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AEROSET® Customer Training Guide

Abbott Laboratories
Abbott Park, IL 60064
94858-103 — July 2003
NOTES

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Revision Status

REVISION STATUS
The AEROSET System is manufactured and/or distributed by Abbott Laboratories, U.S.A.,
Abbott Park, IL, 60064.

REVISION STATUS

Part Number Revision Date Pages Revised and Added

N/A 7/98 Original Issue


N/A 7/98 page iii
N/A 7/98 pages 6-6 and 6-8
30-1389/R1 8/98 All
30-1761/R2 4/99 All
94858-101 7/01 All
94858-102 6/02 All
94858-103 07/03 All

Copyright 2002, 2003, Abbott Laboratories


AEROSET, AxSYM and IMx 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.
SmartWash is a trademark of Abbott Laboratories.
Probe Rebound is a trademark of Abbott Laboratories.

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. All other trademarks, brands,
product names, and trade names are the property of their respective companies.
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 operation of ABBOTT products by
Abbott trained personnel or informational use only, the information is not modified in any way, and no

AEROSET® Customer Training Guide iii


94858-103 — July 2003
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.
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.
The information was developed to be used by Abbott Laboratories trained personnel, by other persons
knowledgeable or experienced with the operation and service of the product identified, or under the
direct supervision and with co-operation from Abbott Laboratories technical sales or service
representatives.
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.

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Revision Status

Dear AEROSET Customer,


Welcome to AEROSET Customer Training! Abbott Diagnostics is dedicated to quality laboratory
products and strives to provide the best, most reliable systems available. Quality Customer
Training is an important ingredient to ensure quality results. The AEROSET Customer Training
Guide is designed to be your introduction to using the AEROSET System.
The Modules in this guide are intended for initial training of Operators and should be used in
conjunction with the AEROSET System Operations Manual and the AEROSET Application
Manual/Package Insert Binder.
Any product information in this document should be used in conjunction with the latest
revision of the Operations Manual. If any discrepancies in information exist within this
document or any other, the latest revision of the AEROSET System Operations Manual takes
precedence.

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MASTER TABLE OF CONTENTS

INTRODUCTION and ORGANIZATION OF TRAINING . . vi


SYSTEM TOUR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
BASIC RUN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
DAILY START UP AND CHECKS . . . . . . . . . . . . . . . . . 3-1
RUN OPTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
RESULT HANDLING . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
CALIBRATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
QUALITY CONTROL . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
CONFIGURATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
ICT™ UNIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
COMPONENT REPLACEMENT AND
TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
ACTIVITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
GLOSSARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . Glossary-1
HAZARDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix-1
INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index-1

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Introduction

INTRODUCTION
The AEROSET System is a fully automated, random and continuous
access, high throughput clinical chemistry system. The instrument
utilizes a dual pipetting system with a maximum throughput of up to
2,000 tests/hour when running both photometric and potentiometric
assays. The AEROSET System is an open system, which allows the
option of using non-Abbott manufactured reagents. The AEROSET
System processes routine and STAT samples using independent carousel
and FastTrack™ Samplers.

Overview
The AEROSET System Training Program is an integrated, ongoing
approach designed to provide optimum use of the AEROSET System.
The Abbott Customer Service Organization presents information and
provides support to ensure the continuing, successful use of this System.
As a foundation for this process, the goal of the class presentation is to
give the Operator basic tools for effective use of the AEROSET System
in a working environment.

Training Guide Goals


The primary goals of the training guide are to present:
• Procedures to perform basic operation and maintenance
• Information on configuring the System
• Troubleshooting information to resolve common operational
problems

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ORGANIZATION OF TRAINING

AEROSET System Customer Training Class


The information for the AEROSET Customer Training class will be
presented by an instructor using the following materials:
• AEROSET Customer Training Guide
• AEROSET System Operations Manual
• AEROSET System Maintenance Log
• AEROSET Application Manual/Package Insert Binder

AEROSET Customer Training Guide


The AEROSET Customer Training Guide directs classroom activities.
The manual is organized in Modules. Each Module contains the
following:
• Objectives for the Module
• Discussion of the information to be presented
• Supporting illustrations and examples
• Supporting exercises
• Review questions and answers
Example screens and printouts throughout the training guide are used to
acquaint the Operator with the format and content of the various types of
AEROSET System screens and printouts. Information on these screens
and printouts are meant for training purposes only and must not be used
in your laboratory for evaluating specimen results or instrument
performance.
The training guide includes a glossary that defines the vocabulary words
used for each Module as well as terms used during the training sessions.
Throughout the training guide, extra information may be added in the
form of a “NOTE”, “CAUTION”, or “WARNING”. These designations
emphasize special information pertaining to the operation and
performance of the System... BE SURE to read them carefully.
NOTE:This icon is used to indicate important information or
information that represents an exception to conventional methods.

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Organization of Training

Safety icons in this manual and on the AEROSET System identify poten-
tially dangerous conditions or situations. Operators must recognize the
icons and understand the type and degree of potential hazard. A brief
explanatory message labeled WARNING or CAUTION, depending on
the nature of the hazard, accompanies the icon.

Safety Icon Descriptions

Icon Description

WARNING: Identifies an activity or area where Operators


Potential may be exposed to potentially infectious sub-
Biohazard stances.

WARNING: Indicates the possibility of electrical shock if


Electrical procedural or engineering controls are not
Shock Hazard observed.

WARNING: The general WARNING icon identifies an


activity or area that may present a physical,
! mechanical, or chemical hazard which could
result in moderate to serious personal injury.
CAUTION: The general CAUTION icon identifies an
activity or area that may present a physical,
! mechanical, or chemical hazard which could
result in minor injury.
CAUTION: Avoid exposure. Do not stare into the beam.
Class II Laser Do not look into the apertures or remove the
Product Bar Code Reader covers. Laser light is emit-
ted from the apertures. 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.

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Safety Icon Descriptions (Continued)

Icon Description

CAUTION: Indicates some components of a product are


Xn, Xi classified as harmful (Xn) or an irritant (Xi).

CAUTION: Indicates that some component of a product is


classified as a corrosive.

AEROSET System Operations Manual


The Abbott AEROSET System Operations Manual is a complete
reference to the operation of the AEROSET System. During the class,
reference will be made to sections in the Operations Manual. The
Operations Manual is a valuable reference guide to the operation of the
AEROSET System.
You will be referred to sections of the Abbott AEROSET System
Operations Manual using the book icon. When you see the icon, you
will be instructed to review detailed information in the Operations
Manual on a particular procedure or topic.

AEROSET Application Manual / Package Insert Binder


Provides a repository for assay-specific Abbott Clinical Chemistry
Package Inserts and Application Sheets for Abbott reagents used with the
AEROSET System.

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Biosafety Procedures in the Classroom

BIOSAFETY PROCEDURES IN THE CLASSROOM


Use appropriate biosafety practices when handling specimens, reagents,
and contaminated instruments.
• Consider all clinical specimens, reagents, controls, and calibrators,
etc., that contain human blood or serum as potentially infectious.
Wear gloves, lab coats, and safety glasses, and follow other
biosafety practices as specified in the OSHA Bloodborne Pathogens
Rule 29 CFR 1910.1030, or other equivalent biosafety procedures.
• Avoid contact with the tips of the Sample Probes, since they are
sharp and contaminated with potentially infectious materials.
• Dispose of all clinical specimens, reagents, controls, calibrators,
standards (as appropriate), cuvettes, and other disposables that may
be contaminated, in accordance with local, state, and federal
regulations governing the treatment of regulated medical waste.
¾ Solid Waste
Generally accepted procedures for the treatment of consumable
potentially infectious waste include incineration or
autoclaving. If an autoclave is used, verify the effectiveness of
the decontamination cycle.
¾ Sharps
Sharps, such as contaminated probes, must be placed in an
appropriately marked puncture-resistant container prior to
treatment and disposal.
¾ Liquid Waste
Liquid waste should be treated with the addition of disinfectant
prior to disposal.
The addition of a disinfectant to the waste container helps to
inactivate the infectious organisms that may be collected in the
waste. This reduces the risk to personnel who must handle this
material. Sodium hypochlorite and glutaraldehyde solutions
have been shown to be effective in inactivating organisms such
as HBV, HCV, and HIV, and can be used for this purpose.
Appropriate personal protective equipment should be worn
when these materials are handled.

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COURSE DESCRIPTION

Outline The knowledge and skills you learn during the AEROSET Customer Train-
ing Class are organized into the following Training Manual Modules.

Module 1 System Tour introduces the principal hardware and software components of
the AEROSET System.

Module 2 Basic Run provides an overview of how to order and run a sample.

Module 3 Daily START UP and Checks includes information which explains how to per-
form the Daily Checks and START UP Procedures, and when performance of
these procedures must be done.

Module 4 Run Options examines the various options available to order and run sam-
ples.

Module 5 Result Handling presents the procedures used to review and handle the assay
results reported by the AEROSET System.

Module 6 Calibration provides an overview of the different methods the AEROSET


System uses to measure assays. This Module also includes information on
how to perform a calibration.

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Course Description

Module 7 Quality Control presents the procedures and options for running quality con-
trol samples and management of quality control data.

Module 8 Configuration provides the information you will need to customize the
AEROSET System for your laboratory.

Module 9 ICT™ Unit provides an overview of the design and operation of the Inte-
grated Chip Technology™ (used for ISE measurement).

Module 10 Maintenance provides important information on how to perform the


required Weekly and Monthly Maintenance Procedures on the AEROSET
System.

Module 11 Component Replacement and Troubleshooting discusses useful troubleshoot-


ing approaches and replacement of some of the major System components.

Module 12 Activities consists of exercises which strengthen and reinforce learning.

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MODULE 1: SYSTEM TOUR

MODULE 1:
SYSTEM TOUR

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MODULE 1: SYSTEM TOUR

CONTENTS
Page

Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Instrument Tour . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Consumables and Accessories . . . . . . . . . . . . . . . . . . . 1-17
Software Tour . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29
Review Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-39
Answers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-40
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-41

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Objectives

MODULE 1: SYSTEM TOUR

OBJECTIVES
Upon completion of this Module, you will be able to:
1. Locate and identify the AEROSET System components
2. Identify and state the use of each consumable and accessory
3. Identify and describe the use of each screen area
4. Describe screen navigation

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MODULE 1: SYSTEM TOUR

INTRODUCTION
The AEROSET System includes hardware and software components.
This Module will familiarize you with these components as well as
accessories and consumables.
The first section takes you on a tour of the instrument and introduces the
principal hardware components. Your attention is focused on the
identification and location of hardware components, accessories, and
consumables. The tour also includes information which describes sample
progression during a run.
The second section takes you on a tour of the AEROSET System
software. In this section, emphasis is placed on basic knowledge of the
main screen functions and screen operations.

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Instrument Tour

INSTRUMENT TOUR

Overview
The primary components of the AEROSET System include the
following:
1. System Control Center, including:
• Color Touchscreen Monitor
• Keyboard
• Computer (CPU)
• Printer
• Component Stand (optional)
• GPIB Communication Cable

2. Analyzer, including:
• Sampling/Processing Area
• Front Door Area
• Right-Side Panel Area
• Left-Side Panel Area
• Back Panel Area

Analyzer

System Control
Center 125602

Figure 1.1: Primary Components of the AEROSET System

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MODULE 1: SYSTEM TOUR

Hardware Tour

System Control Center


The System Control Center (SCC) controls the operation of the System.
Using the SCC, the Operator orders tests, reviews data, defines
configuration, initiates a run or maintenance procedure, reviews error
messages, etc.

3 4
125620

Figure 1.2: System Control Center

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Instrument Tour

The components of the System Control Center are described in the


following table.

Item SCC Component Description


1 Color Touchscreen Color monitor with touch function.
Monitor The monitor plugs into the computer.
2 Keyboard Standard alphanumeric.
3 Computer (CPU) IBM PC/AT compatible.
The computer plugs into the Analyzer.
4 Floppy Disk Drive Used to install assay files, upgrade System software, and copy
files from the CPU.
5 Printer Dot matrix printer.
The printer plugs directly into the wall.
6 Component Stand Provides support for the SCC.
(optional)
7* GPIB Communication Transmits all communications between the SCC and the
Cable Analyzer.
*This component is not shown in the illustration. The
instructor will show you this component.

Top-Main
Cover

Front-Right
Door
Front-Middle
Door
Left-Side Front-Left
Panel Door
125601

Figure 1.3: AEROSET Analyzer (Front View)

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MODULE 1: SYSTEM TOUR

Rear Folding Panel

ICT Pump
ICT™ Pump
Access Door

Rear-Right Panel

Right-Side
Panel Rear-Left Panel
125625

Figure 1.4: AEROSET Analyzer (Back View)

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Instrument Tour

B-Line
11 Cuvette Washer
A-Line
10 Mixer Unit
9 Reagent Arm 2
12 ICT Unit

9 Reagent Arm 1 5 Reagent Supply


Center 1

6 Reagent Supply
Center 2

B-Line
A-Line
3 Reaction
Carousel

8 Sample Arm

Reserved STAT Position B-Line


A-Line
Calibrator/Control
Carousel
2 Carousel
Sampler

1 FastTrack Sampler
Sample
Carousel

125672

Figure 1.5: Sampling/Processing Area

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MODULE 1: SYSTEM TOUR

Analyzer
The components in the Sampling/Processing Area of the Analyzer
perform the functions of identifying and dispensing the samples and
reagents, mixing the sample and reagent mixture, performing optical
readings, measuring electrolytes, and washing cuvettes.
The components of the Sampling/Processing Area are described in the
following table.

Item Component Description


1 FastTrack™ Routine patient samples are identified and transported to the Sample
Sampler Arm.
The FastTrack™ Sampler moves right to left to present samples to
the Sample Arm.
The FastTrack Sampler moves left to right to automatically return
the samples when in the Rerun mode.
The gray lines on the FastTrack Sampler are used for aligning the
Sample Carrier Trays. The center of the Sample Carrier Trays are
aligned with the raised bumps for proper loading on the FastTrack
Sampler.
2 Carousel Sampler
• Lift Carousel out • Calibrator/ Calibrators and controls are loaded in sample cups in fixed positions.
to show. Control The temperature is 10°C below the interior of the Analyzer.
(C/C) Carousel
• Lift Carousel out • Sample Carousel Routine and priority patient samples are identified and presented to the
to show. Sample Arm; calibrators may also be loaded.
The System can be configured to prioritize samples on the Sample
Carousel over the FastTrack Sampler.
Holds up to 30 tubes or sample cups.
Sample cups must be placed in adapters on the Sample Carousel.
• Reserved STAT A single fixed position for STAT patient samples. There is no Sample
Position Bar Code Reader for this position.
3 Reaction Carousel Contains 165 cuvette pairs (330 total cuvettes).
Water in water bath continuously circulates.
4* Cuvette Segments Contains 15 segments with 11 cuvette pairs per segment.
Water is kept in the cuvettes to keep them moist and to prevent dust
from clinging to the interior of the cuvette.
The moisture from the water aids the sample to spread into the bottom
of the cuvette.

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Instrument Tour

Item Component Description


• Remove Carousel 5 Reagent Supply Refrigerated reagent storage area for 56 Reagent Cartridges.
covers. Center 1 Water is pumped into the bottom to provide humidity.
• R1 Center (Green) - contains R1’s and reagent for assays with only
6 Reagent Supply
1 reagent, diluents, water bath additive, and onboard solutions.
Center 2
• R2 Center (Orange) - contains R2’s and onboard solutions.
7* Bar Code Readers
• Show location. • Sample Carousel Positively identifies sample tubes in the Sample Carousel.
Bar Code Reader
• Point out windows • Reagent Supply 2D Bar Code Readers used to identify Reagent Cartridges in the
at back of each Center Bar Code Reagent Supply Centers.
center. Readers
• Show location. • Sample Carrier Identifies the Sample Carrier number by reading the bar code on the
Bar Code Reader carrier.
• Show location. • FastTrack™ Positively identifies sample tubes in the Sample Carriers on the
Sampler FastTrack™ Sampler.
Bar Code Reader
8 Sample Arm Dual probes on a single arm.
Dual fluidics system, identified as A-Line and B-Line, serves to
increase throughput.
9 Reagent Arms Dual arms with a single probe per arm.

• Show Mixers 10 Mixer Unit Contains two pairs of Mixers to mix after the first and second reagents
from the back. are dispensed.
Piezo electric technology provides current to a crystal which causes
the mixer blades to vibrate.
R1 Mixers are toward the front of the Analyzer.
R2 Mixers are toward the back of the Analyzer.
11 Cuvette Washer Contains eight pairs of nozzles which:
• 1st pair - aspirates High-Concentration Waste (sample and reagent
mixture).
• 2nd pair - washes the cuvettes with Alkaline Wash solution.
• 3rd pair - washes the cuvettes with Acid Wash solution.
• 4th/5th pair - washes the cuvettes with water.
• 6th pair - adds water for the water blank reading.
• 7th pair - aspirates out the water.
• 8th pair - dryer tips dry the cuvettes.
• Show unit from 12 ICT™ Unit Uses Integrated Chip Technology™ (ICT™) to measure Na+, K+, and
back. Cl- in serum, plasma, and urine.
The probe aspirates the diluted sample from the cuvette.

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MODULE 1: SYSTEM TOUR

Item Component Description


13* Sample Carousel • Blinking red - carousel is moving.
Movement Indicator • Solid red - Sample Arm is aspirating a sample.
Light
• Off - idle.
14* STAT Sampling Indicates when a STAT sample is being aspirated.
Indicator Light The Operator may add samples when the light is not illuminated.
15* FastTrack™ Tray Status LED - indicates the presence, status, and movement of the
Sampler Indicator Sample Carrier Trays.
Lights LEDs • Blinking orange - FastTrack Sampler is not in the home position.
• Solid blue - indicates the presence of a Sample Carrier Tray to the
right of the sampling area. The blue lights will blink when the
FastTrack is moving.
Carrier Entry Position LED - indicates the position where the Sample
Carrier will be moved into the AEROSET System for sample
aspiration. The red arrow illuminates when the Sample Carrier is in
the sampling position.
16* Front Display Panel Indicates the Power status and FastTrack Sampler status.
• Refrig - Main Circuit Breaker Switch is ON.
• Auto - Rotary Power Switch is in the Auto position.
• Power - Main Circuit Breaker Switch is ON and the Rotary
Power Switch is in the ON position.
• Run - samples are being aspirated from the FastTrack Sampler.
• Rerun - samples are automatically returned to the sampling area for
rerun.
• Remove - a Sample Carrier Tray has hit one of the bumpers
(> 4 loaded).
• Set - it is OK to add Sample Carrier Trays to the FastTrack
Sampler.
17* Local User Interface Control Panel on the Analyzer, used to initiate movement of the
(LUI) FastTrack Sampler and Reagent Supply Centers.
• Tray Home - homes the FastTrack Sampler.
• Remove Rack - will remove the Sample Carrier from the sampling
area.
• R1/R2 - when illuminated it is OK to access the particular Reagent
Supply Center.
When these buttons are first pressed, the Reagent Supply Center
homes. Pressing these buttons again rotates the center 1/3 of a turn.
• Tray → or ← - moves the FastTrack Sampler one position to the
right or left.
R

NOTE: Components marked with an asterisk (*) are not


shown on the illustrations. Your instructor will show you
these components.

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Instrument Tour

The components behind the front doors are described in the following
tables.

Behind the Front-Left Door


Item Component Description
1 High-Concentration Waste Performs the initial aspiration from
Pumps the cuvettes to remove the High-
Concentration Waste to a separate
container, if desired.
2 Probe Wash Pumps Used to wash the inside of the
Sample and Reagent Probes.

Behind the Front-Middle Door


Item Component Description
3 Sample Syringe Drives Performs sample aspiration and
dispense.
4 Reagent 1 Syringe Drives Performs Reagent 1 aspiration and
dispense.
5 Reagent 2 Syringe Drives Performs Reagent 2 aspiration and
dispense.

1 = Sample A Syringe Drive


2 = Reagent 1A Syringe Drive
3 = Reagent 2A Syringe Drive
High-Concentration Waste
4 = Sample B Syringe Drive
Drain Hose
5 = Reagent 1B Syringe Drive
6 = Reagent 2B Syringe Drive

High-
Concentration Waste
Pump (A) Probe Wash Pump (B)

High-Concentration Probe Wash Pump (A)


Waste Pump (B)
Figure 1.6: View Behind Front-Left and Front-Middle Doors

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MODULE 1: SYSTEM TOUR

Behind the Front-Right Door


Component Description
Wash Solution Pump Dilutes and supplies Alkaline and Acid
Wash Solutions to the Cuvette Washer.
Bulk Solutions The onboard supply of ICT™ Reference
Solution, Alkaline Wash Solution, and Acid
Wash Solution are placed on the platforms
that will generate an Error Message when
the minimum level is reached.

Acid Wash Solution


Alkaline Wash Solution
ICT Reference Solution
Wash Solution Pump
125669

Figure 1.7: View Behind the Front-Right Door

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Instrument Tour

Behind the Right-Side Panel


Component Description
ICT™ Aspiration Pump Performs the aspiration of the samples and
ICT Reference Solution into the ICT Unit.
ICT Reference Solution Pump Moves ICT Reference Solution from the
Bulk Solution bottle, through the preheater
tubing in the incubator, to the cup beneath the
ICT Unit.

ICT Reference
ICT Aspiration Pump Solution Pump 125621

Figure 1.8: View Behind the ICT Pump Access Door

Left Side of Analyzer


Component Description
Rotary Power Control Three position switch:
Switch • ON - All components are Powered ON
• AUTO - System can Power ON/OFF
automatically at preset times, power is supplied
to the entire System
• OFF - Power is OFF to all components except
the refrigeration for the Reagent Supply
Centers

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MODULE 1: SYSTEM TOUR

• Point out location of the instrument


serial number. Customer instruments Rear of Analyzer
will have a plate attached to the left-
Item Component Description
rear of the instrument above the
water supply/drainage panel, and also 1 Main Circuit Breaker Turns the power ON/OFF for the entire
on TSB sticker located in front, Switch System.
behind front-left door. 2 Water Supply and Incoming Deionized Water supply and
Drainage Tubing drainage tubing for the water bath,
Low-Concentration Waste, overflow, and
refrigerator. Also includes the
High-Concentration Waste tubing which can be
attached to a separate Waste Container.
The serial number is located above this area.
3 Refrigerator Captures condensation from the reagent
Condensation Pan refrigeration units.
4 GPIB Connector Transmits all communications between the
SCC and the Analyzer.

1-Main
Circuit Breaker

4-GPIB
3-Refrigerator Connector
Condensation
Pan

2-Water Supply/
Drainage Panel 125671

Figure 1.9: Rear View of the AEROSET Analyzer

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Consumables and Accessories

CONSUMABLES AND ACCESSORIES

The AEROSET System 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

The AEROSET System 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
† Application Manual / Package Insert Binder

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94858-103 — July 2003
MODULE 1: SYSTEM TOUR

Consumables

Sample Cups
The sample cups are used to load calibrators, controls, and patient
samples on the Analyzer. They can be placed in the Calibrator/Control
Carousel, Sample Carousel, Reserved STAT Position, and Sample
Carriers. Volume graduation lines at 1 mL and 2 mL help the Operator
fill sample cups, eliminating the need for precision pipetting.
The following table provides the minimum sample volume required in a
sample cup. The minimum volume required is 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 Pair


Minimum Volume Required
Volume

2 - 40 µL 60 µL + combined sample volumes of all assays


ordered

40 - 70 µL * 166 µL + combined sample volumes of all assays


ordered

*All Abbott assay applications have a defined sample volume of 20 µL


or less. This volume requirement would only apply if non-Abbott assay
applications are defined with a sample volume greater than 20 µL.
For 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: For individual assay sample volume requirements, refer


to the parameters in the assay-specific AEROSET Reagent
Application Sheets or package inserts.

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Consumables and Accessories

NOTE: The Cup/Tube Adapter is required when loading sample


cups in all positions except on the Calibrator/Control
Carousel.

2 mL

1 mL

Figure 1.10: AEROSET System Sample Cup

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MODULE 1: SYSTEM TOUR

Reagent Cartridges
The Reagent Cartridges are used in the Reagent Supply Centers to
contain the reagents used during operation. They may also contain
supplies of ICT™ Sample Diluent, diluted Wash Solutions, and Water
Bath Additive.
There are four types of Reagent Cartridges:
• Large, White or Natural (approximately 90 mL)
• Small, White or Natural (approximately 55 mL)
• 20 mL, White or Natural (only available with some prepackaged
reagents, cannot be ordered separately)
• 100 mL, White or Natural (only available with some prepackaged
reagents, cannot be ordered separately)

Large (90 mL) 100 mL

Small (55 mL) 20 mL


Figure 1.11: Reagent Cartridges

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Consumables and Accessories

ICT™ Sample Diluent


The ICT Sample Diluent is prepackaged in large bar coded reagent
• ICT™ Sample Diluent on board cartridges and is placed in an outer segment of Reagent Supply Center
stability is 14 days. 1. This diluent is used to dilute samples for ICT analysis.

Figure 1.12: ICT Sample Diluent

ICT Calibrators
• Good 7 days after opening at 2- The ICT Calibrators (7% bovine serum albumin base) and ICT Urine
8°C. Calibrators (aqueous base) are used to calibrate the ICT Module. Each
• Point out values on the box. set contains two levels (Low and High). Unopened bottles are stored at
room temperature. Once opened, the bottles must be refrigerated. Refer
to the ICT Calibrator Package Inserts for additional information.

125627

Figure 1.13: ICT Calibrators

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94858-103 — July 2003
MODULE 1: SYSTEM TOUR

ICT™ Cleaning Fluid


• Good 14 days after opening The ICT Cleaning Fluid (deproteinizer) is placed in the Calibrator/
at 2-8°C. Control Carousel and is used daily during the START UP or
SHUTDOWN Procedures to clean the ICT Module. The lyophilized
material is reconstituted with the supplied diluent. Unopened bottles are
stored at room temperature. Once reconstituted (opened), the bottles
must be refrigerated.

125640

Figure 1.14: ICT Cleaning Fluid

ICT Reference Solution


• Unopened - Store at room The ICT Reference Solution container is loaded onto a weight platform
temperature. behind the front-right door. It is aspirated and analyzed by the ICT Unit,
before and after each sample, to provide a reference concentration used
to calculate results.

Wash Solutions

• Caustic - need gloves and CAUTION: Chemical Hazard. Refer to Appendix,


goggles. ! Hazards of this manual.
• ½ Liter There are two Wash Solutions used on the AEROSET System:
• Unopened - Store at room • Alkaline Wash Solution
temperature.
• Acid Wash Solution
The containers are loaded onto a weight platform behind the front-right
door. The Wash Solutions are used by the Cuvette Washer to clean the
cuvettes after sample analysis.

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Consumables and Accessories

Diluted Wash Solutions must also be prepared to be used for probe


washing. The diluted Wash Solutions are placed in the Reagent Supply
Centers and Calibrator/Control Carousel.

Water Bath Additive


• ½ Liter The Water Bath Additive is used to minimize bacterial growth in the
water bath. A supply of the Water Bath Additive is placed in an outer
• Unopened - Store at room segment of Reagent Supply Center 1. It is dispensed into the water bath
temperature. during the Change Water In Bath Procedure performed during START
UP or SHUTDOWN. Water Bath Additive is ready to use and may
remain onboard until depleted.

125642

Figure 1.15: Water Bath Additive

Calibrators
• Show MCC’s. A variety of calibrators are used on the AEROSET System. Both serum
and aqueous based materials are used. Refer to the assay-specific
• Show Iron/Mg Calibrators. Package Inserts to identify the calibrators used for each assay.
Point out values on bottles.

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MODULE 1: SYSTEM TOUR

Accessories

Sample Carriers
The Sample Carriers are used to hold tubes and cups for use on the
FastTrack™ Sampler. The carriers have bar code labels for
identification on the System. The System comes with two sets of Sample
Carriers labeled 1 - 40. Higher number labels are available. Each carrier
has five positions designed to hold the following types of sample
containers:
• 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
The tubes can be labeled with bar codes for positive identification.
Although sample cups cannot be labeled with bar codes, the cups can be
placed in a bar code labeled tube for sampling and identification.

125605

Figure 1.16: Sample Carrier

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Accessories

End-of-Run Sample Carrier


The End-of-Run Sample Carrier is a blue carrier labeled with the number
zero (0). It is placed in the last position of a run on the FastTrack™
Sampler. When the End-of-Run Carrier is identified, the FastTrack
Sampler stops sampling. If Auto Return is defined, the Analyzer then
returns the carriers to the starting position and begins sampling reruns.
Samples must not be loaded in this carrier.

Cup/Tube Adapters
The 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. Sample bar code labels must be positioned
toward the opening of the adapter.

125629

Figure 1.17: Cup/Tube Adapter

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94858-103 — July 2003
MODULE 1: SYSTEM TOUR

Sample Carrier Trays


The Sample Carrier Trays are used to hold the Sample Carriers for
loading on the FastTrack™ Sampler. Each tray holds up to 10 Sample
Carriers.

125606

Figure 1.18: Sample Carrier Tray with Sample Carriers

Sample Carrier Tray Covers


The Sample Carrier Tray Covers can be placed on the Sample Carrier
Trays to cover open sample containers. The covers can be used while
running. There are two types:
• High - Designed to sit higher on the tray to cover taller tubes
• Low - Designed to cover short tubes and sample cups

• High

• Low

125641

Figure 1.19: Sample Carrier Tray Covers

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Accessories

Reagent Cartridge Adapters


• 20 mL adapters-make sure barcode is There are two types of Reagent Cartridge adapters used on the
facing outward. AEROSET System:
• Install reagent vial from the bottom of
the 20 mL adapter. • 20 mL Reagent Cartridge Adapters
• Small adapter should be placed into
Reagent Supply Center first, then the • Small Reagent Cartridge Adapters
Reagent Cartridge is loaded.
The adapters are used to ensure correct alignment of the 20 mL and
Small Reagent Cartridges when they are placed in the Reagent Supply
Centers. For loading instructions refer to Loading Reagent Cartridges
in Module 2, Daily Start Up and Checks.

20 mL Small

125628a

Figure 1.20: Reagent Cartridge Adapters

Manuals
Two manuals are provided with the AEROSET System:
• AEROSET System Operations Manual
A complete reference to the operation of the AEROSET
System. During the class, references will be made to
sections in the Operations Manual.
• AEROSET Application Manual / Package Insert Binder
A repository for assay-specific Abbott Clinical Chemistry
Package Inserts and Application Sheets for Abbott
reagents used with the AEROSET System.

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MODULE 1: SYSTEM TOUR

Sample Progression
During a run, the Reaction Carousel rotates approximately ¼ turn
counterclockwise every 4.5 seconds. During each cycle, a pair of
samples is dispensed. As the Reaction Carousel continues to rotate,
reagents are added to the samples, the samples and reagents are mixed,
33 photometric readings are taken, etc., until the tests are completed.
(This process takes approximately 9.6 minutes.) The cuvette is then
washed and another pair of samples is dispensed.

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Action Area of the Main Display

94858-103 — July 2003


RUN OPTIONS System Config Sampling Seq
SOFTWARE TOUR

Start QC Rules

AEROSET® Customer Training Guide


RUN OPTIONS System Config Sampling Seq
QC Rules
SELECT ASSAYS FOR STAT

START UP OPTIONS

SHUTDOWN OPTIONS

REAGENT SCAN

STOP
Print System
ERROR LOG Beep Off SCC
Reset Err Sampling
MAINTENAN
Rgt Area 1
CE UTILITIES
Rgt Area 2
Host
Online Config Rxn Area
Communication
SW Info
Printer Config

Log On
Software Tour

1-29
Information Access Area of the Main

1-30
Display

C/C Carousel
CAL/ Set 1
CONTROL Set 2
Dates Set 3
CAL Details
SUMMARY Stored
Del Prev
Print Options
MODULE 1: SYSTEM TOUR

Print Page Setup Accept


Order Samples Export
Order Options RxnGraph
Order Query Abs Data
On-line FreeText Rerun
Query by SID Import Edit
Query by C/P Export Recalc
Send Results Form 1/2 Delete
RESULT Sample Result Add
SOFTWARE TOUR (CONTINUED)

View
R1-A
R1-B
R1-C
Report
R1-D
R2-A Clear All
R2-B
R2-C
R2-D
Details
QC SUMMARY LJ Graph Datalist
Export Outline
Print
Base
Calibration Import
Export
QC
Save
SmartWash
Delete
Config Rerun Rules
ASSAYS Assay Status Calib Cal Details Details
QC QC Chart Datalist
Status Error Status Export

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Software Tour

Screen Display
After Log On, the screen for operating the AEROSET System is
displayed. The Main Display is divided into the following areas:

Status
Area

Display Area

Action
Area

Run Progress Area Information Access Area

Figure 1.21: Main Display

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MODULE 1: SYSTEM TOUR

Information Access Area


The following table describes the buttons located in the Information
Access Area.

To Access this
Press this Button… Description
Information
Calibrator/Control When selected, displays the configuration of the Calibrator/
Carousel Display and Control Carousel (expected values can be entered). Positions
Configuration 38 - 45 are predefined.
Reagent Supply Display When selected, displays the Reagent Supply Center
and Configuration inventory. The Operator can view the position in which the
reagent is located and the remaining reagent volume, both by
number of tests remaining and by % volume remaining.
Calibration Summary When selected, displays the current calibration absorbance
values and factors for all assays. The data can be saved so that
the averages for a month can be displayed. It also allows for
the deletion of previous calibration curves.
Quality Control When selected, accesses the QC SUMMARY screen in
Summary which the Operator can view a summary of the QC statistics
for all assays and levels. The Operator can also access the
Levey-Jennings Graphs and QC Details from this screen.
Database When selected, displays the DATABASE screens. These
screens are used to create patient sample orders, view
completed results, view Result Error Codes, and access result
handling functions.
Assays Display When selected, displays the ASSAYS screen to enable access
to the ASSAY STATUS screens for each assay. Displayed on
the ASSAY STATUS screen are the current calibration curve,
reagent status, and a summary of the QC statistics. The Assay
Configuration, Levey-Jennings Graph, and Calibration
Details are also accessed from this screen. The assay-specific
button in the ASSAYS screen displays different colors to
indicate assay status:
• Pink - The reagent is expired or empty or the calibration is
expired / unusable.
• Yellow - The reagent is below the alert level or a calibration
error has occurred.
• Black - An assay parameter is defined incorrectly.
• Green - The assay is OK.
Select <Status> on the ASSAY STATUS screen for an
explanation of the cause of the color change to the button.

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Software Tour

Action Area
The following table describes the buttons located in the Action Area.

To Perform this
Press this Button… Description
Action
Initiate a run or When selected, accesses the RUN OPTIONS screen. From this
perform System screen, the Operator selects the types of samples to be run and
configuration initiates the run process. Calibrations and Controls are ordered from
this screen. SYSTEM CONFIGURATION is also accessed from
this screen.
PAUSE the System When selected, accesses the RUN OPTIONS screen. From this
during a run screen the Operator can PAUSE the System which temporarily
stops the movement of the Reagent 1 Probes, Sample Probes,
Carousel Sampler, and FastTrack™ Sampler.
WARNING: If a diluted sample has been dispensed, the Sample
! Arm may move after the status has changed to PAUSE. Wait 20
seconds before accessing the Carousel Sampler area.
WARNING: The AEROSET System does not stop the
! movement of the Reagent 2 Probes, ICT™ Unit, Mixers, or
Cuvette Washers so the Assay Read Times are not affected.
CAUTION: The System completes the dispensing and mixing of
! any sample and reagent already aspirated. Confirm the PAUSE
status in the System Status Area and confirm that the R1
indicator on the Local User Interface (LUI) Control Panel is
illuminated before proceeding.
Order and start a When selected, accesses the screen to order a sample in the
STAT sample Reserved STAT Position and initiates the processing.
Initiate the START When selected, allows the Operator to define and initiate the
UP Procedure START UP Procedures.
Initiate the When selected, allows the Operator to define and initiate the
SHUTDOWN SHUTDOWN Procedures.
Procedure
Scan bar code When selected, initiates a scan of the bar codes on the Reagent
labeled Reagent Cartridges in the Reagent Supply Centers.
Cartridges
Stop the System When selected, completely stops a run (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. Confirm the READY status in
the System Status Area before proceeding.

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MODULE 1: SYSTEM TOUR

To Perform this
Press this Button… Description
Action
Process progress This cannot be selected to perform an action, but instead displays
display the progress of processes, such as, when multiple reports have been
selected to print, or multiple samples are being sent to the Host
computer. This button displays a green bar and the percent
completed.
Review the When selected, displays the Error Message Log. The background
Error Log color of the Error icon changes to indicate that an error has
occurred and indicates 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.
To perform When selected, displays the MAINTENANCE UTILITIES
Maintenance Utilities screens in which components can be moved (using the
Touchscreen) for maintenance and troubleshooting purposes. These
screens also allow software Backup and Restore features.
Define options for When selected, allows clearing of the printer buffer and defines the
Printer A automatic report printing options.
NOTE: The format of the Patient Reports is configured in
the DATABASE screen.
Define options for When selected, allows most of the same options as Printer A.
Printer B
Define options for When selected, allows access to the Host interface functions. The
the Host interface Operator has the ability to enable, disable, and configure the
connections communications with the laboratory Host computer.
Print a copy of the When selected, prints a copy of the currently displayed screen. The
screen Print Screen function is only allowed when the System Status is
READY. The Print Screen icon is disabled when the System is in
RUN, SAMPLING END, PAUSE, CUVETTE FILL, and
SUSPEND status.
Exit the System When selected, exits the System software and returns to the Log
software On dialog window. The Log On dialog window can be used to shut
down the System software prior to Powering OFF or prior to Log
On with another Password.

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Software Tour

Display Area
This area of the screen displays the information or actions corresponding
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 (typically


by selecting <OK>), before selecting a new option, 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, CUVETTE FILL,
SUSPEND, STANDBY, START
UP, SHUTDOWN, and RGT SCAN

Date
Time

High-Concentration
Water Bath Level Waste Full Indicator
(Green = OK, Blue = Cold, Pink = Hot) (Visible when full)

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MODULE 1: SYSTEM TOUR

Run Progress Area


This area shows the progress of assay analysis. When measurement is
started, a colored bar appears at the left end of the Run Progress Area,
then moves toward the right as the measurement continues. When the bar
reaches the red mark in the center of the display, the second reagent is
dispensed (where appropriate). When the bar reaches the right end, the
sample is complete and the results are displayed in the DATABASE
screens.

NOTE: The Run Progress Area bar represents approximately 10


minutes of processing time. The black marks divide the bar into
approximately one minute intervals.

Figure 1.22: Run Progress Area of the Main Display

The bar color indicates the type of sample currently being analyzed. The
following table describes the colors that appear.

Color Sample Type


Green Calibrator
Pink STAT Sample
Gray Patient Sample
Yellow Control

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Software Tour

Screen Navigation
There are several ways to access and display information on the
AEROSET System screens. The buttons discussed in the previous
section allow the Operator to access information. This section shows the
other types of access and displays.

CAUTION: After entering information into a field, the


! Operator has 30 seconds to move to the next field to
accept the entry (e.g., using the tab, Enter key, or the
Touchscreen). Failure to move to the next field
within 30 seconds causes the field to revert to the
previous entry.

Buttons
Pictures or text are displayed on the buttons or icons. When a button or
icon is selected, the frame of the button changes to blue or the button
changes colors.

Tabs
• Use Assay Configuration or Some areas of the software contain many pages. Tabs are shown along
Maintenance Utilities to
the top of the Display Area to access the different pages. An example of
demonstrate.
tabs from the Assay Configuration screen is shown below.

Scroll Bar
• Use Database or Printer/Page Setup A scroll bar appears on some screens when a list is displayed. The
to demonstrate.
Operator can touch the scroll bar or use the keyboard arrow keys to view
all the list items. An example of a scroll bar is shown below.

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MODULE 1: SYSTEM TOUR

Drop-down List Box


• Use Patient demographics to If there are several choices for a single field, a Drop-down list box is
demonstrate.
displayed. Press the arrow button to the right of the field to show the
other choices. When the selection has been made from the displayed
items, press the return arrow button at the bottom of the list. An example
of a Drop-down list box is shown below.

Combo Box
• Use Patient demographics to The combo box looks exactly like the Drop-down list box and allows the
demonstrate.
Operator to select from the list, but it also allows the Operator to create
new items on the list through keyboard entry.

Checkbox
• Use Startup, Shutdown, or Run On screens where checkboxes appear, multiple items can be selected by
Options to demonstrate.
touching the box to place a checkmark in it. An example checkbox is
shown below.

Single Selection Item


• Use Order Screen Measurement On screens where single selection items are displayed, only one item can
Type to demonstrate.
be selected by touching the circle to place a checkmark in it. An example
of a single selection item is shown below.

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Review Questions

REVIEW QUESTIONS
1. What is the name of the Control Panel on the Analyzer that allows
movement of the FastTrack™ Sampler and the Reagent Supply
Centers?

2. What are the three solutions that are placed on weight platforms
behind the front-right door?

3. Other than reagents, what solutions are placed in the Reagent


Supply Centers?

4. What must the Operator use to run a sample cup in a Sample


Carrier?

5. What are the two Wash Solutions used by the Cuvette Washer?

6. How often does the Reaction Carousel rotate during sample


analysis?

7. Name the five areas of the Main Display.

8. What button is selected on the Main Display to manually order


patient samples?

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MODULE 1: SYSTEM TOUR

ANSWERS
1. LUI - Local User Interface
2. ICT™ Reference Solution
Alkaline Wash Solution
Acid Wash Solution
3. 1% Alkaline Wash Solution
Saline Diluent
0.5% Acid Wash Solution
Water Bath Additive (R1 only)
ICT Sample Diluent (R1 only)
4. Cup/Tube Adapter
5. Alkaline Wash Solution
Acid Wash Solution
6. Every 4.5 seconds
7. Information Access Area
Action Area
Display Area
Status Area
Run Progress Area
8. <Database>

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Summary

SUMMARY
In this Module, you have:
• Located and identified each of the AEROSET System components
• Identified and described the use of each consumable and accessory
• Identified and described the use of each screen area and the screen
navigation

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MODULE 1: SYSTEM TOUR

NOTES

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MODULE 3: BASIC RUN

MODULE 2:
BASIC RUN

AEROSET® Customer Training Guide 2-1


94858-103 — July 2003
MODULE 2: BASIC RUN

CONTENTS
Page

Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Checking Reagent Inventory . . . . . . . . . . . . . . . . . . . . . . . 2-5
Reagent Loading Activity . . . . . . . . . . . . . . . . . . . . . . . . 2-17
Basic Steps to Order and Run a Sample . . . . . . . . . . . . 2-19
Basic Run Activity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29
Review Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31
Answers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-32
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33

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Objectives

MODULE 2: BASIC RUN

OBJECTIVES
Upon completion of this Module, you will be able to:
1. Manually order patient samples to run on the FastTrack™
Sampler
2. Load samples
3. Initiate a patient run
4. Recognize the various System messages that are displayed during
processing
5. Identify the screens required to verify reagent inventory
6. Load reagents

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MODULE 2: BASIC RUN

INTRODUCTION
You will use this Module to practice the correct procedure for performing
a basic run on the AEROSET System. This Module focuses on the steps
that are necessary to analyze samples on the FastTrack™ Sampler.

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Checking Reagent Inventory

CHECKING REAGENT INVENTORY


Demonstrate on SCC (use view To avoid interruptions during operation and to ensure maximum
screen). Reagent Scan may be done efficiency, it is recommended that the Operator check the reagent
only when instrument is in the inventory before beginning a run. This ensures that there is sufficient
Ready status. reagent onboard.
Review:
• The ASSAYS screen after each reagent To initiate a scan of the Reagent Supply Centers to ensure that the
bar code scan and correct as appropriate. current status is reviewed, select <RGT SCAN> in the Action Area.
• The key conditions of the assay buttons
in the ASSAYS screen when the assay The volume remaining in the Reagent Cartridges onboard can be viewed
button is BLACK, YELLOW, PINK, or by selecting <Reagents> in the Information Access Area.
GREEN.
• If text on assay button is BLACK, the
reagent name won’t appear on the
Reagents view screen.

Reagent View
The View page of the REAGENTS screen is displayed.

Figure 2.1: REAGENTS Screen, View page

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MODULE 2: BASIC RUN

The View page displays the reagents loaded in all sections of both
Reagent Supply Centers and the remaining tests in each. An example of
one reagent is shown below.

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 has been exceeded.
• Brown – The volume is below the configured Reagent Low (Rgt Lo)
Alert level.
• Red – The reagent is empty
• Black – NLLS (no liquid level sense)

When <Report> is selected on the REAGENTS screen, a complete


inventory of onboard reagents displays on the Reagent Report screen.

Figure 2.2: Reagent Report Screen

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Checking Reagent Inventory

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
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 Tests # Estimated remaining reagent volume by 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.

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MODULE 2: BASIC RUN

Reagent Details
Other Reagent Segment tabs in the REAGENTS screen can be selected
to view more details of each Reagent Supply Center segment. An
example of one reagent position is shown below.

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
the Reagent View section above.

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. For more information about loading
new reagent cartridges, refer to Loading Reagent Cartridges in
this Module.

The color of the reagent name indicates whether the reagent was
manually configured (black) or scanned in by the Reagent Supply Center
bar code reader (brown).

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Checking Reagent Inventory

Check Reagent Inventory


1. Select <RGT SCAN> in the Action Area of the Main 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.
2. Select <Reagents> in the Information Access Area of the Main
Display. The REAGENTS screen displays.

Figure 2.3: REAGENTS Screen, View Page


3. Review all reagent volumes. Verify positions for the reagent
cartridges without bar code labels.
4. Replace any reagent with insufficient volume.
CAUTION: When either the R1 or R2 reagent cartridge
! becomes empty, the assay button text turns pink if the
Multiple Rgt Ctgs option is OFF, and turns black if the
Multiple Rgt Ctgs option is ON. Refer to Load Reagents
in this section for details.

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MODULE 2: BASIC RUN

5. For details on each Reagent Supply Center segment, select the


appropriate Reagent Segment tab. The selected Reagent Segment
page displays.

Figure 2.4: REAGENTS Screen, R1-A Page


6. When all reagent cartridges have been reviewed, select <OK> in the
upper-right corner of the screen.
7. If desired, select <Report> then <Print> to print the Reagent
report. Refer to Appendix B, AEROSET System Printed Reports in
the AEROSET System Operations Manual for an example of this
report.

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Checking Reagent Inventory

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

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MODULE 2: BASIC RUN

Reagent Supply Center 2

C
Reagent Supply Center 1

D C

B
A

B
Shaded = A-Line (Outer) A
Unshaded = B-Line (Inner)

Figure 2.5: 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 RUN OPTIONS screen
displays.
2. Select <Pause> in the right column of the screen to pause 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.
3. Remove the Reagent Supply Center cover and use the following
table to determine the loading position.

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Checking Reagent Inventory

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

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MODULE 2: BASIC RUN

Unit Configuration Description of Parameter Rules for Loading Reagents: If Parameter Is...
Parameter ON OFF ON OFF
Multiple Rgt Ctgs Allows for multiple A maximum of two If two or more New reagent cartridges
(e.g., more than two) sets of reagent cartridges with the should be placed in a
reagent cartridges per cartridges/pairs per same reagent name are higher numbered position
assay to be placed on assay will be used by loaded in a Reagent than cartridges already
the System. the System. Supply Center at the onboard. A maximum of
same time, new two reagent cartridges/
cartridges must be pairs per assay are utilized
loaded in a higher by the System.
! CAUTION: numbered position than
If the Multiple Rgt the cartridges already
Ctgs option is onboard. The System
configured ON, the first aspirates from the
Reagent Link option is cartridge in the lowest
not functional— i.e., number position. An
R1 and R2 cartridges Error Log Message is
are not linked. 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 on board at the
same time.

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Checking Reagent Inventory

Unit Configuration Description of Parameter Rules for Loading Reagents: If Parameter Is...
Parameter ON OFF ON OFF
Reagent Link Allows the R1 and R2 R1 and R2 cartridges The linked reagent pair New reagent cartridges
reagent pair to be are not linked. R1 and (R1/R2) to be used first should be placed in a
linked by position. A R2 are utilized must be placed in the higher numbered position
maximum of two sets independently. lowest available than cartridges already
of reagent cartridges position. After the onboard. R1 and R2 are
per assay are allowed. reagent pair is linked utilized independently.
The lowest R1 by the System, the
position is linked to Operator must verify it
the lowest R2 position is always utilized as a
and the highest R1 pair.
position is linked to
highest R2 position.
Each time a reagent
scan is performed, the
System relinks
! NOTE: The
reagents according to R1/R2 pair must be
position. placed onboard at the
same time.

NOTE: If the
Multiple Rgt Ctgs
option is configured
ON, the Reagent Link
option is not
functional— i.e., R1
and R2 cartridges are
not linked.

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 clean applicator stick.
Alternatively, allow the reagent to set 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.

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MODULE 2: BASIC RUN

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.
8. Select <RGT SCAN> in the Action Area of the Main Display to
update the reagent status.
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.
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 of the AEROSET System
Operations Manual 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 when 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.

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Reagent Loading Activity

Prior to activity, instructor should remove Creat, TP, ALT, Glucose, and ALBP from reagent supply center and
perform a reagent scan.

REAGENT LOADING ACTIVITY

Introduction:
In the activity, you will determine where to load reagents, how to use the
appropriate adaptors, and how to check reagent inventory.

Objective:
Upon the completion of the reagent loading activity, you will be familiar
with:
• Determining the line a reagent gets loaded on
• Loading reagents using the appropriate adaptors
• Checking reagent inventory
• Reagent scan
• Assay status after reagent scan

Necessary Materials:

Reagents:
• Creatinine
• Total Protein
• ALT
• Glucose
• Albumin P

Additional Materials:
• 20 mL adaptors
• Small adaptors

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MODULE 2: BASIC RUN

Procedure:
1. Determine the appropriate line for creatinine.
2. Determine if any adaptors are needed for this reagent.
3. Load the R1 reagent on the appropriate line in any empty reagent
position in the R1 reagent carousel.
4. Load the R2 reagent on the appropriate line in any empty reagent
position in the R2 reagent carousel.
5. Repeat steps one through four for the following reagents:
• Total Protein
• ALT
• Glucose
• Albumin P
6. After completion of loading above reagents, select <RGT SCAN>
in the action area of the screen.
7. Select <OK> to start reagent scan.
8. After reagent scan is complete, select <Assays> in the information
access area.
9. Ensure that the text for the first 14 assays is not black.
10. Select <Reagents> in the information access area.
• Advise customer to check all 11. Review Reagents screens, including Reagent View and Reagent
Reagent Supply Center Tabs. Supply Center Tabs.

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Basic Steps to Order and Run a Sample

BASIC STEPS TO ORDER AND RUN A SAMPLE

Step Action
1 Order patient samples.
2 Review and print the Loadlist.
3 Load samples.
4 Select Run options.
5 Start the run.

Ordering Patient Samples on the FastTrack™ Sampler


• Prior to starting the demo, the 1. Select <Database> from the Information Access Area, if the
Instructor should copy an order 4x to DATABASE screen is not currently displayed.
allow demonstration of the different
ways to select samples for printing a
loadlist.
• Delete all samples created for the
demo before the customer begins the
activity.
• Using the SCC, review the basic
steps of manual entry for the
FastTrack.
• Deselecting panel does not deselect
tests.
• Selecting “New” automatically
increments position #.

Figure 2.6: DATABASE Screen


2. Select <Order> in the right-hand column on the DATABASE
screen. If an order already exists and it is highlighted, the Order
Samples dialog window is displayed.

Figure 2.7: Order Samples Dialog Window

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MODULE 2: BASIC RUN

3. Select <New>. The Order Samples screen is displayed.


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

Figure 2.8: Order Samples Screen


4. Enter the patient sample information. Within 30 seconds after
entering the information, press either [Enter] or [Tab] on the
keyboard. If [Enter] or [Tab] is not pressed, the information
entered returns to the previously displayed information.
NOTE: Selecting another field on the Touchscreen also
prevents this from occurring.

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Basic Steps to Order and Run a Sample

Field Action Description


Sample ID Enter the Sample The Sample ID field can contain up to 20
ID alphanumeric characters.

CAUTION: The Sample ID must be


! entered to ensure proper identification.
Name Enter the patient The Last Name field can contain up to 20
(L/F) last and first alphanumeric characters, and the First
name, if desired Name field can contain up to 10
alphanumeric characters.
C/P Enter the carrier The C/P is a required field unless the
ID number and sample has a bar code label and the System
position is configured for sample bar codes.
NOTE: The information required
in this field when ordering samples
in the Sample Carousel is
described in Module 4, Run
Options.
Order D/T No action The current date and time are automatically
required displayed.

NOTE: The Manual Dilution, Replicates, and


Measurement Type fields are described in Module 4, Run
Options.
5. Select the assays or panels to be run. The first two rows of buttons
display the panels configured on the System. If more panels are
configured than can be displayed, use the up and down arrow
buttons to view the additional panels (up to 100).
NOTE: Assays with button text that is green in color meet
all required conditions. If the button text is pink or yellow,
further investigation is necessary before performing the
assay. For more information, refer to Confirmation of
Assay Parameter Settings in Section 2, Installation
Procedures and Special Requirements of the AEROSET
System Operations Manual.
6. Select <New> in the right-hand column of the Order Samples
screen to save the order and continue to the next patient sample
order.
7. Repeat steps 4 - 6 for all patient samples to be ordered.
8. When ordering is complete, select <OK> in the right-hand column
of the Order Samples screen.

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MODULE 2: BASIC RUN

Reviewing and Printing the Loadlist


Show how to: When ordering is complete, the patient samples are displayed in the
• Select multiple samples (consecutive) DATABASE screen. To print a Loadlist Report, perform the following
Shift + arrow down. steps:
• Select multiple samples (not
consecutive) Ctrl + touch each sample 1. Select all samples to be printed. To highlight multiple samples,
on screen. select the first sample in the list and then highlight the remaining
• Select a block of samples samples by holding [Shift] and pressing [↓] on the keyboard.
(consecutive), select first sample + shift
+ touch or arrow to the last sample in 2. Select <Print> in the right-hand column of the DATABASE
block. screen. The Print Options dialog window displays.
Print and show an example of the
Order List and Loadlist.

Figure 2.9: Print Options Dialog Window


3. Select <Loadlist>. The print confirmation dialog box displays.

Figure 2.10: Loadlist Dialog Window


4. Select <OK>.
NOTE: In the Print Options dialog window, the Loadlist
option prints only the sample information and positions.
The Order List option prints the sample information,
positions, and the assays ordered.

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Basic Steps to Order and Run a Sample

Loading the Patient Samples to Run on the FastTrack™ Sampler


WARNING: Potential Biohazard. Refer to Appendix,
Hazards of this manual.

When loading samples, ensure that the following conditions are met:
• Prior to loading a tube, verify that the size of the tube is listed as an
acceptable sample container.
• Ensure there is sufficient sample volume to run the ordered tests
plus any anticipated reruns.
– For primary tubes ensure that 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)
Top of clot, gel, of sample
or plasma/red cell
interface

– For a sample cup used in conjunction with a 100 mm


(height) sample tube, do not fill the specimen in the
cup above the height of the tube.
The following table provides the minimum sample volume required in a
sample cup. The minimum volume required is dependent upon the
largest possible aspiration volume of an assay pair ordered on the
sample.

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MODULE 2: BASIC RUN

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


Minimum Volume Required
Volume
2 - 40 µL 60 µL + combined sample volumes of all assays
ordered
40 - 70 µL * 166 µL + combined sample volumes of all assays
ordered
*All Abbott assay applications have a defined sample volume of 20 µL
or less. This volume requirement would only apply if non-Abbott assay
applications are defined with a sample volume greater than 20 µL.
For 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: For individual assay sample volume requirements, refer


to the parameters in the assay-specific Package Inserts.

• Verify that samples are free of foam, bubbles, fibrin, or particulate


matter.
• Use Cup/Tube Adapters for 13 mm tubes and sample cups.
NOTE: 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.
NOTE: Use of AEROSET sample cups is required to
adequately accommodate the AEROSET System sample
probe.
CAUTION: Do not run samples if these conditions are not
! met. Patient results could be affected.

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Basic Steps to Order and Run a Sample

1. Load the samples in the specified Sample Carrier and position. If the
sample tube is bar code labeled, face the label toward the right-hand
side of the Sample Carrier.
NOTE: When the System is configured to read sample bar
code labels, the patient samples may be placed in any
Sample Carrier and position. Refer to Module 8,
Configuration, for information on configuring the System
to read sample bar code labels.
2. Place the Sample Carrier(s) into a Sample Carrier Tray.
3. Place the blue End-of-Run Carrier to the right of the last Sample
Carrier loaded with samples, if the System is configured for auto
return of the FastTrack™ Sampler.
4. Place the Sample Carrier Tray onto the FastTrack Sampler, to the
right of the Sampler Area, so that 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.

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MODULE 2: BASIC RUN

Selecting the Run Options and Starting the Run


1. Select <RUN> in the Action Area. The RUN OPTIONS screen is
displayed.

Figure 2.11: RUN OPTIONS Screen


2. Place a checkmark (;) in the box to the left of the Patient option by
touching the box.
3. Select <Start> in the right-hand corner of the RUN OPTIONS
screen to initiate sample processing.
NOTE: If calibration is due for an assay, the System
prompts the Operator to perform the calibration. If
calibration is not desired at that time, select <Cancel> on
the displayed dialog window.

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Basic Steps to Order and Run a Sample

Viewing System Status and Run Progress


During a run, there are three ways to monitor the progress of the run:
• By viewing the Run Progress Area (described in Module 1, System
Tour)
• By the System status displayed in the upper right-hand corner of the
screen
• By viewing the color change of the samples in the DATABASE
screen

System Status
The following System status types are displayed during a run:

Status System Action


READY The System is not performing any operation and is
ready to begin the run.
RUN The System is sampling and processing samples.
SAMPLING END The System has 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 has paused the System by selecting
<PAUSE> in the Action Area.

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MODULE 2: BASIC RUN

Color Display in 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.

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Basic Run Activity

BASIC RUN ACTIVITY

Introduction
• During the activity, point out color In this exercise, you will manually order and run several patient samples
changes on database screen, changes in on the FastTrack™ Sampler following the steps described in this
system status, and lines in Run Progress Module.
Area.
• Instructor will need prepared tubes for
the activity.

Objective
Upon completion of the Basic Run Activity, you will be familiar with:
• Ordering patient samples on the FastTrack Sampler
• Printing a Loadlist
• Loading samples
• Selecting Run options
• Starting a run
• System status types that are displayed during a run

Necessary Materials

Reagents:
• ICT™ Sample Diluent, Albumin, ALT, AST, Calcium, Creatinine,
Glucose, Phosphorus, Total Protein, Urea, and Iron

Other:
• Patient samples

Procedure

NOTE: Panel names have bolded text.

1. Select <Database> from the Information Access Area.


2. Select <Order>.

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MODULE 2: BASIC RUN

3. Select <New>, if necessary to display the Order Samples screen.


4. Enter the following information:
SID Name C/P Assays
501 Tress, Matt 1/1 Na-S, K-S, Cl-S, Crea, Urea

5. Select <New>.
6. Repeat steps 4 and 5 to order the following additional samples.
SID Name C/P Assays
502 Trola, Vic 1/2 Glu, AST, ALT, Iron
503 Fresco, Al 1/3 Chem1, Phos
504 Lifeboats, Mandy 1/4 Chem2, TP, AlbP
505 Pendous, Stu 1/5 Chem1, TP, AlbP
506 DeLyon, Dan 2/1 Crea, Urea, Phos
507 Moe, Ali 2/2 Chem1, TP, Crea, Urea

7. Select <OK> to return to the DATABASE screen.


8. Highlight all ordered samples.
9. Select <Print>.
10. Select <Loadlist>.
11. Select <OK> on the confirmation dialog window.
12. Load the samples in the specified positions and place on the
FastTrack™ Sampler.
13. Select <RUN> from the Action Area.
14. Select the Patient option and deselect all Calibration and QC
options.
15. Select <Start>.
16. During the run, observe the System status, run progress, and
database changes.

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Review Questions

REVIEW QUESTIONS
1. What screen is used to order patient samples and print a Loadlist?

2. What screen is used to start the run?

3. What is C/P?

4. How do you display more panels on the Order Samples screen if


you have more than 20 panels configured?

5. What is the difference between the Loadlist and the


Order List in the Print Options screen.

6. What is the purpose of the End-of-Run Carrier?

7. Why is it important to remove bubbles from the samples?

8. What color are the samples in the DATABASE screen while they
are running?

9. If two Albumin Reagent Cartridges are loaded in Reagent Supply


Center 1, one in position A-9 and another in position B-3, which will
the instrument aspirate from first?

10. When viewing the REAGENTS screen, you note that the remaining
volume of a reagent is displayed in pink. What does this indicate?

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MODULE 2: BASIC RUN

ANSWERS
1. The DATABASE screen
2. The RUN OPTIONS screen
3. Carrier and position number
4. By touching the scroll bar to the right of the panel buttons
5. The Loadlist prints sample information and position.
The Order List prints the sample information, position,
and assays ordered.
6. It indicates to the System to stop sampling from the Sample Carriers
and if Auto Rerun is configured it will return the trays to the starting
position and begin sampling any reruns.
7. Bubbles can cause level sense errors or inaccurate test results due to
inaccurate aspiration.
8. Brown
9. The cartridge in position A-9
10. The reagent is expired.

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Summary

SUMMARY
In this Module, you have:
• Manually ordered patient samples to run on the FastTrack™
Sampler
• Loaded samples
• Initiated a patient run
• Observed the various System status types displayed during
processing
• Identified the screens required to verify reagent inventory
• Loaded reagents

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MODULE 2: BASIC RUN

NOTES

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MODULE 2: DAILY START UP AND CHECKS

MODULE 3:
DAILY START UP
AND CHECKS

AEROSET® Customer Training Guide 3-1


94858-103 — July 2003
MODULE 3: DAILY START UP AND CHECKS

CONTENTS
Page

Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
System Log On and Log Off . . . . . . . . . . . . . . . . . . . . . . . 3-5
START UP and SHUTDOWN . . . . . . . . . . . . . . . . . . . . . . . 3-7
Solutions Used for START UP, SHUTDOWN, and
Daily Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Solution Volume Display . . . . . . . . . . . . . . . . . . . . . . . . 3-18
Daily Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
Review Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32
Answers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-33
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-35

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Objectives

MODULE 3: DAILY START UP AND CHECKS

OBJECTIVES
Upon completion of this Module, you will be able to:
1. Log On to the AEROSET System
2. Describe and perform START UP Procedures
3. Describe and perform SHUTDOWN Procedures
4. Describe and perform the Daily Check Procedures

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MODULE 3: DAILY START UP AND CHECKS

INTRODUCTION
To ensure smooth daily work flow, it is important to perform the Daily
Checks and START UP. This Module familiarizes you with these
procedures and how to perform them.

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System Log On and Log Off

SYSTEM LOG ON AND LOG OFF


When the AEROSET System is Powered ON, the software on the
System Control Center opens to the Log On dialog window. This screen
is shown below:

Figure 3.1: Log On Dialog Window

Log On
• guest/xxxx* (numbered password) To Log On to the AEROSET System, perform the following procedure:
• extra/ex_tra*
*Abbott personnel only
1. Type the User Code.
NOTE: Do not press [Enter] after typing the User Code.
• These user codes/passwords are
configured on training instruments
only. They will not be configured on 2. Press [Tab] on the keyboard.
customer’s instrument.
- abbott/Aeroset 3. Type the Password.
- aeroset/user NOTE: Both fields are case sensitive.

4. Press [Enter] or select <OK>.

NOTE: For the procedure on creating User


Code/Passwords, refer to Module 8, Configuration.

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94858-103 — July 2003
MODULE 3: DAILY START UP AND CHECKS

Log Off
The Operator must Log Off to enable another Operator to Log On or to
perform the Power OFF Procedure.
1. Close or exit any open screens.
2. Select the Exit icon from the Action Area of the Main
Display.

3. The EXIT dialog window is displayed.

Figure 3.2: EXIT Dialog Window


4. Select <OK>. The Log On screen is displayed.

NOTE: For the Power OFF Procedure, refer to Module 11,


Component Replacement and Troubleshooting.
5. The System is ready for the new Operator to perform the Log On
Procedure.

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START UP and SHUTDOWN

START UP AND SHUTDOWN


The START UP and SHUTDOWN Procedures are performed daily. The
Operator can initiate the procedures upon request or the System can be
configured to perform START UP and SHUTDOWN procedures
automatically at a specified time of the day.

NOTE: Refer to Section 2, Installation Procedures and Special


Requirements of the AEROSET System Operations Manual
for details on configuring automatic START UP and
SHUTDOWN Procedures.

The following table lists the options available on the START UP


OPTIONS and SHUTDOWN OPTIONS screens.
Point out that:
Option Description Screen
• #3 and #8 are SHUTDOWN
only Change Water in Bath START UP or
1
• #7 is START UP only SHUTDOWN
Wash Cuvettes START UP or
2
SHUTDOWN
3 Fill with Dtg (not currently used) SHUTDOWN only
Wash Probes with START UP or
• Water SHUTDOWN
• 1% Alkaline Wash Solution
4
• 0.5% Acid Wash Solution
NOTE: The mixers are also
washed.
Wash ICT™ with START UP or
5 • ICT Cleaning Fluid SHUTDOWN
• ICT Reference Solution
Drain & Fill IRef Cup START UP or
6
SHUTDOWN
7 Flush Water Lines START UP only
Clear Database SHUTDOWN only
• Cal, QC
• Patients
8 • All Records
• Cal, QC, QCAvg
• Patients, QCAvg
• All Rec, QCAvg

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94858-103 — July 2003
MODULE 3: DAILY START UP AND CHECKS

START UP and SHUTDOWN Procedures should be scheduled based


on instrument usage. Two different usage types are described in the
following sections.
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 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.
Cal, QC, QCAvg Deletes Cal/QC records from the Database and
converts patient records to preserved samples. The text
color on the Database 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.

24 Hour Operation
If the AEROSET System is operational for the entire 24 hour period or
idle for less than eight hours per day, the following START UP and
SHUTDOWN options should be performed daily at the intervals
specified below.

START UP (30 min)


These options should be performed once per 24 hour period and require
30 minutes to complete:
• Change Water in Bath
• Wash Cuvettes
• Wash Probes (and Mixers) with 1% Alkaline Wash Solution
• Wash ICT™ with ICT Cleaning Fluid and ICT Reference Solution
• Drain & Fill IRef Cup
• Flush Water Lines

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START UP and SHUTDOWN

SHUTDOWN (1 min)
These options should be performed once per 24 hour period and require
one minute to complete:
• Clear Database, All Records
NOTE: The capacity of the Database screen is 8,000
sample records or 30,000 results. The Operator will be
notified by an Error Log Message when the capacity is
depleted to 100 records. When the capacity is totally
depleted the Operator will be notified and no additional
orders will be accepted.
When the System is configured to Save by Carrier
ID (no sample bar codes) Sample Carrier/Positions
cannot be reused and must be cleared using this
procedure.
The Delete function on the Database screen will
not clear the Database.
NOTE: If the Cal, QC option or Cal, QC, QC Avg option
is selected instead of the All Records option to Clear
Database, then:
• C/P, SID, and PID are deleted for complete,
incomplete, and validated results; these
samples become preserved samples.
• A search cannot be performed for a preserved
sample.
• Text color on the DATABASE screen is green
for a preserved sample.
• The C/P, SID, and PID of the preserved samples
can be used for new patient samples.
• <Rxn Graph> cannot be selected to view a
reaction graph for a preserved sample.

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MODULE 3: DAILY START UP AND CHECKS

Partial Day Operation


If the System is idle for eight or more continuous hours per day on a
regular basis, the following START UP and SHUTDOWN options
should be performed daily at the times specified below.

START UP (22 min)


These options should be performed at the beginning of the daily
operation and require 22 minutes to complete:
• Change Water in Bath
• Wash Cuvettes
• Wash Probes (and Mixers) with Water
• Wash ICT™ module with ICT Reference Solution
• Drain & Fill IRef Cup
• Flush Water Lines

SHUTDOWN (30 min)


These options should be performed at the end of the daily operation and
require 30 minutes to complete:
• Change Water in Bath
• Wash Cuvettes
• Wash Probes (and Mixers) with 1% Alkaline Wash Solution
• Wash ICT module with ICT Cleaning Fluid and ICT Reference
Solution
• Drain & Fill IRef Cup
• Clear Database, All Records
NOTE: The capacity of the Database screen is 8,000
sample records or 30,000 results. The Operator will be
notified by an Error Log Message when the capacity is
depleted to 100 records. When the capacity is totally
depleted the Operator will be notified and no additional
orders will be accepted.

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START UP and SHUTDOWN

When the System is configured to Save by Carrier


ID (no sample bar codes) Sample Carrier/Positions
cannot be reused and must be cleared using this
procedure.
The Delete function on the Database screen will
not clear the Database.
NOTE: If the Cal, QC option or Cal, QC, QC Avg option
is selected instead of the All Records option to Clear
Database, then:
• C/P, SID, and PID are deleted for complete,
incomplete, and validated results; these
samples become preserved samples.
• A search cannot be performed for a preserved
sample.
• Text color on the DATABASE screen is green
for a preserved sample.
• The C/P, SID, and PID of the preserved samples
can be used for new patient samples.
• <Rxn Graph> cannot be selected to view a
reaction graph for a preserved sample.
NOTE: If the Wash Cuvettes option is not performed as
part of the SHUTDOWN Procedure, Cuvette Integrity
Check data is not reset. Refer to Section 10,
Troubleshooting and Diagnostics for more information.

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MODULE 3: DAILY START UP AND CHECKS

Performing the START UP Procedure


1. Select <START UP> in the Action Area to display the START UP
OPTIONS screen.
• Can use screens and order samples
during START UP.
• Show how to setup START UP and
SHUTDOWN screens.

Figure 3.3: START UP OPTIONS Screen


2. Place a checkmark (;) in the box beside each desired option by
touching the box.
3. Ensure there are sufficient volumes of all solutions required.
NOTE: Refer to Solutions Used for START UP,
SHUTDOWN, and Daily Operation and Solution
Volume Display within this Module for details.
4. Select <Start> to begin the START UP Procedure.
NOTE: If the power to the System is turned OFF, when
power is reinitiated, the text on the START UP button is
pink. The text turns black if all procedures complete
successfully.

NOTE: A pink line below the text of any START UP


or SHUTDOWN option indicates the option was
not completed successfully, or power to the System
was turned off. Review any Error Log Message that
was generated, then repeat the START UP or
SHUTDOWN option that was underlined.

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START UP and SHUTDOWN

Performing the SHUTDOWN Procedure


1. Select <SHUTDOWN> in the Action Area to display the
• Discuss need to clear database, due to
memory only able to hold 8,000
SHUTDOWN OPTIONS screen.
samples or 30,000 results.
• At 8,000 samples, it will not accept
any more orders, and you will get a
warning when there is only space for
100 more.
• If not bar coded, can’t reuse carrier/
position # until database is cleared.
Only have 200 total positions
{40 carriers x 5 positions in each},
must clear database.
• Water Bath Additive position must be
configured upon system install.

IDil

Figure 3.4: SHUTDOWN OPTIONS Screen


2. Place a checkmark (;) in the box beside each desired option by
touching the box.
3. Ensure there are sufficient volumes of all solutions required.
NOTE: Refer to Solutions Used for START UP,
SHUTDOWN, and Daily Operation and Solution
Volume Display within this Module for details.
4. Select <Start> to begin the SHUTDOWN Procedure.

NOTE: A pink line below the text of any START UP


or SHUTDOWN option indicates the option was
not completed successfully, or power to the System
was turned off. Review any Error Log Message that
was generated, then repeat the START UP or
SHUTDOWN option that was underlined.

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MODULE 3: DAILY START UP AND CHECKS

Automatic Power ON, START UP, and SHUTDOWN


• Only one option/day. The AEROSET System can be configured to Power ON, perform
• If you are running the START UP and SHUTDOWN options automatically, even when the
instrument at the time of auto Operator is not present.
START UP or SHUTDOWN, it
won’t do them. On the System page of the MAINTENANCE UTILITIES screen, the
time and mode (Power ON, START UP, SHUTDOWN) are defined for
each day of the week.
The Rotary Power Control Switch must be set in the AUTO position
for the preset option to execute at the specified time.
To configure the Automatic Power ON, START UP, and SHUTDOWN
options, select the Maintenance Utilities icon in the Action
Area to access the MAINTENANCE UTILITIES screen.
For information about configuration of the Automatic Power ON,
START UP, and SHUTDOWN options, refer to MAINTENANCE
UTILITIES Screen in Section 2, Installation Procedures and Special
Requirements of the AEROSET System Operations Manual.
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.

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Solutions Used for START UP, SHUTDOWN, and

SOLUTIONS USED FOR START UP, SHUTDOWN, AND


DAILY OPERATION
The following table describes the solutions used for each START UP
and SHUTDOWN option and for Daily Operations. It also indicates the
placement of the solutions.
Solutions for START UP and SHUTDOWN
Option Solution Used Placement
Change Water In Bath Water Bath Additivea Reagent Supply Center 1, outer segment
Wash Cuvettes Alkaline Wash Solution On the weight platform behind the front-right door
Acid Wash Solution On the weight platform behind the front-right door
Fill with Dtg Optional detergent • Reagent Supply Center 1, outer segment
(for future application) • Reagent Supply Center 1, inner segment
Wash Probes with Water None
1% Alkaline Wash • Calibrator/Control Carousel, Position 44 (1 mL)
Solutionb • Reagent Supply Center 1, outer segment
• Reagent Supply Center 1, inner segment
• Reagent Supply Center 2, outer segment
• Reagent Supply Center 2, inner segment
Wash ICT™ with ICT Cleaning Fluidd Calibrator/Control Carousel Position 43 (200 µL)
ICT Sample Diluent Reagent Supply Center 1, outer segment
ICT Reference Solution On the weight platform behind the front-right door
Drain & Fill IRef Cup ICT Reference Solution On the weight platform behind the front-right door
Flush Water Lines None None

Solutions for Daily Operation


Option Solution Used Placement
Wash Cuvettes Alkaline Wash Solution On the weight platform behind the front-right door
Acid Wash Solution On the weight platform behind the front-right door
SmartWash™ 1% Alkaline Wash • Calibrator/Control Carousel, Position 44
Solutionb • Reagent Supply Center 1, outer segment
• Reagent Supply Center 1, inner segment
• Reagent Supply Center 2, outer segment
• Reagent Supply Center 2, inner segment
0.5% Acid Wash • Calibrator/Control Carousel, Position 45
Solutionc • Reagent Supply Center 1, outer segment
• Reagent Supply Center 1, inner segment
• Reagent Supply Center 2, outer segment
• Reagent Supply Center 2, inner segment
ICT Analysis ICT Sample Diluent Reagent Supply Center 1, outer segment
ICT Reference Solution On the weight platform behind the front-right door
Sample Dilution Saline • Reagent Supply Center 1, outer segment
• Reagent Supply Center 1, inner segment

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94858-103 — July 2003
MODULE 3: DAILY START UP AND CHECKS

. a. Preparation of Water Bath Additive – Transfer the Water Bath Additive to an empty Reagent Cartridge and
place it in an outer segment of Reagent Supply Center 1. Approximately 3 mL is required to perform the
Change Water In Bath option.
. b. Preparation of 1% Alkaline Wash Solution – Mix 10 mL of Alkaline Wash Solution with 990 mL of DI
Water (Type II). Approximately 10 mL is required in each Reagent Cartridge listed in the preceding table.
Approximately 1 mL is required in the sample cup. The prepared solution is stable for 30 days when stored
at room temperature and protected from light. Transfer the solution to empty Reagent Cartridges for place-
ment in the defined position in the Reagent Supply Centers and to a sample cup for placement in the Cal-
ibrator/Control Carousel. Onboard stability for this reagent, when placed in the Reagent Supply
Centers, is 14 days. When placed in the Calibrator/Control Carousel, the stability is one day.

The Reagent Supply Center positions for the 1% Alkaline Wash Solution and 0.5% Acid Wash
Solution are pre-configured on the System Configuration Disk.

Chemical Hazard. Refer to Appendix, Hazards of this manual.


!
. c. Preparation of 0.5% Acid Wash Solution – Mix 5 mL of Acid Wash Solution with 995 mL of DI Water
(Type II). Prepared solution is stable. Transfer the solution to empty Reagent Cartridges for placement in
the defined position in the Reagent Supply Centers and to a sample cup for placement in the Calibrator/
Control Carousel. Onboard stability for this reagent, when placed in the Reagent Supply Centers, is 30
days. When placed in the Calibrator/Control Carousel, the stability is one day.

d. Preparation of ICT™ Cleaning Fluid – Add 12 mL of Cleaning Fluid Diluent. The prepared solution is sta-
ble for 14 days when stored at 2 - 8×C. Transfer the solution to a sample cup for placement in the Calibra-
tor/Control Carousel. Approximately 200 µL is required in the sample cup. Onboard stability for this
reagent, when placed in the Calibrator/Control Carousel is one day.

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Solutions Used for START UP, SHUTDOWN, and

Summary of Positions for Loading Solutions


The following table provides a quick reference of the positions for the
solutions required for START UP, SHUTDOWN, and Daily Operation
as configured on the Assay Disk.

Reagent Supply Reagent Supply Calibrator/


Center 1 Center 2 Control Front-Right Door
Carousel
Outer Inner Outer Inner
1% Alkaline Wash C-11 D-19 C-11 D-19 44
Solution

0.5% Acid Wash C-12 D-20 C-12 D-20 45


Solution

Water Bath Additive C-9


ICT™ Sample A-Line
Diluent

ICT Cleaning Fluid 43

ICT Reference 9
Solution

Alkaline Wash 9
Solution

Acid Wash Solution 9

Saline (for sample C-10 D-18


dilution)

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MODULE 3: DAILY START UP AND CHECKS

SOLUTION VOLUME DISPLAY


The solution volumes are displayed at the bottom of the START UP
OPTIONS and SHUTDOWN OPTIONS screens.

(11)
(12)
(13)

Screen Positions (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Figure 3.5: Solution Volume Display
The following table identifies the solutions in screen positions 1 - 10.
These solutions are located in the Reagent Supply Centers and the
volume is indicated in % remaining and by a colored bar. Each color
indicates a different status.
• Green – The volume is sufficient.
• Pink – The expiration date specified in the Reagent Configuration
screen has been exceeded.
• Brown – The volume is below the specified Rgt Lo Alert level.
Position Definition

1 1% Alkaline Wash Solution in Reagent Supply Center 1, outer segment

2 0.5% Acid Wash Solution in Reagent Supply Center 1, outer segment

3 1% Alkaline Wash Solution in Reagent Supply Center 1, inner segment

4 0.5% Acid Wash Solution in Reagent Supply Center 1, inner segment

5 1% Alkaline Wash Solution in Reagent Supply Center 2, outer segment

6 0.5% Acid Wash Solution in Reagent Supply Center 2, outer segment

7 1% Alkaline Wash Solution in Reagent Supply Center 2, inner segment

8 0.5% Acid Wash Solution in Reagent Supply Center 2, inner segment

9 Water Bath Additive in Reagent Supply Center 1, outer segment

10 ICT™ Sample Diluent in Reagent Supply Center 1, outer segment

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Solution Volume Display

The following table identifies the solutions in screen positions 11 - 13.


These solutions are located on the weight platforms behind the front-
right door and the volume is indicated by the color of the position. The
status is indicated by the following colors:
• Green – The volume is sufficient.
• Red – The volume is insufficient. The approximate volume
remaining in each bottle is:
• I Ref < 140 mL
• Alk W < 64 mL
• Acid W < 64 mL
Position Definition

11 ICT™ Reference Solution


12 Alkaline Wash Solution
13 Acid Wash Solution

NOTE: Since the indicators for the solutions on the weight


scales do not display remaining volume, it is recommended
that the bottles be checked visually.

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MODULE 3: DAILY START UP AND CHECKS

Loading Bulk Solutions

Alkaline and Acid Wash Solution Loading


CAUTION: Chemical Hazard. Refer to Appendix,
! Hazards of this manual.

Procedure:

NOTE: The Wash Solutions should not be changed when the


System status is RUN, PAUSE, or SAMPLING END because
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 Messages are generated
during a run, the System automatically goes into a PAUSE
status. No further samples are aspirated, but the samples already
dispensed continue to process. Once the Run Progress bar (in the
lower left-hand screen) indicates that all the samples have been
processed, select <STOP> to change the status to READY.

1. Ensure the System status is READY prior to loading the Wash


Solution.
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 into the new bottle and seat the cap on the bottle
opening. Firmly press down on the cap to secure it on the opening.
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.

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Solution Volume Display

ICT™ Reference Solution Loading

Procedure
CAUTION: The ICT Reference Solution should not be
! changed when the System status is RUN, PAUSE, or
SAMPLING END because 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 of the AEROSET System Operations
Manual for details on initial recovery from Error Log
Message 88.
1. Ensure the System status is READY prior to loading the ICT
Reference Solution.
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.

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94858-103 — July 2003
MODULE 3: DAILY START UP AND CHECKS

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.

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 (5) 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.

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Daily Checks

DAILY CHECKS
To ensure proper operation of the AEROSET System, the following
Daily Checks must be performed:
• Demonstrate Daily Checks at • Check 1 mL Syringes
instrument.
• Check Wash Solution Trays
• Check Sample and Reagent Syringes and Solenoid Valves
• Check High-Concentration Waste Container
• Check Refrigerator Condensation Pan
• Check DI Water System
• Check Reagent Inventory

Check 1 mL Syringes
1. Open the front-right door to access the Wash Solution pump 1 mL
syringes.

1mL
Syringes

125686

Figure 3.6: Wash Solution Pump

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MODULE 3: DAILY START UP AND CHECKS

2. Check each of the syringes in the pump. Visually inspect the syringe
interior, below the plunger tip, for evidence of leakage.

Check for
Leakage

125634

Replace the syringe if leaking is observed. For replacement of a


1 mL syringe, refer to Component Replacement in Section 9,
Service and Maintenance of the AEROSET System Opera-
tions Manual.
3. Open the ICT™ Pump access door to access the ICT Aspiration
Pump and ICT Reference Solution Pump 1 mL syringes.

ICT Reference
ICT Aspiration Pump Solution Pump
Figure 3.7: ICT Aspiration Pump and ICT Reference
Solution Pump

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Daily Checks

4. Check each of the syringes in the pumps as described in step 2.


NOTE: Replace if leaking is observed.

NOTE: Refer to Component Replacement in Section 9,


Service and Maintenance of the AEROSET System
Operations Manual for details.
NOTE: It is normal for bubbles to appear in the Left ICT
Reference Pump syringe and associated tubing.
5. Close the front-right door and ICT Pump access door of the
Analyzer.

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MODULE 3: DAILY START UP AND CHECKS

Check Wash Solution Trays


1. Open the front-right door of the Analyzer to access the Wash
Solution weight platforms.
2. Verify that no liquid has accumulated in the tray under the Wash
Solution bottles.
3. Check that the bottles have not overfilled, indicating that a solenoid
valve is defective. Contact your Abbott Representative if there is an
indication of overfill.
4. Close the front-right door.
CAUTION: Chemical Hazard. Refer to Appendix, Haz-
! ards of this manual. Also refer to product-specific
Material Safety Data Sheets (MSDS).

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Daily Checks

Check Sample and Reagent Syringes and Solenoid Valves


1. Open the front-middle door of the Analyzer.
1 = Sample A Syringe Drive
2 = Reagent 1A Syringe Drive
3 = Reagent 2A Syringe Drive
4 = Sample B Syringe Drive
5 = Reagent 1B Syringe Drive
6 = Reagent 2B Syringe Drive

2. Inspect the Sample and Reagent Syringes for leaks from the syringe
body.
3. Inspect the three (3) connections of the Sample and Reagent
Syringes for leaks as shown in the following illustration.
3

1
125635

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MODULE 3: DAILY START UP AND CHECKS

NOTE: Condensation inside the lower syringe body is


acceptable as long as there are no leaks at the bottom of the
syringe.
NOTE: If leaking is observed, refer to Observed
Problems (Sample/Reagent Syringe Leaks) in Section
10, Diagnostics and Troubleshooting of the AEROSET
System Operations Manual.
4. Observe the six (6) solenoid valves.

Solenoid
Valves

125675

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Daily Checks

5. Touch the three (3) valve connections shown in the following


illustration to check for leakage.

NOTE: If a leak is observed, refer to Observed Problems,


(Sample/Reagent Syringe solenoid valve leaks) in Section 10,
Diagnostics and Troubleshooting of the AEROSET System
Operations Manual.

2
125645

6. Close the front-middle door.

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MODULE 3: DAILY START UP AND CHECKS

Check High-Concentration Waste Container (If used)


• If local regulations permit, High- WARNING: Potential Biohazard. Refer to Appendix, Hazards
concentration Waste may be drained of this manual.
to a floor drain.
• Instruments in the training do not CAUTION: Chemical Hazard. Refer to Appendix,
have a waste container; therefore,
this will not be demonstrated.
! Hazards of this manual. Also refer to product-specific
Material Safety Data Sheets (MSDS).

CAUTION: The high-concentration waste container is


! heavy when full. Use care when handling the container
to reduce the risk of injury.

1. Ensure that the System status is READY.


2. Disconnect the float switch cable from the
High-Concentration Waste Container cap by unscrewing the
locking ring and disconnecting the cable.
Locking Ring

Cable

3. Place an absorbent towel next to the container to catch any drips


from the container cap.
4. Unscrew the High-Concentration Waste Container from the cap,
being careful not to kink the tubing.
5. Place the cap (with the attached tubing) on the absorbent towel.
6. Empty the Waste Container according to local waste handling
procedures.
7. Screw the Waste Container onto the cap, being careful not to kink
the tubing.
8. Reconnect the float switch cable by inserting the cable and
tightening the locking ring.

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Daily Checks

Check Refrigerator Condensation Pan (If used)


• May be drained to a floor drain if 1. Locate the Refrigerator Condensation Pan underneath the rear of the
diameter of drain is ≥ 3.5” and Analyzer just to the right of the water supply/drainage panel.
height is ≤ 3”.

Refrigerator
Condensation
Pan
Figure 3.8: Refrigerator Condensation Pan
2. Pull the pan out, keeping it level to prevent spills.
3. Empty the water collected in the condensation pan.
NOTE: This water is condensation from the reagent
refrigeration units and is not considered potentially
biohazardous.
4. To replace, align the center of the pan with the center of the large
vent on the rear of the Analyzer.
5. Slide the pan underneath the Analyzer just far enough so that it does
not extend beyond the Analyzer.

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MODULE 3: DAILY START UP AND CHECKS

Check DI Water System


Check the water quality indicator on the DI Water system supplying
water to the AEROSET System.

NOTE: For water specifications, refer to Section 4,


Performance Characteristics and Specifications of the
AEROSET System Operations Manual.

CAUTION: If the DI Water supply does not meet the


! appropriate specification, patient results can be
affected. Action must be taken to resolve the concern.

Check Reagent Inventory


See Module 2, page 2-5.

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Review Questions

REVIEW QUESTIONS
1. How do you Log Off the System to allow another Operator to Log
On?

2. When deciding which START UP and SHUTDOWN Procedures


to perform, what should you consider?

3. What solution is used during the Change Water in Bath Procedure?

4. Where is the ICT™ Cleaning Fluid placed onboard the instrument?

5. How does the System indicate that one or more of the START UP
or SHUTDOWN options was not completed due to an error?

6. What button is selected from the Main Display to configure the


Automatic START UP and SHUTDOWN Procedures?

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MODULE 3: DAILY START UP AND CHECKS

ANSWERS
1. Select the Exit icon to return to the Log On screen.
2. If the instrument is operational for a 24 hour period or if the
instrument is idle for less than eight hours/day
3. Water Bath Additive
4. Position 43 on the Calibrator/Control Carousel
5. The option is underlined in pink on the START UP OPTIONS or
SHUTDOWN OPTIONS screens.
6. The Maintenance Utilities icon/button in the Action Area

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Summary

SUMMARY
In this Module, you have:
• Performed the Log On Procedure
• Described and performed the START UP, SHUTDOWN, and
Daily Check Procedures

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MODULE 3: DAILY START UP AND CHECKS

NOTES

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MODULE 4: RUN OPTIONS

MODULE 4:
RUN OPTIONS

AEROSET® Customer Training Guide 4-1


94858-103 — July 2003
MODULE 4: RUN OPTIONS

CONTENTS
Page

Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Order Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Sample Order Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Ordering and Running a STAT Sample . . . . . . . . . . . . . 4-16
Editing Patient Sample Orders . . . . . . . . . . . . . . . . . . . . 4-19
Adding Samples During a Run . . . . . . . . . . . . . . . . . . . . 4-20
Activity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
Review Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29
Answers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-32

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Objectives

MODULE 4: RUN OPTIONS

OBJECTIVES
Upon completion of this Module, you will be able to:
1. Run patient samples with a Host interface download or Host Query
2. Enter patient orders manually to run in the Sample Carousel
3. Order sample replicates
4. Order samples for onboard dilution or to be corrected for manual
dilution
5. Enter patient demographic information
6. Create batch orders
7. Order a patient sample to run in the Reserved STAT Position
8. Edit patient sample orders
9. Add samples during a run

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MODULE 4: RUN OPTIONS

INTRODUCTION
Prior to beginning the Module, In Module 2, you learned about a basic run. In this Module, you will
instructor should ensure that Host learn the various Run options that are available for performing tests on
Configuration Protocol Type is Type the AEROSET System.
1’.

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Order Entry

ORDER ENTRY
There are three ways to enter orders:
• Manually, in the Order Samples screen
• Downloaded from a Host computer
• Host Order Query

Manual Order Entry


In Module 2, Basic Run, you performed manual order entry. To review
the steps:
1. Select <Database> from the Information Access Area.
2. Select <Order>.
3. Enter the desired sample information:
• Sample ID (required)
• Name
• C/P (required)
• Manual Dil*
• Replicates*
• Measurement Type*
• Patient Demographics*
4. Select the assay(s) and/or panel(s).
5. Select <New> to order more patient samples or <OK> when
ordering is complete.
* These options will be described in this Module.

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MODULE 4: RUN OPTIONS

Download Order From Host Computer


To download orders from a Host computer:
1. Select <Database> from the Information Access Area.
2. Select <On-line> from the right-hand column of the screen. The
On-line Data Transfer dialog window is displayed.

Figure 4.1: On-line Data Transfer Dialog Window


3. Select the desired option.

Option Description

Order Query To download all pending orders


from the Host.

Order Query by Sample ID To download orders for specified


samples.

Order Query by C/P To download orders for specified


carrier and position number(s).

4. The selected patient samples are downloaded and displayed in the


DATABASE screen.

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Order Entry

Host Order Query


• Reads 5, 4, 3, 2, 1 and does 5 orders The AEROSET System can also be configured for Host Order Query.
at a time. This feature allows the AEROSET System to query the Host computer
for the tests to run on a sample when the AEROSET System encounters
the sample and identifies it by reading a 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.

NOTE: Configuring the AEROSET System for downloading or


Host Order Query is discussed in Module 8, Configuration.

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MODULE 4: RUN OPTIONS

SAMPLE ORDER OPTIONS

Ordering Patient Samples on the Sample Carousel


• Pull out sample carousel and show 1. Select <Database> in the Information Access Area of the Main
students sections A-F, 5 positions in Display if the DATABASE screen is not currently displayed.
each and how sections relate to Run
Options screen.
• Ask - What would the Carrier ID and
position # be for Position A3?
• Have an unlimited # of carousel #’s.
• Would have to redefine each time you
want to reuse the positions.

Figure 4.2: DATABASE Screen

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.

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Sample Order Options

3. Select <Order> in the right column of the DATABASE screen.


The Order Samples screen displays.

Figure 4.3: Order Samples Screen

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.
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.
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.
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.

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MODULE 4: RUN OPTIONS

Loading the Patient Samples to Run in the Sample Carousel


WARNING: Potential Biohazard. Refer to Appendix, Hazards
of this manual.

1. Confirm that the Sample Carousel Movement Indicator LED is not


illuminated. Samples can be loaded into any carrier/position not
covered by the Sample Carousel Safety Shield.

STAT
Position
Access

125643

Figure 4.4: Calibrator/Control Carousel with Sample Carousel


Safety Shield

2. Load the samples in the specified carrier and position. If the sample
tube is bar code labeled, face the label toward the center of the
Sample Carousel.
NOTE: When the System is configured to read sample bar
code labels, the patient samples may be placed in any
carrier and position.
Refer to Section 2, Installation Procedures and Special
Requirements of the AEROSET System Operations
Manual for details on configuring the System to read
sample bar code labels.
Remember to use the Cup/Tube Adapter for sample cups.
If sample cups are loaded without the adapter, the
sample cup is not detected and the patient sample is
not run.

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Sample Order Options

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.

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MODULE 4: RUN OPTIONS

Additional Options on the Order Samples Screen

Figure 4.5: Order Samples Screen

Sample Replicates
Enter the number of replicates desired in the Replicates field. Up to 5
replicates can be entered.
Example: If 3 replicates are entered, the System will dispense and
analyze each selected assay 3 times.

Manual Dilution
• Manual dilution field holds 3 digits. Enter a multiplier in the Manual Dil field, if an off-line dilution was
done. The multiplier will be used to correct the final result for all assays
ordered, both photometric and potentiometric.
Example: If a 1:5 dilution was performed, enter a 5 in this field. The
System will multiply the final result by 5 to correct for the dilution.

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Sample Order Options

Onboard Dilution
• Dil 1 and 2 (Dilutions must be The measurement type for each assay can be selected. The options are:
configured for each assay and will
vary. Cannot see dilution on this Option Description
screen— would have to go to assay
file.
Standard The default dilution configured
Dil 1 Dilution Option 1
Dil 2 Dilution Option 2

NOTE: Configuration of these options is discussed in Module 8,


Configuration.

To define the measurement type for each assay, first select the type and
then select the assay button. The measurement type is visually displayed
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
ordered 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.

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MODULE 4: RUN OPTIONS

NOTE: The following table describes how the System handles


dilutions for calculated assays.

If... Then

• A calculated assay is manually


requested
and
• A dilution is requested for one or • The constituent assay displays
more of the assays used in the with a blue or yellow underline to
ratio calculation indicate the dilution protocol
and requested (Dil 1 or Dil 2).

• The Order Samples screen for • A green line appears under the
this sample is accessed again prior diluted assay indicating a standard
to sample processing dilution.
and
• <OK> is selected on the screen • The System accepts the standard
or dilution and the dilution protocol
is not run.

• <Cancel> is selected on the • The standard dilution is not


screen accepted and the assay is diluted
as originally requested.

Patient Demographics
• If age/sex related reference ranges Additional patient information may be entered by selecting <Demog>
used, must enter both on located in the upper right-hand corner of the Order Samples screen
demographic screen. above the panel buttons. The Patient Demographics dialog window
displays.

Figure 4.6: Patient Demographics Dialog Window

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Sample Order Options

The Patient Demographics dialog window allows the Operator to enter


the following information:

Option Description
Patient ID Up to 20 alphanumeric characters can be entered.
Sex Select from Unknown, Male, or Female using a Drop-down
list box.
Age Up to 3 digits are allowed for the year; up to 2 digits are
(yyy/mm) allowed for the month.
Birthdate 4 digits are required for the year; up to 2 digits are allowed
for the month and day. Once entered, the System will
automatically calculate the age.
Doctor A maximum of 20 alphanumeric characters can be entered
or a selection can be made from the list in the Drop-down
list box. Entries can be added (up to 32) to the list to appear
in the Drop-down list box.
Location
• To add an entry to the list: Select <Add>.
• To remove an option from the list: Highlight the option
on the list and select <Delete>.
Comment

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.

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MODULE 4: RUN OPTIONS

Batch Ordering
• When Alphanumeric SID IS Batch ordering is used when the same assays will be ordered for more
SELECTED in system than one sample.
configuration, the SID WILL NOT
increment. If Alphanumeric SID is
NOT selected in system
NOTE: Prior to using the Batch option, verify that sequentially
configuration, the SID WILL numbered carrier/positions are available for the number of
increment. SID can be edited if samples in the batch.
desired.
• After touching “OK” to close “Copy 1. Enter the first patient sample order.
Order” dialog box, can use “Next”
to access records to edit SID. On last 2. Select <Copy> in the right-hand column of the Order Samples
copy, touch “OK” or “New”. screen. The Copy Order dialog window is displayed.
• Show that Sample Carousel C/P
does not automatically increment
from 1000/5 to 2000/1.

Figure 4.7: Copy Order Dialog Window

3. Enter the number of additional samples in the batch, then select


<OK>. The order is copied for the specified number of samples.
The patient name and demographic information are not copied. The
C/P automatically increments. The Sample ID automatically
increments, only if it is defined as numeric format in 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: Configuring the Sample ID format is reviewed in
Module 8, Configuration.
4. When ordering is complete, select <OK> in the right-hand column
of the Order Samples screen.

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Ordering and Running a STAT Sample

ORDERING AND RUNNING A STAT SAMPLE


1. The STAT patient sample must be loaded in the Reserved STAT
Position in the Sample Carousel prior to placing the order. Confirm
that the STAT Sampling Indicator Light is not illuminated and place
the sample in the STAT position.
Reserved
STAT
Position

125696

Figure 4.8: Top View of the Sample Carousel

2. Lift the STAT position access portion of the Sample Carousel


Safety Shield. Load the sample into the Reserved STAT Position.
Lower the shield.

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94858-103 — July 2003
MODULE 4: RUN OPTIONS

3. Select <STAT> from the Action Area. The SELECT ASSAYS


FOR STAT screen is displayed.

Figure 4.9: SELECT ASSAYS FOR STAT Screen

4. Enter the following sample information:


• Sample ID (required)
NOTE: Sample bar code labels are not read in the
Reserved STAT Position. A sample Bar Code Reader is not
available for that location.
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.
• Manual Dilution
• Measurement Type

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Ordering and Running a STAT Sample

5. Select the assays or panels to be run.


NOTE: Assays with button text that is green in color meet
all required conditions. If the button text is pink or yellow,
further investigation is necessary before performing the
assay.
For more information, refer to Confirmation of Assay
Parameter Settings in Section 2, Installation Procedures
and Special Requirements of the AEROSET System
Operations Manual.
6. Select <Start> in the upper right-hand corner of the SELECT
ASSAYS FOR STAT screen.
NOTE: If the AEROSET System is configured for Host
Order Query, only the Sample ID is required. The assay
orders are sent from the Host system.

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MODULE 4: RUN OPTIONS

EDITING PATIENT SAMPLE ORDERS


• To change a dilution, must deselect 1. Select <Database> from the Information Access Area, if the
and then reselect the assay button DATABASE screen is not currently displayed.
with the new measurement type.
2. Select the order to be edited. Only orders with a Pending status (pink
text) can be edited.
3. Select <Order> in the right-hand column on the DATABASE
screen. The Order Samples dialog window is displayed.
4. Select <Edit>. The Order Samples screen is displayed.
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 the appropriate buttons.
6. Select <OK> in the upper right-hand corner of the Order Samples
screen. The edit is saved and the DATABASE screen is displayed.

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Adding Samples During a Run

ADDING SAMPLES DURING A RUN


WARNING: Potential Biohazard. Refer to Appendix, Hazards
of this manual.

Use 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 Sampler is Busy Sampling


• Refer to the flip chart page for When samples are being aspirated from the FastTrack Sampler, the
summary of statuses and actions System status is RUN.
needed to start the run.
1. Order the patient samples in the Order Samples screen.
2. Place the sample in the specified carrier and position.
CAUTION: The FastTrack Sampler moves soon
! after the Tray Status LED begins blinking orange.
3. Confirm that the Tray Status LED is not blinking orange and place
the Sample Carrier on a free section of the Sample Carrier Tray, to
the right of the Sampler area.

When the FastTrack Sampler has Completed Sampling


When the FastTrack Sampler has 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 using the steps for a new run.
CAUTION: If the AEROSET System is configured
! to automatically return the trays to the starting posi-
tion and aspirate reruns, the System remains in the
RUN status, and the Rerun Indicator Light in the
front display panel is illuminated red. Samples can-
not be added during the rerun process.

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94858-103 — July 2003
MODULE 4: RUN OPTIONS

• If the System status is SAMPLING END, perform the following


steps:
1. Order the patient samples in the Order Samples
screen.
2. Confirm that the red Rerun Indicator Light is not
illuminated and that the System status is SAMPLING
END before performing this procedure.
3. Select <PAUSE> from the Action Area. The RUN
OPTIONS screen is displayed.
4. Select <Pause> in the right-hand column of the RUN
OPTIONS screen to pause sampling.
5. Wait for the System status to change to PAUSE.
6. Place the sample in the specified carrier and position.
7. Place the Sample Carrier on a free section of the
Sample Carrier Tray.
8. Select <UNPAUSE> in the Action Area. The RUN
OPTIONS screen is displayed.
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.
9. Ensure that the Patient option is still selected.
10. Select <Unpause> in the right-hand column of the
RUN OPTIONS screen to resume sampling.
NOTE: The Operator can select <UnpsTrk>, if desired,
and the Sample Carousel remains in the PAUSE status.

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Adding Samples During a Run

Adding Samples on the Sample Carousel

When the Sample Carousel is Busy Sampling


• To speed up when the sample is When samples are being aspirated from the Sample Carousel, the
aspirated, assign a C/P close to the System status is RUN, and the Sample Carousel Movement Indicator
position currently being aspirated. Light is illuminated or blinking.
1. Order the patient samples in the Order Samples screen.
2. Select <PAUSE> in the Action Area. The RUN OPTIONS screen
is displayed.
3. Select <Pause> in the right-hand column of the RUN OPTIONS
screen to pause sampling.
WARNING: If a diluted sample has been dispensed, the
! Sample Arm may move after the status has changed to
PAUSE. Wait 20 seconds before accessing the Sample
Carousel area.

WARNING: The AEROSET System does not stop the


! movement of the Reagent 2 Probes, ICT™ Unit, Mixers,
or Cuvette Washers so the Assay Read Times are not
affected.

CAUTION: The System completes the dispensing


! and mixing of any sample and reagent already aspi-
rated. Confirm the PAUSE status in the System Sta-
tus Area and confirm that the R1 Indicator on the
LUI (Local User Interface) is illuminated before pro-
ceeding.
4. Wait for the System status to change to PAUSE and then place the
samples in the Sample Carousel in the specified positions.
NOTE: For priority sampling, load the sample in the first
available position next to the position currently being
aspirated.

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94858-103 — July 2003
MODULE 4: RUN OPTIONS

5. Select <UNPAUSE> in the Action Area. The RUN OPTIONS


screen is displayed.
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.
6. Ensure that the Patient option is still selected and that the carrier
number specified when the test was initially ordered is entered in the
Car’r column of the RUN OPTIONS screen.
7. Select <Unpause> in the right-hand column of the RUN
OPTIONS screen to resume sampling.
NOTE: The Operator can select <UnpsCrsl> and the
FastTrack Sampler remains in the PAUSE status.

When the Sample Carousel has Completed Sampling


When the Sample Carousel has completed sampling the Sample
Carousel Movement Indicator Light is not illuminated or blinking. If the
FastTrack™ Sampler is still sampling, the System status is RUN but if
both the Sample Carousel and the FastTrack Sampler have 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 using the steps for a new run.
• If the System status is RUN or SAMPLING END, perform the
following steps:
1. Order the patient samples in the Order Samples
screen.
2. Confirm that the Sample Carousel Movement
Indicator Light is not illuminated or blinking.
3. Select <PAUSE> in the Action Area. The RUN
OPTIONS screen is displayed.
4. Select <Pause> in the right-hand column of the RUN
OPTIONS screen to pause sampling.
5. Wait for the System status to change to PAUSE.
6. Place the samples in the Sample Carousel in the
specified position.

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Adding Samples During a Run

NOTE: 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.
7. Select <UNPAUSE> in the Action Area. The RUN
OPTIONS screen is displayed.
CAUTION: Do not select <RUN> to reinitiate sam-
! pling. If <RUN> is selected, all samples remaining
on the System with tests still in process are sampled
again.
8. Ensure that the Patient option is still selected and
that the carrier number specified when the test was
initially ordered is entered in the Car’r section of the
RUN OPTIONS Screen.
9. Select <Unpause> in the right-hand column of the
RUN OPTIONS screen to resume sampling.

NOTE: The Operator can select <UnpsCrsl> and


the FastTrack™ Sampler remains in the PAUSE
status.

What’s the Status?


Use the information in the following table to determine which process to
initiate for each status message.

Instrument Status Process

*READY 1. RUN in Action Area.


2. Check run options.
*CUVETTE FILL
3. START in Run Options.
*SUSPEND

*RUN (Sample Carousel) 1. PAUSE in Action Area.


2. Check run options.
*SAMPLING END
3. PAUSE in Run Options.
4. UNPAUSE in Action Area
5. UNPAUSE in Run Options.

RUN (FastTrack) Place the sample carrier to the right of the


Sampler Area on the FastTrack.

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MODULE 4: RUN OPTIONS

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Activity

ACTIVITY

Introduction
• Instructor will need the prepared tubes In this exercise, you will manually order and run several patient samples
for the Run Options module. on the FastTrack™ Sampler and Sample Carousel with the additional
• Point out that run is not started until Run options described in this Module.
step #10.
• Wait for sampling to begin before
ordering the STAT.

Objective
Upon completion of the Run Options Activity, you will be familiar with:
• Ordering patient samples in the Sample Carousel and FastTrack
Sampler
• Creating batch orders
• Editing patient sample orders
• Entering patient demographic information
• Ordering sample replicates
• Ordering samples for onboard dilution
• Ordering a patient sample to run in the Reserved STAT Position
• Adding samples during a run

Necessary Materials

Reagents:
• ICT™ Sample Diluent, Albumin, ALT, AST, Calcium, Creatinine,
Glucose, Phosphorus, Total Protein, Urea, and Iron

Other:
• Patient samples

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MODULE 4: RUN OPTIONS

Procedure

NOTE: Panel names have bolded text.

Order Patient Samples in the Sample Carousel


1. Select <Database> from the Information Access Area.
2. Select <Order>.
3. Select <New>, if necessary to display the Order Samples screen.
4. Order the following patient samples in the Sample Carousel:

SID Name C/P Assays


601 Pole, Tad 1000 / 1 Chem2, ALT, AST
602 Twishes, Bess 1000 / 2 ICT, Ca
603 Board, Bill 1000 / 3 Crea, Urea
604 Gator, Ali 1000 / 4 Chem1
5. Select <New> after each sample.

Create a Batch Order


1. Enter the following information:

SID C/P Assays


A12345 3/1 Glu
2. Select <Copy>.
3. Enter 4 for the number of copies.
4. Select <OK> on the Copy Order dialog window.
5. Select <OK> on the Order Samples screen.

Edit Patient Sample Orders


1. In the DATABASE screen, highlight the first sample of the batch
(Sample ID – A12345).
2. Select <Order> in the right-hand column.
3. Select <Edit> on the Order Samples dialog window.
4. Enter the following information:

NOTE: Select <Next> after editing each sample to save


the edits and move to the next sample.

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Activity

C/P SID Name PID Patient Info Edits

3/1 A12345 Beans, Frank N. 123-45-6789 Age: 47 Add a Crea to run as


Dil 1

3/2 B12345 Cloth, Terry HAP7865 Birthdate: October Add the ICT panel
1, 1970

3/3 C12345 Gate, Della 555-8888 Doctor: Who Add Phos and run
this sample with 3
replicates

3/4 D12345 Hyde, Jacquelyn A1B2C3 Location: Add Ca and TP


Outpatient

3/5 E12345 Mellow, Marsha 9876543210 Comment: Frozen Add Crea to run as
Sample Dil 2 and Urea to run
as Dil 1

5. Load patient samples in the Sample Carousel, Section A, positions


1 - 4.
6. Load patient samples in Sample Carrier 3, Positions 1 - 5. Place the
carrier on a tray and place on the FastTrack™ Sampler.
7. Select <RUN> in the Action Area.
8. Place a checkmark (;) in the box to the left of the Patient option by
touching the box.
9. Confirm that the Car’r number defined for Sample Carousel,
Section A is 1000.
10. Select <Start>. Wait for sampling to begin before proceeding to the
next step.

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MODULE 4: RUN OPTIONS

Add a Sample in the Reserved STAT Position


1. Confirm that the STAT Sampling Indicator Light is not illuminated
and place the sample in the Reserved STAT Position.
2. Select <STAT> from the Action Area.
3. Enter the following information:

SID Assays
789STAT Chem1

4. Select <Start>.

Add Samples During a Run


1. Select <Database> from the Information Access Area.
2. Select <Order>.
3. Select <New>, if necessary, to display the Order Samples screen.
4. Order the following patient samples in the Sample Carousel:

SID Name C/P Assays


3050 Tannic, Ty 2000 / 1 Chem2, Iron
3067 Ester, Polly 2000 / 2 ICT, Phos, AST, ALT
3071 Kew, Barbie 2000 / 3 Glu, TP, AlbP, Iron
5. Select <PAUSE> in the Action Area.
6. Select <Pause> in the right-hand column of the RUN OPTIONS
screen.
7. Wait for the System status to change to PAUSE and then place the
samples in the Sample Carousel in Section B, Positions 1 - 3.
8. Select <UNPAUSE> in the Action Area.
9. Confirm that the checkmark (;) in the box to the left of the Patient
option is still present. Confirm that the Car’r number defined for
Sample Carousel, Section B is 2000.
10. Select <Unpause>.

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Review Questions

REVIEW QUESTIONS NOTES


1. Name the three ways to enter orders.

2. When ordering patient samples in the Sample Carousel, on which


screen is the carrier number defined?

3. What is the maximum number of replicates that can be ordered for


a sample?

4. When should batch ordering be used?

5. Where must a STAT patient sample be loaded in the Sample


Carousel?

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MODULE 4: RUN OPTIONS

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Answers

ANSWERS
1. a. Manually
b. Downloaded from a Host computer
c. Host Order Query
2. RUN OPTIONS screen
3. Five
4. Batch ordering is used when the same assays will be ordered for
more than one sample.
5. Reserved STAT Position

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MODULE 4: RUN OPTIONS

SUMMARY
In this Module, you have:
• Discussed how to run patient samples with a Host interface
download or Host Order Query
• Manually entered patient orders to run in the Sample Carousel
• Ordered sample replicates and samples for onboard dilution or to be
corrected for manual dilution
• Entered patient demographic information
• Created batch orders
• Ordered a patient sample to run in the Reserved STAT Position
• Edited patient sample orders
• Added samples during a run

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MODULE 5: RESULT HANDLING

MODULE 5:
RESULT HANDLING

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MODULE 5: RESULT HANDLING

CONTENTS
Page

Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Reviewing Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Accepting Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
Validating Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
Printing Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
The Limited Run Feature . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
Rerunning Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
Reviewing and Selecting Rerun and
Replicate Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26
Adding Assays to a Completed Sample . . . . . . . . . . . . 5-30
Editing Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31
Deleting Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32
Transmitting Results to the Host . . . . . . . . . . . . . . . . . . 5-34
Exporting Results to a Floppy Disk . . . . . . . . . . . . . . . . 5-35
Activity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37
Review Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-40
Answers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-42
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-43

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Objectives

MODULE 5: RESULT HANDLING

OBJECTIVES
Upon completion of this Module, you will be able to:
1. Review, accept, validate, and delete results in the DATABASE and
RESULT screens
2. Find results, save results, print results, and retransmit results to the
Host computer
3. Describe the Limited Run feature
4. Rerun results and add new assays
5. Edit results
6. Identify the Processing Codes, Result Flags, and Result Error Codes

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MODULE 5: RESULT HANDLING

INTRODUCTION
Alternate Method of Training this This Module provides information on result handling. You will learn how
Module to view, accept, delete, print, rerun, export results, and limit a run.
Show the layout of the
DATABASE and Result Screens
(Reviewing Results Section), then
show the following functions on
the RESULT Screen only.
• Print
• Accept
• Rerun
• Edit
• Select
• Delete
• Add
Next, show the following
functions on the DATABASE
Screen.
• Explain the functions that
are similar to the RESULT
screen contrasting single
result vs. multiple samples or
assays.
• Print
• Accept
• Rerun
• Delete
• Show functions unique to
the DATABASE screen.
• Export

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Reviewing Results

REVIEWING RESULTS
Once a sample is complete, you can review the results. There are two
screens from which results may be viewed:
• DATABASE screen
• RESULT screen

Reviewing Results on the DATABASE Screen


1. To access the DATABASE screen, select <Database> in the
Information Access Area. The DATABASE screen is displayed.

• Discuss how the Training


Guide shows reviewing results
on database screen and
reviewing results in Results
screen (good reference tool).
• Tab to end and see
demographics after the
100 assays.

Figure 5.1: DATABASE Screen

2. To view the results for the samples displayed in the DATABASE


screen, select the arrow buttons at the bottom of the right-hand
column or press [→] or [←] on the keyboard to scroll right and left.
The DATABASE screen is configured like a spreadsheet with rows and
columns. A sample occupies one row and the different columns are
viewed by scrolling right and left.
The C/P and Sample ID columns do not scroll. These columns remain
fixed for data identification. The following columns are displayed in the
DATABASE screen:
• Processing Code
• C/P (Carrier/Position)

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MODULE 5: RESULT HANDLING

• 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-hand column prior to the C/P column)
displays a single-letter code to indicate the status of the completed
samples. The following Processing Codes may be displayed:

Processing
Status Description
Code
Incomplete An error occurred for one or more of the
sample results. This may also indicate that
I
the sample is an original sample, with rerun
or replicate results.
Accepted All results ordered for the sample
A
completed with no errors.
Validated The sample has been validated. This can be
done by the Operator or the System can
V
auto-validate if configured to do so in the
SYSTEM CONFIGURATION screen.
Rerun A rerun was requested for one or more
R
results on the sample.
Linked This sample is a rerun of an original sample
L
order and is linked to the original sample.
Replicate This sample is a replicate of an original
r sample order and is linked to the original
sample.

The Assay Name columns display the results of the assays ordered for
each sample. If an “*“ is displayed, the result is not complete. If a “C” is
displayed next to the result, an error has occurred for the result. To
review the Result Error Code, access the RESULT screen.

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Reviewing Results

Limited View Buttons


• R = Rerun is pink, but is Upon entering the DATABASE screen, the following buttons at the
not the same as pending. bottom of the Display Area are highlighted to indicate which orders and
results are displayed. Text color on the buttons corresponds to
• Pending results have not
yet been run. DATABASE screen text colors.
• #’s on each button show • <Pending>—Pink
how many of each type.
• <Incompl> (incomplete)—Blue
• The processing samples
(brown) are reflected in the • <Rerun>—Pink
number on the incomplete • <Complete>—Blue
button.
• <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.

Customized View Option


A customized view can be defined to display whenever <Custom> is
• Discuss the fact the
customized view options are selected. Perform the following steps to configure the customized view.
the same as the buttons on 1. Select <Database> in the Information Access Area, if the screen is
the bottom of the database not currently displayed.
screen.
2. Select <Custom> at the bottom of the DATABASE screen. The
• Discuss how to configure a
customized view. Customized View dialog window is displayed.
• Example: Check pending,
incomplete, and rerun to
show that when you choose
custom, it will only pull
those up.
• Cal and QC, once selected,
will continue to be displayed Figure 5.2: Customized View Dialog Window
until deselected.

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MODULE 5: RESULT HANDLING

3. Select <Modify>. The Modify Customized View dialog window is


displayed.

Figure 5.3: Modify Customized View Dialog Window

4. Place a checkmark (;) in the box to the left of each desired Sample
Status and Sample Type option to be included in the customized
view.
5. Select <OK> to save the settings.

NOTE: Selected Sample Type options remain on the


DATABASE screen until they are deselected on the Modify
Customized View dialog window.

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Reviewing Results

Sort Options
There are four methods of sorting and displaying the samples in the
DATABASE screen.
• Sort by date and time ordered
• Sort by date and time completed
• Sort by carrier/position (C/P)
• Sort by Sample ID
To select the type of sort desired, perform the following procedure:
1. Select <Database> in the Information Access Area, if the screen is
not currently displayed.
2. Select <Custom> at the bottom of the Display Area. The
Customized View dialog window displays.

3. Select <Sort> on the Customized View dialog window. The Sort


dialog window is displayed.

Figure 5.4: Sort Dialog Window

4. Select the Checkbox (5) next to the desired Sort option.


5. Select <OK> to save the settings.

NOTE: The Sample ID option is only available when the


Alphanumeric Sample ID option on the SYSTEM
CONFIGURATION screen is not selected.

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MODULE 5: RESULT HANDLING

Searching for Results


• Can do searches using The search function allows the Operator to enter specific criteria used to
multiple fields. search for specific orders and results. To use the search function, perform
• Use “Clear” to delete all the following steps.
fields.
1. Select <Database> in the Information Access Area, if the screen is
• You can also select “Clear” not currently displayed.
then “Search” to end the
search function. 2. Select <Search> at the bottom of the DATABASE screen.
3. The Search dialog window is displayed.

Figure 5.5: Search Dialog Window

4. The following criteria can be entered for the search:


Criteria Description
Sample ID An individual Sample ID can be entered.
Last Name Enter up to 20 alphanumeric characters.
Patient ID Enter up to 20 alphanumeric characters.
Car’r Range A single carrier number or range of carriers can be
entered.
Date Range Enter a date range using 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.

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Reviewing Results

5. Select <Search> to initiate the search. All samples and results


meeting the search criteria are displayed.
NOTE: After a search has been performed, a magnifying
glass icon appears on <Search> on the Search dialog
window. When the magnifying glass is displayed, the
DATABASE screen is not updated when the sample status
is changed. To return to the Real Time display mode, select
<Search>, and then select <Cancel>.

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MODULE 5: RESULT HANDLING

Reviewing Results on the RESULT Screen


1. Select <Database> in the Information Access Area, if the screen is
not currently displayed.
2. Select the sample to be reviewed.
3. Select <Result> in the right-hand column. The RESULT screen is
displayed.

Figure 5.6: RESULT Screen

For each completed result, the following information is displayed:

Result Information Description


Processing Code A single-letter code to indicate the status of the result:
• A - Accepted
• E - Edited
• R - Rerun
• D - Deleted
• S - Selected
Assay Name The assay name is displayed.

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Reviewing Results

Result Information Description


Numerical Result The result displays unless an error occurred which
prevented the result from calculating. The color of the
result numerical text varies depending on the type of
code associated with it.
• Black - The result is acceptable.
• Brown - The result is outside the reference range
and the appropriate L/H Flag is displayed.
• Red - A Result Error Code has been generated for
the result and the code is displayed.
Result Flag A single-letter flag to indicate when a result is outside
the defined reference range.
• L - Out of range low
• H - Out of range high
Result Error Code If one or more errors occurred for the result, the
highest priority Result Error Code is displayed.
Example:
• SS - Short Sample
• CAL - Calibration Error
• Show sample with different
measurement types. • LMP - Lamp Intensity Low
To view all Result Error Codes generated for a result,
• If you order a BUN/Crea ratio,
select <RxnGraph>.
but only order a BUN, the
instrument will order the Measurement Type Indicated by a colored line beneath the assay name.
Crea for you and mark it with • Green - Standard
a pink underline, but will not • Blue - Dil 1
be reported.
• Yellow - Dil 2
• Pink - Reference assay (System ordered assays for
calculated tests and Sample Interference Indices).

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MODULE 5: RESULT HANDLING

ACCEPTING RESULTS
The AEROSET System auto-accepts all results that are completed with
no associated Result Error Codes. The Processing Code “A” displays by
each accepted result in the RESULT screen. If all results on a sample are
auto-accepted, the “A” is also displayed by the sample in the
DATABASE screen.
If a sample has one or more results with an associated Result Error Code,
the Processing Code “I” is displayed by the sample in the DATABASE
screen. The results for this sample will need to be evaluated by the
Operator for acceptance or further action (rerunning, diluting, editing,
etc.)
To review and accept the results, perform the following procedure:
1. Select <Database> in the Information Access Area, if the screen is
not currently displayed.
2. Select the sample to be reviewed.
3. Select <Result> in the right-hand column. The RESULT screen is
displayed.

Figure 5.7: RESULT Screen

4. If the result displayed is determined by the Operator to be


acceptable without further action, the Operator should highlight the
result by touching it.
5. Select <Accept> in the right-hand column (or press [A] on the
keyboard). An “A” is displayed next to the assay name.

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Validating Samples

VALIDATING SAMPLES
After all the results on a sample have been accepted, the sample may be
validated. The AEROSET System may be configured to only allow
validated results to be printed or transmitted to a Host. The System can
also be configured to auto-validate samples when all results are
acceptable.

NOTE: For the procedures to define the On-line configuration,


Print options and System configuration, refer to Module 8,
Configuration.

To validate a sample after all results are acceptable, perform the


following procedure:
1. Select <Database> in the Information Access Area, if the screen is
not currently displayed.
2. Select the sample to be validated.
3. Select <Accept> in the right-hand column. The Accept Results
dialog window is displayed.

Figure 5.8: Accept Results Dialog Window

4. Select <All Results>. The Accept confirmation dialog window is


displayed.

Figure 5.9: Accept Confirmation Dialog Window

5. Select <OK>.
6. A “V” is displayed by the sample in the DATABASE screen and the
text turns black to indicate that the sample has been validated.

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MODULE 5: RESULT HANDLING

PRINTING RESULTS
Two forms may be printed, Form 1 and Form 2.
Refer to Appendix B of the AEROSET System Operations Manual for
details.

Printing a Single Result Report from the DATABASE Screen


1. Select <Database> in the Information Access Area, if the screen is
not currently displayed.
2. Select the sample to be printed.
3. Select <Print> in the right-hand column of the DATABASE
screen. The Print Options screen is displayed.

4. Select <Form 1> or <Form 2>. A confirmation dialog window is


displayed.
5. Select <OK>.

Printing Multiple Result Reports from the DATABASE Screen


1. Select <Database> in the Information Access Area, if the screen is
not currently displayed.
2. Select the samples 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 [↓] on the keyboard.
• To highlight multiple random samples, hold down [Ctrl] while
selecting the samples on the screen.
3. Select <Print> in the right-hand column of the DATABASE
screen. The Print Options screen is displayed.
4. Select <Form 1> or <Form 2>. A confirmation dialog window is
displayed.
5. Select <OK>.

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Printing Results

Printing a Single Result Report from the RESULT Screen


1. Select <Database> in the Information Access Area, if the screen is
not currently displayed.
2. Select the sample to be printed.
3. Select <Result> in the right-hand column of the DATABASE
screen.
4. Select <Print> in the right-hand column of the RESULT screen. A
confirmation dialog window is displayed.
5. Select <OK>.
NOTE: The Form 1 Result Report is printed when using
the print request in the RESULT screen. If Form 2 Result
Reports are desired, use the Print option in the
DATABASE screen.

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MODULE 5: RESULT HANDLING

THE 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. This feature
may be used when:
• The reagent for an assay is not onboard
• The sample requires pretreatment before the assay can be performed
(TIBC, etc.)

Limiting Assays in a Run


WARNING: Potential Biohazard. Refer to Appendix,
Hazards of this manual.

1. Order and load the patient samples.


2. Select <RUN> in the Action Area. The RUN OPTIONS screen is
displayed.

Figure 5.10: RUN OPTIONS Screen

3. Place a checkmark (;) in the box to the left of the Patient option by
touching the box.
4. Place a checkmark (;) in the box to the left of the Limited option
by touching the box.

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The Limited Run Feature

5. Select <Order> to the right of the Limited option. The SELECT


ASSAYS TO RUN screen is displayed.

Figure 5.11: SELECT ASSAYS TO RUN Screen

6. Select the assays to be run (the assays to be excluded must not be


selected).
WARNING: Assays with button text that is green in color meet
! all required conditions. If the button text is pink or yellow,
further investigation is necessary before performing the assay.
For more information, refer to Confirmation of Assay
Parameter Settings in Section 2, Installation Procedures and
Special Requirements of the AEROSET System Operations
Manual.
7. When assay selection is complete, select <OK> in the upper right-
hand corner of the SELECT ASSAYS TO RUN screen. The RUN
OPTIONS screen displays.
8. Select <Start> in the right-hand column to initiate the run with the
excluded assays.

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MODULE 5: RESULT HANDLING

Deselecting the Limited Run Feature


Perform the following procedure when assays should no longer be
excluded.
1. Select <RUN> from the Action Area. The RUN OPTIONS screen
is displayed.
2. Remove the checkmark (;) from the Limited option by touching
the box.
3. Select <Start> in the upper, right corner of the RUN OPTIONS
screen to begin sampling. All pending assays are aspirated.
CAUTION: If the limited assay required 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.

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Rerunning Results

RERUNNING RESULTS
An Operator may schedule results to be rerun from both the DATABASE
screen and the RESULT screen. 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 a • The subsequent sample(s)


rerun ordered and processed will NOT automatically be
and returned to the sample
• The same carrier/position is handler for processing
used for a subsequent and
sample(s) • The Operator must manually
and move the sample to the right
• A rerun is scheduled for the of the sample handler to be
subsequent sample(s) as rerun or move the sample to
indicated by an “R” another carrier/position
Processing Code on the
DATABASE screen

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MODULE 5: RESULT HANDLING

Rerunning Results from the DATABASE Screen


The DATABASE screen is used to request that all assays ordered for a
sample be rerun or to request that an assay be rerun on multiple samples.

Rerunning Selected Assays


• Caution students about 1. Select <Database> in the Information Access Area, if the screen is
selecting an assay to be rerun not currently displayed.
when the assay has not been
run on that sample. 2. Select the sample(s) to be rerun.
• The system will turn the • To highlight multiple consecutive samples in a list, select the
sample to pink, place an first sample in the list then highlight the remaining samples by
R processing code, but never holding [Shift] and pressing [↓] on the keyboard.
aspirate the sample for rerun.
• To highlight multiple random samples, hold down [Ctrl] while
selecting the samples on the screen.
3. Select <Rerun> in the right-hand column. The Rerun dialog
window is displayed.

Figure 5.12: Rerun Dialog Window

4. Select <Select Assay>. The Select Assays screen is displayed.


5. Select the assay(s) to be rerun. The sample measurement type
(Standard, Dil 1, or Dil 2) can be selected prior to selecting the
assay, if desired.
NOTE: The Sample Measurement Type selected for an
assay applies to all samples that were highlighted in step 2.
6. Select <OK>. Each assay selected is scheduled to rerun for all
samples that were highlighted in step 2.
NOTE: If the System is not configured for Auto Return,
the Operator must manually move the sample to a
sampling position.
NOTE: If a rerun is selected for an assay that was not run
initially, the rerun is not performed.

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Rerunning Results

7. To initiate the run, select <RUN> in the Action Area. The RUN
OPTIONS screen displays.
8. Select the options desired, then select <Start> in the upper
right-hand corner of the RUN OPTIONS screen.

Rerunning All Assays


When this option for rerunning all assays on a sample is selected, all
assays will rerun with the same measurement type (Standard, Dil 1, Dil
2) as originally selected.
1. Select <Database> in the Information Access Area, if the screen is
not currently displayed.
2. Select the sample(s) to be rerun.
• 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 [↓] on the keyboard.
• To highlight multiple random samples, hold down [Ctrl] while
selecting the samples on the screen.
3. Select <Rerun> in the right-hand column. The Rerun dialog
window is displayed.

Figure 5.13: Rerun Dialog Window

4. Select <All Results>. A confirmation dialog window is displayed.

Figure 5.14: Rerun Confirmation Dialog Window

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MODULE 5: RESULT HANDLING

5. Select <OK>. All assays on the selected sample(s) are scheduled to


rerun.
NOTE: If the System is not configured for Auto Return,
the Operator must manually move the sample to a
sampling position.
6. To initiate the run, select <RUN> in the Action Area. The RUN
OPTIONS screen is displayed.
7. Select the options desired, then select <Start> in the upper
right-hand corner of the RUN OPTIONS screen.

Rerunning Results from the RESULT Screen


To request that a single result be rerun, the RESULT screen is used.
1. Select <Database> in the Information Access Area, if the screen is
not currently displayed.
2. Select the sample to be reviewed.
3. Select <Result> in the right-hand column. The RESULT screen is
displayed.
4. Select the result that needs to be rerun.
5. Select the measurement type desired.
6. Select <Rerun> in the right-hand column (or press [R] on the
keyboard).
An “R” Processing Code is placed to the left of the result.
7. Select <OK>. In the DATABASE screen the sample also has an
“R” Processing Code and turns pink to indicate that it is pending.
NOTE: If the System is not configured for Auto Return,
the Operator must manually move the sample to a
sampling position.
8. To initiate the run, select <RUN> in the Action Area. The RUN
OPTIONS screen is displayed.
9. Select the options desired, then select <Start> in the upper
right-hand corner of the RUN OPTIONS screen.

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Rerunning Results

Rerunning Results in the Reserved STAT Position


1. Request the rerun in the DATABASE or RESULT screens as
described in the previous section.
2. Confirm that the correct sample is located in the Reserved STAT
Position.
CAUTION: It is important to confirm the identification of
! the sample in the Reserved STAT Position because bar
code labels are not read in this position. Failure to confirm
the identification of the sample could result in sample
misidentification.
3. Select <STAT> in the Action Area. The SELECT ASSAYS FOR
STAT screen is displayed.
4. Enter the Sample ID (must be the same Sample ID displayed in the
DATABASE screen). Do not select any assays.
5. Select <START> in the right-hand column.

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MODULE 5: RESULT HANDLING

REVIEWING AND SELECTING RERUN AND REPLICATE


RESULTS
Original, rerun, and replicate results are displayed in the DATABASE
screen. When a rerun is complete, the original sample has a Processing
Code of “I” to the left side of the sample information on the DATABASE
screen. The rerun sample has a Processing Code of “L” (Link) because it
is linked to the original sample. The replicate sample has a processing
code of “r”.

Reviewing Rerun Results


• When viewing links, To review the results of the original, and rerun or replicate samples,
measurement type underline perform the following procedure:
will only appear under assays
with reruns. 1. Select <Database> in the Information Access Area, if the screen is
not currently displayed.
• Show how reruns and linked
samples can be displayed by 2. Select the original sample to be reviewed (the sample with the
selecting the Result # Drop Processing Code of “I”).
down box
3. Select <Result> in the right-hand column. The RESULT screen is
• Rerun = Link 1, Link 2...
displayed.
• Replicate = Orig-1
Orig-2....

Result #
Indicator

Figure 5.15: RESULT Screen

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Reviewing and Selecting Rerun and Replicate Results

4. The Result # indicator in the upper left corner of the screen indicates
how many reruns or replicates were performed and which result is
being viewed. For example, in the screen shown above the Result #
indicator shows 1/2. This indicates that this sample was run twice
and that the original result is displayed.
5. The Drop-down list box to the right of the Result # indicates that 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.).
NOTE: Replicates are displayed in the list box as Orig-1
for the first replicate (Orig-2 = second replicate, Orig-3 =
third replicate, etc.).

Drop-Down
List Box

Figure 5.16: RESULT Screen Drop-Down List Box

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MODULE 5: RESULT HANDLING

7. Select the return arrow. The RESULT screen displays with the
original result and the selected rerun or replicate result.

Original Result

Rerun Result

Figure 5.17: RESULT Screen

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Reviewing and Selecting Rerun and Replicate Results

Selecting the Rerun or Replicate Result to Report


Once a sample rerun is complete, the Operator has the option to select
the rerun result or accept the original result. The original result can be
accepted by following the Accepting Results Procedure described in this
Module. To select a rerun or replicate result to report, perform the
following procedure:
1. Display the desired rerun or replicate result, using the procedure
described in the preceding section.
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-hand column of the RESULT screen (or
• With 1.02ER000 software, an press [S] on the keyboard).
operator can replace original/ CAUTION: Once a rerun or replicate result is selected,
first replicate results with rerun
or replicate results displayed
! the original result is no longer accessible.
on the RESULT screen at once 4. An “S” displays to the left of the assay name, and the rerun or
by pressing [O] key on the replicate result is copied over the original result for this assay.
keyboard. Select <OK> twice to
complete the action. 5. Select <OK> to exit the RESULT screen.
6. A request to validate all results is displayed.
7. If all results for the sample are acceptable, select <OK>.
8. If results need to be validated later, select <Cancel>.

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MODULE 5: RESULT HANDLING

ADDING ASSAYS TO A COMPLETED SAMPLE


1. Select <Database> in the Information Access Area, if the screen is
not currently displayed.
2. Select the sample to which assays will be added.
3. Select <Result> in the right-hand column. The RESULT screen is
displayed.
4. Select <Add> in the right-hand column of the RESULT screen.
The Add Assays screen is displayed.

Figure 5.18: Add Assays Screen

5. Select the assay(s)/panel(s) to be added 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 is
displayed with an “R” Processing Code and pink text to indicate that
it is pending.
NOTE: If the System is not configured for Auto Return,
the Operator must manually move the sample to a
sampling position.
8. To initiate the run, select <RUN> in the Action Area. The RUN
OPTIONS screen is displayed.
9. Select the options desired, then select <Start> in the upper
right-hand corner of the RUN OPTIONS screen.

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Editing Results

EDITING RESULTS
• Manually edit 1 result at a Whenever a result is edited, the Processing Code “E” (Edited) is
time. displayed for the result. The “E” remains even after the result has been
• Will give an “E” flag on that accepted and validated. To edit a result, perform the following
result on screen, can be procedure:
configured to appear on
printout. “E” flag will be sent
1. Select <Database> in the Information Access Area, if the screen is
to the Host. not currently displayed.
2. Select the desired sample.
3. Select <Result> in the right-hand column. The RESULT screen is
displayed.
4. Touch the desired assay result.
5. Select <Edit> in the right-hand column of the RESULT screen (or
press [E] on the keyboard).
6. A blue box appears around the result to be edited, and a cursor
appears in the Result field.

Result
Field

Figure 5.19: Editing the RESULT Screen

7. Type in the result desired.


8. Press [Enter]. An “E” is displayed 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
box displays which prompts the Operator to validate the sample.
Select <OK> to validate or <Cancel> to exit.

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MODULE 5: RESULT HANDLING

DELETING RESULTS

Deleting Samples from the DATABASE Screen


1. Select <Database> in the Information Access Area, if the screen is
not currently displayed.
2. Select the sample(s) to be deleted:
• 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 [↓] on the keyboard.
• To highlight multiple random samples, hold down [Ctrl] while
selecting the samples on the screen.

NOTE: A sample cannot be deleted while it is running


(the 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-hand column. The Delete confirmation
dialog window is displayed.

Figure 5.20: 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 clearing
of the Database (All Records) option in the SHUTDOWN
Procedure.

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Deleting Results

Deleting Results from the RESULT Screen


• If the deletion of an edited 1. Select <Database> in the Information Access Area, if the screen is
value was in error, a value not currently displayed.
can be edited back in to the
2. Select the desired sample.
result field to clear the “R”
code brought on by the 3. Select <Result> in the right-hand column. The RESULT screen is
deletion. displayed.
• Instrument needs to have a
4. Select the result to be deleted.
number in the field to
transmit. 5. Select <Delete> in the right-hand column (or press [D] on the
keyboard).
• If the result is an edited result, the Result field clears 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” is
displayed on the left by the assay name.
NOTE: The printed report for a sample with a deleted
result will only print the assay name and any Result Error
Code (if present). The area where the result should
normally print is blank.
6. The deleted results are not sent to the Host or printed on reports, but
can still be viewed in the RESULT screen.
7. Select <OK> to exit to the DATABASE screen.

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MODULE 5: RESULT HANDLING

TRANSMITTING RESULTS TO THE HOST


• If you accept the original, Results are transmitted to the Host system automatically if the
linked/replicate does not go AEROSET System is configured to do so in the On-line Configuration
to host. screen.

NOTE: For details on defining On-line configuration, refer to


Module 8, Configuration.

If the AEROSET System is not configured to send results automatically,


or if Host communication was temporarily suspended and results must be
present, perform the following procedure:
1. Select <Database> in the Information Access Area, if the screen is
not currently displayed.
2. Select the sample(s) to be transmitted:
• 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 [↓] on the keyboard.
• To highlight multiple random samples, hold down [Ctrl] while
selecting the samples on the screen.
3. Select <On-line> in the right-hand column. The On-line Data
Transfer dialog window is displayed.

Figure 5.21: On-line Data Transfer Dialog Window

4. Select <Send Results>. The results of the highlighted samples are


sent to the Host system.

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Exporting Results to a Floppy Disk

EXPORTING RESULTS TO A 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.
• Exported results can be To transfer result records from the AEROSET System to a floppy disk,
imported into a spread sheet perform the following procedure:
program on an external PC.
You cannot import them NOTE: Use a formatted floppy disk. The disk can be formatted
back onto the AEROSET for on the System Control Center. If an alternate format is used, the
viewing. format must be Windows® 95 or DOS 5.0 (or higher).
• The spreadsheet program
need not be a Windows® 95 1. Insert a disk into the floppy disk drive of the SCC computer.
or DOS 5.0 (or higher) based
application. 2. Select <Database> in the Information Access Area, if the screen is
not currently displayed.
3. Select the sample(s) to be exported:
• 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 [↓] on the keyboard.
• To highlight multiple random samples, hold down [Ctrl] while
selecting the samples on the screen.
4. Select <Export> in the right-hand column. The Export dialog
window is displayed.

Figure 5.22: Export Dialog Window

5. Enter a file name (up to 8 characters).

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MODULE 5: RESULT HANDLING

6. Select <OK>. The Export confirmation dialog window is


displayed.

Figure 5.23: 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.

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Activity

ACTIVITY

Introduction
In this exercise, you will order routine and priority samples to generate
results. You will also perform the result handling procedures described in
this Module.

Objective
Upon completion of the Results Handling Activity, you will be familiar
with:
• Reviewing results
• Rerunning results
• Adding assays to a completed sample
• Editing results
• Printing results
• Selecting rerun results
• Accepting and validating results

Necessary Materials

• Instructor will need Reagents:


prepared tubes for Result
handling. • ICT™ Sample Diluent, Albumin, ALT, AST, Calcium, Creatinine,
Glucose, Phosphorus, Total Protein, Urea, and Iron.
• Highlight that in step 4, an
empty tube is loaded for
the Forrest Ranger. Other:
• Patient samples

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MODULE 5: RESULT HANDLING

Procedure

NOTE: Panel names have bolded text.

1. Select <Database> from the Information Access Area.


2. Select <Order>.
3. Select <New>, if necessary to display the Order Samples screen.
4. Order the following patient samples:
SID Name C/P Assays
1201 Daktul, Terry 8/1 ICT™, Glu
1206 Sklue, Elmer 8/2 Chem2
1208 Tard, Leah 8/3 Ca, Phos
1209 Zoff, Hans 8/4 Chem2
1211 Baer, Ted E. 8/5 ICT, Urea
1212 Closed, Doris 9/1 Ca, Iron
1215 Tone, Barry 9/2 Ca, Enz
1216** Ranger, Forrest 9 / 3** TP, AlbP
1217 Graph, Otto 9/4 Chem1, Phos
1220 Nems, Emmy 9/5 AST, TP, AlbP
** Load an empty tube into this position.
5. Select the ordered patient samples on the DATABASE screen and
print an Orderlist.
6. Load the samples in the Sample Carriers with an empty tube and an
adapter in Sample Carrier 9, Position 3. Place the carriers on the
FastTrack™ Sampler.
7. Select <RUN> from the Action Area.
8. Select the Patient option.
9. Select <Start>.
10. While the System is sampling, add the following Priority samples:
SID Name C/P Assays
1225 Less, Ruth 3000 / 1 ICT
1226 Less, Penny 3000 / 2 Glu, Urea

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Activity

Reviewing Results
When the patient samples are completed, perform the following steps:
1. Review the Result Error Codes displayed for Forrest Ranger.
Request a rerun of all assays ordered and place a tube containing
sample into the carrier.
2. The Phosphorus reagent was expired, rerun all the Phosphorus
results.
3. Doctor Betterlate called and wants to add a Glucose to Barry Tone.
4. Marcus Wellbyme called and wants the Glucose result on Terry
Daktul. Review and print the results from the RESULT screen.
5. Doctor Dolittle wants the Na+ on Ted E. Baer rerun.
6. Elmer Sklue was supposed to have a low Glucose result of 35. Edit
the result and reprint a report.
7. Search for the results on the Less girls by name. Print
Form 2 Result Reports for both.

Selecting, Accepting, and Validating Results


When the reruns are complete, perform the following steps:
1. Validate all samples with a processing code of “A” in the
DATABASE screen.
2. Select the rerun results to report for Forrest Ranger and validate the
sample.
3. Select the rerun results to report for all Phosphorus results and
validate the samples.
4. Accept the original Na+ result for Ted E. Baer and validate the
sample.

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MODULE 5: RESULT HANDLING

REVIEW QUESTIONS
1. Name the two screens on which results can be viewed.

2. When would the processing code of “L” be displayed on the


DATABASE screen?

3. You want to view only the pending samples. List the steps involved,
beginning at the Main Display.
a. ______________________________________________
b. ______________________________________________

4. What would a yellow line under the assay name in the RESULT
screen indicate?

5. What color would the result text be if the result was outside the
defined reference range?

6. What is the Limited Run feature?

7. From what screen can assays be added to a completed sample?

8. You want to resend results to the Host computer. List the steps
involved, beginning at the Main Display.
a. ______________________________________________
b. ______________________________________________
c. ______________________________________________
d. ______________________________________________

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Review Questions

NOTES

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MODULE 5: RESULT HANDLING

ANSWERS
1. DATABASE and RESULT screens
2. When a sample has been rerun, the rerun results are displayed with
an “L” to indicate that they are linked to the original results.
3. a. Select <Database>.
b. Deselect all limited view buttons at the bottom of the
DATABASE screen except <Pending>.
4. The result was analyzed using the Dil 2 option.
5. Brown
6. The Limited Run feature allows the Operator to exclude assays
scheduled for a patient sample without changing the order.
7. RESULT screen
8. a. Select <DATABASE>.
b. Select all samples to be resent.
c. Select <On-line>.
d. Select <Send Results>.

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Summary

SUMMARY
In this Module, you have:
• Reviewed, accepted, validated, and deleted results in the
DATABASE and RESULT screens
• Demonstrated how to find, save, and print results
• Discussed how to retransmit results to the Host computer
• Described the Limited Run feature
• Rerun results and added new assays
• Edited results
• Identified the Processing Codes, Result Flags, and Result Error
Codes

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MODULE 5: RESULT HANDLING

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MODULE 6: CALIBRATION

MODULE 6:
CALIBRATION

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MODULE 6: CALIBRATION

CONTENTS
Page

Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Calibration Theory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Calibration Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
Calibration Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Calibrating an Assay . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
Calibration Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19
Activity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
Review Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-36
Answers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-38
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-39

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Objectives

MODULE 6: CALIBRATION

OBJECTIVES
Upon completion of this Module, you will be able to:
1. Demonstrate a basic knowledge of kinetic rate and end-point assays
and the different calibration methods
2. Describe the calibration types available
3. State the reasons for calibrating the AEROSET System
4. Order calibrations and load the calibrators
5. Identify the screens and reports used to review calibration results
6. Recognize Calibration Error Codes associated with calibration
failure

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MODULE 6: CALIBRATION

INTRODUCTION
Assays must be calibrated before you can run samples on the AEROSET
System. In this Module, you will learn how assays are calibrated.
This Module introduces you to the different types of calibration for
photometric assays, the frequency of calibration, and how to order
calibrations. In addition, basic calibration theory is presented, and you
will learn how to review and manage calibration data.

NOTE: Calibration information for the ICT™ assays is


presented in Module 9, ICT Unit.

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Calibration Theory

CALIBRATION THEORY
Calibration can be described as analyzing samples of known
concentrations, recording the absorbance value(s) calculated for each
sample, and plotting the measured absorbance values versus the known
concentration to create a graph for evaluating unknown sample
absorbances. To understand how the AEROSET System calculates the
measured absorbance values used for calibration and to understand how
the System calculates patient results, it is important to know the different
assay types and the different methods of measuring and calculating the
absorbance values.

Assay Types
Two different photometric reaction types are measured on the AEROSET
System.
• End-point - The reaction reaches an equilibrium and at that time
there is little or no further change in the absorbance readings. The
absorbance readings used for calibration and the absorbance
readings used to calculate results are measured during this
equilibrium time.
• Rate - 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.
• Displayed absorbance data are In addition, at each read point the AEROSET System can measure at one
converted to readings for a 10mm (monochromatic) or two (bichromatic) wavelengths. Most AEROSET
light path length.
System assays are bichromatic. The following table explains how the
absorbance is calculated for each of these types:

Number of Wavelengths How the Absorbance Values are


Measured at Each Read Point Calculated
1 - Monochromatic The reading from only the single
wavelength is used.
2 - 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.

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MODULE 6: CALIBRATION

Calibration Methods
After the AEROSET System has measured absorbance values for each of
the calibrators, a calibration curve is plotted. The System has eleven
different methods of analyzing the data, known as “Math Models”. The
term “Math Model” defines any mathematical procedure used to analyze
any given data. The procedure may range in complexity from a simple
subtraction to a non-linear least squares best fit. The available methods
are:
• *Abs
• *Factor
• *1-Point Linear (Blank and one calibrator)
• *Multi-Point Linear (Blank and 2 - 8 calibrators)
• Isozyme
• Logit-4
• Logit-5
• Exponent
• *Spline
• Use Factor
• *Use Fac/Blk (Factor and Blank)
NOTE: The calibration type is defined in the Assay
Configuration screens, Calibration page. For further
information, refer to Module 8, Configuration.
The methods marked with an “*” are used for the
currently available Abbott AEROSET System reagent
applications. These six methods are described in the
following paragraphs:

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Calibration Theory

Abs
• An example is Sample Interference Results are obtained from the absorbance data based on comparison to
Indices, Drugs of Abuse the absorbance of water. End-point assays are represented as absorbance,
and rate assays are expressed as rate of absorbance change/minute.
During calibration, sample blank correction is not performed, even when
sample blank is specified for the end-point assay.

Factor
• All enzymes = rates These assays are typically measuring for enzyme activity. Enzyme assays
are measuring a chromophore (NADH, PNP, etc.) that has a specific
response that varies little between different instruments and reagent lots;
therefore, a single factor is used to calculate all results. Only a reagent
blank is performed for calibration. To calculate results, the reagent blank
absorbance is subtracted from the measured absorbance, and the
difference is multiplied by the factor.
Conc = (measured Abs - Rgt Blank Abs) x Factor

NOTE: The single factor used for the Factor method is entered
in the Calibration page of the Assay Configuration screen. For
further information, refer to Module 8, Configuration.

1-Point Linear
• An example is HDL A reagent blank and a single calibrator are measured. A calibration curve
is generated using these two data points.

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MODULE 6: CALIBRATION

Multi-Point Linear
• Even though you are doing point-to- On the AEROSET System, the multi-point linear calibration uses a
point, linearity is a best fit line, so it reagent blank (water) and two levels of calibrators. The following table
should still show a linear curve for
studies.
describes the steps used to calculate the calibration curve.
• Linear Rates-show Crea and/or Urea.
Step Action Example
- These assays are multi-point
linear but are rates. Absorbance values are measured Rgt Blk = 0.0023
- Show curve and how it takes a for the reagent blank (water) and (Conc = 0.0)
measurement over time instead the two calibrator levels.
of at an endpoint. Level 1 = 0.1105
1
(Conc = 2.0)

Level 2 = 0.3010
(Conc = 5.1)
For each of the two calibrators, the Level 1
reagent blank absorbance is 0.1105 - 0.0023 = 0.1082
2 subtracted from the measured
absorbance.
Level 2
0.3010 - 0.0023 = 0.2987
The reagent blank absorbance and
the corrected calibrator
absorbances are plotted vs. the
0.2987
concentration.
3 Abs
0.1082

2.0 5.1
Conc
Each point is connected for a
point-to-point line. The calibration Factor 2 = 16.3
factor is calculated for each
0.2987
segment of the line.
4 Factor = 1 / Slope Abs ∆Y
(Slope = ∆Y / ∆X)
0.1082
∆X

2.0 5.1
Factor 1 = 18.5 Conc
The following formula is used to calculate QC and patient sample
concentrations:
Concentration = (Sample Abs - Rgt Blank Abs) x Factor*
* The factor from the appropriate section of the curve is used according
to the measured absorbance value of the sample.

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Calibration Theory

Spline
• Show IgA. The Spline method is a non-linear curve calculation used for data points
• Is a point to point, but cannot easily that lie on a slight curve. On the AEROSET System, the spline
calculate factors. calibration uses a reagent blank (water) and five levels of calibrators.
• Curve is basically symmetrical.

Use Fac/Blk (Factor and Blank)


If an assay is defined as Use Fac/Blk, 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 reagents (example: Serum Calcium and Urine Calcium, etc.).

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MODULE 6: CALIBRATION

CALIBRATION FREQUENCY

Required Calibration
You must perform a full calibration run when:
• The Abbott AEROSET System is installed.
• The calibration curve has expired.
• A new reagent lot number is used.
• Existing assay file parameters have been updated or changed.
• A new assay file is installed.
• An Abbott Field Service Representative replaces the System
Control Center (SCC) and assay files have not been backed up. It is
recommended that a backup be performed routinely.
• It is required per assay application.
• An ICT™ component is removed and replaced.
• The ICT Reference Solution is replaced.

Optional Calibration
You may need to perform a new calibration run on an assay in the
following situations:
• Assay control values are out of specification.
• Any System component is replaced.
• Any System maintenance procedure is performed.
• Assay-specific calibration checks are not within specification.

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Calibration Options

CALIBRATION OPTIONS
In addition to full calibration, which renews all data points, three other
options of calibration correction are available for photometric tests. After
correcting the absorbance data, a new calibration curve is generated.
Listed below are the four calibration types.
• Full Calibration
• Blank Calibration
• 1-Point Adjustment
• 2-Point Adjustment

Full Calibration
All data points (reagent blank and calibrators) specified 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 and time.

Other Calibrations
See the AEROSET System Operations Manual for additional
information about Blank Calibrations, 1-Point Adjustments, and 2-Point
Adjustments.

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MODULE 6: CALIBRATION

Automatic Calibration Options


The Operator may configure the AEROSET System to perform
automatic calibrations for the following situations:
• Calibration at the end of the specified calibration interval
• Calibration after reagent lot change
• Operator will be notified when the
calibration interval is exceeded if don’t • Calibration after Reagent Cartridge change
have Auto Cal configured. NOTE: When calibration is automatic (initiated by the
System), the Operator will not have the opportunity to
cancel the calibration unless it occurs simultaneously with
another assay calibration exceeding its configured interval.
NOTE: For further information about defining calibration
When an assay calibration (not parameters in the Assay Configuration screen, refer to
configured for auto-calibration) exceeds Module 8, Configuration.
its configured interval, the “Cancel” key
will be available. Selecting the “Cancel” NOTE: For the Automatic Calibration option to be used,
key will cancel over-interval calibrations the calibrators must be defined on the Calibrator/Control
as well as auto-calibrations.
Carousel.
NOTE: When configured, an automatic calibration is
performed only when a reagent lot change or cartridge
change occurs during a run. An 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: Stability of calibrators on the Calibrator/Control
carousel has not been established.

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Calibrating an Assay

CALIBRATING AN ASSAY

Ordering Calibration
To order a calibration for one or more assays, perform the following
procedure:
1. Select <RUN> in the Action Area. The RUN OPTIONS screen is
displayed.

Figure 6.1: RUN OPTIONS Screen

2. Place a checkmark (;;) in the box to the left of the Calibration


option by touching the box.
3. Touch the Drop-down list box next to Calibration and select the
Calibrator/Control Carousel and Sample Carousel
configurations desired.

Option Calibrator Locations


The System only uses calibrators on the Calibrator/Control Carousel.
Set 1 The System uses calibrators on the Calibrator/Control Carousel and the
Set 1 configuration of the Sample Carousel.
Set 2 The System uses calibrators on the Calibrator/Control Carousel and the
Set 2 configuration of the Sample Carousel.
Set 3 The System uses calibrators on the Calibrator/Control Carousel and the
Set 3 configuration of the Sample Carousel.

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MODULE 6: CALIBRATION

4. Select the return arrow.


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 only place a checkmark (;) by either the
Patient or Calibration option. The other option is
automatically deselected.
Example: The RUN OPTIONS screen has a checkmark
(;) by the Calibration option and Set 1 configuration is
selected. If the Operator selects the Patient option, the Cal-
ibration option is no longer selected.
If the blank (_______) Calibration option is selected, then
only patient samples can be loaded in the Sample Carou-
sel and calibrators can only be loaded in the Calibrator/
Control Carousel. The System then allows both the Cali-
bration and the Patient options to be selected.
• The assays last selected and saved 5. Select <Order> to the right of the Calibration option. The
are highlighted. Deselect, then SELECT ASSAYS FOR CALIBRATION screen is displayed.
select new ones.

Figure 6.2: SELECT ASSAYS FOR CALIBRATION Screen

6. Select the full calibration option.


7. Select the assay button for the assays to be calibrated. Individual
assays or panels may be selected.

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Calibrating an Assay

8. When all desired assays have been selected, select <OK> in the
upper right-hand corner of the SELECT ASSAYS FOR
CALIBRATION screen. The RUN OPTIONS screen is displayed.
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, Installation Procedures and
Special Requirements of the AEROSET System
Operations Manual for information on calibration
configuration.
NOTE: To run quality control after calibration, place a
checkmark (; ;) in the box to the left of the QC after Calib
option by touching the box. Controls run automatically
after calibration for the assays selected to calibrate. Also,
select the checkbox under the desired QC levels.
9. Select <Save> in the right-hand column of the RUN OPTIONS
screen to save the calibration order. A confirmation dialog window
is displayed.

Figure 6.3: Save Confirmation Dialog Window

10. Select <OK>.


11. Select <Cancel> on the RUN OPTIONS screen to exit the screen
without starting the run.

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MODULE 6: CALIBRATION

Loading the Calibrators


Show MCC’s 1. Select <Cal/Control> in the Information Access Area. The
• A lot change in calibrators will have CALIBRATOR/CONTROL screen is displayed. The calibrators
a corresponding change in values. required to perform the selected assays are highlighted with a green
• Point out the need to use AEROSET line under the Calibrator Name on each button.
values.
• MCC Calibrators expire 7 days after
opening.

Figure 6.4: CALIBRATOR/CONTROL Screen

NOTE: If the QC after Calib option has been selected, the


required QC samples are highlighted with a yellow line
under the QC name on each button.
2. Pipette 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
Calibrator/Control Carousel.
3. Load the calibrators in the carousel positions defined on the
CALIBRATOR/CONTROL screen.

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Calibrating an Assay

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 Calibration Run


1. Select <RUN> from the Action Area of the Main Display to display
the RUN OPTIONS screen.
2. Confirm that the Calibration option is still selected.
3. Select <Start> to initiate the run.

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MODULE 6: CALIBRATION

System-Initiated Calibration
When the AEROSET System determines that a calibration is required at
the time a patient run is initiated and the Calibration option is not
selected on the RUN OPTIONS screen, the System displays a screen to
inform the Operator of this condition. The Operator must determine if
the calibration is required, based on anticipated or current samples to be
processed.
Procedure for System-Initiated Calibration
1. Select <Start> in the RUN OPTIONS screen to initiate a run. The
System determines that a calibration is required, and a screen is
displayed indicating which calibrations are required.
2. Select <OK>. The SELECT ASSAYS FOR CALIBRATION
screen is displayed. Four options are available.
3. Select the desired option:
Option Description
<OK> All suggested calibrations and automatic
calibrations are performed.
<Cancel> No displayed calibrations or automatic
calibrations are performed.
NOTE: Selecting <Cancel> does NOT
prevent the AEROSET System from
running. <Cancel> refers only to the
Calibration option being displayed.
<DSelect> All assays are deselected. Only automatic
calibrations are performed.
NOTE: After selecting <DSelect> the
Operator must then select <OK>.
Manual Selection Select or deselect the desired assay(s). All selected
calibrations and automatic calibrations are
performed.
4. The Operator must load any necessary calibrators.

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Calibration Review

CALIBRATION REVIEW
• Go to Activity and complete the After calibration is performed, the AEROSET System verifies the
Procedures and Loading the calibrator results by comparing them to the assay parameter
Calibrators portions. Return to lecture specifications defined on the Calibration page of the Assay
with Calibration Review.
Configuration screen.
• Remind to check QC after cal in Run
Options. The AEROSET System software requires one valid calibrator replicate
• Uses actual absorbance from 1 rep, per required level to compute a curve, unless a greater number is
average absorbance from 2 reps; for 4
or 5 reps it will throw out low and
specified in the assay-specific Package Inserts.
high, and average remaining.
NOTE: Refer to the System 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 the calibration results are within the assay
parameter specifications, the calibration passes. The assay button text in
the ASSAYS screen is green.
If a System error occurs or if the calibration results fall outside the assay
parameter specifications the following occurs:
• The assay button text in the ASSAYS screen is yellow.
• A Calibration Error Code is displayed in the ASSAY STATUS
screen and Error Log.
• The Result Error Code CAL is displayed in the RESULT screen for
any patient sample run after the failed calibration.

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MODULE 6: CALIBRATION

To review calibration curves (passed or failed) and any associated


Calibration Error Codes, perform the following steps:
1. Select <Assays> in the Information Access Area. The ASSAYS
screen is displayed.

Figure 6.5: ASSAYS Screen

2. Select the desired assay name on the screen. The ASSAY STATUS
screen is displayed.

Calibration
Information

Figure 6.6: ASSAY STATUS Screen

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Calibration Review

ASSAY STATUS Screen


• No intercept used since it always draws The Calibration Information portion of the ASSAY STATUS screen is
a line through 0. shown below.
2. Absorbance Values 3. Factor calculated
4. Calibrator
(C1 - C8 are corrected for each portion of
Concentration
1. Calibration for reagent blank) the curve
Graph

8. Scrolls between
the current,
previous, and
stored calibration
curves

5. Calibration Error
Code Display Area

6. Date and time the 9. Select to view the


7. Date and time the calibration
calibration expires current calibration
was performed
curve

Figure 6.7: Calibration Information Area of the ASSAY STATUS


Screen

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MODULE 6: CALIBRATION

Area Text/Field Description


1 Graph Displays the actual calibration curve.
Blue = Current
Gray = Previous
Pink = Stored
2 Abs This column displays the measured absorbance (or
absorbance change) of the blank and the 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 This column displays the calculated factor for each
section of the curve.
Factor = 1 ÷ Slope
4 Conc This column displays the calibrator concentration
configured in the CALIBRATOR/CONTROL screen.
5 Calibration Error This area displays any Calibration Error Codes
Code associated with the displayed calibration curve.
6 Calibration This area displays the date and time that the calibration
Expiration expires.
NOTE: The text “Automatic Calibration”
displays next to this field when an automatic
calibration is scheduled.
7 Calibration Date This area displays the date and time that the calibration
was performed.
NOTE: This date and time is only updated when
a full calibration is performed.
8 Scroll Buttons These buttons scroll between the current, previous, and
stored calibration curves.
9 CUR This button is selected to view the current calibration
curve.

NOTE: When “*******” is displayed 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 be displayed in this field is 7
(including the negative sign and decimal point).

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Calibration Review

Viewing the Previous Calibration Curve


To compare the current calibration curve data with the previous
calibration curve data, perform the following steps.

1. Select the button on the lower right-hand corner of the


Calibration Information area of the ASSAY STATUS screen.
2. The data from the previous calibration curve are displayed in the
Abs and Factor areas. Both the previous and the current calibration
curve graphs are displayed. The date and time the previous
calibration was performed is displayed in the lower right-hand
corner of the Calibration Information area. The previous calibration
curve and the date and time performed text are gray. The current
calibration is blue.
NOTE: The Conc area displays currently configured
values from the Calibrator/Control screen.

3. To return to the current calibration data, select the button or


the button on the lower right-hand 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 there is a current calibration
curve without an error code. A current calibration curve
with any other error code, e.g., FAC or MON, does not
revert to a previous status.

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MODULE 6: CALIBRATION

Viewing Stored Calibration Curves


Calibration data can be stored in the Stored Calibration Summary file. If
the calibration data is not saved to the Stored Calibration Summary, it is
not available for display on the Assay Status screen.

NOTE: For information about saving calibration data to the


Stored Calibration Summary, refer to the CALIBRATION
SUMMARY screen section in this Module.

To view the stored calibration curves, perform the following steps:

1. Select on the lower right-hand corner of the Calibration


Information area of the ASSAY STATUS screen.
2. The absorbance data and curve from the previous calibration curve
are displayed.

3. Select .
4. The absorbance data and curve of the most recent stored calibration
curve are displayed. The date and time the stored calibration was
performed are displayed in the lower right-hand corner of the
Calibration Information area. The stored calibration curve and the
date and time performed are pink.

5. Continue to select to scroll through all stored calibration curves


(up to 31 can be stored) from the most recent to the earliest
performed.

6. Select to scroll back through to the most recent calibration, or


select to return to the current calibration data.

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Calibration Review

Viewing Calibration Details


For most Abbott AEROSET assay applications, each calibrator is
analyzed three times. The median value is used to calculate the
calibration curve. To view all three absorbance values measured for each
of the calibrators (or mV values for ICT™ assays), perform the
following steps:
1. Select <Calib> in the right-hand column of the ASSAY STATUS
screen. The Calibration Details screen is displayed.
NOTE: This screen can also be accessed by selecting
<Detail> in the CALIBRATION SUMMARY screen.

• Scroll back through stored curves in


assay status screen to view the actual
absorbance values for each point on
the graphs.

Figure 6.8: Calibration Details Screen

2. The absorbance values measured for all the replicates are displayed
on the top half of the Calibration Details screen. The values
displayed have not been corrected for the reagent blank.
NOTE: The bottom half of the Calibration Details screen
displays the stored average data from the CALIBRATION
SUMMARY screens. The graph shows the absorbance of
the stored calibrators. The default view is the blank (BLK)
calibrator. Other calibrator levels may be selected from the
list to the right of the graph. The CALIBRATION
SUMMARY screen is discussed in the next section of this
Module.
NOTE: If the current curve was replaced with a previous
or stored curve, no absorbance values display.

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MODULE 6: CALIBRATION

CALIBRATION SUMMARY Screen


• Use arrow buttons to show Blank to Cal The CALIBRATION SUMMARY screen displays the data from the
8 on spreadsheet. last calibration performed for all assays. Data from a calibration may be
added to a stored average. To view the Calibration Summary data, select
<Cal Summary> in the Information Access Area. The CALIBRATION
SUMMARY screen is displayed.
Calibrator Abs or Absorbance Change Factor/Slope

Concentration

Figure 6.9: CALIBRATION SUMMARY Screen

NOTE: When “*******” is displayed 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 be displayed in this field is 7
(including the negative sign and decimal point).

The current (last calibration performed) calibration data are displayed.


The absorbance and factors of the reagent blank, as well as the
absorbance and factors of all the calibrators, are displayed for
photometric assays. The button can be used to view calibrator levels
not currently displayed.

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Calibration Review

The text color indicates the calibration status:

Color Status
Black OK
Pink Pending or calibration curve expiration date exceeded
Brown Failed

NOTE: To access the Calibration Details screen for an assay,


highlight the assay name and select <Detail>.

To view the date and time that each calibration was performed, select
<Dates> in the right-hand column. The calibration dates are displayed.

Figure 6.10: CALIBRATION SUMMARY Screen

To return to the view of the calibration data, select <Cal Data> from the
right-hand column.

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MODULE 6: CALIBRATION

Saving Calibration Data to the Stored Average


If desired, the current calibration data can be added to the stored average.
Up to 31 curves can be stored. An average of the calibration absorbance
data can be maintained. The SD, CV, and range of the absorbance data
are also calculated. To save data to the stored average perform the
following steps:

NOTE: The System status must be READY to perform 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 [↓] on the keyboard.
• 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-hand column.
2. Select <Average> in right-hand column of the CALIBRATION
SUMMARY screen. A confirmation dialog window is displayed.

Figure 6.11: Average Confirmation Dialog Window

3. Select <OK>. The selected data are added to the stored average.
NOTE: The Operator must ensure that calibration data are
not added to the stored average more than once.

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Calibration Review

Viewing the Stored Calibration Data


To view the stored calibration statistics, select <Stored> in the right-
hand column of the CALIBRATION SUMMARY screen.

Figure 6.12: CALIBRATION SUMMARY Screen, Stored


Calibration Data

The following information is displayed for each calibrator level:


• Conc (concentration)
• Mean
• SD (standard deviation)
• CV (coefficient of variation)
• Range
• N (number)
NOTE: Assay-specific stored calibration averages can be
viewed on the Calibration Details screen accessed by
selecting <Detail> in the CALIBRATION SUMMARY
screen or by selecting <Calib> in 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.

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MODULE 6: CALIBRATION

Deleting Calibration Curve Data

Deleting the Previous Calibration Data


When a calibration for an assay is complete and the factors are
calculated, the AEROSET System compares the factors of the new and
the 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.

NOTE: The System status must be READY to perform this


procedure.

1. Select <Cal Summary> in the Information Access Area. The


CALIBRATION SUMMARY screen is displayed.
2. Select the assay for which the previous calibration curve is to be
deleted by selecting the assay name.
3. Select <Del Prev> in the right-hand column. A confirmation dialog
window is displayed.

Figure 6.13: Delete Confirmation Dialog Window

4. Select <OK>. The previous calibration curve data are deleted.

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Calibration Review

Deleting the Stored Average Data


To delete the stored average data for an assay, perform the following
procedure:

NOTE: The System status must be READY to perform this


procedure.

1. Select <Cal Summary> in the Information Access Area. The


CALIBRATION SUMMARY screen is displayed.
2. Select <Stored> in the right hand column of the CALIBRATION
SUMMARY screen. The stored averages are displayed.
3. Select the assay for which the stored average data are to be deleted
by selecting the assay name.
4. Select <Delete> in the right-hand column. A confirmation dialog
window is displayed.

Figure 6.14: Delete Confirmation Dialog Window

5. Select <OK>. The stored average calibration data are deleted.

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MODULE 6: CALIBRATION

Printing Calibration Summary Information


Printing the Current Calibration Summary
To print a report of the current calibration summary data, perform the
following procedure:

NOTE: This report prints the information from both the Data
and Dates screens of the CALIBRATION SUMMARY screen.

1. Select <Cal Summary> in the Information Access Area. The


CALIBRATION SUMMARY screen is displayed.
2. Select <Print> in the right-hand column of the CALIBRATION
SUMMARY screen. A confirmation dialog window is displayed.

Figure 6.15: Printer Confirmation Dialog Window

3. Select <OK> to print the report.

Printing the Stored Calibration Summary


• Complete the Calibration Review To print a report of the stored calibration summary data, perform the
portion of the activity after this following procedure:
section.
1. Select <Cal Summary> in the Information Access Area. The
CALIBRATION SUMMARY screen is displayed.
2. Select < Stored> in the right-hand column of the CALIBRATION
SUMMARY screen. The stored averages are displayed.
3. Select <Print> in the right-hand column of the CALIBRATION
SUMMARY screen. A confirmation dialog window is displayed.

Figure 6.16: Print Confirmation Dialog Window

4. Select <OK> to print the report.

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Activity

ACTIVITY

Introduction
In this exercise, you will order calibrations, load the samples, and review
the calibration curves upon completion.

Objectives
Upon completion of the Calibration Activity, you will be familiar with:
• Ordering a full calibration
• Ordering QC to run automatically after calibration
• Loading calibrators and controls
• Reviewing and printing calibration data
• Deleting calibration curves

Necessary Materials

• Instructor will need to get Iron/Mg


Reagents:
Calibrators, MCC’s, and QC • Albumin, ALT, AST, Calcium, Creatinine, Glucose, Phosphorus,
material from the refrigerator.
Total Protein, Urea, and Iron
Depending on when activity is done,
may also need ICT Calibrators.
Other:
• Abbott Multiconstituent Calibrators
• Abbott Iron/Magnesium Calibrators
• Quality Control Material

Procedure
1. Select <RUN> in the Action Area.
2. Place a checkmark (;) in the box to the left of the Calibration
option by touching the box.
3. Place a checkmark (;) in the box to the left of the QC after Calib
option by touching the box.
4. Select the Checkbox under the desired QC levels.

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MODULE 6: CALIBRATION

5. Touch the Drop-down list box next to Calibration and select the Set
1 option.
6. Select the return arrow to close the list.
7. Select <Order> to the right of the Calibration option.
8. Ensure that the calibration type of Full is selected.
9. Select the following assays: AlbP, ALT, AST, Glu, Iron, TP, Phos,
Crea, Urea, and CA.
10. When all desired assays have been selected, select <OK>.
11. Select <Save> in the right-hand column.
12. Select <OK> on the confirmation dialog window.
13. Select <Cancel> on the RUN OPTIONS screen to exit the screen
without starting the run.

Loading the Calibrators


1. Select <Cal/Control> in the Information Access Area.
2. Load the highlighted calibrators and controls in the indicated
positions on the Calibrator/Control Carousel.
3. Select <Set 1>.
4. Load the highlighted calibrators in the indicated positions on the
Sample Carousel.
5. Select <OK> to exit the CALIBRATOR/CONTROL screen.
6. Select <RUN> in the Action Area.
7. Confirm that the Calibration (with Set 1) and QC after Calib options
are still selected.
NOTE: Ensure that the Patient option is not selected.

8. Select <Start> to initiate the run.

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Activity

Calibration Review
When the calibrations are complete, perform the following:
1. Print a copy of the current calibration summary.
2. Delete the previous calibration curve data for Phosphorus.
3. Select the current calibration data for all assays calibrated and copy
to the stored average.

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MODULE 6: CALIBRATION

REVIEW QUESTIONS
1. What are the six Calibration Methods (Math Models) currently used
for calibration on the AEROSET System?
a. ______________________________________________
b. ______________________________________________
c. ______________________________________________
d. ______________________________________________
e. ______________________________________________
f. ______________________________________________

2. What is the most common Calibration option used on the Aeroset?

3. Does the AEROSET System require you to calibrate an assay, if the


controls are out of range?

4. On the CALIBRATOR/CONTROL screen, how does the System


indicate that a calibrator is required for a run?

5. On what screen is the calibration curve displayed?

6. Why might a previous calibration curve need to be deleted?

7. Name the two screens in which an Operator can view an average of


the absorbance values measured for a calibrator.
a. ______________________________________________
b. ______________________________________________

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Review Questions

8. How does the AEROSET System indicate that a calibration has


failed?

9. How does the AEROSET know to use calibrators loaded in the


Sample Carousel?

10. Can the AEROSET run a calibration using calibrators from set 1, 2,
or 3 and patient samples at the same time?

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ANSWERS
1. a. Factor
b. Multi-point linear
c. Spline
d. Use Factor/BLK
e. 1-Point Linear
f. Abs
2. Full
3. No, it does not require calibration, but the Operator may choose to
calibrate the assay, if necessary, to resolve the concern.
4. There is a green line below the calibrator name on the button.
5. The ASSAY STATUS screen
6. If the factors from the new and the previous curve vary by more than
the defined FAC limit %.
7. a. CALIBRATION SUMMARY (stored)
b. Calibration Details
8. The assay button text in the ASSAYS screen is yellow, a Calibration
Error Code is displayed in the ASSAY STATUS screen, the CAL
Error Code is displayed in the RESULT screen, the calibration
information in the CALIBRATION SUMMARY screen is
displayed in brown, and a calibration error code is displayed in the
Error Log.
9. The Set 1, Set 2, or Set 3 option must be selected in the RUN
OPTIONS screen.
10. No

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Summary

SUMMARY
In this Module, you have:
• Demonstrated a basic knowledge of kinetic rate and end-point
assays, and the different calibration methods
• Listed the available calibration options
• Stated the reasons for calibrating the AEROSET System
• Ordered calibrations and loaded the calibrators
• Identified ‘‘the screens and reports used to review calibration results
• Identified Calibration Error Codes associated with calibration
failure

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NOTES

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MODULE 7: QUALITY CONTROL

MODULE 7:
QUALITY CONTROL

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CONTENTS
Page

Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Ordering Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
Reviewing QC Results . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-12
Deleting QC Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-27
Printing QC Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-28
QC Summary Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-35
Westgard QC Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-40
Review Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-42
Answers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-44
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-45

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Objectives

MODULE 7: QUALITY CONTROL

OBJECTIVES
Upon completion of this Module, you will be able to:
1. Identify the different methods of running QC and how to order them
2. Load QC samples and initiate the run
3. Identify the screens and reports used to review QC results
4. State the Westgard QC Rules and how the System uses them to
evaluate QC results

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MODULE 7: QUALITY CONTROL

INTRODUCTION
This Module presents the different methods of running Quality Controls
on the AEROSET System. Information is included to explain how to
review QC data and how the AEROSET System can monitor QC data
and apply the Westgard Rules.

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Ordering Controls

ORDERING CONTROLS
To order controls, perform the following procedure:
1. Select <RUN> in the Action Area. The RUN OPTIONS screen is
displayed.

Figure 7.1: RUN OPTIONS Screen

2. Place a checkmark (;) in the box to the left of the QC option


desired by touching the option. There are four options available and
the following table defines these options.

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When this option


The controls are measured... Additional Settings
is selected...
QC after Calib Automatically after calibration, to verify Select desired QC levels,
1
the calibration curve. QC1 - QC8.
Start-QC Prior to the patient samples, at the • Enter the number of replicates,
beginning of the run. 1 - 50 allowed in the Data
Entry field next to Reps.
NOTE: Start-QC will only be run • Select <Order> to display the
if it is selected when the System SELECT ASSAYS FOR
2
Status is READY. START-QC screen. Select the
assays for control
measurement.
• Select desired QC levels,
QC1 - QC8.
Interval-QC At specified count (sample) or time • Select <Order> to display the
intervals defined on the QC tab of the SELECT ASSAYS FOR
Assay Configuration screen. INTERVAL-QC screen.
Select the assays for control
measurement.
NOTE: The count (sample)
interval refers to the total number • If As Needed is selected, QC
of samples aspirated, not the total measurement for an assay is
number of samples run for that performed at the defined
assay. intervals only when that assay
was ordered for at least one
3 Refer to Section 2, Installation
patient sample during the
Procedures and Special
interval.
Requirements of the AEROSET
System Operations Manual for • If As Needed is NOT selected,
details on QC configuration. QC measurement is performed
at the defined intervals even if
the assay was not run on a
patient sample during the
interval.
• Select desired QC levels,
QC1 - QC8.
End-QC After the patient samples are completed Select desired QC levels,
4 and for each assay run on the patient QC1 - QC8.
samples since the last READY status.

3. Select the checkbox (; ;) 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.

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Ordering Controls

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.

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 Rule Configuration in Section 2,


Installation Procedures and Special Requirements of the
AEROSET System Operations Manual 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.

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Loading the Controls


When loading controls, the following conditions must be met:
• Ensure there is sufficient sample volume to run the 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-hand column of the RUN OPTIONS
screen to save the QC order. A confirmation dialog window is
displayed.

Figure 7.2: Save Confirmation Dialog Window

2. Select <OK>.
3. Select <Cancel> on the RUN OPTIONS screen to exit the screen
without starting the run.
4. Select <Cal/Control> in the Information Access Area. The
CALIBRATOR/CONTROL screen is displayed.

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Ordering Controls

5. The controls required to perform the selected assays are highlighted


with a yellow line under the control name on each button.

Figure 7.3: CALIBRATOR/CONTROL Screen

6. Remove the Calibrator/Control Carousel cover.


7. Pipet the highlighted controls into sample cups and load into the
positions indicated on the CALIBRATOR/CONTROL screen.
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, when seated properly, does not rotate.
9. Select <OK> to exit the CALIBRATOR/CONTROL screen.
10. Select <RUN> in the Action Area. The RUN OPTIONS screen is
displayed.
11. Confirm that the QC option is still selected.
12. Select <START> to initiate the run.

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When the Carousel Sampler is Busy Sampling


1. Select <PAUSE> in the Action Area. The RUN OPTIONS screen
is displayed.
2. Select <Pause> in the right-hand column of the RUN OPTIONS
screen to pause sampling.
WARNING: If a diluted sample has been dispensed, the
! Sample Arm may move after the status has changed to
PAUSE. Wait 20 seconds before accessing the Sample
Carousel area.
WARNING: The AEROSET System does not stop the
! movement of the Reagent 2 Probes, ICT™ Unit, Mixers, or
Cuvette Washers so the Assay Read Times are not affected.
CAUTION: The System completes the dispensing
! and mixing of any sample and reagent already
aspirated. Confirm the PAUSE status in the System
Status Area and confirm that the R1 Indicator on
the LUI (Local User Interface) is illuminated before
proceeding.
3. Wait for the System status to change to PAUSE, then place the
controls (in sample cups) in the Calibrator/Control Carousel in
the specified positions.
4. Select <UNPAUSE> in the Action Area. The RUN OPTIONS
screen is displayed.
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.
5. Ensure that the desired control option is selected in the RUN
OPTIONS screen.
NOTE: Start QC is not performed if the run is restarted
using the PAUSE and UNPAUSE commands.
6. Select <Unpause> in the right-hand column of the RUN
OPTIONS screen to resume sampling.
NOTE: The Operator can select <UnpsCrsl> which
unpauses the carousel only.

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Ordering Controls

When the Carousel Sampler has Completed Sampling


1. Confirm that the Sample Carousel Movement Indicator Light is not
illuminated or blinking.
2. Place the controls (in sample cups) in the Calibrator/Control
Carousel in the specified positions.
3. Select <PAUSE> in the Action Area. The RUN OPTIONS screen
is displayed.
4. Select <Pause> in the right-hand column of the RUN OPTIONS
screen to pause sampling.
5. Wait for the System status to change to PAUSE.
6. Select <UNPAUSE> in the Action Area. The RUN OPTIONS
screen is displayed.
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.
7. Ensure that the desired control option is selected in the RUN
OPTIONS screen.
NOTE: Start QC is not performed if the run is restarted
using the PAUSE and UNPAUSE commands.
8. Select <Unpause> in the right-hand column of the RUN
OPTIONS screen to resume sampling.
NOTE: The Operator can select <UnpsCrsl> which
unpauses the carousel only.

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REVIEWING QC RESULTS
When QC results are completed with no errors, the results are saved and
the QC statistics are adjusted accordingly. The QC values and statistics
can be viewed in 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 forms. 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 in the ASSAY STATUS screen.

NOTE: Refer to Section 2, Installation Procedures and Special


Requirements of the AEROSET System Operations Manual
for details on QC configuration.

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Reviewing QC Results

ASSAY STATUS and Levey-Jennings Graph Screens


1. Select <Assays> in the Information Access Area. The ASSAYS
screen is displayed.
2. Select an assay name. The ASSAY STATUS screen is displayed.

Quality Control
Information

Figure 7.4: ASSAY STATUS Screen

The Quality Control Information portion of the ASSAY STATUS screen


is shown below:

Figure 7.5: Quality Control Information Area of the ASSAY


STATUS Screen

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The following table defines each column of the QC information:

Column Description
The QC level (QC1 - QC8) defined in the Assay
QC Configuration screen, QC page and the QC name as
defined in the CALIBRATOR/CONTROL screen
The expected concentration defined in the
Conc CALIBRATOR/CONTROL screen

The actual mean of the QC data


Mean

The actual standard deviation of the QC data


SD

The actual coefficient of variation of the QC data


CV

The actual range (Max value - Min value) of the QC data


Range

The number of QC data points for the level (Max = 450)


N

The value of the last QC sample run for the level.


NOTE: An “L” or “H” Flag is displayed next to
Last the result if the value is outside the defined 2 SD
range, and a Result Error Code is displayed if an
error occurred for the result.
Any Westgard Rule violation is displayed in this column;
QC Rule the highest priority rule displays.

NOTE: The mean, SD, CV, range, and N are calculated using all
data points except those excluded in 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.

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Reviewing QC Results

Levey-Jennings Graph
To display the Levey-Jennings Graph screen, select the QC button in
the right-hand column of the ASSAY STATUS screen.

Figure 7.6: Levey-Jennings Graph Screen

The statistics and graphs are displayed for the first 4 QC levels defined.
To view data for additional control levels select on the screen.
Statistics for all QC values included in the QC files are displayed in the
left-hand section for each level (up to 450 values). The following table
describes the information displayed in the left-hand section:

Item Description
The level defined on the QC page of the Assay
QC1...QC8
Configuration screen
The QC name defined in the CALIBRATOR/
(QC Name)
CONTROL screen
Mean The actual mean of the QC data
SD The actual standard deviation of the QC data
CV The actual coefficient of variation of the QC data
Range The actual range (Max value - Min value) of the QC data
N The number of QC data points for the level (Max = 450)

NOTE: The mean, SD, CV, range, and N are calculated using all
data points except those excluded in the Levey-Jennings Details
screen.

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A Levey-Jennings Graph is displayed for each level in the center


section of the screen.

On the left-hand side of the graph the mean, +1 SD, +2 SD,


-1 SD, and -2 SD values are displayed. The mean value is defined in the
CALIBRATOR/CONTROL screen. The SD value is defined on the
QC page of the Assay Configuration screen.
The graph area displays the ±1 SD range in green, the ±2 SD range in
yellow and the ±3 SD range in red. Each accepted QC value within the
±3 SD range is displayed as a blue or gray dot on the graph. If the value
is greater than ±3 SD, it is displayed 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.
Values can be excluded from the calculation of the 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 subsection.

The dates displayed on the top 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.

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Reviewing QC Results

Levey-Jennings Details
To display information about a point on the Levey-Jennings Graph,
perform the following steps:
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-
hand section of the selected level is colored blue, and a point on the
graph is also highlighted in blue.

Figure 7.7: Levey-Jennings Graph Screen

2. The following information for the highlighted point is displayed at


the bottom of the Levey-Jennings Graph screen:
• Result value (an “L” or “H” Flag is displayed next to the
result if the value is outside the defined 2 SD range, and a
Result Error Code is displayed if an error occurred for the
result)
• Date and time completed
• Result #/total # of QC values for the level
To view information about another point on the graph, select the point by
touching it or press the left arrow and right arrow keys on the keyboard
to scroll left and right.

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• Details let you exclude a point—will The result value of a point on the Levey-Jennings Graph can be
not actually delete the value. displayed on the Details dialog window. Also, on the Details dialog
• A specified date range can be selected window, a result can be excluded from the calculation of the QC
to calculate and print QC Statistics for statistics. To display the Details dialog window for a point, perform the
QC Summary, Levey-Jennings Graph,
and QC Data List reports. The date
following steps:
range is selected on the QC Summary 1. Select the point for which details are desired.
screen.
2. Select <Details> on the right-hand side of the
Levey-Jennings Graph screen. The Details dialog window is
displayed.

Figure 7.8: Details Dialog Window

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Reviewing QC Results

3. The following information is displayed on the Details dialog


window:
Item Description
The result value of the selected QC point
NOTE: An “L” or “H” Flag is displayed
Value next to the result if the value is outside the
defined 2 SD range. A Result Error Code is
displayed if an error occurred for the result.
Min The lowest result value in the QC data
Max The highest result value in the QC data
The completion date and time of the selected QC
Date
point
Mean The actual mean of the QC data
SD The actual standard deviation of the QC data
CV The actual coefficient of variation of the QC data
The User Code of the Operator logged onto the
Operator AEROSET System when the selected QC value was
completed
The selected QC value can be included or excluded
Include/Exclude in the calculation of the QC statistics. Excluded
values are not deleted.
A comment can be selected from the drop-down list
Comment
box or added for a QC value
Excluded by Message displays with pink text when a QC value is
Date Range outside the selected QC date range

NOTE: The mean, SD, and CV are calculated using all


data points except those excluded in the Levey-Jennings
Details screen.
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.

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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 7.9: Comment Drop-down List Box

6. Select <OK>. The selected comment is added to the Details dialog


window.
7. To configure a new comment, select <Comment> on the Details
dialog window. The Comments dialog window displays.

Figure 7.10: 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.

9. Enter the new comment; up to 30 alphanumeric characters can be


entered for each comment.

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10. Select <OK>. The Comment Edited dialog window displays.

Figure 7.11: Comment Edited Dialog Window

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.

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QC Data List
The QC data for an assay are displayed in a list format on the QC Data
List screen. To display the QC Data List screen, select <DataList> on
the right-hand side of the Levey-Jennings Graph screen. The QC Data
List screen displays.
2 3 4

Figure 7.12: QC Data List Screen

All the QC values for the first 3 QC levels display. To view additional
QC values for the displayed levels or to view additional levels, select the
arrow buttons in the right-hand column of the screen . The following
information displays for each value:

Item Description
1 Result = result value
2 R = “L” or “H” 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 are displayed with pink text.

NOTE: The mean, SD, and CV are calculated using all data
points except those excluded on the Levey-Jennings Details
screen.

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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 7.13: QC SUMMARY Screen

The QC statistics for the first level (defined for each assay) display. To
view the statistics for other levels defined, select to scroll right.

NOTE: When the QC SUMMARY screen is displayed, an


Update button appears on the right-hand 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 add the
new results to the QC SUMMARY screen.

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The following information displays for each QC level on the QC


Summary screen.

Column Description
Assay The assay name
The name of the QC selected for the level on QC page of
QC1...QC8
the Assay Configuration screen
The expected concentration defined in CALIBRATOR/
Conc
CONTROL screen
Mean The actual mean of the QC data
SD The actual standard deviation of the QC data
CV The actual coefficient of variation of the QC data
Range The actual range (Max value - Min value) of the QC data
The number of included QC data points for the level (Max
N
= 450)
The value of the last QC sample run for the level
NOTE: An “L” or “H” Flag is displayed next to
the result if the value is outside the defined 2 SD
Last range. A Result Error Code is displayed 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.

NOTE: The mean, SD, CV, range, and N are calculated using all
data points except those excluded in the Levey-Jennings Details
screen.

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Accessing the Levey-Jennings Graph Screen from the QC SUMMARY Screen


The Levey-Jennings Graph screen for an assay can be accessed from
the QC SUMMARY screen by performing the following steps:
1. Select the line that displays the QC statistics of the assay desired.
2. Select <LJ Graph> in the right-hand column. The Levey-Jennings
Graph screen for the selected assay is displayed.

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.

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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.

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Deleting QC Data

DELETING QC DATA
• Highlight that this procedure will The System holds 450 data points per level for each assay. When the
delete all QC data from all QC levels maximum capacity is reached, the System deletes on a first in/first out
from an assay. basis.
This procedure is used to manually delete all QC data from all QC levels
for an assay. A single QC value cannot be deleted, but can be excluded
from the calculation of the QC statistics. To delete all QC data for an
assay, perform the following procedure:

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. The QC


SUMMARY screen is displayed.
2. Select the assay for which all QC data will be deleted by touching
the assay name.
3. Select <Delete> in the right-hand column. A confirmation dialog
window is displayed.

Figure 7.14: Delete Confirmation Dialog Window

4. Select <OK>. All QC data from all QC levels defined for the assay
are deleted.

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MODULE 7: QUALITY CONTROL

PRINTING QC RESULTS
There are three different report types available for printing QC data. For
examples of these QC reports, refer to Appendix B of the AEROSET
System Operations Manual.

Report Type Description


Levey-Jennings Graph Each value is printed with the date completed and
is then plotted on the Levey-Jennings Graph that
prints vertically down the page. All included points
are plotted with an “*” and excluded values are
plotted with a “+”. The QC name and statistics are
printed at the top of the report.
NOTE: An “L” or “H” Flag is displayed
next to the result if the value is outside the
defined 2 SD range. A Result Error Code is
displayed 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.
NOTE: An “L” or “H” Flag is displayed
next to the result if the value is outside the
defined 2 SD range. A Result Error Code is
displayed if an error occurred for the result.
A “D” is displayed for excluded values.
QC Summary Prints the statistics displayed on the QC
SUMMARY screen.

NOTE: If... Then


Enable Control Reports is selected Reference ranges printed
for Printer B (Form 2) on the report are patient
and the Reference Ranges option reference ranges, not QC
on the PAGE SETUP screen is ranges.
selected for Form 2

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Printing QC Results

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 Main
Display. The ASSAYS screen displays.
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.

Figure 7.15: Levey-Jennings Graph Screen

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.

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MODULE 7: QUALITY CONTROL

4. Select <Print> in the right column of the screen. The Print Options
dialog window displays.

Figure 7.16: Print Options Dialog Window

5. Select one of 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 configured date
Range range are printed.

NOTE: To print a date range, select either <Only Selected


Assay> or <All Assays> in addition to <Only Selected Date
Range>.

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Printing QC Results

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 in the
QC reports.
NOTE: When selected, this option
overrides individual QC selections.
QC1–QC8 Individual levels of QC can be selected to
print in the QC reports.
9. Select <OK>. The Print QC Data List confirmation dialog
window displays.

Figure 7.17: Print QC Data List Confirmation Dialog Window

10. Select <OK>.

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MODULE 7: QUALITY CONTROL

QC Data List Report


Use the following instructions to print the QC Data List report.
1. Select <ASSAYS> in the Information Access Area of the Main
Display. The ASSAYS screen displays.
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 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 7.18: QC Data List Screen

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Printing QC Results

5. Select <Print> in the right column of the screen. The Print Options
dialog window displays.

Figure 7.19: Print Options Dialog Window

6. Select one of 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 configured date
Range range are printed.
NOTE: To print a date range, select either <Only Selected
Assay> or <All Assays> in addition to <Only Selected
Date Range>.
7. Select one of the following sort options:
Option Description
Assay All QC report(s) print for one assay before
printing the 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.

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MODULE 7: QUALITY CONTROL

8. Select the QC Data List report category from the following list:
• QC Summary
• Levey-Jennings Graph
• QC Data List
NOTE: One, two, or all three reports can be selected.

9. Select the QC level to be included in the report:


Option Description
All QC All configured QC levels are printed in the
QC reports.
NOTE: When selected, this option
overrides individual QC selections.
QC1–QC8 Individual levels of QC can be selected to
print in the QC reports.
10. Select <OK>. The Print QC Data List confirmation dialog
window displays.

Figure 7.20: Print QC Data List Confirmation Dialog Window

11. Select <OK>.

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QC Summary Report

QC SUMMARY REPORT
Use the following instructions to print a report of the QC summary
statistics.
• Print an example of
Levey-Jennings graph 1. Select <QC Summary> in the Information Access Area of the
and QC Data List Main Display. The QC SUMMARY screen displays.
reports.
2. Select <Print> in the right column of the screen, or select the
desired assays then select <Print>. The Print Options dialog
window displays.

Figure 7.21: Print Options Dialog Window

3. Select one of the following print options:


Option Description
Only Selected Assay Only QC statistics for the assay(s) selected
on the QC SUMMARY screen are printed.
All Assays QC statistics for all configured assays are
printed.
Only Selected Date Only QC statistics for the configured date
Range range are printed.
NOTE: To print a date range, select either <Only Selected
Assay> or <All Assays> in addition to <Only Selected
Date Range>.
4. Select one of the following sort options:
Option Description
Assay All QC report(s) print for one assay before
printing the 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.

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MODULE 7: QUALITY CONTROL

5. Select the QC summary report category from the following list:


• QC Summary
• Levey-Jennings Graph
• QC Data List
NOTE: One, two, or all three reports can be selected.

6. Select the QC level to be included in the report:


Option Description
All QC All configured QC levels are printed in the
QC reports.
NOTE: When selected, this option
overrides individual QC selections.
QC1–QC8 Individual levels of QC can be selected to
print in the QC reports.
7. Select <OK>. The Print QC Data List confirmation dialog
window displays.

Figure 7.22: Print QC Data List Confirmation Dialog Window

8. Select <OK>.

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QC Summary Report

Exporting QC Data
QC data and statistics can be exported from the Levey-Jennings Graph
screen to a floppy disk. The information is saved on the floppy disk in a
.csv format. A file in this format can be opened and viewed in most
commercially available PC spreadsheet programs (Microsoft Excel,
Lotus 1-2-3 programs, etc.).

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.
1. Select <QC Summary> in the Information Access Area of the
Main Display. The QC SUMMARY screen displays.
2. Select <Export> in the right column of the screen, or select the
desired assays then select <Export>. The Export Options dialog
window displays.

Figure 7.23: Export Options Dialog Window

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MODULE 7: QUALITY CONTROL

3. Select one of the following export options:


Option Description
Only Selected Assay Only QC statistics for the assay(s) selected
on the QC SUMMARY screen are exported.
All Assays QC statistics for all configured assays are
exported.
Only Selected Date Only QC statistics for the configured date
Range range are exported.

4. Select one of the following sort options:


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 created for
Assay 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
All QC All configured QC levels are printed in the
QC reports.
NOTE: When selected, this option
overrides individual QC selections.
QC1–QC8 Individual levels of QC can be selected to
export.
7. Select <OK>. The Export QC Data dialog window displays.

Figure 7.24: Export QC Data Dialog Window

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QC Summary Report

8. Enter a file name, up to 8 characters.


9. Insert a disk in the floppy disk drive of the SCC computer.
NOTE: Ensure FLOPPY DISK displays in the Drive field.

10. Select <OK>. The Export QC Data confirmation dialog window


displays.

Figure 7.25: Export QC Data Confirmation Dialog Window

11. Select <OK>. QC data are transferred to the floppy disk.


12. Remove the disk from the floppy disk drive when the export process
is complete.

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MODULE 7: QUALITY CONTROL

WESTGARD QC RULES
• Total of 10 rules; we use 6. The AEROSET System can be configured to evaluate the QC results
• The ones that use QC for one level with the Westgard QC Rules.
are employed here.
• The remaining cover multiple The following rules are available:
levels.
• 12S rule is the threshold. When Rule Description
configured, this rule must be
12S One control value exceeds ± 2 standard deviations.
violated before any other rules will
be looked at. 13S One control value exceeds ± 3 standard deviations.
22S Two consecutive control values for one level exceed ± 2
standard deviations.
R4S The difference between two consecutive control values
exceeds 4 standard deviations.
41S Four consecutive control values for one level exceed ± 1
standard deviation.
10x Ten consecutive control values for one level lie on one side
of the mean.

The Operator can select which rules will be used for evaluation on a
System-wide basis. Each assay can be configured to use the selected
rules or to not use any rules. Different rules cannot be configured for
each assay.

NOTE: For each data point, only the highest priority rule will be
displayed. The priority is shown in the above table.

If the Westgard Rules will be used for evaluation, the expected mean and
SD must be defined for each assay to be evaluated.

NOTE: Refer to Section 2, Installation Procedures and Special


Requirements of the AEROSET System Operations Manual
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.

If the System determines that a control value violates a Westgard Rule,


an Error Log Message is generated. The violated rule is also displayed on
the ASSAY STATUS screen in the QC Rule column.

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Westgard QC Rules

• Instruct class to perform Multi-Skills NOTE: QC data are checked first against the 1-2 SD rule, if
activity from Module 12. enabled. If the data are within 2 SD, the data are considered
• Customer Classroom Only—Instructor “in-control” and are not evaluated against the other QC rules. No
should fill out a pick list.
Westgard rule Error Log Message appears on the ASSAY
• Review issues encountered in Multi-
Skills Activity. STATUS screen when the data are considered “in-control”.

An example of a Westgard Rule violation is shown below:

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MODULE 7: QUALITY CONTROL

REVIEW QUESTIONS
1. List the four QC ordering options in the RUN OPTIONS screen.
a. __________________________________________________
b. __________________________________________________
c. __________________________________________________
d. __________________________________________________

2. How does the System indicate that a QC sample is required for a


run?

3. Starting from the Main Display, list the software steps to view the
Levey-Jennings QC graph for the Calcium assay.
a. __________________________________________________
b. __________________________________________________
c. __________________________________________________

4. How does the System indicate that a Westgard Rule has been
violated?

5. What are the three report types for printing QC data?

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Review Questions

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MODULE 7: QUALITY CONTROL

ANSWERS
1. a. QC after Calib
b. Start - QC
c. Interval - QC
d. End - QC
2. A yellow line is displayed on the button in the
CALIBRATOR/CONTROL screen.
3. a. Select <Assays>.
b. Select <Calc>.
c. Select <QC>.
OR
a. Select <QC Summary>.
b. Highlight Calcium.
c. Select <LJ Graph>.
4. An Error Log Message is generated, and the violated rule with the
highest priority is displayed in the QC section of the ASSAY
STATUS screen.
5. a. Levey-Jennings Graph
b. QC Data List
c. QC Summary

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Summary

SUMMARY
In this Module, you have:
• Identified the different methods of running QC and how to order
them
• Loaded QC samples and initiated a run
• Identified the screens and reports used to review QC results
• Stated the Westgard QC Rules and how the System uses them to
evaluate QC results

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MODULE 7: QUALITY CONTROL

NOTES

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MODULE 8: CONFIGURATION

MODULE 8:
CONFIGURATION

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MODULE 8: CONFIGURATION

CONTENTS
Page

Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Log On Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
System Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9
Print Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19
Host Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-21
Panel Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-23
System Configuration Activity . . . . . . . . . . . . . . . . . . . . 8-24
Assay Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-26
Review Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-43
Answers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-44
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-45

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Objectives

MODULE 8: CONFIGURATION

OBJECTIVES
• Instructor should set up host Upon completion of this Module, you will be able to:
configuration for each
1. Create User Codes and Passwords with different access levels for
instrument.
logging onto the System
2. Define System Configuration options
3. Define Print options
4. Describe the Host Interface options
5. Create assay panels
6. Describe the configuration necessary to define and run an assay
7. Configure the System to evaluate QC results and apply the
Westgard QC Rules

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MODULE 8: CONFIGURATION

INTRODUCTION
Configuration enables you to customize the AEROSET System to meet
your laboratory requirements.
In this Module, you are introduced to the configuration screens and
options. The AEROSET System Operations Manual will be used to
perform the configuration procedures.

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Log On Password

LOG ON PASSWORD
The Log On level determines access to screens and functions. The
ability to “view” or “view and edit” for each level is described in the
• user/user level is following table:
“aeroset/user” on training
instruments user super
System Function
• super/super level is View Edit View Edit
“abbott/aeroset” on Printer A and B NO NO YES YES
training instruments configuration
• user code of guest and daily Result Report Page Set-up NO NO YES YES
numerical password allow System configuration NO NO YES NO
log on at extra level. Hardware options (Bar Code
Numerical password is the Readers, External Robotics,
same as used with IMx® ICT™)
and AxSYM®. Host communication NO NO YES YES
• Must know the password to configuration
delete the log on once it Resetting the Error Log YES Level 2 and 3 YES YES
has been created. No way only
to look up passwords.
Calibration curve data YES NO YES System
• User code is limited to 6 configuration
characters. dependent
• No password is required for Deleting QC YES NO YES YES
user level access. Patient demographics in the NO NO YES System
• Show how to delete RESULT screen configuration
passwords. dependent
Calibrator/Control Carousel NO NO YES YES
• Operator can be viewed in
configuration
database at the end of the
spreadsheet. Reagent configuration NO NO YES YES
Assay counts YES NO YES NO
• 50 total passwords can be
configured. Assay configuration NO NO YES YES

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MODULE 8: CONFIGURATION

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.

Figure 8.1: 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 Keyboard
If User Code Is…
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.

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Log On Password

5. The USER REGISTRATION dialog window displays.

Figure 8.2: 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. <Add> 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.

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MODULE 8: CONFIGURATION

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.

Figure 8.3: 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 Keyboard
If User Code Is…
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.

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System Configuration

SYSTEM CONFIGURATION
The System Configuration options are configured on two screens:
• RUN OPTIONS screen

Figure 8.4: RUN OPTIONS Screen

• SYSTEM CONFIGURATION screen

Figure 8.5: SYSTEM CONFIGURATION Screen

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MODULE 8: CONFIGURATION

RUN OPTIONS Screen


The following System Configuration options are defined on the RUN
OPTIONS screen:

Option Description
Priority Patient samples in the Sample Carousel are prioritized
over samples loaded on the FastTrack™ Sampler
when this option is selected. The default is ON
(selected).
Auto Return: Auto Return The System can be configured to automatically return
• Will make the sample samples identified for rerun to the Sample Arm. When
carousel turn 1 extra time configured, all reruns are presented to the Sample Arm
regardless of whether they are:
• When using this function
with FastTrack, the end of • Manually ordered reruns
run carrier (blue) must be • Auto Reruns
used. The default is OFF (unselected).
• Everything that precedes Car’r Allows the Operator to define the carrier
that carrier will be checked numbers that are used when ordering samples
for reruns. to run in the Sample Carousel. Refer to
Ordering Patient Samples in the Sample
• If position on the FastTrack
Carousel in Section 5, Operating Instructions
has already been used, and
of the AEROSET System Operations
another sample in that
Manual.
position needs a rerun, the
Auto Return feature will The default settings are:
NOT engage. See Rerunning • A = 1000
Results on page 5-94 of the • B = 2000
• C = 3000
• D = 4000
• E = 5000
• F = 6000

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System Configuration

SYSTEM CONFIGURATION Screen


The following System Configuration options are defined on the
SYSTEM CONFIGURATION screen:

Option Description
Auto Rerun When selected, the System automatically reorders assays
for those samples that meet user specified criteria (Rerun
Auto Rerun: Rules), on an “assay by assay” basis. To activate the Auto
• To get System to automatically Rerun feature, this option must be selected and assay-
locate and aspirate reruns specific Rerun Rules defined on the Assay Confguration
without operator screen. The default is OFF.
intervention, auto return must NOTE: Samples are not automatically returned
be ON. to the sample arm unless the Auto Return option
is selected on the RUN OPTIONS screen.
NOTE: For information about configuration of
Rerun Rules, refer to the Assay Configuration
section in this Module.
Run Suspend Allows the Operator to configure how long the System
Time waits (in minutes) once a run is complete. While in the
SUSPEND status, an abbreviated run initialization is
used (when the next run is initiated). The default setting
is 10 minutes.
Enable Cal Edits Allows the Operator to edit read values
(i.e., absorbances) for calibrators in the ASSAY
STATUS screen. The default setting is ON.
NOTE: If configured to ON, only a Log On
level of “super” can edit calibrator values.
Smart Sampling When selected, the System determines the assay sampling
order to maximize throughput, and minimize the number
of empty cuvettes. The default is ON.
For information about configuration of the
sampling sequence, refer to System
Configuration in Section 2, Installation
Procedures and Special Requirements of the
AEROSET System Operations Manual.
Saving Mode When selected, the System minimizes sample usage. The
over-aspiration volume is aspirated once for the same
sample, when aspirating more than one assay, rather than
each time an assay 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.

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MODULE 8: CONFIGURATION

Option Description
1st Carrier for No-Bar Coded 1st Car’r for No- Allows configuration to restrict samples without bar code
Samples: Bcode Smpls (No- labels to specific sample carriers. This option must be
Example: Segregate non-bar coded sam- Bar Coded configured to run samples without bar code labels or with
ples in the Sample Carousel where they Samples) damaged bar code labels. The default setting is 1000.
are more easily tracked. NOTE: Refer to System Configuration (1st
Car’r for No-Bcode Smpls) in this section for
detailed information on available settings and
options.
Example: If set to 5000, the System would allow samples
without bar code labels to be run only in sample carriers
with IDs 5000 or higher.
CAUTION: Reuse of sample carrier positions equal to
! or greater than the setting configured 1st Car’r for
No-Bcode Smpls may result in duplication of
previously assigned sample IDs and generation of
incorrect results. Refer to Loading Patient Samples in
Section 5, Operating Instructions of the AEROSET
System Operations Manual for additional
information about loading samples on the
FastTrack™ Sampler or Sample Carousel.
Cycle Time (0.1): Cycle Time (0.1) Allows the Operator to enter the length of time, in tenths
• (super password) Would never of seconds, for each quarter turn of the Reaction
have any reason to edit this Carousel. The default is 45 (x 0.1 sec = 4.5 seconds).
with Abbott assays. CAUTION: The Abbott applications were determined
If this is changed, you would see multiple ! using a cycle time of 4.5 seconds. If this option is
edited, the timing and results of all assays would be
assay concerns, mainly rate assays affected.
(enzymes) due to their calculation as a
rate of change in absorbance/time. Save by When selected, orders are tracked in the database by
Car’r ID carrier and position. The default setting is ON.
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
! configured ON, a manually entered sample ID is not
verified against the patient bar code label on the tube.
NOTE: If samples have bar code labels and the
Sample Bar Codes option is configured ON, the
Save by Car’r ID option must be OFF
(deselected).

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System Configuration

Option Description

Alphanumeric Allows the Operator to configure for numeric or


Sample ID alphanumeric Sample ID. The default setting is ON.
• When set to OFF, the Sample ID is numeric only and
increments automatically on the ORDER
Bar Code Length-Skip-ID: SAMPLES screen. In addition, the leading empty
spaces are filled by zeros to complete the configured
• Minimum bar code length=6, ID character field (configured in the Bar Code
if alphanumeric sample ID is Length-Skip-ID field).
not ON. With it on, limit is 4.
• When set to ON, the Sample ID is alphanumeric,
• Won’t skip middle or end does not auto-increment and does not fill in empty
characters. spaces with zeros.
• 20-0-20 cover many bar codes.
Bar Code The bar code length can range from 4 to 20 characters.
• Doesn’t have to be defined in Length-Skip-ID Allows configuration of:
order to run bar coded
samples. • Bar code length = total length of the bar code
• Skip = number of characters to skip at the beginning
• Only need if you want to
of the bar code (bar code information that is not part
confirm characters when fixed
of the sample ID)
digits is defined.
• ID = number of characters allowed in the sample ID.
• Will define the number of
The default setting is 20-0-20, which indicates up to
leading zeros in a numeric bar
20 characters are in the total length of the bar code
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.
Example: If 8-1-7 is entered, the total length of the bar
code is 8 characters, the first character is skipped
because it is not part of the Sample ID, and the length of
the Sample ID is 7 characters.
Auto Order When selected, the System automatically performs
Calculations calculations configured when the constituent assays are
ordered. The default setting is ON.
Auto Validate When selected, the System automatically validates
patient results in the database if no Result Error Codes
were generated. If a sample has a processing code of “I”
(Incomplete) due to an error or rerun, the Operator must
review and validate the results. The default setting is
OFF.

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MODULE 8: CONFIGURATION

Option Description

Enable Demog. When selected, the Operator may edit patient


Edits in RESULT demographics in the RESULT screen. The Operator
must have a Log On level of “super”. The default
setting is ON.
Characters for L/ Allows the Operator to select single characters for the
H Flags Low and High Result Flags. The default setting is L and
H.
NOTE: These flags appear next to patient
samples when they are below or above the
configured reference range. These flags also
Sample Bar* Codes: appear next to QC samples when they are
outside the defined 2 SD range.
• Cannot have Save by Carrier ID
ON if this is ON. Sample Bar* Allows configuration that requires the System to match
• Must have one or the other Codes sample bar codes with the entered sample ID. When
selected. selected, orders are tracked in the database by sample
ID. The default setting is OFF.
NOTE: If the Save by Car’r ID option is
selected, the Sample Bar Code option must be
OFF (deselected).
NOTE: This option can only be edited by an
Fixed Digit*: Abbott Representative.
• This is not check sum and must
Fixed Digit* When selected, the System requires the same number of
be used in conjunction with bar
characters for every sample bar code. The number of
code length-Skip-ID.
characters expected is defined in the Bar Code Length-
Skip-ID option. The default setting is OFF.
Reagent Bar* When selected, the System reads reagent bar code
Codes labels. A scan is initiated by selecting <RGT SCAN> in
the Action Area. 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 Section 2,
Installation Procedures and Special
Requirements of the AEROSET System
Operations Manual.
NOTE: This option can only be edited by an
Abbott Representative.

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System Configuration

Option Description

Rgt (reagent) Lo Allows the Operator to configure the System to


Alert (#T) alert the 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
for an individual Reagent Cartridge through the
REAGENTS screen.
External Robotics*: Refer to Reagent Configuration in Section 2,
• If checked with no external Installation Procedures and Special Requirements
robotics, it will alarm of the AEROSET System Operations Manual.
continuously.
External Used with Laboratory Automation Systems. The default
Robotics* is OFF.
NOTE: This option can only be edited by an
Abbott Representative.
ICT* Allows the System to use the ICT™. The default is ICT.
NOTE: This option can only be edited by an
Abbott Representative.
ScreenSaver Allows the Operator to define the number of minutes the
(min) System permits for no screen interaction prior to
initiating the screensaver. The default setting is 10
minutes.
NOTE: External screen savers cannot be loaded
on the AEROSET System.
SmplSeq Allows override of the System default for assay
(Sampling 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.

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MODULE 8: CONFIGURATION

Option Description

SmplSeq • In the desired order, repeat the preceding step for all
(Sampling assays.
Sequence), • To remove an assay from the sampling sequence,
Continued 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.

*The Operator is required to cycle the System power after editing any of
these options.
To configure the RUN OPTIONS and SYSTEM CONFIGURATION
screens:
• Select <RUN> in the Action Area to display the RUN OPTIONS
screen.
• Then, select <SysCfg> to display the SYSTEM
CONFIGURATION screen.
For information about configuration of the System Configuration
options, refer to System Configuration in Section 2, Installation
Procedures and Special Requirements of the AEROSET System
Operations Manual.

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System Configuration

Audible Alert Options


The audible alert options on the SYSTEM CONFIGURATION screen
• Audible Alert-will come allow the Operator to define audible alerts when the following occurs:
with default alarms for
each. • An Error Message is generated
• To test sound, touch • All samples have been aspirated from the Carousel Sampler
button to the left.
• All samples have been aspirated from the FastTrack™ Sampler
• There is a volume control
on the back of the CPU. • A STAT sample has been aspirated
(yellow button)
• The System goes into the SUSPEND status
• The System goes into the READY status
To configure audible alarms on the SYSTEM CONFIGURATION
screen:
• Select <RUN> in the Action Area to display the RUN OPTIONS
screen.
• Then, select <SysCfg> to display the SYSTEM
CONFIGURATION screen.
For information about configuration of the audible alert options, refer to
Audible Alerts in Section 2, Installation Procedures and Special
Requirements of the AEROSET System Operations Manual.

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MODULE 8: CONFIGURATION

Westgard Rule Options


• QC Rules-Westgard Rules The following Westgard Rules are available to evaluate QC data:
defined here. Must decide on
an assay-by-assay basis whether AEROSET QC Westgard
Description
Rule Display Rule
to use the configured rule set.
1-…R-2 12S One control value exceeded ± 2 standard
• Cannot have different rule sets
deviations.
for different assays.
1-…R-3 13S One control value exceeded ± 3 standard
• Point out the 12S is “in deviations.
control.” Won’t generate an
2-…R-2 22S Two consecutive control values for one
error log message.
level exceed ± 2 standard deviations on
• Final slot of “out of control” is the same side of the mean.
linked to a generic Westgard 2-;R-4 R4S The difference between two consecutive
Rule error message. control values exceeded 4 standard
• To disable a specific rule, you deviations.
must place a 0 in for NUM. 4-…R-1 41S Four consecutive control values for one
• When “R” is checked, the QC level exceeded ± 1 standard deviation.
values are compared against 10 - … R - 0 10X Ten consecutive control values for one
each other. If not checked, the level lie on one side of the mean.
QC values are compared
against the mean. NOTE: When the checkbox (5) next to R of the QC rule is
• Can change rule or move one selected, QC values are compared against each other. If not
from out of control to in selected, QC values are compared against the mean.
control.
• If you change a rule, the error To configure Westgard Rules on the SYSTEM CONFIGURATION
code attached would not screen:
change.
• Select <RUN> in the Action Area to display the RUN OPTIONS
screen.
• Select <SysCfg> to display the SYSTEM CONFIGURATION
screen.
• Select <QC Rule> to display the QC Rules screen.
For information about configuration of the Westgard Rules options, refer
to System Configuration in Section 2, Installation Procedures and
Special Requirements of the AEROSET System Operations Manual.

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Print Options

PRINT OPTIONS
Printer Configuration
• Pass out copies of Report Printer A should be designated to print Form 1, and Printer B used to
Forms. print Form 2.
• 1st option asks to clear printer The following options are available for Printer A and Printer B
buffer (select config). configuration:

Option Description
Result Printing Three options are available:
Mode • Request: Reports only print manually by request.
• Valid: Reports print automatically when all results are
validated.
• All: Reports print automatically when the results are
completed. The Default for Printer A is All and Printer
B is Request.
• The Multi-Print options are Wait Time for This option is not used for the default report forms
selected on the Database Multi-Print Feature configured in the System.
screen. (Print/Page Setup) (sec)
Enable Calibration When selected, this form prints automatically according
Reports* to the Result Printing Mode.
Enable Control When selected, this form prints automatically according
Reports to the Result Printing Mode.
Enable Patient When selected, this form prints automatically according
Reports to the Result Printing Mode.
*This option is available for Printer A configuration only.

NOTE: If... Then


Enable Control Reports is selected Reference ranges printed
for Printer B (Form 2) on the report are patient
and the Reference Ranges option reference ranges, not QC
on the PAGE SETUP screen is ranges.
selected for Form 2

To configure Printer A and B:

• Select or in the Action Area.


• Select <Config>.
For information about configuration of Printer A and Printer B, refer to
Printer Icons in Section 2, Installation Procedures and Special
Requirements of the AEROSET System Operations Manual.

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MODULE 8: CONFIGURATION

Sample Results Report Configuration


• With 2 printers-Form The AEROSET System is supplied with two different configured sample
1=A printer and Form 2=B result reports:
printer.
• Form 1 is a compact report that prints the sample results, minimum
• With 1 printer-will print long
sample, and patient identification information. Multiple samples are
Form 2 to printer A when you
printed on each page.
have patient reports
deselected on A and selected • Form 2 is a full page report for each sample and prints the sample
on printer B. results, lab address, and all patient information.
• Recommend saving forms in
The sample result report forms require editing:
library.
• Free text-Define for address. • To add a new assay
• Must define free text using To edit these forms:
free text button on right side.
• Select <Database> in the Information Access Area.
• Form 1 or 2=moves you
from one form to the other. • Select <Print> in the right-hand column.
• Show how to add an assay • Select <Page Setup>.
to page setup.
For information about editing the page set-up of Form 1 and 2,
• Edit/Dil 1/Dil 2 can now be refer to DATABASE Screen in Section 2, Installation
printed on the Sample
Procedures and Special Requirements of the AEROSET
Report.
System Operations Manual.

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Host Configuration

HOST CONFIGURATION
• Offline=A green line through Sample information can be communicated through a Host computer via
computer icon. two methods:
• Computer icon usually blue • Host Download
screen with white box.
• Can temporarily suspend • Host Order Query
communication if you are The following options are configured on the ONLINE
connected and are getting CONFIGURATION screen:
errors.
• When you say “OK to Option Description
suspend”, computer icon goes Protocol Type The types include Offline (default), Type 1, Type 1’, Type
to red screen, black box. 1”, Type 2, Type 3, Type 4, and Type 5.
• When touching icon in the For information about the Protocol Types, refer
suspend mode, prompt says to the AEROSET Host Interface Specifications.
“OK’ then “Resume”. NOTE: When a Host system is not available, the
protocol type should be set to Offline.
Result Determines when the completed results are sent to the
Transmission Host. The options are:
Mode • Request: manual transmission of results specified by
the Operator. All results selected are sent, including
reruns, replicates, and results with Result Error Codes.
REQUEST is the default setting.
• Valid: validated results only
• All: all results are sent as they are completed including
reruns, replicates, and results with Result Error Codes.
Transmit QC When selected, the QC results are transmitted to the Host.
Results
Use Transmission When selected, a check digit is accepted with message
Check Digit transmission to and from the Host to confirm transmission
accuracy. When deselected, only messages are accepted.
Master Control A time is defined which is the minimum amount of time
Time (sec) that the System may remain the master during Host
communications. The default is 6 seconds.
Maximum Wait A time period is defined which is the maximum amount of
Time (sec) time that the System waits for an expected
communication before generating an error. The default
setting is 6 seconds, with a 0-99 second range. However,
greater than 20 seconds is not recommended due to
negative impact to throughput. If no response is detected
during this period, an error is generated in the Error Log.

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MODULE 8: CONFIGURATION

Option Description
• Transmission Interval (sec) - Transmission The delay time between data messages is defined.
Enters a delay from instrument Interval (sec) The default setting is 0 seconds. The acceptable interval is
for a slow host. 0-99 seconds.
RS-232C Config Allows selection of the Data Bits (L), Stop Bits (S) and
Parity (NP = no parity, EP = even parity, and OP = odd
parity).
The baud rate is also selected. The default settings are 8L-
1S-NP and 9600.
To configure the Host communication:

• Select in the Action Area.


• Select <Config>.
For information about configuration of the on-line communication, refer
to Host Configuration in Section 2, Installation Procedures and Special
Requirements of the AEROSET System Operations Manual.
For further information about the AEROSET System Host Interface
Communications, refer to the AEROSET Host Interface
Specifications.

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>.

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Panel Configuration

PANEL CONFIGURATION
• Reinforce must first select an The Panel Configuration option allows the Operator to pre-define groups
empty button before of assays that can be ordered at one time. Up to 100 assay panels can be
configuring a panel. configured on the AEROSET System. The panels are displayed in the
• Panels are displayed on Order Calibration QC and Order screens as well as the Order Samples
Samples screen in the order screen.
entered.
To configure assay panels:
• Each panel must have a unique
number as an identifier. • Select <Database> in the Information Access Area.
• For convenience on these • Select <Order>.
instruments, we’ve started
numbering at 101 since • Select <PanelCfg>.
there are 100 available For information about configuration of assay panels, refer to
assay buttons. Panel Configuration in Section 2, Installation Procedures and
• Show how to clear panel. Special Requirements of the AEROSET System Operations
Manual.

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MODULE 8: CONFIGURATION

SYSTEM CONFIGURATION ACTIVITY

Introduction
Instructor will need to change the follow- In this activity, you will customize the AEROSET System to run in a
ing prior to this activity: Host Query Mode with bar coded samples. You will learn to edit a
• Log on as extra/ex_tra or
sample result print form and edit printer options.
guest/daily numerical
password.
• Save by Carrier ID-Off,
Sample Bar Codes-On.
• Set up Host Configuration for
simulator

Objectives
• Select “Clear Database” on Upon completion of the System Configuration Activity, you will be
SHUTDOWN screen. familiar with:
• Cycle instrument power. • Creating a User Code/Password
• When able to, Log on as • Editing the Printer A and B configuration
abbott/super
• Editing the on-line communication configuration
• Entering an address and editing the assay display order in a sample
result report

Necessary Materials

• Will need a set of bar coded Reagents:


tubes for each instrument,
from refrigerator. • ICT™ Diluent, Albumin, ALT, AST, Calcium, Creatinine,
Glucose, Phosphorus, Total Protein, and Urea

Other:
• Bar coded sample tubes

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System Configuration Activity

Procedure
• Point out that printer 1. Create the following “super” level User Code/Password:
configuration steps in the
• big / tex
activity change default form
from Form 1 to Form 2. 2. On the Printer A Configuration screen make the following edit:
• Deselect the Auto-Print Patient Reports option
3. On the Printer B Configuration screen make the following edits:
• Result Printing Mode > All
• Deselect the Auto-Print Control Reports option
• Select the Auto-Print Patient Reports option
4. Edit the following on-line communication options to:
• Protocol Type > Type 1’
• Result Transmission Mode > All
• Deselect the Transmit QC Results option
• Deselect the Use Transmission Check Digit option
• RS-232 Config > 8L-1S-NP and 9600
5. On the PAGE SETUP screen add IgG assay to Form 2. Place the
assay below the “pack” line in the first available space.
6. Create the following panel:
• Panel Name - Day QC
• Panel Number - 250
• Assays - Na, K, Cl, Glu, Ca, AlbP, TP
7. Load all the bar coded tubes into carriers and initiate the run by
selecting <RUN> in the Action Area. Ensure that only the Patient
option is selected and select <Start>.

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MODULE 8: CONFIGURATION

ASSAY CONFIGURATION
• Steps for multiple Assay Assay configuration includes the following procedures:
Configuration (can also be
used for single):
• Reagent Configuration
1.Load reagents and scan bar codes. • Calibrator Configuration
2. Configure Cals and Controls • Control Configuration
names.
• Assay Parameter Configuration
3. Enter calibrator values and
control means in the Cal and
Control screen.
4. Configure all pages of Assay file.

Reagent Configuration
No reagent configuration is required for bar code labeled reagent
cartridges supplied by Abbott Laboratories. Select <RGT SCAN> from
the Action Area of the Main Display after the reagent cartridges have
been loaded.
For reagent cartridges without bar code labels, configuration is
performed by selecting <Reagents>, and then selecting the button for the
position in which the reagent will be loaded. The following information
is defined:

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Assay Configuration

Field Description
• First three fields are required. Reagent Name Allows entry of up to 7 characters. 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 Type This is a required field. One of the following is selected:
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 Size The size of the cartridge is selected to allow for correct
estimation of the remaining tests. This is a required field.
Exp Date Reagent expiration.
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 # Reagent lot number.
Cartridge # Cartridge serial number, if available.
Rgt (Reagent) An alert will occur when the reagent cartridge volume is
Lo Alert less than the %volume or number of tests defined in this
field.
NOTE: If this option is used, it overrides the alert
configured through System configuration.
For information about configuration of reagents, refer to Reagent
Configuration in Section 2, Installation Procedures and Special
Requirements of the AEROSET Systems Operations Manual.

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MODULE 8: CONFIGURATION

Unit Configuration
Unit configuration parameters influence reagent loading. The three
parameters are:
• Priority on Rgt Bar Code
• Multiple Rgt Ctgs
• Reagent Link
These parameters can only be edited by an Abbott Representative. The
following chart explains the parameters and their impact on Reagent
loading.

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

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Assay Configuration

Unit Configuration Description of Parameter Rules for Loading Reagents: If Parameter Is...
Parameter ON OFF ON OFF
Multiple Rgt Ctgs Allows for multiple A maximum of two If two or more New reagent cartridges
(e.g., more than two) sets of reagent cartridges with the should be placed in a
reagent cartridges per cartridges/pairs per same reagent name are higher numbered position
assay to be placed on assay will be used by loaded in a Reagent than cartridges already
the System. the System. Supply Center at the onboard. A maximum of
same time, new two reagent cartridges/
cartridges must be pairs per assay are utilized
loaded in a higher by the System.
NOTE: If the numbered position
Multiple Rgt Ctgs than the cartridges
option is configured already onboard. The
ON, the Reagent Link System first aspirates
option is not from the cartridge in
functional— i.e., R1 the lowest number
and R2 cartridges are position. An Error Log
not linked. 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.

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MODULE 8: CONFIGURATION

Unit Configuration Description of Parameter Rules for Loading Reagents: If Parameter Is...
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 pair (R1/R2) to be should be placed in a
linked by position. A and R2 are utilized used first must be higher numbered position
maximum of two sets independently. placed in the lowest than cartridges already
of reagent cartridges available position. onboard. R1 and R2 are
per assay are allowed. After the reagent pair utilized independently.
The lowest R1 position is linked by the
is linked to the lowest System, the Operator
R2 position and the must verify it is
highest R1 position is always utilized as a
linked to highest R2 pair.
position. Each time a
reagent scan is
performed, the System
relinks reagents
! CAUTION:
according to position. The R1/R2 pair must
be placed onboard at
the same time.

NOTE: If the
Multiple Rgt Ctgs
option is configured
ON, the Reagent Link
option is not
functional— i.e., R1
and R2 cartridges are
not linked.

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Assay Configuration

Calibrator/Control Configuration
• Calibrators are defined in positions on the Calibrator/Control
Carousel or in the Sample Carousel.
• Controls can only be configured in the Calibrator/Control
Carousel.
• The calibrator or control name and the target values are defined in
the CALIBRATOR/CONTROL screen accessed by selecting
<Cal/Control> from the Information Access Area.
NOTE: If creating a new assay, calibrator and control
targets cannot be configured until the assay parameter
configuration is complete.
For information about configuration of calibrators and controls, refer to
Calibrator/Control Configuration in Section 2, Installation
Procedures and Special Requirements of the AEROSET Systems
Operation Manual.

Assay Parameter Configuration


• Do not go into detail The Assay Configuration screen is accessed by selecting <Assays> in
for all fields of every the Information Access Area. From the ASSAYS screen select the
page. desired assay name (for editing an assay file) or an empty button (for
• Highlight items such as creating a new file).
Linear High and Linear
This section will briefly describe the pages of the Assay Configuration
Low, dilution protocols,
screen for photometric assays. For further information and details, refer
reagents, and rerun
rules. to Assay Configuration in Section 2, Installation Procedures and
Special Requirements of the AEROSET Systems Operation Manual.
• Remind customer that
for all Abbott assays,
this information is
loaded from a disk. For
more information, see
the OPS Manual. This
will be discussed further
in AEROSET Advanced
class.

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MODULE 8: CONFIGURATION

Outline Page

Figure 8.6: Assay Configuration Screen, Outline Page (Photometric


End-point Assay)

Figure 8.7: Assay Configuration Screen, Outline Page (Photometric Rate


Assay)

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Assay Configuration

NOTE: The fields described in the following chart are used for
all assays unless noted.
Field Description
Assay Name The assay name can be up to 6 characters in length.
Assay Number An assay # (range 1 - 9999) must be defined and must be unique for every assay.
(Facilitator Note: See NOTE: If a Host computer is connected, the assay number must match the one used
AEROSET System Opera- by the Host.
tions Manual for additional
information on editing an
assay number.)
A Line / B Line Assays are defined to run in the A-Line (outer) or B-Line (inner).
NOTE: This field is not used for ICT, Indices, and Calculated assay files.

Quantitative Ranges Title of section.


• Allows the Operator to enter text (up to 6 characters) to replace the numerical result when
reporting values below the Min value entered. The default is blank.
• Min and Max value The values in these fields 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.
• Panic-L and Panic-H The values in these fields cause the PVL (Panic Value Low) and PVH (Panic Value High)
Result Error Codes to occur. This field is user defined.
• L-Reference-H The values in these fields represent the reference range of the assay.
NOTE: Each laboratory should establish its own reference range.

• Allows the Operator to enter text (up to 6 characters) to replace the numerical result when
reporting values above the max value entered. The default is blank.
• L-Linear Range-H The values in these fields represent the reportable range of the assay and cause the LL
(Linear Low) and LH (Linear High) 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 adjusted for the sample dilution.

Qualitative Ranges Title of section.


• Upper Row Allows the Operator to enter thresholds for each qualitative result. Values must be entered in
concentration or activity.
• Lower Row Allows the Operator to enter up to six (6) characters to be reported for each range.

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MODULE 8: CONFIGURATION

Base Page

Figure 8.8: Assay Configuration Screen, Base Page (Photometric End-


point Assay)

Figure 8.9: Assay Configuration Screen, Base Page (Photometric Rate


Assay)

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Assay Configuration

NOTE: The fields described in the following chart are only used
for photometric assays unless noted.

Field Description
Reaction Mode Allows selection of the following options: END UP, END DOWN, RATE
UP, and RATE DOWN.
Wavelength Allows the selection of the primary wavelength and secondary wavelength
(Primary/Secondary) (if required).
Main Read Time The range of read points that will be used for result calculation.
Flex Read Time For rate assays only, to define a range of read points that are earlier than the
Main Read Time, to be used for the calculation of higher results.
AbsMaxVar (End-point The acceptable variation allowed for the absorbance readings within the
assays only) Main Read Time.
Linearity% (Rate assays only) The acceptable % difference when the absorbance change of the first three
reads is compared to the last three reads of the Main Read Time.
Sample Blank Test An assay name is selected for assays with a sample blank. Blank can be a
self blank (sample and reagent) or non-self blank (user defined assay file).
Blank Read Time The range of read points that will be used for measuring the Self Blank
(Sample and Reagent). Enter the read time 1-33.
Abs Window A range of read points is defined for measuring the sample color for color
correction of the Abs Limits.
Abs Limits The expected absorbance limits during the Read Time. When measured
outside the defined limits, the System will use data from the Flex Read
Time or will generate the A#0, A#1, or A#2 Result Error Codes.
S.Vol The sample volume is defined for the Standard, Dil 1, and Dil 2 protocols.
NOTE: The sample volume for ICT™ assays is preset to 15 µL.

DS.Vol The diluted sample volume is the amount that is aspirated from the cuvette
used for onboard dilution and dispensed into a different cuvette for
analysis.
D.Vol The diluent volume is defined, if required, for the Standard, Dil 1, and
Dil 2 protocols.
W.Vol The water volume is defined when a concentrated diluent is used.
Diluent If a sample diluent is required, it is defined in the REAGENTS screen and
then selected from a Drop-down list box on the Base page.
Reagent 1 The Reagent 1 is defined in the REAGENTS screen and then selected
from a Drop-down list box on the Base page.
NOTE: The ICT™ Sample Diluent is selected as Reagent 1 for
ICT assays.
Reagent 2 The Reagent 2, if required, is defined in the REAGENTS screen and then
selected from a Drop-down list box on the Base page.

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MODULE 8: CONFIGURATION

Field Description
R.Vol The reagent volume is defined for Reagent 1 and Reagent 2 (if required).
Range is 10-345 µL.
NOTE: The reagent volume for ICT assays is preset to 345 µL.

W.Vol The water volume is defined when a concentrated reagent is used. Range is
0-345 µL.
Type # Controls dispense speed and over aspiration volumes. Range is 0 to 6; the
default setting is 0.
Refer to Type Number in Section 2, Installation Procedures and
Special Requirements of the AEROSET System Operations
Manual for details.
Reaction Check Used for immunologic reactions to evaluate a reaction for prozone
phenomenon.
Factor/Intercept The factor and intercept can be used to match results to another system.
NOTE: The factor/intercept is used for all assays except calculated
assays.
NOTE: If a value is entered, the quantitative result is corrected
and reported.
Decimal Places The number of decimal places to report for the result are defined. Range is
0-3.
NOTE: The decimal places are defined for all assays.

Units The result units are defined by selecting from the options in the Drop-down
list box. The Operator may also use the keyboard to enter a result unit not
available in the default list.
NOTE: Units are defined for all assays.

NOTE: The maximum volume of sample, reagent, and as


needed water must not exceeded 360 uL.

NOTE: Total volume of sample, reagent, and water must be at


least 160 uL to ensure proper mixing and provide adequate
volume for photometry.

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Assay Configuration

Calibration Page

Figure 8.10: Assay Configuration Screen, Calibration Page (Photometric


End-point Assay)

Figure 8.11: Assay Configuration Screen, Calibration Page (Photometric


Rate Assay)

NOTE: The fields described in the following chart are only used
for photometric assays unless noted.

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MODULE 8: CONFIGURATION

Field Description
Calib Mode The appropriate calibration curve type is selected.
Factor (for Calib Mode of If the Calibration Mode is defined as Factor, the factor is entered and used for result
Factor only) calculation.
Use Cal Factor from: (for Use If the Calibration Mode is defined as Use Factor or as Use Fac/Blk, the Operator must
Factor and Use Fac/Blk only) select the assay name of the assay calibration data that will be used.
Interval (H) The calibration interval in hours. Up to four digits can be entered.
NOTE: The calibration interval is defined for photometric and ICT™ assays.

Blank/Calib Replicates The number of replicates (up to five) for the blank and the calibrators are entered.
NOTE: The Blank/Calib Replicates are defined for photometric and ICT assays.

Extrapolation % Defines extrapolation beyond the linearity of the assay.


NOTE: This only displays for Linear, Spline, Logit-4, Logit-5, Exponent, Use
Factor, and Use FAC/BLK Calibration Modes.
Span If the Span Data check will be performed, the Operator must define the portion of the
curve to check. The absorbance difference will be checked between the blank and
defined calibrator level.
Span Abs Range If the Span Data check will be performed, the Operator must define the acceptable
absorbance difference in the defined span.
Blank Abs Range An acceptable absorbance range may be defined for the blank.
Cal Deviation The maximum absorbance variation of the calibrator replicates may be defined.
SD For non-linear approximation curves only, the sum of the absolute values of the
difference between the calculated calibration curve, and the measured values should not
exceed the value defined in this field.
BLK The water or blank is defined in the CALIBRATOR/CONTROL screen and then
selected from a Drop-down list box.
C1-C8 The calibrator is defined in the CALIBRATOR/CONTROL screen and then selected
from a Drop-down list box.

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Assay Configuration

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 is generated. The default setting is 0, range 0 to 99. If set to zero,
the FAC Limit check is not performed.
NOTE: For a manually configured assay, the FAC Limit % will default to 10.
Any assays imported from the Import Disks listed below on software version
1.02ER000 will have a FAC Limit % default of 0 and must be edited to 10.
• 4E43-02/4E43-05 Import Disk 1-50/Import Disk >50
• 4E43-08/4E43-09 Import Disk Drugs of Abuse Version 5.00
• 4E43-03/4E43-06 Import Disk Serum Proteins Version 3.0
• 4E43-04/4E43-07 Import Disk - TDM Version 4.00
Assays that are export to the AEROSET library with a defined FAC Limit % and
are subsequently imported from that library file will retain the defined value for
FAC Limit %.
NOTE: This option only displays for Linear, Spline, Exponent, Logit-4, and
Logit-5 Calibration Modes.
NOTE: The FAC Limit % was defined as 10% in all versions of software
preceding 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.
NOTE: This option only displays for Factor assays.

S.Vol The sample volume is defined for each calibrator level.


DS.Vol The diluted sample volume is the amount that is aspirated from the cuvette used for
onboard dilution and dispensed into a different cuvette for analysis.
D.Vol The diluent volume is defined, if required, for each calibrator level.
W.Vol The water volume is defined when a concentrated diluent is used.
Lot Change If automatic calibration is desired whenever a new reagent lot is used, the Operator must
select the desired calibration type from the Drop-down list box.
Ctg Change If automatic calibration is desired whenever a new cartridge is used, the Operator must
select the desired calibration type from the Drop-down list box.
Over Interval If automatic calibration is desired whenever the calibration interval has been exceeded,
the Operator must select the checkbox.
NOTE: The Over Interval option is available for photometric and ICT assays.

2-Point The calibrator used with the blank for 2-point calibration is defined.
1-Point The calibrator used for 1-point calibration is defined.

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MODULE 8: CONFIGURATION

QC Page

Figure 8.12: Assay Configuration Screen, QC Page (Photometric Assay)

NOTE: The fields described in the following chart are used for
all assays.

Field Description
Count If the Interval-QC option will be used, the number of assays between QC
runs may be defined.
NOTE: The count (sample) interval refers to the total number of
samples aspirated, not the number of samples run for that assay.
Time (min) If the Interval-QC option will be used, the amount of time (minutes)
between QC runs may be defined.
Use QC Rules Select this option to use the defined Westgard Rules.
QC1 - QC8 The control name, position and expected mean is defined in the
CALIBRATOR/CONTROL screen and then is selected from the QC
Name/Mean/Pos Drop-down list box.
SD The value equal to 1 SD for each QC level is entered.
Lot Change If automatic QC option is desired when a new lot is used, select the
checkbox. The QC levels selected on the RUN OPTIONS screen will be
run.
Ctg Change If automatic QC option is desired when cartridge changeover occurs, select
the checkbox. The QC levels selected on the RUN OPTIONS screen will
be run.

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Assay Configuration

SmartWash™ Page

Figure 8.13: Assay Configuration Screen, SmartWash Page (Photometric


Assay)

NOTE: The fields described in the following chart are only for
photometric and ICT™ assays.

Field Description
Rgt Probe Reagent interference involving the Reagent Probe is minimized.
Reagent Select the interfering reagent. Up to 16 can be defined. Entered name must match reagent name on
the Base Page for the SMARTWASH to occur.
Wash Select the wash method to wash the inside of reagent probes and mixers.
NOTE: The wash cycle is performed only one time.

Vol Enter the volume of the defined wash solution to be used. Range is 10-345 µL.
Cuvette Reagent interference involving the Reaction Cuvette is minimized.
Assay Name Select the assay that interferes. Up to 10 assays can be defined.
Wash Select the wash method to wash the inside of reaction cuvettes.
NOTE: The wash is performed only one time.

Vol Enter the volume of the defined wash solution to be used. Range is 10-345 µL.
Sample Probe When defined, the Sample Probes are washed immediately before aspirating the sample.
Wash Select the solution to be used to wash the inside of the sample probes.
NOTE: The wash cycle is only performed one time.

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MODULE 8: CONFIGURATION

Rerun Rules Page

Figure 8.14: Assay Configuration Screen, Rerun Rules Page (Photometric


Assay)
For each Result Error Code that can be generated for a result, the
Operator can define a rerun option. The options are Same, Dil 1, and Dil
2. The Auto Rerun feature must be selected in the SYSTEM
CONFIGURATION screen to activate the options defined.

NOTE: Auto Rerun is performed only one time and is


performed as a routine assay. Auto Rerun is not performed in
STAT samples.

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Review Questions

REVIEW QUESTIONS
1. What are the two levels of User Code access?

2. When creating a new User Code/Password, what must you do on the


User Registration screen to save the new information?

3. If the Sample Bar Code option is selected, what option must be


deselected?

4. If the Smart Sampling option is selected, the System maximizes


______________________ and minimizes
____________________________________.

5. What button is selected from the Main Display to configure the


System to automatically print the Sample Result Form 2?

6. What screen is used to add an assay to the Sample Result Form?

7. What Result Transmission Mode option would you select on the


ONLINE CONFIGURATION screen, to enable the System to
automatically send validated results to the Host computer?

8. From what screen is the Panel Configuration screen accessed?

9. From what screen is the Westgard Rule configuration accessed?

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MODULE 8: CONFIGURATION

ANSWERS
1. “user” and “super”
2. Select <Add> (press [Enter] if required to make <Add> appear)
3. The Save by Car’r ID option
4. Throughput, empty cuvettes
5. The Printer B icon/button in the Action Area
6. The PAGE SETUP screen, accessed by selecting <Database>,
then <Print>
7. Valid
8. The Order Samples screen, accessed by selecting <Database>,
then <Order>
9. The SYSTEM CONFIGURATION screen, accessed by selecting
<RUN>, <SysCfg>, <QC Rule>

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Summary

SUMMARY
In this Module, you have:
• Created User Codes and Passwords
• Defined System Configuration options
• Described the Host Interface options
• Created assay panels
• Described the configuration necessary to define and run an assay
• Configured the System to evaluate QC results and apply the
Westgard QC Rules

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MODULE 8: CONFIGURATION

NOTES

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MODULE 9: ICT™ UNIT

MODULE 9:
ICT™ UNIT

AEROSET® Customer Training Guide 9-1


94858-103 — July 2003
MODULE 9: ICT™ UNIT

CONTENTS
Page

Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
ICT™ Fluid Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Components of the ICT™ Unit . . . . . . . . . . . . . . . . . . . . . 9-6
Reviewing ICT™ Calibration Information . . . . . . . . . . . . 9-8
ICT™ Unit Component Replacement . . . . . . . . . . . . . . . 9-10
Activity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11
Review Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13
Answers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-14
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-15

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Objectives

MODULE 9: ICT™ UNIT

OBJECTIVES
Upon completion of this Module, you will be able to:
1. Describe the ICT™ or Integrated Chip Technology™ fluid delivery
2. Identify the components of the ICT Unit
3. View the calibration information displayed for the ICT assays
4. Successfully remove and replace the ICT Module and ICT Probe

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MODULE 9: ICT™ UNIT

INTRODUCTION
An Integrated Chip Technology™ (ICT™) is used to measure
electrolytes on the AEROSET System. This Module familiarizes you
with the components used to measure ICT assays and the ICT fluid
delivery. You will also learn how to review the ICT calibration data.

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ICT™ Fluid Delivery

ICT™ FLUID DELIVERY


• Use ICT Module demo. The following flow diagram describes the flow of the ICT sample and
• Reference Solution (Bulk— solutions, which is important to understand for troubleshooting and
behind right-front door). maintenance.

Figure 9.1: Flow Diagram of ICT Fluid Delivery

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MODULE 9: ICT™ UNIT

COMPONENTS OF THE ICT™ UNIT


• If desired, take students to the The AEROSET System measures Na+, K+, and Cl- simultaneously using
instrument and point out Integrated Chip Technology™ (ICT). ICT uses solid state Ion-Selective
components, then discuss at Electrodes contained in a single chip (ICT Module) which reduces the
desk. maintenance required.
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 the
diluted sample. The components of the ICT Unit and other components
used to measure ICT assays are described in the following table.

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 Aspiration A 1 mL syringe drive pump that aspirates samples or ICT
Pump Reference Solution into the ICT Module 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 Reference ICT Reference Solution is measured before and after
Solution each sample to create a baseline for 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 Reference A 1 mL syringe drive pump that aspirates ICT Reference
Solution Pump Solution from the bulk bottle, through the ICT Reference
Solution preheater, and into the ICT Reference Solution
cup. Once measurement is complete, this pump aspirates
the ICT Reference Solution from the cup and moves it
into the water bath/waste overflow area. (This pump is
located behind the ICT Pump access door.)
ICT™ Reference This preheater warms the ICT Reference Solution to
Solution Preheater 37°C, before it is used to fill the ICT Reference Solution
cup. (The ICT Reference Solution preheater is a narrow
metal tube located in the water bath.)
ICT™ Reference Preheated ICT Reference Solution is aspirated from this
Solution Cup cup and measured by the ICT Module. (Located beneath
the ICT Probe when the ICT Unit is in the home
position.)
Water Bath/ Waste The liquid waste from the ICT Unit and the ICT
Overflow Reference Solution cup is dispensed into this waste area,
located on the right-hand side of the Reaction Carousel.
The liquid waste is removed from the Analyzer through
the Low-Concentration Waste tubing.

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Components of the ICT™ Unit

Component Description
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 onboard
Diluent in an outer segment of Reagent Supply Center 1 (A, B,
or C) for processing. After 15 µL of sample is dispensed
into a cuvette by the Sample Probe and 345 µL of the
diluent is dispensed by the R1 Reagent Probe, the sample
and diluent are mixed together by the R1 Mixer.

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MODULE 9: ICT™ UNIT

REVIEWING ICT™ CALIBRATION INFORMATION


Calibration of the ICT assays is requested from the RUN OPTIONS
screen using the same procedure described in Module 6, Calibration. The
ICT calibrators are loaded in the Calibrator/Control Carousel in
Positions 40 and 41, and the ICT urine calibrators are loaded in Positions
38 and 39.
When the calibration is complete the calibration information may be
viewed in the ASSAY STATUS and the CALIBRATION SUMMARY
screens.

ASSAY STATUS Screen


• Discuss + and - mV readings The Calibration Information area of the ASSAY STATUS screen of the
above and below reference Na-S assay is shown below:
solution mV. 1 2 3 4
• Cals run in triplicate.
• Slope is the % of ideal
response - change in mV/time
using the Nernst Equation
(flipchart).
• Ideal = A change 61 mV/decade 5
(Natural log of concentration)
at 37°.
• ICT require calibration every 8
hours.
• SLP Cal Error Code = The slope
of the calibration curve
is < 45%.
Figure 9.2: Calibration Information for Na-S Assay

Most functions and areas of this screen are the same as described in
Module 6, Calibration. The areas that are different are described in the
following table:

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Reviewing ICT™ Calibration Information

Area Text Description


1 Graph Displays the actual calibration curve with a blue line. The
brown line indicates the 45% slope limit.
2 mV This column displays the measured mV (millivolt) values of
the Low and High Calibrators.
3 Slope This field displays the slope of the curve expressed in % of
ideal response. The slope is close to 100% when the ICT™
Module is new and decreases with time and use. The ICT
Module cannot be used with a slope of less than 45%.
4 Conc Calibrator concentration configured in the
CALIBRATOR/CONTROL screen.
5 Idx This area of the screen is not used.

CALIBRATION SUMMARY Screen


Columns from left to right The calibration data of the ICT assays are displayed on the
are: CALIBRATION SUMMARY screen.
• Expected calibrator value (C1)Concentration Calibrator Millivolt reading Slope
• Millivolt reading
• Slope
• Expected C2 calibrator value
• Millivolt reading

Figure 9.3: CALIBRATION SUMMARY Screen

The data are displayed in the C1 and C2 columns. The mV readings and
slope are displayed rather than the absorbance and factors displayed for
the photometric assays.

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MODULE 9: ICT™ UNIT

ICT™ UNIT COMPONENT REPLACEMENT


• ICT Unit = Whole assembly Your instructor will demonstrate the correct removal and replacement
• ICT Module = Electrode Chip procedures of the ICT™ Module and ICT Probe.
only. For information about the removal and replacement of the ICT Module
• ICT Probe is not and ICT Probe, refer to Component Replacement in Section 9, Service
changed each time and Maintenance of the AEROSET System Operations Manual.
module is changed.
• Take students to an
instrument and show how
the ICT module is installed.
• Will need flathead
screwdriver.
• Caution:
- Not to install module upside
down.
- Not to over-tighten probe and
tubing, thereby twisting the O-
rings and blocking flow.
- Not to over-tighten screw for
cable. Can crack assembly.
NOTE:
Stainless steel probe has a
different holder than the
teflon probe.

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Activity

ACTIVITY

Introduction
In this activity, you will remove and replace the ICT™ Unit components
and verify the operation of the ICT Unit by visually inspecting the
components and by performing calibration.

Objectives
Upon completion of the ICT Module Activity, you will be familiar with:
• Removing and replacing the ICT Module
• Removing and replacing the ICT Probe
• Aligning the ICT Probe
• Ordering an ICT calibration and loading the calibrators and controls
• Reviewing the ICT calibration information in the ASSAY STATUS
and CALIBRATION SUMMARY screens

Necessary Materials

Reagents:
• ICT Sample Diluent

Other:
• ICT Serum Calibrators
• Quality Control Materials

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MODULE 9: ICT™ UNIT

Procedure
The information for the following steps is found in the AEROSET
System Operations Manual.
Refer to Component Replacement in Section 9, Service and
Maintenance of the AEROSET System Operations Manual to perform
the following procedures:
1. ICT Module Removal - to remove the ICT Module from the ICT
Module.
2. ICT Probe Removal - to remove the ICT Probe from the ICT
Module.
CAUTION: Inspect the top and bottom port of the
! ICT Module for the presence of a black seal. If
missing, verify that the seal is not stuck to the
tubing connector or probe. Verify that
connections are finger-tight. Replace or reseat the
seal if necessary.
3. Replace the ICT™ Probe and ICT Module.
CAUTION: Ensure that the probe and tubing
! connector are screwed in finger-tight only. If they
are screwed in too tightly, the seal may twist and
block flow through the ICT Module.
Refer to Component Replacement in Section 9, Service and
Maintenance of the AEROSET System Operations Manual to perform
the following procedure.
4. ICT Probe Alignment procedure - to check the ICT probe position.
5. Select <RUN> in the Action Area of the Main Display.
6. Select the Calibration and QC after Calib options.
7. Select <Order> next to the Calibration option and ensure that only
Na+, K+, and Cl- are selected.
8. Select <OK> in the Order Assays for Calibration screen.
9. Load the controls and ICT serum calibrators.
10. Select <Start>.
11. When the calibration is complete, review the ASSAY STATUS
screen to ensure that the calibration completed with no errors and
that the controls were within the expected range.

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Review Questions

REVIEW QUESTIONS
1. Where is the ICT™ Sample Diluent placed onboard the AEROSET
System?

2. How is the ICT Reference Solution preheated to 37°C before filling


the ICT Reference Solution cup?

3. What volume is aspirated from a sample cup or tube for ICT


measurement?

4. Describe the two lines displayed on the calibration graph in the


ASSAY STATUS screen.

Blue Line -

Brown Line -

5. Why is it important to calibrate the ICT assays after any ICT Unit
component is removed and replaced?

6. If an ICT Module seal is lost what concern would be observed?

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MODULE 9: ICT™ UNIT

ANSWERS
1. In Reagent Supply Center 1, in an outer segment
2. By flowing through the ICT Reference Solution preheater (a narrow
metal tubing around the water bath)
3. 15 µL
4. Blue Line - The current calibration slope
Brown Line - The 45% slope limit
5. To ensure that the tubing and probe are correctly connected to the
ICT Module so that there are no bubbles introduced and that the
flow is not blocked by a twisted seal
6. Bubbles In the ICT tubing

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Summary

SUMMARY
In this Module, you have:
• Described the ICT™ fluid delivery
• Identified the components of the ICT Unit
• Viewed the calibration information displayed for the ICT assays
• Removed and replaced the ICT Module and ICT Probe

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MODULE 9: ICT™ UNIT

NOTES

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MODULE 10: MAINTENANCE

MODULE 10:
MAINTENANCE

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MODULE 10: MAINTENANCE

CONTENTS
Page

Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5
Weekly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6
Weekly Maintenance Activity . . . . . . . . . . . . . . . . . . . . . 10-7
Monthly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8
Monthly Maintenance Activity . . . . . . . . . . . . . . . . . . . . . 10-9
Quarterly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . 10-11
Quarterly Maintenance Activity . . . . . . . . . . . . . . . . . . 10-12
Semi-Annual Maintenance . . . . . . . . . . . . . . . . . . . . . . 10-13
Semi-Annual Maintenance Activity . . . . . . . . . . . . . . . 10-14
Annual Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-15
Annual Maintenance Activity . . . . . . . . . . . . . . . . . . . . 10-16
As Needed Maintenance . . . . . . . . . . . . . . . . . . . . . . . . 10-17
As Needed Maintenance Activity . . . . . . . . . . . . . . . . . . 10-18
Review Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-22
Answers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-24
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-25

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Objectives

MODULE 10: MAINTENANCE

OBJECTIVES
Upon completion of this Module, you will be able to:
1. List and perform weekly, monthly, quarterly, semi-annual, and
annual Maintenance Procedures
2. Describe the sections of the AEROSET System Maintenance Log
3. Demonstrate the Additional Maintenance Procedures

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MODULE 10: MAINTENANCE

INTRODUCTION
• Have OPs Manuals available Proper maintenance of your AEROSET System is one of the most
for use with Maintenance important aspects of a complete Quality Assurance program. In Module
procedures. 3, Daily Checks and Start Up, you learned how to perform the Daily
• Have class check off Checks and START UP and SHUTDOWN Procedures.
procedures in the This Module introduces you to the Weekly, Monthly, Quarterly, Semi-
Maintenance Log with the
Annual, and Annual Maintenance Procedures you should perform on the
activity.
System. You will use the AEROSET System Operations Manual to
perform the recommended maintenance procedures.
This Module also discusses the System Backup and Restore Procedures.
This feature is introduced to help you minimize lost data due to a System
(hard disk) failure.
The AEROSET System Maintenance Log is used for recording and
tracking the results of maintenance performed on the AEROSET System.
It is recommended that whenever you complete any of the routine
maintenance procedures, you record the procedure in the AEROSET
System Maintenance Log.

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Maintenance Schedule

MAINTENANCE SCHEDULE

FREQUENCY PROCEDURE
DAILY CHECKS • Check Reagents/Solutions Inventory
• Perform START UP
• Check 1mL Syringes
• Check Wash Solution Trays
• Check Sample and Reagent Syringes and Solenoid Valves
• Check High-Concentration Waste Container
• Check Refrigerator Condensation Pan
• Check DI Water System
• Perform SHUTDOWN
WEEKLY • Check Sample and Reagent Probes
• Clean Outside of the Sample and Reagent Probes
• Clean Mixers
• Check Tubing from the High-Concentration Waste Drain Hose and
High-Concentration Waste Pump Output T-Fitting
• Clean Touchscreen Display
• Check ICT™ Probe and Tubing
MONTHLY • Check/Clean Reagent Supply Centers
• Clean Carousel Sampler Area and Carousels
• Check Sample and Reagent Dispense Components
• Clean Cuvette Washer Nozzles
• Check Cuvette Washer High-Concentration Waste Nozzle Tubing
• Clean DI Water Filter (if installed)
QUARTERLY • Syringe Seal Tip (1 and 2) and O-ring Replacement (on sample, reagent,
and wash solution syringes)
• Wash Solution Syringe (1mL) Replacement
• ICT Reference Solution (1mL) Replacement
• ICT Aspiration Syringe (1mL) Replacement
• 0.22 Micron Filter Replacement (if applicable)
SEMI-ANNUALLY • Wash Solution Filters Replacement
• ICT Reference Solution Filter Replacement
ANNUALLY • Check Valve Replacement (Wash Solution and Reference Solution
Pumps 1mL Syringes)

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MODULE 10: MAINTENANCE

WEEKLY MAINTENANCE
The following Weekly Maintenance Procedures must be performed:
• Clean the Outside of the Sample and Reagent Probes
• Clean Mixers
• Clean Touchscreen Display
• Check ICT™ Probe and Tubing
• Check Sample and Reagent Probes
• Check Tubing from the High-Concentration Waste Drain Hose and
High-Concentration Waste Pump Output T-fitting

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Weekly Maintenance

Weekly Maintenance Activity


Introduction
In this exercise, you will perform the Weekly Maintenance Procedures.

Objective
Upon completion of the Weekly Maintenance Activity, you will be
familiar with:
• Cleaning the Outside of the Sample and Reagent Probes
• Cleaning the Mixers
• Cleaning the Touchscreen Display
• Checking the ICT™ Probe and Tubing
• Check Sample and Reagent Probes
• Check Tubing from the High-Concentration Waste Drain Hose and
High-Concentration Waste Pump Output T-fitting

Necessary Materials
• AEROSET System Operations Manual
NOTE: The materials required for each procedure are
defined in the AEROSET System Operations Manual.

Procedure
Instructor will need the The information for the following steps is found in the AEROSET
following for demo: System Operations Manual.
- 1% Alk Wash Refer to Weekly Maintenance in Section 9, Service and Maintenance of
- Cotton swabs the AEROSET System Operations Manual to perform the following
- DI water procedures:
- Alcohol
- Kay Dry 1. Clean the outside of the Sample and Reagent Probes.
2. Clean the Mixers.
3. Clean the Touchscreen Display.
4. Check the ICT Probe and Tubing.
5. Check sample and reagent probes for damage and protein buildup
6. Check tubing from the High-Concentration Waste Drain Hose and
High-Concentration Waste Pump Output T-fitting.

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MODULE 10: MAINTENANCE

MONTHLY MAINTENANCE
The following Monthly Maintenance Procedures must be performed:
• Clean/Check Reagent Supply Centers
• Clean Carousel Sampler Area and Carousels
• Check Sample and Reagent Dispense Components
• Clean Cuvette Washer Nozzles
• Check Cuvette Washer High-Concentration Waste Nozzle Tubing
• Clean DI Water Filter (if installed)

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Monthly Maintenance

Monthly Maintenance Activity

Introduction
In this exercise, you will perform the Monthly Maintenance Procedures.

Objective
Upon completion of the Monthly Maintenance Activity, you will be
familiar with:
• Cleaning and checking the Reagent Supply Centers
• Cleaning the Carousel Sampler Area and Carousels
• Checking the Sample and Reagent Dispense Components
• Cleaning the Cuvette Washer Nozzles
• Check Cuvette Washer High-Concentration Waste Nozzle Tubing
• Clean DI Water Filter (if installed)

Necessary Materials
• AEROSET System Operations Manual
NOTE: The materials for each procedure are defined in
the AEROSET System Operations Manual.

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MODULE 10: MAINTENANCE

Procedure
Instructor will need the The information for the following steps is found in the AEROSET
following for demo: System Operations Manual.
- Lint-free towels Refer to Monthly Maintenance in Section 9, Service and Maintenance
- 10% bleach of the AEROSET System Operations Manual to perform the following
- DI water
procedures:
- Flathead screwdriver
- Phillips™ screwdriver 1. Clean and check the Reagent Supply Centers.
- Nozzle cleaning wire
- Teri 2-ply wipers 2. Clean the Carousel Sampler area and carousels.
• Cleaning cuvette washer — 3. Check the sample and reagent dispense components.
sometimes there’s a tight
suction between the platform 4. Clean the Cuvette Washer Nozzles.
that the black knob is on and 5. Check the Cuvette Washer High-Concentration Waste Nozzle
its base.
Tubing.
• Do not touch the dryer tips
with ungloved hands. 6. Clean DI Water Filter (if installed).
• Demo how to check if cuvette
washer nozzles are aligned.

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Quarterly Maintenance

QUARTERLY MAINTENANCE
The following Quarterly Maintenance Procedures must be performed:
• Syringe Seal Tip and O-Ring replacement on sample, reagent, and
wash solution syringes
• 1 mL Wash Solution Syringe replacement
• 1 mL ICT™ Reference Solution Syringe replacement
• 1 mL ICT Aspiration Syringe replacement
• 0.22 Micron Filter replacement (if applicable)

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MODULE 10: MAINTENANCE

Quarterly Maintenance Activity

Introduction
In this exercise, you will perform the Quarterly Maintenance Procedures.

Objective
Upon completion of the Quarterly Maintenance Activity, you will be
familiar with:
• Replacing the Syringe Seal Tip and O-Ring on sample, reagent, and
wash solution syringes
• Replacing the 1 mL wash solution syringes
• Replacing the 1 mL ICT™ reference solution syringe
• Replacing the 1 mL ICT aspiration syringe
• 0.22 Micron Filter replacement (if applicable)

Necessary Materials
• AEROSET System Operations Manual
NOTE: The materials for each procedure are defined in
the AEROSET System Operations Manual.

Instructor will need the


Procedure
following for demo:
- Flathead screwdriver The information for the following steps is found in the AEROSET
- Phillips screwdriver System Operations Manual.
- 7mm wrench
- absorbant towels Refer to Component Replacement in Section 9, Service and
- cotton swabs Maintenance of the AEROSET System Operations Manual to
perform the following procedures:
1. Syringe Seal Tip and O-Ring replacement on sample, reagent, and
wash solution syringes
2. 1 mL Wash Solution Syringe replacement
3. 1 mL ICT Reference Solution Syringe replacement
4. 1 mL ICT Aspiration Syringe replacement
5. 0.22 Micron Filter replacement (if applicable)

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Semi-Annual Maintenance

SEMI-ANNUAL MAINTENANCE
Instructor will need the The following Semi-Annual Maintenance Procedures must be
following for demo: performed:
- absorbant towels • Wash Solution Filters Replacement
• ICT™ Reference Solution Filter Replacement

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MODULE 10: MAINTENANCE

Semi-Annual Maintenance Activity

Introduction
In this exercise, you will perform the Semi-Annual Maintenance
Procedures.

Objective
Upon completion of the Semi-Annual Maintenance Activity, you will be
familiar with:
• Replacing Wash Solution Filters
• Replacing the ICT™ Reference Solution Filter

Necessary Materials
• AEROSET System Operations Manual
NOTE: The materials for each procedure are defined in
the AEROSET System Operations Manual.

Procedure
The information for the following steps is found in the AEROSET
System Operations Manual.
Refer to Component Replacement in Section 9, Service and
Maintenance of the AEROSET System Operations Manual to perform
the following procedures:
1. Wash Solution Filters Replacement
2. ICT Reference Solution Filter Replacement

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Annual Maintenance

ANNUAL MAINTENANCE
Instructor will need the The following Annual Maintenance Procedures must be performed:
following for demo:
• Check Valve Replacement (Wash Solution and Reference Solution
- Beaker (large enough to Pump 1 mL Syringes)
accommodate 1 mL syringes with
check valves)
- DI water
- absorbant towel

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MODULE 10: MAINTENANCE

Annual Maintenance Activity

Introduction
In this exercise, you will perform the Annual Maintenance Procedures.

Objective
Upon completion of the Annual Maintenance Activity, you will be
familiar with:
• Replacing Check Valves

Necessary Materials
• AEROSET System Operations Manual
NOTE: The materials for each procedure are defined in
the AEROSET System Operations Manual.

Procedure
The information for the following steps is found in the AEROSET
System Operations Manual.
Refer to Component Replacement in Section 9, Service and
Maintenance of the AEROSET System Operations Manual to perform
the following procedures:
1. Check Valve Replacement

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As Needed Maintenance

AS NEEDED MAINTENANCE
The following maintenance procedures should be performed when
needed to ensure proper operation of the AEROSET System:
• Format a Floppy Disk
• Backup System Configuration Files
• Restore System Configuration Files
• Library Utility and Maintenance
• Clean Reagent Bar Code Reader Windows
• Clean Cuvettes

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MODULE 10: MAINTENANCE

As Needed Maintenance Activity

System Backup
• Time estimates for System The AEROSET System hard disk provides storage for System
backup and restore are given in configuration, assay configuration, assay calibration, quality control, and
Section 9 of the Ops Manual. robotics adjustment data. When the hard disk fails, the System Backup
• Restore from disk. and Restore functions provide an alternative to rerunning all assay
• Make sure to cycle power after calibrations, repositioning all the robotics, and reconfiguring the System.
restoring. System backup is recommended after any of the following:
• Requires use of 2 formatted
• New assay installation and calibration
HD disks.
- Format using • Values for a new lot of multiconstituent calibrators are entered
DOS v5.0 or higher or Windows • QC means are adjusted or edited for a new lot of controls
95 or higher.
- Use preformatted disks. • Changes are made to System configuration files
• Robotic adjustments are made by the Customer or Field Service
Representative
• In addition to the unscheduled System backups listed above, the
Customer should determine an interval for System backup to
capture QC or calibration data.
The AEROSET System Backup Procedure provides a means to transfer
System and assay files onto floppy disks. The files are divided among
five separate Backup and Restore options with each option requiring one
formatted floppy disk. The following table describes the files saved to
each disk:

Option Description
Config • Log On/Password Data • Print Form 1
• Reagent Information • Comments
• Doctor’s Names • Print Form 2
• Calibrator and Control • Panels
Information • System Configuration
• Patient Locations Information
Assay 1 - 50 Assay configuration files 1 - 50 (includes calibration data)
Assay > 50 Assay configuration files 51 - 100 (includes calibration data)
Robotics Robotics positioning information and maintenance utilities
information
Library System Library files (Storage on the hard disk)

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As Needed Maintenance

• Library Maintenance To access the System Backup and Restore options:


• Where you delete files in the 1. Ensure that the AEROSET System status is READY. Exit all open
library. screens displayed in the Display Area.
• Can hold up to 200 of each
type of file. (assays, reagents, 2. Select in the Action Area. The MAINTENANCE
C/C, results, etc.) UTILITIES screen is displayed.
• Print forms here-can also save 3. Select the SCC tab to access the SCC page.
to disk.
• Print form files not displayed
separately here.
• Touch “Delete” when <ALL> is
selected, will clear all files.
• Select drop down box, if you
select a certain file type, then
touch select, you can see
individual files to delete.
• Shift + Ctrl selections are
active.

Figure 10.1: MAINTENANCE UTILITIES Screen, SCC Page


NOTE: A backup process has the following approximate
durations:
• Config = 3 minutes
• Assay 1-50 = less than 15 minutes
• Assay > 50 = less than 15 minutes
• Robotics = less than 10 seconds
• Library = dependent upon the amount of data
stored in the library

For further information and details about using the System Backup and
Restore options, refer to As Needed Maintenance Procedures in
Section 9, Service and Maintenance of the AEROSET System
Operations Manual.

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MODULE 10: MAINTENANCE

Clean the Reagent Bar Code Reader Window


Instructor will need the The reagent Bar Code Readers are located behind each Reagent Supply
following for the demo: Center. The Bar Code Readers scan the bar codes using a laser beam
• Water directed through a glass window located at the back of each Reagent
Supply Center. The window protects the reader from any liquid (water or
• Lint-free towel
reagent) that might be splashed by the Reagent Supply Center pipetting
operations.
Any residue impairs the reader from operating at its highest efficiency.
Clean the windows as needed.
Refer to As Needed Maintenance Procedures in Section 9, Service and
Maintenance of the AEROSET System Operations Manual for more
information on cleaning the reagent Bar Code Reader window.

Clean Cuvettes
A cuvette may become dirty due to build-up over time with usage or if
the water is allowed to dry in the cuvettes repeatedly. The Cuvette Wash
Procedure during a run, or during START UP or SHUTDOWN may not
be able to completely clean the cuvette. If any of the following errors
occur and are isolated to specific cuvettes, it may be necessary to
manually clean the affected cuvette(s).
• RL%, A#0, A#1, or A#2 Result Error Codes for samples without
increased concentration
• Sample results are low or high

NOTE: The cuvette number used for measurement is displayed


in the Reaction Graph screen.

Refer to As Needed Maintenance Procedures in Section 9, Service and


Maintenance of the AEROSET System Operations Manual for more
information on cleaning the cuvettes.

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As Needed Maintenance

NOTES

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MODULE 10: MAINTENANCE

REVIEW QUESTIONS
1. What solution is used to clean the Sample and Reagent Probes
during Weekly Maintenance?

2. What solution is used to clean the Mixers during Weekly


Maintenance?

3. When observing the Wash ICT™ with IRef Procedure what should
not be seen?

4. Why is it necessary to remove the Reagent Supply Center


segments in a specific order?

5. Why are the Sample and Calibrator/Control Carousels cleaned


monthly with a 10% bleach solution?

6. To remove the cover from the ___________ Arm, you must access
the MAINTENANCE UTILITIES screen to move it over the
cuvette dispensing position.
7. Abbott recommends performing System Backup Procedures after:
a. _____________________________________________
b. _____________________________________________
c. _____________________________________________
d. _____________________________________________
e. _____________________________________________
f. ________________________________________________
8. What type of disk must be used for a System Backup option?

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Review Questions

9. When seating any of the 1 mL syringes into the syringe holders,


there are two important steps to ensure that the syringe is correctly
seated and operates properly. Describe the two steps.
a. ______________________________________________
b. ______________________________________________

10. How often should sample, reagent, and wash solution syringe seal
tips and O-rings be replaced?

11. When performing quarterly maintenance, which of the following is


not replaced?
a. O-ring
b. seal tip #2
c. spacer
d. seal tip #1

12. If you suspect that a check valve is not functioning properly, what
can be done to check the function of the check valve?

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MODULE 10: MAINTENANCE

ANSWERS
1. 1% Alkaline Wash Solution
2. Alcohol
3. Bubbles in the tubing or drips from the ICT™ Probe
4. To avoid dripping water from the bottom the Reagent Supply
Center segments into the open Reagent Cartridges
5. To remove spilled or splashed control or sample material to
minimize the biohazard
6. R2-B
7. a. New assay installation and calibration
b. Values for a new lot of multiconstituent calibrators are entered
c. QC means are adjusted or edited for a new lot of controls
d. Changes are made to System configuration files
e. Robotic adjustments are made by the Customer or Field Service
Representative
f. Customer determined interval for System backup to capture QC
or calibration data
8. A formatted floppy disk
9. a. Ensure that the bottom of the syringe barrel is in the groove in
the syringe holder.
b. Ensure that the plunger flange is below the U-shaped bracket.
10. Quarterly
11. c. spacer
12. Check the inlet and outlet ports with water. Ensure that water can
not be drawn in through the outlet port, and water can not be
expelled through the inlet port.

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Summary

SUMMARY
In this Module, you have:
• Performed the Weekly, Monthly, Quarterly, Semi-Annual, and
Annual Maintenance Procedures
• Described the sections of the AEROSET System Maintenance
Log
• Demonstrated the System Backup Procedures

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MODULE 10: MAINTENANCE

NOTES

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MODULE 11: COMPONENT REPLACEMENT AND TROUBLESHOOTING

MODULE 11:
COMPONENT
REPLACEMENT AND
TROUBLESHOOTING

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MODULE 11: COMPONENT REPLACEMENT AND TROUBLESHOOTING

CONTENTS
Page

Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4
Error Codes and Messages . . . . . . . . . . . . . . . . . . . . . . . 11-5
Power OFF Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . 11-11
MAINTENANCE UTILITIES Screen . . . . . . . . . . . . . . . . 11-13
Component Replacement . . . . . . . . . . . . . . . . . . . . . . . 11-20
Component Replacement Activity . . . . . . . . . . . . . . . . 11-22
Review Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-23
Answers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-24
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-25

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Objectives

MODULE 11: COMPONENT REPLACEMENT AND TROUBLESHOOTING

OBJECTIVES
Upon completion of this Module, you will be able to:
1. Identify the different Error Log Messages and Codes that are
displayed by the AEROSET System
2. Demonstrate the correct Power OFF Procedure
3. Identify and use the various pages of the MAINTENANCE
UTILITIES screen to:
• Set the System date and time
• Check temperatures
• Track component usage
• Control robotic movements
• Check photometer performance
• Verify cuvette integrity
• Verify Bar Code Reader performance
4. Successfully remove and replace the following components:
• Sample Probes and tubing
• Reagent Probes and tubing
• Cuvette Washer Dryer Tips
• Mixer
• Cuvette Segment
• Cuvette pair
• Sample Carousel Tube Bottom Holder
• Source lamp

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MODULE 11: COMPONENT REPLACEMENT AND TROUBLESHOOTING

INTRODUCTION
The first section presents the different types of Error Log Messages and
codes that are displayed by the AEROSET System. This section focuses
on where each type of error is displayed and how to find the information
needed to resolve the issue that caused the generation of the code or
message.
The second section presents the correct Power OFF Procedure that
should be used prior to performing some troubleshooting and component
replacement procedures.
The third section describes the various pages of the MAINTENANCE
UTILITIES screen which allow the Operator to set the System date and
time, track specific component usage, and manually move robotics for
maintenance and troubleshooting purposes.
The last section overviews the replacement of System components.
Component replacement may be required, periodically due to normal
use, or as a troubleshooting procedure.

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Error Codes and Messages

ERROR CODES AND MESSAGES

Result Flags
• Ensure Ops Manuals are Result Flags are displayed for patient and control results on the screens
available for use with the Error indicated in the table below. They can also be printed on the patient and
Codes and Messages section.
control reports.

Type of
Screen “L” “H”
Result
Patient DATABASE and Indicates that the Indicates that the
RESULT result is less than result is greater
the defined than the defined
Reference-L Reference-H
Quality DATABASE, Indicates that the Indicates that the
Control RESULT, QC result is greater QC result is greater
ASSAY STATUS, than than
Levey-Jennings –2 SD from the +2 SD from the
Graph, QC Details, mean mean
and QC SUMMARY

Result Error Codes


Result Error Codes are displayed on the RESULT and Reaction Graph
• On database, will see “C” for screens and can be printed on the Patient Reports.
error code.
• The Result Error Codes are assigned a priority with 1 = highest
• Result error code and result, if priority and 14 = lowest priority. The priority does not display on
present will be displayed in
the SCC computer.
Result screen.
• If more than one Result Error Code is generated for a result, the
Result Error Code with the highest priority is displayed in the
RESULT screen and printed on the Patient Report.
• If more than one Result Error Code of the same priority is generated
for a result, the first error to occur is displayed in the RESULT
screen and printed on the Patient Report.
• To view all Result Error Codes generated for a result, access the
Reaction Graph screen.
• If a “C” appears with a result on the DATABASE screen, this
indicates that a Result Error Code has been generated for the
sample.

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MODULE 11: COMPONENT REPLACEMENT AND TROUBLESHOOTING

• Have the class look up The Result Error Codes and their priority are listed with appropriate
a Result Error Code probable causes and corrective action in Section 10, Diagnostics and
and note the priority, Troubleshooting of the AEROSET System Operations Manual.
probable cause, and
corrective action. An example of the RESULT screen with both Result Flags and Result
Error Codes is displayed below.

Result Error Code

Figure 11.1: RESULT Screen

Figure 11.2: RXN Graph with Multiple Error Codes

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Error Codes and Messages

Calibration Error Codes


• MON-switched calibrators, flat Calibration Error Codes are displayed on the ASSAY STATUS screen.
curve. When a Calibration Error Code is generated, the Result Error Code of
• Wrong reagent (R2). CAL is displayed with the corresponding assay results in the RESULT
and Reaction Graph screens.

NOTE: In addition, Error Code 37, “Calibration Failed, Check


Assay Status” is generated as an Error Log Message.

The Calibration Error Codes are listed with appropriate probable causes
and corrective action in Section 10, Diagnostics and Troubleshooting of
the AEROSET System Operations Manual.
An example of the ASSAY STATUS screen with a Calibration Error
Code is displayed below.

Calibration
Error Code

Figure 11.3: ASSAY STATUS Screen

Transmitted Error Codes


For each Result Error Code and Calibration Error Code, a single letter
code is included in the result transmission to the Host Interface system.
To display the Result Error Codes and Calibration Error Codes when
reviewing the results at the Host, the Host system must be defined with
an “interpretation table” and display the equivalent code.
The transmitted Error Codes are listed in the AEROSET Host Interface
Specifications.

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MODULE 11: COMPONENT REPLACEMENT AND TROUBLESHOOTING

Assay-Specific Error Messages


• Example-IgG=black Assay-Specific Error Messages are displayed on the Error Status
screen, accessed by selecting <Status> on the ASSAY STATUS screen.
When assay button text is colored pink, black, or yellow, instead of the
normal green, one or more of these messages is displayed to give an
explanation of the color change.
The Calibration Error Codes are listed with appropriate probable causes
and corrective action in Section 10, Diagnostics and Troubleshooting of
the AEROSET System Operations Manual.
An example of the Error Status screen with Assay-Specific Error
Messages is displayed below.

Figure 11.4: Error Status Screen

NOTE: Errors displayed in the Level-1 Section of the Error


Status screen generate Result Error Codes. Errors displayed in
the Level-2 Section of the Error Status screen do not generate
Result Error Codes.

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Error Codes and Messages

Error Log Messages


The Error Log icon changes colors to indicate that an Error Log Message
has been generated. The color of the icon indicates the severity of the
error that has occurred. The following table explains the different error
levels and icon colors.

Level Button Color Action of the System


• Example: Error code #294 1 Red The System status immediately changes to PAUSE.
Sample Carrier pull in background The System continues to process the samples already
error-will pause all results dispensed, but Result Error Codes are generated for
and will have HW flag. all results. The System cannot be restarted until the
• Those run before error are error is reset in the ERROR LOG screen by an
probably OK. Operator with “super” Log On access.
If a Level 1 error occurs during a START UP or
SHUTDOWN Procedure, the System immediately
stops.
2 Pink The System status immediately changes to PAUSE.
background The System continues to process the samples already
dispensed and Result Error Codes are generated only
for results involved in the error. The System cannot be
restarted until the error is reset in the ERROR LOG
screen. An Operator with any level of Log On access
can reset these errors.
• <Print> prints all 200 If a Level 2 error occurs during a START UP or
error messages. SHUTDOWN Procedure, the System continues with
the procedure.
3 Yellow The System does not PAUSE. All dispensing and
background processing continues.
An example of the ERROR LOG screen with Error Log Messages is
displayed below.

Figure 11.5: ERROR LOG Screen

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MODULE 11: COMPONENT REPLACEMENT AND TROUBLESHOOTING

To reset a message in the ERROR LOG screen, perform the following


steps:

1. Select the Error Log icon in the Action Area.


2. Select <ResetErr> in the right-hand column of the
ERROR LOG screen.
3. Select <OK> on the confirmation dialog window to acknowledge
the new Error Log Message(s).
4. A checkmark (;) is placed next to each Error Log Message, and the
Error Log icon no longer has a colored background.
The Error Log Messages are listed with appropriate probable causes and
corrective actions in Section 10, Diagnostics and Troubleshooting of the
AEROSET System Operations Manual.

NOTE: To display the Error Log Message Code numbers, press


[F1] on the keyboard.

An example of the ERROR LOG screen after [F1] has been pressed is
displayed below.

Error Code
Number

Figure 11.6: ERROR LOG Screen


NOTE: <Print> will print all 200 Error Log Messages.

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Power OFF Procedure

POWER OFF PROCEDURE


When troubleshooting or performing component replacement, it may be
necessary to turn the System power OFF. Perform the following
procedure to shutdown the software prior to turning the power OFF.
1. Close or exit any open screens.

2. Select the Exit icon from the Action Area of the Main
Display.
3. Select <OK> . The Log On screen is displayed.

Figure 11.7: Log On Screen


4. In the User Code entry field, type bye.
5. Press [Enter]. The following messages are displayed:
• “Starting System Power OFF Procedure”
• “Shutdown will be completed in 10 sec”
• “Shutdown Procedure in progress”
• “Please, Power OFF!”

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MODULE 11: COMPONENT REPLACEMENT AND TROUBLESHOOTING

Rotary Power
Control Switch Action
Setting
AUTO Once the Power OFF sequence is complete, the
power is automatically disconnected from the
Analyzer and System Control Center (SCC)
components without any further intervention by
the Operator. However, the Main Circuit Breaker
Switch remains ON unless the Operator manually
moves the switch 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.

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MAINTENANCE UTILITIES Screen

MAINTENANCE UTILITIES SCREEN


• Do not go into great detail The MAINTENANCE UTILITIES screen provides the Operator with
about these screens. OPS the ability to set the System date and time, track specific component
Manual has more detail. usage, and manually move robotics for maintenance and troubleshooting
• Facilitator Notes for purposes. In addition, the screen enables the Operator to perform the
maintenance screens are for System Backup and Restore Procedures. When selected, the
instructor’s reference only. MAINTENANCE UTILITIES screen overlays the entire display.
Therefore, the ErrorLog icon is present on the right-hand column to
allow the Operator to access the Error Log for troubleshooting purposes.
The screen has seven pages which include:
• System
• SCC (System Control Center)
• Sampling
• Rgt (Reagent) Area 1
• Rgt (Reagent) Area 2
• Rxn (Reaction) Area
• SW (Software) Info

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MODULE 11: COMPONENT REPLACEMENT AND TROUBLESHOOTING

System Page
Component 4 5
Tracking

• Select “reset” after 1


new component is
installed. (Current 2
day is entered.)
• ISE cycles do not
differentiate
between ICT and
non-ICT samples.
• Component 3
Tracking
cycles=sample
dispensed
• Both Lamp and ISE
come configured.
• Additional startup
and shutdown
options are Figure 11.8: MAINTENANCE UTILITIES Screen, System Page
explained in
Section 2 of the
Item Field Allows the Operator to…
AEROSET OPs
Manual. 1 Date/Time Adjust the System date and time.
• Additional 2 Temperature View the Avg. (average) and actual temperatures for the:
Component - Water bath,
Tracking is found - Reagent Supply Centers,
in Section 10 of the
- Calibrator/Control Carousel
AEROSET OPs
Manual. - interior of the Analyzer.
• When tracking 3 Component Tracking Track components by time (hours) or cycles.
criteria is exceeded, NOTE: Each sample dispense is one cycle.
the Mtn Utilities
icon and Reset 4 Auto Start Up/ Specify the date, time, and option for Automatic Power
button turn pink. Shutdown Schedule ON, Power OFF, START UP, START UP 2, START UP
3, SHUTDOWN, SHUTDOWN 2, and SHUTDOWN 3.
5 Assay Counts View the individual as well as the total assay counts.
NOTE: When Na+ is ordered and run by itself or
with any other ICT™ assay, the Na+ assay count is
incremented. When K+/Cl- or K+ are ordered and
run, only the K+ assay count is incremented. When
only Cl- is ordered and run, only the Cl- assay
count is incremented.

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MAINTENANCE UTILITIES Screen

SCC Page

1
2

Figure 11.9: MAINTENANCE UTILITIES Screen, SCC Page


Item Field Allows the Operator to…
1 Touchscreen Check Used to determine the accuracy of the Touchscreen.
This is not an alignment procedure.
2 System Backup/Restore Perform the System Backup or Restore Procedure.
This portion of the screen also allows the Operator
to format a floppy disk.
3 Library Maintenance Delete files from the Library.
NOTE: The Library is space on the hard
drive which contains exported files. The
drop-down list box allows the Operator to
view and select types of files, e.g., Assay,
QC, etc., for individual deletion.

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MODULE 11: COMPONENT REPLACEMENT AND TROUBLESHOOTING

Sampling Page
• Carousels — if
doesn’t see bar
code, gets a line. 1
• If button has the
2
word “adj”, when
touched, the word
“adj” will pop-up 3
on the button on
the right.
• If “adj” is touched, 4
will get pop-up
“CW” = clockwise,
or “CCW” = 5
counterclockwise.
(or up and down)

Figure 11.10: MAINTENANCE UTILITIES Screen, Sampling Page

NOTE: Ensure each component is in the home position before


movement or adjustment.

Item Field Allows the Operator to…


1 Smpl Move the Sample Arm horizontally or vertically. The horizontal control allows the Sample Arm to
(Sample) move to the following positions:
Arm Home, STAT, Smpl (Sample Carousel),
C/C (Calibrator/Control Carousel), Wash Cups 1 and 2, Cuv-D (diluted sample), Cuv-S
(sample), Track (FastTrack™) and Opt (External Robotics).
2 <Home All> Home all robotics.
3 Syringe Move the Sample Syringe drive. The Operator may also request the syringe drives to home,
aspirate, or dispense.
4 Carousels Move the Calibrator/Control and Sample Carousels. The Operator may also turn the Bar Code
Reader ON and rotate the Sample Carousel to read the bar code labels on the samples loaded in
the carousel.
5 Track Move the FastTrack Sampler. The Operator may turn ON the Sample ID Bar Code Reader and
Sampler read the bar codes on the samples loaded on the Sample Carrier using the Cycle button. The Car’r
(Carrier) Bar Code Reader may also be activated. Lastly, if a Sample Carrier Tray is loaded, the
Operator may home the tray or move it left (1-L) or right (1-R).
6 This area displays a blue triangle when the System is busy. A green square displays when the status
is READY.
NOTE: When the System is busy, no further commands are acknowledged until the
original command is completed.

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MAINTENANCE UTILITIES Screen

Rgt Area 1 and Rgt Area 2 Page


• Can test bar codes. Don’t see The Rgt Area 1 and Rgt Area 2 pages provide the same functionality for
selection unless reagent bar the corresponding Reagent Arms, Reagent Supply Center segments,
codes are turned ON. reagent pump, and the reagent Bar Code Reader in the Reagent Supply
Center 1 and Reagent Supply Center 2.

Figure 11.11: MAINTENANCE UTILITIES Screen, Rgt Area 1 Page

NOTE: Ensure each component is in the home position before


movement or adjustment.

Item Field Allows the Operator to…


1 Rgt (Reagent) Move the Reagent Arm vertically and horizontally. The horizontal control allows the Reagent
Arm Arm to be moved to the following positions:
Home, CUV (cuvette), Add. (Water Bath Additive dispense position for R1-A only), WCup
(Wash Cup), and Rgt (reagent).
2 Syringe Move the Reagent Syringe drive. The Operator may also request the pump to home, aspirate, or
dispense.
3 A-Line Home the outer or inner Reagent Supply Center segments.
(Outer) and B-
Line (Inner)
4 B.Code Turn the Bar Code Reader ON.
5 This area displays a blue triangle when the System is busy. A green square displays when the
status is READY.
NOTE: When the System is busy, no further commands are acknowledged until the
original command is completed.

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MODULE 11: COMPONENT REPLACEMENT AND TROUBLESHOOTING

Rxn (Reaction) Area Page


• Rxn Carousel: 6 7 8 9 10 12
• Trigger= check on
the reaction
carousel
1
alignment.
Check = FSR use.
• Touch “ON” if
you hear a beep
beep (UFO 2
sound), is aligned
properly. 3
• Try one step for
each trigger. 4
• Photometer:
• Shutter-keeps 5
light from
shining in
photometer.
• Lamp/lens/
11
cuvette/lens
shutter/
Figure 11.12: MAINTNENANCE UTILITIES Screen, Rxn Area Page
photometer
(order of optics).
• Cuvette blank-A Item Field Allows the Operator to…
line and B line 1 Mixer Move the Mixer horizontally or vertically. The horizontal
cuvettes control allows the Mixer to move to the following positions:
• Touch “check” Home, CUV (cuvette), and WCup (Wash Cup).
shows all 165 The Operator may also have the Mixer vibrate.
cuvettes
2 Rxn (Reaction) Move the Reaction Carousel home and move the carousel by
• If any #s here Carousel one step or by ¼ turn. The Operator may test the trigger
exceed check (triggers the photometer read). When the Trigger Check is
values it will be performed, an audible beep indicates that it is performing as
highlighted in red expected.
and cuvette won’t
3 Cuvette Washer Move the Cuvette Washer up, down, step down, or through an
be used. Generates entire cycle.
error log message
338. 4 Photometer Collect electronic A/D data for the photometer and the ICT™,
turn the shutter ON or OFF, and access the cuvette blank/
• Instrument knows Cuvette Integrity data.
to skip bad ones.
5 ICT Move the ICT Unit vertically and horizontally. The horizontal
• If was red in past, control allows the ICT Unit to move to the following positions:
but next time OK, Home, Cuv (cuvette), and Cup (ICT Reference Solution cup).
will display yellow.
• Yellow designation
goes away after

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MAINTENANCE UTILITIES Screen

Item Field Allows the Operator to…


6 Wash Pump Cycle the Probe Wash Pump.
7 W (wash) Cup Cycle the fluid into the wash cups.
8 Bath Drain or fill the water bath. The Fill button may need to be
selected several times to completely fill the water bath.
9 IRef Pump Cycle the pump.
10 Asp (aspiration) Cycle the pump.
Pump
11 This area displays a blue triangle when the System is busy. A
green square will display when the status is READY.
NOTE: When the System is busy, no further
commands are acknowledged until the original
command is completed.
12 <Home All> Home all robotics.

SW (Software) Page
• Current date is also displayed.
• Check sums to check on
install of new software
version.

Figure 11.13: MAINTENANCE UTILITIES Screen, SW Info Page


This page allows the Operator to view the current software version.

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MODULE 11: COMPONENT REPLACEMENT AND TROUBLESHOOTING

COMPONENT REPLACEMENT
Review each component to be replaced and the reasons for doing so, then demo the replacement
procedures using the Ops Manual.

Instructor will need:


Your instructor will demonstrate the correct removal and replacement
• Phillips™ screwdriver procedures of the following components:
• #7 Wrench
• Sample Probes and tubing
• #10 Wrench
• Reagent Probes and tubing
• Absorbent towel
• Flathead screwdriver • Cuvette Dryer Tips
• Cotton swabs • Mixer

• Cuvette Dryer Tips-keep tips in • Cuvette Segment or Cuvette Pair


the bag for installation to • Sample Carousel Tube Bottom Holder
prevent contact by fingers.
• Source lamp
• Cuvette Pair- Caution: Insert
new cuvette with opening to • Poppet valve
the top.
The following table describes some of the common reasons for replacing
the sample and reagent dispense components:

Component Reason for Replacement


Sample and Reagent • Damage due to a probe crash
Probes • The flow from the probe tip is not smooth and
straight
• Result imprecision
Sample and Reagent • The connection between the probes and the
Probe Tubing tubing is loose or leaking
• Bubbles in the tubing are observed during
monthly maintenance
• Result imprecision
Cuvette Dryer Tips • Cuvettes are not being dried completely
• Damage due to contact with the Reaction
Carousel
• Result imprecision
Mixer • Damage due to crash
• Result imprecision
Cuvette Segment • Damaged trigger sensor notch
• Segment broken
Cuvette Pair • Cuvette Integrity Check failed due to a scratched
or worn cuvette

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Component Replacement

Component Reason for Replacement


Sample Carousel Tube • Worn or damaged
Bottom Holder • Missing or lost
Source Lamp • Photometer errors
• Lamp intensity errors
• Result imprecision
Poppet Valve • High-concentration waste not aspirating from
cuvettes
• Dripping from high-concentration waste nozzles
on the cuvette washer
• Movement not as expected

NOTE: The above table includes some of the most common


reasons for replacing the listed components and is not intended
to be a comprehensive list of all the possible reasons for
replacing components.

For information about the removal and replacement of


the sample and reagent dispense components, refer to
Component Replacement in Section 9, Service and
Maintenance of the AEROSET System Operations
Manual.
Perform the Sample and Reagent Dispense Component Replacement
Activity at the end of this Module.

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MODULE 11: COMPONENT REPLACEMENT AND TROUBLESHOOTING

Component Replacement Activity


Introduction
In this exercise, you are going to remove and replace the sample and
reagent dispense components, and the Reaction area components.

Objective
Upon completion of the Component Replacement Activity, you will be
familiar with:
• Removing and replacing the Sample Probes and Sample Probe
tubing
• Removing and replacing the Reagent Probes and Reagent Probe
tubing
• Removing and replacing the Mixers
• Removing and replacing the Cuvette Pairs
• Removing and replacing the Sample Carousel Tube Bottom Holders
• Removing and replacing the Source Lamp
• Removing and replacing Poppet Valves

Necessary Materials
• AEROSET System Operations Manual

Procedure
The information for the following steps is found in the AEROSET
System Operations Manual.
Refer to Component Replacement in Section 9, Service and
Maintenance of the AEROSET System Operations Manual to perform
the following procedures:
1. Remove and replace one of the Sample Probes.
2. Remove and replace one of the Reagent Probes.
3. Remove and replace one of the Mixers.
4. Remove and replace one of the Cuvette Pairs.
5. Remove and replace one of the Sample Carousel Tube Bottom
Holders.
6. Remove and replace the Source Lamp.
7. Remove and replace Poppet Valves.

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Review Questions

REVIEW QUESTIONS
1. If more than one Result Error Code is generated for a result, on
which screen are all the codes displayed?

2. What is typed on the Log On screen to SHUTDOWN the software


prior to Powering OFF?

3. How does the System indicate that a cuvette has failed the Integrity
Check and may need to be changed?

4. An Operator ran some QC samples after replacing the source lamp


and got the Result Error Code of “PHO” for multiple assays. What
could be causing this error?

5. Name six activities that can be performed in the MAINTENANCE


UTILITIES screen.
______________________________________________
______________________________________________
______________________________________________
______________________________________________
______________________________________________
______________________________________________
6. Leaking is observed from the High-Concentration Waste Pumps A
and B or from Probe Wash Pump A or B. What may need to be
replaced?

7. When replacing the dryer tips, a distance of _____________ should


be measured from the bottom of the dryer tip to the underside of the
nozzle mounting plate.

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MODULE 11: COMPONENT REPLACEMENT AND TROUBLESHOOTING

ANSWERS
1. The Reaction Graph screen
2. “bye”
3. An Error Log Message is generated and the cuvette position is
displayed with a red background on the Cuvette Integrity screen in
MAINTENANCE UTILITIES.
4. The lamp housing cover was not correctly seated.
5. Any six of the following:
a. Setting the date and time
b. Defining the Automatic Power ON, START UP, and
SHUTDOWN
c. Component tracking
d. Assay counts
e. System Software Backup and Restore
f. Formatting a floppy disk
g. Library Maintenance
h. Manually moving robotics
i. Scan bar codes
j. View cuvette integrity
k. View electronic A/D data for the photometer and ICT™
Unit
l. View the current software version
6. Poppet Valves
7. 61mm

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Summary

SUMMARY
In this Module, you have:
• Identified the different Error Messages and Codes that are displayed
by the System
• Demonstrated the correct Power OFF Procedure
• Successfully removed and replaced the AEROSET System
components
• Identified and used the various pages of the MAINTENANCE
UTILITIES screen

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MODULE 11: COMPONENT REPLACEMENT AND TROUBLESHOOTING

NOTES

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MODULE 12: ACTIVITIES

MODULE 12:
ACTIVITIES

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MODULE 12: ACTIVITIES

CONTENTS
Page

Multiple Skills Activity . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3


Lab Day Activity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7

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Multiple Skills Activity

MODULE 12: ACTIVITIES

MULTIPLE SKILLS ACTIVITY

Introduction
In this activity, you will combine the basic operations procedures that
have been presented in the Basic Run, Run Options, Result Handling,
Calibration, and Quality Control Modules.

Objective
Upon completion of the Multiple Skills Activity, you will be familiar
with:
• Performing a basic run
• Ordering a calibration
• Ordering controls
• Limiting a run
• Rerunning results
• Editing results
• Selecting rerun results
• Validating results
• Printing results

Necessary Materials

• Instructor will need to get Reagents:


prepared tubes, along with
QC material, MCC’s, and • ICT™ Sample Diluent, Albumin, ALT, AST, Calcium, Creatinine,
possibly ICT calibrators. Glucose, Phosphorus, Total Protein, Urea, and Iron

Other:
• Patient samples, Multiconstituent Calibrators, and QC material

NOTE: Panel names have bolded text.

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MODULE 12: ACTIVITIES

Beginning the Run


1. Select <Database> from the Information Access Area.

2. Select <Order>.

3. Select <New>, if necessary, to display the Order Samples screen.

4. Order the following routine patient samples:


(select any carrier/position on the FastTrack™ Sampler desired)
SID Name PID Other Assays
7896 Mander, Sally 12349876 ICT
crea (Dil 1)
7899 Zuma, Monty A456 Location: Chem2, Iron
ICU
8002 Monk, Chip NUTS ALL
8035 Pease, Warren 1998 Comment: Crea, Urea (a manual
Icteric dilution of 1:10 was
performed on this
sample)
8036 Mander, Jerry ABCD Ca (5 reps)
8037 Ringing, !@#$% ALL
Isobelle
8045 Evore, Herb 555777 ICT, Phos, TP, AlbP

5. Order the following priority patient samples:


(select any C/P in the Sample Carousel desired):
SID Name Assays
8027 Fish, Golda Glu (Dil 2), Crea (Dil 1)
8032 Lergy, Al Ca
8041 Geste, Shirley U. ICT, Crea, Urea

6. Highlight the ordered patient samples on the DATABASE screen


and print a Loadlist.

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Multiple Skills Activity

7. Select <RUN> to display the RUN OPTIONS screen and make the
following selections:
a. Run the patient samples
b. Limit the run to analyze all assays except Phosphorus
c. Run Start-QC for all assays
d. Run End-QC

8. Load the patient and QC samples, then initiate the run.


NOTE: Wait for the samples to begin sampling before
proceeding to the next step.

Adding a Sample in the Reserved STAT Position


1. Confirm that the STAT Sampling Indicator Light is not illuminated,
then place the sample in the Reserved STAT Position.

2. Order the following sample and initiate the run:


SID Assays
8050 ICT, Glu, Ca

Adding Patient Samples During a Run


1. Add the following routine patient samples:
SID Name Assays
8046 Soar, Dinah Chem2
8048 Teak, Anne Chem2
8051 Sharalike, Sharon Chem2

2. Load and initiate the run using the appropriate procedure for the
System status of your instrument.

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MODULE 12: ACTIVITIES

Adding a Calibration
1. Review the Start-QC results for Albumin.

2. Pretend that the Albumin QC results are out of range.

3. Calibrate the Albumin assay and select the QC after Calib option.

4. Load the calibrators and initiate the run.

Rerunning Results
1. Confirm that Albumin calibration is complete.

2. Request that all the Albumin results on the patient samples be rerun.

3. Ensure that the samples are still onboard and available for sampling.

4. Initiate the run using the appropriate procedure for the System status
of your instrument.

5. While in the RUN OPTIONS screen, deselect the Limited Run


option.

Reviewing Results
When all results are complete, perform the following steps:
1. Select the rerun results on Albumin.

2. The sample used for the Calcium result on Al Lergy was manually
diluted 1:2, but you forgot to enter the Manual Dilution factor when
ordering the sample. Multiply the answer by 2 and edit the result.

3. Review all incomplete samples and accept or select the results.

4. Validate all samples.

5. The doctor requested a reprint of the report for Monty Zuma.


Request a print of Form 1 for this sample.

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Lab Day Activity

LAB DAY ACTIVITY

Introduction
• Instructor will need to change The purpose of this exercise is to simulate a typical day in the laboratory.
query mode to sample bar This involves completing common activities such as performing START
codes, clear database, and UP and Daily Checks, ordering tests, and ordering controls. You are
cycle power. Ensure host responsible for organizing workflow, evaluating QC values, and
simulators are properly obtaining results for routine and STAT samples. These realistic
configured and functioning. challenges allow you to integrate the information you have learned.
As with any typical day in the laboratory, not everything will go as
expected. Controls may be out of range, and you may have to rerun
samples. Fortunately, the skills and knowledge you learned in earlier
Modules will allow you to overcome these challenges successfully.

Objective
Upon completion of the Lab Day Activity, you will be familiar with:
• Performing a basic run
• Ordering a calibration
• Ordering quality control
• Rerunning results
• Selecting rerun results
• Validating results
• Printing results

Necessary Materials

• Will need bar coded tube sets Reagents:


from refrigerator and labeled
tubes for 4 non-bar coded • ICT™ Sample Diluent, Albumin, ALT, AST, Calcium, Creatinine,
samples. Glucose, Phosphorus, Total Protein, Urea, and Iron.

Other:
• Patient samples, Multiconstituent Calibrators, and QC material

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MODULE 12: ACTIVITIES

Instrument Set-up
Confirm or edit the following configuration parameters:
1. SYSTEM CONFIGURATION screen:
• Select the Auto Validate option

2. Printer A Configuration screen:


• Result Printing Mode > All
• Select the Auto-Print Calibration Reports option
• Select the Auto-Print Control Reports option
• Select the Auto-Print Patient Reports option

3. Printer B Configuration screen:


• Result Printing Mode > Request
• Select the Auto-Print Control Reports option
• Select the Auto-Print Patient Reports option

4. ONLINE CONFIGURATION screen:


• Protocol Type > Type 1’
• Result Transmission Mode > All
• Deselect the Transmit QC Results option
• Deselect the Use Transmission Check Digit option
• RS-232 Config > 8L-1S-NP and 9600

Begin Your Day


1. Perform the START UP Procedure for 24 hour operation.

2. Perform the Daily Checks.

3. Ensure that all assays are ready to run. If any assay buttons on the
ASSAYS screen are not green, evaluate and resolve the issue
(calibrate, add reagent, etc.).

4. Order and run Start-QC for all assays.

12-8 AEROSET® Customer Training Guide


94858-103 — July 2003
Lab Day Activity

Starting the Patient Samples


1. You have 10 bar code labeled patient samples to run and one of the
samples is STAT. To run the STAT sample perform the following:
a. Load the STAT sample into the Reserved STAT Position.
b. Select <STAT> from the Information Access Area.
c. Enter the bar code number into the Sample ID field on the
ORDER ASSAYS FOR STAT screen. (Do not order any
assays.)
d. Select <Start> in the right-hand column.

2. Load the remaining routine samples on the FastTrack™ Sampler


and initiate the run using the appropriate procedure for the System
status of your instrument.

Controls Out of Range


1. Review the Start-QC results.

2. Determine the cause of any values that are out of range and rerun the
Start-QC, if necessary.

Manually Enter Priority Orders


1. The Emergency Room sent up four priority samples. Manually enter
these orders to be run in the Sample Carousel. SID is required.
Name Assays
Kode, Morris ICT™ assays, Glu, Crea, Urea
Kain, Candy ICT™ assays, Iron
Ferterbest, Hope Ca, Phos, ALT, AST
Septic, Anna Glu

2. Load the samples and initiate the run using the appropriate
procedure for the System status of your instrument.

AEROSET® Customer Training Guide 12-9


94858-103 — July 2003
MODULE 12: ACTIVITIES

Rerunning and Adding Assays


1. The Emergency Room called and asked to add Sodium, Potassium,
Chloride, and Calcium to Anna Septic.

2. Dr. Dolittle wants the glucose rerun on the STAT sample. To rerun
a sample in the Reserved STAT Position, perform the following
steps:
a. Request the rerun on the DATABASE or RESULT screen as
usual.
b. Ensure the correct sample is still loaded in the Reserved STAT
Position.
c. Select <STAT> from the Information Access Area.
d. Enter the bar code number into the Sample ID field on the
ORDER ASSAYS FOR STAT screen. (Do not order any
assays.)
e. Select <Start> in the right-hand column.

Reviewing Results
When the patient samples are completed, perform the following:

NOTE: All samples without Result Error Codes or rerun results


should be auto validated.

1. Select the rerun result for the STAT sample and validate the sample.

2. Review any incomplete samples and accept or select the results.

3. Validate any samples that have not been auto validated.

4. The Emergency Room explained that their computer is down and


that they need to have printed reports sent. Print Form 2 reports for
the 4 priority samples sent from the ER.

12-10 AEROSET® Customer Training Guide


94858-103 — July 2003
GLOSSARY : GLOSSARY

GLOSSARY

AEROSET® Customer Training Guide Glossary-1


94858-103 — July 2003
GLOSSARY

Glossary

1-Point Adjustment A calibration type that uses the absorbance data for a single calibrator to adjust
the calibration curve.

2-Point Adjustment A calibration type that uses the absorbance data for the reagent blank and a
calibrator to adjust the calibration curve.

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 A 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 specified range a Result Error Code is generated.

Absorbance Mode A 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.

Accessory An item that is used repeatedly.

Glossary-2 AEROSET® Customer Training Guide


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GLOSSARY

Acid Wash Solution Used to clean Reagent and Sample Probes and Reaction Cuvettes.

Action Area Right hand column area of the Main Display that displays action area buttons.

A-Line Assay configuration that defines the reagent location as the outer segments (A,
B, or C) of the Reagent Supply Center.

Alkaline Wash Solution Used to clean Reagent and Sample Probes and Reaction Cuvettes.

Application Describes the assay parameter definition procedures, etc.

Auto Rerun A function that allows the Operator to configure the System to automatically
reorder assays for those samples that meet user specified criteria on an “assay
by assay” basis.

Auto Return A System configuration designed to automatically return samples identified for
rerun to the Sample Arm.

AEROSET® Customer Training Guide Glossary-3


94858-103 — July 2003
GLOSSARY

Biohazard A situation where the Operator may be exposed to infectious materials or


substances.

Blank Correction A calibration type performed that uses reagent blank data only to adjust the
calibration curve.

B-Line Assay configuration that defines the reagent location as the inner segment (D)
of the Reagent Supply Center.

Button A screen operation that is selected for a specific action.

Calculated Absorbance The rate of change of absorbance calculated using the Linear Least Squares
method.

Calibration, Automatic A calibration that occurs automatically after a Reagent Cartridge change,
reagent lot change, or at the end of a calibration interval.

Calibration, Exponent A calibration mode for assays in which the absorbance or absorbance change
diverges as the concentration increases.

Glossary-4 AEROSET® Customer Training Guide


94858-103 — July 2003
GLOSSARY

Calibration, Linear Mode A calibration mode in which a reagent blank and one type of calibrator are
(1-Point Method) measured, and a calibration curve is generated using these two data points.

Calibration, Linear Mode A calibration mode in which a reagent blank and two to eight calibrators of
(Multi-Point Method) different concentrations are measured, and a calibration curve is generated
using these data points.

Calibration, Logit-4 A calibration mode for assays in which the absorbance or absorbance change
increases as the concentration increases.

Calibration, Logit-5 A calibration mode for assays in which the absorbance or absorbance change
increases as the concentration increases. Uses one more parameter than Logit-4.

Calibration, Operator- A calibration that is manually requested.


Specified Calibration

Calibration, Spline A non-linear calibration mode.

AEROSET® Customer Training Guide Glossary-5


94858-103 — July 2003
GLOSSARY

Calibration, Use Fac/Blk A calibration mode in which the concentration or activity is calculated using the
(Factor and Blank) factor and reagent blank from a calibration curve generated for another assay.

Calibration, Use Factor A calibration mode in which the concentration or activity is calculated using the
(Factor Only) factor from a calibration curve generated for another test. Reagent blank
measurement is required even if the calibration curve of another assay is used.

Calibrator/Control A carousel (located in the Carousel Sampler) that has the capacity of 45
Carousel positions for calibrators and controls.

Carousel A circular conveyor on which samples are placed.

Carousel Sampler A sampler system on the AEROSET System which contains the Sample
Carousel, Reserved STAT Position, and Calibrator/Control Carousel.

CE (CE Marking) Meets applicable New Approach Directives of the European Union.

Checkbox A screen operation that utilizes a box to the left of an item. By selecting the box,
an item is selected with a check mark.

Glossary-6 AEROSET® Customer Training Guide


94858-103 — July 2003
GLOSSARY

Color Correction Performed on the absorbance data (in the absorbance window) to correct for
sample color.

Color Touchscreen A 17" color CRT monitor with Touchscreen.


Monitor

Computer Refers to an IBM PC/AT compatible computer that is connected to the


AEROSET System.

Consumable An item that is exhausted in the process of running tests.

Cuvette Washer A series of nozzles including a drying nozzle that wash and dry the cuvettes.

Display Area Area of the Touchscreen that displays the information or actions, corresponding
to the button selected, in the Information Access Area or Action Area.

Drop-down List Box A screen operation that shows a single item. Other choices can be seen by
selecting the button on the right side of the Drop-down list box.

AEROSET® Customer Training Guide Glossary-7


94858-103 — July 2003
GLOSSARY

Drying Tip Placed on the end of the Cuvette Washer nozzle that is used to dry the cuvette
before a sample is dispensed.

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 An assay in which the concentration is calculated using the absorbance data
obtained in the Main Read Time specified on the Base page of the ASSAY
CONFIGURATION screen.

Extrapolated Calculation For the calculation of patient samples with concentrations higher than the
calibrators, the calibration curve may be extrapolated.

Factor Mode A calibration mode in which only the reagent blank is measured, and a user
defined factor is used to calculate results.

FastTrack™ Sampler The Track Sampler on the AEROSET System has the capacity of holding up to
200 samples.

Glossary-8 AEROSET® Customer Training Guide


94858-103 — July 2003
GLOSSARY

FlexRate™ Method 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 is identified by "FLX").

Full Calibration A calibration type performed for all data points specified for the reagent blank
and calibrators.

Hazards Situations that could cause physical harm to a user or damage to the Analyzer or
laboratory environment.

Host An auxiliary computer system that can communicate with the AEROSET
System.

Host Interface Operation The act of communication between the AEROSET System and a Host computer
system.

Host Interface Status Display (via the Touchscreen) in which the Host interface status can be
Display checked.

AEROSET® Customer Training Guide Glossary-9


94858-103 — July 2003
GLOSSARY

ICT Diluent The reagent used for ICT assays.

ICT Module Contains the Ion-Selective Electrodes.

ICT Reference Solution Used to rinse the ICT Module between samples and used as a baseline when
calculating ICT results.

ICT Reference Solution Holds the ICT Reference Solution. A sensor detects the remaining volume by
Bottle monitoring weight changes and issues a warning when the volume is less than
the specified level.

ICT Reference Solution Preheats the ICT Reference Solution in the stainless steel tube located in the
Preheater water bath before it is used to fill the ICT Reference Solution cup.

ICT Reference Solution Fills and drains the ICT Reference Solution into the ICT Reference Solution
Pump cup.

ICT Unit Moves the isothermal block equipped with the ICT Module to the ICT
Reference Solution cup and to the Reaction Cuvettes.

Glossary-10 AEROSET® Customer Training Guide


94858-103 — July 2003
GLOSSARY

ICT™ (Integrated Chip Method in which Na+, K+, and Cl- are measured potentiometrically.
Technology)

ICT™ Aspiration Pump Aspirates the 300 µL of ICT Reference Solution or diluted sample into the ICT
Module using a syringe pump.

ICT™ Cleaning Fluid Used to clean the ICT Probe and the ICT Module.

Information Access Area Area at the bottom of the Main Display that contains buttons to select
information, configuration, and databases.

Integrated Chip Solid state Ion-Selective Electrodes utilizing indirect potentiometry for
Technology™ (ICT) determinations of Na+, K+, and Cl-.

Isozyme Mode A calibration mode in which the isozyme activity is calculated from samples
which contain two types of isozymes.

Keyboard Computer component used for entering information into the AEROSET System
Control Center (SCC).

AEROSET® Customer Training Guide Glossary-11


94858-103 — July 2003
GLOSSARY

LED Light emitting diode. Used on the AEROSET System to indicate the status of
the Carousel Sampler and FastTrack Sampler systems.

Levey-Jennings Graphs Control graphs that are used to monitor mean and range of control measurement
values from run to run.

Line Balance™ (LB) A function that improves throughput with efficient utilization of cuvette pairs,
Function minimizing the single-test measurement cycles.

Linearity % A check of a rate assay to ensure that the reaction remains linear during the
Main Read Time. This parameter is used to check for substrate depletion.

Linearity Range The minimum and maximum reportable values of an assay.

Liquid Level Sensing Detection of liquid level; measured by the change in capacitance.

Local User Interface (LUI) Used for manually controlling the FastTrack Sampler and the Reagent Supply
Centers.

Glossary-12 AEROSET® Customer Training Guide


94858-103 — July 2003
GLOSSARY

Main Circuit Breaker Turns the power ON/OFF for the entire System.
Switch

Main Display Main portion (bottom and right-hand frame) of the Touchscreen user interface.

Maintenance Procedures performed on the AEROSET System to ensure continued proper


functioning.

MaxAbsVar The stability of the reaction of an end-point assay during the Main Read Time.

Mixer Unit A unit that houses the Mixers.

Mixers Blades that mix the sample and reagent together.

On-line Configuration System parameters that can be configured to allow the AEROSET System to
communicate with a Host system. For example, communication type, baud rate,
message length, etc.

AEROSET® Customer Training Guide Glossary-13


94858-103 — July 2003
GLOSSARY

Optimum Sampling A function that maximizes the processing speed when the SmartWash™
Sequence™ (OSS) Feature is in use. It rearranges the sampling sequence so that the number of
Function empty Reaction Cuvettes is minimized.

Panel A function where multiple tests can be ordered quickly by touching only one
button instead of all the individual assay buttons.

Panic Value High (PVH) Result code that notifies Operator that the result generated is higher than the
configured High Panic Value.

Panic Value Low (PVL) Result code that notifies Operator that the result generated is lower than the
configured Low Panic Value.

Photometer An instrument for measuring luminous intensity, luminous flux, illumination, or


brightness.

Photometric Reads A series of reads taken on each Reaction Cuvette.

Glossary-14 AEROSET® Customer Training Guide


94858-103 — July 2003
GLOSSARY

Photometric timing Represents the elapsed time at each of the 33 photometric points with the first
photometric point defined at 0 seconds.

Printer AEROSET dot matrix forms printer.

Probe Guard A function of the AEROSET System that stops the lowering of the probe when
an obstacle is detected.

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 due to
antibody depletion.

Qualitative Ranges A function that reports test results using conditional text (+/-, Pos/Neg) instead
of numerical values.

Quality Control The process of tracking and analyzing historical results via standardized
graphing techniques.

Quantitative Ranges A function that reports test results as a numerical value.

AEROSET® Customer Training Guide Glossary-15


94858-103 — July 2003
GLOSSARY

Rate Assay An assay in which activity is calculated using the change of absorbance in the
Main Read Time specified on the Base page of the ASSAY CONFIGURATION
screen.

RATE Linearity The linearity of the absorbance change within the read time.

RATE RATIO A ratio of absorbance changes (A/B) used as a reaction check for Prozone.

RATE SUB Differences between absorbance changes (A-B) used as a reaction check for
Prozone.

Reaction Carousel Carousel that can hold 330 Reaction Cuvettes, and rotates approximately a
quarter turn, counterclockwise, every cycle. Reactions take place here.

Reaction Cuvette Rectangular glass cuvette.

Reaction Temperature Temperature maintained by the water bath.


Control

Glossary-16 AEROSET® Customer Training Guide


94858-103 — July 2003
GLOSSARY

Reagent Arm Holds the Reagent Probe. Moves reagent from each Reagent Supply Center to
the Reaction Carousel.

Reagent Probe Dispenses the specified volumes of reagent.

Reagent Segments Sections (4) of each Reagent Supply Center in which the reagent is placed.

Reagent Supply Center Dual carousel which holds the Reagent Cartridges. There are two Reagent
Supply Centers on the AEROSET System.

Reference Range Normal clinical range of an analyte.

Reportable Range The range of an assay.

Reserved STAT Position A single fixed position in the Carousel Sampler for running STAT samples.

AEROSET® Customer Training Guide Glossary-17


94858-103 — July 2003
GLOSSARY

Result Error Code Error codes of the AEROSET System reported with the result.

Rotary Power Control Turns the power ON/OFF for units other than the reagent refrigerator.
Switch

Run Progress Area Area of the Main Display that shows the progress of analysis.

Sample Arm Holds the Sample Probes. Carries the Sample Probes from the FastTrack™
Sampler or Sample Carousel to the Reaction Carousel.

Sample Blank Test Measurement used for correcting the absorbance data obtained during the Main
Read Time. There are two kinds of Sample Blank Tests (self blank and non-self
blank).

Sample Blank Test, Sample Blank Test used to eliminate the effect of endogenous substances.
Non-Self Blank Performed in a second Reaction Cuvette.

Sample Blank Test, Self Sample Blank Test used to correct the absorbance for sample coloring due to
Blank lipemia, hemolysis, bilirubin, etc. Performed in the same Reaction Cuvette.

Glossary-18 AEROSET® Customer Training Guide


94858-103 — July 2003
GLOSSARY

Sample Carousel A carousel (located in the Carousel Sampler) that has a capacity of 30 samples.

Sample Carrier A carrier that can hold up to five samples. Used in the FastTrack Sampler.

Sample Carrier Tray A tray that can hold up to 10 Sample Carriers. Used in the FastTrack Sampler.

Sample Cup A type of sample container that can be used in the FastTrack and Carousel
Samplers.

Sample Probe Dispenses samples into Reaction Cuvettes.

Scroll Box A screen operation that displays several tests or other items by scrolling with a
scroll bar.

Single Selection Button A circular button that allows for selection of one button or the other, but not
both, and will not allow both to remain unchecked. Also known as radio button.

AEROSET® Customer Training Guide Glossary-19


94858-103 — July 2003
GLOSSARY

SmartWash™ Feature A wash process to wash the Reagent Probes, Sample Probes, and Reaction
Cuvettes completely when combinations of assays which can cause test-to-test
interference are processed.

Solenoid Valve Six valves located at the top of the Sample and Reagent Syringe Drives.

Specifications Describes the measurement principles, power requirements of the AEROSET


System, etc.

Status Area Area of the Main Display that displays the System status, date and time, water
bath level, and High-Concentration Waste Full Indicator.

System Control Center Contains hardware (computer, keyboard, printer, and monitor) and software.
(SCC)

System Control Center A stand which holds the computer, monitor, keyboard, and printer.
Stand

Tab A screen operation that when selected opens the corresponding page.

Glossary-20 AEROSET® Customer Training Guide


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GLOSSARY

Test Limiting Function A function that allows the Operator to exclude some tests, previously scheduled
for the patient sample, without changing the order.

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 Screen that allows the user to make a selection by touching the screen.

Warranty 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 and maintains the reaction
temperature.

AEROSET® Customer Training Guide Glossary-21


94858-103 — July 2003
GLOSSARY

Water Bath Additive A solution added when the bath water is changed to inhibit bacterial growth and
prevent bubble formation.

Westgard Multi-Rule A series of statistical control rules for interpreting control data that keep the
probability for false rejections low and improve the probability for error
detection. Can be adapted to existing Levey-Jennings graphs by addition of one
or two sets of control limits.

Glossary-22 AEROSET® Customer Training Guide


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APPENDIXHAZARDS

APPENDIX:
HAZARDS

AEROSET® Customer Training Guide Appendix-1


94858-103 — July 2003
APPENDIX: HAZARDS

CONTENTS
Page
Hazard Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix-3
Biosafety Hazards . . . . . . . . . . . . . . . . . . . . . . . . Appendix-4
Chemical Hazards . . . . . . . . . . . . . . . . . . . . . . . . Appendix-8
Electrical Hazards . . . . . . . . . . . . . . . . . . . . . . . Appendix-10
Mechanical Hazards . . . . . . . . . . . . . . . . . . . . . . Appendix-11
Physical Hazards . . . . . . . . . . . . . . . . . . . . . . . . Appendix-13

Appendix-2 AEROSET® Customer Training Guide


94858-103 — July 2003
Hazard Types

HAZARD TYPES
Classifications of hazards covered include the following types:
• Biosafety
• Chemical
• Electrical
• Mechanical
• Physical
• Laser

AEROSET® Customer Training Guide Appendix-3


94858-103 — July 2003
HAZARDS

BIOSAFETY HAZARDS
Persons who use the AEROSET System, and persons who are in the
vicinity of the System, must be aware that the following activities
involve the actual or potential presence of a biological hazard:
• 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. Appears on the AEROSET
System and in this manual to identify potentially infectious
areas.

Appendix-4 AEROSET® Customer Training Guide


94858-103 — July 2003
Biosafety Hazards

Required Precautions
Consider all clinical specimens, reagents, controls, etc., that contain
human blood, and surfaces or components that have come into contact
with human blood and the above materials as potentially infectious.
Observe the following precautions when encountering potentially
biohazardous conditions:
• Wear gloves, lab coats, and safety glasses.
• Follow other biosafety practices as specified in the OSHA
Bloodborne Pathogen Rule (29 CFR Part 1910.1030) or other
equivalent biosafety procedures.

Handling Probes
The probes are sharp and potentially contaminated with infectious
materials. Avoid contact with the tip of the probes.

Cleaning Spills
Clean spills of potentially infectious materials in accordance with
established biosafety practices. A generally accepted procedure for
cleaning such spills is to:
1. Absorb the spill with absorbent material.

2. Wipe the spill area with a detergent solution.

3. Wipe the area with an appropriate disinfectant such as a 0.5%


sodium hypochlorite (10% solution chlorine bleach containing at
least 5% sodium hypochlorite).

4. Dispose of spilled and contaminated material in accordance with


local, state and federal regulations.

AEROSET® Customer Training Guide Appendix-5


94858-103 — July 2003
HAZARDS

Handling and Disposing of Waste


Dispose of the following materials in accordance with local, state, and
federal regulations:
• Clinical specimens
• Reagents
• Controls
• Calibrators
• Other consumables that may be contaminated
• AEROSET System bulk solutions
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.

Types of Waste Disposal Method

Solid Waste Use generally accepted procedures such as


incineration or autoclaving to treat potentially
infectious solid waste. If using an autoclave,
verify the effectiveness of the decontamination
cycle.
Sharps Place sharps, such as contaminated probes, in an
appropriately marked, puncture-resistant
container prior to treatment and disposal.

Liquid Waste Neutralize liquid waste containing acid prior to


disposal.
Add a disinfectant to the Waste Container to help
inactivate the infectious organisms.

Appendix-6 AEROSET® Customer Training Guide


94858-103 — July 2003
Biosafety Hazards

Decontamination Procedure Requirements


Instruments must be decontaminated prior to servicing, shipment, or
movement. For the AEROSET System, decontaminate the following
elements:

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 Surfaces and Wipe the surface or component with a detergent solution then wipe the unit with an
Components appropriate disinfectant, such as 0.5% sodium hypochlorite (10% solution of
chlorine bleach containing at least 5% sodium hypochlorite). Allow to air dry at
least 10 minutes.

High-concentration Waste Rinse the container with a detergent solution then rinse the container with an
Container/Hose appropriate disinfectant, such as 0.5% sodium hypochlorite (10% solution of
chlorine bleach containing at least 5% sodium hypochlorite).

Liquid Material Before shipment, servicing, or relocation, remove all samples, reagents, controls,
calibrators, consumable solutions, and disposables from the AEROSET System.

Related Information
Refer to Section 9, Service and Maintenance of the AEROSET System
Operations Manual for additional instructions for cleaning and
maintaining AEROSET System components.

AEROSET® Customer Training Guide Appendix-7


94858-103 — July 2003
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
the assay-specific 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.

Warning Label
CAUTION: Chemical Hazard. Identifies a potential
! chemical hazard.

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.
• If irritation or signs of toxicity occur after exposure, seek medical
attention.
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 on 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.

Appendix-8 AEROSET® Customer Training Guide


94858-103 — July 2003
Chemical Hazards

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.

AEROSET® Customer Training Guide Appendix-9


94858-103 — July 2003
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. Elements of electrical safety include, but are not limited to the
following:
• Periodically inspect electrical cabling into and on the AEROSET
System for signs of wear and damage.
• Turn the instrument OFF before disconnecting the power cord and
before servicing any electrical or internal components.
• 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 equipment.
• Keep liquids away from all connectors of electrical or
communication components. Unplug the instrument before
clean-up of major liquid spills.
• Do not touch any switches or outlets with wet hands.
• Keep the floor dry and clean under and around the AEROSET
System.
• Use only approved power cords and electrical accessories, such as
those supplied with the instrument, to protect against electric shock.
Connect power cords only to properly grounded outlets.
• It is recommended that a ground fault circuit interrupter be used
when working in a wet environment.
• Only qualified personnel should perform electrical servicing.

Appendix-10 AEROSET® Customer Training Guide


94858-103 — July 2003
Mechanical Hazards

MECHANICAL HAZARDS
The AEROSET System is a fully automated, dual pipetting system 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 Analyzer by the
Operator. It is very important that sample cups and reagent cartridges are
correctly positioned before executing any program. 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 Analyzer’s working
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

AEROSET® Customer Training Guide Appendix-11


94858-103 — July 2003
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 Analyzer.
• 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.
• Be especially cautious 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.

Appendix-12 AEROSET® Customer Training Guide


94858-103 — July 2003
Physical Hazards

PHYSICAL HAZARDS
Follow safe practices in the following situations to avoid physical injury.

Exposure to Laser Light


CAUTION: Class II Laser Product. Do not stare into
the beam or view directly with optical instruments.
Class II denotes low-power visible lasers or laser system.
Because of normal human aversion response, e.g.,
blinking, eye movement, etc., they normally do not
present a hazard to eyes. During normal operation, the
inner protective covers must remain in place to prevent
laser light exposure from the optics bench. The inner
protective covers should only be removed by qualified
Abbott Service Representatives.

Exposure to 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.

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.

AEROSET® Customer Training Guide Appendix-13


94858-103 — July 2003
HAZARDS

NOTES

Appendix-14 AEROSET® Customer Training Guide


94858-103 — July 2003
INDEX

AEROSET® Customer Training Guide Index-1


94858-103 — July 2003
Index

A Warning Labels Appendix-8


Component Replacement 11-20
Accepting Results 5-14
Configuration 8-1
Action Area 1-33
Host 8-21
Adding Assays to a Completed Sample 5-30
Log On Password 8-6
Adding Samples on the FastTrack Sampler 4-20
Panel 8-23
Adding Samples on the Sample Carousel 4-22
Printer 8-19
Adding Samples to a Run 4-20
Sample Results Report 8-20
A-Line Tests
System 8-9
Loading 2-11
Consumables and Accessories 1-17
Analyzer 1-10
Cup/Tube Adapters 1-25
Annual Maintenance 10-15
As Needed Maintenance 10-17, 10-18
Assay Configuration 8-26 D
ASSAY STATUS Screen 6-21, 7-13, 9-8 Daily Checks 3-23
Assay-Specific Error Messages 11-8 1 mL Syringes 3-23
Audible Alert Options 8-17 DI Water System 3-32
Automatic Power ON, START UP, and SHUTDOWN 3-14 High-Concentration Waste Container 3-30
Automatic QC 7-7 Refrigerator Condensation Pan 3-31
Sample and Reagent Syringes 3-27
B Solenoid Valves 3-27
Wash Solution Trays 3-26
Basic Run 2-1
DATABASE Screen, Colors 2-28
Batch Ordering 4-15
Decontamination Procedures Appendix-7
Biosafety Hazards Appendix-4
Deleting Calibration Curve Data 6-30
Decontamination Procedure Appendix-7
Deleting QC Data 7-27
Required Precautions Appendix-5
Deleting Results 5-32
Warning Label Appendix-4
DATABASE Screen 5-32
Biosafety Procedures in the Classroom 1-x
RESULT Screen 5-33
B-Line Tests
DI Water System 3-32
Loading 2-11
Display Area 1-35
Downloading from a Host 4-6
C
Calibrating an Assay 6-13 E
Initiating the Calibration Run 6-17
Edit Comment Dialog Window 7-20
Loading the Calibrators 6-16
Editing Patient Sample Orders 4-19
Ordering Calibration 6-13
Editing Results 5-31
System-Initiated Calibration 6-18
Electrical Hazards Appendix-10
Calibration Error Codes 11-7
End-of-Run Sample Carrier 1-25
Calibration Frequency 6-10
End-Point Assay 6-5
Optional Calibration 6-10
Error Codes and Messages 11-5
Required Calibration 6-10
Error Log Messages 11-9
Calibration Methods 6-6
Export Options (QC) Dialog Window 7-37
Calibration Options 6-11
Exporting QC Data 7-37
Automatic Calibration 6-12
Exporting Results to Floppy Disk 5-35
Full Calibration 6-11
Exposure
Other Calibrations 6-11
Heavy Objects Appendix-13
Calibration Review 6-19
Hot Objects Appendix-13
CALIBRATION SUMMARY Screen 6-26, 9-9
Calibration Theory 6-5
Calibrators 1-23 F
Chemical Hazards Appendix-8 Factor Calibration 6-7
Required Precautions Appendix-8 FastTrack Sampler 2-19

Index-2 AEROSET® Customer Training Guide


94858-103 — July 2003
Index

Adding Samples 4-20 As Needed 10-17, 10-18


Loading Patient Samples 2-23 Clean Cuvettes 10-20
Ordering Patient Samples 2-19 Clean the Reagent Bar Code Reader Window 10-20
Monthly 10-8
H Quarterly 10-11
Schedule 10-5
Hardware Tour 1-6
Semi-Annual 10-13
Hazards
System Backup 10-18
Biosafety Hazards Appendix-4
Weekly 10-6
Chemical Hazards Appendix-8
MAINTENANCE UTILITIES Screen 11-13
Electrical Hazards Appendix-10
Manual Dilution 4-12
Mechanical Hazards Appendix-11
Manual Order Entry 4-5
Physical Hazards Appendix-13
Mechanical Hazards Appendix-11
High-Concentration Waste Container 3-30
Monthly Maintenance 10-8
Host Configuration 8-21
Multi-Point Linear Calibration 6-8
Host Order Query 4-7

I O
Onboard Dilution 4-13
ICT Calibration Information 9-8
Operation
ICT Calibrators 1-21
24 Hour 3-8
ICT Cleaning Fluid 1-22
Partial Day 3-10
ICT Fluid Delivery 9-5
Order and Run a Sample 2-19
ICT Reference Solution 1-22
Order Entry 4-5
ICT Sample Diluent 1-21
Download Order From Host Computer 4-6
ICT Unit Component Replacement 9-10
Host Order Query 4-7
ICT Unit Components 9-6
Manual Order Entry 4-5
Information Access Area 1-32
Order Samples Screen 4-12
Instrument Tour 1-5
Ordering
Inventory
Calibration 6-13
Reagents 2-9
Controls 7-5
Patient Samples 2-19
L Samples 2-19
Levey-Jennings Stat Sample 4-16
Details 7-17
Graph 7-15 P
Limited Run Feature 5-17
Panel Configuration 8-23
Deselecting 5-20
Password 8-5, 8-6, 8-7
Limiting Assays in a Run 5-18
Patient Demographics 4-13
Loading
Physical Hazards Appendix-13
A-Line Tests 2-11
Exposure to Heavy Objects Appendix-13
B-Line Tests 2-11
Exposure to Hot Objects Appendix-13
Bulk Solutions 3-20
Exposure to Laser Light Appendix-13
Calibrators 6-16
Trip Hazard Appendix-13
Controls 7-8
Power OFF Procedure 11-11
Reagents 2-11
Print Options (QC) Dialog Window 7-30
Log Off 3-6
Printer Configuration 8-19
Log On 3-5, 8-5
Printing
Log On Screen 8-6, 8-8
Calibration Summary 6-32
Current 6-32
M Stored 6-32
Maintenance Levey-Jennings Graph Report 7-29
Annual 10-15 Loadlist 2-22

AEROSET® Customer Training Guide Index-3


94858-103 — July 2003
Index

QC Data List Report 7-32 RESULT Screen 5-24


QC Results 7-28 Result Error Codes 11-5
Results 5-16 Result Flags 11-5
Multiple Result Reports from the DATABASE Screen 5- Result Handling 5-1
16 Results
Single Result Report from the DATABASE Screen 5-16 Accepting 5-14
Single Result Report from the RESULT Screen 5-17 Deleting 5-32
Procedure Editing 5-31
Reagent Inventory 2-9 Exporting to Floppy 5-35
Printing 5-16
Q Rerunning 5-21
Reviewing 5-5, 5-26
QC
Selecting Rerun and Replicate 5-26
Data List Report
Transmitting 5-34
Print Options 7-33
Reviewing QC Results 7-12, 7-44
Summary Report 7-35
Reviewing Rerun Results 5-26
Print Options 7-35
Reviewing Results 5-5
Sort Options 7-35
DATABASE Screen 5-5
QC Data Deleting 7-27
RESULT Screen 5-12
QC Data Exporting 7-37
Run Options 4-1
QC Data List 7-22
RUN OPTIONS Screen 8-10
QC Data List Screen 7-32
Run Progress 2-27
QC Results
Run Progress Area 1-36
Printing 7-28
Running a Stat Sample 4-16
Reviewing 7-12
QC SUMMARY Screen 7-23
Accessing Levey-Jennings Graph 7-25 S
QC Westgard Rules 7-40 Safety Icons 1-viii
Quarterly Maintenance 10-11 Sample Carousel
Adding Samples 4-22
R Loading the Patient Samples 4-10
Ordering Patient Samples 4-8
Rate Assay 6-5
Sample Carrier Trays 1-26
Reagent
Sample Carriers 1-24
Inventory Procedure 2-9
Sample Cups 1-18
Loading 2-11
Sample Order Options 4-8
Reagent Cartridge Adapters 1-27
Sample Progression 1-28
Reagent Cartridges 1-20
Sample Replicates 4-12
Reagent Inventory
Sample Results Report Configuration 8-20
Reagent Details 2-8
Samples
Reagent View 2-5
Adding Assays 5-30
Reagent Report Screen 2-6
Adding During a Run 4-20
REAGENTS Screen
Adding on the Sample Carousel 4-22
R1-A Page 2-10
Editing Patient Orders 4-19
Refrigerator Condensation Pan 3-31
Ordering a STAT Sample 4-16
Report
Running a STAT Sample 4-16
QC Summary 7-35
Validating 5-15
Required Precautions
Screen
Cleaning Spills Appendix-5
Comments Dialog Window 7-20
Handling and Disposing of Waste Appendix-6
Export Options (QC) Dialog Window 7-37
Handling Potentially Contaminated Materials Appendix-5
Log On 8-6, 8-8
Rerunning Results 5-21
On-line Data Transfer 4-6
DATABASE Screen 5-22
Print Options (QC) Dialog Window 7-30
Reserved STAT Position 5-25

Index-4 AEROSET® Customer Training Guide


94858-103 — July 2003
Index

QC Data List 7-32 Sample Syringes 3-27


Reagent Report 2-6 System Backup 10-18
REAGENTS, R1-A Page 2-10 System Configuration 8-9
USER REGISTRATION Dialog Window 8-7 System Configuration Parameters
Screen Display 1-31 SmplSeq (Sampling Sequence) 8-15, 8-16
Action Area 1-33 SYSTEM CONFIGURATION Screen 8-11
Display Area 1-35 System Control Center 1-6
Information Access Area 1-32 System Status 2-27
Run Progress Area 1-36 System-Initiated Calibration 6-18
Screen Navigation 1-37
Buttons 1-37 T
Drop-down List Box 1-38
Transmitted Error Codes 11-7
Scroll Bar 1-37
Transmitting Results to the Host 5-34
Single Selection Item 1-38
Tabs 1-37
Selecting Rerun or Replicate Results 5-29 U
Selecting the Run Options 2-26 Unit Configuration Parameters 2-13, 8-28
Semi-Annual Maintenance 10-13 Unloading 7-44
Shutdown Procedure 3-13 Use Factor and Blank 6-9
Software Tour 1-29 User Code 8-7
Solenoid Valves 3-27 Delete Existing 8-8
Solutions USER REGISTRATION Dialog Window 8-7
Daily Operation 3-15 Password 8-7
Loading Bulk Solutions 3-20 User Code 8-7
Alkaline and Acid Wash 3-20
ICT Reference Solution 3-21
Positions for Loading 3-17
V
START UP and SHUTDOWN 3-15 Validating Samples 5-15
Volume Display 3-18 Volume Display 3-18
Spline 6-9
Start Up and Shutdown 3-7 W
Start Up Procedure 3-12 Wash Solution Trays 3-26
Starting the Run 2-26 Wash Solutions 1-22
Status Area 1-35 Water Bath Additive 1-23
Syringes Weekly Maintenance 10-6
1 mL Syringes 3-23 Westgard QC Rules 7-40
Reagent Syringes 3-27 Westgard Rule Options 8-18

AEROSET® Customer Training Guide Index-5


94858-103 — July 2003
Index

NOTES

Index-6 AEROSET® Customer Training Guide


94858-103 — July 2003

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