear Low and
Linear High values should be
adjusted for the dilution on
assays which dilute the sample
as part of the standard
protocol to prevent erroneous
flagging, i.e., urine Creatinine.
NOTE: These values are
dilution.
NOTE: Rounding must be taken into

consideration when setting the Quantitative
Ranges fields. A result is rounded to the reporting
number of decimals for an assay after comparing
the results against the range.

200154-101—November 2004
For example, for a value of 100 or above to be flagged

with PVH, the Panic-H must be set at the specified value.
Actual Rounded # PVH Error Code

Result Results Decimals Limit Flag
99.499 99 0 99.499 None
99.500 100 0 99.499 PVH
99.949 99.9 1 99.949 None
99.950 99.9 1 99.949 PVH
99.951 100.0 1 99.949 PVH
99.994 99.99 2 99.994 None
99.995 99.99 2 99.994 PVH
99.996 100.00 2 99.994 PVH
2. Age/gender specific ranges can be configured.

3. Enter the age in the Age field. Select the list box icon,
select month or year, then select the return arrow to close
the list.
4. Enter the male or female ranges for each age range.
D
A
E
B
F
C
G
When Age Is: Male/Female Reference Range Is:

<A D
A age < B E
B age < C F
C G
NOTE: For the age/gender specific ranges to

generate an “L” or “H” Result Flag, both the age
and gender of the sample must be configured on
the Patient Demographics dialog window.
NOTE: If the gender is defined without an age
when a sample is ordered, the reference range
designated on line D is used.

200154-101—November 2004
Qualitative Ranges
1. If a qualitative result will be reported, select Qualitative
Ranges. Use the following instructions to configure ranges
and the qualitative result.
a. Upper row—enter thresholds for each qualitative
result in the five fields. Values must be entered in
concentration or activity.
b. Lower row—enter qualitative results to be reported in
the six fields, up to 6 characters.
A1 A2 A3 A4 A5
B1 B2 B3 B4 B5 B6
When Measured Value Is: Qualitative Result Is:

< A1 B1
A1 measured value < A2 B2
A5 B6
2. Select <Save> in the right column of the Assay

Configuration screen. The Save Assay Parameters dialog
window displays.

200154-101—November 2004
Photometric Base Page

1. On the Assay Configuration screen, select the Base tab.
The Base page displays.
Assay Configuration Screen,

Photometric Base Page Parameters
Field Description
Reaction Select the list box icon to display the
Mode following options:
• END UP
• END DOWN
• RATE UP
• RATE DOWN
Select the desired option then select the
Wavelength– Select the list box icon to display
Prim/Sec available wavelengths. Select the desired
wavelength then select the return arrow
to close the list.

200154-101—November 2004

Photometric Base Page Parameters (Continued)
Field Description
Main Read Enter the Main Read Time, range 1 to 33.
Time At least 1 photometric point must be
included in the Main Read Time. The
maximum number of photometric points
is 33. Information on the calculation
method of end-point assays, based on
number of points used, follows:
• If 1 point is used—the absorbance value
corresponding to the specified point is
used for calculation.
• If 2 points are used—the average of the
absorbance values is used for
calculation.
• If 3 points are used—the maximum and
minimum values are excluded and the
remaining value is used for calculation.
• If 4 to 5 points are used—the maximum
and minimum values are excluded and
the average of the remaining values is
used for calculation.
For rate assays, all points are used for
calculation.
Flex Read For rate assays—enter the Flex Read Time,
Time range 1 to 33. Refer to FlexRate™
Method in this section for details.
AbsMaxVar Enter the acceptable variation allowed for
(End-point absorbance readings within the Main
assays only) Read Time. When zero, the default
setting is entered, the check is not
performed. Refer to Result Data Checks,
End-point Absorbance Variation in this
section for details.
Linearity% Enter the %limit for the linearity of the
(Rate assays absorbance change within the Main Read
only) Time. When zero is entered the check is
not performed. The default setting is
10%. Refer to Result Data Checks, Rate
Linearity in this section for details.

200154-101—November 2004

Field Description
Sample A Sample Blank Test can be a Self Blank
Blank Test (sample and reagent) or a non-Self Blank
(user-defined assay file). Refer to Sample
Blank in this section for details.
Blank Read Enter a read time for measuring a Self
Time Blank (sample and reagent). Enter the
read time, range 1 to 33.
Abs Window Enter a read time range for color
correction. Refer to Color Correction in
this section for details.
Abs Limits This range is used to check for high
concentration samples and to determine
when Flex Read Time is used. Enter the
lower and upper absorbance limit
expected during the Main and Flex Read
Times. When zero, the default setting, is
entered for both the lower and upper
limits of the range, the check is not
performed. Refer to Result Data Checks,
Absorbance Range Limits in this section
for details.
S.Vol Enter the sample volume for the
Standard, Dil 1, and Dil 2 dilution
protocol.
DS.Vol Enter the diluted sample volume, if
appropriate, for the Standard, Dil 1, and
Dil 2 dilution protocol.
D.Vol Enter the diluent volume, if appropriate,
for the Standard, Dil 1, and Dil 2 dilution
protocol. The diluent is defined on the
REAGENTS screen.
W.Vol When concentrated diluent is used, enter
the water volume needed to dilute the
concentrated diluent.
NOTE: Refer to Configuring Sample and Diluent

Volumes in this section for details.

200154-101—November 2004
CAUTION: If the Dil 1 or Dil 2 option will not be

! used, define volumes the same as the Standard
option. This ensures the system dispenses a valid
sample volume instead of the default volume
(2.0 µL) if the Dil 1 or Dil 2 option is ordered
erroneously.
3.
If... Then
Reagents or Select <Save> in the right column of
onboard diluent the Assay Configuration screen. The
need to be Save dialog window displays. Select
configured <OK> to save the settings. Proceed to
step 4.
Reagents or Proceed to step 13.
onboard diluent
are already
configured
4. To configure the reagent and/or an onboard diluent, select

<Reagents> in the Information Access Area of the Main
Display. The REAGENTS screen displays.
Figure 2.49: REAGENTS Screen, View Page
5. Select the page tab for the Reagent Supply Center segment
where the reagent or onboard diluent will be placed. Refer
to Reagent Configuration in this section for details.

200154-101—November 2004

segment position where the reagent cartridge or onboard
diluent will be placed. The Position dialog window
displays.
7. Select <Clear> to clear all previous entries, if necessary.

8. Select <OK>.
display.

200154-101—November 2004

NOTE: <RGT SCAN> in the Action Area of the
Main Display can be selected to scan reagent bar
codes of reagents supplied by Abbott Laboratories.
After the scan is complete, Reagent Low (Rgt Lo)
Alert can be configured.
REAGENTS Screen, Reagent Position Dialog Window

(Reagent) Parameters
Field Description
CAUTION: If the reagent name is
! edited for an existing assay, any
assay with a reagent probe
SmartWash™ defined for the
existing reagent name must be
edited to the new reagent name. If
the reagent name on the Base page
of the donor assay and SmartWash
page of the recipient assay are not
identical, SmartWash will not occur
and erroneous results could be
produced.
Reagent Select the list box icon to display available
Type options. Select R1 for Reagent 1 or Diluent
for sample diluent, then select the return
arrow to close the list. This is a required
field. Refer to the assay-specific package
inserts for details.
displays.
Log Message.

200154-101—November 2004

(Reagent) Parameters (Continued)
Field Description
available.
Lo Alert NOTE: If this option is used, it
10. Verify all fields are complete and correct.

dialog window. The Save Reagent dialog window
displays.
Figure 2.51: Save Reagent Dialog Window

13. Select <OK>.

200154-101—November 2004

screen. The Base page of the Assay Configuration screen
displays.

200154-101—November 2004

Field Description
Reagent 1 Reagent 1 is defined on the
REAGENTS screen then selected in a
drop-down list box on the Base page.
Reagent 2 Reagent 2, if required, is defined on
the REAGENTS screen then selected
in a drop-down list box on the Base
page.
R.Vol Reagent volume is defined for
Reagents 1 and 2, if required. Range
is 10 to 345 µL.
W.Vol Water volume is defined when a
concentrated reagent is used. Range
is 0 to 345 µL.
Type # Controls dispense speed and
over-aspiration volumes. Range is
0 (zero) to 6; the default setting is 0.
Refer to Type Number in this section
for details.
Diluent If a sample diluent is required, it is
defined on the REAGENTS screen
then selected in a drop-down list box
on the Base page.
Reaction Check Used for immunologic reactions to
evaluate a reaction for prozone
phenomenon.
NOTE: Total volume of sample, reagent, and water

must be at least 160 µL to ensure proper mixing
and provide adequate volume for photometry.
NOTE: The maximum volume of sample, reagent,
and as needed water must not exceed 360 µL.

200154-101—November 2004

Field Description
Factor/Intercept Enter a factor and intercept if the
result requires a calculation to match
another system.
NOTE: If the Factor/Intercept
fields are defined with any
value other than 1.0/0.0, refer
to Appendix A, AEROSET
System Math Models for details
on result correction using
factor and intercept.
NOTE: If a value is entered,
the quantitative result is
corrected and reported.
Decimal Places Enter the number of decimal places
for the result, 0 to 3.

200154-101—November 2004

Field Description
Units Select the list box icon to display
available result units then select the
desired option. Default result unit
options include:
U/L µg/L mmol/L
µkat/L g/L ng/dL
pmol/L mEq/L mg/dL
Abs/min g/dL IU/L
µg/dL nkat/L mg/L
IU/d ng/L Abs
µmol/L
NOTE: Changing the
reporting units does NOT
automatically convert the
appropriate parameters.
If units are changed, the
following fields must also be
edited to reflect the units
selected:
• Calibrator values
• Panic Range
• Min and Max values
• Reference Range
• Linear Range
• Qualitative Range
• Control means
The keyboard can also be used to
enter a result unit not available in
the default list.


200154-101—November 2004
Photometric Calibration Page

1. On the Assay Configuration screen, select the
Calibration tab. The Calibration page displays.
Figure 2.53: Assay Configuration Screen, Calibration Page
Assay Configuration Screen, Photometric

Calibration Page Parameters
Field Description
Calib Mode Select the list box icon. Select the
desired option then select the return
arrow to close the list. Refer to
Appendix A, AEROSET System Math
Models for details.
Interval (H) Enter calibration interval in hours.
NOTE: Only a full calibration
updates the calibration
date/time.
Blank/Calib Enter number of replicates for the
Replicates blank and calibrators.

200154-101—November 2004

Calibration Page Parameters (Continued)
Field Description
Extrapolation% Enter extrapolation% allowed
beyond linearity of the assay. If zero,
the default setting, is entered the
curve is extrapolated indefinitely.
Refer to Result Data Checks,
Extrapolated Calculation in this
NOTE: This option only
displays for Linear, Spline,
Logit-4, Logit-5, Exponent,
Use Factor, and Use Fac/Blk
calibration modes.
Span If a Calibration Data Check is needed
to check absorbance change
differences between the reagent
blank and one of the calibrators,
enter the number of the calibrator.
The default setting is 1 for the
C1 calibrator.
Span Abs Range If Span Data Check is defined, enter
the upper and lower limits for the
acceptable absorbance range. If zero,
the default setting, is entered for
both the upper and lower limits,
Span Check is not performed.
BLK Abs Range If a Blank Absorbance Check is
needed, enter the upper and lower
limits for the acceptable absorbance
range. If zero, the default setting, is
entered for both the upper and lower
limits, Blank Absorbance Check is
not performed. Refer to Calibration
Data Check in Section 6, Calibration
Procedures for details.

200154-101—November 2004

Field Description
Cal Deviation To check deviation of the calibrator
replicates, enter the maximum
absorbance difference allowed
between replicates. This check is
performed only for C1 to C8. It is
not checked for the blank. If zero,
the default setting, is entered,
Calibrator Deviation Check is not
performed. Refer to Calibration
Data Check in Section 6, Calibration
Procedures for details.
SD To check curve fit and accuracy,
enter the maximum acceptable SD. If
zero, the default setting, is entered,
SD Check is not performed. Refer to
Calibration Data Check in Section 6,
Calibration Procedures for details.
displays for non-linear
approximation curve (Logit-4,
Logit-5, Exponent) calibration
modes.
Use Cal Factor If an assay is defined as Use Fac/Blk,
From it does not generate a calibration
curve but uses the factors and
reagent blank from a calibration
curve for another assay. This method
is used when two or more assays use
the same reagent.
displays for Use Factor,
Use Fac/Blk, and Isozyme
calibration modes.

200154-101—November 2004

Field Description
FAC Limit (%) This option is used to evaluate an
assay calibration against the last
accepted calibration for that assay. If
the % difference between the first
factor of the new calibration and the
first factor of the last accepted
calibration is greater than the
defined FAC Limit %, a FAC
Calibration Error Code is generated.
The default setting is 0, range 0 to
99. If set to zero, the FAC Limit
check is not performed.
displays for Linear, Spline,
Exponent, Logit-4, and Logit-5
calibration modes.
NOTE: Refer to the ASSAY
PARAMETERS section of the
assay-specific package inserts
for this parameter setting. If it
is not listed, enter 10 in the
FAC Limit % field (Abbott
assays only). This was not an
editable field in AEROSET
software prior to version
1.02ER000.
Factor Used to calculate results of a factor
assay, the factor is a fixed value and
only the reagent blank is performed
for calibration.
displays for Factor assays, a
single factor is used to
calibrate all results for an
assay.

200154-101—November 2004
3.
If... Then
Calibrator name Select <Save> in the right column of
and/or the Assay Configuration screen. The
concentration Save dialog window displays. Select
need to be <OK> to save the settings. Proceed to
configured step 4.
Calibrator name Proceed to step 13.
and/or
concentration are
already
configured
4. To configure the calibrator position, name, and

concentration, select <Cal/Control> in the Information
Access Area of the Main Display. The
CALIBRATOR/CONTROL screen displays.
Figure 2.54: CALIBRATOR/CONTROL Screen

200154-101—November 2004
One blank and up to eight calibrators (C1 to C8) can be

configured for each assay.
NOTE: Positions 1 to 37 on the Calibrator/Control
Carousel are available for calibrator and control
configuration. Positions 38 to 45 on the
Calibrator/Control Carousel are predefined. Set 1,
Set 2, and Set 3 configuration of the Sample
Carousel is used only for calibrators.
NOTE: If automatic calibration options will be
used, calibrators must be defined on the
5. Select the button in the right column of the screen that
corresponds to the desired carousel configuration.
6. Select the button corresponding to the Calibrator/Control
Carousel position where the blank or calibrator will be
defined. The Position dialog window displays. Configured
assay files display in the lower section of the dialog
window.
NOTE: When water is required for the blank,
select <Water> in the lower-left corner of the
CALIBRATOR/CONTROL screen. Enter 0.0 for
the desired assay or select <Zero Set> in the right
column of the screen to enter 0.0 for all assays.
Figure 2.55: Position 4 Dialog Window
7. Enter the C/C (calibrator) name and comment, up to

8 characters.
8. Enter the calibrator value in the field next to the
appropriate assay.

200154-101—November 2004

displays.
WARNING: If calibrator values are edited, the

! calibration curve for the assay will be invalid.
text on the ASSAYS screen turns yellow or pink,
curve will have a CAL Result Error Code. A full
calibration is required to remove the INV
Calibration Error.
11. Repeat steps 5 through 10 for additional calibrators.
CALIBRATOR/CONTROL screen. The Calibration page
of the Assay Configuration screen displays.

200154-101—November 2004
13. On the Calibration page, select the list box icon next to
BLK (blank) or C1 to display configured calibrators. Select
the desired blank solution or calibrator then select the
NOTE: The position numbers displayed in the BLK
and C1–C8 drop-down list boxes for calibrators
configured in the Set 1, Set 2, and Set 3 positions
are listed in the following table.
Sample Carousel Position

Set
Positions Numbers
Set 1 A1 to F5 R1A1 to R1F5
Set 2 A1 to F5 R2A1 to R2F5
Set 3 A1 to F5 R3A1 to R3A5
NOTE: When water is defined for the blank, it is

dispensed by the system from the sample probe.
Therefore, water is not loaded on the
Assay Configuration Screen, Photometric Calibration

Page Parameters (Continued)
Field Description
S.Vol Enter sample volume for the blank and
calibrators.
DS.Vol Enter diluted sample volume, if
appropriate, for the calibrators. This field
represents the diluted sample volume of
the calibrator used for measurement, when
using a concentrated calibrator.
D.Vol Enter diluent volume. This field represents
the volume needed when an onboard
diluent is used to dilute the calibrator(s).
The diluent must be defined on the
REAGENTS screen.
concentrated diluent.
NOTE: Refer to Diluting the Blank/Calibrator in this

section for more information.

200154-101—November 2004
15. Repeat steps 13 and 14 for all calibrators.

16. Configure automatic calibration parameters using the
following information.

Field Description
Lot Change Calibration type (Full, Blank, 1-point, and
2-point)
Ctg Calibration type (Full, Blank, 1-point, and
(Cartridge) 2-point)
Change
Over A full calibration is required. Select the
Interval checkbox (聺) if needed.
NOTE: The Calibration option must
be selected on the RUN OPTIONS
screen for Over Interval calibration
to occur.
NOTE: Only a full calibration updates the

calibration date/time.
17. Define the following for use with 2-point and 1-point
calibration.

Field Description
2-point Calibrator used with the blank for 2-point
calibration
1-point Calibrator used for 1-point calibration


200154-101—November 2004
Photometric QC Page
1. On the Assay Configuration screen, select the QC tab.
The QC page displays.
Figure 2.57: Assay Configuration Screen, QC Page
2. If the Interval-QC option will be used on the RUN

OPTIONS screen, configure the Interval option. Enter
either the number of assays between QC runs in the Count
(Sample) field, or the length of time (minutes) between
QC runs in the Time field.
NOTE: The Count (Sample) interval refers to the
total number of samples aspirated, not the number
of samples run for that assay.
3. Select the checkbox (聺) next to Use QC Rules to enable
use of Westgard rules configured on the QC Rules dialog
window of the SYSTEM CONFIGURATION screen. Refer
to AEROSET System Configuration in this section.

200154-101—November 2004
4.
If... Then
Control name Select <Save> in the right column of
and mean need the Assay Configuration screen. The
to be configured Save dialog window displays. Select
<OK> to save the settings. Proceed to
step 5.
Control name Proceed to step 13.
and mean are
already
configured
5. To configure the control position, name, and mean


200154-101—November 2004
Up to eight controls (QC1 to QC8) can be configured for

each assay.
Carousel position where the control will be defined. The
Position dialog window displays.
7. Enter the C/C (control) name and comment, up to
8 characters.
8. Enter the control mean value in the field next to the
appropriate assay.
displays.
NOTE: Calibration curves are not affected when

control means are edited.
11. Repeat steps 6 through 10 for all control levels.
CALIBRATOR/CONTROL screen. The QC page displays.
13. Select the list box icon next to each QC level field to
display the QC Name/Mean/Pos configured on the
CALIBRATOR/CONTROL screen. Select the desired level
then select the return arrow to close the list.
14. For each QC level, enter the result value equal to 1 SD.

200154-101—November 2004
15. Select the checkbox (聺) next to the Lot Change and/or
Ctg Change (Cartridge Change) option to enable use of
automatic QC options. The QC levels selected on the RUN
OPTIONS screen will be run as a result of cartridge
changeover.

200154-101—November 2004
Photometric SmartWash™ Page

The SmartWash feature provides an additional wash process
for the reagent probes, reaction cuvettes, and sample probes
when needed. Use of this feature prevents any assay-to-assay
or sample-to-sample interference when certain combinations
of assays are tested.
If combinations of assays causing assay-to-assay interference
are known, interference can be avoided by setting the
combination as a SmartWash pair to execute the additional
wash process between measurements of these assays.
SmartWash configuration is provided for reagents
manufactured by Abbott Laboratories for the AEROSET
System.
NOTE: Refer to Reagent Carryover in this section for
non-Abbott applications.
measured consecutively. If separation of the assays is
not possible, the SmartWash feature activates
automatically.
SmartWash tab. The SmartWash page displays.
Figure 2.60: Assay Configuration Screen, SmartWash Page

200154-101—November 2004
2. Configure one of the following three methods to

minimize assay-to-assay or sample-to-sample interference.
a. Wash Reagent Probes (Rgt Probe)
Reagent interference involving the reagent probe is
minimized. Configure the following parameters.
– Reagent—select the interfering reagent in the
drop-down list box. Up to 16 reagents can be
defined.
CAUTION: Verify the selected reagent is
! identical to the reagent name selected on
the Base page of the Assay Configuration
screen of the interfering (donor) assay(s). If
the reagent name on the Base page of the
interfering assay and SmartWash™ page of
this assay are not identical, SmartWash will
not occur and erroneous results could be
produced.
– Wash—select one of the following methods to
wash the inside of reagent probes and mixers.
• Water, to wash with deionized water.
• Reagent, to wash with the specified reagent.
• Acid wash solution, to wash with 0.5% acid
wash solution.
• Alkaline wash solution, to wash with
1% alkaline wash solution.
• Other wash solution, Dtg, to wash with other
wash solution.
– Vol—enter the volume of wash solution; range is
10 to 345 µL.
NOTE: The wash cycle is performed only one time.
b. Wash Reaction Cuvettes (Cuvette)

Reagent interference involving reaction cuvettes is
– Assay Name—select the interfering assay in the
drop-down list box. Up to 10 assays can be
defined.

200154-101—November 2004

wash the inside of reaction cuvettes.
wash solution.
wash solution.
10 to 345 µL.
c. Wash Sample Probes (Sample Probe)

Sample probes are washed immediately before sample
aspiration. Configure the following parameters.
Wash—select one of the following methods to wash
insides of sample probes.
• Acid wash solution, to wash with 0.5% acid wash
solution.
• Alkaline wash solution, to wash with 1% alkaline
wash solution.

200154-101—November 2004
Photometric Rerun Rules Page

To activate the Auto Rerun feature, Auto Rerun must be
configured on the SYSTEM CONFIGURATION screen. Refer to
Run Options Configuration in this section for details.
When the end-of-run carrier is detected after sample analysis,
rerun is executed automatically according to defined Rerun
rules without operator intervention. For the system to
automatically send the sample to the sample arm, the Auto
Return option must be selected on the RUN OPTIONS screen
for both the Sample Carousel and FastTrack™ Sampler.
1. On the Assay Configuration screen, select the Rerun
Rules tab. The Rerun Rules page displays.
Figure 2.61: Assay Configuration Screen, Rerun Rules Page
2. Select the list box icon next to the desired Result Error
Codes for Auto Rerun. Same, Dil 1, and Dil 2 dilution
protocol options display.
NOTE: When the Same option is selected, reruns
are performed at the same dilution that was
originally ordered.
NOTE: The LMP and SWS Result Error Codes are
disabled.

200154-101—November 2004
3. Select the desired rerun dilution then select the return

arrow to close the list. When an assay measurement results
in one of the selected Result Error Codes, a pending order
displays on the DATABASE screen.
NOTE: Auto Rerun is performed only one time
and is performed as a routine assay. Auto Rerun is
not performed on non-bar code labeled samples,
and reruns must be requested manually.
5. Select <OK> to save the settings. The ASSAY STATUS
screen displays.

200154-101—November 2004
Calculated Assay (Ratios) Configuration

NOTE: The DATABASE and RESULT screens and
associated printed reports include the calculated assay,
as well as assays used in the calculation.
Assays included in a calculated assay must be performed
during the same run for the calculation to take place. The
result is calculated using the original assay results and does not
automatically recalculate using an assay’s rerun data.
When a Result Error Code other than PVL, PVH, or FLX is
generated for a test result used to derive a calculated result, the
calculated test result will also be flagged. If a retest is necessary
for one of the assays of a calculated result, retest all assays
included in the calculated result.
Use the following instructions to configure calculated assays.
2. Select an empty button. The selection order determines
the assay display order. The Select Reaction Mode dialog
window displays.

200154-101—November 2004
3. Select the checkbox (聺) next to Calculated then select

<OK>. The Assay Configuration screen displays.

200154-101—November 2004
Calculated Outline Page

The Outline page view is the default view on the Assay
to the original number.
used by the Host.
Quantitative Ranges
A B F C D C F B E
Calculated Assays, Quantitative Ranges

Parameters
Field Description
value entered.

200154-101—November 2004

Field Description
defined minimum and
maximum text field.
range.

200154-101—November 2004

Field Description
value entered.
Codes to occur.
Linear High values must be
dilution.


200154-101—November 2004


99.499 99 0 99.499 None
99.500 100 0 99.499 PVH
99.949 99.9 1 99.949 None
99.950 99.9 1 99.949 PVH
99.951 100.0 1 99.949 PVH
99.994 99.99 2 99.994 None
99.995 99.99 2 99.994 PVH
99.996 100.00 2 99.994 PVH

the list.
D
A
E
B
F
C
G

<A D
A age < B E
B age < C F
C G


200154-101—November 2004
Qualitative Ranges
A1 A2 A3 A4 A5
B1 B2 B3 B4 B5 B6

< A1 B1
A5 B6

window displays.

200154-101—November 2004
Calculated Base Page


200154-101—November 2004
Assay Configuration Screen, Calculated Base Page

Parameters
Field Description
options include:
U/L µg/L mmol/L
µkat/L g/L ng/dL
pmol/L mEq/L mg/dL
Abs/min g/dL IU/L
µg/dL nkat/L mg/L
IU/d ng/L Abs
µmol/L
NOTE: Changing the
selected.
• Panic Range
• Reference Range
• Linear Range
• Control means
The keyboard may also be used to
the default list.

200154-101—November 2004
Assay Configuration Screen, Calculated Base Page

Field Description
Calculation • Select the list box icon to display
assays configured on the system.
• Select the first assay then select the
NOTE: Only individual assays
can be selected, not another
calculation (ratio).
• Select the desired function on the
display using the keyboard.
• Select the list box icon to display
assays then select the next desired
assay.
• Select the return arrow to close the
list.
• Continue this process until
calculation is defined.
NOTE: Ln = natural log,
Exp = exponent, Sqrt = square
root, BS = backspace.

200154-101—November 2004

window displays.
Calculated QC Page


200154-101—November 2004
4.
If... Then
and mean need to the Assay Configuration screen.
be configured The Save dialog window displays.
Select <OK> to save the settings.
Proceed to step 5.
and mean are
already
configured
5. To configure control position, name, and mean


each assay.

200154-101—November 2004
6. Select the button corresponding to the calibrator/control

position where the control will be defined. The Position
8 characters.
appropriate assay.
displays.

15. Select the checkbox (聺) next to the Lot Change and/or
Ctg Change (Cartridge Change) option to enable use of
automatic QC options. The QC levels selected on the RUN
OPTIONS screen will be run as a result of cartridge
changeover.

200154-101—November 2004
Calculated Rerun Rules Page

2. Select the list box icon next to the desired Result Error
Codes for Auto Rerun. Same, Dil 1, and Dil 2 dilution
originally ordered.

200154-101—November 2004
3. Select the desired rerun dilution then select the return

arrow to close the list. When an assay measurement results
in one of the selected Result Error Codes, a pending order
displays on the DATABASE screen.
NOTE: Assays included in a calculated assay must
be performed during the same run for the
calculation to take place. The result is calculated
using the original assay results and does not
automatically recalculate using an assay’s rerun
data.
NOTE: When a Result Error Code other than PVL,
PVH, or FLX is generated for a test result used to
derive a calculated result, the calculated test result
is also flagged. If a retest is necessary for one of the
assays of a calculated result, retest all assays
included in the calculated result.
screen displays.

200154-101—November 2004
Potentiometric Assay Configuration

Use the following instructions to configure potentiometric
assays measured by Integrated Chip Technology™ (ICT).
2. Select an empty assay button. The selection order

determines the assay display order. The Select Reaction

200154-101—November 2004
3. Select the desired assay.

NOTE: Na-Serum, K-Serum, Cl-Serum, Na-Urine,
K-Urine, and Cl-Urine are already configured on
the AEROSET System.
NOTE: After an electrolyte assay file is selected and
configured, selection of the assay on the Select
Reaction Mode dialog window is not possible.
4. Select <OK> in the upper-right corner of the Select
Reaction Mode dialog window. The Assay Configuration
screen displays.

200154-101—November 2004
Potentiometric Outline Page

1. The Outline tab view is the default view on the Assay
used by the Host.
Quantitative Ranges
A B F C D C F B E
Potentiometric Assays,
Quantitative Ranges Parameters
Field Description
value entered.

200154-101—November 2004
Quantitative Ranges Parameters (Continued)
Field Description
defined minimum and
maximum text field.
range.

200154-101—November 2004
Quantitative Ranges Parameters (Continued)
Field Description
value entered.
Codes to occur.
dilution.


200154-101—November 2004


99.499 99 0 99.499 None
99.500 100 0 99.499 PVH
99.949 99.9 1 99.949 None
99.950 99.9 1 99.949 PVH
99.951 100.0 1 99.949 PVH
99.994 99.99 2 99.994 None
99.995 99.99 2 99.994 PVH
99.996 100.00 2 99.994 PVH

the list.
D
A
E
B
F
C
G

<A D
A age < B E
B age < C F
C G


200154-101—November 2004
Qualitative Ranges
A1 A2 A3 A4 A5
B1 B2 B3 B4 B5 B6

< A1 B1
A5 B6

window displays.

200154-101—November 2004
Potentiometric Base Page

2. For electrolyte assays, the sample volume (S.Vol) and

reagent volume (R.Vol) fields are predefined.

200154-101—November 2004
Assay Configuration Screen, Potentiometric Base

Page Parameters
Field Description
Factor/Intercept Enter a factor and intercept if the
result requires a calculation to match
another system.
NOTE: If entered, the
quantitative result is corrected
and reported.
options include:
U/L µg/L mmol/L
µkat/L g/L ng/dL
pmol/L mEq/L mg/dL
Abs/min g/dL IU/L
µg/dL nkat/L mg/L
IU/d ng/L Abs
µmol/L
NOTE: Changing the
selected.
• Panic Range
• Reference Range
• Linear Range
• Control means
The keyboard can also be used to
the default list.

200154-101—November 2004
4.
If... Then
Reagents or Select <Save> in the right column of
onboard diluent the Assay Configuration screen. The
need to be Save dialog window displays. Select
configured <OK> to save the settings. Proceed to
step 5.
Reagents or Proceed to step 14.
onboard diluent
are already
configured
5. To configure the reagent, select <Reagents> in the

Information Access Area of the Main Display. The
REAGENTS screen displays.
6. Select the page tab associated with the Reagent Supply

Center segment where the reagent will be placed. ICT™
diluent must be placed in the R-1 A, B, or C segments only.

200154-101—November 2004

segment position where the reagent cartridge or onboard
diluent will be placed. The Position dialog window
displays.
8. Select <Clear> to clear all previous entries, if necessary.

9. Select <OK>.
display.

200154-101—November 2004

codes of reagents supplied by Abbott Laboratories
for the AEROSET System. After the scan is
complete, Reagent Low (Rgt Lo) Alert can be
configured.

(Reagent) Parameters
Field Description
CAUTION: If the reagent name is
! edited for an existing assay, any
assay with a reagent probe
SmartWash™ defined for the
existing reagent name must be
edited to the new reagent name. If
the reagent name on the Base page
of the donor assay and SmartWash
page of the recipient assay are not
identical, SmartWash will not occur
and erroneous results could be
produced.
Type options. Select R1 then select the return
arrow to close the list. This is a required
field. Refer to the assay-specific package
inserts for details.
displays.
Log Message.

200154-101—November 2004

(Reagent) Parameters (Continued)
Field Description
available.
Lo Alert NOTE: If this option is configured, it
11. Verify all fields are complete and correct.

displays.
Figure 2.76: Save Reagent Dialog Window

14. Select <OK>.
screen. The Base page of the Assay Configuration screen
displays.
16. On the Base page, select the list box icon next to
Reagent 1, select <ICTD061>, then select the return arrow
to close the list.

200154-101—November 2004
Potentiometric Calibration Page

Calibration tab. The Calibration page displays.
Assay Configuration Screen, Potentiometric

Calibration Page Parameters
Field Description
Interval (H) Enter calibration interval in hours.
Slope Limit (%) Enter the slope limit in %.
Index Range This field is not currently used.
Index/Pos This field is not currently used.
NOTE: Although not currently
used, the I-Index position
must be configured on the
CALIBRATOR/CONTROL
screen with a concentration of
zero (0) for all ICT™ assays.
Index/Pos The default setting is 0.
Replicates

200154-101—November 2004
Assay Configuration Screen, Potentiometric

Field Description
Calibrator Calibrator names and C/C Carousel
Low/Pos positions are predefined.
Calibrator
High/Pos
Calibrator Enter the number of replicates for
Low/Pos & the calibrators.
High/Pos
Replicates
Over Interval Select the checkbox (聺) next to Over
Interval if automatic calibration is
desired.

5. To configure the calibrator concentrations, select
<Cal/Control> in the Information Access Area of the
Main Display. The CALIBRATOR/CONTROL screen
displays.

200154-101—November 2004
6. I-Lo and I-Hi calibrators are predefined on positions 40

and 41. I-UrLo and I-UrHi calibrators are defined on
positions 38 and 39. Select <I-Lo Position> (40). The
Position 40 dialog window displays.
7. Enter the calibrator concentration and comment, up to
8 characters.
displays.

text on the ASSAYS screen turns yellow or pink,
curve will have a CAL Result Error Code. It is
necessary to perform a full calibration before
reporting patient results.
CAUTION: Failure to calibrate after editing
! calibrator values could produce erroneous results.
10. Repeat steps 6 through 9 for the I-Hi, I-UrLo, and I-UrHi
calibrators.
CALIBRATOR/CONTROL screen. The Calibration page
of the Assay Configuration screen displays.

200154-101—November 2004
Potentiometric QC Page


200154-101—November 2004
4.
If... Then
and mean need to the Assay Configuration screen.
be configured The Save dialog window displays.
Select <OK> to save the settings.
Proceed to step 5.
and mean are
already
configured
5. To configure control position, name, and mean


each assay.
Carousel can only be used for calibrators.

200154-101—November 2004

8 characters.
appropriate assay.
displays.

10. Select <OK> to save the settings. Calibration curves are not
affected when control means are edited.

200154-101—November 2004
Potentiometric SmartWash™ Page

The SmartWash feature provides an additional wash process
for reagent probes, reaction cuvettes, and sample probes when
needed. Use of this feature prevents any assay-to-assay or
sample-to-sample interference when certain combinations of
assays are tested.
If combinations of assays causing assay-to-assay interference
are known, interference can be avoided by setting the
combination as a SmartWash pair to execute the additional
wash process between measurements of these assays.
SmartWash configuration is provided for reagents
manufactured by Abbott Laboratories for the AEROSET
System.
NOTE: Refer to Reagent Carryover in this section for
non-Abbott applications.
measured consecutively. If separation of the assays is
not possible, the SmartWash feature activates
automatically.
SmartWash tab. The SmartWash page displays.
Figure 2.83: Assay Configuration Screen, SmartWash Page

200154-101—November 2004
2. Configure one of the following three methods to

minimize assay-to-assay or sample-to-sample interference.
a. Wash Reagent Probes (Rgt Probe)
Reagent interference involving the reagent probe is
– Reagent—select the interfering reagent in the
drop-down list box. Up to 16 reagents can be
defined.
CAUTION: Verify the selected reagent is
! identical to the reagent name selected on
the Base page of the Assay Configuration
screen of the interfering (donor) assay(s). If
the reagent name on the Base page of the
interfering assay and SmartWash™ page of
this assay are not identical, SmartWash will
not occur and erroneous results could be
produced.
wash the inside of reagent probes and mixers.
• Reagent, to wash with the specified reagent.
wash solution.
wash solution.
10 to 345 µL.
NOTE: The wash reagent probes cycle is performed
only one time.
b. Wash Reaction Cuvettes (Cuvette)

Reagent interference involving reaction cuvettes is
– Assay Name—select the interfering assay from the
drop-down list box. Up to 10 assays can be
defined.

200154-101—November 2004

wash the inside of reaction cuvettes.
wash solution.
wash solution.
10 to 345 µL.
NOTE: The wash reaction cuvettes cycle is
performed only one time.
c. Wash Sample Probes (Sample Probe)

Sample probes are washed immediately before sample
aspiration. Configure the following parameter.
wash the inside of sample probes.
wash solution.
NOTE: The wash sample probes cycle is performed
only one time.

200154-101—November 2004
Potentiometric Rerun Rules Page

2. Select the list box icon next to the Result Error Codes
desired for Auto Rerun. Same, Dil 1, and Dil 2 dilution
originally ordered.
NOTE: The AEROSET System does not perform
onboard dilutions of samples for ICT™ assays.
NOTE: The IRO, MVR, and SWS Result Error Codes
are disabled.

200154-101—November 2004
3. Select <Same> then select the return arrow to close the

list. When an assay measurement results in one of the
selected Result Error Codes, a pending order displays on
the DATABASE screen.
screen displays.

200154-101—November 2004
Sample Interference Indices Configuration

The Sample Interference Indices feature allows estimation of
hemoglobin, bilirubin, and lipids present in hemolyzed,
icteric, and lipemic samples, respectively. These estimates are
also known as “indices”.
The estimation is based on absorbance measurement of:
• red color for hemoglobin (hemolysis)
• yellow color for bilirubin (icterus)
• turbidity for lipids (lipemia)
Specimens containing these interfering substances absorb at
different wavelengths as illustrated in the following graph.
Absorbance
Hemolyzed
Icteric
NADH
Lipemic
Figure 2.85: Absorption Spectra of NADH and Hemolyzed,

Icteric, and Lipemic Samples
The AEROSET System uses specific wavelength combinations

to measure absorbance of hemolysis, icterus, and lipemia (refer
to the following table). Absorbance data are converted to
values according to the specific formulas shown below. The
operator can choose between semi-quantitative (e.g., index
units) or qualitative (0, 1+, 2+, 3+, 4+) result format.
A1 500 nm/524 nm
A2 572 nm/604 nm

200154-101—November 2004
Hemolysis = M (a05 × A1 + a06 × A2 + a07 × A3 + a08 × A4)

Icterus = M (a09 × A1 + a10 × A2 + a11 × A3 + a12 × A4)
Lipemia = M (a01 × A1 + a02 × A2 + a03 × A3 + a04 × A4)
M = (Reagent volume + Sample volume) ×
(Sample dilution ratio/Sample volume)
a01, a02, a03...a12 = Constants used by the system to calculate
the Sample Interference Indices. These are not user-definable.
Hemolysis Icterus Lipemia

Constant a05, a06, a09, a10, a01, a02,
a07, a08 a11, a12 a03, a04
Reference File Options

To estimate hemolysis, icterus, and lipemia on a sample, a
reference photometric assay file must be configured. To
configure this file, the operator determines which reagent
(saline, ALT, or AST) to use for analysis.
NOTE: For non-Abbott applications, reagent carryover
must be evaluated. SmartWash™ configuration is
provided for reagents manufactured by Abbott
Laboratories for the AEROSET System.
NOTE: Package inserts are available for both the Saline
and ALT/AST Protocols to run the Sample Interference
Indices.
Common Test File

ALT or AST reagent can be used because wavelengths used for
these assays are different than those used for the indices. If
ALT or AST are routinely ordered on many of the samples, it is
advantageous to use one of these reagents. Hemolysis, icterus,
and lipemia would be measured in the same cuvette, without
impact to system throughput.
NOTE: The remaining reagent volume for the
photometric test selected does not include volume
required for Sample Interference Indices measurement.
NOTE: The result is calculated using the last two points
(32 and 33) of the reaction curve. Read times do not
need to be configured.

200154-101—November 2004
Extra Test File

When ALT or AST are not routinely ordered, saline may be
used to measure Sample Interference Indices. Although using
saline does not consume ALT or AST reagent, it does lower
throughput because use of an extra cuvette is necessary.
Reference File Configuration
Using the Saline Protocol
Reagent Configuration
1. Fill an empty reagent cartridge with 0.9% NaCl and place
in an A-Line position in Reagent Supply Center 1. Refer to
the Sample Interference Indices, Saline Protocol
application sheet.
3. Select the segment and position where saline is located
and manually configure the file.
Assay Configuration
2. Select an empty assay button. The Select Reaction Mode

200154-101—November 2004
3. Select the checkbox (聺) next to Photometric then select

<OK>. The Assay Configuration screen displays.
4. Insert an Assay Disk in the floppy disk drive.
5. Select <Import> in the right column of the Assay
Configuration screen. The Import Assay Configuration
6. Select the list box icon next to the Drive field. Select the
FLOPPY DISK option then select the return arrow to close
the list.
7. Select the list box icon next to the File Name field. The file
names display.
8. Select the HILref file for the Saline protocol then select the
9. Select <OK>. The Import confirmation dialog window
displays.
10. Select <OK>. The file is imported.
Using ALT or AST

When configuring hemolysis, icterus, and lipemia files, select
ALT or AST as the photometric assay. Additional SmartWash™
parameters must be configured for ALT or AST. Refer to the
Sample Interference Indices, ALT/AST Protocol application
sheet.

200154-101—November 2004
Sample Interference Index File Configuration

NOTE: A separate assay file needs to be configured for
each of the indices (H, I, L).
Use the following instructions for each index file.
1. Select <Assays> in the Information Area of the Main
Display. The ASSAYS screen displays.
2. Select an empty assay button. The Select Reaction Mode
3. Select the desired sample interference assay then select

<OK> in the upper-right corner of the dialog window. The
4. Insert an Assay Disk in the floppy disk drive.
5. Select <Import> in the right column of the Assay
Configuration screen. The Import Assay Configuration
FLOPPY DISK option then select the return arrow to close
the list.
names display. Select the H, I, or L file then select the
8. Select <OK>. The Import confirmation dialog window
displays.
9. Select <OK>. The file is imported.
10. Repeat steps 3 through 9 to import the remaining H, I, and
L files.

200154-101—November 2004
Sample Interference Indices Outline Page

1. The Outline tab view is the default view of the Assay
used by the Host.
Quantitative Ranges
A B F C D C F B E
Sample Interference Indices, Quantitative Ranges

Parameters
Field Description
value entered.

200154-101—November 2004

Field Description
defined minimum and
maximum text field.
range.

200154-101—November 2004

Field Description
value entered.
Codes to occur.
dilution.


200154-101—November 2004


99.499 99 0 99.499 None
99.500 100 0 99.499 PVH
99.949 99.9 1 99.949 None
99.950 99.9 1 99.949 PVH
99.951 100.0 1 99.949 PVH
99.994 99.99 2 99.994 None
99.995 99.99 2 99.994 PVH
99.996 100.00 2 99.994 PVH

the list.
D
A
E
B
F
C
G

<A D
A age < B E
B age < C F
C G


200154-101—November 2004
Qualitative Ranges
A1 A2 A3 A4 A5
B1 B2 B3 B4 B5 B6

< A1 B1
A5 B6

window displays.

200154-101—November 2004
Sample Interference Indices Base Page

Sample Interference Indices, Base Page

Parameters
Field Description
Photometric • Select the configured reference file:
Assay ALT, AST, or HILref.
• Specified assay is used for
measurement of all three serum
indices: hemolysis, icterus, or
lipemia.
Factor/Intercept Enter the factor and intercept
appropriate for the selected
photometric assay. Refer to the
AEROSET SYSTEM ASSAY
PARAMETERS section of the Sample
Interference Indices application
sheet.

200154-101—November 2004
Sample Interference Indices, Base Page

Field Description
Units Index.
NOTE: To report
semi-quantitative results using
different units than the
default setting, appropriate
fields for the selected units
must also be edited. Refer to
the Sample Interference
Indices application sheet for
these parameters. Changing
the reporting units does NOT
selected.
• Panic Range
• Reference Range
• Linear Range
• Control means


200154-101—November 2004
Sample Interference Indices QC Page



200154-101—November 2004
4.
If... Then
and mean need the Assay Configuration screen. The
to be configured Save dialog window displays. Select
<OK> to save the settings. Proceed to
step 5.
and mean are
already
configured
5. To configure the control position, name, and mean


each assay.

200154-101—November 2004

8 characters.
appropriate assay.
displays.

11. Repeat steps 6 through 10 for all controls levels.

200154-101—November 2004
Measurement
Calibration is not performed for Sample Interference Indices
measurement.
NOTE: When ALT or AST is used as the reference
photometric assay for Sample Interference Indices, the
photometric assay itself must be calibrated.
Sample Interference Indices are ordered on the Order Samples
screen. The operator does not need to order the reference
photometric assay.
Hemolysis, icterus, and lipemia can also be ordered separately
from the Host computer. Sample Interference Indices results
are not used to correct the photometric test result.
Hemolysis, icterus, and lipemia assay files can be configured
on a panel. Refer to Panel Configuration in this section.

200154-101—November 2004
Confirmation of Assay Parameter Settings

The text color on each assay button indicates the assay
parameters status and reagent settings. The following table
describes text colors and probable causes when settings are
incorrect.
Text Color Probable Cause

Black
• Assay number – Range not between 1 to 9999.
• Photometric – Reagent(s) not configured and placed in
and the defined position.
potentiometric – A calibrator is configured, and is not
(ICT™) assays placed in the defined position.
• Photometric – A diluent is configured, and is not
assays placed in the defined position or is
empty.
– A non-Self (user-defined assay file)
Blank is defined, and the specified test
is not configured.
– A Use Factor calibration method is
defined, and the assay for the referred
calibration curve is not configured.
– Reagent bar code scan was
unsuccessful. Reposition the cartridge
and rescan, or manually configure the
reagent.
– Reagent was not loaded on the
appropriate line (A-Line or B-Line).
• Sample – Photometric assays to be run are not
Interference defined and configured.
Indices
• Calculation – All assays used for the calculation are
assays not configured.
• Multiple Rgt – R1 or R2 reagent cartridge is empty.
Ctgs option is
ON

200154-101—November 2004
Text Color Probable Cause

Yellow – One of the required reagents is below
the alert level. Remove cartridges with
zero remaining tests before performing
a reagent scan.
– Error other than the expiration date
(EXP) error occurred for the calibration
curve.
– Reagent Link option is ON, and an
empty cartridge (zero remaining tests)
in the lowest position was not removed
before performing a reagent scan.
Pink – One of the required reagents expired,
was not placed in the defined position,
or is empty.
NOTE: If the Multiple Rgt Ctgs
option is ON and the reagent
cartridge becomes empty, the assay
button text turns black.
– The calibration curve interval expired
or is unusable.
NOTE: When using the Abs
calibration mode, assay button text
remains green even when the
calibrator absorbance value is
expired.
Green – All required conditions were met.
When the color of text on the button is not green, review the
assay status error messages for additional details.
NOTE: An assay with black text is not available to order
manually. However, the illegal assay can be
downloaded by the Host computer but will not be run.
NOTE: Select only assays with green button text. If
button text is pink or yellow, further investigation is
necessary before running the assay.
2. Select the desired assay button. The ASSAY STATUS
screen displays.

200154-101—November 2004
3. Select <Status> in the right column of the ASSAY STATUS

screen. The Error Status screen displays.
4. Review the Assay-specific Error Messages. Refer to
Section 10, Troubleshooting and Diagnostics for details.
ASSAY STATUS Screen

When an assay button on the ASSAYS screen is selected,
information for the assay displays.
The screen that displays assay information is the ASSAY
STATUS screen. This screen is used to check the calibration
curve and control results, and configure assay parameters.
Assay Name
Display Area
Calibration
Data Display
Area
Reagent
Information
Display Area
Control Data
Display Area
Figure 2.92: ASSAY STATUS Screen

200154-101—November 2004
Assay Name Display Area

1
2
Figure 2.93: Assay Name Display
• 1—displays assay name corresponding to the selected

button.
• 2—displays number of the assay, with the line where it is
processed.
• 3—displays Log On user code, and the last edit date of the
configuration, calibration curve, or QC information.
Reagent Information Display Area
2
3
Figure 2.94: Reagent Information Display
• 1—displays remaining volumes of the Reagent 1 (R1),

Reagent 2 (R2), and diluent (Dil).
NOTE: When overlapped indicators are used to
display remaining reagent volume, the system is
configured to aspirate reagent from another
reagent cartridge with the same name when the
current reagent cartridge is empty. In this case, the
currently used cartridge displays in front.
• 2—displayed values, located below the indicator, are
estimates for the number of remaining tests that can be
run with the volume of the current reagent cartridge.
• 3—displays the Reagent Supply Center segment position,
below the estimated number of remaining tests.

200154-101—November 2004
Calibration Data Display Area

1 2
Figure 2.95: Calibration Data Display
• 1—displays the calibration curve. For ICT™ assays, the

vertical axis represents the electric potential (mV).
• 2—displays calibrator data.
– Abs—the absorbance accepted for the calibration
curve. C1 to C8 are the values after subtracting the
blank value. For ICT assays, this column is labeled
“mV” and displays accepted mV values.
– Factor—the inverse of the slope between two points
calculated using the accepted absorbance data. When
the calibration mode is set to FACTOR, the blank
value multiplied by the factor displays. For ICT assays,
this column is labeled “Slope” and displays the
% ideal response.
– Conc—displays configured calibrator values defined
on the CALIBRATOR/CONTROL screen. For ICT
assays, displays values for the I-Lo (low-concentration)
and I-Hi (high-concentration) calibrators.
• 3—displays error(s) that occurred during calibration.
• 4—
These buttons are used to display calibration data for a
specific date. When <CUR> (current) is selected, the most
current data display.
NOTE: Refer to Section 6, Calibration Procedures for
details on reviewing calibrations.

200154-101—November 2004
Control Data Display Area
Figure 2.96: Control Data Display
• Up to eight control names display.

• Control results and associated control data display.
• Westgard rule violations (QC rules) display.
NOTE: Refer to Section 5, Operating Instructions for
details on QC data.

200154-101—November 2004
Measurement Options
Measurement options include:

• Line Balance™
• Sample Blank
• Color Correction
• Type Number
• Prozone Reaction Check
• FlexRate™ Method
• Diluting Patient Samples
• Diluting Blanks and Calibrators

200154-101—November 2004
Measurement Options Section 2
Line Balance™
The Line Balance feature is used to improve system throughput
by efficient utilization of cuvette pairs. Maximum efficiency is
achieved when both cuvettes (A-Line and B-Line) in the pair
are used with every cycle. The system software pairs assays for
each run.
Each assay is configured as an A-Line or B-Line assay during
assay configuration. The following points should be
considered to determine ideal balance.
NOTE: Ideal Line Balance for Abbott assays was
determined for typical laboratory use, and is configured
upon installation of the AEROSET Assay Disk. If
non-Abbott assays are configured, or if the laboratory
has a unique mix of assays, the following should be
considered.
CAUTION: If any Abbott assays are moved to a
! different line, the assay-specific package inserts must be
reviewed to ensure SmartWash™ pairs are configured
correctly.
1. Ensure frequently run assays are positioned on opposite
lines. There are two components to this determination:
• Assays frequently ordered together should be
configured on opposite lines, e.g., Urea and
Creatinine, Total and Direct Bilirubin, Cholesterol and
Triglyceride, ICT™ and CO2, etc.
• Evaluate the most frequently run panels or assays, and
ensure the assays are evenly distributed between the
A-Line and B-Line.
2. Less commonly ordered assays, or assays typically ordered
alone, e.g., Ammonia, should be configured on the A-Line
because there are more positions in A-Line (outer)
segments of the Reagent Supply Centers.
3. Assays that share reagents should be located on the same
line, e.g., Iron and TIBC, or serum and urine applications
of the same assay.

200154-101—November 2004
Section 2 Measurement Options
4. If the operator determines there is significant interference

between two reagents that may not be completely
eliminated by defining them as a SmartWash™ pair, the
assays should be configured on opposite lines. Refer to the
appropriate SmartWash Page in this section for
information on configuring SmartWash pairs.
NOTE: Refer to Reagent Carryover in this section
for non-Abbott applications.
5. If two assays have sample volume greater than 15 µL, they
should be configured on opposite lines.
NOTE: The most important consideration for Line
Balance™ is step 1. If changes to Line Balance are
made in steps 2 through 5, the operator should
review step 1 again to ensure the new changes did
not affect balance of commonly ordered assays.

200154-101—November 2004
Sample Blank
A Sample Blank Test utilizing a Self Blank or non-Self Blank
can be configured on the Assay Configuration screen.
Self Blank—Sample blank data are used to correct the
absorbance for sample coloring due to hemolysis, bilirubin,
lipemia, etc.
Non-Self Blank—Sample blank data are also used to eliminate
the effect of endogenous substances.
Sample blank measurement is performed during the Blank
Read Time, and the data obtained are used to correct
absorbance data obtained during the Main Read Time. Refer to
Calculation for Self Blank Test, which follows.
Main Read Time
Absorbance
Blank Read Time
S: Sample Dispense
R1: First Reagent Dispense
R2: Second Reagent Dispense
Photometric Points
S R1 R2
Figure 2.97: Self Blank Correction
Calculation for Self Blank Test:
Vs + VR1
Calculated Absorbance A = Ai – -------------------------------------------- xxxAb
Vs + VR1 + VR2

200154-101—November 2004
Where:
A Absorbance after blank correction
Ai Absorbance or absorbance change obtained during
Main Read Time defined on the Assay
Configuration screen
Ab Absorbance or absorbance change obtained during
Blank Read Time defined on the Assay
Vs Sample volume
VR1 First reagent (R1) volume
VR2 Second reagent (R2) volume
NOTE: If sample blank measurement is performed after

addition of the second reagent, it is unnecessary to
correct absorbance for sample and reagent volume. The
calculation would be:
Calculated Absorbance A = Ai – Ab

200154-101—November 2004
Assay Parameter Setting

1. Self Blank:
Correction is performed using a single reaction cuvette.
a. Select <Assays> in the Information Access Area of the
b. Select the desired assay button. The ASSAY STATUS
screen displays.
c. Select <Config> in the right column of the screen.
The Assay Configuration screen displays.
d. On the Assay Configuration screen, select the Base
tab. The Base page displays.
Sample Blank
Test
e. Select the list box icon next to Sample Blank Test.

Select the currently displayed assay name then select
the return arrow to close the list.
f. Blank Read Time—enter the desired time. The color of
the sample itself is measured during this time.
CAUTION: If the assay number on the Outline page of
! a Self Blank assay file is changed, access the Base page
before saving the assay file to verify the Sample Blank
Test field matches the new assay number. If not, edit
the assay name and number by selecting the correct
assay name and number in the drop-down list box of
the Sample Blank Test field.

200154-101—November 2004
2. Non-Self Blank:
The Sample Blank test is measured using two reaction
cuvettes.
NOTE: If a non-Self Blank is selected, color
correction cannot be performed.
a. Define parameters for the assay to be used as the
Sample Blank test. Refer to Photometric Assay
Configuration in this section.
CAUTION: A non-Self Blank assay must not be
! configured for use as the Sample Blank Test for
other assays.
b. Access the Assay Configuration screen for the assay
for which the Sample Blank test will be calculated.
Select <Assays> in the Information Access Area of the
c. Select the desired assay button. The ASSAY STATUS
screen displays.
d. Select <Config> in the right column of the screen.
The Assay Configuration screen displays.
e. Access the Assay Configuration screen for the assay
for which the Sample Blank test will be calculated.
f. On the Assay Configuration screen, select the Base
tab. The Base page displays.
Sample Blank
Test

200154-101—November 2004
g. Select the list box icon under Sample Blank Test. Select
the test defined in step a, then select the return arrow
to close the list.
CAUTION: If the assay number of an assay
! used as a non-Self Blank for another assay is
edited, select the correct assay name and
number in the drop-down list box of the
Sample Blank Test field.
CAUTION: When ordering calibration, order
! calibration for both the defined test and the
Sample Blank test.
NOTE: Measurement is automatically
performed first for the Sample Blank test, then
for the defined test.
The absorbance or absorbance change to be used for
calculating concentration or activity is obtained using the
following formula.
Final Abs or ∆Abs = (Abs or ∆Abs of the specified test)
– (Abs or ∆Abs of the Sample Blank
Test)

200154-101—November 2004
Color Correction
Color correction is used to correct the Abs Limits range so
Result Error Codes A#0, A#1, and A#2 are not generated
because of sample color, but only due to actual analyte
absorbance. This option does not correct the reported result in
any way.
This correction is performed on absorbance data measured at
the primary wavelength only in the absorbance window to
correct for sample color.
Absorbance is measured during the time specified for Abs
window. Reagent blank absorbance (obtained from the
calibration blank) is subtracted from the absorbance measured
during the Abs window to calculate absorbance due to sample
color. Sample color absorbance is added to both the upper and
lower limit of the defined Abs Limits. This new Abs Limit
range is used to evaluate if Result Error Codes A#0, A#1, or A#2
are generated for a sample.
Absorbance
First Reagent Dispense Second Reagent Dispense
Absorbance of
Sample Color
Reagent Blank
Absorbance
Abs of
Sample
Color
After Correction
Before Correction
Abs Window
Figure 2.100:Abs Window Correction

200154-101—November 2004

2. Select the desired assay button. The ASSAY STATUS screen
displays.
Absorbance
Window
Figure 2.101:Assay Configuration Screen, Base Page
5. In the Abs (Absorbance) Window field, enter the

photometric points for checking the sample color. If the
Abs Window field is configured as 0 - 0, the default
setting, color correction is not performed.
NOTE: If a non-Self Blank is selected, color
correction cannot be performed. Refer to Sample
Blank, Assay Parameter Setting in this section for
additional information regarding non-Self Blank.
NOTE: If the subtraction result between the
sample absorbance and reagent blank absorbance
is negative, color correction is not performed.
NOTE: The primary wavelength is used for
checking the sample color.

200154-101—November 2004

NOTE: When running an assay that utilizes an
absorbance window, a PHO (Photometer) Result Error
Code may be generated on initial calibration. This is
due to the system software initializing absorbance
window variables during installation of an Assay Disk
and initial calibration. This is a software operation
internal to the AEROSET System, and does not affect
system performance or impact operation. If the PHO
Result Error Code is generated during initial full
calibration, recalibrate the assay and proceed. Refer to
Section 10, Troubleshooting and Diagnostics if the error
persists. To prevent generation of the PHO error, a
blank calibration should be performed before the initial
full calibration. Refer to Section 6, Calibration Procedures
for additional information.

200154-101—November 2004
Type Number Configuration

Definitions
Type—refers to the reagent pipetting profiles available for
aspirating and dispensing reagents
Syringe Speed—refers to dispense speed and can be configured
to a slower speed to prevent bubbles at the end of the dispense
cycle for viscous reagents
Over-aspiration Volume—refers to volume of reagent
over-aspiration
• Normal = Reagent volume (in microliters from assay
configuration) × 8% + 6 µL
• Decreased = Reagent volume (in microliters from assay
configuration) × 4% + 3 µL
• Configurable = requires configuration parameters that are
not currently available
Volume Correction—allows for more accurate reagent dispense
when needed by regulating the pump dispense.
Example of Volume Correction

If the defined reagent volume on the Assay Configuration
screen is 300 µL, then:
For Type 0: Volume Correction = No
• Aspirated reagent volume = 330 µL
• Pump dispense = 300 µL
• Actual dispense = 302 µL
For Type 1: Volume Correction = Yes
• Aspirated reagent volume = 330 µL
• Pump dispense = 298 µL
• Actual dispense = 300 µL

200154-101—November 2004
Dispense Mode R1
This allows the operator to select the reagent pipetting profile
used to aspirate and dispense reagent. Available options for
Reagent 1 include:
Syringe Over-aspiration Volume

Type
Speed Volume Correction
0 (default) Normal Normal No
1 Slower (80% Normal Yes
of normal)
2 Slower (80% Decreased Yes
of normal)
3 (* not Slower (80% Configurable Yes
functional) of normal)
4 (* not Normal Configurable Yes
functional)
5 (Not available for R1 reagents)
6 Very slow Normal Yes
(60% of
normal)
* Requires configuration parameters that are not currently
available

200154-101—November 2004
Dispense Mode R2
This allows the operator to select the reagent pipetting profile
used to aspirate and dispense reagent. Available options for
Reagent 2 include:

Type
of normal)
of normal)
functional)
5 Faster (130% Normal Yes
of normal)
6 (Not available for R2 reagents)
available

200154-101—November 2004
Diluent Dispense Mode

This allows the operator to select the pipetting profile used to
aspirate and dispense sample diluent. Available options for
diluent include:

Type
of normal)
of normal)
functional)
5 (Not available for diluents)
6 Very slow Normal Yes
(60% of
normal)
available

200154-101—November 2004
Prozone Reaction Check

Prozone Reaction Check is used to evaluate the reaction for
prozone phenomena. In immune reactions, if the antigen
concentration in the sample greatly exceeds antibody
concentration in the reagent, the result is falsely low due to
antibody depletion.
In addition to the Main and Flex Read Times for calculating
concentration or activity, Read Times A and B are defined for
the Prozone Reaction Check.
For end-point or rate assays, the absorbance or absorbance
change in Read Time A is compared with that of Read Time B,
expressed as:
• Difference between absorbance or absorbance change
(A - B)
• Ratio of absorbance or absorbance change (A/B)
NOTE: Absorbances for this check are measured at
the main wavelength.
An RCD Result Error Code displays when any of the following
is detected:
• A Prozone phenomenon
• Abnormal absorbance changes due to sample interference
(e.g., hemolysis, lipemia, etc.)
• Abnormal absorbance changes due to improper specimen
handling or collection

200154-101—November 2004
Example:
Absorbance
Read Time
Prozone
Normal
Photometric Points
Figure 2.102:Prozone Reaction Check

200154-101—November 2004

displays.
Reaction Check

200154-101—November 2004
Prozone Reaction Check Parameters

Field Description
Reaction Check Select the list box icon. The
following options display:
• END SUB—difference between
absorbances (A – B)
• END RATIO—ratio of absorbances
(A/B)
• RATE SUB—difference between
absorbance changes (A – B)
• RATE RATIO—ratio of absorbance
changes (A/B)
Select the test method to calculate
absorbance data for Read Times A
and B then select the return arrow to
close the list.
Read Time–A/B Enter Read Times A and B using
photometric points.
Range Enter the lower and upper limits for
the acceptable range for calculated
results of the two read times.
Minimum The minimum absorbance change
should be configured when END
RATIO or RATE RATIO is selected as
the test method. Enter the minimum
acceptable absorbance change
during Read Time B. Reaction Check
is not performed for samples with
absorbance changes less than the
defined minimum value.


200154-101—November 2004
FlexRate™ Method
The FlexRate method extends the reportable range of enzyme
assays and reduces necessity of reruns. High enzyme activity
can cause substrate depletion by the time the rate is normally
measured (Main Read Time).
If less than three data points fall within the absorbance range
during the Main Read Time, the system uses Flex Read Times
to calculate the results.
The FlexRate method allows rate measurements earlier than
the Main Read Time, when:
• Sufficient substrate is present
• The rate is linear
• Results are accurate
Absorbance data obtained in the Flex Read Time are identified
by FLX, displayed as the Result Error Code. Data identified by
FLX can be accepted.
NOTE: FLX does not indicate an instrument error
occurred. Evaluate results before reporting.
Absorbance
Flex Read Time Main Read Time
Normal Sample
Absorbance Range
High Conc or High

Activity Sample
Photometric Points
S R1 R2
O: Data Points Used for Results Calculation
Figure 2.104:FlexRate
NOTE: If an absorbance data error occurs when the

FlexRate method is used, Result Error Codes A#0, A#1,
or A#2 display. Reduce the sample volume, or dilute the
sample and perform the measurement again.

200154-101—November 2004

NOTE: FlexRate™ times are configured for Abbott
enzyme assays.
Use the following instructions for non-Abbott enzyme
applications.
displays.
Flex Read
Time
Absorbance
Limits
5. Select the list box icon next to the Reaction Mode field.
Select either the RATE UP or RATE DOWN option then
select the return arrow to close the list.
6. For Flex Read Time, enter the Read Time for high-activity
samples.
7. Enter upper and lower absorbance limits in the Abs
(Absorbance) Limits fields.

200154-101—November 2004
Diluting Samples
Two cuvette pairs are used for sample dilution. Sample is
added to cuvette A or B of a cuvette pair then diluent is added
from Reagent Supply Center 1. Sample and diluent are mixed
by the R1 mixer, then an aliquot of the diluted sample is
moved to the corresponding cuvette (A or B) in the next
cuvette pair for measurement.
Sample
Dispense
Mix
Dilution
Cuvette
4.5 s × 1 cycle 4.5 s × 1 cycle
Diluent Diluted Sample Aspiration

Dispense (R1 Supply)
4.5 s × 2 cycles
Figure 2.106:Onboard Dilution

200154-101—November 2004
Configuring Sample and Diluent Volumes

Use the following instructions to configure sample and diluent
volumes for patient sample dilution. Refer to Photometric
Assay Configuration in this section for details on assay
configuration.
displays.

200154-101—November 2004
Sample Dilution Parameters

Field Description
S.Vol Enter the sample volume to be aspirated
from the sample cup. Aspirated sample is
dispensed in a reaction cuvette and diluted
before measurement. Range is 2.0 to
35.0 µL, in 0.1 µL increments. If 0 is
entered, the sample is not aspirated.
DS.Vol Enter the diluted sample volume needed
for analysis. The diluted sample is aspirated
from the reaction cuvette where the sample
is diluted, then dispensed in the reaction
cuvette for measurement. Range is 2.0 to
15.0 µL, in 0.1 µL increments.
D.Vol Enter the diluent volume needed for
sample dilution. Range is 10 to 345 µL, in
1 µL increments.
concentrated diluent. Range is 10 to
345 µL, in 1 µL increments.
Diluent Select the diluent type by reagent ID.
CAUTION: Total volume of sample, diluent, and

! water must be at least 100 µL to ensure uniform
mixing. If total volume is less than 100 µL, patient
results could be affected.

200154-101—November 2004

CAUTION: If the Dil 1 or Dil 2 option will not be
! used, define volumes the same as the Standard
option. This ensures the system dispenses a valid
sample volume instead of the default volume
2.0 µL if the Dil 1 or Dil 2 option is ordered
erroneously.
NOTE: Concentrated diluent can also be used. For
example, when using physiological saline to dilute
samples, physiological saline (concentrated to
one-tenth its original volume) can be placed in the
Reagent Supply Center and prepared at the needed
dilution ratio with water. System operation for
sample dilution using concentrated diluent is as
follows:
a. Sample is dispensed in a reaction cuvette.
b. Concentrated diluent is aspirated by the
reagent probe and dispensed together with
water in the reaction cuvette.

200154-101—November 2004
Configuring the Diluent

Figure 2.108:REAGENTS Screen, View Page
2. Select the page tab for the Reagent Supply Center segment
where reagent or onboard diluent will be placed. Refer to
Reagent Configuration in this section for details.
3. Select the segment position number. The Position dialog
window displays.
Figure 2.109:R1-A No. 10 Dialog Window

200154-101—November 2004

codes of reagents supplied by Abbott Laboratories.
After the scan is complete, Reagent Low (Rgt Lo)
Alert can be configured.
Diluent
Field Description
Type options. Select Diluent then select the
return arrow to close the list. This is a
required field. Refer to the assay-specific
package inserts for details.
displays.
Log Message.
available.
Lo Alert NOTE: If this option is configured, it

200154-101—November 2004

displays.
Figure 2.110:Save Reagent Dialog Window
6. Select <OK>. The Reset Reagent Volume dialog window

displays.
7. Select <OK>.
NOTE: Refer to Assay Configuration in this
section for details on defining the diluent for an
assay.

200154-101—November 2004
Diluting the Blank/Calibrator

Diluting a Single Calibrator
Use the following instructions to configure the system to
perform serial dilutions of a single calibrator. Refer to
Photometric Assay Configuration in this section for details
on assay configuration.
NOTE: A single calibrator name and concentration
must first be defined on the CALIBRATOR/CONTROL
screen.
displays.
3. Select <Config> in the right column of the ASSAY
STATUS. The Assay Configuration screen displays.
4. Select the Calibration tab. The Calibration page displays.
Figure 2.111:Assay Configuration Screen, Calibration Page

200154-101—November 2004
Blank/Calibrator Dilution Parameters

Field Description
S.Vol Enter the blank/calibrator volume to be
aspirated from the sample cup on the
Calibrator/Control Carousel. Range is 2.0
to 35.0 µL, in 0.1 µL increments.
DS.Vol Enter the diluted blank/calibrator volume
needed for analysis. Range is 2.0 to 15.0 µL,
in 0.1 µL increments.
D.Vol Enter the diluent volume needed to dilute
the blank/calibrator. Range is 10 to 345 µL,
in 1 µL increments. Define the diluent
volume so the total volume of diluent and
water is 345 µL. The diluent should be
configured on the Base page.
W.Vol Enter the water volume needed to dilute
the concentrated diluent. Range is 10 to
345 µL, in 1 µL increments.
6. Select <Save> in the upper-right corner of the Assay

The system automatically calculates the calibrator
concentration based on the dilution for each level of
calibrator, using the single calibrator name and concentration.
NOTE: In the following example, a single calibrator
with a concentration of 100 is defined on the
CALIBRATOR/CONTROL screen. On the ASSAY
STATUS screen, the C1 and C2 concentrations (20, 40)
shown below are automatically calculated based on the
dilution defined on the Assay Configuration screen.

200154-101—November 2004
Single
Calibrator
Figure 2.112:Assay Configuration Screen

.
C1
C2
Figure 2.113:ASSAY STATUS Screen
NOTE: To configure the system to perform serial

dilutions of a single calibrator, the calibrator must be
configured on the CALIBRATOR/CONTROL screen.
On the Calibration tab, select this calibrator for each
level of calibration required. Enter the sample volume
(S.Vol), diluted sample volume (DS.Vol), and diluent or
water volume required for the dilution. The system
recalculates the calibrator concentration for each level
of calibrator.

200154-101—November 2004
Diluting a Multiple Calibrator

When configuring dilution protocol on multiple levels and/or
concentrations of calibrators, individual calibrator names
must be defined for all calibrators on the
CALIBRATOR/CONTROL screen. The system calculates the
calibrator concentration for only the calibrator with the
highest concentration. The calibrator values for the remaining
calibrators must be manually calculated based on the dilution
and configured on the CALIBRATOR/CONTROL screen.
NOTE: In the following example, multiple calibrators
with concentrations of 200, 400, 600, and 1000 are
defined and diluted l:5. The highest calibrator
concentration (C4) is automatically calculated
(corrected) for dilution (1000 ÷ 5 = 200), but the
remaining calibrator concentrations must be manually
calculated and configured on the
Highest
Calibrator
Figure 2.114:Assay Configuration Screen

200154-101—November 2004
Manually
corrected for
dilution and
configured on
CALIBRATOR/
CONTROL
screen
Entered 1000 on
CALIBRATOR/
CONTROL
screen. Value
automatically
corrected for
dilution
(1000 ÷ 5 = 200)
Figure 2.115:ASSAY STATUS Screen
NOTE: When configuring multiple levels of calibrators

for dilution protocol, the system recalculates the
calibrator concentration for only the calibrator with the
highest concentration. The corrected calibrator value
for the remaining calibrators must be manually
calculated and configured on the

200154-101—November 2004
NOTES

200154-101—November 2004
Result Data Checks
Result data checks include:

• Absorbance Range Lower/Upper Limits
• End Stability
• Rate Linearity
• Extrapolated Calculation
Refer to Assay Configuration in this section for details on
configuring result data checks. Refer to Section 10,
Troubleshooting and Diagnostics for details on troubleshooting
Result Error Codes.

200154-101—November 2004
Result Data Checks Section 2
Absorbance Range Limits

Occasionally, samples contain extremely high analyte
concentrations or high enzyme activity. Results for these
samples may not be calculated correctly if performance limits
of the system are exceeded. The Absorbance Limits Check is
performed at the primary wavelength to detect these
conditions.
Abs (Absorbance) Limits are configured on the Base page of
the Assay Configuration screen.
Absorbance
Limits
The lower and upper limit of the expected absorbance range

during the Main Read Time is defined.

200154-101—November 2004
Section 2 Result Data Checks
If data points within the Main Read Time are outside the lower
or upper limits, the data points are not used for calculation.
When the number of acceptable data points within the read
time is 0, 1, or 2, the corresponding Result Error Code A#0,
A#1, or A#2 is reported.
Absorbance
Read Time
Upper
Limit
Normal
Sample
Lower
Limit
Photometric Points
S R1 R2
High-concentration/High-activity Sample
Figure 2.117:Absorbance Range Lower/Upper Limits
NOTE: The Absorbance Limits Check is performed

starting from the first data point in the Main Read
Time. When a data point is outside the limit, the
subsequent data points are also assumed to be outside
the limit.
If Flex Read Time is defined, the system uses data points from
Flex Time to calculate results. Absorbance Limits Checks are
also performed for Flex Read Time data, and Result Error Codes
A#0, A#1, or A#2 are generated. Refer to FlexRate™ Method
in this section for details on configuring Flex Read Time.
Absorbance Limits can be adjusted to account for sample color.
Refer to Color Correction in this section for details.

200154-101—November 2004
End-point Absorbance Variation

To evaluate stability of the reaction of an end-point assay
during the Main Read Time, absorbance variation within the
Main Read Time is checked when an end-point assay is
selected as the Reaction Mode.
AbsMaxVar (Absorbance Maximum Variability) is configured
on the Base page of the Assay Configuration screen.
AbsMaxVar
Acceptable absorbance variation within the Main Read Time is

defined. Result Error Code RF (Read Fluctuation) displays
when absorbance variation exceeds the defined limit.
Absorbance Main Read TIme
Abs Max Var
Photometric Points
Figure 2.119:End-point Absorbance Variation

200154-101—November 2004
Rate Linearity
To evaluate the linearity of the absorbance change within the
Main Read Time, linearity of the absorbance change within
the Main Read Time is checked when a rate assay is defined as
the Reaction Mode.
Linearity% is configured on the Base page of the Assay
Linearity%
To perform the linearity check during the Main Read Time, the
absorbance change/minute of the last three reads is subtracted
from the absorbance change/minute of the first three reads,
divided by absorbance change/minute of all reads (expressed
in %).
∆Af ∆Ab
--------
- – -----------
min min
----------------------------- x x x 100 = Rate Linearity%
∆A
---------
min

200154-101—November 2004
Where:
∆Af/min Absorbance change per minute of the first three
reads
∆Ab/min Absorbance change per minute of the last three
reads
∆A/min Absorbance change per minute of all reads (%)
If the result is greater than the specified limit, Result Error

Code RL% (Abnormal Rate Linearity%) displays.
Absorbance
∆Af
min
∆A
min
∆Ab
min
Photometric Point
Read Time
Figure 2.121:Rate Linearity
NOTE: Linearity check is not performed in the

following cases:
1. When zero is entered for the rate limit.
2. When three or less absorbance data points are used
for concentration or activity calculation.
3. When ∆Af/min – ∆Ab/min is 0.006 Abs/min or less.
4. When ∆A/min is 0.006 Abs/min or less.

200154-101—November 2004
Extrapolated Calculation
To calculate patient samples with concentrations higher than
the calibrators, the calibration curve may be extrapolated.
The Extrapolation% Result Flag is a numeric value beyond
which results are flagged when exceeding that percentage of
the absorbance of the highest calibrator.
Extrapolation% is configured on the Calibration page of the
Assay Configuration screen.
Extrapolation%
Figure 2.122:Assay Configuration Screen, Calibration Page
Extrapolation is defined by entering the acceptable limit

(expressed in %) the curve will be extended. The acceptable
limit for which the curve can be extrapolated is determined by
the linearity of the reaction.
For data (absorbance or absorbance change) outside the
extrapolated range, Result Error Code EXT displays.
If Extrapolation% is defined as zero, the curve is extrapolated
indefinitely.

200154-101—November 2004
An example using 50% is illustrated in the following figure.
Result Error Code EXT

displays for data beyond
this point
Absorbance of Highest
Calibrator
Concentration
blk Calibrator
Figure 2.123:Extrapolated Calculation

200154-101—November 2004
Reagent Carryover
The following cross-contamination protocol should be used as
part of the routine evaluation and integration of any alternate
reagent application on the AEROSET System. This procedure
identifies carryover between reagents run on the same line.
Identification of reagent cross-contamination allows the
operator to take the appropriate precautions, e.g.,
incorporating a SmartWash™ to ensure reliable results are
obtained.
Cross-contamination Protocol
Purpose
There are two objectives for this procedure.
1. To determine whether carryover exists between Abbott
and non-Abbott reagents that are not line-separated.
2. To reduce any potential carryover between an Abbott and
non-Abbott reagent.
Definitions
Recipient assay—an assay whose results could be affected by
reagent carryover from another assay.
Donor assay—an assay that may contribute reagent carryover
into subsequent assays.
Saline assay—a simulated assay used to clean all probes
between carryover opportunities.

200154-101—November 2004
Procedure
Use the following instructions to configure a saline assay.
1. Assay Configuration
a. Select <Assays> in the Information Access Area of the
b. Select an empty assay button. The Select Reaction
Figure 2.124:Select Reaction Mode Dialog Window
c. Select the checkbox (聺) next to Photometric then

select <OK> in the upper-right corner of the dialog
window. The Assay Configuration screen displays.
Figure 2.125:Assay Configuration Screen, Outline Page
d. Type Saline in the Assay Name field.

e. Type a unique assay number in the Assay # field.

200154-101—November 2004
f. Select the appropriate A-Line or B-Line tab

corresponding to the location of the donor and
recipient assays.
g. Configure the following parameters.
Tab Field Parameter

Base Reaction Mode End Up
Wavelength 340/380
Read Time 21-33
S.Vol 15
Reagent 1 200
Reagent 2 60
Calibration Calib Mode Factor
Factor 8141
Interval (H) 9999
Blank/Calib Reps 3
BLK Water
S.Vol 15
h. Select <Save> in the right column of the Assay

Configuration screen. The Save Assay Parameters
i. Select <OK> to save the settings.
2. Reagent Configuration
a. Fill empty reagent cartridges with saline and place on
the appropriate A-Line or B-Line in both the R1 and
R2 Reagent Supply Centers.
b. Select <Reagents> in the Information Access Area of
the Main Display. The REAGENTS screen displays.
c. Select the appropriate A-Line or B-Line tab and an
empty position for configuration.
d. Type Saline1 in the Reagent Name field for Reagent 1.
e. Select <R1> as the Reagent Type. DO NOT assign as
Diluent. Select the appropriate cartridge size in the
drop-down list box then select the return arrow to
close the list.
f. Select <OK> three times to save the changes to reagent
configuration.

200154-101—November 2004
g. Type Saline2 in the Reagent Name field for Reagent 2.

h. Select <R2> as Reagent Type. DO NOT assign as
Diluent. Select the appropriate cartridge size in the
drop-down list box.
i. Select <OK> three times to save the changes to reagent
configuration.
j. Return to the Assay Configuration screen for Saline
then select the Base tab.
k. For Reagent 1, select the list box icon next to the
Assay Name field. Select <Saline1> then select the
l. For Reagent 2, select <Saline2> in the drop-down list
box for the Assay Name field then select the return
m. Select <OK> two times to save the changes to reagent
configuration.
3. Calibrator Configuration
a. Select <Cal/Control> in the Information Access Area
of the Main Display. The CALIBRATOR/CONTROL
screen displays.
b. Select <Water>.
c. Enter zero for the saline assay value.
Before starting the protocol, verify the calibrations and QC
values for the donor and recipient assays are acceptable.
Perform the carryover run using the following table for
instructions on samples, replicates, and calculations. After
completion of this run, reverse the testing order of the
recipient and the donor assays and repeat the run. This process
should be followed for each assay that shares the same line as
the donor assay.

200154-101—November 2004
NOTE: Use only one level of the same control material

for both the donor and recipient assays. Configure all
the following positions as patient samples.
Sample Test to
Position Replicates Calculations Purpose
Material Order
1 Saline Saline 5 N/A Cleans reagent
assay probes
2 Control Recipient 5 Mean Defines the target
material assay for the
uncontaminated
recipient assay
3 Saline Saline 5 N/A Cleans reagent
assay probes
4 Control Donor 5 N/A Introduces any
material assay carryover to the
recipient assay
5 Control Recipient 5 Calculate the following: Generates
material assay a. %difference from Replicate 1
target: %difference, which
rep 1 – target × 100 demonstrates
target whether the first
b. difference of each replicate is
rep from the target contaminated by
the donor assay
Interpretation of Results
If reagent carryover is present, the first replicate of the
recipient assay following the donor assay replicates does not
match the target of the recipient assay. If reagent carryover is
absent, each of the recipient assay replicates run after the
donor assay closely agrees with the recipient assay’s target
value. There is no specific value given to determine the
acceptance criteria for the replicate 1 difference or percent
difference from target. The operator and vendor of the assay in
question should determine the acceptable criteria based on
precision information or the clinical significance of the assay.
For mathematical examples of data calculations, refer to
Example at the end of this section. This is simulated data and
is not intended to illustrate expected results.

200154-101—November 2004
Implementation and Verification of the SmartWash™ Feature

If reagent carryover is observed, the SmartWash feature should
be incorporated into the recipient assay configuration.
Use the following instructions to configure SmartWash.
NOTE: For the SmartWash feature to function
appropriately for assays with two reagent components,
each component must be uniquely identified. For
example, a donor calcium assay in which both
components are named CA must be renamed CA1 and
CA2.
SmartWash tab. The SmartWash page of the recipient
assay displays.
Figure 2.126:Assay Configuration Screen, SmartWash Page
2. Select an area to wash, such as the reagent probe and/or

cuvette.
3. Reagent—select the interfering reagent in the drop-down
list box. Up to 16 reagents can be defined.
4. Wash—select water or a wash solution in the drop-down
list box.
5. Volume—enter a volume of water or wash solution that
exceeds the total volume in the cuvette
(sample + reagents + diluents).

200154-101—November 2004
6. Repeat the testing defined in the previous table to ensure

the SmartWash™ is adequate.
If this wash is successful in reducing carryover, save this
configuration for the SmartWash. If unsuccessful, repeat the
preceding steps.
NOTE: Use of the SmartWash feature may impact
throughput due to additional system washes.
Example
The following information is provided as a sample of
mathematical calculations only, and is not intended to
illustrate expected results.
If the recipient assay in position 2 produces the following
replicates, the mean is 11.1. This is the target for the
uncontaminated recipient assay.
Replicate 1 = 10.5
Replicate 2 = 11.2
Replicate 3 = 10.9
Replicate 4 = 11.5
Replicate 5 = 11.4
If the recipient assay in position 5 produces the following
replicates, the percent difference of replicate 1 from the target
is 36.9%.
Replicate 1 = 15.2
Replicate 2 = 14.8
Replicate 3 = 13.0
Replicate 4 = 11.9
Replicate 5 = 11.5
Percent difference
from target = rep 1 – target × 100
Target
= 15.2 – 11.1
× 100
11.1
= 36.9%

200154-101—November 2004
The difference of each replicate from the target provides

another approach to determine if reagent carryover is present.
Difference from 11.1
(target)
Replicate 1 = 15.2 -4.1
Replicate 2 = 14.8 -3.7
Replicate 3 = 13.0 -1.9
Replicate 4 = 11.9 -0.8
Replicate 5 = 11.5 -0.4

200154-101—November 2004
Import and Export Functions
System software enables import and export of files to:

• Formatted floppy disk
• Hard disk (Library)
Import and export functions are accessed on the following

screens:
• DATABASE
• ASSAYS
• REAGENT
• CALIBRATOR/CONTROL

200154-101—November 2004
Import and Export Functions Section 2
Import Function
1. Select <Import> in the right column of the selected
screen. The Import dialog window displays.
Figure 2.127:Import Dialog Window
FLOPPY DISK or HARD DISK option then select the return
names display.
4. Select the desired file name then select the return arrow to
close the list.
5. If importing files from a floppy disk, insert the disk in the
floppy disk drive of the SCC computer.
6. Select <OK> on the Import dialog window. The Import
Figure 2.128:Import Confirmation Dialog Window
7. Select <OK>. The file(s) transfers to the system.

CAUTION: A system backup must be performed
! after new files are imported. If a backup is not
performed and a problem occurs with the SCC
computer, new files could be lost.
Erase files copied to the Library as soon as they are not
needed. This prevents the risk of importing incorrect files.
Refer to As Needed Maintenance Procedures in Section 9,
Service and Maintenance for details.

200154-101—November 2004
Section 2 Import and Export Functions
Export Function
1. Select <Export> in the right column of the selected screen.
The Export dialog window displays.
Figure 2.129:Export Dialog Window
FLOPPY DISK or HARD DISK option then select the return
3. Enter a file name in the File Name field, up to 8 characters.
The system automatically adds the appropriate file
extension upon completion.
4. If exporting files to a floppy disk, insert the formatted disk
in the floppy disk drive of the SCC computer.
5. Select <OK> on the Export dialog window. The Export
Figure 2.130:Export Confirmation Dialog Window
6. Select <OK>. The file(s) transfers to the selected drive.

200154-101—November 2004
Import and Export Functions Section 2
NOTES

200154-101—November 2004
Instrument Relocation
WARNING: Potential Biohazard. Before the AEROSET

System can be moved, decontamination is required.
Refer to Decontamination Procedure Requirements
in Section 8, Hazards.
Distant Relocation
For distant relocation, the Abbott Field Service Representative
prepares the decontaminated system for shipment. This
includes repacking.
Local Relocation
Prepare the instrument for local relocation:
• Verify the new environment meets all requirements
• Decontaminate the system
• Remove all bulk solutions, consumables, and drain all
water
• Place all covers and doors in their proper positions
• Disconnect all power and communication cables
• Secure cabling on the system clear of the floor
• Raise the leveling feet until the system rests on its casters
Movement
When the system is ready to be moved:
• Ensure adequate help is available
• Push only on solid sections of the housing; do not exert
pressure on unsupported sections of the shell
• Move slowly
Reinstallation
Upon arrival at the new location:
• Level the system
• Reassemble all accessories
• Connect the power
• Perform an Installation Checkout

200154-101—November 2004
Instrument Relocation Section 2
NOTES

200154-101—November 2004
Section 3
Section 3: Principles of Operation
Principles of Operation

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Sample Progression . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Reaction Carousel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
AEROSET System Reaction Table . . . . . . . . . . . . . . . . . . . . . 3-5
Details of Cuvette Positions for Each Operation . . . . . . 3-5
Photometry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Photometric System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Photometric Timing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Photometric Timing Table . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Assay Types. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Photometric Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
End-point Assay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Rate Assay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Potentiometric Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
ICT™ Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
ICT Flow Diagram . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
Components of the ICT Unit . . . . . . . . . . . . . . . . 3-13
ICT Sample Progression . . . . . . . . . . . . . . . . . . . . . 3-15
ICT Module Design . . . . . . . . . . . . . . . . . . . . . . . . 3-16
Calculation Method . . . . . . . . . . . . . . . . . . . . . . . 3-17

200154-101—November 2004
Principles of Operation Section 3
NOTES

200154-101—November 2004
Section 3 Principles of Operation
Section 3: Principles of Operation
Overview
This section provides information on methodologies utilized
to process assays on the AEROSET System.
Included in this section:
• Reaction Timing
• Assay Types
– Photometric
• End-point
• Rate
– Potentiometric
• Integrated Chip Technology™ (ICT) (Ion-selective
Electrodes)

200154-101—November 2004
Principles of Operation Section 3
NOTES

200154-101—November 2004
Sample Progression
Reaction Carousel
4 After three movements the cuvette pair is at the first mixing position, where
the sample (dispensed in position 1) and reagent
(dispensed in position 2) are mixed.
Second mixing position
First mixing position
ICT aspirate position

3
5 Every 4.5 seconds, the
carousel rotates
After four movements, the Second reagent dispense position counterclockwise
carousel has moved 41 cuvette pair positions.
Photometric position
164 cuvette pair positions.
Because a total of 165 cuvette
pair positions are in the
carousel, the starting cuvette
pair is now one position
behind where it started. If a
dilution is required, diluted
sample aspiration occurs
here. First reagent dispense position
Diluted sample aspirate position
Sample dispense position
1
Starting Position
2 After dispensing sample, the Reaction Carousel turns 41 cuvette pair
positions. The cuvette pair where sample was just dispensed is now at the
first reagent dispense position.
1. Sample is dispensed into a cuvette or cuvette pair at the

starting position.
2. After dispensing sample, the Reaction Carousel turns
41 cuvette pair positions. The cuvette pair where sample
was just dispensed is now at the first reagent dispense
position.
3. Every 4.5 seconds, the carousel rotates counterclockwise
41 cuvette pair positions.
4. After three movements, the cuvette pair is at the first
mixing position, where sample (dispensed in position 1)
and reagent (dispensed in position 2) are mixed.

200154-101—November 2004
Sample Progression Section 3
5. After four movements, the carousel has moved

164 cuvette pair positions. Because a total of 165 cuvette
pair positions are in the carousel, the starting cuvette pair
is now one position behind where it started. If a dilution
is required, diluted sample aspiration occurs here.
The counterclockwise rotations continue every 4.5 seconds
and the following functions occur at the specified times.
• When the cuvette pair reaches position 31, the ICT™ unit
aspirates the sample.
• When the cuvette pair reaches position 67, the second
reagent is dispensed, if required.
• When the cuvette pair reaches position 68, it is mixed if
the second reagent was dispensed in the previous step.
• The cuvette can be read any time it passes the photometric
position. The cuvette passes this point during each fourth
movement of the carousel.

200154-101—November 2004
Section 3 Sample Progression
AEROSET System Reaction Table

Details of Cuvette Positions for Each Operation
Photometric Photometric
Position Operation Position Operation
Point Point
1 Sample dispense 50
2 First reagent dispense 51
3 52 13
4 First reagent mix 1 53
5 Diluted sample aspiration 54
6 55
7 56 14
8 2 57
9 58
10 59
11 60 15
12 3 61
13 62
14 63
15 64 16
16 4 65
17 66
18 67 Second reagent dispense
19 68 Second reagent mix 17
20 5 69
21 70
22 71
23 72 18
24 6 73
25 74
26 75
27 IRef aspiration (urine) 76 19
28 7 77
29 IRef aspiration (urine & serum) 78
30 79
31 ICT aspiration 80 20
32 8 81
33 IRef aspiration (urine & serum) 82
34 83
35 IRef aspiration (urine) 84 21
36 9 85
37 86
38 87
39 88 22
40 10 89
41 90
42 91
43 92 23
44 11 93
45 94
46 95
47 96 24
48 12 97
49 98

200154-101—November 2004
Sample Progression Section 3
Position Operation Position Operation
Point Point
99 133
100 25 134
101 135
102 136 High-concentration waste aspiration
103 137
104 26 138
105 139
106 140 Wash with alkaline wash
107 141
108 27 142
109 143
110 144 Wash with acid wash
111 145
112 28 146
113 147
114 148 Wash with DI water (Type II)
115 149
116 29 150
117 151
118 152 Wash with DI water (Type II)
119 153
120 30 154
121 155
122 156 Water blank measurement
123 157
124 31 158
125 159
126 160 Water aspiration
127 161
128 32 162
129 163
130 164 Drying
131 165
132 33

200154-101—November 2004
Photometry
The photometric method used on the AEROSET System is a

direct photometry system. This method utilizes a concave
diffraction grating and is capable of taking measurements at
16 different wavelengths (monochromatic and bichromatic).
Photometric System
The reaction cuvette is a rectangular glass cuvette. The
photometric lamp is a tungsten-halogen lamp. The light
detector uses a silicon photodiode array.
Photometric Timing
• Sample and first reagent are dispensed into the cuvette.
• The second reagent is dispensed approximately five
minutes after the first reagent.
• There is approximately five minutes between the second
reagent dispense and the last photometric point.
The following diagram shows progression of the reaction from
the initial dispense cycle to the final read phase.
Absorbance
Approximately 5.1 minutes
Approximately 9.6 minutes
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33
Photometric Point
Sample Dispense Second Reagent Dispense

First Reagent Dispense Second Mix
First Mix
Figure 3.1: Photometric Timing

200154-101—November 2004
Photometry Section 3
Photometric Timing Table

The following table represents the elapsed time at each of the
33 photometric points with the first photometric point
defined at zero seconds.
Measurement time after second reagent dispense represents
the approximate time between second reagent dispense and
photometric reads.
Measurement Time
Photometry Photometry after Second
Timing Timing
Reagent Dispense
Point Position sec min sec Point Position sec min sec sec min sec
1 4 0 0 0 17 68 288 4 48 0 0 0
2 8 18 0 18 18 72 306 5 07 18 0 18
3 12 36 0 36 19 76 324 5 24 36 0 36
4 16 54 0 54 20 80 342 5 42 54 0 54
5 20 72 1 12 21 84 360 6 00 72 1 12
6 24 90 1 30 22 88 378 6 18 90 1 30
7 28 108 1 48 23 92 396 6 36 108 1 48
8 32 126 2 06 24 96 414 6 54 126 2 06
9 36 144 2 24 25 100 432 7 12 144 2 24
10 40 162 2 42 26 104 450 7 30 162 2 42
11 44 180 3 0 27 108 468 7 48 180 3 0
12 48 198 3 18 28 112 486 8 06 198 3 18
13 52 216 3 36 29 116 504 8 24 216 3 36
14 56 234 3 54 30 120 522 8 42 234 3 54
15 60 252 4 12 31 124 540 9 00 252 4 12
16 64 270 4 30 32 128 558 9 18 270 4 30
33 132 576 9 36 288 4 48

200154-101—November 2004
Assay Types
AEROSET System assays are measured by two different

methodologies:
• Photometric
– End-point
– Rate
• Potentiometric
– ICT™ (Ion-selective Electrodes)
In addition, at each read point the AEROSET System can
measure at one (monochromatic) or two (bichromatic)
wavelengths. Most AEROSET System assays are bichromatic.
The following table describes how absorbance is calculated for
each of these types.
Number of Wavelengths
How Absorbance Values Are
Measured at Each Read
Calculated
Point
One—monochromatic The reading from only the
single wavelength is used.
Two—bichromatic The reading taken at the
secondary wavelength is
subtracted from the reading
taken at the primary
wavelength, and the difference
is used as the absorbance value.
NOTE: Displayed absorbance data are converted to

readings for a 10 mm light path length.

200154-101—November 2004
Assay Types Section 3
Photometric Assays
End-point Assay
For end-point assays, concentration is calculated using the
absorbance data obtained in the Main Read Time defined on
the Base page of the Assay Configuration screen. Refer to
Section 2, Installation Procedures and Special Requirements for
information on configuring the Base page.
The reaction reaches equilibrium, and at that time there is
little or no additional change to the absorbance readings. The
absorbance readings used for calibration and to calculate
results are measured during this equilibrium time.
Main Read Time

Absorbance
S: Sample Dispense
Photometric Points
S R1 R2
Time
Figure 3.2: Example of End-point Assay Reaction Curve
Rate Assay
For rate assays, activity is calculated using the change of
absorbance per minute (∆Abs/min) in the Main Read Time
defined on the Base page of the Assay Configuration screen.
Refer to Section 2, Installation Procedures and Special
Requirements for information on configuring the Base page.

200154-101—November 2004
Section 3 Assay Types
There is a constant change in absorbance over time. Readings

are performed several times during this reaction and the
absorbance change over time (activity) is calculated and used
for calibration and to calculate results.
Main Read Time
Reaction Curve
S: Sample Dispense
Absorbance
Lower Limit of Abs Range
Photometric Points
S R1 R2
Time
Figure 3.3: Example of a Down Rate Assay Reaction Curve
At least three photometric points must be included in the

Main Read Time. The maximum number of photometric
points is 33.
Calculated absorbance—the rate of change of absorbance
(change per minute) is calculated using the Linear Least
Squares method.

200154-101—November 2004
Potentiometric Assays
ICT™ Unit
ICT Flow Diagram

The following diagram describes the flow of the electrolyte
sample and solutions; full understanding is important for
maintenance and troubleshooting.
µL
µL
ICT Reference
Solution Preheater
Figure 3.4: Flow Diagram of ICT Fluid Delivery

200154-101—November 2004
Components of the ICT™ Unit

The AEROSET System simultaneously measures Na+, K+, and
Cl- using Integrated Chip Technology. ICT uses solid state
ion-selective electrodes contained in a single chip (ICT
module), which reduces the required maintenance.
The ICT module is contained in the ICT unit. The ICT unit can
move into position over the ICT reference solution cup to
aspirate ICT reference solution or over the Reaction Carousel
to aspirate diluted sample. Components of the ICT unit and
other components used to measure ICT assays are described in
the following table. Refer to Section 1, Use or Function for
additional information and illustrations.
Component Description
ICT Module The ICT module is an integrated chip
composed of a Na+, K+, Cl-, and reference
electrode. The module is located in the ICT
unit.
ICT A 1 mL syringe drive pump aspirates samples
Aspiration or ICT reference solution into the ICT module
Pump for measurement, then moves waste into the
water bath/waste overflow area when
measurement is complete. This pump is
located behind the ICT pump access door.
ICT ICT reference solution is measured before and
Reference after each sample to create a baseline for
Solution checking for electrode drift. The second read
measurement is used to calculate the sample
result. This bulk solution is placed on a weight
platform behind the front-right door.
ICT A 1 mL syringe drive pump aspirates ICT
Reference reference solution from the bulk bottle,
Solution through the ICT reference solution preheater,
Pump and into the ICT reference solution cup.
When measurement is complete, this pump
aspirates ICT reference solution from the cup
and moves it into the water bath/waste
overflow area. The ICT reference solution
pump is located behind the ICT pump access
door.

200154-101—November 2004
ICT™ The preheater warms ICT reference solution to
Reference 37°C before it is used to fill the ICT reference
Solution solution cup. The ICT reference solution
Preheater preheater is a narrow metal tube located in the
water bath.
ICT Preheated ICT reference solution is aspirated
Reference from this cup and measured by the ICT
Solution Cup module. The ICT reference solution cup
contains a sensor that detects both the
presence of ICT reference solution and
aspiration of reference solution by the ICT
sample probe. The ICT reference solution cup
is located beneath the ICT probe when the
ICT unit is in the home position.
Water Bath/ Liquid waste from the ICT unit and reference
Waste solution cup is dispensed into this waste area,
Overflow located to the right of the Reaction Carousel.
Area Liquid waste is removed from the analyzer
through the low-concentration waste tubing.
ICT Probe The ICT probe is connected to the ICT module
in the ICT unit. This probe aspirates diluted
sample from the reaction cuvette or aspirates
ICT reference solution from the cup into the
ICT module for processing.
ICT Sample A supply of ICT sample diluent must be placed
Diluent onboard in an outer segment (A, B, or C) of
Reagent Supply Center 1 for processing. After
15 µL of sample is dispensed by the sample
probe into a cuvette and 345 µL of diluent is
dispensed by the R1 reagent probe, the sample
and diluent are mixed together by the
R1 mixer.

200154-101—November 2004
ICT™ Sample Progression

Sample and ICT sample diluent are dispensed into a cuvette
using the same process used for photometric assays.
The following steps are performed during serum measurement
at the identified Reaction Carousel positions:
• Position 1—15 µL of sample is aspirated by the sample
arm from the sample cup or tube, then dispensed into the
A-Line cuvette of a cuvette pair.
• Position 2—the Reaction Carousel rotates to the
Reagent 1 dispense position and 345 µL of ICT sample
diluent is dispensed by the Reagent 1-A arm into the
cuvette.
• Position 4—the Reaction Carousel rotates two times to
the Reagent 1 mixing position, and the sample and ICT
sample diluent are mixed.
• Position 29—when the diluted sample reaches this
position, ICT reference solution is aspirated from the ICT
reference solution cup and measured by the ICT module.
• Position 31—the Reaction Carousel rotates to the ICT
sample aspiration position. By now, the sample is warmed
to 37°C. The ICT probe aspirates 300 µL of diluted sample
from the cuvette and the ICT module measures the diluted
sample.
• Position 33—the Reaction Carousel rotates to the next
position. ICT reference solution is aspirated again then
measured by the ICT module.
• ICT results for the sample are calculated by comparing the
mV (millivolt) readings of the sample to mV readings of
the second ICT reference solution measurement.
NOTE: The same steps are performed for urine ICT
measurement, except ICT reference solution is
aspirated two times before the ICT sample
(positions 27 and 29) and two times after the ICT
sample (positions 33 and 35).

200154-101—November 2004
ICT™ Module Design
ICT Module
Sodium
Potassium
Chloride
125673
The ICT module contains solid state ion-selective electrodes in

a single chip.
Figure 3.5: ICT Module

200154-101—November 2004
Electrode Description
Sodium (Na+) Crown Ether ionophore, incorporated into
an ion-selective plastic membrane. It is not a
glass electrode, and is less affected by pH
changes.
Potassium (K+) Valinomycin, incorporated in an
ion-selective plastic membrane.
Chloride (Cl-) Solid silver chloride (AgCl) disk.
Reference Silver/silver chloride electrode in a
potassium chloride (KCl) gel inner solution,
separated from the sample by a porous
ceramic tube.
Calculation Method
1. Measurement and correction of the ICT™ reference
solution:
Electrolyte concentration is calculated using the
electromotive force of ICT reference solution after sample
measurement and electromotive force of the sample.
Sample (Es,i)
B
Ei = Es,i - E ,i
N
EMF (mv)
ICT Reference B
ICT Reference Solution E ,i
Solution N
Figure 3.6: Electromotive Force Calculation

200154-101—November 2004
Where:
∆Ei Potential difference between the sample
and ICT™ reference solution for each
electrode
Potential of each electrode (i), in contact
EB, with ICT reference solution
N
Es,i Potential of each electrode (i), in contact

with the sample
i Ion of interest (Na+, K+, and/or Cl-)
2. Slope calculation:
Low and high calibrators are used for calibration of serum
and urine. The electromotive force of the low and high
calibrators are represented as electromotive force
differences between these and ICT reference solution, and
are used for calculating the slope of the calibration curve.
ICT Reference Solution

(mV)
Figure 3.7: Relationship between Ion Electrolyte

Concentration and Electromotive Force

200154-101—November 2004
Where:
S Slope (mV/decade) of each electrode
CL, CH Concentration of low and high calibrators
CN Concentration of ICT™ reference solution
∆EL, ∆EH Difference in potential of each electrode
between ICT reference solution and the
calibrator
Ci Concentration of the ion of interest
(mV)
Figure 3.8: Electrode (mV) Response Curve during Calibration
Where:
CL, CH Concentration of low and high calibrators
CN Concentration of ICT reference solution
∆EL, ∆EH Difference in potential of each electrode
between ICT reference solution and the
calibrator

200154-101—November 2004
3. Sample Measurement:
The difference between electromotive forces of ICT™
reference solution and the sample (∆Ei) is measured. The
unknown concentration (Ci) is calculated by the
following equation using S and ∆EL, obtained in the
calibration, and ∆Ei.
Ci = CL × 10 ((∆Ei -∆EL)/S)
CN Ci CN CN
Ei Ei
EMF
Serum Urine
Time
Figure 3.9: Electrode (mV) Response Curve during

Sample Measurement
Where:
Ci Concentration of the ion of interest in the
sample
CL Concentration of the ion of interest in the
low calibrator
(This is the baseline for sample
calculations.)
S Slope of the ICT electrode of interest
∆Ei Difference in ICT electrode potential, when
exposed to the sample and ICT reference
solution
∆EL Difference in the ICT electrode potential,
when exposed to ICT reference solution
and the low calibrator during calibration
CN Concentration of ICT reference solution

200154-101—November 2004
Section 4
Section 4. Performance Characteristics and Specifications
Performance Characteristics
and Specifications

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . 4-2
Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Environmental Requirements . . . . . . . . . . . . . . . . . . . . . 4-6
Uninterruptible Power Supply (UPS) . . . . . . . . . . . . . . . 4-8
Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Optical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Computer and Interface Specifications . . . . . . . . . . . . 4-10
Capacities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Sample Tube Specifications . . . . . . . . . . . . . . . . . . . . . . 4-11

200154-101—November 2004
Performance Characteristics and Specifications Section 4
NOTES

200154-101—November 2004
Section 4 Performance Characteristics and Specifications
Section 4: Performance Characteristics and Specifications
and Specifications
Overview
This section provides information on performance
characteristics and specifications of the AEROSET System.
The performance characteristics are summarized to provide
details on instrument capabilities during normal operation.
Specifications are included in this section as well. Parameters
related to the design of the system, important for installation
and operation, are also provided.
The following are included in this section:
• Performance Characteristics
• Physical Specifications
• Environmental Requirements
• Uninterruptible Power Supply (UPS)
• Electrical Specifications
• Optical Characteristics
• Computer and Interface Specifications
• Capacities
• Sample Tube Specifications

200154-101—November 2004
Reaction Types Photometric: End-point and rate

Potentiometric: Integrated Chip Technology™ (ICT)
ion-selective electrodes
Sample Types Refer to the assay-specific package inserts
Assay Report Types User-configurable
Quality Control Levey-Jennings analysis
Westgard Multi-rule
Identification Bar code
Technology
Sample Bar Code Code 128, I 2 of 5, Code 3 of 9, and Codabar
Symbology
Reagent Bar Code PDF-417 2-D
Symbology
Operator Interface Color Touchscreen and keyboard
Host Interface Bi-directional
Onboard Data Up to 8,000 patient records or 30,000 results
Storage
Operational Basis 24 hours
Individual Assay Approximately 10 minutes
Time, Routine
Individual Assay Approximately 10 minutes
Time, STAT
Warm-up Time Approximately 30 minutes
from Cold Start

200154-101—November 2004
Performance Characteristics (Continued)
Sample Volume Minimum volume required in a sample cup is

Required dependent upon the largest possible aspiration
volume of an assay pair ordered on the sample.
Largest assay pair volume = Largest defined assay
volume ordered on the A-Line + Largest defined assay
volume ordered on the B-Line.
Largest Assay
Minimum Volume Required
Pair Volume
2 to 40 µL 60 µL + combined sample
volumes of all assays ordered
41 to 70 µL * 166 µL + combined sample
volumes of all assays ordered
* All Abbott assay applications for the AEROSET
System have a defined sample volume of 20 µL or less.
This volume requirement only applies if non-Abbott
assay applications are defined with a sample volume
greater than 20 µL.
Example: The minimum sample required for a panel
including the following assays (Urea, Crea, Glu, Na, K,
Cl, CO2) is:
60 µL + 31.4 µL (combined sample volume) = 91.4 µL
NOTE: Sample volumes can be approximated
by using the guidelines provided; however,
certain conditions require additional volume.
For tests requiring onboard dilutions or sample
volumes exceeding 15 µL, an additional 8 µL
volume of sample—the “over-aspiration”
volume—may be aspirated by each probe. The
additional number of over-aspirations required
for these scenarios is variable, and can be
aspirated from the current sample and/or the
following sample. When using tests that meet
these conditions, allow for the possibility of
over-aspiration volumes when dispensing
sample.

200154-101—November 2004
Performance Characteristics (Continued)
Throughput End-point, rate, and ICT™ (electrolyte) assays: up to

2,000 tests per hour
End-point and rate assays only: up to 1,600 tests per

hour
ICT assays only: up to 600 tests per hour

Reaction 37°C ± 0.3°
Temperature
Sample System
Method Pipetting, dual-test sampling with two probes
Pump Pulse count method (quantitative)
Liquid Level Detection of liquid level due to change in capacitance
Sense
Calibrator/ Minimum: –2°C
Control Maximum:
Carousel
• If the interior temperature is > 15°C, the maximum
is 5°C below the interior temperature
• If the interior temperature is 15°C, the maximum
is 10°C below the interior temperature
Reagent System
Method Pipetting, single probe with an integrated level sensor
Pump Pulse count method (quantitative)
Liquid Level Detection of liquid level due to change in
Sense conductance
Reagent Onboard refrigeration, two Reagent Supply Centers
Compartments with capacity up to 56 reagent cartridges each.
The Reagent Carousel plate temperature is maintained
10°C. Reagent Supply Center readings (average and
actual) are air temperature readings. An algorithm
correlates the air temperature to liquid temperature of
the carousels. The corresponding error detection
range for air temperature is 0 to 15°C.

200154-101—November 2004
Performance Characteristics, Continued
Maintenance Required
Approximately:
Daily 5 minutes *
Weekly 10 minutes
Monthly 30 minutes
Quarterly 105 minutes
Semi-Annually 10 minutes
Annually 20 minutes
* Operator-attended time
Physical Specifications
Physical Specifications
Analyzer Dimensions
Depth 44.1 in (112 cm)
Width 74.5 in (189 cm)
Height 43.5 in (110.5 cm)
Analyzer Weight Approximately 1,500 lb (680 kg)
Dimensions with Stand
Depth 18 in (45.7 cm)
Width 24 in (60.9 cm)
Height 42.5 in (107.9 cm)
Height with monitor 60.5 in (154 cm)
Weight Approximately 190 lb (86 kg)

200154-101—November 2004
Environmental Requirements
Environmental Requirements
For Indoor Use Do not locate in direct sunlight

Clearances
Left 31.5 in (80 cm)
Right 31.5 in (80 cm)
Rear 20 in (51 cm)
Surface Level, solid floor capable of
supporting 2,000 lb (908 kg)
Temperature, Ambient 15 to 30°C
(Operational)
Humidity—Analyzer 15% to 85%
(Non-condensing)
Humidity—SCC Refer to the respective component
Components manufacturer’s information
Operating Altitude Limit 6,600 ft (2,000 m)

200154-101—November 2004
Environmental Requirements (Continued)
BTU Output 6,551 BTU/hr

Water Supply/Drainage
Deionized Water • 47.5 L per hour during normal
Consumption operation
• 52 L per hour during normal
operation with Sample Carryover
Reduction feature installed
Purity of Deionized 1.0 MΩ per cm
Water Bacterial count of DI
water < 1,000 CFU/mL
Drainage Port A drainage port should be provided
within 9.5 ft (2.9 m) from the rear
of the system unit
Diameter • 6.4 cm (2.5 in) without
refrigerator drain
• 9 cm (3.5 in) with refrigerator
drain
Height • 10.0 cm (4 in) without
refrigerator drain
• 7.62 cm (3 in) with refrigerator
drain
Drainage Capacity 200 L per hour

200154-101—November 2004
Uninterruptible Power Supply (UPS)
UPS—USA
Input Voltage 208 Volts ± 10%

Input Plug NEMA L6 - 30P
Output Voltage 208 Volts ± 10%
Capacity 3 kVA
Output Receptacle NEMA L6 - 30R
Online Yes
Backup Time 10 minutes @ full load
UPS—Europe
Input Voltage 220 to 240 Volts ± 10%

Input Plug IEC 309 Male
Output Voltage 220 to 240 Volts ± 10%
Capacity 3 kVA
Output Receptacle IEC 309 Female
Online Yes
Backup Time 10 minutes @ full load

200154-101—November 2004
Electrical Specifications
Electrical Specifications
Voltage Single-phase 200, 210, 220, 230,

240 ± 10% VAC
Frequency 50/60 Hz ± 1%
Power 3 kVA (20 Amp breaker/20 Amp fuse)
Grounding Clamp on ammeter reads zero (0.000A).
Must be provided in accordance with all
applicable local legal requirements
Power Cord US/Canada, UL/CSA approved
Receptacle Dedicated duplex NEMA reference,
L6 - 30R (US only)
Within 12 ft (3.7 m) from left side of
analyzer
System Control 100 VAC ± 10%, UL listed, CSA certified
Center Outlet (US/Canada) supplied by the analyzer
Optical Characteristics
Optical Characteristics
Light Source Tungsten-halogen lamp

Detector Silicon photodiode array
Light Path 5 mm
Length
Photometric Concave diffraction grating
Method
Reaction Rectangular glass cuvette
Cuvette
Wavelengths 16 wavelengths (340, 380, 404, 412, 444,
476, 500, 524, 548, 572, 604, 628, 660,
700, 748, and 804 nm)
Photometric –0.1 to 3.0 Abs (converted to 10 mm light
Range path length)
Linearity Within ± 2% (at 2.0 Abs)

200154-101—November 2004
Computer and Interface Specifications
Computer and Interface Specifications
Computer IBM PC/AT compatible

Display Color monitor with Touchscreen
Keyboard Alphanumeric full keyboard
Printer AEROSET dot matrix forms printer
Host Interface RS-232C
Capacities
Capacities
FastTrack™ Sampler 200 samples (4 trays)

Sample Carrier 5 samples per carrier
Sample Carrier Tray 10 sample carriers per tray
Calibrator/Control 45 positions
(C/C) Carousel Maintained approximately
10°F (5.6°C) below the interior
temperature
Sample Carousel for 30 samples
Routine and Priority
Samples
Reserved STAT Position Single fixed position
for STAT Samples

200154-101—November 2004
Sample Tube Specifications

Sample Tube Specifications
Minimum Inside Outside Diameter Height

Tube Volume
Diameter (mm) Limits (mm) (mm)
10 mL (16 mm) 15.0 to 16.0
10.2 99 to 101
7 mL (13 mm) * 12.2 to 12.9
7 mL (16 mm) 15.0 to 16.0
9.8 74 to 76
5 mL (13 mm) * 11.8 to 12.9
* Adapter required

200154-101—November 2004
NOTES

200154-101—November 2004
Section 5
Section 5: Operating Instructions
Operating Instructions

General Operational Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Power ON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Log On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
PAUSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
UNPAUSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
START UP and SHUTDOWN . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Log Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Power OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
Stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
Reagent Supply Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
Reagent View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Reagent Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20
Check Reagent Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
Load Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-24
Bulk Solution Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31
Alkaline and Acid Wash Solution Loading . . . . . . . . . . . . . 5-33
ICT™ Reference Solution Loading . . . . . . . . . . . . . . . . . . . 5-34
Ordering and Running Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37

Ordering Patient Samples on the FastTrack™ Sampler . . . 5-37
Sample Order Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-40
Ordering Patient Samples on the Sample Carousel . . . 5-40
Additional Options on the Order Samples Screen . . . . 5-42
Sample Replicates . . . . . . . . . . . . . . . . . . . . . . . . . 5-42
Manual Dilution . . . . . . . . . . . . . . . . . . . . . . . . . . 5-43
Onboard Dilution . . . . . . . . . . . . . . . . . . . . . . . . . 5-43
Patient Demographics . . . . . . . . . . . . . . . . . . . . . . 5-44
Batch Ordering . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-45
Printing the Loadlist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-46
Patient Sample Requirements . . . . . . . . . . . . . . . . . . . . . . . 5-47
Sample Vessel Requirements . . . . . . . . . . . . . . . . . . . . . 5-47
Sample Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-48
Sample Integrity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-50

200154-101—November 2004
Operating Instructions Section 5
Sample Bar Code Labels . . . . . . . . . . . . . . . . . . . . . . . . 5-51

Bar Code Label Specifications . . . . . . . . . . . . . . . . 5-51
Sample ID (Identification) Length . . . . . . . . . . . . 5-52
Label Length . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-53
Label Placement . . . . . . . . . . . . . . . . . . . . . . . . . . 5-53
Tube Labeling Requirements . . . . . . . . . . . . . . . . 5-53
Loading Patient Samples . . . . . . . . . . . . . . . . . . . . . . . . . . 5-55
FastTrack™ Sampler . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-57
Sample Carousel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-58
Selecting Run Options and Starting the Run . . . . . . . . . . . 5-59
Viewing System Status and Run Progress . . . . . . . . . . . . . . 5-60
Run Progress Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-60
Status Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-61
Color Display on the DATABASE Screen . . . . . . . . . . . 5-62
Editing Patient Sample Orders . . . . . . . . . . . . . . . . . . . . . . 5-63
Ordering and Running a STAT Sample . . . . . . . . . . . . . . . 5-64
Adding Samples during a Run . . . . . . . . . . . . . . . . . . . . . . 5-69
Adding Samples on the FastTrack Sampler . . . . . . . . . 5-69
When the FastTrack Is Busy Sampling . . . . . . . . . 5-69
When the FastTrack Completes Sampling . . . . . . 5-69
Adding Samples on the Sample Carousel . . . . . . . . . . . 5-70
When the Sample Carousel Is Busy Sampling . . . 5-70
When the Sample Carousel Completes Sampling 5-72
Limited Run Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-73
Limiting Assays in a Run . . . . . . . . . . . . . . . . . . . . . . . 5-73
Deselecting the Limited Run Feature . . . . . . . . . . . . . . 5-75
Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-77
Reviewing Results on the DATABASE Screen . . . . . . . . . . . 5-77
Limited View Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . 5-79
Customized View Option . . . . . . . . . . . . . . . . . . . . . . . 5-80
Sort Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-81
Searching for Results . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-82
Reviewing Results on the RESULT Screen . . . . . . . . . . . . . 5-84
Reviewing Results with Replicates . . . . . . . . . . . . . . . . 5-86
Selecting the Replicate Result to Report . . . . . . . . . . . . 5-88
Accepting Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-89
Validating Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-91
Printing Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-92
Printing a Single Result Report from the DATABASE
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-92
Printing Multiple Result Reports from the DATABASE
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-92
Printing a Single Result Report from the RESULT
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-93

200154-101—November 2004
Section 5 Operating Instructions
Displaying Reaction Graphs . . . . . . . . . . . . . . . . . . . . . . . . 5-94

Single Result from the DATABASE Screen . . . . . . . . . . 5-94
Multiple Results from the DATABASE Screen . . . . . . . . 5-95
Single Result from the RESULT Screen . . . . . . . . . . . . . 5-97
Rerunning Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-98
Rerunning Results from the DATABASE Screen . . . . . . 5-98
Rerunning Selected Assays . . . . . . . . . . . . . . . . . . 5-98
Rerunning All Assays . . . . . . . . . . . . . . . . . . . . . . 5-100
Rerunning Results from the RESULT Screen . . . . . . . . 5-101
Rerunning Results in the Reserved STAT Position . . . 5-102
Reviewing and Selecting Rerun Results to Report . . . . . . 5-103
Reviewing Rerun Results . . . . . . . . . . . . . . . . . . . . . . . 5-103
Selecting the Rerun Result to Report . . . . . . . . . . . . . 5-106
Adding Assays to a Completed Sample . . . . . . . . . . . . . . 5-107
Editing Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-108
Recalculating Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-109
Recalculating Results from the DATABASE Screen . . . 5-109
Recalculating Selected Assays . . . . . . . . . . . . . . . 5-109
Recalculating All Assays . . . . . . . . . . . . . . . . . . . 5-110
Recalculating Results from the RESULT Screen . . . . . 5-111
Deleting Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-112
Deleting Results from the DATABASE Screen . . . . . . . 5-112
Deleting Results from the RESULT Screen . . . . . . . . . 5-113
Exporting Results to Floppy Disk . . . . . . . . . . . . . . . . . . . 5-114
Running the AEROSET System with a Host Computer . . . . . . . . . . . . . . . . . 5-117

Downloading Orders from the Host Computer . . . . . . . . 5-117
Host Order Query . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-118
Transmitting Results to the Host . . . . . . . . . . . . . . . . . . . 5-119
Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-121
Ordering Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-121
Automatic QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-124
Loading Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-125
Loading Controls When the Sample Carousel Is Busy
Sampling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-127
Loading Controls When the Sample Carousel
Completes Sampling . . . . . . . . . . . . . . . . . . . . . . . . 5-128
Reviewing QC Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-129
ASSAY STATUS Screen . . . . . . . . . . . . . . . . . . . . . . . . . 5-129

200154-101—November 2004
Operating Instructions Section 5
QC SUMMARY Screen . . . . . . . . . . . . . . . . . . . . . . . . 5-131

Selecting Date Range . . . . . . . . . . . . . . . . . . . . . . 5-133
Deselecting Previously Stored Date Range . . . . . 5-133
Accessing the Levey-Jennings Graph Screen
from the QC SUMMARY Screen . . . . . . . . . . . . 5-134
Levey-Jennings Graph Screen . . . . . . . . . . . . . . . . . . . 5-135
Levey-Jennings Details . . . . . . . . . . . . . . . . . . . . 5-138
QC Data List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-143
Deleting QC Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-145
Printing QC Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-146
Levey-Jennings Graph Report . . . . . . . . . . . . . . . . . . 5-147
QC Data List Report . . . . . . . . . . . . . . . . . . . . . . . . . . 5-150
QC Summary Report . . . . . . . . . . . . . . . . . . . . . . . . . 5-153
Exporting QC Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-155
QC SUMMARY Screen . . . . . . . . . . . . . . . . . . . . . . . . 5-155
Levey-Jennings Graph Screen . . . . . . . . . . . . . . . . . . . 5-158
Westgard QC Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-161
Unloading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-163
Samples and Sample Carriers . . . . . . . . . . . . . . . . . . . . . . 5-163
Reagent Cartridges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-164

200154-101—November 2004
Section 5: Operating Instructions
General Operational Utilities
Overview
This subsection provides information on the general
operational utilities of the AEROSET System, which includes:
• Power ON
• Log On
• PAUSE
• UNPAUSE
• START UP and SHUTDOWN
• Log Off
• Power OFF
• RUN
• STOP

200154-101—November 2004
General Operational Utilities Section 5
Power ON
The AEROSET System has two power switches, the Main
Circuit Breaker Switch and Rotary Power Control Switch.
• The Main Circuit Breaker Switch is located on the
rear-right panel of the analyzer. This power switch is ON
in the UP position and OFF in the DOWN position.
Main Circuit
Breaker Switch
125932a
Figure 5.1: Main Circuit Breaker Switch (Rear of Analyzer)
• The Rotary Power Control Switch is located on the

left-side panel of the analyzer. It has three positions.
Position Description
OFF Power is supplied only to the Reagent
Supply Center cooling units by the
Main Circuit Breaker Switch.
AUTO Power is supplied to the entire system.
When set to AUTO, the system
automatically powers ON, performs
START UP and SHUTDOWN, and
powers OFF at configured times.
ON Power is supplied to the entire system.

200154-101—November 2004
Section 5 General Operational Utilities
Rotary Power
Switch
125931a
Figure 5.2: Rotary Power Switch (Left-side Panel)
Use the following instructions to power ON the AEROSET

System.
1. Move the Main Circuit Breaker Switch to the UP (ON)
position.
2. Turn the Rotary Power Control Switch to the ON position.
A blank screen displays on the System Control Center
(SCC) Touchscreen and the operating system is
initialized. The AEROSET System software initializes and
the Log On screen displays when initialization is
complete.
NOTE: If an error occurs during initialization, the
error message displays on the screen. Refer to
Section 10, Troubleshooting and Diagnostics for
instructions.
After Log On, the Main Display appears on the SCC
Touchscreen.
NOTE: It may take several minutes for the Main
Display to appear.

200154-101—November 2004
Log On
The Log On screen displays after the Power ON Procedure is
complete or when the Exit icon in the Action Area of the Main
Display is selected.
1. Type the user code.

NOTE: Do not press [Enter] after typing the user
code.
2. Press [Tab] on the keyboard.
3. Type the password.
NOTE: Both fields are case sensitive.
4. Press [Enter].
When Log On is complete, the DATABASE screen displays.

NOTE: Refer to Configure Log On Password in
Section 2, Installation Procedures and Special Requirements
for details on user codes and password creation.

200154-101—November 2004
PAUSE
The PAUSE function allows the operator to interrupt sampling
during RUN status. During PAUSE status the system stops
pipetting new samples and Reagent Supply Center 1 reagents,
but continues to process samples already pipetted.
Pause the AEROSET System when loading:
• Additional samples on the Sample Carousel
• Calibrators or controls on the Calibrator/Control Carousel
• Reagents in Reagent Supply Center 1
NOTE: <RGT SCAN> is not available when the
instrument is in PAUSE status.
In addition, the PAUSE function is used when loading samples
on the FastTrack™ Sampler when the system status is
SAMPLING END.
1. Select <PAUSE> in the Action Area of the Main Display.
The RUN OPTIONS screen displays.
2. Select <Pause> in the right column of the screen to pause

sampling.
! dispensed, the sample and R1 reagent arms may
move after the status has changed to PAUSE. Wait
25 seconds before accessing the Sample Carousel
and Reagent Supply Center 1 areas.

200154-101—November 2004
WARNING: The AEROSET System does not stop

! movement of the Reagent 2 probes, ICT™ unit,
mixers, or cuvette washers so Assay Read Times are
not affected.
CAUTION: The system completes dispensing and
! mixing of any sample and reagent already
aspirated. Confirm the PAUSE status in the system
Status Area and confirm the R1 Indicator on the
Local User Interface (LUI) Control Panel is
illuminated before proceeding.

200154-101—November 2004
UNPAUSE
The UNPAUSE function resumes pipetting operation after a
PAUSE.
1. Select <UNPAUSE> in the Action Area of the Main
Display. The RUN OPTIONS screen displays.
2. Select <Unpause> in the right column of the screen to

UNPAUSE and resume sampling.

200154-101—November 2004
START UP and SHUTDOWN

START UP and SHUTDOWN Procedures are performed daily.
The system can be configured to automatically perform START
UP and SHUTDOWN Procedures at a defined time of day.
The following table lists available options on the START UP
OPTIONS and SHUTDOWN OPTIONS screens.
Option Description Screen
1 Change Water In Bath START UP or
SHUTDOWN
2 Wash Cuvettes START UP or
SHUTDOWN
3 Fill with Dtg (not currently used) SHUTDOWN
only
4 Wash Probes with: START UP or
• Water SHUTDOWN
• 1% alkaline wash solution
NOTE: The mixers are also
washed.
5 Wash ICT™ with: START UP or
• ICT cleaning fluid SHUTDOWN
• ICT reference solution
6 Drain & Fill IRef Cup START UP or
SHUTDOWN
7 Flush Water Lines START UP only
8 Clear Database SHUTDOWN
• Cal, QC only
• Patients
• All Records
• Cal, QC, QCAvg
• Patients, QCAvg
• All Rec, QCAvg
START UP and SHUTDOWN Procedures should be scheduled
based on instrument usage. Refer to Daily Checks in Section 9,
Service and Maintenance for details on START UP and
SHUTDOWN Procedures.

200154-101—November 2004
NOTE: The QCAvg option is not active in the AEROSET

System. Refer to the following table for an explanation
of Clear Database options.
Option Description
Cal, QC Deletes Cal/QC records from the database
and converts patient records to preserved
samples. The text color on the DATABASE
screen for these samples is green.
Patients Deletes Cal/QC records and any patient
records that are not preserved from the
database.
All Records Deletes all records from the database,
including preserved samples.
Cal, QC, QCAvg Deletes Cal/QC records from the database
and converts patient records to preserved
samples. The text color on the DATABASE
screen for these samples is green.
Patients, QCAvg Deletes Cal/QC records and any patient
records that are not preserved from the
database.
All Rec, QCAvg Deletes all records from the database,
including preserved samples.

200154-101—November 2004
Log Off
The operator must Log Off the system to allow another
operator to Log On.
1. Close or exit any open screens.
2. Select the Exit icon in the Action Area of the Main
Display. The EXIT dialog window displays.
Figure 5.6: EXIT Dialog Window
4. The system is ready for the new operator to perform the

Log On Procedure.

200154-101—November 2004
Power OFF
The Power OFF Procedure allows the system to perform
software shutdown before turning the power OFF.
1. Close or exit any open screens.
2. Select the Exit icon in the Action Area of the Main
Display. The EXIT dialog window displays.
Figure 5.8: EXIT Dialog Window
4. Type bye in the User Code field.

5. Press [Enter] on the keyboard. The following messages
display:
• “Starting System Power OFF Procedure”
• “Shutdown will be completed in 10 sec”
• “Shutdown procedure in process”
• “Please, Power OFF!”

200154-101—November 2004
Rotary Power Control

Action
Switch Setting
AUTO When the power OFF sequence is
complete, power is automatically
disconnected from the analyzer
and SCC components without
further operator intervention.
However, the Main Circuit Breaker
Switch remains ON unless it is
manually moved to the OFF
position.
ON Turn the switch to the OFF
position to complete the power
OFF sequence.
WARNING: Power is still supplied to the refrigerated

compartments on the AEROSET System.
6. To completely power OFF the system, turn the Main
Circuit Breaker Switch to the OFF position. Refer to
Figure 5.1 in this section for an illustration of the Main
Circuit Breaker Switch.

200154-101—November 2004
Run
Select <RUN> in the Action Area of the Main Display to
initiate sample processing.
1. Ensure all controls, calibrators, and patient samples, as
appropriate, are loaded according to the DATABASE
screen, CALIBRATOR/CONTROL screen, or printed
Loadlist. Refer to Appendix B, AEROSET System Printed
Reports.
RUN OPTIONS screen displays. Select the desired options.
3. Select <Start> in the upper-right corner of the RUN
OPTIONS screen to initiate sample processing.
NOTE: Assays with green button text meet all required
conditions. If button text is pink or yellow, further
investigation is necessary before performing the assay.
Refer to Confirmation of Assay Parameter Settings in
Section 2, Installation Procedures and Special Requirements
Stop
To completely stop a run, select <STOP> in the Action Area of
the Main Display. When selected, all movement and
processing cease. Any samples in progress are not completed
and remain pending. When the run is reinitiated by selecting
<RUN>, these samples are repipetted.
WARNING: The system attempts to home all robotics
! before movement stops. Confirm the READY status in
the System Status Area before proceeding. Refer to
Emergency SHUTDOWN Procedure in Section 8,
Hazards.

200154-101—November 2004
NOTES

200154-101—November 2004
Inventory
This section provides information for checking and loading

onboard reagents and solutions on the AEROSET System.
CAUTION: Before system set-up, perform system
! maintenance to ensure accurate test results. Refer to
Section 9, Service and Maintenance for detailed
information about maintenance procedures and
schedules. Check expiration dates before adding
onboard supplies. Do not use expired supplies.
To avoid delays and error messages during operation, verify
there is adequate inventory of all onboard bulk solutions and
reagents.
NOTE: Warnings and cautions placed before procedural
text are reminders, and are not intended to be complete
explanations of system hazards. Before performing any
procedure, carefully read the warnings and cautions
associated with that procedure. Refer to Section 7,
Operational Precautions and Limitations and Section 8,
Hazards for additional information.

The volume remaining in onboard reagent cartridges can be
viewed by selecting <Reagents> in the Information Access
Area of the Main Display. The status of reagents, diluted wash
solutions, water bath additive, and ICT™ sample diluent can
be viewed and verified using these screens.

200154-101—November 2004
Inventory Section 5
The operator can select the segment where the reagent is

located to review the remaining reagent volume, by both
number of remaining tests and %volume.
NOTE: The “remaining volume” field displays NLLS
(no liquid level sense) for a new reagent cartridge. The
volume updates when the reagent probe senses fluid in
the cartridge at first use. Refer to Load Reagents in this
section for additional information about loading new
reagent cartridges.
NOTE: When a reagent cartridge is configured for two
different assays, the number of tests is divided by two
and that volume displays for each assay. For example,
assays with both a serum and urine application,
e.g., urine Glucose and serum Glucose, both use the
same reagent cartridge but have different assay
numbers. The total number of tests is divided by two,
half for the serum assay and half for the urine assay.

200154-101—November 2004
Section 5 Inventory
Reagent View
The View page of the REAGENTS screen displays when
<Reagents> is selected in the Information Access Area of the
Main Display.
The View page displays the reagents loaded in all sections of

both Reagent Supply Centers and estimated number of
remaining tests in each. An example of one reagent is shown.
Estimated Remaining
Tests
Reagent Supply
Center Position
Reagent
Name
The color of the number in the “remaining tests” field
indicates the status of the reagent.
• Green—the volume is sufficient.
• Pink—the expiration date was exceeded.
• Red—the reagent is empty.
• Brown—the volume is below the configured Reagent Low
(Rgt Lo) Alert level.
• Black—NLLS (no liquid level sense).

200154-101—November 2004
Inventory Section 5
When <Report> is selected on the REAGENTS screen, a

complete inventory of onboard reagents displays on the
Reagent Report screen.
Figure 5.11: Reagent Report Screen
The Reagent Report screen can be sorted by the following

options:
• Position
• Reagent Name
• Reagent Type
• Expiration Date
• Remaining (%)
The following information displays on the Reagent Report
screen.
Reagent Report Screen

Column Description
Pos Reagent segment and position
* Active reagent
Name Reagent name
Type R1, R2, additive, diluent, acid, or alkaline
wash

200154-101—November 2004
Section 5 Inventory
Reagent Report Screen (Continued)

Column Description
Exp Date Expiration date
* Past expiration date
Lot Lot number
Ctg Reagent cartridge number
%Volume Alert Reagent low alert by %volume
* Reagent is lower than the configured alert
Remaining Rgt Estimated remaining reagent volume by
(%) %volume
* Empty after level sense
Remaining Estimated remaining reagent volume by
Tests # number of tests
M Indicates the reagent was manually
configured
Perform the following steps to print a Reagent report.

1. Select the desired sort option in the drop-down list box on
the Reagent Report screen. Select the return arrow to
close the list.
2. Select <Print>. The REAGENTS dialog window displays.
3. Select <OK> to print the report.

200154-101—November 2004
Inventory Section 5
Reagent Details
Other Reagent Segment tabs on the REAGENTS screen can be
selected to view additional details of each Reagent Supply
Center segment. An example of one reagent position is shown.
Reagent In-use Indicator
(Green line = reagent cartridge currently in use)
Estimated Remaining Volume (%Volume)
Estimated Remaining Volume (Number of Tests)
Reagent Supply Center Position
Reagent Name
(Brown Text = Bar Coded
Black Text = Manually Configured)
The remaining reagent volume is indicated in %volume and

by a colored bar. The color of the bar indicates the same
reagent status described in preceding subsection, Reagent
View.
NOTE: The “remaining volume” field displays NLLS
(no liquid level sense) for a new reagent cartridge. The
volume updates when the reagent probe senses fluid in
the cartridge at first use and with each aspiration. Refer
to Load Reagents in this section for additional
information about loading new reagent cartridges.
The color of the reagent name indicates whether the reagent
was manually configured (black) or scanned by the Reagent
Supply Center bar code reader (brown).

200154-101—November 2004
Section 5 Inventory
Check Reagent Inventory

Display to update the status of the reagent inventory.
NOTE: Inventory status only updates for Abbott
bar code labeled reagents.
NOTE: If any reagent configuration is edited and
saved after the reagent scan is complete, this
reagent becomes manually configured. Refer to
Load Reagents in this section for details.
3. Review all reagent volumes. Verify positions for the

reagent cartridges without bar code labels.

200154-101—November 2004
Inventory Section 5
4. Replace any reagent with insufficient volume.

NOTE: If the Reagent Link option is ON, the
linked R1/R2 cartridge pair must be replaced at the
same time.
CAUTION: When either the final remaining R1 or
! R2 reagent cartridge becomes empty, the assay
button text turns pink if the Multiple Rgt Ctgs
option is OFF, and/or the Reagent Link option is
ON; the button turns black if the Multiple Rgt Ctgs
option is ON. Refer to Load Reagents in this
If the Reagent Link option is ON and a cartridge in
the lowest position becomes empty, the assay
button text turns yellow after performing a
reagent scan. This indicates a cartridge with a
volume below the alert level is in use.
5. For details on each Reagent Supply Center segment, select
the appropriate Reagent Segment tab. The selected
Reagent Segment page displays.
Figure 5.13: REAGENTS Screen, R1-A Page
6. When a manually configured reagent becomes empty,

select the reagent-specific Position button, then select
<New Ctg> on the Position dialog window. The Reset
Reagent Volume dialog window displays.

200154-101—November 2004
Section 5 Inventory
7. Select <OK>. Select <OK> in the upper-right corner of the

Position dialog window. The Save Reagent dialog
window displays.
8. Select <OK> to save the changes.
9. If desired, select <Report> then <Print> to print the
Reagent report. Refer to Appendix B, AEROSET System
Printed Reports for an example of this report.
10. When all reagent cartridges have been reviewed, select
<OK> in the upper-right corner of the screen.

200154-101—November 2004
Inventory Section 5
Load Reagents
Rules for loading reagent cartridges:
• R1 reagents must always reside in Reagent Supply
Center 1.
• R2 reagents must always reside in Reagent Supply
Center 2.
• AEROSET System assays are divided into two distinct
categories (A-Line and B-Line) to allow the system to
process tests at the fastest possible throughput.
– A-Line Tests—reagents always reside in segments A, B,
or C.
– B-Line Tests—reagents always reside in segment D.
• New cartridges should always be loaded in a higher
numbered position than cartridges of the same reagent
already onboard. The system always aspirates first from
the cartridge in the lowest numbered position.
• For assays using two reagent cartridges, the R1/R2 pair
must be placed onboard at the same time. Refer to the
assay-specific package inserts for specific reagent handling
instructions.
• After loading reagents, a reagent scan must be performed
to update the inventory.
CAUTION: With the Reagent Link option ON

! (enabled), the system always aspirates first from the
cartridge in the lowest numbered position. The system
does this even if the cartridge has zero tests remaining
and previously generated the Error Log Message
“Transfer to New Cartridge”. Failure to remove empty
(zero remaining tests) cartridges before performing a
reagent scan may cause erroneous results.

200154-101—November 2004
Section 5 Inventory
C
D C
B A
B A
Shaded = A-Line (Outer)
Unshaded = B-Line (Inner)
Figure 5.14: Location of A-Line and B-Line on the Reagent

Supply Centers
Use the following instructions to load reagent cartridges.

1. Reagents can be loaded on the system when the status is
READY or PAUSE. If the system is in any other state, select
<PAUSE> in the Action Area of the Main Display. The
sampling.
NOTE: Pausing the system only allows access to
Reagent Supply Center 1. The system status must
be READY to gain access to both Reagent Supply
Centers. A reagent scan must be performed to
update reagent inventory. Reagent scan can only
be performed when the system status is READY.
Observe the R1 and R2 Indicators on the Local User
Interface Control Panel before accessing any reagent
position. A green light indicates access is permitted.

200154-101—November 2004
Inventory Section 5
3. Remove the Reagent Supply Center cover and use the

following table to determine the loading position.
NOTE: Unit Configuration parameters were
previously established by an Abbott
Representative, and can only be edited by an
Abbott Representative.
Unit
Configuration Description of Parameter Rules for Loading Reagents: If Parameter Is...
Parameter
ON OFF ON OFF
Priority on Rgt When a reagent scan When a reagent scan Place reagents with Place reagents with bar
Bar Code is performed, bar code is performed, bar code labels in any code labels in any open
labeled reagents manually defined open position of the position of the
overwrite (e.g., have reagents have priority appropriate segment. appropriate segment.
priority over) over bar code labeled Place reagents without Place reagents without
manually defined reagents. bar code labels in bar code labels in
reagents configured manually defined manually defined
for the same position. segment positions. segment positions.
NOTE: If any To manually delete the
reagent reagent information,
configuration select <Clear> on the
is edited and Reagent Specific
saved after the Position dialog window.
reagent scan is When <Clear> is
complete, this selected, reagent type
reagent and cartridge size
becomes defaults display.
manually CAUTION: If a
configured.
For example,
! different reagent
is loaded in a
if the reagent position
expiration previously
date was configured with
edited to a manually
reflect defined reagent,
onboard the manual entry
stability, this must be deleted
manual before
configuration performing a
will be reagent scan.
overwritten Failure to
by a bar coded comply could
reagent each lead to erroneous
time a reagent results.
scan is
performed.

200154-101—November 2004
Section 5 Inventory
Unit
Parameter
ON OFF ON OFF
Multiple Rgt Allows for multiple A maximum of two If two or more New reagent cartridges
Ctgs (e.g., more than two) reagent cartridges with the should be placed in a
reagent cartridges per cartridges/pairs per same reagent name higher numbered
assay to be placed on assay will be used by are loaded in a position than cartridges
the system. the system. Reagent Supply already onboard. A
NOTE: If the Center at the same maximum of two
Multiple Rgt time, new cartridges reagent cartridges/pairs
Ctgs option is must be loaded in a per assay are utilized by
configured higher numbered the system.
ON, the position than the
Reagent Link cartridges already
option is not onboard. The system
functional— first aspirates from the
i.e., R1 and R2 cartridge in the lowest
cartridges are number position. An
not linked. Error Log Message is
generated each time a
cartridge is empty and
the system transfers to
the next cartridge. For
assays using two
reagent cartridges, the
R1/R2 pair must be
placed onboard at the
same time.

200154-101—November 2004
Inventory Section 5
Unit
Parameter
ON OFF ON OFF
Reagent Link Allows the R1 and R2 R1 and R2 cartridges The linked reagent New reagent cartridges
reagent pair to be are not linked. R1 and pair (R1/R2) to be should be placed in a
linked by position. A R2 are utilized used first must be higher numbered
maximum of two sets independently. placed in the lowest position than cartridges
of reagent cartridges available position. already onboard. R1 and
per assay are allowed. After the reagent pair R2 are utilized
The lowest R1 is linked by the independently.
position is linked to system, the operator
the lowest R2 position must verify it is
and the highest R1 always utilized as a
position is linked to pair.
highest R2 position. CAUTION:
Each time a reagent
scan is performed, the
! The R1/R2
pair must be
system relinks placed
reagents according to onboard at the
position, and same time.
aspirates first from the CAUTION:
cartridge pair in the
lowest numbered
! After a reagent
scan, the
position (even if a system
cartridge has zero aspirates first
remaining tests). from the
NOTE: If the cartridge pair
Multiple Rgt in the lowest
Ctgs option is numbered
configured position, even
ON, the if it has zero
Reagent Link remaining
option is not tests. Failure
functional— to remove
i.e., R1 and R2 empty (zero
cartridges are tests)
not linked. cartridges
before
performing a
reagent scan
may cause
erroneous
results.

200154-101—November 2004
Section 5 Inventory
4. Gently invert the reagent to ensure a homogenous

solution then remove the cap.
NOTE: Most reagents require inversion; however,
it is recommended that the assay-specific package
inserts be reviewed for special handling
requirements.
5. Remove air bubbles, if present, with a new applicator stick.
Alternatively, allow the reagent to sit at the appropriate
storage temperature until bubbles dissipate. To minimize
volume depletion, do not use a transfer pipette to remove
the bubbles.
CAUTION: Reagent bubbles may interfere with
! proper detection of reagent level in the cartridge,
causing insufficient reagent aspiration which
could impact results.
6. The reagent cartridge is triangle-shaped to match
positions in the segments. Align the cartridge with the
position and load the reagent cartridge. Seat the cartridge
completely.
NOTE: The small reagent cartridge and 20 mL
reagent cartridge require the use of an adapter.
Load the adapter first, ensuring proper alignment.
Insert the cartridge in the adapter and seat the
cartridge completely. When loading a 20 mL
reagent cartridge, face the bar code label toward
the outside of the Reagent Supply Center. Ensure
the reagent cartridge is completely seated in the
adapter.
7. Replace the Reagent Supply Center cover. Verify the cover
is seated by attempting to move it left or right. The cover
does not rotate when seated properly.

200154-101—November 2004
Inventory Section 5

Display to update the reagent status.
NOTE: Reagent information only updates for bar
code labeled Abbott reagents. Non-Abbott reagent
information must be manually entered and
verified. Refer to Reagent Configuration in
Section 2, Installation Procedures and Special
Requirements for details.
9. The expiration date of reagents (bar code scanned and
manually configured reagents) is checked when the
system is powered ON, a reagent scan is performed, and
the system date changes. Reagent expiration dates are
monitored by date, so a reagent expires at midnight on the
date of expiration.
NOTE: The expiration date must be configured to
generate an expired (EXP) Result Error Code and
Error Log Message.

200154-101—November 2004
Section 5 Inventory
Bulk Solution Inventory

Volumes of ICT™ reference solution, alkaline wash solution,
and acid wash solution are verified by individual weight
sensors.
Bulk solution volumes display on the START UP OPTIONS,
SHUTDOWN OPTIONS, and RUN OPTIONS screens. The
volume can also be checked by inspecting the bottles in the
bulk solution area behind the front-right door of the analyzer.
1. Select <START UP> in the Action Area of the Main
Display. The START UP OPTIONS screen displays.
Bulk
Solution
Volumes
Figure 5.15: START UP OPTIONS Screen
2. Check the bulk solution status.
1
2
3
Figure 5.16: Bulk Solution Volumes

200154-101—November 2004
Inventory Section 5
The following table identifies solutions in positions 1

to 3. These solutions are located on the weight platforms
behind the front-right door of the analyzer and the
volume is indicated by the color of the position. Each
color indicates a different status.
• Green—the volume is sufficient.
• Red—the volume is insufficient. The approximate
volume remaining in each bottle is:
IRef 140 mL
AlkW 64 mL
AcidW 64 mL
Bulk Solutions
Position Definition
1 ICT™ reference solution
2 Alkaline wash solution
3 Acid wash solution
NOTE: Since the indicators for solutions on the

weight scales do not display remaining volume, a
visual check of the bottles is recommended.
3. Visually inspect the bulk solution bottles and verify the
following conditions exist:
• Remaining volume is sufficient
• Area is clean and free of debris
• Bottles are seated properly
• Upward movement of the wash solution trays is not
restricted
4. While the system status is READY, verify the function of
the tray sensor by removing the ICT reference solution
bottle. Ensure the Error Log Message “88 - Inventory
Empty, ICT Reference Solution” is generated.
5. If the volume of any solution is insufficient, replace the
solution.

200154-101—November 2004
Section 5 Inventory
Alkaline and Acid Wash Solution Loading

CAUTION: Chemical Hazard. Refer to Section 8,
! Hazards. Also refer to product-specific Material Safety
Data Sheets (MSDS).
NOTE: Wash solutions should not be changed when
the system status is RUN, PAUSE, or SAMPLING END;
the system is using the wash solutions at these times.
NOTE: If the “86 - Inventory Empty, Alkaline Wash” or
“87 - Inventory Empty, Acid Wash” Error Log Message
is generated during a run, the system automatically
switches to PAUSE status. No additional samples are
aspirated, but samples already dispensed continue to
process. When the progress bar (in the lower-left area of
the screen) indicates all samples have been processed,
select <STOP> to change the status to READY.
1. Ensure the system status is READY.

2. Open the front-right door of the analyzer.
3. Remove the used wash solution bottle.
4. Remove the cap and tubing from the used bottle.
5. Remove the cap from the new wash solution bottle.
6. Insert the tubing in the new bottle and seat the cap on the
bottle opening. Firmly press down on the cap to secure it
on the opening.
NOTE: Ensure the cap covers the threads on the
neck of the bottle, and the tubing is inserted to
reach the bottom of the bottle.
7. Place the bottle securely on the tray.
8. Close the front-right door of the analyzer.
9. Perform the Wash Cuvettes option of the START UP
Procedure.

200154-101—November 2004
Inventory Section 5
ICT™ Reference Solution Loading

CAUTION: ICT reference solution should not be
! changed when the system status is RUN, PAUSE, or
SAMPLING END; the system is using the solution at
these times and sample results could be affected.
NOTE: If the “88 - Inventory Empty, ICT Reference
Solution” Error Log Message is generated during a run,
the system automatically switches to PAUSE status. No
additional samples are aspirated but samples already
dispensed continue to process. The operator can:
• Allow these samples to complete.
• Select <STOP> to change the system status to
READY.
• Select <UNPAUSE> to continue sample aspiration
of photometric assays only.
ICT results completed after the Error Log Message is
generated should be rerun.
NOTE: Refer to Error Log Messages—Supplemental
Information in Section 10, Troubleshooting and
Diagnostics for details on initial recovery from Error Log
Message 88.
1. Ensure the system status is READY.
2. Open the front-right door of the analyzer.
3. Remove the used ICT reference solution bottle from the
tray.
4. Remove the reference pump tubing and associated cap
from the used bottle.
5. Prepare the new ICT reference solution by removing the
shipping cap from the bottle.
6. Insert the ICT reference pump tubing in the new bottle
and seat the cap on the bottle opening. Firmly press down
on the cap to secure it on the opening.
NOTE: Ensure the cap covers the ICT reference
solution bottle threads on the neck of the bottle,
and the tubing is inserted to reach the bottom of
the bottle.
CAUTION: Failure to comply could cause
! aspiration of air and erroneous results.

200154-101—November 2004
Section 5 Inventory
7. Place the bottle securely on the tray. Verify the following

conditions exist:
• Area is clean and free of debris
• Bottles are seated properly
• Upward movement of the wash solution tray is not
restricted
8. Close the front-right door of the analyzer.
9. Select <START UP> in the Action Area of the Main
Display. The START UP OPTIONS screen displays.
10. Select the checkbox (聺) next to the Wash ICT™ with IRef
and Drain & Fill IRef Cup options. Ensure all other
options are deselected (□).
11. Select <Start> in the upper-right corner of the START UP
OPTIONS screen to begin the procedure.
12. When START UP is complete, perform an ICT calibration
and run all levels of QC.

200154-101—November 2004
Inventory Section 5
NOTES

200154-101—November 2004
Ordering and Running Tests
Ordering Patient Samples on the FastTrack™ Sampler

Main Display if the DATABASE screen is not currently
displayed.
Figure 5.17: DATABASE Screen
2. Select <Order> in the right column of the screen. If a

pending order already exists and is highlighted, the Order
Samples dialog window displays.
Figure 5.18: Order Samples Dialog Window
3. Select <New>. The Order Samples screen displays.

NOTE: If an order does not already exist, the
Order Samples screen displays when <Order> is
selected.

200154-101—November 2004
Ordering and Running Tests Section 5
4. Enter the patient sample information.
Field Description
Sample ID The Sample ID field accommodates up to
20 alphanumeric characters.
CAUTION: The sample ID must
! be entered to ensure proper
identification.
Name (L/F) The Last Name field accommodates up
to 20 alphanumeric characters, and the
First Name field up to 10.
C/P C/P is a required field for non-bar code
labeled samples.
NOTE: Information required in
this field when ordering samples
on the Sample Carousel is
described in the following
subsection, Ordering Patient
Samples on the Sample
Carousel.
Order D/T The current date and time automatically
display.

200154-101—November 2004
Section 5 Ordering and Running Tests
5. Select the assays or panels to run. The first two rows of

buttons display the panels configured in the system. If
more panels are configured than can display, select the up
and down arrow buttons on the screen to view additional
panels (up to 100).
NOTE: Assays with green button text meet all
required conditions. If button text is pink or
yellow, further investigation is necessary before
performing the assay. Refer to Confirmation of
Assay Parameter Settings in Section 2, Installation
Procedures and Special Requirements for additional
information.
6. Select <New> in the right column of the Order Samples
screen to save the order and continue to the next patient
sample order.
7. Repeat steps 4 through 6 for all patient samples to be
ordered.
8. When ordering is complete, select <OK> in the
upper-right corner of the Order Samples screen.

200154-101—November 2004
Sample Order Options

Ordering Patient Samples on the Sample Carousel
displayed.
2. Determine which available Sample Carousel carrier and

position will be used for the sample to be run.
NOTE: If no carrier/positions are available,
highlight the sample(s) occupying the position(s)
to be used, and delete those samples.

200154-101—November 2004
3. Select <Order> in the right column of the DATABASE

screen. The Order Samples screen displays.
4. Enter the sample ID (required) and name.

5. For the position where the sample will be placed, enter the
carrier number (required) and position number (required)
in the C/P field. The carrier number is defined on the RUN
OPTIONS screen for each section of the Sample Carousel.
Example: For a sample placed in section E/position 1 of
the Sample Carousel, the operator should enter 5000 in
the C (Carrier) field and 1 in the P (Position) field.
6. Select the assay(s) and/or panel(s) be run on the sample.
information.

200154-101—November 2004
7. Select <New> to order more patient samples or <OK>

when ordering is complete.
CAUTION: New sample orders can only be placed
! in the sample locations deleted in step 2. Failure to
comply with these instructions will result in a
sample acquiring the sample ID and test request(s)
from the sample previously stored in the database
for that carrier number and position.
8. Repeat steps 1 through 7 for each new sample loaded in
the Sample Carousel.
Additional Options on the Order Samples Screen
Sample Replicates
Enter the number of desired replicates in the Replicates field.
Up to five replicates can be entered.
Example: If three replicates are entered, the system dispenses
and analyzes each selected assay three times.

200154-101—November 2004
Manual Dilution
Enter a multiplier in the Manual Dil field if an offline dilution
was performed. The multiplier is used to correct the final result
for all assays ordered, both photometric and potentiometric.
Example: If a 1:5 dilution was performed, enter 5 in this field.
The system multiplies the final result by 5 to correct for the
dilution.
Onboard Dilution
The measurement type for each assay can be selected.
The options are:
Option Description
Standard The default dilution configured
Dil 1 Dilution option 1
Dil 2 Dilution option 2
NOTE: Refer to Section 2, Installation Procedures and

Special Requirements for details on configuring dilution
options.
To define the measurement type for each assay, first select the
type, then select the assay button. The measurement type
displays as a colored line on the assay button.
NOTE: The AEROSET System does not perform onboard
dilutions of samples for ICT™ assays. Therefore, if an
option is selected, the underline remains green.
Option Line Color

Standard Green
Dil 1 Blue
Dil 2 Yellow
CAUTION: The operator must verify the correct

! dilution is selected for each assay on each patient
sample order entered manually. Failure to verify
dilution could affect patient results.
NOTE: If Dil 1 or Dil 2 is selected for HIL, the underline
remains green. However, if the Dil 1 or Dil 2 option is
selected for the HIL reference assay, the selected index
assay has a blue or yellow underline as appropriate.

200154-101—November 2004
Patient Demographics
On the Order Samples screen, additional patient information
can be entered by selecting <Demog> in the upper-right
corner above the panel buttons. The Patient Demographics
Figure 5.23: Patient Demographics Dialog Window
The following parameters are configured on the Patient

Demographics dialog window.
Field Description
Patient ID Enter up to 20 alphanumeric characters.
Sex Select from Unknown, Male, or Female in the
drop-down list box.
Age (yyy mm) Up to 3 digits are allowed for the year; up to
2 digits are allowed for the month.
Birthdate Four digits are required for the year; up to
2 digits are allowed for the month and day.
Doctor A maximum of 20 alphanumeric characters
can be entered, or a selection can be made
from the drop-down list box. Up to 32 entries
can be added to the list to display in the
Location drop-down list box.
• To add an entry to the list, select <Add>.
• To remove an option from the list, select
Comment the option in the list, then select <Delete>.
NOTE: For the age/gender specific ranges to generate

an “L” or “H” Result Flag, both the age and gender of
the sample must be configured on the Patient
Demographics dialog window.

200154-101—November 2004
Batch Ordering
The Batch Ordering option is used when the same assays are
ordered for more than one sample.
NOTE: Before defining the Batch Ordering option,
verify that sequentially numbered carrier/positions are
available for the number of samples in the batch.
1. Enter the first patient sample order.
2. Select <Copy> in the right column of the Order Samples
screen. The Copy Order dialog window displays.
Figure 5.24: Copy Order Dialog Window
3. Enter the number of additional samples in the batch then

select <OK>. The order is copied for the defined number of
samples. The patient name and demographic information
are not copied. The C/P automatically increments. The
sample ID automatically increments only if defined with
numeric format on the SYSTEM CONFIGURATION
screen.
NOTE: When using the Batch Ordering option on
the Sample Carousel, ensure the configured carrier
positions on the RUN OPTIONS screen match
those of the automatically incremented samples.
NOTE: Refer to AEROSET System Configuration
in Section 2, Installation Procedures and Special
Requirements for details on configuring sample ID
format.
4. When ordering is complete, select <OK> in the
upper-right corner of the Order Samples screen.

200154-101—November 2004
Printing the Loadlist

When ordering is complete, the patient samples display on the
DATABASE screen. Use the following instructions to print a
Loadlist report.
1. Select all samples to be printed. To highlight multiple
samples, select the first sample in the list then highlight
the remaining samples by holding [Shift] and pressing
[앗] on the keyboard.
2. Select <Print> in the right column of the DATABASE
screen. The Print Options dialog window displays.
3. Select <Loadlist>. The Loadlist dialog window displays.
Figure 5.26: Loadlist Dialog Window
4. Select <OK>.
NOTE: On the Print Options dialog window, the
Loadlist option prints only sample information and
positions. The Order List option prints sample
information, positions, and assays ordered.

200154-101—November 2004
Patient Sample Requirements

This subsection describes procedures used to prepare and load
patient samples.
Sample Vessel Requirements

The following vessels are acceptable for use on the AEROSET
System.
• AEROSET System sample cups
• AEROSET System sample cups used with sample tubes
• Open aliquot and primary sample tubes
Refer to the following table to determine acceptable aliquot
and primary sample tubes for use on the AEROSET System
Minimum Inside Outside Diameter Height

Tube Volume
Diameter (mm) Limits (mm) (mm)
10 mL (16 mm) 15.0 to 16.0
10.2 99 to 101
7 mL (13 mm) * 12.2 to 12.9
7 mL (16 mm) 15.0 to 16.0
9.8 74 to 76
5 mL (13 mm) * 11.8 to 12.9
* Adapter required
NOTE: Use of serum filters in sample tubes is

acceptable if the opening (inside diameter) and height
of the filter meet sample tube specifications.

200154-101—November 2004
Sample Volume
Sample cups are used to load calibrators, controls, and patient
samples on the AEROSET System. They can be placed on the
Calibrator/Control Carousel, Sample Carousel, Reserved STAT
position, and sample carriers. Volume graduation lines at 1 mL
and 2 mL are useful when filling sample cups, eliminating
need for precision pipetting.
requirements.
NOTE: Cup/tube adapters are required when loading
sample cups in all positions except those on the
When using primary tubes, verify there is sufficient sample
volume for the assays to be measured, plus ½ inch (13 mm)
sample above the clot, gel separator, or plasma/red cell
interface. If the specimen volume is less than ½ inch (13 mm),
transfer the specimen into a sample cup.
½ inch
Sample (13 mm)
Top of clot, gel, or of sample
plasma/red cell
interface

200154-101—November 2004
The following table lists the minimum sample volume

required in a sample cup. Minimum volume required is
dependent on the largest possible aspiration volume of an
assay pair ordered on the sample.
Largest assay pair volume = Largest defined assay volume
ordered on the A-Line + Largest defined assay volume ordered
on the B-Line.
Largest Assay
Pair Volume
2 to 40 µL 60 µL + combined sample volumes of all
assays ordered
41 to 70 µL * 166 µL + combined sample volumes of
all assays ordered
* All Abbott assay applications for the AEROSET System have a

defined sample volume of 20 µL or less. This volume
requirement only applies if non-Abbott assay applications are
defined with a sample volume greater than 20 µL.
Example: With Sample Saving mode ON, the minimum
sample required for a panel including the following assays
(Urea, Crea, Glu, Na, K, Cl, CO2) is:
NOTE: Sample volumes can be approximated by using
the guidelines provided; however, certain conditions
require additional volume. For tests with onboard
dilutions or sample volumes exceeding 15 µL, an
additional 8 µL volume of sample—the
“over-aspiration” volume—may be aspirated by each
probe. The additional number of over-aspirations
required for these scenarios is variable, and can be
aspirated from the current sample and/or the following
sample. When using tests that meet these conditions,
allow for the possibility of over-aspiration volumes
when dispensing sample.
probe.

200154-101—November 2004
Sample Integrity
Refer to Specimens in Section 7, Operational Precautions and
Limitations and the assay-specific package inserts for detailed
information about specimen collection, preparation, and
storage.

200154-101—November 2004
Sample Bar Code Labels

Factors that affect positive sample identification:
• Bar code labels must meet the recommended
specifications.
• Bar code labels must be properly applied to the sample
tubes.
Bar Code Label Specifications

Meeting the following specifications allows the highest
probability of reading the sample ID on a bar code label.
Bar Code Label Specifications

Printer type Thermal printer with minimum
resolution of 300 dpi (dots per inch).
Proper maintenance of the bar code
label printer is essential.
NOTE: Laser jet and ink jet
printers with less than 300 dpi
resolution may not produce
acceptable labels. Dot matrix
printers are not recommended.
Label stock Good quality white label stock. The
black ink used to print bar codes must be
compatible with the label stock used.
CAUTION: Failure to comply
! could produce erroneous results.
NOTE: Labels must meet the
American National Standards
Institute (ANSI)
recommendations, or equivalent,
for bar code print quality (grade
levels A and B). Contact your bar
code label supplier or your print
supplier for assistance in grading
your labels.

200154-101—November 2004
Bar Code Label Specifications (Continued)

Symbology Symbologies allowed on the AEROSET
System include:
• Code 39
• Codabar
• Code I 2 of 5
• Code 128 (subset A, B, and C)
NOTE: No checksums or start/stop
characters are allowed.
Quiet zone The quiet zone is the distance from the
first black bar to the left edge of the label
and the distance from the last black bar
to the right edge of the label.
Quiet zone distance—0.197 in (5 mm)
Density (narrow Minimum density—0.0075 in (0.1 mm)
bar width)
Ratio (wide to • 1:2.2 to 1:3.0 (when narrow bar width
narrow bar) is < 0.508 mm)
• 1:2.0 to 1:3.0 (when narrow bar width
is 0.508 mm)
Sample ID (Identification) Length

The following factors affect the number of characters that can
fit on a sample bar code label.
• Label length
• Label placement
• Symbology used (described in preceding table)
• Density (narrow bar width, described in preceding table)
• Ratio (wide to narrow bar ratio, described in preceding
table)
• Quiet zone (described in preceding table)
The AEROSET System allows 2 to 20 characters on the sample
bar code label.

200154-101—November 2004
Label Length
Both 75 mm and 100 mm length (13 x 75, 13 x 100, 16 x 100,
and 16 x 75 mm) tubes can be used on the AEROSET System.
Maximum bar code lengths:
• 2.4 in (60 mm) label for 75 mm tubes
• 3.4 in (85 mm) label for 100 mm tubes
Label Placement
The bar code label should be top-justified (label edge aligned
with the top of the tube). Place the tube in the sample carrier
and/or the cup/tube adapter so the bar code fills the width of
the window.
NOTE: Bar code labels must be placed on tubes as
vertically straight as possible. If the vertical angle
exceeds five (5) degrees, the sample bar code reader
may have difficulty locating required quiet zones. Refer
to the following figure for a description of label
placement requirements.
Tube Labeling Requirements

The following figures illustrate correct and incorrect
placement of labels on sample tubes.
Quiet
Zone
0.197 in (5 mm)
0.590 in
(15 mm)
75 mm tube
0.984 in
(25 mm)
100 mm tube
Figure 5.27: Correct Label Placement

200154-101—November 2004
1 2 3 4 5
Figure 5.28: Incorrect Label Placement
1. Angled placement
2. Edges peeled loose
3. Clear tape over label
4. Flap extends from label
5. Label extends beyond bottom of tube

200154-101—November 2004
Loading Patient Samples

WARNING: Potential Biohazard. Refer to Section 8,
Hazards.
When loading samples on the AEROSET System, ensure the

following conditions are met.
• Before loading a tube, verify the size meets the
specifications listed in Sample Vessel Requirements in
this subsection.
• Ensure there is sufficient sample volume to run the
ordered tests plus any anticipated reruns.
• When using primary tubes, verify there is sufficient
sample volume for the assays to be measured, plus ½ inch
(13 mm) of sample above the clot, gel separator, or
plasma/red cell interface. If the specimen volume is less
than ½ inch (13 mm), transfer the specimen into a sample
cup.
½ inch
Sample (13 mm)
plasma/red cell
interface

200154-101—November 2004

required in a sample cup. The minimum volume required is
on the B-Line.
Largest Assay
Pair Volume
2 to 40 µL 60 µL + combined sample volumes of
all assays ordered
all assays ordered

requirements.
• Verify the samples are free of foam, bubbles, fibrin, or
other particulate matter when placed on the analyzer.
• Use cup/tube adapters for 13 mm tubes and sample cups.
If sample cups are loaded without adapters, the sample
cup is not detected and the patient sample is not run.

200154-101—November 2004

probe.
CAUTION: Do not run samples if these conditions are
! not met. Patient results could be affected.
FastTrack™ Sampler
1. Load the samples in the defined sample carrier and
position. If the sample tube is bar code labeled, face the
label toward the right side of the sample carrier.
2. Place the sample carrier(s) in a sample carrier tray.
3. Place the sample carrier tray on the FastTrack Sampler to
the right of the sampler area, so it is aligned between the
gray positioning marks. The white bump on the track belt
should be centered under the tray.
NOTE: Do not load trays when the red Rerun
Indicator on the front display panel is illuminated.
4. Place the blue end-of-run sample carrier to the right of the

last sample carrier loaded with samples, if the system is
configured for Auto Return of the FastTrack Sampler.

200154-101—November 2004
Sample Carousel
1. Confirm the Sample Carousel Movement Indicator LED is
not illuminated. Samples can be loaded in any carrier and
position not covered by the Sample Carousel safety shield.
STAT
Position
Access
Figure 5.30: Calibrator/Control Carousel with Sample

Carousel Safety Shield
2. Load the samples in the defined carrier and position. If the

sample tube is bar code labeled, face the label toward the
center of the Sample Carousel.
Remember to use cup/tube adapters for sample cups. If
sample cups are loaded without adapters, the sample cup
is not detected and the patient sample will not be run.
3. When loading samples during the READY status, the
Sample Carousel begins with position A1. When loading
samples during the PAUSE status, the Sample Carousel
begins with the position located at the aspirate position.
For priority sampling, load the sample in the first available
position next to the position currently being aspirated.

200154-101—November 2004
Selecting Run Options and Starting the Run

2. Select the checkbox (聺) next to the Patient option by

touching the box.

200154-101—November 2004
Viewing System Status and Run Progress

Progress of the run during processing can be monitored by
viewing the:
• Run Progress Area
• System Status Area displayed in the upper-right corner of
the screen
• Color change of samples on the DATABASE screen
Run Progress Area

This area displays the progress of assay analysis. When
measurement is started, a colored bar appears at the left end of
the Run Progress Area, then moves to the right as
measurement continues. When the bar reaches the red mark
in the center of the display, the second reagent, if appropriate,
is dispensed. When the bar reaches the far right, the sample is
complete and results display on the DATABASE screen.
NOTE: The Run Progress Area bar represents
approximately 10 minutes of processing time, divided
into approximately one minute intervals.
Run Progress
Area
Figure 5.32: Run Progress Area of the Main Display

200154-101—November 2004
The bar color indicates the type of sample currently being

analyzed, listed in order of priority.
Color Sample Type

Green Calibrator
Yellow Control
Pink STAT sample
Gray Patient sample
Status Area
The following system status terms display in the Status Area
during a run.
Status System Action

READY The system is not performing any
operation and is ready to begin a run.
RUN The system is sampling and processing
samples.
SAMPLING END The system completed sampling and is
processing the samples.
CUVETTE FILL The samples are completed and the
system is adding water to the cuvettes.
SUSPEND The system is ready to perform a new run.
During this status the system begins the
new run with an abbreviated run
initialization sequence.
PAUSE The operator paused the system by
selecting <PAUSE> in the Action Area of
the Main Display.

200154-101—November 2004
Color Display on the DATABASE Screen

The status of samples displayed on the DATABASE screen can
be differentiated by the color of text in which they display.
Processing
Text Color Status
Code
Pink Pending
Pink Waiting for a rerun R
Brown Running
Blue Incomplete, linked to rerun L
Blue Incomplete, replicate r
Blue Complete, but not validated A
Black Validated V
Green Validated (preserved)* V
*When auto SHUTDOWN is performed, there are several

possible options for Clear Database. If the Cal, QC option is
selected, SID and C/P are deleted for complete, incomplete,
and validated samples. These samples are now “preserved
samples” and display with green text.

200154-101—November 2004
Editing Patient Sample Orders

displayed.
2. Select the order to be edited. Only orders with pending
status (pink text) can be edited.
3. Select <Order> in the right column of the DATABASE
screen. The Order Samples dialog window displays.
4. Select <Edit>. The Order Samples screen displays.
5. Make the desired edits. Sample information can be added
or edited, and assays or panels can be added or deleted by
selecting or deselecting appropriate buttons.
6. Select <OK> in the upper-right corner of the Order
Samples screen. The edits are saved and the DATABASE
screen displays.

200154-101—November 2004
Ordering and Running a STAT Sample

Hazards.
When loading samples on the AEROSET System, ensure the

following conditions are met.
• Before loading a tube, verify the size meets the
specifications listed in Sample Vessel Requirements in
this section.
ordered tests plus any anticipated reruns.
• When using primary tubes, verify there is sufficient
sample volume for the assays to be measured, plus ½ inch
(13 mm) of sample above the clot, gel separator, or
plasma/red cell interface. If the specimen volume is less
than ½ inch (13 mm), transfer the specimen into a sample
cup.
½ inch
Sample (13 mm)
plasma/red cell
interface
• Verify samples previously loaded in the STAT position

have been aspirated. Upon aspiration, the sample displays
with brown text on the DATABASE screen.
CAUTION: It is necessary to confirm
! identification of the sample in the Reserved STAT
position because bar code labels are not read in
this position. Failure to verify identification of the
sample could result in sample misidentification.

200154-101—November 2004

required in a sample cup. The minimum volume required is
on the B-Line.
Largest Assay
Pair Volume
2 to 40 µL 60 µL + combined sample volumes of
all assays ordered
all assays ordered

requirements.
• Verify the samples are free of foam, bubbles, fibrin, or
other particulate matter when placed on the analyzer.
• Use cup/tube adapters for 13 mm tubes and sample cups.
If sample cups are loaded without adapters, the sample
cup is not detected and the patient sample is not run.

200154-101—November 2004

probe.
CAUTION: Do not run samples if these conditions are
! not met. Patient results could be affected.
1. The STAT patient sample must be loaded in the Reserved
STAT position of the Sample Carousel before placing the
order. Confirm the STAT Sampling Indicator LED is not
illuminated then place the sample in the STAT position.
Reserved
STAT
Position
125696a
Figure 5.33: Top View of the Sample Carousel

200154-101—November 2004
2. Lift the STAT position access section of the Sample

Carousel safety shield. Load the sample in the Reserved
STAT position. Lower the shield.
STAT
Position
Access
Figure 5.34: Calibrator/Control Carousel with Sample
Carousel Safety Shield
3. Select <STAT> in the Action Area of the Main Display. The

SELECT ASSAYS FOR STAT screen displays.
Figure 5.35: SELECT ASSAYS FOR STAT Screen
4. Select the assays or panels to run.

200154-101—November 2004
5. Enter the following sample information.

• Sample ID (required)
• Manual dilution
• Measurement type
NOTE: Sample bar code labels are not read in the
Reserved STAT position. A sample bar code reader
is not available for that position.
NOTE: If the operator does not enter the STAT
sample ID on the SELECT ASSAYS FOR STAT
screen, the system automatically issues a STAT
sample ID. The format of the assigned SID is
S***1234. The number of asterisks varies based on
the SID length configured on the SYSTEM
CONFIGURATION screen. The last 4 digits
represent the identification number automatically
issued by the AEROSET System.
6. Select <Start> in the upper-right corner of the SELECT
ASSAYS FOR STAT screen to initiate sample processing.
NOTE: If the AEROSET System is configured for Host
Order Query, only sample ID is required. The orders are
sent from the Host system.

200154-101—November 2004
Adding Samples during a Run

Hazards.
Perform the following procedures to add samples during a run.

NOTE: Do not reintroduce samples already in progress
to the sampler area. Wait until processing is complete,
otherwise samples will be reaspirated.
Adding Samples on the FastTrack™ Sampler
When the FastTrack Is Busy Sampling

When samples are being aspirated from the FastTrack Sampler,
the system status is RUN.
1. Order patient samples on the Order Samples screen.
2. Place the sample in the defined carrier and position.
CAUTION: The FastTrack Sampler moves soon
! after the Tray Status LED begins blinking orange.
3. Confirm the Tray Status LED is not blinking orange, then
place the sample carrier in a free section of the sample
carrier tray to the right of the sampler area.
When the FastTrack Completes Sampling

When the FastTrack Sampler completes sampling, the system
status is SAMPLING END, CUVETTE FILL, or SUSPEND.
• If the system status is CUVETTE FILL or SUSPEND, load
the samples and initiate the run performing the steps for a
new run.
CAUTION: If the AEROSET System is configured
! to automatically return the trays to the starting
position and aspirate reruns, the system status
remains RUN and the Rerun Indicator on the front
display panel is illuminated red. Samples cannot
be added during the rerun process.

200154-101—November 2004
• If the system status is SAMPLING END, perform the

following steps.
a. Order patient samples on the Order Samples screen.
b. Confirm the red Rerun Indicator on the front display
panel is not illuminated and the system status is
SAMPLING END.
c. Select <PAUSE> in the Action Area of the Main
d. Select <Pause> in the right column of the screen to
pause sampling.
e. Wait for the system status to change to PAUSE.
f. Place the sample in the defined carrier and position.
g. Place the sample carrier on a free section of the
sample carrier tray.
h. Select <UNPAUSE> in the Action Area of the Main
NOTE: Do not select <RUN> to reinitiate
sampling. If <RUN> is selected, all samples
remaining on the system with tests still in
process, are sampled again.
i. Ensure the Patient option is still selected.
j. Select <Unpause> in the right column of the RUN
OPTIONS screen to resume sample processing.
NOTE: <UnpsTrk> can be selected, and the
Sample Carousel remains in PAUSE status.
Adding Samples on the Sample Carousel
When the Sample Carousel Is Busy Sampling

When samples are being aspirated from the Sample Carousel,
the system status is RUN and the Sample Carousel Movement
Indicator LED is illuminated or blinking.

200154-101—November 2004

sampling.
WARNING: If a diluted sample has been dispensed, the
! sample and R1 reagent arms may move after the status
has changed to PAUSE. Wait 25 seconds before
accessing the Sample Carousel and Reagent Supply
Center 1 areas.
! movement of the Reagent 2 probes, ICT™ unit, mixers,
or cuvette washers so Assay Read Times are not affected.
! mixing of any sample and reagent already aspirated.
Confirm the PAUSE status in the System Status Area
and confirm the R1 Indicator on the Local User
Interface (LUI) Control Panel is illuminated before
proceeding.
4. Wait for the system status to change to PAUSE then place
the samples on the Sample Carousel in the defined
positions.
NOTE: For priority sampling, load the sample in
the first available position next to the position
currently being aspirated.
remaining on the system with tests still in process,
are sampled again.
6. Ensure the Patient option is still selected and the carrier
number specified in step 1 is entered in the Car’r column
of the RUN OPTIONS screen.
resume sample processing.
NOTE: <UnpsCrsl> can be selected, and the
FastTrack™ Sampler remains in PAUSE status.

200154-101—November 2004
When the Sample Carousel Completes Sampling

When the Sample Carousel completes sampling, the Sample
Carousel Movement Indicator LED is not illuminated or
blinking. If the FastTrack™ Sampler is still sampling, the
system status is RUN; if both the Sample Carousel and
FastTrack Sampler completed sampling the system status is
SAMPLING END, CUVETTE FILL, or SUSPEND.
• If the system status is CUVETTE FILL or SUSPEND, load
the samples and initiate the run following the procedure
for a new run.
• If the system status is RUN or SAMPLING END, perform
the following steps.
2. Confirm the Sample Carousel Movement Indicator
LED is not illuminated or blinking.
3. Select <PAUSE> in the Action Area of the Main
4. Select <Pause> in the right column of the screen to
pause sampling.
5. Wait for the system status to change to PAUSE.
6. Place the samples on the Sample Carousel in the
defined positions.
NOTE: When loading samples during READY
status, the Sample Carousel begins with
position A1. When loading samples during
PAUSE status, the Sample Carousel begins with
the position located at the aspirate position.
CAUTION: Do not select <RUN> to reinitiate
! sampling. If <RUN> is selected, all samples
remaining on the system with tests still in
progress, are sampled again.
8. Ensure the Patient option is still selected and the
carrier number specified in step 1 is entered in the
Car’r column of the RUN OPTIONS screen.
resume sample processing.
NOTE: <UnpsCrsl> can be selected, and the
FastTrack Sampler remains in PAUSE status.

200154-101—November 2004
Limited Run Feature

The Limited Run feature allows the operator to exclude assays
scheduled for a patient sample without changing the order.
The AEROSET System aspirates all scheduled assays except the
excluded assays. Orders remain pending and no errors are
generated. Examples of when this feature can be used include:
• Reagent for an assay is not onboard.
• The sample requires pretreatment before the assay can be
performed.
Limiting Assays in a Run

Hazards.
1. Order and load the patient samples.

3. Select the checkbox (聺) next to the Patient option by

touching the box.
4. Select the checkbox (聺) next to the Limited option.

200154-101—November 2004
5. Select <Order> to the right of the Limited option. The

SELECT ASSAYS TO RUN screen displays.
Figure 5.37: SELECT ASSAYS TO RUN Screen
6. Select the assays to be run; assays to be excluded

(previously ordered on the Order Samples screen) must
not be selected.
information.
7. When assay selection is complete, select <OK> in the
upper-right corner of the SELECT ASSAYS TO RUN
screen. The RUN OPTIONS screen displays.
8. Select <Start> in the upper-right corner of the screen to
initiate sample processing with the excluded assays.

200154-101—November 2004
Deselecting the Limited Run Feature

Use the following instructions when assays should no longer
be excluded.
2. Deselect the checkbox (□) next to the Limited option by
touching the box.
OPTIONS screen to initiate sample processing. All
pending assays are aspirated.
CAUTION: If the limited assay requires pretreatment,
! load the pretreated sample in the correct carrier
position. If the original sample is not removed and
replaced with the pretreated sample, patient results are
affected.
Ensure all samples are present and ready to run when the
Limited Run feature is deselected.

200154-101—November 2004
NOTES

200154-101—November 2004
Results
When sample processing is complete, the results can be

reviewed. There are two screens on the AEROSET System where
results are accessed and viewed:
• DATABASE screen
• RESULT screen
Reviewing Results on the DATABASE Screen

1. To access the DATABASE screen, select <Database> in the
DATABASE screen displays.
2. To view results for the samples displayed on the

DATABASE screen, select the arrow buttons at the bottom
of the right column, or press the left and right arrow keys
[씯] [씮] on the keyboard to scroll left and right.

200154-101—November 2004
Results Section 5
The DATABASE screen is formatted like a spreadsheet

with rows and columns. A sample occupies one row, and
different columns are viewed by scrolling right and left.
The C/P and Sample ID columns do not scroll, remaining
fixed for data identification. The following columns
display on the DATABASE screen.
• Processing Code
• C/P (Carrier/Position)
• Sample ID
• Patient Name
• Date and Time Ordered
• Patient ID
• Date and Time Completed
• Assay Name (1 through 100)
• Operator
• Comment
• Doctor Name
• Location
The Processing Code column (left of the C/P column)
displays a single-letter code to indicate the status of
completed samples. The following Processing Codes
display.
Processing
Status Description
Code
I Incomplete An error occurred for one or
more of the sample results. This
may also indicate the sample is
an original sample, with rerun
or replicate results.
A Accepted All results ordered for the
sample completed without
errors.
V Validated The sample is validated. This
can be done by the operator, or
the system can auto-validate if
configured on the SYSTEM
CONFIGURATION screen.

200154-101—November 2004
Section 5 Results
Processing
Status Description
Code
R Rerun A rerun was requested for one
or more results of the sample.
L Linked This sample is a rerun of an
original sample order and is
linked to the original sample.
r Replicate This sample is a replicate of an
original sample order and is
linked to the original sample.
The Assay Name columns display results of the assays

ordered for each sample. If “*” displays, the result is not
completed. If “C” displays next to a result, an error
occurred for the result. To review the Result Error Code,
access the RESULT screen.
Limited View Buttons

When accessing the DATABASE screen, the buttons at the
bottom of the Display Area are highlighted to indicate which
orders and results display. Text color on the buttons
corresponds to DATABASE screen text colors.
• <Pending>—Pink
• <Incompl> (incomplete)—Blue
• <Rerun>—Pink
• <Complete>—Blue
• <Valid> (validated)—Black
The buttons can be deselected to change the view. To return to
the default view, select <All> at the bottom of the Display
Area.

200154-101—November 2004
Results Section 5
Customized View Option

A customized view can be defined to display when <Custom>
is selected. Use the following instructions to configure the
customized view.
displayed.
2. Select <Custom> at the bottom of the DATABASE screen.
The Customized View dialog window displays.
Figure 5.39: Customized View Dialog Window
3. Select <Modify>. The Modify Customized View dialog

window displays.
Figure 5.40: Modify Customized View Dialog Window
4. Select the checkbox (聺) next to each desired Sample

Status and Sample Type option to be included in the
customized view.
NOTE: Selected Sample Type options remain on the
DATABASE screen until they are deselected on the
Modify Customized View dialog window.

200154-101—November 2004
Section 5 Results
Sort Options
There are four methods to sort and display samples on the
DATABASE screen.
• Sort by date and time ordered
• Sort by date and time completed
• Sort by C/P (carrier/position)
• Sort by sample ID
Use the following instructions to select the desired type of sort.

displayed.
2. Select <Custom> at the bottom of the Display Area. The
Customized View dialog window displays.
Figure 5.41: Customized View Dialog Window
3. Select <Sort>. The Sort dialog window displays.
Figure 5.42: Sort Dialog Window
4. Select the checkbox (聺) next to the desired Sort option.

NOTE: The Sample ID option is only available when
the Alphanumeric Sample ID option on the SYSTEM
CONFIGURATION screen is not selected.

200154-101—November 2004
Results Section 5
Searching for Results

The search function allows an operator to enter criteria to
search for specific orders and results. Use the following
instructions to perform the search function.
displayed.
2. Select <Search> at the bottom of the DATABASE screen.
The Search dialog window displays.
Figure 5.43: Search Dialog Window
3. The following options can be selected for the search.
Option Description
Sample ID Enter an individual sample ID.
Last Name Enter up to 20 alphanumeric characters.
Patient ID Enter up to 20 alphanumeric characters.
Car’r Range Enter a single carrier number or range of
carriers.
Date Range Enter a date range using the day, month,
year, and/or time.
Dr. Name Enter up to 20 alphanumeric characters
or select from the drop-down list box.
Location Enter up to 20 alphanumeric characters
or select from the drop-down list box.

200154-101—November 2004
Section 5 Results
4. Select <Search> to initiate the search. All samples and

results that meet the search criteria display.
NOTE: After a search is performed, a magnifying
glass icon appears on <Search> on the Search
dialog window. When the magnifying glass
displays, the DATABASE screen is not updated
when the sample status is changed. To return to
the Real Time display mode, select <Search> then
select <Cancel>.

200154-101—November 2004
Results Section 5
Reviewing Results on the RESULT Screen

displayed.
2. Select the sample to be reviewed.
3. Select <Result> in the right column of the screen. The
RESULT screen displays.
Figure 5.44: RESULT Screen
The following information displays for each completed

result.
Result
Description
Information
Processing A single-letter code indicates the status of
Code the result:
• A—Accepted
• E—Edited
• R—Rerun
• D—Deleted
• S—Selected
Assay Name The assay name displays.

200154-101—November 2004
Section 5 Results
Result
Description
Information
Numerical The result displays unless an error
Result occurred that prevented the result from
calculating. The color of the result
numerical text varies based on the type
of code associated with it.
• Black—the result is acceptable.
• Brown—the result is outside the
reference range or 2 SD control range
and the appropriate L/H Result Flag
displays.
• Red—a Result Error Code was
generated for the result and the code
displays.
Result Flag A single-letter flag to indicate a result is
outside the defined reference range or
2 SD control range.
• L—out of range low
• H—out of range high
Result Error If one or more errors occurred for the
Code result, the highest priority Result Error
Code displays.
Example:
• SS—Short Sample
• CAL—Calibration Error
To view all Result Error Codes generated
for a result, select <RxnGraph>.
Measurement Indicated by a colored line beneath the
Type assay name.
• Green—Standard
• Blue—Dil 1
• Yellow—Dil 2
• Pink—Reference assay (system ordered
assays for calculated tests and Sample
Interference Indices)

200154-101—November 2004
Results Section 5
Reviewing Results with Replicates

Original and replicate results display on the DATABASE
screen. When the replicate is complete, the original sample
displays with the Processing Code “I” to the left of sample
information on the DATABASE screen. The replicate sample
has the Processing Code “r”.
Use the following instructions to review the results of the
original and replicate sample.

displayed.
2. Select the original sample to be reviewed, the sample with
Processing Code “I”.
Result #
Indicator
4. The Result # indicator in the upper-left corner of the

screen indicates the number of replicates performed and
which result is being viewed. For example, on the screen
above, the Result # indicator displays 1/2. This indicates
the sample was run two times and the original result is
displayed.
5. The drop-down list box to the right of Result # indicates
the original result is displayed.

200154-101—November 2004
Section 5 Results
6. To view the replicate result, touch the drop-down list box

and select Orig –1 to view the first replicate
(Orig –2 = second replicate, Orig –3 = third replicate, etc.).
Drop-down
List Box
Figure 5.46: RESULT Screen Drop-down List Box
7. Select the return arrow to close the list. The RESULT

screen displays the original result and the selected
replicate.
Original Result
Replicate Result

200154-101—November 2004
Results Section 5
Selecting the Replicate Result to Report

When the sample replicate is complete, the operator can select
the replicate result or accept the original result. The original
result can be accepted by performing the Accepting Results
Procedure, which follows.
Use the following instructions to select a replicate result.
1. Display the desired replicate result, using the procedure
described in the preceding subsection.
2. Select <Select> in the right column of the RESULT screen.
NOTE: After a replicate result is selected, the
original result is no longer accessible.
3. An “S” displays to the left of the assay name and the
replicate result is copied over the original result for this
assay.
4. Select <OK> to exit the RESULT screen.
5. A dialog window displays, requesting validation of all
results.
6. If all results for the sample are acceptable, select <OK> to
validate.
7. If results will be validated later, select <Cancel>.

200154-101—November 2004
Section 5 Results
Accepting Results
The AEROSET System auto-accepts all results that are
completed without associated Result Error Codes.
NOTE: Refer to Result Error Codes in Section 10,
Troubleshooting and Diagnostics for details.
The Processing Code “A” displays next to each accepted result
on the RESULT screen. If all results for a sample are
auto-accepted, “A” also displays to the left of the sample on
the screen.
If a sample has one or more results with an associated Result
Error Code, the Processing Code “I” displays to the left of the
sample on the DATABASE screen. The results for this sample
need evaluation by the operator for acceptance or further
action, e.g., rerunning, diluting, editing, etc.
Use the following instructions to review and accept results.
displayed.

200154-101—November 2004
Results Section 5
4. If the displayed result is acceptable without further action,

highlight the result by touching it.
5. Select <Accept> in the right column of the RESULT
screen. An “A” displays next to the assay name.

200154-101—November 2004
Section 5 Results
Validating Samples
After all results for a sample are accepted, the sample can be
validated. The AEROSET System can be configured to allow
only validated results to be printed or transmitted to a Host.
The system can also be configured to auto-validate samples
when all results are accepted.
Special Requirements for details on system configuration.
Use the following instructions to validate a sample after all
results are accepted.
displayed.
2. Select the sample to be validated.
3. Select <Accept> in the right column of the DATABASE
screen. The Accept Results dialog window displays.
Figure 5.49: Accept Results Dialog Window
4. Select <All Results>. The Accept confirmation dialog

window displays.
Figure 5.50: Accept Confirmation Dialog Window
5. Select <OK>.
6. A “V” displays next to the sample on the DATABASE
screen, with black text to indicate the sample was
validated.

200154-101—November 2004
Results Section 5
Printing Results
Printing a Single Result Report from the DATABASE Screen
displayed.
2. Select the sample to be printed.
4. Select <Form 1> or <Form 2>. A confirmation dialog

window displays.
5. Select <OK>.
Printing Multiple Result Reports from the DATABASE Screen

displayed.
2. Select the sample(s) to be printed.
• To highlight multiple consecutive samples in a list,
select the first sample in the list then highlight the
remaining samples by holding [Shift] and pressing
• To highlight multiple random samples, hold down
[Ctrl] while selecting the samples on the screen.
4. Select <Form 1> or <Form 2>. A confirmation dialog
window displays.
5. Select <OK>.

200154-101—November 2004
Section 5 Results
Printing a Single Result Report from the RESULT Screen

displayed.
2. Select the sample to be printed.
3. Select <Result> in the right column of the DATABASE
screen. The RESULT screen displays.
4. Select <Print> in the right column of the RESULT screen.
A confirmation dialog window displays.
5. Select <OK>.
NOTE: The Form 1 Result report prints when
selecting the Print option on the RESULT screen.
If Form 2 Result reports are needed, use the Print
option on the DATABASE screen. Refer to
Appendix B, AEROSET System Printed Reports for
examples of these printed reports.

200154-101—November 2004
Results Section 5
Displaying Reaction Graphs

The reaction curve corresponding to a photometric assay result
can be displayed on the Reaction Graph screen.
Single Result from the DATABASE Screen

Use the following instructions to display the Reaction Graph
screen for one result from the DATABASE screen.
displayed.
2. Select the sample to display.
3. Select <RxnGraph> in the right column of the DATABASE
screen. The Reaction Graph screen displays.
Assay
Drop-down
List Box
Figure 5.52: Reaction Graph Screen
4. To select the desired assay, touch the drop-down list box

of assay names in the upper-right area of the screen.
5. Select the name of the assay to view then select the return
arrow to close the list. The Reaction Graph of the selected
assay displays.

200154-101—November 2004
Section 5 Results
6. The following options for Reaction Graphs are available.
Option Description
Normal The ABS (Absorbance) axis default
(default screen) ranges from 0.0000 to 3.000. The
normal absorbance scale limits are
–0.1 to 3.0.
Adjusted The ABS (Absorbance) axis is
adjusted to fill the display.
Free The operator can define the ABS
(Absorbance) axis.
NOTE: <AbsData> can be selected on the

Reaction Graph screen to view absorbance data
for all 33 reads.
Multiple Results from the DATABASE Screen

The Reaction Graph screen displays up to eight sample results
at the same time. Use the following instructions to display the
Reaction Graph screen for multiple samples from the
DATABASE screen.
displayed.
2. Select the sample(s) to display, up to eight.

200154-101—November 2004
Results Section 5
3. Select <RxnGraph> in the right column of the DATABASE

screen. The Reaction Graph screen displays.
Assay
Drop-down
List Box
Figure 5.53: Reaction Graph Screen
4. To select the desired assay, touch the drop-down list box

of assay names in the upper-right area of the screen.
5. Select the assay to view then select the return arrow to
close the list. The Reaction Graph of the selected assay for
each sample displays. The graph for each assay is
color-coded. The Color Key column in the lower-right area
of the screen identifies each graph.
Option Description
–0.1 to 3.0.
Adjusted The ABS (Absorbance) axis is adjusted
to fill the display.
(Absorbance) axis.

for all 33 reads.

200154-101—November 2004
Section 5 Results
Single Result from the RESULT Screen

The Reaction Graph screen can also be accessed from the
RESULT screen. Use the following instructions to display the
Reaction Graph screen from the RESULT screen.
displayed.
2. Select the sample(s) to display.
4. Highlight the desired assay to display the Reaction Graph.
5. Select <RxnGraph> in the right column of the RESULT
screen. The Reaction Graph of the selected sample and
result displays.
Option Description
–0.1 to 3.0.
Adjusted The ABS (Absorbance) axis is adjusted
to fill the display.
(Absorbance) axis.

for all 33 reads.

200154-101—November 2004
Results Section 5
Rerunning Results
Results can be scheduled for rerun from both the DATABASE
and RESULT screens. Results can be rerun at the same
dilution, or the dilution option can be changed before rerun.
NOTE: Because the system tracks the samples by
carrier/position, samples will not always be
automatically returned for a rerun.
Auto return for a sample does NOT occur if the Auto
Return (for Sample Crsl and/or Track Sampler), Auto
Rerun, and Sample Bar Codes options are all configured
ON and the following conditions also exist.
If... Then
• A completed sample had • The subsequent
a rerun ordered and sample(s) will NOT
processed automatically be
and returned to the sample
handler for processing
• The same
carrier/position is used and
for a subsequent • The operator must
sample(s) manually move the
and sample to the right of
the sample handler to
• A rerun is scheduled for
be rerun or move the
the subsequent sample(s)
sample to another
as indicated by an “R”
carrier/position
Processing Code on the
DATABASE screen
Rerunning Results from the DATABASE Screen

To request a rerun of all assays ordered for a sample or request
that an assay be rerun on multiple samples, use the
DATABASE screen.
Rerunning Selected Assays

displayed.
2. Select the sample(s) to be rerun.

200154-101—November 2004
Section 5 Results

3. Select <Rerun> in the right column of the DATABASE
screen. The Rerun dialog window displays.
Figure 5.54: Rerun Dialog Window
4. Select <Select Assay>. The Select Assays screen displays.

5. Select the assay(s) to be rerun. The sample measurement
type (Standard, Dil 1, or Dil 2) can be selected before
selecting the assay, if desired.
NOTE: The sample measurement type selected for
an assay applies to all samples selected in step 2.
6. Select <OK>. Each assay selected is scheduled to rerun for
all samples selected in step 2.
NOTE: If the system is not configured for Auto
Return, the operator must manually move the
sample.
NOTE: If a rerun is selected for an assay that was
not run initially, the rerun is not performed.
7. To initiate the run, select <RUN> in the Action Area of the
Main Display. The RUN OPTIONS screen displays.
8. Select the desired options then select <Start> in the
upper-right corner of the screen to initiate sample
processing.

200154-101—November 2004
Results Section 5
Rerunning All Assays

When the option of rerunning all assays on a sample is
selected, all assays rerun with the same measurement type
(Standard, Dil 1, Dil 2) as originally selected.
displayed.
2. Select the sample(s) to be rerun.
3. Select <Rerun> in the right column of the DATABASE
screen. The Rerun dialog window displays.
Figure 5.55: Rerun Dialog Window
4. Select <All Results>. The Rerun confirmation dialog

window displays.
Figure 5.56: Rerun Confirmation Dialog Window
5. Select <OK>. All assays in the selected sample(s) are

scheduled for rerun.
sample.

200154-101—November 2004
Section 5 Results

processing.
Rerunning Results from the RESULT Screen

To request a rerun of a single result, use the RESULT screen.
displayed.
4. Select the result that needs to be rerun.
5. Select the desired measurement option.
6. Select <Rerun> in the right column of the RESULT screen
or press [R] on the keyboard. The Processing Code “R”
displays to the left of the result.
7. Select <OK>. On the DATABASE screen, the sample
displays the Processing Code “R” and the text is pink to
indicate it is pending.
sample.
processing.

200154-101—November 2004
Results Section 5
Rerunning Results in the Reserved STAT Position

1. Request the rerun on the DATABASE or RESULT screens
as previously described.
2. Verify the correct sample is located in the Reserved STAT
position.
CAUTION: It is necessary to confirm
! identification of the sample in the Reserved STAT
position, because bar code labels are not read in
this position. Failure to verify identification of the
sample could result in sample misidentification.
3. Select <STAT> in the Action Area of the Main Display. The
SELECT ASSAYS FOR STAT screen displays.
4. Enter the sample ID (must be the same sample ID
displayed on the DATABASE screen). Do not select any
assays.

200154-101—November 2004
Section 5 Results
Reviewing and Selecting Rerun Results to Report

Original and rerun results display on the DATABASE screen.
When a rerun is complete, the original sample displays with
the Processing Code “I” to the left of the sample information
on the DATABASE screen. The rerun sample displays with the
Processing Code “L” (Link) because it is linked to the original
sample.
Reviewing Rerun Results

Use the following instructions to review the results of the
original and rerun samples.
displayed.
2. Select the original sample to review, the sample with
Processing Code “I”.
Result #
Indicator

200154-101—November 2004
Results Section 5
4. The Result # indicator in the upper-left corner of the

screen indicates the number of reruns performed and
which result is being viewed. For example, on the screen
previously shown, the Result # indicator displays 1/2. This
indicates the sample was run two times and the original
result is displayed.
5. The drop-down list box to the right of Result # indicates
the original result is displayed.
6. To view the rerun result, touch the drop-down list box and
select Link 1 to view the first rerun (Link 2 = second rerun,
Link 3 = third rerun, etc.).
Drop-down
List Box
Figure 5.58: RESULT Screen Drop-down List Box

200154-101—November 2004
Section 5 Results
7. Select the return arrow to close the list. The RESULT

screen displays the original result and selected rerun
result.
Original Result
Rerun Result

200154-101—November 2004
Results Section 5
Selecting the Rerun Result to Report

When a sample rerun is complete, the operator can select the
rerun result or accept the original result. The original result is
accepted by performing the Accepting Results Procedure.
Use the following instructions to select a rerun result.
1. Display the desired rerun result(s) by following the steps
described in the preceding subsection, Reviewing Rerun
Results.
2. Highlight the assay for which the rerun result will be
accepted.
NOTE: To select all rerun results for a sample, press
[O] or [o] (not case-sensitive) on the keyboard.
3. Select <Select> in the right column of the RESULT screen.
CAUTION: After a rerun result is selected, the
! original result is no longer accessible.
4. An “S” displays to the left of the assay name and the rerun
result is copied over the original result for each selected
assay.
5. Select <OK> to exit the RESULT screen.
6. If all results for the sample have been accepted, a dialog
window displays to request validation of the sample.
Select <OK> to validate or <Cancel> to exit.

200154-101—November 2004
Section 5 Results
Adding Assays to a Completed Sample

displayed.
2. Select the sample to which assays will be added.
4. Select <Add> in the right column of the screen. The Add
Assays screen displays.
Figure 5.60: Add Assays Screen
5. Select the assay(s)/panel(s) to add to the completed

sample.
6. Select <OK>. The added assays display on the RESULT
screen.
7. Select <OK> to exit to the DATABASE screen. The sample
displays with the Processing Code “R” and the text is pink
to indicate it is pending.
sample.
processing.

200154-101—November 2004
Results Section 5
Editing Results
When a result is edited, the Processing Code “E” (Edited)
displays with the result. The “E” remains after the result is
accepted and validated.
Use the following instructions to edit a result.
displayed.
2. Select the desired sample.
4. Select the desired assay result.
5. Select <Edit> in the right column of the RESULT screen.
6. A blue box appears around the result to be edited, and the
cursor displays in the Result field.
Result
Field
Figure 5.61: Editing the RESULT Screen
7. Type the edited result.

8. Press [Enter] on the keyboard. An “E” displays next to the
edited result.
9. Select <OK> to exit to the DATABASE screen.
10. If all results for the sample have been accepted or edited, a
dialog window displays to request validation of the
sample. Select <OK> to validate or <Cancel> to exit.

200154-101—November 2004
Section 5 Results
Recalculating Results
Completed patient results can be recalculated, based on a new
calibration curve or after changing assay parameters. The
Recalculate Results feature uses the existing conditions, assay
parameters, and calibration curve.
CAUTION: This feature should not be used if the
! testing conditions have changed, e.g., addition of new
reagent or after maintenance procedures. Patient results
could be affected.
Recalculating Results from the DATABASE Screen
Recalculating Selected Assays

displayed.
2. Select the sample(s) to be recalculated.
3. Select <ReCalc> in the right column of the DATABASE
screen. The Recalculate Results dialog window displays.
Figure 5.62: Recalculate Results Dialog Window
4. Select <Select Assay>. The Select Assays screen displays.

5. Select the assay(s) to be recalculated.
6. Select <OK>. Each assay selected is recalculated for all
samples selected in step 2.

200154-101—November 2004
Results Section 5
Recalculating All Assays

displayed.
2. Select the sample(s) to be recalculated.
3. Select <ReCalc> in the right column of the DATABASE
screen. The Recalculate Results dialog window displays.
Figure 5.63: Recalculate Results Dialog Window
4. Select <All Results>. The Recalc confirmation dialog

window displays.
Figure 5.64: Recalc Confirmation Dialog Window
5. Select <OK>. All assays in the selected sample(s) are

recalculated.

200154-101—November 2004
Section 5 Results
Recalculating Results from the RESULT Screen

To request recalculation of a single result, use the RESULT
screen.
displayed.
2. Select the desired sample.
4. Select the result to be recalculated.
5. Select <ReCalc> in the right column of the RESULT
screen. The result is recalculated.

200154-101—November 2004
Results Section 5
Deleting Results
Deleting Results from the DATABASE Screen
displayed.
2. Select the sample(s) to be deleted.
NOTE: A sample cannot be deleted when it is
running (text is brown).
NOTE: Deletion of an original sample also deletes
all reruns and replicates ordered for that sample.
3. Select <Delete> in the right column of the DATABASE
screen. The Delete confirmation dialog window displays.
Figure 5.65: Delete Confirmation Dialog Window
4. Select <OK> to delete the selected samples.

NOTE: Deleting samples from the DATABASE
screen does not accomplish the same function as
the daily Clear Database (All Records) option of
the SHUTDOWN Procedure.

200154-101—November 2004
Section 5 Results
Deleting Results from the RESULT Screen

displayed.
2. Select the sample(s) to be deleted.
4. Select the result to be deleted.
5. Select <Delete> in the right column of the RESULT screen
or press [D] on the keyboard.
• If the result is an edited result, the Result field is
cleared but the assay name remains and the assay
result remains pending.
• If the result was completed and calculated by the
AEROSET System, the assay name and result remains
but a “D” displays to the left of the assay name.
NOTE: The printed report for a sample with a
deleted result only prints the assay name and any
Result Error Code (if present). The area where the
result normally prints is blank.
6. The deleted results are not sent to the Host or printed on
reports, but can be viewed on the RESULT screen.

200154-101—November 2004
Results Section 5
Exporting Results to Floppy Disk

Sample information and results can be exported from the
DATABASE screen to a floppy disk. The information is saved
in a .csv format on the disk. A file in this format can be opened
and viewed using most commercially available PC spreadsheet
programs (Microsoft Excel, Lotus 1-2-3, etc.). Exported results
cannot be imported back to the database.
Use the following instructions to transfer result records from
the AEROSET System to a floppy disk.
NOTE: Use a formatted floppy disk. The disk can be
formatted on the System Control Center. If an alternate
format is used, the format must be Windows 95 or
DOS 5.0 (or higher).
1. Insert a disk in the floppy disk drive of the SCC computer.

displayed.
3. Select the sample(s) to be exported.
4. Select <Export> in the right column of the DATABASE
screen. The Export dialog window displays.
Figure 5.66: Export Dialog Window
5. Enter a file name, up to 8 characters.

200154-101—November 2004
Section 5 Results
6. Select <OK>. The Export confirmation dialog window

displays.
Figure 5.67: Export Confirmation Dialog Window
7. Select <OK>. Result data are transferred to the floppy disk.

8. Remove the disk from the floppy disk drive when the
export process is complete.

200154-101—November 2004
Results Section 5
NOTES

200154-101—November 2004
Running the AEROSET System

with a Host Computer
Downloading Orders from the Host Computer

Use the following instructions to download orders from the
Host computer.
displayed.
2. Select <Online> in the right column of the screen. The
On-line Data Transfer dialog window displays.
Figure 5.68: On-line Data Transfer Dialog Window
3. Select one of the following options.
Option Description
Order Query Instructs the Host to transmit all
pending orders for the AEROSET
System.
Order Query by Instructs the Host to transmit
Sample ID orders for specified sample(s).
Order Query by C/P Instructs the Host to transmit all
orders for the specified C/P.
4. The selected patient samples are downloaded and display

on the DATABASE screen.

200154-101—November 2004
Running the AEROSET System with a Host Computer Section 5
Host Order Query

The AEROSET System can also be configured to use the Host
Order Query feature. This feature enables the AEROSET System
to query the Host computer for the tests to be run on a sample
when the AEROSET System encounters the sample and
identifies it by reading the bar code.
If the AEROSET System is configured for Host Order Query, the
operator loads the bar code labeled samples and initiates a run.
The AEROSET System scans the bar code and determines it
lacks an order for the sample, then sends a message to the Host
requesting the order. The AEROSET System waits for the Host
to reply and runs the sample when the order is received.

200154-101—November 2004
Section 5 Running the AEROSET System with a Host Computer
Transmitting Results to the Host

Results are transmitted to the Host computer automatically if
the AEROSET System is configured accordingly on the
ONLINE CONFIGURATION screen.
Use the following instructions to transmit results if the
AEROSET System is not configured to automatically transmit
results, or if Host communication was temporarily suspended
and results must be resent.
displayed.
2. Select the sample(s) to be transmitted.
3. Select <Online> in the right column of the DATABASE
screen. The On-line Data Transfer dialog window
displays.
Figure 5.69: On-line Data Transfer Dialog Window
4. Select <Send Results>. Results of the selected samples are

sent to the Host system.

200154-101—November 2004
Running the AEROSET System with a Host Computer Section 5
NOTES

200154-101—November 2004
Controls
Ordering Controls
Use the following instructions to order controls.
2. Select the checkbox (聺) next to the desired QC option by

touching the box. There are four available options,
defined in the following table.
When This
Controls Are
Option Is Additional Settings
Measured...
Selected...
QC after Automatically after Select desired QC levels,
Calib calibration, to verify QC1–QC8.
the calibration curve.

200154-101—November 2004
Controls Section 5
When This
Controls Are
Measured...
Selected...
Start–QC Before patient • Enter the number of
samples, at the replicates next to the
beginning of the run. Reps field, 1 to 50.
NOTE: • Select <Order> to
Start–QC will display the SELECT
only be run if it ASSAYS FOR
is selected START-QC screen.
when the Select the assays for
system status is control measurement.
READY. • Select desired QC
levels, QC1–QC8.
Interval–QC At the specified count • Select <Order> to
(sample) or time display the SELECT
intervals defined on ASSAYS FOR
the QC page of the INTERVAL–QC
Assay Configuration screen. Select the
screen. assays for control
NOTE: The measurement.
count (sample) • If the As Needed
interval refers option is selected, QC
to the total measurement for an
number of assay is performed at
samples the defined intervals
aspirated, not only when that assay
the total is ordered for at least
number of one sample of the
samples run for interval.
that assay. • If the As Needed
Refer to Section 2, option is NOT
Installation Procedures selected, QC
and Special measurement is
Requirements for performed at the
details on QC defined intervals even
configuration. if the assay was not
run on a patient
sample during the
interval.
• Select desired QC
levels, QC1–QC8.

200154-101—November 2004
Section 5 Controls
When This
Controls Are
Measured...
Selected...
End–QC After patient samples Select desired QC levels,
are complete and for QC1–QC8.
each assay run on
patient samples.
3. Select the checkbox (聺) under the desired QC level by

touching the box. Up to eight levels of QC can be run for
an assay. The selected levels apply to all assays ordered for
that QC run.
NOTE: If a QC level is not selected, QC will not be
performed for that run. The selected level applies
to all assays ordered for that QC run.
NOTE: For ICT™ analytes—QC results are
generated for all three ICT assays when any ICT
QC is ordered.

200154-101—November 2004
Controls Section 5
Automatic QC
The AEROSET System can be configured to perform automatic
QC at the following times:
• After reagent lot change
• After reagent cartridge change
NOTE: When configured, automatic QC is performed

only when a reagent lot change or cartridge change
occurs during a run. Automatic QC is not performed
when a reagent lot or cartridge change is detected at the
start of a run that is initiated from the READY status.
NOTE: If automatic QC is expected during a run,
ensure the correct controls are loaded before starting
the run.
NOTE: Refer to QC Rules Configuration in Section 2,
Installation Procedures and Special Requirements for
information on Automatic QC options.
NOTE: Controls must be defined on the
Calibrator/Control Carousel for the Automatic QC
option to be used.
NOTE: Stability of QC material on the
Calibrator/Control Carousel has not been established.

200154-101—November 2004
Section 5 Controls
Loading Controls
When loading controls, the following conditions must be
verified:
ordered tests.
• Inspect the samples for splashing, air bubbles, and
foaming. Do not run samples when these conditions exist.
Use the following instructions to load controls.

1. Select <Save> in the right column of the RUN OPTIONS
screen to save the QC order. The Save confirmation dialog
window displays.
2. Select <OK>.
3. Select <Cancel> on the RUN OPTIONS screen to exit the
screen without starting the run.
displays.

200154-101—November 2004
Controls Section 5
5. The controls necessary to perform the selected assays are

highlighted with a yellow line under the control name on
each button.
6. Remove the Calibrator/Control Carousel cover.

7. Pipet the highlighted controls into sample cups and load
in positions defined on the CALIBRATOR/CONTROL
screen.
NOTE: I-Index (index solution—position 42)
underlined is currently not in use. It does not need
to be loaded.
8. Replace the Calibrator/Control Carousel cover. Align the
hole in the cover with the track that indicates the area of
movement for the sample arm. The cover does not rotate
when seated properly.
9. Select <OK> on the CALIBRATOR/CONTROL screen to
exit.
11. Confirm the QC option is still selected.

200154-101—November 2004
Section 5 Controls
Loading Controls When the Sample Carousel Is Busy Sampling

sampling.
! dispensed, the sample and R1 reagent arms may
move after the status has changed to PAUSE. Wait
25 seconds before accessing the Sample Carousel
and Reagent Supply Center 1 areas.
! movement of the Reagent 2 probes, ICT™ unit,
mixers, or cuvette washers so Assay Read Times are
not affected.
! mixing of any sample and reagent already
aspirated. Confirm the PAUSE status in the System
Status Area and confirm the R1 Indicator on the
Local User Interface (LUI) Control Panel is
illuminated before proceeding.
3. Wait for the system status to change to PAUSE, then place
the controls (in sample cups) on the Calibrator/Control
Carousel in the defined positions.
are sampled again.
5. Ensure the desired control option is still selected.
NOTE: Start–QC will not be run if it is selected
when the system status is PAUSE.
6. Select <Unpause> in the right column of the RUN
NOTE: <UnpsCrsl> can be selected, which
unpauses the carousel only.

200154-101—November 2004
Controls Section 5
Loading Controls When the Sample Carousel Completes Sampling

1. Confirm the Sample Carousel Movement Indicator LED is
not illuminated or blinking.
2. Place the controls (in sample cups) on the
Calibrator/Control Carousel in the defined positions.
sampling.
5. Wait for the system status to change to PAUSE.
are sampled again.
7. Ensure the desired control option is still selected.
NOTE: Start–QC will not be run if it is selected
when the system status is PAUSE.
8. Select <Unpause> in the right column of the RUN
NOTE: <UnpsCrsl> can be selected, which
unpauses the carousel only.

200154-101—November 2004
Section 5 Controls
Reviewing QC Results
When QC results are completed without errors, the results are
saved and QC statistics adjusted accordingly. QC values and
statistics can be viewed on the ASSAY STATUS,
Levey-Jennings Graph, QC Data List, and QC SUMMARY
screens. The data can be printed on the Levey-Jennings graph
or QC Data List reports. The QC data can also be exported to a
floppy disk.
Expected concentration and SD can be defined for the QC, and
Westgard rules can be selected to evaluate the QC. If a
Westgard rule is violated, an Error Log Message is generated
and the rule displays next to the QC data on the ASSAY
STATUS screen.
Installation Procedures and Special Requirements for details
on QC configuration.
ASSAY STATUS Screen

2. Select an assay name. The ASSAY STATUS screen displays.
Quality Control
Information

200154-101—November 2004
Controls Section 5
The Quality Control Information area of the ASSAY STATUS

screen is shown.
Figure 5.74: Quality Control Information Area of the ASSAY

STATUS Screen
The following table describes each column of QC information

in the Quality Control Information area of the ASSAY STATUS
screen.
Column Description
QC QC level (QC1–QC8) defined on the QC page
of the Assay Configuration screen, and the
QC name as defined on the
Conc Expected concentration defined on the
Mean Actual mean of the QC data
SD Actual standard deviation of the QC data
CV Actual coefficient of variation of the QC data
Range Actual range (Max value–Min value) of the QC
data
N Number of QC data points for the level
(Max = 450)
Last The value of the last QC sample run for the
level.
NOTE: An “L” or “H” Result Flag
displays next to the result if the value is
outside the defined 2 SD range. A Result
Error Code displays if an error occurred
for the result.
QC Rule Any Westgard rule violation displays in this
column; the highest priority rule displays.

200154-101—November 2004
Section 5 Controls
NOTE: The mean, SD, CV, range, and N are calculated

using all data points except those excluded on the
Levey-Jennings Details screen.
NOTE: For a QC result to be flagged with an “L” or “H”
Result Flag, the mean concentration and SD must be
considered. A result is rounded to the reporting number
of decimals for an assay after comparing the result to
the QC range.
QC SUMMARY Screen
The QC SUMMARY screen displays the statistics for all assays
and all levels of QC. To view the statistics, select
<QC Summary> in the Information Access Area of the Main
Display. The QC SUMMARY screen displays.
Figure 5.75: QC SUMMARY Screen
The QC statistics for the first level (defined for each assay)
display. To view the statistics for other levels defined, select
or on the screen to scroll left or right.

200154-101—November 2004
Controls Section 5
NOTE: When the QC SUMMARY screen displays, an

Update button appears in the right column of the
screen when a date range is activated or deactivated,
new QC results are complete, or when QC data points
are included or excluded on the Levey-Jennings Graph
screen. Select <Update> to recalculate the statistics on
the QC SUMMARY screen.
The following information displays for each QC level on the
QC SUMMARY screen.
Column Description
Assay Assay name
QC1...QC8 Name of the QC selected for the level on the
QC page of the Assay Configuration screen
Conc Expected concentration defined on
Range Actual range (Max value–Min value) of the QC
data
(Max = 450)
Last Value of the last QC sample run for the level.
displays next to the result if the value is
outside the defined 2 SD range. A Result
Error Code displays if an error occurred
for the result.
NOTE: If a date range is configured,
value is the last QC sample run in the
date range.


200154-101—November 2004
Section 5 Controls
Selecting Date Range

A specific date range can be configured on the QC SUMMARY
screen to calculate QC statistics.
1. In the right column of the QC SUMMARY screen, select
<D.Range>. The Date Range dialog window displays.
2. Enter the date range then select <ON> to confirm the
selection. The Date Range dialog window displays.
3. Select <OK>. Statistics for the selected date range of the
highlighted assay display.
NOTE: A value within the defined date range displays
as a blue dot on the Levey-Jennings graph. A value
outside the defined date range displays as a gray dot on
the graph.
NOTE: The pink update button will display to alert the
operator that statistics were changed. Press <Update>
to clear the button.
• When a date range is activated for an assay, the text
is blue.
• The date range will display on the “from__/__/__ to
__/__/__” below the D.Range button when the assay
is highlighted on the QC SUMMARY screen.
• If multiple assays are selected on the QC
SUMMARY screen with an activated date range,
“from__/__/__ to __/__/__” will be blank.
Deselecting Previously Stored Date Range

1. Select <D.Range>. The Date Range dialog window
displays.
2. Select <OFF>. The Date Range dialog window displays.
3. Select <OK>.
4. When date range is deactivated for an assay, the text is
black and “from__/__/__ to __/__/__” is black.
NOTE: The pink update button will display to alert the
operator that statistics were changed. Press <Update>
to clear the button.

200154-101—November 2004
Controls Section 5
Accessing the Levey-Jennings Graph Screen from the

QC SUMMARY Screen
Use the following instructions to access the Levey-Jennings
Graph screen for an assay from the QC SUMMARY screen.
1. Select the line that displays the QC statistics of the selected
assay.
2. Select <LJ Graph> in the right column of the
QC SUMMARY screen. The Levey-Jennings Graph screen
displays for the selected assay.

200154-101—November 2004
Section 5 Controls
Levey-Jennings Graph Screen

To display the Levey-Jennings Graph screen, select <QC> in
the right column of the ASSAY STATUS screen, or select
<LJ Graph> on the QC SUMMARY screen.
Figure 5.76: Levey-Jennings Graph Screen
The statistics and graphs display for the first four QC levels
defined. To view data for additional control levels select
on the screen.

200154-101—November 2004
Controls Section 5
Statistics for all QC values included in the QC files display in

the left section of the screen for each level (up to 450 values).
The following information displays on the Levey-Jennings
Graph screen.
Item Description
QC1...QC8 Level defined on the QC page of the Assay
(QC Name) QC name defined on the
Range Actual range (Max value–Min value) of the
QC data
(Max = 450)

A Levey-Jennings graph displays for each level in the center
section of the screen.
On the left side of the graph, the configured mean, + 1 SD,

+ 2 SD, – 1 SD, and – 2 SD values display. The mean value is
defined on the CALIBRATOR/CONTROL screen. The
SD value is defined on the QC page of the Assay
The graph area displays the ± 1 SD range in green, ± 2 SD
range in yellow, and ± 3 SD range in red. Each accepted
QC value within the ± 3 SD range displays as a blue or gray dot
on the graph. If the accepted value is greater than ± 3 SD, it
displays as a blue or gray bar at the top or bottom of the graph.
Excluded values greater than ± 3 SD display as pink bars at the
top or bottom of the graph. The vertical dotted lines indicate
separate days.

200154-101—November 2004
Section 5 Controls
Values can be excluded from the calculation of statistics. If a

value is excluded, the displayed dot is white with a pink
outline. If the excluded value is greater than ± 3 SD, the
displayed bar is pink.
NOTE: The procedure for excluding QC values is
described in the next section, Levey-Jennings Details.
The dates displayed in the upper-left and right of the graph are
the completion dates of the first and last QC values in the file
(up to 450).
The dates displayed on the bottom left and right of the graph
area are the completion dates of the first and last QC values
currently displayed in the graph (up to 31 points). To display a
different date range of the graph, select or on the
screen to scroll left or right.

200154-101—November 2004
Controls Section 5
Levey-Jennings Details
Use the following instructions to display information for a
point on the Levey-Jennings Graph screen.
1. Select the Levey-Jennings graph for the QC level to be
viewed, by selecting the area of the screen where the graph
displays. The left section of the selected level is colored
blue and a point on the graph is also highlighted in blue.
2. The following information for the highlighted point

displays at the bottom of the Levey-Jennings Graph
screen.
• Result value (an “L” or “H” Result Flag displays next to
the result if the value is outside the defined 2 SD range
and a Result Error Code displays if an error occurred
for the result)
• Date and time completed
• Result #/total # of QC values for the level
To view information for another point on the graph, select the
point by touching it, or press the left and right arrow keys
[씯] [씮] on the keyboard to scroll left and right.
The result value of a point on the Levey-Jennings Graph
screen can be displayed on the Details dialog window. Also,
on the Details dialog window, a result can be excluded from
calculation of the QC statistics.

200154-101—November 2004
Section 5 Controls
Use the following instructions to display the Details dialog

window for a point.
1. Select the point for which details are needed.
2. Select <Details> in the right column of the
Levey-Jennings Graph screen. The Details dialog
window displays.
Figure 5.78: Details Dialog Window
3. The following information displays on the Details dialog

window.
Details Dialog Window

Item Description
Value Result value of the selected QC point
NOTE: An “L” or “H” Result
Flag displays next to the result if
the value is outside the defined
2 SD range. A Result Error Code
displays if an error occurred for
the result.
Min Lowest result value in the QC data
Max Highest result value in the QC data
Date Completion date and time of the
selected QC point
SD Actual standard deviation of the QC
data
CV Actual coefficient of variation of the
QC data
Operator User code of the operator who last
defined or edited the assay

200154-101—November 2004
Controls Section 5
Details Dialog Window (Continued)

Item Description
Include/Exclude The selected QC value can be included
or excluded in the calculation of the
QC statistics
Comment A comment can be selected from the
drop-down list box or added for a QC
value
Excluded by This message displays in pink text
Date Range when a QC value is outside the
selected QC date range
NOTE: The mean, SD, and CV are calculated using

all data points except those excluded on the
4. To exclude the displayed value, select the Exclude option
at the bottom of the Details dialog window.
NOTE: If a date range is configured for the assay:
– QC values for the selected date range are blue.
– Excluded QC values are white.
– QC values outside the date range are gray.
5. To add a comment, touch the drop-down list box to view
the available comments. Select the desired comment then
select the return arrow to close the list.
Figure 5.79: Comment Drop-down List Box
6. Select <OK>. The selected comment is added to the

Details dialog window.

200154-101—November 2004
Section 5 Controls
7. To configure a new comment, select <Comment> on the

Details dialog window. The Comments dialog window
displays.
Figure 5.80: Comments Dialog Window
8. Move the cursor to an empty position; up to 50 comments

can be configured. Select <Edit> in the right column of the
Comments dialog window. The Edit Comment dialog
window displays.
Figure 5.81: Edit Comment Dialog Window
9. Enter the new comment; up to 30 alphanumeric

characters can be entered for each comment.
10. Select <OK>. The Comment Edited dialog window
displays.
Figure 5.82: Comment Edited Dialog Window

200154-101—November 2004
Controls Section 5
11. Select one of the following options.
Option Description
Delete The new comment is added to the comment
list. If a previous comment was edited, this
selection deletes the previous comment, and
No Comment is the default setting in the
Comment field for any QC values with this
comment.
Replace The new comment is added to the comment
list. If a previous comment was edited, this
selection replaces the previous comment for
any QC values with this comment.
Cancel Returns to the Comments dialog window.
12. To delete a previous comment, select <Delete> on the

Comment Edited dialog window. A pop-up window
displays the message “Now deleting comment”. For all QC
values with that assigned comment, the deleted comment
is replaced with “No Comment”.
13. Select <OK> to return to the Details dialog window.
14. To replace a previous comment, select <Replace> on the
Comment Edited dialog window. For all QC values with
that assigned comment, the previous comment is now
replaced with the edited comment.
15. Select <OK> to return to the Details dialog window.
16. If <Cancel> is selected on the Comment Edited dialog
window, the Comments dialog window displays.
NOTE: It is not possible to edit a previous QC comment
and allow the previous QC comment to remain
unedited when assigned to QC values before the edit.
This feature only allows removal of an existing
comment, adding “No Comment” or replacing a
previous comment with the edited comment.

200154-101—November 2004
Section 5 Controls
QC Data List
QC data for an assay display in a list format on the QC Data
List screen. To display the assay data, select <DataList> in the
right column of the Levey-Jennings Graph screen. The
QC Data List screen displays.
2 3 4
Figure 5.83: QC Data List Screen
All QC values for the first three QC levels display. To view

additional QC values for the displayed levels or to view
additional levels, select the arrow buttons in the right column
of the screen.

200154-101—November 2004
Controls Section 5
The following information displays for each value.
Item Description
1 Result = result value
2 R = “L” or “H” Result Flag (if the value is outside the
defined 2 SD range)
3 ERR = Result Error Code (if an error occurred for the
result)
4 Aspirate Date = date and time aspirated
NOTE: Excluded values display with pink text.
NOTE: If a date range is configured for the assay:

– QC values for the selected date range are black.
– Excluded QC values are pink.
– QC values outside the date range are gray.
NOTE: The mean, SD, and CV are calculated using all
data points except those excluded on the

200154-101—November 2004
Section 5 Controls
Deleting QC Data
The AEROSET System holds 450 data points per level for each
assay. When the maximum capacity is reached, the system
deletes data on a first in/first out basis.
This procedure is performed to manually delete all QC data
from all QC files for an assay. A single QC value cannot be
deleted, but can be excluded from the calculation of the QC
statistics.
Use the following instructions to delete all QC data for an

assay.
NOTE: After the QC data are deleted, they are no longer
accessible on the QC SUMMARY, Levey-Jennings
Graph, and QC Data List screens. The QC data
continues to display on the DATABASE screen until the
database is cleared during SHUTDOWN.
1. Select <QC Summary> in the Information Access Area of
the Main Display. The QC SUMMARY screen displays.
2. Select the assay for which all QC data will be deleted.
3. Select <Delete> in the right column of the QC SUMMARY
screen. The Delete confirmation dialog window displays.
4. Select <OK>. All QC data from all QC levels defined for the
assay are deleted.

200154-101—November 2004
Controls Section 5
Printing QC Results
Three report formats are available for printing QC data. Refer
to Appendix B, AEROSET System Printed Reports for examples of
these QC reports.
Report Description
Levey-Jennings Each value prints with the date completed
Graph and is plotted on the Levey-Jennings graph
that prints vertically down the page. All
included points are plotted with “*” and
excluded values are plotted with “+”. The
QC name and statistics are printed at the
top of the report.
displays next to the result if the
value is outside the defined 2 SD
range. A Result Error Code displays if
an error occurred for the result.
QC Data List Lists all QC values with the date aspirated.
The QC name and statistics are printed at
the top of the report.
displays next to the result if the
value is outside the defined 2 SD
range. A Result Error Code displays if
an error occurred for the result. “D”
displays for excluded values.
QC Summary Prints the statistics displayed on the
QC SUMMARY screen.
NOTE:
If... Then
Enable Control Reports is Reference ranges printed
selected for Printer B (Form 2) on the report are patient
and reference ranges, not QC
ranges.
the Reference Ranges option on
the PAGE SETUP screen is
selected for Form 2

200154-101—November 2004
Section 5 Controls
Levey-Jennings Graph Report

Use the following instructions to print the Levey-Jennings
graph report.
1. Select <ASSAYS> in the Information Access Area of the
2. Select the assay name. The ASSAY STATUS screen
displays.
3. Select <QC> in the right column of the screen. The
Levey-Jennings Graph screen displays.
NOTE: The Levey-Jennings Graph screen can also be

accessed from the QC SUMMARY screen. Select the line
that displays the QC statistics of the selected assay then
select <LJ Graph> in the right column of the screen.
The Levey-Jennings Graph screen displays.

200154-101—November 2004
Controls Section 5

5. Select from the following print options.
Option Description
Only Selected Assay Only QC statistics for the assay
selected on the ASSAYS or QC
SUMMARY screen are printed.
NOTE: If multiple assays are
highlighted on the QC
SUMMARY screen and the
Print Options dialog
window is accessed from the
Levey-Jennings Graph or
QC Data List screen, only
statistics for the displayed
assays are printed.
All Assays QC statistics for all configured
assays are printed.
Only Selected Date Only QC statistics for the
Range configured date range are printed.
NOTE: To print a date range, select either <Only

Selected Assay> or <All Assays> in addition to
<Only Selected Date Range>.

200154-101—November 2004
Section 5 Controls
6. Select one of the following sort options.
Option Description
Assay All QC report(s) print for one assay
before printing QC report(s) for the
next assay.
Category Each category of the QC report
prints for all assays before printing
the next QC report category.
7. Select the Levey-Jennings graph report category from the

following list.
• QC Summary
• Levey-Jennings Graph
• QC Data List
NOTE: One, two, or all three reports can be
selected.
8. Select the QC level to be included in the report.
Option Description
All QC All configured QC levels are
printed on the QC reports.
NOTE: When selected, this
option overrides individual
QC selections.
QC1–QC8 Individual levels of QC can be
selected to print on the QC reports.
9. Select <OK>. The Print QC Data List confirmation dialog

window displays.
Figure 5.87: Print QC Data List Confirmation Dialog

Window
10. Select <OK>.

200154-101—November 2004
Controls Section 5
QC Data List Report

Use the following instructions to print the QC Data List report.
displays.
NOTE: The QC SUMMARY screen can also be used
to access the Levey-Jennings Graph screen. Select
the line that displays the QC statistics of the
selected assay then select <LJ Graph> in the right
column of the screen. The Levey-Jennings Graph
screen displays.
4. Select <DataList>. The QC Data List screen displays.
Figure 5.88: QC Data List Screen

200154-101—November 2004
Section 5 Controls

Option Description
Only Selected Assay Only QC statistics for the assay
SUMMARY screen are printed.
NOTE: If multiple assays are
highlighted on the QC
SUMMARY screen and the
Print Options dialog
window is accessed from the
Levey-Jennings Graph or
QC Data List screen, only
statistics for the displayed
assays are printed.
assays are printed.


200154-101—November 2004
Controls Section 5
Option Description
before printing the QC report(s) for
the next assay.
8. Select the QC Data List report category from the following

list.
• QC Summary
• QC Data List
selected.
Option Description
QC selections.
10. Select <OK>. The Print QC Data List confirmation dialog

window displays.
Figure 5.90: Print QC Data List Confirmation Dialog

Window
11. Select <OK>.

200154-101—November 2004
Section 5 Controls
QC Summary Report
Use the following instructions to print a report of the
QC summary statistics.
2. Select <Print> in the right column of the screen, or select
the desired assays then select <Print>. The Print Options
Option Description
Only Selected Assay Only QC statistics for the assay(s)
selected on the QC SUMMARY
screen are printed.
assays are printed.


200154-101—November 2004
Controls Section 5
Option Description
before printing the QC report(s) for
the next assay.
5. Select the QC summary report category from the following

list.
• QC Summary
• QC Data List
selected.
Option Description
QC selections.
7. Select <OK>. The Print QC Summary confirmation dialog

window displays.
Figure 5.92: Print QC Summary Confirmation Dialog

Window
8. Select <OK>.

200154-101—November 2004
Section 5 Controls
Exporting QC Data
QC data and statistics can be exported from the QC
SUMMARY or Levey-Jennings Graph screen to a floppy disk.
The information is saved in a .csv format on the disk. A file in
this format can be opened and viewed in most commercially
available PC spreadsheet programs (Microsoft Excel,
Lotus 1-2-3, etc.). Exported QC data cannot be imported back
to the system.
NOTE: Use a formatted floppy disk. The disk can be
formatted on the System Control Center. If an alternate
format is used, the format must be Windows 95 or
DOS 5.0 (or higher).
QC SUMMARY Screen
Use the following instructions to transfer QC data from the
AEROSET System to a floppy disk, from the QC SUMMARY
screen.
2. Select <Export> in the right column of the screen, or
select the desired assays then select <Export>. The Export
Figure 5.93: Export Options Dialog Window

200154-101—November 2004
Controls Section 5
3. Select one of the following export options.
Option Description
selected on the QC SUMMARY
screen are exported.
assays are exported.
Range configured date range are
exported.
Option Description
Assay All QC statistics display for one
assay before displaying QC
statistics for the next assay.
Category Each category of QC data displays
for all assays before displaying the
next QC data category.
Separate Report by If selected, a separate file will be
Assay created for each assay.
5. Select the QC report category from the following list.

• QC Summary
• QC Data List
NOTE: One or both reports can be selected.
6. Select the QC level to be exported.
Option Description
QC selections.
selected to export.

200154-101—November 2004
Section 5 Controls
7. Select <OK>. The Export QC Data dialog window

displays.
Figure 5.94: Export QC Data Dialog Window

NOTE: Ensure FLOPPY DISK displays in the Drive
field.
10. Select <OK>. The Export QC Data confirmation dialog
window displays.
Figure 5.95: Export QC Data Confirmation Dialog Window
11. Select <OK>. QC data are transferred to the floppy disk.


200154-101—November 2004
Controls Section 5
Levey-Jennings Graph Screen

Use the following instructions to transfer QC data from the
AEROSET System to a floppy disk, from the Levey-Jennings
Graph screen.
displays.
NOTE: The QC SUMMARY screen can also be used
to access the Levey-Jennings Graph screen. Select
the line that displays the QC statistics of the
selected assay then select <LJ Graph> in the right
column of the screen. The Levey-Jennings Graph
screen displays.
4. Select <Export> in the right column of the screen. The
Export Options dialog window displays.
Figure 5.96: Export Options Dialog Window

200154-101—November 2004
Section 5 Controls
5. Select one of the following export options.
Option Description
SUMMARY screen are exported.
assays are exported.
Range configured date range are
exported.
Option Description
Assay All QC statistics display for one
assay before displaying QC
statistics for the next assay.
Category Each category of QC data displays
for all assays before displaying the
next QC data category.
Separate Report by If selected, a separate file will be
Assay created for each assay.
7. Select the QC report category from the following list.

• QC Summary
• QC Data List
NOTE: One or both reports can be selected.
8. Select the QC level to be exported.
Option Description
QC selections.
selected to export.

200154-101—November 2004
Controls Section 5
9. Select <OK>. The Export QC Data dialog window

displays.
Figure 5.97: Export QC Data Dialog Window

NOTE: Ensure FLOPPY DISK displays in the Drive
field.
12. Select <OK>. The Export QC Data confirmation dialog
window displays.
Figure 5.98: Export QC Data Confirmation Dialog Window
13. Select <OK>. QC data are transferred to the floppy disk.


200154-101—November 2004
Section 5 Controls
Westgard QC Rules
The AEROSET System can be configured to evaluate QC results
with Westgard QC rules. The following rules are available in
order of priority, from highest to lowest.
Rule Description
13S One control value exceeds ± 3 SD.
22S Two consecutive control values for one level
exceed ± 2 SD.
R4S The difference between two consecutive control
values exceeds 4 SD.
41S Four consecutive control values for one level
exceed ± 1 SD.
10x Ten consecutive control values for one level lie on
one side of the mean.
The operator selects the rules to be used for evaluation. Also,

each assay can be configured to use the selected rules or not
use any rules on the QC page of the Assay Configuration
screen.
NOTE: For each data point, only the highest priority
rule displays. Priority is described in the preceding
table.
If Westgard rules will be used for evaluation, the expected
mean and SD must be defined for each assay to be evaluated.
Installation Procedures and Special Requirements for details
on configuring QC rules.
NOTE: For other QC rules to be checked when a value
is within 2 SD, the first QC rule (1-2 SD) must be
modified by adding a zero in the Num field box of this
rule. This would allow QC results to be evaluated
against the other rules.

200154-101—November 2004
Controls Section 5
If the system determines a control value violates a Westgard

rule, an Error Log Message is generated. The violated rule also
displays in the QC Rule column on the ASSAY STATUS screen.
NOTE: QC data are checked first against the 1-2 SD
rule, if enabled. If the data are within 2 SD, the data are
considered “in-control” and are not evaluated against
the other QC rules. No Westgard rule Error Log Message
appears on the ASSAY STATUS screen when the data
are considered “in-control”.
An example of a Westgard rule violation on the ASSAY
STATUS screen is shown.

200154-101—November 2004
Unloading
Samples and Sample Carriers

Hazards.
Use the following instructions to unload samples and sample

carriers.
1. Carefully lift the sample carrier tray and remove it from
the FastTrack™ Sampler. Use caution when transporting
sample carrier trays to avoid sample splashing outside the
sample vessels.
2. Carefully remove the sample carriers from the sample
carrier tray.
3. Carefully remove the samples from the sample carrier.
4. Dispose of sample vessels according to laboratory
guidelines.

200154-101—November 2004
Unloading Section 5
Reagent Cartridges
Reagent cartridges are unloaded from the Reagent Supply
Centers for the following reasons:
• When reagents are depleted or expired
• To allow room for different assay reagent cartridges
• When power to the refrigeration units (Main Circuit
Breaker Switch) will be OFF
Use the following instructions to unload reagent cartridges

from the Reagent Supply Centers.
1. Both Reagent Supply Centers can be accessed when the
system status is READY. If the system status is not READY,
pausing the system allows access to Reagent Supply
Center 1 as soon as the R1 Indicator on the Local User
Interface (LUI) Control Panel illuminates green. Refer to
PAUSE in this section for details. When all assays in
process are complete, the R2 Indicator illuminates,
indicating Reagent Supply Center 2 can be accessed.
REMOVE
RACK
TRAY
HOME
TRAY
FEED
TRAY
FEED R2 R1
Figure 5.99: Local User Interface Control Panel
2. Open the main cover to the analyzer.

3. Remove the Reagent Supply Center cover.
4. Press the R1 or R2 Indicator on the LUI Control Panel to
advance the Reagent Supply Center to the desired
position.
5. Remove the reagent cartridge from the carousel.
6. The reagent cartridge should be capped when moved to
refrigerated storage.
7. Replace the Reagent Supply Center cover.

200154-101—November 2004
Section 6
Section 6:
Calibration Procedures

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Calibration Theory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Calibration Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Photometric . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Potentiometric . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
ICT™ Calibration Method . . . . . . . . . . . . . . . . . . . 6-3
Calibration Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Full Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Blank Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
1-point Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
2-point Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Automatic Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7

Required Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Optional Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Calibration Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Performing a Calibration Run . . . . . . . . . . . . . . . . . . . . . . . 6-9
Loading Calibrators . . . . . . . . . . . . . . . . . . . . . . . . 6-13
Initiating the Run . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
System-initiated Calibration . . . . . . . . . . . . . . . . . . . . . . . 6-14
Procedure for System-initiated Calibration . . . . . . . . . 6-14
Calibration Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
Calibration Data Check . . . . . . . . . . . . . . . . . . . . . . . . 6-16
ASSAY STATUS Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20
View Previous Calibration Curve . . . . . . . . . . . . . . . . . 6-23
View Stored Calibration Curves . . . . . . . . . . . . . . . . . . 6-24
View Calibration Details . . . . . . . . . . . . . . . . . . . . . . . . 6-24
Replace Current Calibration with Previous
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-26
Reviewing ICT Calibration Information . . . . . . . . . . . . 6-28
CALIBRATION SUMMARY Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-29
Calibration Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-31

Saving Calibration Data to the Stored Average . . . . . . . . . 6-31
Viewing the Stored Calibration Data . . . . . . . . . . . . . . . . . 6-32
Deleting Calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
Deleting the Previous Calibration Data . . . . . . . . . . . . 6-33
Deleting the Stored Average . . . . . . . . . . . . . . . . . . . . . 6-34

200154-101—November 2004
Calibration Procedures Section 6
Printing Calibration Summaries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-35

Current Calibration Summary . . . . . . . . . . . . . . . . . . . . . . 6-35
Stored Calibration Summary . . . . . . . . . . . . . . . . . . . . . . . 6-36

200154-101—November 2004
Section 6 Calibration Procedures
Section 6: Calibration Procedures
Overview
This section provides information for performing assay
calibrations on the Abbott AEROSET System, including:
• When to calibrate
• Ordering a calibration
• Loading calibrators
NOTE: Several types of calibrators are used on the
AEROSET System, both serum and aqueous based
materials. Refer to the CALIBRATION section of
the Abbott Clinical Chemistry Package Inserts
• Reviewing calibration results

200154-101—November 2004
Calibration Theory
Calibration can be described as analysis of samples with
known concentrations, recording the absorbance value(s), and
plotting the measured absorbance values against known
concentration—to create a graph for evaluating unknown
sample absorbances.
Calibration Methods
Photometric
After the AEROSET System measures absorbance values for
each of the calibrators, a calibration curve is plotted. The
system has 11 different methods of analyzing data, known as
“Math Models”. The term Math Model defines a mathematical
procedure used to analyze given data. The procedure can range
in complexity from a simple subtraction to a non-linear least
squares best fit. The available methods include:
• Abs (Absorbance)
• Factor
• 1-point Linear (blank and one calibrator)
• Multi-point Linear (blank and two to eight calibrators)
• Isozyme
• Logit-4
• Logit-5
• Exponent
• Spline
• Use Factor
• Use Fac/Blk (Factor and Blank)
NOTE: The calibration method is defined on the
Calibration page of the Assay Configuration screen.
Requirements for more information. For additional
information on Math Models, refer to Appendix A,
AEROSET System Math Models.

200154-101—November 2004
Potentiometric
ICT™ Calibration Method

ICT assays (electrolytes) are calibrated using solutions with
known concentrations of sodium (Na+), potassium (K+), and
chloride (Cl-). Serum ICT calibrators are protein-based
material, while the urine calibrators are aqueous. Urine
calibrators span a greater range of concentration due to
characteristics of urine samples.
The millivolts (mV) measured by each electrode are plotted
against the known concentration of electrolyte in the
calibrator. The slope of the calibration curve is expressed as a
percentage of the ideal slope. Electrolyte determinations are
made at 37°C; therefore, the ideal slope of the electrode is
62 mV/decade. The ratio of the measured slope and the ideal
slope are calculated, then the result is expressed as a
percentage.
NOTE: An ideal slope is 100%. For example, if the slope
is calculated as 31 mV/decade, the ratio, as a
percentage, is 50 (%).
As each sample is processed, ICT reference solution is aspirated
and measured before and after each sample. ICT reference
solution mV is measured and evaluated against the calibration
curve. The potential difference of each electrode is determined
when it contacts the sample and ICT reference solution. This
potential difference is used to compute the overall potential
difference between the low calibrator and sample, which is
used to calculate the sample concentration.
NOTE: Refer to the assay-specific and calibrator-specific
package inserts for information on calibrator handling,
calibration configuration, and calibration curve
stability.

200154-101—November 2004
Calibration Options
Four calibration options are available for photometric assays.
• Full Calibration
• Blank Calibration
• 1-point Adjustment
• 2-point Adjustment
Full Calibration
All data points (reagent blank and calibrators) defined on the
Calibration page of the Assay Configuration screen are
reanalyzed and a new calibration curve is generated.
NOTE: A full calibration is required to update the
calibration date.
Blank Calibration
Only the reagent blank is reanalyzed. Use the following
instructions to adjust the calibration curve with new reagent
blank data.
Step Action
1 The new measurement is performed for the reagent
blank.
2 The value of the reagent blank absorbance obtained
in the new measurement replaces the value obtained
in the previous measurement.
3 The curve is adjusted up or down, based on the
change in the reagent blank.

200154-101—November 2004
1-point Adjustment
A single calibrator is reanalyzed. The calibrator used is defined
on the Calibration page of the Assay Configuration screen.
Use the following instructions to adjust the calibration curve
with new calibrator data.
Step Action
1 The new measurement is performed for the
calibrator.
2 A ratio is calculated comparing new and previous
absorbance data.
Ratio = New measured absorbance
Previously measured absorbance
3 All other calibrators (except the reagent blank) are
adjusted using the calculated ratio.
4 A new calibration curve is generated using the data
points after adjustment.
2-point Adjustment
Both the reagent blank and a single calibrator are reanalyzed.
The calibrator used is defined on the Calibration page of the
Assay Configuration screen. Use the following instructions to
adjust the calibration curve with the new calibrator data.
Step Action
1 The new measurement is performed for the reagent
blank and calibrator.
2 The value of the reagent blank absorbance obtained
in the new measurement replaces the value obtained
in the previous measurement.
3 The curve is adjusted up or down based on the
change in the reagent blank.
4 A ratio is calculated comparing new and previous
absorbance data.
Ratio = New measured absorbance
Previously measured absorbance
5 All other calibrators (except the reagent blank) are
adjusted using the calculated ratio.
6 A new calibration curve is generated using the data
points after adjustment.

200154-101—November 2004
Automatic Calibration
The AEROSET System can be configured to perform automatic
calibrations for the following situations:
• Calibration at the end of the defined calibration interval
• Calibration after reagent lot change
• Calibration after reagent cartridge change
NOTE: When configured, automatic calibration is
performed only when a reagent lot change or cartridge
change occurs during a run. Automatic calibration is
not performed when a reagent lot or cartridge change is
detected at the start of a run that is initiated from the
READY status.
NOTE: If an automatic calibration is expected during a
run, ensure the correct calibrators are loaded before
starting the run.
NOTE: Refer to Assay Configuration in Section 2,
information on Automatic Calibration options.
NOTE: Calibrators must be defined on the
CALIBRATOR/CONTROL screen for the Automatic
Calibration option to be used.
NOTE: Stability of calibrators on the Calibrator/Control
Carousel has not been established.

200154-101—November 2004
Calibration Guidelines
Required Calibration
A calibration run on every assay must be performed when:
• The AEROSET System is installed.
• An Abbott Field Service Representative replaced the
System Control Center (SCC) and assay files were not
backed up. It is recommended to perform routine backups.
A full calibration run on a particular assay must be performed
when:
• A new reagent lot number is used.
• The calibration curve is expired.
• Existing assay file parameters were updated or changed.
• A new assay file was installed.
Optional Calibration
A new calibration run for an assay may be necessary in the
following situations:
• Assay control values are out of specification.
NOTE: Refer to the assay-specific package inserts
for specific information regarding quality control.
• Any system maintenance or component replacement
procedure was performed.
Refer to Section 10, Troubleshooting and Diagnostics to determine
if recalibration is necessary when an error occurs.
NOTE: It is recommended that all levels of appropriate
controls are run whenever an assay is calibrated. Refer
to Section 5, Operating Instructions for information on
quality control procedures.

200154-101—November 2004
Calibration Guidelines Section 6
Calibration Rules
Calibrators are aspirated before pipetting of any control or
patient sample if calibrations are ordered before initiation of a
run.
If a calibration passes all criteria, the AEROSET System:
• Moves the existing curve to the previous file
• Stores the successful calibration in the current file
• Automatically defaults to the current curve
If a calibration fails, the AEROSET System:

• Stores the failed curve in the current file
• Attempts to use the failed curve, but flags patient and
control results with a Result Error Code CAL
If a usable calibration curve cannot be generated (calibrators
not loaded, Result Error Code SR) the AEROSET System:
• The current curve is unusable
• Flags patient and control results with Result Error Code
UTC
NOTE: The AEROSET System uses only the current
calibration curve to generate patient and/or control
results.
If a current calibration curve is flagged with EXP:
• The curve moves to the previous file as soon as a new
calibration curve is completed.
• Absorbance values print for the calibration with an EXP
flag, but the system does not calculate a calibration curve.
Refer to Calibration Error Codes in Section 10,
Troubleshooting and Diagnostics.
If a calibration is terminated by a hardware error or by

selecting <STOP> before completion:
The current and previous calibration data do not change.

200154-101—November 2004
Section 6 Calibration Guidelines
Performing a Calibration Run

Use the following instructions to order a calibration for one or
more assays.
2. Select the checkbox (聺) next to the Calibration option by

touching the box.
3. Touch the drop-down list box next to Calibration then
select the desired Calibrator/Control Carousel and Sample
Carousel configuration option.
Option Calibrator Locations

The system only uses calibrators on the
Set 1 The system uses calibrators on the
Calibrator/Control Carousel and the Set 1
configuration of the Sample Carousel.

200154-101—November 2004
4. Select the return arrow to close the list.

NOTE: The system does not allow the Sample
Carousel to be used for calibrators and patient
samples at the same time. If the Set 1, Set 2, or
Set 3 options are selected, the operator can select
the checkbox (聺) next to either the Patient or
Calibration option. The other option is
automatically deselected (□).
Example: The RUN OPTIONS screen has a
checkmark (聺) next to the Calibration option and
Set 1 configuration is selected. If the Patient
option is selected, the Calibration option is
deselected (□).
If the blank (_______) Calibration option is
selected, only patient samples can be loaded on
the Sample Carousel and calibrators loaded on the
Calibrator/Control Carousel. The system then
allows both the Calibration and Patient options to
be selected.
5. Select <Order> to the right of the Calibration options
drop-down list box. The SELECT ASSAYS FOR
CALIBRATION screen displays.
Figure 6.2: SELECT ASSAYS FOR CALIBRATION Screen

200154-101—November 2004
6. At the top of the screen, select the checkbox (聺) next to

the desired Calibration option by touching the box. The
following options are available.
• Full
• Blank
• 1-point
• 2-point
NOTE: A full calibration is the only option
available for potentiometric assays.
NOTE: When running an assay that utilizes an
absorbance window, Result Error Code PHO
(photometer) may be generated on initial
calibration. This is due to the system software
initializing absorbance window variables during
installation of the Assay Disk and initial
calibration. This is a software operation internal to
the AEROSET System and does not impact system
performance or user operation. If the PHO error
code is generated during initial full calibration,
recalibrate the assay and proceed. If the error
persists, refer to Section 10, Troubleshooting and
Diagnostics. To prevent generation of the PHO
error, a blank calibration should be performed
before the initial full calibration.
7. Select the assay button for the assays to be calibrated.
Individual assays or panels can be selected. The defined
Calibration option is indicated by a colored line under the
assay name on the buttons.
NOTE: Different Calibration options can be
selected for different assays in one calibration run.
Select the Calibration option before selecting the
assay name button and verify the Calibration
option by viewing the colored line under the assay
name.

200154-101—November 2004
8. When all desired assays are selected, select <OK> in the

upper-right corner of the SELECT ASSAYS FOR
CALIBRATION screen. The RUN OPTIONS screen
displays.
NOTE: It is necessary to perform a full calibration
on any assay for which the configured calibrator
values have been edited. This calibration must be
performed immediately after the edits. Refer to
Calibrator/Control Configuration in Section 2,
information on calibration configuration.
NOTE: To perform control measurement after
calibration, select the checkbox (聺) next to the
QC after Calib option by touching the box.
Controls are run automatically after calibration is
run for the assays selected to calibrate. Also, select
the checkbox (聺) under the desired QC level(s).
9. Select <Save> in the right column of the RUN OPTIONS
screen to save the calibration order. A Save confirmation
10. Select <OK>.

11. Select <Cancel> on the RUN OPTIONS screen to exit the
screen without starting the run.

200154-101—November 2004
Loading Calibrators
displays. Calibrators that need to be loaded display with a
green line under the calibrator name.
2. Pipet the appropriate calibrator materials into sample
cups.
NOTE: When water is defined for the blank, water
is dispensed by the system from the sample probe.
Therefore, water does not need to be loaded on the
3. Load the calibrators in the carousel positions defined on
the CALIBRATOR/CONTROL screen.
4. If the Set 1, Set 2, or Set 3 options are selected on the RUN
OPTIONS screen, select the corresponding button on the
CALIBRATOR/CONTROL screen to view the calibrators
that need to be loaded.
NOTE: I-Index (index solution) is not currently
used, but Calibrator/Control position 42 (I-Index)
must have a concentration of zero defined for all
ICT™ assays. If the concentrations are not defined,
the ICT buttons do not display on the SELECT
ASSAYS FOR CALIBRATION screen.
Initiating the Run

2. Ensure the Calibration option is still selected.
3. Select <Start> in the upper-right corner of the screen to
initiate the calibration run.
CAUTION: A calibration should not be initiated when
! a previously ordered calibration for that assay is still
processing. The calibration curve and date will not be
updated properly.

200154-101—November 2004
System-initiated Calibration
When the AEROSET System determines a calibration is
required at the time a patient run is initiated and the
Calibration option is not selected on the RUN OPTIONS
screen, a screen displays to alert the operator of this condition.
Based on anticipated or current samples to be processed, the
operator must determine if calibration is required.
Procedure for System-initiated Calibration

OPTIONS screen to initiate sample processing. The system
determines a calibration is required, and a screen displays
to indicate which calibrations are required.
2. Select <OK>. The SELECT ASSAYS FOR CALIBRATION
screen displays. Four options are available.
Option Description
OK All suggested calibrations and
automatic calibrations are
performed.
Cancel No displayed calibrations or
performed.
NOTE: Selecting <Cancel>
does NOT stop the AEROSET
System from running.
<Cancel> refers only to the
Calibration option displayed.
DSelect All assays are deselected. Only
performed.
NOTE: After selecting
<DSelect>, <OK> must be
selected.
Manual Selection Select or deselect the desired
assay(s). All selected calibrations and
performed.
3. Select the desired option.

4. Any necessary calibrators must be loaded.

200154-101—November 2004
Calibration Review
After calibration is performed, the AEROSET System verifies
calibrator results by comparing them to assay parameter
specifications defined on the Calibration page of the Assay
The AEROSET System software requires one valid calibrator
replicate per required calibrator level to compute a curve,
unless a greater number is specified in the assay-specific
package inserts.
NOTE: Refer to the ASSAY PARAMETERS section of the
assay-specific package inserts for information on the
minimum number of replicates for a specific assay.
If no system errors occur and calibration results are within
assay parameter specifications, the calibration passes. Assay
button text on the ASSAYS screen is green.
If a system error occurs or if calibration results fall outside
assay parameter specifications, the following occur:
• Assay button text on the ASSAYS screen is yellow
• Calibration Error Code displays on the ASSAY STATUS
screen and Error Log
• Result Error Code CAL displays on the RESULT screen for
any patient sample run after the failed calibration

200154-101—November 2004
Calibration Data Check

Seven types of check functions are available to verify generated
calibration curves. Refer to the assay-specific package inserts
for information on required checks for an assay. The check
functions are listed below, with explanations and illustrations.
Slope Check
Reagent
Blank
Absorbance
Check
Calibrator
Replicate
Deviation
Check
Factor
Comparison
Check
1. Reagent Blank Absorbance Check:

The Calibration Error Code BLK appears even if only one
absorbance value obtained through reagent blank
measurement (up to 5 absorbance values are obtained) is
outside the range defined for Blank Range.
NOTE: This Calibration Error Code may display
because of a data value that was rejected, though
the accepted absorbance values fall within the
defined range.
NOTE: If the selection for these fields is 0, this
data check is not performed.

200154-101—November 2004
2. Calibrator Replicate Deviation Check:

Calibration Error Code DEV appears if the variation of
data (absorbance or absorbance change) obtained in
replicate measurements of calibrators is greater than the
defined acceptable range.
NOTE: If the selection for this field is 0, this data
3. Slope Check:
Calibration Error Code SPN appears if the absorbance
change differences between the reagent blank and the
calibrator defined in Span BLK are outside the acceptable
range.
4. Factor Comparison Check:
Calibration Error Code FAC appears if the factor
(reciprocal of the slope) for the reagent blank and
Calibrator 1 on the calibration curve differ more than the
configured FAC Limit (%) from the same factor of the
previous calibration curve.
NOTE: The default setting is 0. If the selection for
this field is 0, this data check is not performed.
Requirements for additional information on configuration.
Factor Error
Previous Calibration
Curve
Factor Error
Figure 6.5: Factor Comparison Check

200154-101—November 2004
5. SD Check:
Calibration Error Code SD appears for a non-linear
approximation calibration curve when the sum of the
absolute values of the absorbance differences, between
the calculated calibration curve (Logit-4, Logit-5, or
Exponent) and the measured values exceed the defined
SD value.
SD
Check
6. Monotonic Check:
Calibration Error Code MON appears if the absorbances
are not monotonic (i.e., each successive read did not
follow the trend, up or down, of the preceding read). The
error occurs with the following conditions:
• When the accepted absorbance of the calibrator is not
monotonic
• When the approximate curve generated in Logit-4,
Logit-5, or Exponent mode is not monotonic
• When the interpolated curve generated in Spline
mode is not monotonic
NOTE: Assay parameter definition is not required.

200154-101—November 2004
7. Approximation Convergence Error:

Calibration Error Code CON appears for a non-linear
calibration curve, if the absorbance or absorbance change
does not converge even after the calculation is repeated
the defined number of times.
NOTE: Assay parameter definition is not required.

200154-101—November 2004
ASSAY STATUS Screen

Use the following instructions to review calibration curves
(passed or failed) and any associated Calibration Error Codes.
2. Select the desired assay name on the screen. The ASSAY

Calibration
Information

200154-101—November 2004
The Calibration Information area of the ASSAY STATUS

screen is shown.
2. Absorbance Values 3. Factor calculated

for each section of 4. Calibrator
(C1–C8 are corrected Concentration
for reagent blank) the curve
1. Calibration
Graph
8. Scrolls
between current,
previous, and
stored
calibration
5. Calibration Error curves
Code Display Area
6. Date and time the 7. Date and time the 9. Select to view
calibration expires calibration was performed the current
calibration curve
Figure 6.9: ASSAY STATUS Screen, Calibration Information
Area

200154-101—November 2004
ASSAY STATUS Screen, Calibration Information Area

Area Text/Field Description
1 Graph Displays the actual calibration curve.
Blue = current
Gray = previous
Pink = stored
2 Abs Displays the measured absorbance (or
absorbance change) of the blank and
calibrators. The absorbance values
displayed are the median or mean values
of the calibrator replicates and have been
corrected by the blank value.
3 Factor Displays the calculated factor for each
section of the curve.
Factor = 1 ÷ Slope
4 Conc Displays the calibrator concentration
configured on the
5 Calibration Area where any Calibration Error Codes
Error Code associated with the displayed calibration
curve are listed.
6 Calibration Displays the date and time the
Expiration calibration expires.
NOTE: The text “Automatic
Calibration” displays next to this
field when an automatic
calibration is scheduled.
7 Calibration Displays the date and time the
Date calibration was performed.
NOTE: This date and time only
updates when a full calibration is
performed.
8 Scroll Used to scroll between the current,
Buttons previous, and stored calibration curves.
9 CUR Select to view the current calibration
curve.
NOTE: When “*******” displays in the Factor/Slope
field, the number of decimal places configured must be
reduced to allow the system to display the actual
factor/slope. The maximum number of digits that can
display in this field is 7, including the negative sign and
decimal point.
200154-101—November 2004
View Previous Calibration Curve

Use the following instructions to compare the current
calibration curve data with previous calibration curve data.
1. On the ASSAY STATUS screen, select the button in the
lower-right corner of the Calibration Information area.
2. Data from the previous calibration display in the Abs and
Factor areas, and both the previous and current calibration
curve graphs display. The date the previous calibration
was performed displays in the lower-right corner of the
Calibration Information area. The previous calibration
curve and date performed text are gray. The current
calibration curve is blue.
NOTE: The Conc area displays currently
configured values from the
3. To return to current calibration data, select <CUR> or the
button in the lower-right corner of the Calibration
Information area of the ASSAY STATUS screen.
NOTE: If a current calibration curve is flagged with the
EXP Calibration Error Code, the curve reverts to a
previous status as soon as a new calibration curve is
completed. A current calibration curve with any other
error code, e.g., FAC or MON, does not revert to a
previous status.

200154-101—November 2004
View Stored Calibration Curves

Calibration data can be stored in the Stored Calibration
Summary file.
NOTE: Refer to Saving Calibration Data to the Stored
Average in this section for information about saving
calibration data to the Stored Calibration Summary.
NOTE: Stored calibration curves are viewable on the
ASSAY STATUS screen for photometric assays only.
Stored calibration curves for potentiometric assays are
not viewable on this screen.
Use the following instructions to view the stored calibration

curves.
2. The absorbance data and curve from the previous
calibration curve display.
3. Select the button on the screen. The absorbance data
and curve of the most recently stored calibration curve
display. The date the stored calibration was performed
displays in the lower-right corner of the Calibration
Information area. The stored calibration curve and date
performed text are pink.
4. Continue to select to scroll through all stored
calibration curves (up to 31), from the most recent to
earliest performed.
5. Select the button to scroll back to the most recent
calibration, or select <CUR> to return to current
calibration data.
View Calibration Details

For most Abbott AEROSET assay applications, each calibrator is
analyzed three times. The median value is used to calculate the
calibration curve. Use the following instructions to view all
three absorbance values measured for each of the calibrators
(or mV values for ICT™ assays).

200154-101—November 2004
1. Select <Calib> in the right column of the ASSAY STATUS

screen. The Calibration Details screen displays.
NOTE: This screen can also be accessed by
selecting <Detail> on the CALIBRATION
SUMMARY screen.
Figure 6.10: Calibration Details Screen
2. The absorbance values measured for all the replicates

display in the upper half of the screen. The displayed
values have not been corrected for the reagent blank.
NOTE: If the current curve was replaced with a
previous or stored curve, no absorbance values
display.
3. When entering the screen, blank absorbance values from
the stored averages display on the graph. Absorbance
values from each calibrator level can be displayed by
selecting each calibrator from the list next to the graph.

200154-101—November 2004
Replace Current Calibration with Previous Calibration

The AEROSET System allows use of data from the previous
calibration when current calibration data are unacceptable.
Use the following instructions to replace the current
calibration data with previous calibration data.
CAUTION: When the operator replaces current
! calibration data with the previous calibration data,
current calibration data are deleted and cannot be used.
CAUTION: Calibration curve replacement should not
! be performed if the previous calibration was performed
using calibrators with different concentration values
than those used for the current curve. The replacement
procedure only replaces absorbance values and the
curve is incorrectly calculated with new calibrator
values.
NOTE: The AEROSET System does not allow
replacement of a current curve with a previous or
stored curve that has a Calibration Error Code EXP or
INV. The Replace Calibration Data dialog window
displays.
Figure 6.11: Replace Calibration Data Dialog Window

200154-101—November 2004
NOTE: The system status must be READY to perform

the following procedure.

2. Data from the previous calibration curve display.
3. Select <Replace> in the right column of the screen. The
Replace Calibration Data confirmation dialog window
displays.
Figure 6.12: Replace Calibration Data Confirmation Dialog

Window
4. Select <OK>.
5. The ASSAY STATUS screen displays only the previous
calibration data.
6. Select <OK> on the ASSAY STATUS screen to exit. The
Save Calibration Edits dialog window displays.
Figure 6.13: Save Calibration Edits Dialog Window
7. Select <OK> to save the changes to calibration data.

200154-101—November 2004
Reviewing ICT™ Calibration Information

Calibration of ICT assays is requested on the RUN OPTIONS
screen. ICT serum calibrators are loaded on the
Calibrator/Control Carousel in positions 40 and 41, and ICT
urine calibrators are loaded in positions 38 and 39.
When the calibration is complete, calibration information can
be viewed on the ASSAY STATUS and CALIBRATION
SUMMARY screens. The Calibration Information area of the
ASSAY STATUS screen of the Na (Serum) assay is shown.
1 2 3 4
Figure 6.14: Calibration Information for Na (Serum) Assay
Functions of this screen are described in the following table.
Area Text Description

1 Graph Displays the actual calibration curve with a
blue line. The brown line indicates the 45%
slope limit.
2 mV Displays the measured mV (millivolt) values
of the low and high calibrators.
3 Slope Displays the slope of the curve expressed in
% ideal response. The slope is nearly 100%
when the ICT module is new, then decreases
with time and use. The ICT module cannot
be used with a slope less than 45%.
4 Conc Calibrator concentration defined on the
5 Idx This area of the screen is not used.

200154-101—November 2004
CALIBRATION SUMMARY Screen
The CALIBRATION SUMMARY screen displays data from the

last calibration performed for all assays. Data from a
calibration can be added to a stored average. To view the
calibration summary data, select <Cal Summary> in the
CALIBRATION SUMMARY screen displays.
Calibrator
Abs or Absorbance Change
Concentration Factor/Slope
Figure 6.15: CALIBRATION SUMMARY Screen
NOTE: When “*******” displays in the Factor/Slope

column, the number of decimal places configured must
be reduced to allow the system to display the actual
factor/slope. The maximum number of digits that can
display in this field is 7, including the negative sign and
decimal point.
The current (last) calibration performed displays. The
absorbance and factors of the reagent blank, as well as
absorbance and factors of all calibrators, display for
photometric assays. Slope and mV values display for
potentiometric assays. The button can be selected to view
calibrator levels not displayed.

200154-101—November 2004
CALIBRATION SUMMARY Screen Section 6
Text color indicates the calibration status:
Color Status
Black OK
NOTE: When using the Abs
calibration mode, text color is black
to indicate an OK status, even when
the calibrator absorbance value is
expired. The EXP Calibration Error
Code displays to alert the operator
of the expired calibration status.
When using the Abs calibration
mode, the operator must ensure a
valid cutoff calibrator absorbance
value is in use before releasing
results.
Pink Pending or calibration curve expiration
date exceeded
Brown Failed
NOTE: To access the Calibration Details screen for an

assay, highlight the assay data then select <Detail>.
To view the date and time each calibration was performed,
select <Dates> in the right column of the CALIBRATION
SUMMARY screen. The calibration dates display.
Figure 6.16: CALIBRATION SUMMARY Screen
To return to the view of calibration data, select <Cal Data> in

the right column of the screen.
200154-101—November 2004
Calibration Data
Saving Calibration Data to the Stored Average

If needed, current calibration data can be added to the stored
average. An average of the calibration absorbance data can be
maintained. The SD, CV, and range of the absorbance data are
also calculated. Use the following instructions to save data to
the stored average.
this procedure.
1. Select the desired assay calibration data to save to the

stored average, by selecting the assay name.
• To highlight multiple consecutive assays in the list,
select the first assay name in the list then highlight
the remaining assays by holding [Shift] and pressing
• To highlight multiple random assays, hold down
[Ctrl] while selecting the assay names on the screen.
• To highlight all assays, select <All> in the right
column of the screen.
2. Select <Average> in the right column of the
CALIBRATION SUMMARY screen. The Average
Figure 6.17: Average Confirmation Dialog Window
3. Select <OK>. The selected data are added to the stored

average.
NOTE: The operator must ensure calibration data
are added to the stored average only one time.

200154-101—November 2004
Calibration Data Section 6
Viewing the Stored Calibration Data

To view the stored calibration statistics, select <Stored> in the
right column of the CALIBRATION SUMMARY screen.
Figure 6.18: CALIBRATION SUMMARY Screen, Stored Calibration

Data
The following data display for each calibrator level:

• Conc (concentration)
• Mean
• SD (standard deviation)
• CV (coefficient of variation)
• Range
• N (number)
NOTE: Assay-specific calibration averages can be
viewed on the Calibration Details screen, accessed by
selecting <Detail> on the CALIBRATION SUMMARY
screen or by selecting <Calib> on the ASSAY STATUS
screen. The default view when entering the screen
displays absorbances of the blank. The other calibrators
in the list can be viewed by highlighting the average
data for the level on the Calibration Details screen.

200154-101—November 2004
Section 6 Calibration Data
Deleting Calibrations
Deleting the Previous Calibration Data
When a calibration for an assay is complete and the factors are
calculated, the AEROSET System compares factors of the new
and previous calibration curves.
If the percent difference between the first factor of the new
calibration and the first factor of the last accepted calibration
is greater than the defined FAC Limit %, a FAC Calibration
Error Code is generated. If the new calibration curve is
acceptable after reviewing calibration and QC data, the
previous curve must be deleted.
Use the following instructions to delete the previous
calibration curve.
this procedure.
1. Select <Cal Summary> in the Information Access Area of

the Main Display. The CALIBRATION SUMMARY screen
displays.
2. Select the assay for which the previous calibration data
will be deleted, by selecting the assay name.
3. Select <Del Prev> in the right column of the screen. The
Delete confirmation dialog window displays.
4. Select <OK>. The previous calibration curve data are

deleted.

200154-101—November 2004
Calibration Data Section 6
Deleting the Stored Average

Use the following instructions to delete the stored average data
for an assay.
this procedure.

displays.
2. Select <Stored> in the right column of the CALIBRATION
SUMMARY screen. The stored averages display.
3. Select the assay for which the stored average data will be
deleted, by selecting the assay name.
4. Select <Delete> in the right column of the screen. The
Delete confirmation dialog window displays.
5. Select <OK>. The stored average calibration data are

deleted.

200154-101—November 2004
Printing Calibration Summaries
Refer to Appendix B, AEROSET System Printed Reports for

examples of printed reports.
Current Calibration Summary

Use the following instructions to print a report of the current
calibration summary data.
NOTE: This report prints information from both the
Data and Dates screens of the CALIBRATION
SUMMARY screen.

displays.
Figure 6.21: Print Confirmation Dialog Window

200154-101—November 2004
Printing Calibration Summaries Section 6
Stored Calibration Summary

Use the following instructions to print a report of the stored
calibration summary data.
displays.
2. Select <Stored> in the right column of the screen. The
stored averages display.
3. Select <Print> in the right column of the CALIBRATION
SUMMARY screen. The Print confirmation dialog
window displays.
Figure 6.22: Print Confirmation Dialog Window

200154-101—November 2004
Section 7
Section 7: Operational Precautions and Limitations
Operational Precautions
and Limitations

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Operator Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Related Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
General Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
System Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Before You Begin . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
During Operation . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Reagents, Calibrators, Controls, and Bulk Solutions . . . 7-5
Storage and Handling . . . . . . . . . . . . . . . . . . . . . . . 7-5
Requirements for Use . . . . . . . . . . . . . . . . . . . . . . . 7-6
Specimens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
Preparation and Storage . . . . . . . . . . . . . . . . . . . . . 7-7
Results Interpretation and Reporting . . . . . . . . . . . 7-8

200154-101—November 2004
Operational Precautions and Limitations Section 7
NOTES

200154-101—November 2004
Section 7 Operational Precautions and Limitations
Section 7: Operational Precautions and Limitations
Operational Precautions
and Limitations
Overview
This section includes information about actions or conditions
that can impact system and assay performance which, in turn,
can impact the integrity of the AEROSET System and accuracy
of patient results.
The following topics are included in this section:
• General precautions
• System operation
• Consumables
• Reagents, calibrators, controls, and bulk solutions
• Specimens
Operator Responsibility
AEROSET System operators are responsible for using the
system only as designed. Failure to follow safe use instructions
could cause injury to the operator, damage to the system, or
adversely affect assay results.
Related Information
Refer to Section 8, Hazards for additional information on
hazards discussed in this section.

200154-101—November 2004
General Precautions
Observance of the following AEROSET System environmental
requirements is necessary to ensure proper system
performance.
• Operate the AEROSET System on a flat, level surface.
• Locate the system away from direct sunlight, heat and
drafts, and heat generating devices. Exposure to heat and
drafts can interfere with the system’s ability to maintain
the operating temperature within acceptable range.
• Maintain the required free space on all sides of the system.
This is essential for adequate cooling of electrical
components, for accurate temperature control of the
processing center, to allow access for maintenance, and to
allow access for disconnecting the power cord when
required.
• Do not attempt to install the system. Contact your Abbott
Representative to perform installation.
• Leave the Main Circuit Breaker Switch turned ON
continuously, unless otherwise instructed in a
maintenance or troubleshooting procedure, or if an
emergency situation occurs.
• Routinely and consistently perform maintenance
procedures as recommended in Section 9, Service and
Maintenance.
• Do not attempt any maintenance and/or repairs that are
not included in documentation provided by Abbott
Laboratories.
Refer to Section 4, Performance Characteristics and Specifications
for additional information about clearances, temperature, and
other system requirements.

200154-101—November 2004
System Operation
The following precautions must be observed when operating
the AEROSET System. Failure to comply could cause damage to
the system and adversely affect patient results.
Before You Begin

Before operating the system:
• Read the Precautions for Users section of the assay-specific
package inserts.
• Load reagents in the appropriate segment of the Reagent
Supply Center.
• Verify onboard volumes of reagents and bulk solutions are
adequate.
• Keep all analyzer doors closed and covers in place during
operation, unless otherwise instructed by a maintenance
or troubleshooting procedure.
During Operation
While operating the system:
• Do not disconnect any electrical connections when the
power is ON.
• Respond to system notifications regarding waste levels
during processing. Consider all liquid and solid waste
generated by the system to be potentially infectious.
Follow appropriate procedures for handling and disposal.

200154-101—November 2004
Consumables
Observe the following precautions when handling
consumables.
• Do not reuse or substitute consumables. Abbott
Laboratories cannot accept responsibility for system
performance and assay results when consumables are
reused or have been manufactured by anyone other than
Abbott Laboratories.
• Keep all consumables clean and free of dust.
• Use caution when handling consumables to prevent
contamination.
• Use dated consumables within their specified dating
period.
• Store all consumables in their original containers so
information such as expiration dates and lot numbers is
available, if needed.
• Consider all used system consumables as potentially
infectious. Follow appropriate procedures for handling
and disposal.

200154-101—November 2004
Reagents, Calibrators, Controls, and Bulk Solutions

The following precautions must be observed when handling
reagents, calibrators, controls, and bulk solutions to ensure
both operator safety and accurate assay results. Refer to the
Abbott Clinical Chemistry Package Inserts or the specific
product label for detailed information. Refer to Hazard Types
in Section 8, Hazards for additional information.
Storage and Handling

Observe the following requirements for storage and handling
of reagents, calibrators, controls, and bulk solutions.
• Do not substitute. Abbott Laboratories manufactures
substances and components to rigidly controlled quality
standards. Substitution of materials could affect AEROSET
System performance, assay results, safety, and equipment
life.
• If reagents, calibrators, controls, or bulk solutions are
received in a condition contrary to Abbott Clinical
Chemistry Package Insert or label recommendation, or
are damaged, contact your local Abbott Customer
Support.
• Store reagents, calibrators, and controls according to
directions in the package inserts. Store bulk solutions as
instructed on their labels.
• Use caution when handling reagents, calibrators, controls,
and bulk solutions to prevent contamination.
• Wear clean gloves when loading an uncapped reagent
bottle on the system to avoid contamination.
• Avoid excessive mixing or shaking of liquids to minimize
formation of foam and bubbles.
• Remove air bubbles, if present in the reagent cartridge,
with a new applicator stick. Alternatively, allow the
reagent to sit at the appropriate storage temperature to
allow the bubbles to dissipate. To minimize volume
depletion, do not use a transfer pipette to remove the
bubbles.
CAUTION: Reagent bubbles may interfere with
! proper detection of reagent level in the cartridge,
causing insufficient reagent aspiration which
could impact results.

200154-101—November 2004
• Do not pipet by mouth.

• Do not smoke, eat, drink, apply cosmetics, or handle
contact lenses in areas where specimens, reagents,
calibrators, or controls are handled.
• Reagents can be stored on or off the AEROSET System. If
reagents are removed from the system, store in an upright
position with replacement caps applied.
Requirements for Use

Observe the following requirements when using reagents,
calibrators, controls, and bulk solutions.
• Verify all necessary assay components are present in the
kit when loading new reagents.
• Verify master lot numbers and expiration dates of each
reagent kit component before loading the components in
the Reagent Supply Center.
• Do not use reagent, calibrators, controls, and bulk
solutions beyond their expiration dates.
• Do not use reagent kits onboard the system beyond the
maximum number of days, as stated in the Abbott
Clinical Chemistry Package Inserts.
• Do not mix reagents, calibrators, or controls within a lot
or between lots.

200154-101—November 2004
Specimens
Refer to the Abbott Clinical Chemistry Package Inserts for
detailed, assay-specific information about specimen collection,
preparation, and storage. All specimens should be considered
potentially infectious.
Collection
Observe the following requirements for specimen collection.
NOTE: Only human specimens have been tested and
approved for analysis on the AEROSET System.
Performance has not been established using cadaver
specimens or body fluids other than those described in
the Abbott Clinical Chemistry Package Inserts.
• Follow all usual precautions for collecting blood by
venipuncture to avoid specimen hemolysis.
• Refer to the Abbott Clinical Chemistry Package Inserts
for appropriate specimen types for each assay.
• The AEROSET System lacks the capability to verify
specimen type. It is the responsibility of the operator to
verify the correct specimen type(s) is (are) used.
Preparation and Storage

Observe the following requirements when preparing and
storing specimens.
• Sample carryover requirements are not the same for all
instruments. The requirements for clinical chemistry
analyzers may be less stringent than for immunoassay
analyzers. The possibility of sample carryover should be
considered when transferring samples that have been
processed on one analyzer to another for additional
testing.
NOTE: The optional Sample Carryover Reduction
feature includes a new wash cup with additional
software improvements, which work together to
reduce sample-to-sample carryover on the
AEROSET System. Contact your Abbott
Representative for additional details.
• Ensure serum specimens collected in tubes with a gel
separator have ½ inch (13 mm) serum above the gel. If the
specimen volume is less than ½ inch (13 mm), transfer the
specimen into a sample cup.

200154-101—November 2004
• Inspect all samples for bubbles. Remove bubbles with an

applicator stick; use a new stick for each sample to prevent
cross contamination.
• Serum and plasma specimens should be free of fibrin, red
blood cells, and other particulate matter.
• Mix and centrifuge patient samples after any freeze thaw
cycle or to remove red blood cells or particulate matter.
Refer to the assay-specific package inserts for limitations
and interfering substances.
• For serum specimens, ensure complete clot formation has
taken place prior to centrifugation. Some specimens,
especially those from patients receiving anticoagulant or
thrombolytic therapy, may take longer to complete their
clotting processes. Fibrin clots may subsequently form in
these sera and the clots could cause erroneous test results.
• For individual assay sample volume requirements, refer to
the ASSAY PARAMETERS section of the assay-specific
package inserts.
• Separate serum or plasma from the clot, serum separator,
or red blood cells before freezing.
• Remove closures from specimen tubes before loading.
Results Interpretation and Reporting

Assay results must be used in conjunction with other clinical
data, e.g., symptoms, result of other tests, patient history,
clinical impressions, information available from clinical
evaluation, and other diagnostic procedures. All of these data
must be considered for patient care management.
If assay results are inconsistent with clinical evidence,
additional testing is suggested to confirm the result.

200154-101—November 2004
Section 8
Section 8: Hazards
Hazards

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Operator Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Emergency SHUTDOWN Procedure . . . . . . . . . . . . . . . . . . . 8-2
Safety Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Biological Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Warning Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
Chemical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Spill Clean-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9
Waste Handling and Disposal . . . . . . . . . . . . . . . . . . . . . . 8-10
Decontamination Procedure Requirements . . . . . . . . . . . . 8-11
Related Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12
Electrical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13
Mechanical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14
Physical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-16
Probes and Sharps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-16
Exposure to Laser Light . . . . . . . . . . . . . . . . . . . . . . . . . 8-16
Heavy Objects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-17
Exposure to Hot Objects . . . . . . . . . . . . . . . . . . . . . . . . 8-17
Trip Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-17

200154-101—November 2004
Hazards Section 8
NOTES

200154-101—November 2004
Section 8 Hazards
Section 8: Hazards
Hazards
Overview
This section provides information on potential hazards to
AEROSET System operators, and potential damage to the
laboratory environment. Hazards discussed in this section
include:
• Emergency SHUTDOWN Procedure
• Safety Icons and Hazard Symbols
• Biological Hazards
• Chemical Hazards
• Spill Clean-up
• Waste Handling and Disposal
• Decontamination Procedure Requirements
• Electrical Hazards
• Mechanical Hazards
• Physical Hazards
Operator Responsibility
AEROSET System operators are responsible for using the
system only as designed. Operators must be adequately trained
before operating the system. Failure to follow safe use
instructions could cause injury to the operator, damage to the
system, or adversely affect assay results.
Refer to Section 7, Operational Precautions and Limitations for
information on actions or conditions that could impact the
AEROSET System or assay performance.

200154-101—November 2004
Hazards Section 8
Emergency SHUTDOWN Procedure

In the event of an emergency, immediately turn OFF the Main
Circuit Breaker Switch, located on the rear-right panel of the
analyzer (to the DOWN position).
Main Circuit
Breaker Switch
125932a
Figure 8.1: Main Circuit Breaker Switch (Rear of Analyzer)

200154-101—November 2004
Section 8 Hazards
Safety Icons
Safety icons in this manual and on the AEROSET System
identify potentially dangerous conditions. Operators must
recognize the icons and understand the type and degree of
potential hazard. The following icons may be used with text or
in lieu of text. If text accompanies the icon, it describes the
nature of the hazard and is labeled with WARNING or
CAUTION.
WARNING is defined as a physical, mechanical, or procedural
condition that could result in moderate to serious personal
injury.
CAUTION is defined as a condition that could result in minor
injury or interfere with proper functioning of the system
Table 8.1: Safety Icon Definition and Description
Icon Definition/Description
WARNING: Potential Biohazard Identifies an
activity or area where operators may be exposed to
potentially infectious material.
WARNING: Electrical Shock Hazard Indicates the
possibility of electrical shock if procedural or
engineering controls are not observed.
:
CAUTION: Class II Laser Product. Avoid exposure
to Class II Laser radiation. Do not stare into the
beam. Do not look into the aperture or remove the
bar code reader covers of the Sample Carousel,
Reagent Supply Centers, Sample Carrier, or
FastTrack™ Sampler. These apertures emit laser light.
The scanners use a low power, visible laser diode.
Although momentary exposure to a CDRH Class II
laser is not known to be harmful, failure to follow
proper procedures may result in a potentially
hazardous condition. Use of controls or adjustments
or performance of procedures other than those
specified herein may result in hazardous radiation
exposure.
CAUTION: Hot Surface Identifies an activity or area
where hot surfaces are present.
Identifies an activity that may present a safety

! related hazard, and advises the operator to consult
the associated caution/warning instructions
provided.

200154-101—November 2004
Hazards Section 8
AEROSET System product labeling may include one or more of

the following hazard symbols. The symbols are used to convey
particular properties of the chemical or chemical mixture, and
to notify the operator that precautions should be taken when
working with the material.
Table 8.2: Hazard Symbol and Definition/Description
Hazard Definition/Description
Symbol (with Standard Abbreviation)
This symbol indicates that some component(s) of
the product has flammable (F) or extremely
flammable (F+) properties.

the product has toxic (T) or very toxic (T+)
properties.

the product has harmful (Xn) or irritant (Xi)
properties.
: .
the product has corrosive (C) properties.

the product has properties that are dangerous for
the environment (N).

200154-101—November 2004
Section 8 Hazards
Biological Hazards
The following activities may involve the presence of biological
materials:
• Handling samples, reagents, calibrators, and controls
• Cleaning spills
• Handling and disposing of waste
• Moving the system
• Performing maintenance procedures
• Performing decontamination procedures
• Performing component replacement procedures
Warning Label
WARNING: Potential Biohazard
Identifies an activity or area where operators may be
exposed to potentially infectious material.

200154-101—November 2004
Hazards Section 8
Precautions
Consider all clinical specimens, reagents, controls, and
calibrators that contain human sourced material and
instrument surfaces or components that have come in contact
with human sourced material as potentially infectious. No
known test method can offer complete assurance that
products derived from human sourced material or instrument
components exposed to human sourced material will not
transmit infection. Therefore, all products derived from
human sourced materials and instrument components
exposed to human sourced material should be considered
potentially infectious.
It is recommended that all potentially infectious materials be
handled in accordance with the OSHA Standard on
Bloodborne Pathogens. Biosafety Level 2 or other appropriate
biosafety practices should be used for materials that contain or
are suspected of containing infectious agents. Precautions
include, but are not limited to the following:
• Wear gloves, lab coats, and protective eye wear when
handling human sourced material or contaminated
instrument components.
• Do not pipet by mouth.
• Do not eat, drink, smoke, apply cosmetics, or handle
contact lenses when handling human sourced material or
contaminated instrument components.
• Clean spills of potentially infectious materials and
contaminated instrument components with an
appropriate disinfectant, such as 0.5% sodium
hypochlorite or other suitable disinfectant.
• Decontaminate and dispose of all specimens, reagents,
and other potentially contaminated materials in
accordance with local, state, and federal regulations.
Operators exposed to biohazardous or potentially infectious
materials should immediately seek medical attention and take
steps to cleanse the affected area:
1. Eyes—rinse with water for 15 minutes.
2. Mouth—rinse with water.
3. Skin—wash the affected area with soap and water.
4. Puncture wound—allow to bleed freely. Wash the affected
area with soap and water.

200154-101—November 2004
Section 8 Hazards
Chemical Hazards
Operators may be exposed to hazardous chemicals when
handling reagents, calibrators, controls, or bulk solutions.
Operator exposure to hazardous chemicals is minimized by
following instructions provided in assay-specific
documentation (e.g., package inserts) and product-specific
Material Safety Data Sheets (MSDS). Exposure levels are further
reduced by the “hands-off” design features of the instrument
when it is used properly.
Precautions
In general, observe the following precautions when handling
chemicals:
• Consult Material Safety Data Sheets for safe use
instructions and precautions.
• Avoid contact with skin and eyes. If contact with material
is anticipated, wear impervious gloves and protective eye
wear and clothing.
• Always maintain good housekeeping. Do not eat, drink, or
store food and beverages in areas where chemicals are
used.
• Seek medical attention if irritation or signs of toxicity
occur after exposure.
Hazard symbols that appear on AEROSET System product
labeling are accompanied by Risk (R) and Safety (S) numbers
and represent specific risk and safety phrases as defined by
European Community Directives. The risk and safety phrases
describe precautions to be used when working with a
particular chemical or chemical mixture. For all (R) and (S)
numbers that appear on product labeling, refer to the
corresponding phrases indicated in the package insert.
For products containing sodium azide, do not autoclave.
Sodium azide has been reported to form lead or copper azide
in lead or copper pipes in laboratory plumbing. These azides
can explode upon percussion, such as hammering. To prevent
formation of lead or copper azide, flush drains thoroughly
with water after disposing of solutions containing sodium
azide.

200154-101—November 2004
Hazards Section 8
To remove contamination from old drains suspected of azide

accumulation, the U.S. National Institute of Occupational
Safety and Health recommends the following procedure:
1. Siphon liquid from the trap using a rubber or plastic hose.
2. Fill the trap with 10% sodium hydroxide solution.
3. Allow the solution to stand in the trap for 16 hours.
4. Flush the trap thoroughly with water.

200154-101—November 2004
Section 8 Hazards
Spill Clean-up
Clean spills in accordance with established biosafety practices.
In general, safe work practices for cleaning spills include:
1. Wear appropriate personal protective equipment.
2. Absorb the spill with absorbent material.
3. Wipe the spill area with detergent solution.
4. Wipe the area with an appropriate disinfectant such as a
0.5% sodium hypochlorite.
5. Dispose of spilled and contaminated material in
accordance with local, state, and federal regulations.

200154-101—November 2004
Hazards Section 8
Waste Handling and Disposal

Dispose of the following materials in accordance with local,
state, and federal regulations:
• Clinical specimens
• Reagents
• Controls
• Calibrators
• AEROSET System bulk solutions
• Other consumables that may be contaminated
It is the responsibility of each facility to characterize its waste
stream to ensure the waste is disposed of in accordance with
the appropriate waste disposal regulations.
Some reagents, calibrators, and controls contain thimersol or
mercury, and may be considered hazardous under various
environmental regulatory agencies. Check with your local
sanitary district to determine limits for mercury in waste water.

200154-101—November 2004
Section 8 Hazards
Decontamination Procedure Requirements

Instruments must be decontaminated before servicing,
shipment, or relocation. Always wear appropriate personal
protective equipment while performing decontamination
activities. The following components of the AEROSET System
must be decontaminated as described.
Table 8.3: Decontamination Procedures
Element Decontamination Method
Probes Avoid contact with probes. Flush the
probes with a disinfectant solution,
such as 0.1% sodium hypochlorite.
During maintenance procedures,
clean the outside of the probes with
alkaline wash solution. Refer to
Section 9, Service and Maintenance for
instructions.
If probes will be reused, place in a
disinfectant solution a minimum of
30 minutes before reinstallation.
AEROSET System Wipe the surface or component with
Surfaces and a detergent solution then wipe the
Components unit with an appropriate
disinfectant, such as 0.5% sodium
hypochlorite. Allow to air dry at least
10 minutes.
High-concentration Rinse the container with a detergent
Waste Container/Hose solution then rinse the container
with an appropriate disinfectant,
such as 0.5% sodium hypochlorite.
Liquid Material Before shipment, servicing, or
relocation, remove all samples,
reagents, controls, calibrators,
consumable solutions, and
disposables from the AEROSET
System.

200154-101—November 2004
Hazards Section 8
Related Information
Refer to Section 9, Service and Maintenance for additional
instructions for cleaning and maintaining AEROSET System
components.

200154-101—November 2004
Section 8 Hazards
Electrical Hazards
The AEROSET System does not pose uncommon electrical
hazards to operators if it is installed and operated without
alteration, and is connected to a power source that meets
required specifications. Refer to Electrical Specifications in
Section 4, Performance Characteristics and Specifications for
details.
Basic electrical hazard awareness is essential to the safe
operation of any system. Only qualified personnel should
perform electrical servicing.
Elements of electrical safety include, but are not limited to the
following:
• Inspect electrical cabling into and on the AEROSET System
for signs of wear and damage.
• Use only approved power cords and electrical accessories,
such as those supplied with the system, to protect against
electric shock.
• Use a properly grounded electrical outlet of correct voltage
and current handling capability.
• In the event of a blown fuse or thrown circuit breaker,
determine the cause and correct the problem before
attempting to resume operation of the system.
• Do not disconnect any electrical connection or service any
electrical or internal components while the power is ON.
• Disconnect the power cord from the UPS (uninterruptible
power supply) before servicing.
• Unplug the instrument before clean-up of major liquid
spills.
• Keep liquids away from all connectors of electrical or
communication components.
• Do not touch any switches or outlets with wet hands.
• Keep the floor dry and clean under and around the
AEROSET System.
• Use a ground fault circuit interrupter when working in a
wet environment.
• Clean spilled fluids immediately.

200154-101—November 2004
Hazards Section 8
Mechanical Hazards
The AEROSET System is a fully automated, dual pipetting
instrument that operates under computer control. As with
most automated equipment, there is potential for injury and
bodily harm from moving mechanical components whenever
the instrument is in operation. The AEROSET System
minimizes mechanical hazards by providing guards to protect
against accidental contact with moving components, and
encoding the software with safety features.
The AEROSET System requires accurate positioning of all
samples, reagents, calibrators, controls, and consumables on
the instrument by the operator. It is very important that
sample cups and reagent cartridges are correctly positioned
before initiating any operation. Although the sample and
reagent arms are equipped with Probe Rebound™ technology
features to stop the lowering of the probes when an obstacle is
detected in its path, it is never acceptable to reach into the
processing area when the instrument is in an operating mode.
Should operator intervention be necessary during a run, the
run should be interrupted according to instructions defined in
Stop in Section 5, Operating Instructions.
Operators of the AEROSET System are potentially exposed to
the following moving mechanical components:
• Sample and reagent arms, including probes
• FastTrack™ Sampler
• Carousel Sampler
• Reagent Supply Centers
• Reaction Carousel
• Mixer unit
• Cuvette washer
• ICT™ unit

200154-101—November 2004
Section 8 Hazards
Basic elements of mechanical equipment safety include:

• Never bypass or override a safety device.
• Keep all protective covers and barriers in place.
• Never perform manual tasks on the work surface of the
instrument.
• Never allow any part of your body to enter a range of
mechanical movement during system operation.
• Do not wear articles of clothing or accessories that could
catch on the system. Keep pockets free of items that could
fall into the system.
• Use caution when performing adjustment, maintenance,
cleaning, or repair procedures.
• Use caution when loading sample carriers and Reagent
Supply Centers.
• In the event of an instrument malfunction or an
unexpected sequence of movements, be aware that
unexpected operator reflex actions could occur, causing
injury.
• Do not open Reagent Carousel covers unless indicator
lights on the LUI Control Panel are illuminated.

200154-101—November 2004
Hazards Section 8
Physical Hazards
Safe practices should be observed in the following situations to
avoid physical injury.
Probes and Sharps

The probes are sharp and potentially contaminated with
infectious materials. Avoid contact with tips of the probes.
Although the sample and reagent arms are equipped with
Probe Rebound™ technology features to stop the lowering of
the probes when an obstacle is detected, the operator should
never reach into the instrument while it is in operation.
The leaf springs used in various components are very sharp;
handle cautiously to prevent injury.
In general, minimize use of sharps and glassware. Use
mechanical means to remove contaminated broken glassware.
Dispose of sharps in an appropriately marked,
puncture-resistant, and leakproof container before treatment
and disposal.
Exposure to Laser Light

WARNING: Class II Laser Product
Avoid exposure to Class II Laser radiation. Do not stare
into the beam. Do not look into the aperture or remove
the bar code reader covers of the Sample Carousel,
Reagent Supply Centers, Sample Carrier, or FastTrack™
Sampler. These apertures emit laser light. The scanners
use a low power, visible laser diode.
Although momentary exposure to a CDRH Class II laser
is not known to be harmful, failure to follow proper
procedures may result in a potentially hazardous
condition. Use of controls or adjustments or
performance of procedures other than those specified
herein may result in hazardous radiation exposure.
Because of normal human aversion response such as blinking,
eye movement, etc., these lasers normally do not present a
hazard to eyes. During normal operation, the protective covers
must remain in place to prevent laser light exposure from the
optics bench. The protective covers should only be removed
by qualified Abbott Service Representatives.

200154-101—November 2004
Section 8 Hazards
Heavy Objects
CAUTION: Lifting Hazard
! The high-concentration waste container is heavy when
full. Use care when handling the container to reduce
the risk of injury.
The instrument is extremely heavy and has unsupported
sections of the shell. Use adequate assistance when attempting
to move the system. Push only on solid sections of the
housing; do not exert pressure on unsupported sections of the
shell.
Exposure to Hot Objects

CAUTION: Hot Surface
The lamp and lamp housing may be hot. Before
replacing the system source lamp, wait at least five
minutes after turning the power OFF to allow the lamp
and lamp housing to cool.
Trip Hazard
The AEROSET System is equipped with a power cord and
various computer connectors. To avoid a tripping hazard to
operators, ensure cords in high traffic areas are properly
stowed.

200154-101—November 2004
Hazards Section 8
NOTES

200154-101—November 2004
Glossary
Glossary
AEROSET Instrument Terms

A-Line Assay configuration that defines the reagent location in the
outer segments (A, B, or C) of the Reagent Supply Center.
Action Area Right column area of the Main Display where the action
buttons are located, e.g., RUN, START UP, SHUTDOWN, etc.
Application Describes assay parameter definition procedures, etc.
Auto Rerun System configuration that when enabled, automatically

reorders assays for those samples that meet user-defined
criteria on an “assay-by-assay” basis.
Auto Return System configuration that when enabled, automatically

returns samples identified for rerun to the sample arm.
B-Line Assay configuration that defines the reagent location as the

inner segment (D) of the Reagent Supply Center.
Biohazard Situation with potential for exposure to infectious materials

and/or substances.
Button Screen operation selected to perform a specific action.
Calibrator/Control Carousel Carousel located in the Carousel Sampler with a 45-position

capacity for calibrators and controls.
Carousel Circular conveyor where samples are placed.
Carousel Sampler Sampler system on the AEROSET System which contains the
Sample Carousel, Reserved STAT position, and
CE (Marking) Common Europe certification; meets applicable New

Approach Directives of the European Union.
Checkbox Screen operation that utilizes a box to the left of an option. By

selecting the box, the option is enabled (selected) and displays
with a check mark (聺).
Color Touchscreen Monitor Color monitor with Touchscreen.
AEROSET® System Operations Manual Glossary-1

200154-101—November 2004
Glossary
Computer Refers to an IBM PC/AT compatible computer connected to

the AEROSET System.
Cuvette Washer Series of nozzles, including a dryer nozzle, that wash and dry
the reaction cuvettes.
Display Area Area of the Touchscreen that displays information or actions

corresponding to the selected button in the Information
Access Area or Action Area.
Drop-down List Box Screen operation that displays one of several available options
in a list. Other choices can be viewed by selecting the button
(list box icon) on the right side of the drop-down list box.
Dryer Tip Located on the end of the cuvette washer nozzle, used to
remove fluid from the cuvette before a sample is dispensed.
FastTrack™ Sampler The track sampler on the AEROSET System, with capacity to
hold up to 200 samples.
Hazard Situation with potential to cause physical harm to a user

and/or damage to the analyzer or laboratory environment.
Host Auxiliary computer system with the ability to communicate

with the AEROSET System.
Host Interface Operation Communication between the AEROSET System and a Host
computer system.
Host Interface Status Display Display (accessed via the Touchscreen) from which the Host
interface status can be checked.
ICT™ Aspiration Pump Aspirates 300 µL ICT reference solution or diluted sample into
the ICT module, using a syringe pump.
ICT Module Contains ion-selective electrodes for measurement of Na+, K+,

and Cl-.
ICT Reference Solution Preheats ICT reference solution in the stainless steel tube
Preheater located in the water bath, before it is filled into the ICT
reference solution cup.
ICT Reference Solution Pump Fills and drains ICT reference solution into the ICT reference
solution cup.
Glossary-2 AEROSET® System Operations Manual

200154-101—November 2004
Glossary
ICT™ Unit Moves the isothermal block equipped with the ICT module to
the ICT reference solution cup and the reaction cuvettes.
Information Access Area Area at the bottom of the Main Display that contains buttons
to access configuration, calibration, QC, and database
information.
Integrated Chip Technology Solid state ion-selective electrodes using indirect

(ICT) potentiometry for the determination of Na+, K+, and Cl-.
Keyboard Computer component used to enter information in the

AEROSET System Control Center (SCC).
LED Light emitting diode. Used on the AEROSET System to

indicate the status of the Carousel Sampler and FastTrack™
Sampler systems.
Line Balance™ (LB) Feature Feature which improves throughput with efficient utilization
of cuvette pairs, in turn minimizing single-test measurement
cycles.
Liquid Level Sensing Detection of liquid level; measured by the change in

capacitance.
Local User Interface (LUI) Control panel that can be used to manually operate the
FastTrack Sampler and Reagent Supply Centers.
Main Circuit Breaker Switch Turns the power ON/OFF for the entire system.
Main Display Main section (bottom and right frames) of the Touchscreen
user interface.
Maintenance Procedures performed on the AEROSET System to ensure

optimum, continuous, and efficient operation.
Mixer Unit Unit that houses the mixers.
Mixers Blades which mix the sample and reagent together.
Online Configuration System parameters configured to enable the AEROSET System

to communicate with a Host computer system. This includes
communication type, baud rate, message length, etc.

200154-101—November 2004
Glossary
Optimum Sampling Feature that maximizes sample processing speed when the
Sequence™ (OSS) Feature SmartWash™ feature is in use. It rearranges the sampling
sequence to minimize the number of used empty reaction
cuvettes.
Panel Feature where multiple tests can be ordered quickly by

touching only one button on the screen, instead of individual
assay buttons.
Photometer Instrument used to measure luminous intensity, luminous

flux, illumination, or brightness.
Photometric Reads Series of reads taken on each reaction cuvette.
Printer AEROSET dot matrix forms printer.
Probe Guard Feature of the AEROSET System that stops lowering of the
probe when an obstacle is detected.
Qualitative Ranges Option, when selected, that reports test results using
conditional text (+/-, Pos/Neg) instead of numerical values.
Quantitative Ranges Option, when selected, that reports test results as numerical
values.
Reaction Carousel Carousel with capacity to hold 330 reaction cuvettes, and
rotates counterclockwise approximately a quarter turn every
cycle. Reactions take place on this carousel.
Reaction Cuvette Rectangular glass cuvette.
Reaction Temperature Temperature maintained by the water bath.

Control
Reagent Arm Holds the reagent probe. Moves reagent from each Reagent
Supply Center to the Reaction Carousel.
Reagent Probe Dispenses the defined volumes of reagent into the reaction
cuvettes.
Reagent Segment Sections (four) of each Reagent Supply Center where the
reagent is placed.
Reagent Supply Center Dual carousel where reagent cartridges are positioned. There
are two Reagent Supply Centers on the AEROSET System.

200154-101—November 2004
Glossary
Reserved STAT Position Single fixed position in the Carousel Sampler used to run
STAT samples.
Result Error Code Error code of the AEROSET System reported with the result.
Rotary Power Control Switch Turns the power ON/OFF for units on the analyzer, except the
reagent refrigerator.
Run Progress Area Area of the Main Display that shows the progress of analysis.
Sample Arm Holds the sample probes. Moves the sample probes from the
FastTrack™ Sampler or Sample Carousel to the Reaction
Carousel.
Sample Carousel Carousel (located in the Carousel Sampler) with capacity to

hold 30 samples.
Sample Carrier Carrier that holds up to five samples. Used in the FastTrack™
Sampler.
Sample Carrier Tray Tray with capacity to hold up to 10 sample carriers. Used in
the FastTrack Sampler.
Sample Cup Type of sample container used in the FastTrack and Carousel
Samplers.
Sample Probe Dispenses sample into reaction cuvettes.
Scroll Box Screen operation that displays several tests or items in a list by
scrolling with a scroll bar.
Single Selection Button Circular button on software screens that allows for selection
of one option or the other, but not both, and does not allow
both to remain unchecked (deselected). Also known as a radio
button.
SmartWash™ Feature Process to completely wash the reagent probes, sample

probes, and reaction cuvettes when combinations of assays
which can cause test-to-test interference are processed.
Solenoid Valve Six valves that are located at the top of the sample and
reagent syringe drives.
Specifications Describes measurement principles, power requirements, etc.

of the AEROSET System.

200154-101—November 2004
Glossary
Status Area Area of the Main Display where the system status, date and
time, water bath level, and high-concentration waste full
indicator display.
System Control Center (SCC) Includes hardware (computer, keyboard, printer, and
monitor) and software.
System Control Center Stand Auxiliary stand located next to the AEROSET System, which
holds the computer, monitor, keyboard, and printer.
Tab Screen operation that opens the corresponding page when

selected on the Touchscreen.
Timer Functions The AEROSET System can be configured to Power ON, initiate
START UP, or perform SHUTDOWN operations automatically
at a programmed time of day for each day of the week.
Touchscreen Computer monitor that allows the user to make selections by

directly touching the screen.
Warranty Written guarantee for the AEROSET System defining Abbott

Laboratories’ responsibility for the repair and replacement of
defective parts. It continues for a period of one year,
commencing twenty-one days from the date of shipment to
the original purchaser, or until title is transferred from the
original purchaser, whichever occurs first (the “Warranty
Period”).
Wash Solution Pump Aspirates wash solutions.
Water Bath Incubator that surrounds the reaction cuvettes with heated
water to maintain the reaction temperature.

200154-101—November 2004
Glossary
AEROSET Chemistry Terms

1-point Adjustment Calibration type that uses absorbance data for a single
calibrator to adjust the calibration curve.
2-point Adjustment Calibration type that uses absorbance data for the reagent
blank and a calibrator to adjust the calibration curve.
AbsMaxVar Stability of the reaction of an end-point assay during the

Main Read Time.
Absorbance Limit Configured range of absorbance values that are considered

acceptable for measurement purposes. Values outside this
range are not used for calculation.
Absorbance Limit Check Calibration data check that evaluates the absorbance or
change in absorbance obtained during sample measurement.
If the absorbance or change in absorbance is outside the
defined range, a Result Error Code is generated.
Absorbance Mode Calibration mode in which results are based on the

absorbance of water and are represented as absorbance in the
case of an end-point assay or as absorbance change (rate of
absorbance change per minute) in the case of a rate assay.
Blank Correction Calibration type that uses reagent blank data only to adjust
the calibration curve.
Calculated Absorbance Rate of change of absorbance calculated using the Linear Least
Squares method.
Calibration, Automatic Calibration that occurs automatically after a reagent cartridge

change, reagent lot change, or at the end of a calibration
interval.
Calibration, Exponent Calibration mode in which the absorbance or absorbance

change diverges as the concentration increases.
Calibration, Linear Mode Calibration mode in which a reagent blank and one type of
(1-point Method) calibrator are measured and a calibration curve is generated
using these two data points.
Calibration, Linear Mode Calibration mode in which a reagent blank and two to eight
(Multi-point Method) calibrators of different concentrations are measured, and a
calibration curve is generated using these data points.

200154-101—November 2004
Glossary
Calibration, Logit-4 Calibration mode in which the absorbance or absorbance

change increases as the concentration increases.
Calibration, Logit-5 Calibration mode in which the absorbance or absorbance

change increases as the concentration increases. Uses one
more parameter than Logit-4.
Calibration, Operator-defined Calibration that is manually requested.

Calibration
Calibration, Spline Non-linear calibration mode.
Calibration, Use Fac/Blk Calibration mode in which the concentration or activity is

(Factor and Blank) calculated using the factor and reagent blank from a
calibration curve generated for another assay.
Calibration, Use Factor Calibration mode in which the concentration or activity is

(Factor Only) calculated using the factor from a calibration curve generated
for another test. Reagent blank measurement is required even
if the calibration curve of another assay is used.
Color Correction Adjustment performed on absorbance data (in the absorbance

window) to correct for sample color.
END RATIO Ratio of absorbances (A/B) used as a reaction check for

Prozone.
END SUB Difference between absorbances (A - B) used as a reaction

check for Prozone.
End-point Assay Assay in which the concentration is calculated using the

absorbance data obtained in the Main Read Time defined on
the Base page of the Assay Configuration screen.
Extrapolated Calculation For calculation of patient samples with concentrations higher

than the calibrators, the calibration curve may be
extrapolated.
Factor Mode Calibration mode in which only the reagent blank is

measured and a user defined factor is used to calculate results.
FlexRate™ Feature To extend the linear range of an enzymatic assay and reduce
the necessity of a rerun, data points in the Flex Read Time are
used for high-activity and high-concentration samples (data
are identified by “FLX”).

200154-101—November 2004
Glossary
Full Calibration Calibration type performed for all data points defined for the
reagent blank and calibrators.
ICT™ (Integrated Chip Method in which Na+, K+, and Cl- are measured
Technology) potentiometrically.
Isozyme Mode Calibration mode in which the isozyme activity is calculated

from samples which contain two types of isozymes.
Levey-Jennings Graph Control graph used to monitor mean and range of control
measurement values from run to run.
Linearity% Check of a rate assay to ensure the reaction remains linear

during the Main Read Time. This parameter is used to check
for substrate depletion.
Linearity Range Minimum and maximum reportable values of an assay.
Panic Value High (PVH) Result Error Code that occurs when the generated result is
higher than the configured High Panic Value.
Panic Value Low (PVL) Result Error Code that occurs when the generated result is
lower than the configured Low Panic Value.
Photometric Timing Represents the elapsed time at each of the 33 photometric

points, with the first photometric point defined at zero
seconds.
Prozone Reaction Check In immune reactions, if the antigen concentration in the

sample greatly exceeds the antibody concentration in the
reagent, the result is falsely low from antibody depletion.
Quality Control Process of tracking and analyzing historical results using

standardized graphing techniques.
Rate Assay Assay in which the concentration is calculated using the

change of absorbance in the Main Read Time defined on the
Base page of the Assay Configuration screen.
Rate Linearity Linearity of the absorbance change within the read time.
Rate Ratio Ratio of absorbance changes (A/B) used as a reaction check for
Prozone.

200154-101—November 2004
Glossary
Rate Sub Difference between absorbance changes (A - B) used as a

reaction check for Prozone.
Reference Range Normal clinical range of an analyte.
Reportable Range Range of an assay.
Sample Blank Test Measurement used for correcting the absorbance data
obtained during the Main Read Time. There are two types of
Sample Blank Tests, Self Blank and non-Self Blank.
Sample Blank Test, non-Self Sample Blank Test used to eliminate the effect of endogenous
Blank substances in the sample. It is performed in a second reaction
cuvette.
Sample Blank Test, Self Blank Sample Blank Test used to correct the absorbance for sample
coloring due to hemolysis, bilirubin, lipemia, etc. It is
performed in the same reaction cuvette.
Test Limiting Feature Feature that allows exclusion of some tests previously
scheduled for the patient sample, without changing the order
of the remaining tests.
Westgard Multi-rule Series of statistical control rules for interpreting control data
that keeps the probability of false rejections low, and
improves probability of error detection. Can be adapted to
existing Levey-Jennings graphs by the addition of one or two
sets of control limits.

200154-101—November 2004
Glossary
AEROSET Accessories and Consumables Terms

Accessory Item used repeatedly when processing patient samples, e.g.,
tubing, ICT™ module, adapters.
Acid Wash Solution Solution used to clean reagent and sample probes and
reaction cuvettes.
Alkaline Wash Solution Solution used to clean reagent and sample probes and
reaction cuvettes.
Consumable Item exhausted in the process of running tests, e.g., ICT

diluent, printer ribbon, reaction cuvettes, sample cups. Also
known as a disposable.
ICT Cleaning Fluid Solution used to clean the ICT probe and ICT module.
ICT Diluent Reagent used for ICT assays.
ICT Reference Solution Solution used to rinse the ICT module between samples, and
used as a baseline when calculating ICT results.
ICT Reference Solution Bottle Container that holds ICT reference solution. A sensor detects
the remaining volume by monitoring weight changes, and
issues a warning when the volume is less than the defined
level.
Water Bath Additive Solution added to the water bath when the water is changed,
to inhibit bacterial growth and prevent bubble formation.

200154-101—November 2004
Glossary
NOTES

200154-101—November 2004
Index
Section 1. Index
Photometry 3-7
Numerics Primary Components 1-3
0.22 micron Filter Replacement—20 L Water Analyzer 1-5
Reservoir 9-112 Bulk Solution Area 1-23
0.22 micron Filter Replacement—30 L Water Covers, Doors, and Panels 1-6
Reservoir 9-116 Front Display Panel 1-21
1 mL Syringes Inspection Procedure 9-37 Local User Interface Control Panel 1-18
1-point Adjustment (Calibration) 6-5 Processing Area 1-10
1st Car’r for No-Bcode Smpls 2-24 Bar Code Readers 1-17
2-point Adjustment (Calibration) 6-5 ICT™ Module 1-16
ICT Unit 1-16
A Reaction Carousel Area 1-13
Abbott Instrument Warranty xiii Reagent Supply Centers 1-12
Abs Calibration Appendix A-1 Sample and Reagent Arms 1-10
Absorbance Data 10-34 Wash System 1-17
Absorbance Data Screen 10-34 Sampling Area 1-7
Absorbance Range Limits 2-210 Carousel Sampler 1-9
Accessories FastTrack Sampler 1-7
Cup/Tube Adapters 1-32 System Control Center 1-4
End-of-Run Sample Carrier 1-32 Product Listing Appendix C-1
Manuals 1-34 Reaction Table 3-5
Non-bar Code Labeled Sample Carrier (Optional) Sample Forms Appendix F-1
1-32 Sampling Capacities 4-10
Reagent Cartridge Adapters 1-34 Software 1-39
Sample Carrier Tray Covers 1-33 Solutions Appendix C-5
Sample Carrier Trays 1-33 Special Features
Sample Carriers 1-31 Clot Detection System 1-37
Accessories and Consumables 1-25 Lamp Monitoring Feature 1-37
AEROSET Disposables Appendix C-5 Optimum Sampling Sequence™ 1-36
AEROSET Documentation Appendix C-5 Sample Carryover Reduction Feature 1-38
AEROSET Products Appendix C-1 SmartWash™ 1-35
AEROSET Solutions Appendix C-5 Specifications
Action Area 1-44 Computer and Interface 4-10
Buttons 1-44 Electrical 4-9
Add Assays Screen 5-107 Physical 4-5
Adding Samples Sample Tube 4-11
on the FastTrack™ UPS 4-8
When FastTrack Completes Sampling 5-69 Agency Approval xvi
When FastTrack Is Busy Sampling 5-69 A-Line Tests
on the Sample Carousel Loading 5-24, 9-12
When Sample Carousel Completes Sampling Location on Reagent Supply Centers 2-60
5-72 Analyzer Component Replacement 9-155
When Sample Carousel Is Busy Sampling 5-70 Cuvette Segment or Cuvette Pair 9-181
AEROSET System Cuvette Segment Removal and Replacement
Accessories 1-25 9-183
Characteristics Cuvette Washer Dryer Tips 9-188
Optical 4-9 High-concentration Waste Container and Cap
Performance 4-2 9-156
Consumables 1-25 High-concentration Waste Float Switch Cable
Disposables Appendix C-5 9-158
Documentation Appendix C-5 ICT Aspiration Syringe (1 mL) 9-102
Environmental Requirements 4-6 ICT Module/Probe 9-196
Manuals 1-34 ICT Reference Solution Filter 9-121
Math Models Appendix A-1
AEROSET® System Operations Manual Index-1

200154-101—November 2004
Index
ICT™ Reference Solution Syringes (1 mL) 9-99 Assay Types 3-9

Lamp 9-105 End-point Assay 3-10
Mixer 9-192 Rate Assay 3-10
Pump Poppet Valve 9-178 Assays
Reagent Arm Tubing 9-172 Adding to Completed Sample 5-107
Reagent Probes 9-167 ASSAYS Screen 2-46
Sample and Reagent Syringe Assay-specific Error Messages 10-67
Installation 9-88 Index of 10-182
Removal 9-84 Automatic (Updated) Calibration Report
Sample Arm Tubing 9-163 Appendix B-16
Sample Carousel Tube Holder 9-195 Automatic Calibration 6-6
Sample Probes 9-159 Configuration 2-104
Seal Tips and O-ring Removal and Replacement Automatic QC 5-124
9-86, 9-93 Automatic SHUTDOWN Options 2-30, 9-36
Syringe Seal Tip (1 and 2) and O-ring 9-82 Automatic START UP Options 2-30, 9-36
Wash Solution Filter 9-119 Automatic START UP/SHUTDOWN
Wash Solution Syringe Enabling 2-29, 9-35
Installation 9-95
Removal 9-89 B
Wash Solution Syringes (1 mL) 9-96
Backup System Configuration Files 9-136
Annual Maintenance 9-123
Bar Code Label Specifications 5-51
Check Valve Replacement 9-124
Length 5-53
As Needed Maintenance 9-133
Placement 5-53
Backup System Configuration Files 9-136
Sample ID Length 5-52
Clean Cuvettes 9-147
Tube Labeling 5-53
Clean Reagent Bar Code Reader Windows 9-145
Bar Code Readers
Format a Floppy Disk 9-134
(illus) 1-17
Library Utility 9-142
Description 1-17
Restore System Configuration Files 9-139
Batch Ordering 5-45
Assay Configuration 2-75
Biological Hazards 8-5
Categories 2-75
Precautions 8-6
Confirm Parameter Settings 2-169
Warning Label 8-5
Assay Configuration Screen
Biological Precautions
Base Page 2-68
Probes and Sharps 8-16
Calibration Page 2-96
Biosafety Hazards
Outline Page 2-77, 2-115
Warning Label 8-5
QC Page 2-105
Blank Calibration 6-4
Rerun Rules Page 2-112
Blank/Calibrator Dilution 2-203
SmartWash™ Page 2-109
B-Line Tests
Assay Files
Loading 5-24, 9-12
Delete 2-48
Location on Reagent Supply Centers 2-60
Export 2-46
Bulk Solution Area
Import 2-49
(illus) 1-23
Assay List Report Appendix B-17
Description 1-23
Assay Parameter Settings 2-169
Bulk Solutions
Color Correction Feature 2-184
Inventory 5-31, 9-19
FlexRate Method Feature 2-195
Requirements for Use 7-6
Prozone Reaction Check Feature 2-192
Storage and Handling 7-5
Sample Blank Feature 2-180
Buttons 1-49
ASSAY STATUS Screen 2-171, 6-20
Explanation How-5
Assay Name Display Area 2-172
Keyboard How-5
Calibration Data Display Area 2-173
Control Data Display Area 2-174
Quality Control Information Area 5-130
Reagent Information Display Area 2-172
Index-2 AEROSET® System Operations Manual

200154-101—November 2004
Index
C Linear Mode (1-point Method) Appendix A-3

Linear Mode (Multi-point Method) Appendix A-4
Calculated Assay Results (Ratios) 2-114
Logit-4 Mode Appendix A-12
Base Page Configuration 2-121
Logit-5 Mode Appendix A-14
Outline Page Configuration 2-116
Spline Mode Appendix A-18
QC Page Configuration 2-124
Use Factor Appendix A-20
Qualitative Ranges 2-120
Use Factor and Blank Appendix A-22
Quantitative Ranges 2-116
Calibration Rules 6-8
Rerun Rules Page Configuration 2-127
Calibration Run 6-9
Calibration 6-1
Initiating the Run 6-13
Data Check 6-16
Loading Calibrators 6-13
Deleting 6-33
Procedure 6-9
Previous Calibration Data 6-33
Calibration Summary (Current) Report
Stored Average 6-34
Appendix B-12
Guidelines 6-7
Calibration Summary (Stored) Report Appendix B-14
Calibration Rules 6-8
CALIBRATION SUMMARY Screen 6-29
Optional Calibration 6-7
Saving Calibration Data to Stored Average 6-31
Required Calibration 6-7
Viewing Stored Calibration Data 6-32
Methods 6-2
Calibrator/Control Configuration 2-71
Photometric 6-2
Calibrator/Control List Report Appendix B-20
Potentiometric 6-3
CALIBRATOR/CONTROL Screen
Options 6-4
Buttons
1-point Adjustment 6-5
Calibrator/Control Carousel 2-71
2-point Adjustment 6-5
Set 1 2-71
Automatic Calibration 6-6
Set 2 2-71
Blank Calibration 6-4
Set 3 2-71
Full Calibration 6-4
Configuration 2-71
Printing Summaries 6-35
Calibrators 1-30
Current 6-35
Dilution 2-203
Stored 6-36
Review 6-15
ASSAY STATUS Screen 6-20
Capacities, Sampling 4-10
Calibration Data Check 6-16
Carousel Sampler
ICT™ Information 6-28
(illus) 1-7
Replace Current Calibration with Previous 6-26
Description 1-7, 1-9
View Details 6-24
Carousel Sampler Area and Carousels Cleaning
View Previous Calibration Curve 6-23
Procedure 9-65
View Stored Calibration Curves 6-24
CE Mark xv
System-initiated 6-14
Changes from Previous AEROSET Operations
Theory 6-2
Manual v
Calibration Curves
Check Sample and Reagent Dispense Components
Previous 6-23
Check Probe Screws for Tightness 9-72
Stored 6-24
Check Sample and Reagent Arms and Syringes
Calibration Details Screen 6-25
9-68
Calibration Error Codes, ASSAY STATUS Screen
Check Valve
10-57
Verification 9-124
Calibration Error Codes, Index of 10-182
Checkbox 1-50
Calibration Information Area, ASSAY STATUS Screen
Chemical Hazards 8-7
6-21
Precautions 8-7
Calibration Options
Clot Detection Screen 10-12
Abs Appendix A-1
Clot Detection System 1-37, 10-11
Exponent Mode Appendix A-16
Color Correction Feature 2-183
Factor Appendix A-2
Isozyme Mode Appendix A-6
Combo Box 1-50

200154-101—November 2004
Index
Comments Dialog Window 5-141 Rate Linearity 2-213

Common Test File 2-154 Reagents
Component Tracking 10-5 with Bar Code Labels 2-62
Computer and Interface Specifications 4-10 without Bar Code Labels 2-64
Concentrated Reagents 2-68 Reference File 2-155
Parameters Using ALT or AST 2-156
R.Vol 2-69 Using Saline 2-155
Reagent 1/Reagent 2 2-69 Result Print Format Parameters 2-37
W.Vol 2-69 Run Options 2-11
Configuration Sample Interference Index File 2-157
Absorbance Limits 2-210 Sample Interference Indices
Absorbance Maximum Variability 2-212 Base Page 2-163
Assay Display Order 2-46 Outline Page 2-158
Assays 2-75 QC Page 2-165
ASSAYS Screen 2-46 Reference File 2-155
Automatic Power ON, START UP and SHUTDOWN Sample Volume 2-197
2-29, 9-35 SYSTEM CONFIGURATION Screen 2-13, 2-24
Blank/Calibrator Dilution 2-203 Type Number 2-186
Calculated Assay Results (Ratios) 2-114 Westgard Rules 2-25
Base Page 2-121 Consumables 1-25
Outline Page 2-116 Calibrators 1-30
QC Page 2-124 ICT™ Calibrators 1-28
Rerun Rules Page 2-127 ICT Cleaning Fluid 1-29
Calibrator/Control 2-71 ICT Reference Solution 1-29
Concentrated Reagents 2-68 ICT Sample Diluent 1-28
DATABASE Screen 2-31 Reagent Cartridges and Caps 1-27
Diluent 2-200 Sample Cups 1-26
Diluent Volume 2-197 Wash Solutions 1-29
Extrapolated Calculation 2-215 Water Bath Additive 1-30
Host Communication 2-55 Controls
Log On Password 2-8 Configuration 2-71
MAINTENANCE UTILITIES Screen 2-28 Loading 5-125
Page Format Parameters 2-40 When Sample Carousel Completes Sampling
PAGE SETUP Screen 2-35 5-128
Parameters 2-41 When Sample Carousel Is Busy 5-127
Panel 2-31 Ordering 5-121
Photometric Assays 2-76 Requirements for Use 7-6
Base Page 2-85 Storage and Handling 7-5
Calibration Page 2-96 Cross-contamination Protocol 2-217
Outline Page 2-78 Donor Assay 2-217
QC Page 2-105 Recipient Assay 2-217
Rerun Rules Page 2-112 Saline Assay 2-217
SmartWash™ Page 2-109 Cup/Tube Adapter 1-32
Potentiometric Assays 2-129 (illus) 1-32
Base Page 2-136 Customer Support x
Calibration Page 2-142 Customized View Option 5-80
Outline Page 2-131 Cuvette
QC Page 2-145 Cleaning Procedure 9-147
Rerun Rules Page 2-151 Positions 3-5
SmartWash Page 2-148 Removal and Replacement 9-185
Printer Cuvette Blank Screen 10-19, 10-20
A and B 2-52 Cuvette Integrity Check 10-19
Sample Report Forms 2-34 Data Interpretation 10-23
QC Rules 2-25 Cuvette Integrity Check Screen 10-22

200154-101—November 2004
Index
Cuvette Segment 1-14 Dilution

(illus) 1-14 Manual 5-43
Removal and Replacement 9-183 Multiple Calibrator 2-206
Cuvette Washer 1-15 Onboard 5-43
(illus) 1-15 Single Calibrator 2-203
Cuvette Washer Nozzles Cleaning Procedure 9-76 Disclaimer
Master Table of Contents/Index xii
D Pictorial xi
Disk Formatting Procedure 9-134
Daily Checks 9-5
Dispense Mode
Check 1 mL Syringes 9-37
R1 2-187
Check DI Water Purity 9-48
R2 2-188
Check High-concentration Waste Container 9-45
Display Area 1-47
Check Refrigerator Condensation Pan 9-47
Donor Assay (Definition) 2-217
Check Sample and Reagent Syringes 9-42
Download Orders from Host Computer 5-117
Check Solenoid Valves 9-42
Drop-down List Box 1-50
Check Wash Solution Trays 9-41
Database Capacity 9-26, 9-27
DATABASE Screen 2-31, 5-77, 10-37 E
Color Display 5-62 Edit Comment Dialog Window 5-141
Decontamination 9-205 Editing
Decontamination Procedures 8-11 QC Rules 2-27
Requirements 8-11 Results 5-108
Deleting Electrical
Assay Files 2-48 Specifications 4-9
Existing User Code 2-10 Electrical Hazards 8-13
Previous Calibration Data 6-33 Electrolytes (Potentiometric Assays)
QC Data 5-145 Base Page Configuration 2-136
Results 5-112 Calibration Page Configuration 2-142
from RESULT Screen 5-113 Outline Page Configuration 2-131
Samples from DATABASE Screen 5-112 QC Page Configuration 2-145
Selected Files within a Library Folder 9-144 Qualitative Ranges 2-135
Stored Average Calibration Data 6-34 Quantitative Ranges 2-131
DI Water Rerun Rules Page Configuration 2-151
Filter Cleaning Procedure 9-79 SmartWash™ Page Configuration 2-148
System Check 9-48 Emergency SHUTDOWN Procedure 8-2
Diluent End-point Absorbance Variation 2-212
Configuration 2-200 End-point Assay 3-10
Parameters Environmental Requirements 4-6
Cartridge # 2-201 Error Code Index 10-181
Cartridge Size 2-201 Error Log Messages, ERROR LOG Screen 10-81
Exp Date 2-201 Error Log Messages—Supplemental Information
Lot # 2-201 10-158
Reagent Name 2-201 Error Log Report Appendix B-2
Reagent Type 2-201 Exponent Mode Calibration Appendix A-16
Rgt (Reagent) Lo Alert 2-201 Export Function 2-227
Diluent Dispense Mode 2-189 Export Options (QC) Dialog Window 5-155, 5-158
Diluent Volume Configuration 2-197 Exporting
Diluting Assay Files 2-46
Blank/Calibrator 2-203 Files to Disk 2-227
Patient Samples 2-196 QC Data 5-155
Results to Floppy Disk 5-114

200154-101—November 2004
Index
Exposure Host Communication Parameters

Heavy Objects 8-17 Master Control Time 2-56
Hot Objects 8-17 Maximum Wait Time 2-57
Laser Light 8-16 Protocol Type 2-56
Extra Test File 2-155 Result Transmission Mode 2-56
Extrapolated Calculation 2-215 RS-232C Config 2-57
Transmission Interval 2-57
F Transmit QC Results 2-56
Use Transmission Check Digit 2-56
Factor and Intercept, Result Correction
Host Computer 5-117
Appendix A-24
Download Orders from 5-117
Factor Calibration Appendix A-2
Host Order Query 5-118
FastTrack™ Sampler 5-57
Icon Online Status 1-46
(illus) 1-7
Transmitting Results to 5-119
Description 1-7
Host Interface Icon Online Status 1-46
FlexRate Method Feature 2-194
Host Order Query 5-118
How to Use This Manual How-1
Floppy Disk Formatting Procedure 9-134
Flush, Initiating 9-71
Foreword x I
Form 1 Report Appendix B-5 Icons
Form 2 Report Appendix B-6 BIOHAZARD How-4, 8-3
Form Options Dialog Window 2-35 CAUTION How-4, 8-3
Front Display Panel CAUTION Hot Surface How-4
(illus) 1-21 Class II Laser Product How-4, 8-3
Front Display Panel Indicators 5-57 Description 1-49
(illus) 1-21 Electrical Shock Hazard 8-3
Full Calibration 6-4 Host Communication 2-55
Hot Surface 8-3
G in Text How-4
NOTE How-4
General Operational Utilities 5-1
Printer 2-52
General Precautions, Operational 7-2
Safety 8-3
General Result Form Parameters 2-41
WARNING 8-3
Graphic Conventions How-5
ICT™
Calibration 6-3
H Calibration Information 6-28
Hazards 8-1 Calibrators 1-28
Biological 8-5 Cleaning Fluid 1-29
Chemical 8-7 Probe (illus) 9-198
Decontamination Procedure Requirements 8-11 Probe Alignment 9-201
Electrical 8-13 Reference Solution 1-29
Mechanical 8-14 Sample Diluent 1-28
Physical 8-16 Sample Progression 3-15
Spill Clean-up 8-9 ICT Module
Symbols 8-4 (illus) 1-16, 3-16, 9-199
Waste Handling and Disposal 8-10 Design 3-16
High-concentration Waste Removal Procedure 9-196, 9-199
Container and Cap Replacement 9-156 Replacement Procedure 9-199
Container Inspection Procedure 9-45 ICT Module/Probe Replacement 9-196
Float Switch Cable Replacement 9-158 ICT Probe
Highlights of Changes in this Manual Version v Removal Procedure 9-199
Host Replacement Procedure 9-199
Communication Icon 2-55 ICT Probe and Tubing Inspection 9-58
Configuration 2-55 ICT Reference Solution Loading 5-34, 9-22

200154-101—November 2004
Index
ICT™ Reference Solution Pump Syringes (illus) Library Files, Delete All 9-143
9-127, 9-131 Library Folder, Delete Selected 9-144
ICT Unit 3-12 Library Maintenance 9-142
Calculation Method 3-17 Access 9-143
Components 3-13 Library Overview 9-142
Flow Diagram 3-12 Limited Run Feature
Sample Progression 3-15 Deselecting 5-75
Import and Export Functions 2-225 Limited View Buttons 5-79
Import Function 2-226 Limiting Assays in a Run 5-73
Importing Line Balance Feature 2-176
Assay Files 2-49 Linear Mode (1-point Method) Calibration
Files to Disk 2-226 Appendix A-3
Index, Error Codes 10-181 Linear Mode (Multi-point Method) Calibration
Information Access Area 1-42 Appendix A-4
Buttons 1-42 Loading
Instrument Labeling xv A-Line Tests 5-24, 9-12
Symbols Used on xiv B-Line Tests 5-24, 9-12
Instrument Relocation 2-229 Controls 5-125
Distant 2-229 When Sample Carousel Completes Sampling
Local 2-229 5-128
Movement 2-229 When Sample Carousel Is Busy Sampling 5-127
Re-installation 2-229 Reagents 5-24
Interface (LUI) Control Panel Loading Reagents 5-24, 9-12
(illus) 1-18 Loadlist
Description 1-18 Printing Report 5-46
Inventory Reviewing and Printing 5-46
Bulk Solutions 5-31, 9-19 Loadlist Report Appendix B-19
Reagents 5-21 Location 9-13
Isozyme Mode Calibration Appendix A-6 Log Off
Procedure 5-10
K Log On
Configure Password 2-8
Keyboard
Procedure 5-4
Operation 1-51
Log On Screen 2-8, 2-10, 5-4
Replacement Procedure 9-152
Logit-4 Mode Calibration Appendix A-12
Logit-5 Calibration Mode Appendix A-14
L LUI Control Panel
Labels (illus) 1-18
Instrument xiv Description 1-18
Sample Bar Code 5-51
Sample Carrier 2-2 M
Symbols xiv
Main Circuit Breaker Switch 5-2
Lamp Monitoring Feature 1-37
(illus) 5-2
Lamp Replacement 9-105
Main Display Screen 1-39
Levey-Jennings
Maintenance
Details 5-138
Annual Procedures 9-123
Graph Report 5-147, Appendix B-11
As Needed Procedures 9-133
Graph Screen 5-135
Daily Checks 9-5
Access from QC SUMMARY Screen 5-134
Monthly Procedures 9-61
Levey-Jennings Graph Screen 5-138
Quarterly Procedures 9-81
Library
Semi-Annual Procedures 9-119
Access Library Maintenance Functions 9-143
Weekly Procedures 9-49
Delete All Library Files 9-143
Delete Selected Files within Library Folder 9-144
Delete Selected Library Folder 9-144

200154-101—November 2004
Index
Maintenance Schedule 9-3 N

Annual 9-4
Non-bar Code Labeled Sample Carrier 1-32
As Needed 9-4
Daily 9-3
Decontamination 9-4 O
Monthly 9-3 Observed Problems 10-161
Quarterly 9-3 Index of 10-191
Semi-Annual 9-3 Onboard Dilution 5-43
Weekly 9-3 ONLINE CONFIGURATION Screen 2-55
MAINTENANCE UTILITIES Screen 2-28, 10-3 Operation
Component Tracking 10-6 Cuvette Positions 3-5
Rgt Area 1 and 2 Page 10-15 Operational Precautions and Limitations 7-1
Rgt Area 1 Page 10-15 Operator Responsibilities 7-1, 8-1
Rgt Area 2 Page 9-69 Optical Characteristics 4-9
Rxn (Reaction) Area Page 10-17 Optimum Sampling Sequence™ Feature 1-36
Rxn Area Page 9-54, 10-17 Optional Calibration 6-7
Sampling Page 9-73, 10-9 Options
SCC Page 9-134, 10-7 Calibration 6-4
SW (Software) Info Page 10-24 Customized View 5-80
System Page 2-29, 10-4 Measurement 2-175
Manual Order Samples Screen 5-42
How to Use How-1 Reference File 2-154
Structure, Content, and Order How-1 Run 5-59
Text Conventions How-4 Sample Order 5-40
Manual Dilution 5-43 Sort 5-81
Master Table of Contents/Index Disclaimer xii Order List Report Appendix B-18
Math Models, System Appendix A-1 Order Samples Screen 2-31, 5-42
Measurement Options 2-175 Ordering
Color Correction 2-183 and Running Tests 5-37
Diluting Multiple Calibrator 2-206 Controls 5-121
Diluting Patient Samples 2-196 Patient Samples
Diluting Single Calibrator 2-203 in the Sample Carousel 5-40
Diluting the Blank/Calibrator 2-203 on the FastTrack™ Sampler 5-37
FlexRate Method 2-194 OSS™ Feature 1-36
Line Balance 2-176 Operation during SmartWash™ Processing 1-36
Prozone Reaction Checks 2-190
Sample Blank 2-178 P
Measurement, Sample Interference Indices 2-168
Page Format Parameters 2-40
Mechanical Hazards 8-14
PAGE SETUP Screen 2-35, 2-37
Mixer
Panel Configuration 2-31
Cleaning Procedure 9-53
Parameters
Replacement 9-192
Panel # 2-33
Modes of Operation 5-1
Panel Name 2-33
Monthly Maintenance 9-61
Panel Configuration Screen 2-32
Check Sample and Reagent Dispense Components
Password 2-8, 2-9
9-68
Patient Demographics Dialog Window 5-44
Check/Clean Reagent Supply Centers 9-62
Patient Sample Orders
Clean Carousel Sampler Area 9-65
Editing 5-63
Clean Carousels 9-65
Ordering 5-37
Clean Cuvette Washer Nozzles 9-76
PAUSE Function 5-5
Clean DI Water Filter 9-79
Performance Characteristics 4-2

200154-101—November 2004
Index
Photometric Assays 3-10 PRINTER A Dialog Window 2-52

Base Page Configuration 2-85 Printer Parameters
Calibration Methods 6-2 Enable Calibration/Control/Patient Reports 2-53
Calibration Page Configuration 2-96 Result Printing Mode 2-53
Outline Page Configuration 2-78 Wait Time for Multi-print Feature 2-53
QC Page Configuration 2-105 Printing
Qualitative Ranges 2-84 Calibration Summaries 6-35
Quantitative Ranges 2-80 Current Calibration Summary 6-35
Rerun Rules Page Configuration 2-112 Loadlist 5-46
SmartWash™ Page Configuration 2-109 Stored Calibration Summary 6-36
Photometry 3-7 Printing Reference Ranges 2-43
Photometric System 3-7 Probe Screws Tightness Inspection Procedure 9-72
Photometric Timing 3-7 Procedure
(diagram) 3-7 Calibration Run 6-9
Table 3-8 Check Reagent Inventory 9-9
Physical Hazards 8-16 Emergency SHUTDOWN 8-2
Exposure to Hot Objects 8-17 Instrument Decontamination 8-11
Exposure to Laser Light 8-16 Log Off 5-10
Trip Hazard 8-17 Log On 5-4
Physical Specifications 4-5 Power OFF 5-11
Potentiometric Assays 2-129, 3-12 Power ON 5-2
Base Page Configuration 2-136 Reagent Inventory 5-21, 9-9
Calibration Methods 6-3 SHUTDOWN 5-8, 9-24
Calibration Page Configuration 2-142 START UP 5-8, 9-24
Outline Page Configuration 2-131 System-initiated Calibration 6-14
QC Page Configuration 2-145 Processing Codes 5-78
Qualitative Ranges 2-135 Proprietary Statement xi
Quantitative Ranges 2-131 Prozone Reaction Check Feature 2-190
Rerun Rules Page Configuration 2-151 Assay Parameter Settings 2-192
SmartWash Page Configuration 2-148
Power OFF Procedure 5-11 Q
Power ON Procedure 5-2
QC
Precautions
Data List 5-143
Consumables 7-4
Data List Report 5-150, Appendix B-9
Operational 7-2
Print Options 5-151
Reagents, Calibrators, Controls, and Bulk
Deleting Data 5-145
Solutions 7-5
Exporting Data 5-155
Result Interpretation and Reporting 7-8
Rules Parameters 2-25
Specimens 7-7
Summary Report 5-153
Collection 7-7
Print Options 5-153
Preparation and Storage 7-7
Sort Options 5-153
System Operation 7-3
Westgard Rules 5-161
Preserved Samples 5-62, 9-26
Editing Configuration 2-27
Pressure Monitor Screen 10-12, 10-13
QC Data List Screen 5-143, 5-150
Primary Components (of the AEROSET) 1-3
QC Results
Principles of Operation 3-1
ASSAY STATUS Screen 5-129
Print Options (QC) Dialog Window 5-148
Levey-Jennings Screen 5-135
Print Options Dialog Window 2-34, 5-46
Printing 5-146
Printer
Reviewing 5-129
Configuration
QC Rules (illus) 2-26
Printer A and B 2-52
QC Rules Configuration 2-25
Configure Sample Report Forms 2-34
QC Rules Dialog Window 2-25
Icons 2-52
QC Summary Report Appendix B-7
Replacement Procedure 9-153

200154-101—November 2004
Index
QC SUMMARY Screen 5-131 Reagent Arm Tubing Replacement 9-172

Qualitative Ranges Reagent Arms 1-11
Calculated Assay Results (Ratios) 2-120 Reagent Bar Code Reader Cleaning Procedure 9-145
Photometric Assays 2-84 Reagent Carryover 2-217
Potentiometric Assays 2-135 Cross-contamination Protocol 2-217
Sample Interference Indices 2-162 Implementation and Verification of SmartWash™
Quality Control Information Area, ASSAY STATUS 2-222
Screen 5-130 Reagent Cartridge Adapters 1-34
Quantitative Ranges (illus) 1-34
Calculated Assay Results (Ratios) 2-116 Reagent Cartridge Configuration Parameters
Photometric Assays 2-80 Cartridge # 2-66
Potentiometric Assays 2-131 Cartridge Size 2-66
Sample Interference Indices 2-158 Exp Date 2-66
Quarterly Maintenance 9-81 Lot # 2-66
0.22 micron Filter Replacement, 20 L Water Reagent Name 2-66
Reservoir 9-112 Reagent Type 2-66
0.22 micron Filter Replacement, 30 L Water Rgt (Reagent) Lo Alert 2-67
Reservoir 9-116 Reagent Cartridges
ICT™ Aspiration Syringe (1 mL) Replacement (illus) 1-27
9-102 Description 1-27
ICT Reference Solution Syringe (1 mL) Loading Locations 2-61
Replacement 9-99 with Bar Code Labels 2-62
Source Lamp Replacement 9-105 without Bar Code Labels 2-64
Syringe Seal Tip (1 and 2) and O-ring Replacement Reagent Configuration 2-59
9-82 Reagent Inventory 9-6
Wash Solution Syringe (1 mL) Replacement 9-96 Procedure 5-21, 9-9
Reagent Details 9-9
R Reagent Supply Centers 5-25, 9-13
Reagent View Page 5-17, 9-6
Rate Assay 3-10
Reagent Probe Replacement 9-167
Rate Linearity 2-213
Reagent Report Screen 5-18, 9-7
Reaction Carousel 3-3
Reagent Supply Centers 2-59, 5-15, 9-13
Reaction Carousel Area
Configured Positions 2-59
Description 1-13
Description 1-12
Reaction Cuvette Segment 1-14
Inspecting/Cleaning Procedure 9-62
Reaction Graph Screen 5-94, 10-25
Segment Location 2-60
Absorbance Data 10-34
Reagent View Page 5-17, 9-6
Adjusting Reaction Graph Absorbance Scale 10-29
Reagents
Reaction Graph Area 10-26
Result Display Area 10-28
Viewing a Graph of Absorbance Readings at the
Reagents List Report Appendix B-3
Primary or Secondary Wavelength Individually
REAGENTS Screen 2-64
10-32
R1-A Page 2-63, 5-22
Viewing Multiple Result Error Codes for a Result
R1-C Page 2-65
10-35
View Page 2-88, 5-17, 9-6
Reaction Graphs 10-25
Recalculating
Display 5-94
All Assays 5-110
Multiple Results from DATABASE Screen 5-95
Results 5-109
Single Result from DATABASE Screen 5-94
from DATABASE Screen 5-109
Single Result from RESULT Screen 5-97
from RESULT Screen 5-111
Reaction Table 3-5
Selected Assays 5-109
Reagent
Recipient Assay (Definition) 2-217
Details 5-20, 9-9
Reference Ranges
Inventory Procedure 5-21, 9-9
Printing 2-43
Loading 5-24, 9-12

200154-101—November 2004
Index
Refrigerator Condensation Pan 9-47 Recalculating 5-109

Inspection Procedure 9-47 from DATABASE Screen 5-109
Relocation, Instrument 2-229 from RESULT Screen 5-111
Report Selected Assays 5-109
Assay List Appendix B-17 Rerunning 5-98
Automatic (Updated) Calibration Appendix B-16 All Assays 5-100
Calibration Summary (Current) Appendix B-12 from DATABASE Screen 5-98
Calibration Summary (Stored) Appendix B-14 from RESULT Screen 5-101
Calibrator/Control List Appendix B-20 in the Reserved STAT Position 5-102
Configure Sample Report Forms 2-34 Selected Assays 5-98
Error Log Appendix B-2 Reviewing 5-77
Form 1 Appendix B-5 on DATABASE Screen 5-77
Form 2 Appendix B-6 on RESULT Screen 5-84
Levey-Jennings Graph 5-147, Appendix B-11 QC 5-129
Loadlist Appendix B-19 Reviewing QC 5-129
Order List Appendix B-18 Searching 5-82
QC Data List 5-150, Appendix B-9 Transmitting to Host Computer 5-119
QC Summary 5-153, Appendix B-7 Validating 5-91
Reagents List Appendix B-3 Results Data Checks 2-209
Reporting Units 2-95, 2-122, 2-137, 2-164 Revision
Required Calibration 6-7 Log ix
Required Precautions Status iii
Biosafety Hazards 8-6 Rotary Power Control Switch 5-2
Chemical Hazards 8-7 Run 5-13
Rerun Results Limiting Assays in 5-73
Reviewing and Selecting Results to Report 5-103 Run Options and Starting the Run 5-59
Selecting Replicate Result to Report 5-88 Run Options Parameters
Selecting Rerun Result to Report 5-106 Auto Return 2-11
Rerunning Results 5-98 Car’r 2-12
Responsibilities (of AEROSET Operator) 8-1 Priority 2-11
Result Correction Appendix A-24 RUN OPTIONS Screen 2-11, 5-5, 5-59
Result Display Area 10-28 Run Progress 5-60
Result Error Codes, DATABASE and RESULT Screen Area 1-48
10-37 Viewing 5-60
Result Error Codes, Index of 10-181 Run Progress Area 1-48, 5-60
Result Print Format Parameters 2-37
RESULT Screen 5-84, 10-37 S
Results
Safety Icons 8-3
Accepting 5-89
Descriptions 8-3
Data Checks 2-209
Saline Assay (Definition) 2-217
End-point Absorbance Variation 2-212
Saline Protocol 2-155
Extrapolated Calculation 2-215
Sample and Reagent Arm Cover
Rate Linearity 2-213
Removal 9-68
Deleting 5-112
Replacement 9-74
from RESULT Screen 5-113
Sample and Reagent Arms and Syringes Inspection
Editing 5-108
Procedure 9-68
Exporting to Disk 5-114
Sample and Reagent Probes (Outside) Cleaning
Printing 5-92
Procedure 9-51
Multiple Result Reports from DATABASE Screen
Sample and Reagent Syringe
5-92
Installation 9-88
QC 5-146
Removal 9-84
Single Result Report from DATABASE Screen
Sample and Reagent Syringes and Solenoid Valves
5-92
Inspection Procedure 9-42
Single Result Report from RESULT Screen 5-93

200154-101—November 2004
Index
Sample Arm 1-10 Sampling Capacities 4-10

Sample Arm Tubing Replacement 9-163 Save Assay Configuration Dialog Window 2-47
Sample Blank Feature 2-178 SCC Component Replacement 9-151
Assay Parameter Settings 2-180 Keyboard 9-152
Sample Carousel 5-58 Printer 9-153
Sample Carrier 1-31 Screen
(illus) 1-8, 1-31 Absorbance Data 10-34
Bar Code Label Placement 2-4 Add Assays 5-107
Bar Code Labels 2-3 Assay Configuration, Base Page 2-68
Label Placement 2-2 Assay Configuration, Calibration Page 2-96
Labels 2-2 Assay Configuration, Outline Page 2-77, 2-115
Numeric Code Label Placement 2-5 Assay Configuration, QC Page 2-105
Sample Carrier Tray 1-8, 1-33 Assay Configuration, Rerun Rules Page 2-112
(illus) 1-8, 1-33 Assay Configuration, SmartWash™ Page 2-109
Cover 1-33 ASSAY STATUS 2-171, 5-129, 6-20
(illus) 1-33 ASSAYS 2-46
Sample Carryover Reduction Feature 1-38 Calibration Details 6-25
Sample Forms Appendix F-1 CALIBRATION SUMMARY 6-29
Sample Interference Index File Configuration 2-157 CALIBRATOR/CONTROL 2-71
Sample Interference Indices 2-153 Comments Dialog Window 5-141
Base Page Configuration 2-163 Customized View Dialog Window 5-81
Measurement 2-168 Cuvette Blank 10-20
Outline Page Configuration 2-158 Cuvette Integrity Check 10-22
QC Page Configuration 2-165 DATABASE 2-31, 5-77, 10-37
Qualitative Ranges 2-162 Define Free Text 2-44
Quantitative Ranges 2-158 Edit Comment Dialog Window 5-141
Reference File Configuration 2-155 ERROR LOG 10-81
Reference File Options 2-154 Export Options (QC) Dialog Window 5-155, 5-158
Common Test File 2-154 Form Options Dialog Window 2-35
Extra Test File 2-155 Levey-Jennings Graph 5-135, 5-138
Sample Order Options 5-40 Log On 2-8, 2-10, 5-4
Sample Probe Replacement 9-159 Main Display 1-39
Sample Progression 3-3 MAINTENANCE UTILITIES 2-28
Reaction Carousel 3-3 MAINTENANCE UTILITIES, Rgt Area 1 Page 10-15
Sample Replicates 5-42 MAINTENANCE UTILITIES, Rgt Area 2 Page 9-69
Sample Report Form MAINTENANCE UTILITIES, Rxn Area Page 9-54,
Page Setup Parameters 10-17
Date and Time Format 2-36 MAINTENANCE UTILITIES, Sampling Page 9-73,
Multi-print 2-36 10-9
Paper Size 2-36 MAINTENANCE UTILITIES, SCC Page 9-134, 10-7
Sample Tube Specifications 4-11 MAINTENANCE UTILITIES, SW Info Page 10-24
Sample Vessel Requirements 5-47 MAINTENANCE UTILITIES, System Page 2-29,
Bar Code Labels 5-51 9-35, 10-4
Sample Integrity 5-50 ONLINE CONFIGURATION 2-55
Sample Volume 4-3, 5-48 On-line Data Transfer Dialog Window 5-117
Sample Volume Order Samples 2-31, 5-42
Configuration 2-197 PAGE SETUP 2-35
Requirements 4-3, 5-48 Panel Configuration 2-32
Samples Patient Demographics Dialog Window 5-44
Adding during a Run 5-69 Pressure Monitor 10-13
Adding on FastTrack™ Sampler 5-69 Print Options (QC) Dialog Window 5-148
Adding on Sample Carousel 5-70 Print Options Dialog Window 2-34, 5-46, 5-92
Preserved 5-62, 9-26 PRINTER A Dialog Window 2-52
Unloading 5-163 QC Data List 5-143, 5-150
Validated (Preserved) 5-62, 9-26 QC Rules Dialog Window 2-25

200154-101—November 2004
Index
QC SUMMARY 5-131 Software 1-39

Reaction Graph 5-94, 10-25 Action Area 1-44
Reagent Report 5-18, 9-7 Display Area 1-47
Reagent View Page 5-17 Information Access Area 1-42
REAGENTS 2-64 Run Progress Area 1-48, 5-60
REAGENTS, R1-A Page 2-63, 5-22 Screen Layout 1-39
REAGENTS, R1-C Page 2-65 Screen Navigation 1-49
REAGENTS, View Page 2-88, 5-17, 9-6 Status Area 1-47
RESULT 5-84, 10-37 Sort Options 5-81
RUN OPTIONS 2-11, 5-5, 5-59 Source Lamp Replacement 9-105
Run Progress Area (of the Main Display) 1-48, 5-60 Specifications
Search Dialog Window 5-82 Bar Code Label 5-51
SELECT ASSAYS FOR CALIBRATION 6-10 Specimens
SELECT ASSAYS FOR STAT 5-67 Collection 7-7
SELECT ASSAYS TO RUN 5-74 Precautions 7-7
Select Reaction Mode Dialog Window 2-48 Preparation and Storage 7-7
SHUTDOWN OPTIONS 9-31 Spill Clean-up 8-9
Sort Dialog Window 5-81 Spline Mode Calibration Appendix A-18
START UP OPTIONS 5-31, 9-29 START UP and SHUTDOWN 9-24
Status Area (of the Main Display) 1-47 24 Hour Operation 9-26
SYSTEM CONFIGURATION 2-13 Partial Day Operation 9-27
USER ALERT Dialog Window 2-50, 2-79 Solution Volume Display 9-33
USER REGISTRATION Dialog Window 2-9 Solutions Used 9-32
Screen Hierarchy 1-41 START UP Options 5-8, 9-26, 9-27
Screen Navigation 1-49 Automatic 2-30, 9-36
Buttons and Icons 1-49 START UP OPTIONS Screen 5-31, 9-29
Check Box 1-50 Options 5-8, 9-24
Combo Box 1-50 START UP Procedure 5-8, 9-29
Drop-down List Box 1-50 STAT Samples 5-64
Keyboard Operation 1-51 Ordering and Running 5-64
Scroll Bar 1-49 Status Area 1-47
Single Selection Item 1-50 Stop 5-13
Tabs 1-49 Supplemental Information
Scroll Bar 1-49 Error Log Messages 10-158
Seal Tips and O-ring Removal and Replacement Symbols Used on Instrument Labeling xiv
9-86, 9-93 Syringe Seal Tip and O-ring Replacement 9-82
SELECT ASSAYS FOR CALIBRATION Screen 6-10 System Configuration Files
SELECT ASSAYS FOR STAT Screen 5-67 Backup Procedure 9-137
SELECT ASSAYS TO RUN Screen 5-74 Restore Procedure 9-139
Select Reaction Mode Dialog Window 2-48 System Configuration Parameters
Semi-Annual Maintenance 9-119 1st Car’r for No-Bcode Smpls 2-16, 2-24
ICT™ Reference Solution Filter Replacement Alphanumeric Sample ID 2-17
9-121 Audible Alerts 2-20
Wash Solution Filters Replacement 9-119 Auto Order Calculations 2-18
Service and Maintenance 9-1 Auto Rerun 2-14
SHUTDOWN Options 5-8, 9-24, 9-27 Auto Validate 2-18
Automatic 2-30, 9-36 Bar Code Length-Skip-ID 2-18
SHUTDOWN OPTIONS Screen 9-31 Calibrator 2-22
Options 5-8, 9-24 Characters for L/H Flags 2-19
SHUTDOWN Procedure 5-8, 9-31 Control 2-22
SHUTDOWN Procedure, Emergency 8-2 Cycle Time 2-16
Single Selection Item 1-50 Enable Cal Edits 2-14
Site Preparation (for the AEROSET) 2-1 Enable Demog. Edits in RESULT 2-19
SmartWash™ Feature 1-35 External Robotics 2-20

200154-101—November 2004
Index
Fixed Digits 2-19 W

ICT™ 2-20
Warning Label
Reagent Bar Codes 2-20
Biosafety Hazards 8-5
Rgt (Reagent) Lo Alert (#T) 2-20
Warranty
Run Suspend Time 2-14
ICT Module xiii
Sample Bar Codes 2-19
Instrument xiii
Sample Clot Detection System 2-21
Warranty Statement xii
Save by Car’r ID 2-17
Wash Solution Pump Syringes (illus) 9-125, 9-129
Saving Mode 2-15
Wash Solution Syringe
ScreenSaver 2-21
Installation 9-95
Smart Sampling 2-14
Removal 9-89
SmplSeq (Sampling Sequence) 2-22, 2-23
Wash Solution Trays Inspection Procedure 9-41
Wash Count for Removing Clot 2-21
Wash Solutions 1-29
SYSTEM CONFIGURATION Screen 2-13
Loading 5-33, 9-21
System Control Center (SCC)
Wash System
Description 1-4
Components 1-17
System Preparation (for the AEROSET) 2-1
Description 1-17
System Status and Run Progress 5-60
Waste Handling and Disposal 8-10
System Status Area 5-61
Water Bath Additive 1-30
System-initiated Calibration Procedure 6-14
Weekly Maintenance 9-49
Check ICT Probe and Tubing 9-58
T Check Sample and Reagent Probes 9-50
Tabs 1-49 Clean Mixers 9-53
Text Conventions How-4 Clean Outside of the Sample and Reagent Probes
Icons How-4 9-50
Touchscreen Display Cleaning Procedure 9-57 Clean Touchscreen Display 9-57
Touchscreen Operation 1-49 Westgard QC Rules 5-161
Trademark Statements xvii Configuration 2-25
Transmitting Results to Host Computer 5-119
Troubleshooting Logic Model 10-1, 10-2
Type Number
Definitions 2-186
Diluent Dispense Mode 2-189
Dispense Mode
R1 2-187
R2 2-188
Type Number Configuration 2-186
U
Unit Configuration Parameters 5-26, 9-14
Units of Measure 2-95, 2-122, 2-137, 2-164
Unloading
Reagent Cartridges 5-164
Samples and Sample Carriers 5-163
UNPAUSE Function 5-7
UPS 4-8
Use Factor and Blank Calibration Appendix A-22
Use Factor Calibration Appendix A-20
USER ALERT Dialog Window 2-50, 2-79
User Code 2-9
Delete Existing 2-10
USER REGISTRATION Dialog Window 2-9
Password 2-9
User Code 2-9

200154-101—November 2004

Operations Manual: List No. 9D06-05 Volume 1 of 2

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Operations Manual

List No. 9D06-05

Abbott Laboratories ©1998, 2004 Abbott Laboratories

ii AEROSET® System Operations Manual

Document Revision Section(s) Pages Revised Software

9D06-01 6/98 Original Issue Original Issue Version

AEROSET® System Operations Manual iii

94819-106, 6/03 Section 3 3-16, 3-19, 3-22 Version

iv AEROSET® System Operations Manual

AEROSET® System Operations Manual v

Section 1, Use or Function

Section 2, Installation and Special Procedures

Section 5, Operating Instructions

vi AEROSET® System Operations Manual

Section 10, Troubleshooting and Diagnostics

AEROSET® System Operations Manual vii

viii AEROSET® System Operations Manual

Document Revision Software Version Revision Date

AEROSET® System Operations Manual ix

x AEROSET® System Operations Manual

AEROSET System Operations Manual

AEROSET® System Operations Manual xi

xii AEROSET® System Operations Manual

AEROSET® System Operations Manual xiii

Key to Symbols Used on Instrument Labeling

For in vitro diagnostic use *Caution or Warning:

List number/Catalog number *Caution or Warning: Electrical shock

Serial number *Caution: Hot surface

Batch code/Lot number Caution: Potential biohazard

Unit *Caution: Class II Laser Product

Item Use by/Expiration date

Quantity Temperature limitation

Size AC input power

ASSAY DISK Assay disk

IMPORT DISK Import disk

DRUGS OF ABUSE Drugs of abuse

THERAPEUTIC DRUG MONITORING Therapeutic drug monitoring

SERUM PROTEINS Serum proteins

CONVENTIONAL UNITS Conventional units

SYSTEM CONFIGURATION SOFTWARE System configuration software

* Symbols have black text with yellow background.

xiv AEROSET® System Operations Manual

If the following label is on the instrument, the instrument is

AEROSET® System Operations Manual xv

In Vitro Diagnostic Directive 98/79/EC

xvi AEROSET® System Operations Manual

AEROSET® System Operations Manual xvii

xviii AEROSET® System Operations Manual

How to Use This Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . How-1

Section 1. Use or Function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Section 2. Installation Procedures and Special Requirements . . . . . . . 2-1

Section 3. Principles of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Section 4. Performance Characteristics and Specifications . . . . . . . . . 4-1

Section 5. Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Section 6. Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

Section 7. Operational Precautions and Limitations. . . . . . . . . . . . . . . . 7-1

Section 8. Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

AEROSET® System Operations Manual Master Table of Contents-1

Section 9. Service and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

Section 10. Troubleshooting and Diagnostics . . . . . . . . . . . . . . . . . . . . 10-1

Appendix A. AEROSET System Math Models. . . . . . . . . . . . . Appendix A-1

Appendix B. AEROSET System Printed Reports . . . . . . . . . . Appendix B-1