Beckman Coulter Immage 800 User manual 2

IMMAGE® 800

A11403-AB

March 2004

®

Immunochemistry System

REPEC
Beckman Coulter Ireland, Inc.
Mervue Business Park,
Mervue Galway,
Ireland 353 91 774068

For In Vitro Diagnostic Use

Operations Manual

© Copyright 2004 Beckman Coulter, Inc.

BECKMAN COULTER, INC. • 4300 N. Harbor Blvd., Fullerton, CA U.S.A. 92835

TABLE OF CONTENTS

SAFETY NOTICE

CHAPTER 1 General Information/Precautions and Hazards ................................................ 1-1

CHAPTER 2 System Description .......................................................................................... 2-1

CHAPTER 3 Theory of Operations ....................................................................................... 3-1

CHAPTER 4 System Power On/Off ...................................................................................... 4-1

CHAPTER 5 System Setup .................................................................................................... 5-1

CHAPTER 6 Reagents/Calibration ........................................................................................ 6-1

CHAPTER 7 Sample Programming ...................................................................................... 7-1

CHAPTER 8 Results Recall .................................................................................................. 8-1

CHAPTER 9 Quality Control ................................................................................................ 9-1

CHAPTER 10 Utilities ........................................................................................................... 10-1

CHAPTER 11 System Status/Instrument Commands ........................................................... 11-1

APPENDIX A Part Number List ............................................................................................. A-1

APPENDIX B Instrument Codes .............................................................................................B-1

APPENDIX C Reports .............................................................................................................C-1

GLOSSARY

INDEX

IMMAGE 800 Operations Manual A11403 Table of Contents
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Safety Notice

Introduction

This safety notice summarizes information basic to the safe operation of the
IMMAGE® 800 Immunochemistry System described in this manual. The
international symbol displayed above is a reminder that all safety instructions should
be read and understood before installation, operation, maintenance, or repair of this
instrument. When you see the symbol on other pages, pay special attention to the
safety information presented. Observance of safety precautions will also help to avoid
actions that could damage or adversely affect the performance of the instrument.

Other symbols may also be displayed on the equipment. These are reproduced and
described in the Operating Precautions and Hazards section.

Safety During Installation and/or Maintenance

This instrument is designed to be installed by a Beckman Coulter Field Service
representative. Installation by anyone other than authorized Beckman Coulter
personnel invalidates any warranty covering the instrument.

Introduction

Any servicing of this equipment that requires removal of any covers can expose parts
which involve the risk of electric shock or personal injury. Make sure that the power
switch is turned OFF and that the instrument is disconnected from the main power
source. Refer such maintenance to qualified service personnel.

Electrical Safety

• To reduce the risk of electrical shock, this instrument uses a three-wire electrical
cord and plug to connect to earth-ground. Make sure that the matching wall outlet
receptacle is properly wired and earth-grounded.

• Never remove or install any circuit board, connect or disconnect any plug or cable,
while the power is ON. Always use the antistatic wrist strap located in the electronic
board compartment when removing or installing any circuit board.

• Do not place containers holding liquid on top of the instrument. If a spill occurs,
liquid may get into the instrument and damage electrical or mechanical components.

Safety Against Risk of Fire

Fuses protect certain electrical circuits within this instrument against overcurrent
conditions. For continued protection against the risk of fire, replace only with the
same type and rating specified.

IMMAGE 800 Operations Manual A11403 Safety Notice
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Mechanical Safety

Mechanical Safety

For safe operation of the equipment, observe the following:

• Operate the system with reagent door and covers and shields in place.

• During power up, routine operation, and diagnostic procedures, keep hands and/or
foreign objects out of the path of the carousels and probes.

• Do not attempt to clean around the carousels and probes while they are in motion.
Wait until the instrument is in "standby" to perform cleaning procedure.

Chemical and Biological Safety

Normal operation may involve the use of solutions and test samples that are
pathogenic or infectious. Observe all laboratory policies or procedures which pertain
to the handling of these materials.

• The reagents and other chemical preparations used with the system will not
normally cause adverse reactions; however, those persons with sensitive skin should
wear protective gloves before attempting to work with reagents and other chemical
preparations.

• Do not handle sample or solutions without proper protection. Body fluids and other
infectious samples must be handled according to good laboratory practice to prevent
spread of disease.

• When performing maintenance, service, or troubleshooting on elements of the
system that have contacted sera or other biological fluids, observe standard
laboratory precautions. It is always necessary to wash your hands thoroughly after
performing any routine maintenance.

Dispose of all waste solutions according to appropriate environmental health and
safety guidelines.

Safety Notice IMMAGE 800 Operations Manual A11403
Page 2 of 2 March 2004

CHAPTER 1 General Information/Precautions and Hazards

Table of Contents

General Information/Precautions and Hazards ........................................................................... 1-2

Introduction ............................................................................................................................. 1-2

How to Use This Manual ........................................................................................................ 1-3

Warranty and Service Policy Information .............................................................................. 1-5

Precautions .............................................................................................................................. 1-6

Hazards .................................................................................................................................... 1-7

Symbols and Labels ................................................................................................................ 1-9

1

IMMAGE 800 Operations Manual A11403 General Information/Precautions and Hazards
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Introduction

Intended Use

Introduction

Intended Use

The Beckman Coulter IMMAGE® 800 Immunochemistry System is a fully automated,
computer controlled, bench-top analyzer designed for the in vitro quantitation of
biological fluid components and therapeutic drugs. The system methodologies are rate
turbidimetry and rate nephelometry.

The IMMAGE 800 is a high throughput, random access analyzer that features bar code
identification of samples and reagents to perform sample testing. It automatically
dilutes the samples and delivers them to the reaction cuvette along with other reaction
constituents. The system analyzes up to 72 samples per run with up to 24 analytes per
sample.

General Information/Precautions and Hazards

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How to Use This Manual

Scope of This Manual

This manual provides information on the operation of the IMMAGE 800. Diagnostic
interpretation or the clinical significance of the assay results provided by the system
are not discussed in this manual. Typical and actual results are shown only to
demonstrate the operating procedures, parameters, and characteristics of the system.

IMMAGE Chemistry Information Manual

This manual should be used in conjunction with the IMMAGE Immunochemistry
Systems Chemistry Information Manual which contains specific chemistry
information for the full range of analytes available on the IMMAGE 800.

Manual Conventions

The IMMAGE 800 Immunochemistry System Operations Manual uses the following
printed and visual cues to guide the user in how to respond to printed directions.

How to Use This Manual

Scope of This Manual

1

Table 1.1 IMMAGE 800 Conventions

Convention Description

Icon Buttons Icon buttons are in bold with one letter underlined. The

underline indicates which letter to press in combination
with the Alt key to select the icon button from the
keyboard.

Function Buttons [F1] Function buttons are in bold with the corresponding

function key in square brackets ( [ ] ).

<Buttons> The "less than" (<) and "greater than" (>) symbols enclose

a button’s name in bold.

Options button <▼> The "less than" (<) and "greater than" (>) symbols enclose

a black triangle, preceded by the phrase "options button",
all in bold.

Text field Names of text fields are followed by the word "field", all

in bold.

[X], [ → ] or [Tab] Keyboard keys are in bold and enclosed by square

brackets ( [ ] ).

[Alt + X] Combination keys are in bold and enclosed by square

brackets ( [ ] ) with a plus (+) between each key.

Manual Format

Information in this manual is presented in modular units. Each unit of information is
described by a brief title in the left margin.

Many units consist of a table which presents a procedure, process, or description.

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How to Use This Manual

Procedure Tables

Procedure Tables

Procedure tables are the most common type of table in this manual. They list each step
of a procedure by number with the corresponding action that is to be performed.

A "Refer to Figure x.x." instruction directs the operator to the screen that displays as a
result of the action requested in the step.

Occasionally, a decision must be made at a step within a procedure. A smaller
decision table is then presented which describes the variable conditions in the left
column and the appropriate action for each condition in the right column.

Example of Procedure Table

The following table is an example of a procedure table that contains a decision table.

Step Action

1Select Rerun Samples [F6]. (Refer to Figure x.x.)
2

To enter... type...

individual Sample IDs, the Sample IDs for rerun in the

Sample IDs field.

a range of Sample IDs, the Sample ID at the beginning of

the range in the Range field.

3 Select a button from the bottom of the dialog box.

Read the decision table as complete sentences, using the first heading to introduce the
condition and the second heading to introduce the action. Step 2 of the table is read:

To enter individual Sample IDs, type the Sample IDs for rerun in the Sample IDs
field.

To enter a range of Sample IDs, type the Sample ID at the beginning of the range in the
Range field.

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Warranty and Service Policy Information

Warranty Policy

The IMMAGE 800 Immunochemistry System is covered by and subject to the
exceptions of the standard warranty enclosed with each system. Failure to operate the
system in accordance with this manual voids the warranty.

Service Information

If any fault develops in the system, call the Beckman Coulter Clinical Support Center.
Give full details of the difficulty. Be sure to have the model and serial number (located
on the lower right side of the instrument near the front.)

For USA and Canadian customers only:

Call your local Beckman Coulter office toll-free from anywhere in the continental
United States, Alaska, Hawaii, and Canada at [phone].

Warranty and Service Policy Information

Warranty Policy

1

For customers outside the USA and Canada:

Call the nearest Beckman Coulter Field Service Office.

Responsibility During the Warranty Period

The user is responsible for the routine preventive maintenance procedures described in
the maintenance section of this manual. Repairs arising from failure to perform these
maintenance procedures at the indicated time intervals will be made at the user’s
expense.

Shipping Damage

Each IMMAGE 800 System is carefully examined and checked by Beckman Coulter
before it is shipped. When you receive your new IMMAGE 800 System, visually
inspect the shipping container for any possible damage. If there is damage, notify the
Beckman Coulter Service Representative before his/her arrival at your facility to
install your system.

If no damage is found to the shipping container, the Beckman Service Representative
will supervise the unpacking of your system. If it is damaged in any way, the customer
should file a claim with the carrier. If no damage is found, a visual and operational
check of your system will be performed.

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Precautions

Introduction

Precautions

Introduction

The operational precautions below enable the user to avoid those actions which could
result in an invalid quantitative determination.

Proper Handling of Diskettes

The 3.5 inch floppy diskettes require special handling to prevent damage.

• Do not store or place a diskette near electrical motors, power supplies, or generators.

• Do not store or place a diskette near magnets or a magnetic field.

Proper Handling of Compact Disks

Compact disks (CD-ROMs) require special handling to prevent damage.

• Do not place a CD-ROM in direct sunlight or excessive heat or humidity.

• Hold a CD-ROM by the edges.

• Replace a CD-ROM in its case after use.

Sample Volumes

Sample containers must contain an adequate volume of test specimen to ensure
accurate aspiration. Refer to the IMMAGE Immunochemistry Systems Chemistry
Information Manual and the Sampling Template for information regarding volume
requirements.

CAUTION

Use extreme care when removing bar coded or labeled glass sample tubes from the
IMMAGE 800 sample racks to avoid breakage. Rotating the tube slightly while
pushing from the bottom of the tube may make removal easier.

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Hazards

Introduction

The following hazards are identified to ensure maximum safety of the user.

Booting Up

Close reagent and sample carousel covers and keep clear of all mechanical assemblies
when booting up the system.

Three-pronged Power Plugs

The three-pronged power plug from all system components of the IMMAGE 800
Immunochemistry System must be connected to a three-wire grounded power source.

• Do not use an adapter to connect the power plug to a two-pronged outlet.

• If the electrical outlet will not accept the three-pronged plug, notify qualified
maintenance personnel; they will supply the required electrical ground.

Hazards

Introduction

1

DO NOT UNDER ANY CIRCUMSTANCES OPERATE THE SYSTEM UNTIL AN
ELECTRICAL GROUND IS PROVIDED AND THE POWER CORD IS PROPERLY
CONNECTED TO GROUND.

Emergency Stop

Turn the instrument main power switch off if the stop button on the screen is
unavailable, and the instrument must be stopped immediately.

Cranes

Keep clear of both cranes while the instrument is running.

Covers

Keep all covers and shields in place while the instrument is running.

Adding Samples to an Operating Instrument

The instrument status must be in Standby when adding or changing reagents, buffers,
diluents, or dilution segments. The instrument status must be in Standby or Pausing-
OK to load samples when adding or removing samples. Keep reagent and sample
carousel covers closed while the instrument is running.

Pausing the System to Load Samples

If you pause the system to load or remove samples while the system is running, DO
NOT load or remove samples until the OK to load samples message appears on the
screen. Failure to comply may cause personal injury.

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Hazards

Replacing Mechanical or Electrical Parts

Replacing Mechanical or Electrical Parts

Before replacing any defective mechanical or electrical part in the system, confirm that
the power to the system is turned off.

Bar Code Readers

DO NOT tamper with or remove the housing of any bar code reader.

Disposal of Waste Liquids

All waste liquids from the IMMAGE 800 Immunochemistry System should be
disposed of in an approved method for handling biohazardous material.

Biological Samples

Observe all laboratory policies or procedures pertaining to the handling of biological
samples that may contain pathogens.

Preservatives

Sodium azide preservative may form explosive compounds in metal drain lines. See
National Institute for Occupational Safety and Health bulletin: Explosive Azide
Hazards (8/16/76).

Incineration of used reagent cartridges may produce toxic fumes.

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Symbols and Labels

Introduction

The following list of symbols and labels is used on the IMMAGE 800
Immunochemistry System. The symbols are affixed to the appropriate components of
the system as described briefly below.

Instrument or Uninterruptible Power Supply (UPS) Power Switch, ON

This symbol is located on the instrument and the UPS main power switches. When the
portion of the switch that displays this symbol is depressed, the instrument is ON.

Instrument or UPS Power Switch ON

Symbols and Labels

Introduction

1

Instrument or UPS Power Switch, OFF

This symbol is also located on the instrument and the UPS main power switches.
When the portion of the switch that displays this symbol is depressed, the instrument is
OFF.

Instrument or UPS Power Switch OFF

Computer Power Switch

This symbol is located above the computer power button. A green light indicates the
power to the computer is ON.

Computer Power Switch

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Symbols and Labels

Monitor Power Switch

Monitor Power Switch

This symbol is located on the monitor power button. A green light indicates the power
to the monitor is ON.

Printer Power Switch

This symbol is located beside the printer power button. A green light indicates the
power to the printer is ON.

Monitor Power Switch

Printer Power Switch

Connection Between Computer and Mouse

This symbol is located beside the connection between the computer and the mouse.

Computer - Mouse Connection

Connection Between Computer and Keyboard

This symbol is located beside the connection between the computer and the keyboard.

Computer - Keyboard Connection

Connection Between Computer and Printer

This text is located next to the connection between the computer and the printer.

Parallel

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Connection Between Computer and Monitor

This symbol is located beside the connection between the computer and the monitor.

Computer - Monitor Connection

High Voltage - Electric Shock Risk

This symbol indicates high voltage or risk of electric shock.

Connection Between Computer and Monitor

Symbols and Labels

1

Read Manual

This symbol cautions that the manual should be read before using the system.

General Biohazard Caution

This symbol is the international symbol for biohazardous material.

High Voltage - Electric Shock Risk

Read Manual

Biohazard Label

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Symbols and Labels

Caution Biohazard

Caution Biohazard

This cautionary label is located between the sample and reagent carousels. Operate
the system with all covers in place.

Bar Code Caution

This label is placed on the cover of any laser-based bar code reader. Do not stare into
laser light beam when cover is open or removed.

Caution Biohazard Label

Laser

This label is placed near any opening through which a bar code reading beam emits.
Avoid exposure to laser light emitted from the opening.

Class II Laser Caution

This cautionary label is located between the sample and reagent carousels. Do not
stare into laser light beam.

Bar Code Caution Label

Laser Caution Label

Class II Laser Caution Label

General Information/Precautions and Hazards IMMAGE 800 Operations Manual A11403
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Class III B Laser Caution

This cautionary label is located at the top of the optics module. Avoid direct exposure
to laser light beam.

Reagent Compartment Cover Notice

This label is located on the reagent compartment cover. The instrument will stop if the
cover is opened.

A010648L.EPS

Class III B Laser Caution Label

Symbols and Labels

Class III B Laser Caution

1

A010647L.EPS

Reagent Compartment Cover Label

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CHAPTER 2 System Description

Table of Contents

Hardware Components ............................................................................................................... 2-2

Overview ................................................................................................................................. 2-2

Instrument ............................................................................................................................... 2-3

Reagent Compartment ............................................................................................................. 2-4

Reagent Crane ......................................................................................................................... 2-6

Reaction Module ..................................................................................................................... 2-8

Sample Carousel ................................................................................................................... 2-10

Sample Crane ........................................................................................................................ 2-12

Upper Instrument Subsystems .............................................................................................. 2-14

Wash Solution Box and Waste Container ............................................................................. 2-17

Racks ..................................................................................................................................... 2-19

Computer ............................................................................................................................... 2-21

Printer .................................................................................................................................... 2-25

Software Overview ................................................................................................................... 2-26

Overview ............................................................................................................................... 2-26

Screen Format ....................................................................................................................... 2-27

Text Fields ............................................................................................................................. 2-30

Buttons .................................................................................................................................. 2-31

Toggle Buttons ...................................................................................................................... 2-32

Check Boxes ......................................................................................................................... 2-33

Performing Software Functions ............................................................................................ 2-34

Selecting vs. Choosing .......................................................................................................... 2-36

Dialog Boxes ......................................................................................................................... 2-37

Deleting Data From a Text Field and Printing Data from a Screen ...................................... 2-38

Page Up/Page Down ............................................................................................................. 2-39

Program Structure ................................................................................................................. 2-40

Sample Programming Overview ........................................................................................... 2-45

System Specifications and Characteristics ............................................................................... 2-46

Instrument Specifications ......................................................................................................2-46

Peripheral Devices Specifications ........................................................................................ 2-48

Sample Container Information .................................................................................................. 2-49

Sample Containers Allowed .................................................................................................. 2-49

Bar Code Types and Options ................................................................................................ 2-50

Bar Code Label Specifications .............................................................................................. 2-52

Applying Bar Code Labels .................................................................................................... 2-54

Sample Volume ..................................................................................................................... 2-55

Loading Tubes Into Racks .................................................................................................... 2-56

Instrument Operation Overview .............................................................................................. 2-57

Instrument Operation ............................................................................................................ 2-57

2

IMMAGE 800 Operations Manual A11403 System Description
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Overview

Introduction

Overview

Introduction

Hardware Components

The IMMAGE® 800 Immunochemistry System is a bench-top analyzer composed of
the IMMAGE 800 instrument, computer and printer. (Refer to Figure 2.1.) The
system is shipped complete for installation. The system will be installed by a
Beckman Coulter Representative.

1

1. Instrument

2. Computer

3. Printer

2

Figure 2.1 The IMMAGE 800 Immunochemistry System

3

A011408P.EPS

System Description IMMAGE 800 Operations Manual A11403
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Instrument

Description

The IMMAGE 800 instrument is the analytical unit where the samples and reagents
are loaded and where the chemical reactions take place.
(Refer to Figure 2.2.)

Instrument

Description

6

1

2

2

3

1. Reagent Compartment

2. Reagent Crane

3. Reaction Module

4. Sample Carousel

5. Sample Crane

6. Upper Instrument Subsystems

Figure 2.2 IMMAGE 800 Instrument

5

4

A011409P.EPS

IMMAGE 800 Operations Manual A11403 System Description
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Reagent Compartment

Description

Reagent Compartment

Description

The reagent compartment is the area of the instrument where the removable reagent
carousel is stored. The temperature of the compartment is maintained at
approximately 15°C. (Refer to System Specifications and Characteristics,
"Temperature and Humidity" in this chapter.)

Reaction buffer bottles are placed in the center of the reagent compartment. The
bottles are maintained at room temperature. (Refer to Figure 2.3.)

1

A

6

77

B

2

3

1. Reagent Compartment Cover

2. Reagent Carousel

3. Reaction Buffer Bottle

4. Reagent Cartridges (Compartments A and B)

4

Figure 2.3 The Reagent Compartment

NOTICE

The instrument will stop if the reagent compartment cover is opened.

5

A011410P.EPS

5. Reagent Bar Code Reader

6. Fans

7. Temperature Sensor

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Component List

The following table lists each component of the reagent compartment with its
function.

Table 2.1 Reagent Compartment Components

Number Component Function

Reagent Compartment

Component List

2

1 Reagent Compartment

Cover

Necessary to maintain temperature within
compartment.

2 Reagent Carousel Holds up to 24 reagent cartridges and 4 reaction

buffer bottles.

3 Reaction Buffer

Contain reaction buffers.

Bottles

4 Bar Coded Reagent

Cartridges

Contain chemistry specific reagent including
(where applicable):

• Reagent

• AGXS (antigen excess) Solution

• Co-reagent

• Conjugate

• Evaporation Caps

The cartridges are bar coded to allow for
instrument identification of each cartridge.

5 Reagent Bar Code

Reads bar codes on reagent cartridges.

Reader
6 Fans Circulate cool air in reagent compartment.
7 Peltier Temperature

Helps control 15°C in reagent compartment.

Sensor

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Reagent Crane

Description

Reagent Crane

Description

The reagent crane transfers reagents and buffers from the reagent compartment to the
reaction wheel. (Refer to Figure 2.4.)

1. Reagent Probe/Mixer

2. Reagent Syringe Pump

3. Reagent Crane Wash Station

4. Reagent Addition Ports

Figure 2.4 Reagent Crane

System Description IMMAGE 800 Operations Manual A11403
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Component List

The following table lists each component of the reagent crane with its function.

Table 2.2 Reagent Crane Components

Number Component Function

Reagent Crane

Component List

1 Reagent Probe Aspirates reagents and buffer from the reagent

compartment and dispenses them into a cuvette
on the reaction wheel.

Reagent Paddle Mixer Mixes the contents of a cuvette after reagent or

buffer has been dispensed.

2

2 Reagent Syringe

Pump (500 µL)

3 Reagent Crane Wash

Station
4 Reagent Addition

Ports

Mechanism for accurate reagent and buffer
aspiration and delivery through the reagent
probe.

Washes interior and exterior of reagent probe/
mixer.

Two openings in reaction module cover to allow
reagents to be added to one of two different
cuvette locations.

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Reaction Module

Description

Reaction Module

Description

The reaction module is the area of the instrument where the reaction takes place. The
temperature of the reaction module is maintained at approximately 37°C. (Refer to
Figure 2.5 and System Specifications and Characteristics, "Temperature and
Humidity" in this chapter.)

1. Optics

2. Reaction Wheel

3. Cuvette

4. Reference Cuvette

Figure 2.5 Reaction Module

5. Cuvette Wash Station

6. Heat Block Temperature Sensor

7. Status Monitor Temperature Sensor

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Component List

The following table lists each component of the reaction module with its function.

Table 2.3 Reaction Module Components

Number Component Function

Reaction Module

Component List

1 Optics Measures light scatter in nephelometric

reactions (670 nm wavelength) and
turbidimetric reactions (940 nm wavelength).

2 Reaction Wheel Holds 39 reaction cuvettes and the reference

cuvette. Spins to move individual cuvettes to
correct positions for each stage of the analysis.

3 Cuvettes Hold the combined reactants. The reaction

being measured takes place in the clear, plastic
cuvettes. The optics pass light through the
cuvette to measure scatter.

2

4 Reference Cuvette Has a known scatter value. The instrument

measures the scatter from the on-board
reference cuvette. It then adjusts the optics
based on these measurements and the known
reference values.

5 Cuvette Wash Station Washes the cuvette after the reaction is

complete.

6 Heat Block

Controls 37°C in reaction module.

Temperature Sensor
7 Status Monitor

Monitors reaction module temperature.

Temperature Sensor

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Sample Carousel

Description

Sample Carousel

Description

The sample carousel is the area of the instrument where the samples are loaded onto
the system and where the diluents are placed. Samples are loaded onto the system via
sample racks. All sample cups must be placed on the system using the Sample Cup
Holder Kit. Refer to Appendix A, Part Number List. To ensure sufficient sample
aspiration, do not place sample cups directly into the racks or use 1.0 mL sample cups.
Sample dilutions are made in dilution wells. (Refer to Figure 2.6.)

5

2

6

1. Sample Carousel Cover

2. Sample Diluent Bottle

3. Sample Rack

4. Dilution Segment

Figure 2.6 Sample Carousel

1

4

7

3

A011411P.EPS

5. Sample Bar Code Reader

6. Sample Carousel Advance Button

7. Background Bar Code Label

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Component List

The following table lists each component of the sample carousel with its function.

Table 2.4 Sample Carousel Components

Number Component Function

Sample Carousel

Component List

2

1 Sample Carousel

Reduces evaporation of sample.

Cover
2 Sample Diluent

Contain sample diluents.

Bottles
3 Sample Racks Hold sample tubes. (Refer to Racks in this

section of the manual.)

4 Dilution Segments The various sample dilutions are automatically

made in the wells of the dilution segments
before delivery to the reaction wheel. The
disposable dilution segments are placed on the
system by the user.

5 Sample Bar Code

Reader

Scans bar codes on the sample carousel
including:

• bar coded sample tubes

• sample rack bar codes

• background bar codes

• calibrator bar codes

• reagent bar code cards

• calibrator bar code cards

6 Sample Carousel

Advance Button

Rotates the Sample Carousel to allow access for
loading sample racks, dilution segments, and
sample diluent bottles.

7 Background Bar Code

Label

Informs instrument of presence or absence of
sample tube. When the sample bar code reader
can read the background bar code, no sample
tube is present at that position.

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Sample Crane

Description

Sample Crane

Description

The sample crane transfers samples and diluents. Sample dilutions are made in the
dilution wells and then delivered to the reaction wheel. The Sample Crane functions
in the same manner as the Reagent Crane. (Refer to Figure 2.7.)

1. Sample Probe/Mixer

2. Sample Syringe Pump

3. Sample Crane Wash Station

4. Sample Addition Ports

Figure 2.7 Sample Crane

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Component List

The following table lists each component of the sample crane with its function.

Table 2.5 Sample Crane Components

Number Component Function

Sample Crane

Component List

1 Sample Probe Aspirates sample and diluent and dispenses

them into the dilution well. Aspirates diluted
sample from the dilution well and dispenses it
into a cuvette on the reaction wheel.

Sample Paddle Mixer Mixes the contents of a cuvette while diluted

sample is dispensed. Also mixes in dilution
wells.

2

2 Sample Syringe Pump

(250 µL)

3 Sample Crane Wash

Station
4 Sample Addition

Ports

Mechanism for accurate sample, diluent, and
diluted sample aspiration and delivery through
the sample probe.

Washes interior and exterior of sample probe/
mixer.

Two openings in reaction module cover to allow
samples to be added to one of two different
cuvette locations.

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March 2004 Page 2-13

Upper Instrument Subsystems

Upper Subsystem List

Upper Instrument Subsystems

Upper Subsystem List

The upper portion of the instrument contains three subsystems.

• Hydro Pneumatics

• Electronics Control Compartment

• Power Supply Assembly

Hydro Pneumatics

The hydro pneumatics control the flow of wash solution through the system and the
flow of waste out of the system. Pressure and vacuum control this fluid motion.
(Refer to Figure 2.8.)

1. Pressure Reservoir-Liquid

2. Pressure Reservoir-Air

3. Vacuum Reservoir

Figure 2.8 Hydro Pneumatics

System Description IMMAGE 800 Operations Manual A11403
Page 2-14 March 2004

Electronics Compartment

The electronics compartment contains the electronic circuit boards. (Refer to Figure

2.9.) Electronic circuit boards should only be handled by a Beckman Coulter service
representative.

Upper Instrument Subsystems

Electronics Compartment

2

1. Circuit Boards

Figure 2.9 Electronics Compartment

IMMAGE 800 Operations Manual A11403 System Description
March 2004 Page 2-15

Upper Instrument Subsystems

Power Supply Assembly

Power Supply Assembly

All of the power supplies used by the IMMAGE 800 instrument are contained in this
area of the instrument. (Refer to Figure 2.10.) Power supply assemblies should only
be handled by a Beckman Coulter service representative.

1. Power Tower

2. Power Switch

3. Electrical Outlet/Voltage Selector

Figure 2.10 Power Supply Assembly

System Description IMMAGE 800 Operations Manual A11403
Page 2-16 March 2004

Wash Solution Box and Waste Container

Description

The wash solution box and waste container are stored separately from the IMMAGE
800 instrument. (Refer to Figure 2.11.)

Wash Solution Box and Waste Container

Description

2

1. Wash Solution Box

2. Wash Solution Tubing

3. Waste Container

4. Waste Tubing

Figure 2.11 Wash Solution Box and Waste Container

Component List

The following lists the components depicted in Figure 2.11.

Table 2.6 Wash Solution Box and Waste Container Components

Item Component Function

1 Wash Solution Box Holds wash solution.
2 Wash Solution Tubing

(blue and orange)

Blue: Connects wash solution box to
instrument.

Orange: vents wash solution to box.
3 Waste Container Holds waste. (A drain can be used instead.)
4 Waste Tubing (green) Outlet for waste leading to waste container or

drain.

IMMAGE 800 Operations Manual A11403 System Description
March 2004 Page 2-17

Wash Solution Box and Waste Container

Wash Solution

Wash Solution

The wash solution is used to wash the probes, mixers, and cuvettes.

Wash Solution Box Placement

The wash solution box must be close enough to the instrument to allow connection of
the wash solution tubing.

Waste Container Placement

The waste container must be placed with the opening of the waste container no higher
than the top of the instrument.

System Description IMMAGE 800 Operations Manual A11403
Page 2-18 March 2004

Racks

Description

Description

Each sample rack holds up to nine sample tubes. Each rack is bar coded to allow
identification of the rack number by the instrument. (Refer to Figure 2.12.)

2

3

Racks

2

1. Rack Bar Code Label

2. Rack Number

3. Handle

Figure 2.12 Sample Rack

Types of Racks

There are four types of racks. They are identified by the size of sample tube that they
hold. (Refer to APPENDIX A, Part Number List.)

• 16 × 100 mm

• 16 × 75 mm

• 13 × 100 mm

• 13 × 75 mm

1

A012184P.EPS

Applying Rack Labels

Refer to CHAPTER 5, System Setup, Instrument Setup, Placing Labels on a Rack for a
detailed procedure for label placement.

IMMAGE 800 Operations Manual A11403 System Description
March 2004 Page 2-19

Racks

Loading Rack onto the Sample Carousel

Loading Rack onto the Sample Carousel

Follow the steps below to load a rack onto the sample carousel. (Refer to Figure 2.13.)

Step Action

1 Press the Advance button to advance the sample carousel to an empty slot.
2 Lift the rack by its handle.
3 Open the cover of the sample carousel.
4 Align rack pegs over holes in the sample carousel.
5 Lower rack pegs into carousel holes.

Figure 2.13 Loading Rack onto the Sample Carousel

System Description IMMAGE 800 Operations Manual A11403
Page 2-20 March 2004

Computer

Description

Computer

Description

The computer supplies the user interface to the IMMAGE 800 Immunochemistry
System and stores data.

The user performs all software interaction on the computer portion of the system. This
software interaction is stored on the computer and is sent to the instrument at the
appropriate time.

Additionally, patient results, control results, and setup parameters are stored on the
computer.

NOTICE
Only the computer supplied by Beckman Coulter is to be used with the IMMAGE 800
Immunochemistry System.

2

Changing the Date on the PC

The PC supplied with some IMMAGE 800 systems contains a battery that provides
power to the computer’s internal clock during power off. The status of the battery is
checked every time the Power On sequence is performed.

The date and time must be reset each time the Power On sequence is performed on a
computer with a dead CMOS (Complementary Metal Oxide Semiconductor) battery.
Contact Beckman Coulter Clinical Support or the nearest local Beckman Coulter Field
Service office for assistance in replacing the battery.

CAUTION

IMMAGE 800 Operations Manual A11403 System Description
March 2004 Page 2-21

Computer

Changing the Date on the PC

Table 2.7 Computer Components

Number Component Description

1 Personal Computer

The PC contains the:

(PC)

• CPU (Central Processing Unit)

• hard disk drive

• floppy diskette drive

• CD-ROM Drive

2 Floppy Diskette Drive Where a 3.5 inch floppy diskette is placed and

read.
3 CD-ROM Drive Where a CD-ROM is placed and read.
4 Keyboard 101- key enhanced keyboard.
5 Mouse A two-button movable input device.
6 Monitor Displays user interface (touch screen).
7 Uninterruptible Power

Source (UPS)

The backup power source providing temporary

power to the computer for a limited period of

time in the event of brownouts or low line

voltage conditions.

System Description IMMAGE 800 Operations Manual A11403
Page 2-22 March 2004

Keyboard

Figure 2.14 depicts the 101- key enhanced keyboard used on the IMMAGE 800.

Computer

Keyboard

2

1. Escape Key

2. Function Keys

3. Tab Key

4. Caps Lock Key

5. Shift Keys

6. Control Keys

7. Alt Keys

8. Backspace Key

9. Enter Key

10. Delete Key

11. Page Up Key

12. Page Down Key

13. Arrow Keys

Figure 2.14 IMMAGE 800 Keyboard

IMMAGE 800 Operations Manual A11403 System Description
March 2004 Page 2-23

Computer

Port Connections

Port Connections

Figure 2.15 shows the back of the computer and where each cable connects.

1

3

2

4

A011412P.EPS

1. Printer Port

2. Monitor Port

3. Mouse/Keyboard Port

4. Instrument Port

Figure 2.15 CPU Ports

Proper Care and Handling of a Floppy Diskette

Diskettes require special care in handling.

• Recommended diskette: 3.5 inch Double-sided, High-density, IBM formatted
diskette.

• Store away from electrical motors, power supplies, or generators.

• Keep away from magnets and magnetic fields.

Proper Care and Handling of a Compact Disk

Compact disks (CD-ROMs) require special care in handling.

• Store away from direct sunlight, excessive heat, and humidity.

• Hold the CD-ROM by the edges.

• Replace the CD-ROM in its case after use.

System Description IMMAGE 800 Operations Manual A11403
Page 2-24 March 2004

Printer

Description

Printer

Description

The printer supplied with the IMMAGE 800 Immunochemistry System is the HP
DeskJet printer. The printer is designed to use single sheet paper.

The printer is set up to use 8.5 × 11 inch paper. Paper size can be chosen in Printer
Setup.

Refer to the manual that accompanies the printer for proper setup, care, and handling
of the printer.

2

IMMAGE 800 Operations Manual A11403 System Description
March 2004 Page 2-25

Overview

Introduction

Overview

Introduction

Software Overview

The IMMAGE 800 is controlled through a graphical user interface (GUI). This
section describes the basic functions within the interface. The concepts presented in
this section should be understood by the user before attempting to use the IMMAGE

800. The Main Software screen is shown below.

Figure 2.16 Main Screen

E011433S.EPS

System Description IMMAGE 800 Operations Manual A11403
Page 2-26 March 2004

Screen Format

Introduction

The IMMAGE 800 Immunochemistry System is designed to have a user friendly
interface. Figure 2.17 shows the sample programming screen of the IMMAGE 800 as
an example of this interface. This screen is broken into six functional areas:

• Status Bar

• Menu Bar

• Title Bar

• Function Buttons

• Message Bar

• Working Area

Screen Format

Introduction

3

2

Status Bar

1

2
4

5
6

1. Status Bar

2. Menu Bar

3. Icon Button

4. Title Bar

5. Function Buttons

6. Message Bar

7. Working Area

Figure 2.17 Sample Programming Screen

7

E011413S.EPS

The blue bar at the top of the screen is the status bar. This bar shows the instrument
status, date and time.

IMMAGE 800 Operations Manual A11403 System Description
March 2004 Page 2-27

Screen Format

Menu Bar

Menu Bar

Below the status bar is a row of icon buttons called the menu bar. These icon buttons
can be selected to access various functional areas of the interface. These areas are:

•Main

•Samples

• Results

• Rgts/Cal (Reagent load and calibration)

• QC (Quality control)

•Setup

• Utils (Utilities)

• Status

• Stop - F12

• About

The menu bar consists of these specific icon buttons regardless of the current screen.

Title Bar

Below the menu bar is a bar containing the title of the current screen with some
possible additional information.

Function Buttons

At the bottom of the screen is an area for up to ten function buttons. These function
buttons perform functions that are specific to the particular screen. Each function
button on the screen corresponds to a function key on the keyboard read from left to
right (F1, F2, F3, etc.). The screen function buttons are labeled with the action the
function button performs and the corresponding keyboard function key.

Options Button

Within the working area, and occasionally on screens or dialog boxes, are buttons that
perform a different function than the "F" numbered function buttons. These buttons,
called options buttons, appear triangular in shape (▼) and often accompany a text
field. When an options button is selected, it presents a list of items, or options, from
which a user may choose.

Message Bar

The blue bar at the bottom of the screen is the message bar. This bar is used for
instructions and error messages. The first line displays instructions and the second
line displays error messages. These messages are related to activities in the working
area. (Refer to Figure 2.18.)

System Description IMMAGE 800 Operations Manual A11403
Page 2-28 March 2004

Working Area

The middle portion of the screen is referred to as the working area. The user enters
data into the working area via:

•Text fields

• Buttons

• Toggle buttons

• Check boxes

Screen Format

Working Area

5

1

2
3

2

4

E010270S.EPS

1. Text Field

2. Cursor

3. Options Button

4. Toggle Button

5. Check Box

Figure 2.18 Working Area of Program Sample Screen

IMMAGE 800 Operations Manual A11403 System Description
March 2004 Page 2-29

Text Fields

Definition of Text Field

Text Fields

Definition of Text Field

Text fields are white areas on the screen in which the user types data.

Definition of Cursor

When a text field is chosen, a cursor displays in that field. This cursor indicates where
text will be entered.

Characteristics of Text Fields

Unless otherwise noted, most text fields can accept any alphanumeric characters. This
means that the user can type in any letter, number, or a space.

Each text field has a limited number of characters that can be entered. Most text fields
have a restricted set of characters that can be entered.

Example: If the user attempts to enter anything other than a number in a numeric field
the character will not be entered. A message will display which reads "Only numeric
characters are allowed."

NOTICE
The alphanumeric characters "|" (piping bar), "\" (backslash), " ^" (caret), and "&"
(ampersand) are not allowed because they are host interface delimiters.

System Description IMMAGE 800 Operations Manual A11403
Page 2-30 March 2004

Buttons

Function

Example

Buttons

Function

Buttons on the screen perform as their name implies. When they are selected or
"pressed" an action is performed in the software. Often this action will be used to
access a new screen or dialog box.

The icons in the menu bar and the function buttons on the bottom of the screen operate
like buttons.

The options button <▼> next to the Sample Comment field on the Program Sample
screen is an example of a button.

2

IMMAGE 800 Operations Manual A11403 System Description
March 2004 Page 2-31

Toggle Buttons

Function

Toggle Buttons

Function

Toggle buttons function in the same manner as buttons, except when they are selected
or "pressed", their state is changed.

Selected or Unselected

Toggle buttons may either be in the selected or unselected state. If a toggle button is
selected it will be highlighted in blue.

Example

Each chemistry button in the list of chemistries on the Program Sample screen is an
example of a toggle button.

System Description IMMAGE 800 Operations Manual A11403
Page 2-32 March 2004

Check Boxes

Function

Check boxes are similar to toggle buttons because they are either toggled on or off.
When selected, a check box will change state.

States

A check box is either checked or unchecked. When checked, a check mark will appear
in the check box.

Example

The STAT check box on the Sample Program screen is an example of a check box.

Check Boxes

Function

2

IMMAGE 800 Operations Manual A11403 System Description
March 2004 Page 2-33

Performing Software Functions

Introduction

Performing Software Functions

Introduction

The IMMAGE 800 Immunochemistry System uses a graphical user interface.
Functions can be performed by using a mouse to point and click, with keyboard
equivalents, or with an optional touch screen.

Using the Mouse

The mouse is the recommended method for performing actions with the IMMAGE

800. When the mouse is moved, the arrow on the screen moves with it. This arrow is
called the pointer. Movements of the pointer correspond to movements of the mouse.
When the pointer tip is touching an item on the screen, the pointer is pointing to that
item. Pressing the left button on the mouse and quickly releasing it is called clicking.
Clicking a button on the screen that the pointer is pointing to will select that button.
Clicking twice in rapid succession is called double-clicking. Pressing and holding
down the left mouse button and moving the mouse is referred to as dragging.

Using Keyboard Equivalents

All actions on the IMMAGE 800 can be performed with keyboard equivalents as well.
The screen navigation will be affected by the location of the cursor on the screen. The
cursor movement is directed either within a partition (local movement), which is a
logical grouping of data fields that may or may not be visually distinct from other
groupings, or is directed globally, which is movement throughout the entire screen.
Keyboard equivalent methods include:

• [Alt + Key]

• Function Buttons

• Tabs + Spacebar

• Arrow Keys + Spacebar

• Page Up/Page Down Keys

• Selecting a number from a list

[Alt + Key]

Icon buttons on the menu bar, at the top of the screen, can be selected by pressing and
holding down the [Alt] key and then pressing the key that corresponds to the
underlined letter in the title of that icon. For example, to show the Main screen, press
the key combination [Alt + m]. Buttons in dialog boxes may be selected using the [Alt
+ key] method as well.

Function Buttons

Functions buttons on the bottom of the screen can be selected by pressing the function
keys at the top of the keyboard (F1, F2, F3, ...). The function buttons on the screen are
numbered from left to right just as they are on the keyboard.

System Description IMMAGE 800 Operations Manual A11403
Page 2-34 March 2004

Tab + Spacebar

The items in the working area of the screen can be chosen by using the [Tab] key.
Pressing the [Tab] key moves the highlight forward (generally left to right and top to
bottom) through the various text fields and screen buttons that may be chosen. If the
item is a text field, data may be entered as soon as the item is chosen. If the item is a
button, the button can be selected by pressing the [Spacebar].

Arrow Keys + Spacebar

The Arrow Keys on the keyboard may also be used to move the highlight between the
various items on the screen that may be chosen. The highlight moves in the direction
of the arrow. If a text field is chosen, [ ← ] and [ → ] will move through each letter in
the field before moving to the next item. If the item is a text field, data may be entered
as soon as the item is chosen. If the item is a button, the button can be selected by
pressing the [Spacebar].

Page Up/Page Down Buttons

An exception to the use of the [Tab] key or arrow keys are page up/page down buttons.
These buttons cannot be chosen. The [Page Up] and/or [Page Down] keys on the
keyboard are equivalent to the <Page Up> and <Page Down> buttons, respectively.

Performing Software Functions

Tab + Spacebar

2

Selecting a Number from a List

If there is a list of items to choose from, the user may select an item by typing the
number of the item in the text box and pressing [Enter].

A range of numbers can be entered by entering the first number followed by a dash
followed by the last number in the range (Example: 1-5 selects 1, 2, 3, 4, and 5).

A list of discontinuous numbers can be entered by separating the items with a comma
(Example: 1, 5, 8-10 selects 1, 5, 8, 9, and 10).

Using the Touch Screen

When the touch screen is used, the screen can be touched with a finger or any other
object. Any button on the screen can be selected by touching the button on the screen.
Any text field can be chosen by touching the field on the screen.

IMMAGE 800 Operations Manual A11403 System Description
March 2004 Page 2-35

Selecting vs. Choosing

Introduction

Selecting vs. Choosing

Introduction

Selecting an item or field is different from choosing the item or field. Text fields can
only be chosen. Buttons, toggle buttons, and check boxes can be chosen and selected.

"Choosing" Definition

Using the [Tab] key or arrow keys moves the user to the various items on the screen by
highlighting one item at a time. An item is highlighted when a dark line appears
around it. When the item is highlighted that item is chosen but no action occurs.

"Selecting" Definition

Pressing the [Spacebar] selects the chosen item on the screen. When an item is
selected the software performs the appropriate action.

Text fields cannot be selected, only chosen.

Selecting/Choosing by Mouse or Touch screen

Buttons, toggle buttons, and check boxes are selected with the user’s first action and
the [Spacebar] is not needed when using the mouse or touch screen.

System Description IMMAGE 800 Operations Manual A11403
Page 2-36 March 2004

Dialog Boxes

Definition

Dialog boxes are smaller than the total size of the screen and generally do not include
a bottom row of function keys. The purpose of a dialog box is to input a single piece
of data. This piece of data may be as simple as confirming the user’s request for the
system to perform an action. (Refer to Figure 2.19.)

Data is entered into dialog boxes the same as it is entered into the working area of any
screen.

Dialog Boxes

Definition

2

<Cancel>

<OK>

E010254S.EPS

Figure 2.19 Dialog Box Example

Most dialog boxes will have a <Cancel> button. This button closes the dialog box
without entering the requested data or denies confirmation of an action. If this button
is selected:

• no data is entered

• no action is performed

• the dialog box closes

This button can also be selected by pressing [Alt + c].

Some dialog boxes will have an <OK> button. This button accepts the data being
entered or confirms a user’s request for an action. If this button is selected:

• the data is entered into the system or the action is performed

• the dialog box closes

This button can also be selected by pressing [Alt + o].

<Print> or <Display>

Some dialog boxes may contain <Print> or <Display> buttons.

IMMAGE 800 Operations Manual A11403 System Description
March 2004 Page 2-37

Deleting Data From a Text Field and Printing Data from a Screen

Deleting Data from a Text Field

Deleting Data From a Text Field and Printing Data from a Screen

Deleting Data from a Text Field

Follow the steps below to delete data from a text field.

Step Action

1 Choose the text field.
2 Choose one:

• Press the [Delete] key to delete the entire field.

• Press the [Backspace] key to delete a single character prior to the cursor.

• Drag through any portion of the text to highlight it and then press the

[Backspace] key to delete the highlighted text.

Printing Data from a Screen

Many screens contain data that may be printed by selecting Print [F10].

Printing a Screen

Any screen can be printed by pressing [Ctrl] + [P] simultaneously.

System Description IMMAGE 800 Operations Manual A11403
Page 2-38 March 2004

Page Up/Page Down

Definition of Multipage

Some screens contain lists of data. If this list contains more data than an individual
screen can show the list is said to be multipage.

Example:

The chemistry list on the Program Sample screen is a multipage list.

Use of Page Up/Page Down

The user can access additional pages of data by selecting the page up and page down
buttons on the right. The page numbers are shown above the buttons. Selecting the
Page Down button will advance the page to the next page. Selecting the Page Up
button will return the page to the previous page. These buttons only appear if more
than one page of data exists.

Page Up/Page Down

Definition of Multipage

2

Keyboard Equivalents

The keyboard equivalent of the screen Page Up and Page Down buttons are the [Page
Up] and [Page Down] keys, respectively.

IMMAGE 800 Operations Manual A11403 System Description
March 2004 Page 2-39

Program Structure

Introduction

Program Structure

Introduction

The software or interface of the IMMAGE 800 Immunochemistry System is divided
into functional areas based on different tasks. The icons in the menu bar at the top of
the screen represent the various functional areas. The following menu tree displays an
overview to the structure of the IMMAGE 800 software divided into its functional
groups.

Main

Home
Pause
Run

Samples Control Batch [F1]

Demog [F2] (Demographics) Program Sample [F1]

Save Next [F10]

Sample Options [F3]

Set Variable
OK
Cancel

End Batch [F10]

Select Control [F5] Sample Options [F3]
Select Control [F5]
Clear Chem [F7]
Cancel/Edit [F9]
Save/Next [F10]

Rerun Samples [F6]

Rerun Samples
Rerun Chems
Cancel

Stop

Link Sample

Program Batch [F4] Select Racks [F1]

Edit Samples

Clear Samples [F7]

Post Run Summary [F8]

Load List [F9]

Save/Next [F10]

E011369L.EPS

Figure 2.20 IMMAGE 800 Program Tree (1 of 5)

System Description IMMAGE 800 Operations Manual A11403
Page 2-40 March 2004

Results Display Results [F1] Update Sample [F2]
Send to Host [F6]
Report Format [F7]
Print Report [F8]
Prev Sample [F9]
Next Sample [F10]

Cancel Send [F4]

Send to Host [F8]

Report Format [F9]

Print Report [F10]

Rgts/Cal Read Reagent [F1]

(Reagents/
Calibration) Reagent Summary [F2]

Buffer Diluent [F3]

Program Structure

Introduction

2

Request Cal [F4] Clear Racks [F1]
(Request Calibration) Save [F9]
Cancel [F10]

Cal Options [F5]

(Calibration Options)

Slope/Offset Adjustment

Calibrator Summary

Print Last Calibration Results

Cal LdList [F6]
(Calibration Loadlist)

Cancel Request [F7]

Read Cards [F8]

Figure 2.21 IMMAGE 800 Program Tree (2 of 5)

E011370L.EPS

IMMAGE 800 Operations Manual A11403 System Description
March 2004 Page 2-41

Program Structure

Introduction

QC Review Control [F1] Control ID [F2]

(Quality Delete Control [F3]
Control) Print Control [F10]

Define/Edit [F2] Add/Del Chems [F1]
Control ID [F2]
Delete Control [F3]

Delete Control [F3]

QC File List [F4] List CtlName [F1]
List File# [F2]
List SelChem [F3]
List AllChem [F4]
Print [F10]

QC Log [F5] QC Log [F1]
Reagent Lot [F2]
Delete Result [F3]
*Action Log [F4]
Print [F10]

QC Summary [F6] Print Inter-Lab [F9]

Print [F10]

QC Chart [F7] Control Chems [F1]
QC File # [F2]

Print [F10]

Figure 2.22 IMMAGE 800 Program Tree (3 of 5)

System Description IMMAGE 800 Operations Manual A11403
Page 2-42 March 2004

Program Structure

Introduction

2

Setup

Define PrtName [F3]
(Define Print Name)
Clear All [F4]
Insert Chem [F5]
(Insert Chemistry)
Delete Chem [F6]
(Delete Chemistry)
UDR Main [F9]

Delete Panels [F2] Panels Summary [F2]
Print All [F10] Prev. Panel [F9]
Next Panel [F10]

Select TUrine [F2]
Define Calc [F3]
Delete Calc [F4]
Define Var [F5]

Chemistry

Beckman Chems [F1]

Configuration

Panels

Bar Code

Define/Edit [F1] Clear Chem [F1]

Restore Default [F1]

Reference Interval

Report Setup

Calculations

Restore Default [F1]

View/Edit [F1]

(Beckman Chemistries)

Change Date [F2]
Change Time [F3]

Units/Non-standard Dilutions

Antigen Excess

Date/Time

Host Communications

Restore Default [F1]

Restore Default [F1]

Restore Default [F1]

Default Setup

Restore Default [F1]
Print All [F10]

Sample Comments

Demographics Setup

Printer Setup

Restore Default [F1]

Languages/Keyboard

Chemistry Protocol Diskette

Instrument Serial Number

Figure 2.23 IMMAGE 800 Program Tree (4 of 5)

IMMAGE 800 Operations Manual A11403 System Description
March 2004 Page 2-43

Program Structure

Introduction

Utils

Prime

(Utilities)

Event Log

Display Events [F1]
Copy to Disk [F2]
Date/Time [F3]
Clear Events [F4]
Print [F10]

Diagnostics

Cycle Count

Call. Diagnostics

Alignment

Format QNX Diskettes

Prev Align [F1] (Previous Alignment)

Backup/Restore

Wash Cuvettes

Fill Internal Wash
Bottle

Stop Print

Reload DAS Code

Calibrate Touch Screen

Shutdown

Status

Dilution Segments

Sample Carousel Status

Figure 2.24 IMMAGE 800 Program Tree (5 of 5)

System Description IMMAGE 800 Operations Manual A11403
Page 2-44 March 2004

Sample Programming Overview

Introduction

This section summarizes the sample programming methods for the IMMAGE 800
Immunochemistry System.

Sample Programming Options

The following table will summarize the sample programming options based on the
variables of bar coded samples and host interface. For detailed explanations of sample
programming refer to CHAPTER 7, Sample Programming, of this manual.

Table 2.8 Sample Programming Options

Sample Programming Overview

Introduction

2

Bar Coded

Samples

Yes Host Query None required. Load samples in any rack and

No Bi-directional None required. Load samples in rack and

Yes Bi-directional None required. Load samples in any rack and

No Unidirectional Required. Enter rack and position number,

Yes Unidirectional Required. Enter sample ID, and chemistries.

No None Required. Enter rack and position number,

Yes None Required. Enter sample ID, demographics, and

Host Interface Sample Programming

position.

position assigned by host.

position.

sample ID, and chemistries. Load samples in
assigned rack and position.

Load samples in any rack and position.

sample ID, demographics, and chemistries.
Load samples in assigned rack and position.

chemistries. Load samples in any rack and
position.

IMMAGE 800 Operations Manual A11403 System Description
March 2004 Page 2-45

Instrument Specifications

Placement

System Specifications and Characteristics

Instrument Specifications

Placement

The surface on which the unit rests must be free of vibration and must be level, 1° or
<0.75 inch (1.9 cm) slope across the length and the width of the instrument. Do not
place instrument in direct sunlight or drafts or near a heating or cooling duct.

Clearance

Sides - 6 inches (15.2 cm) minimum
Back - None
Front - 3 inches (7.6 cm) minimum
Top - 4 inches (10.1 cm) from top of instrument

Dimensions (Excluding Wash and Waste Bottles)

Height = 30 inches (76.2 cm)
Depth = 25.5 inches (64.8 cm)
Length = 43.5 inches (110.5 cm)

Weight

250 lb. (120 kg)

Power Requirements

Operating Range 115 (90-132) VAC RMS, Single Phase

Frequency 50/60 Hz nominal (47-63 Hz)
Transient Suppression Recommended
BTU Generated 2,900 BTU/hour
Electrical Outlet Grounded per Local Code
Surge Protector Recommended
Current 8.0 Amps (normal) 12 Amps surge

Temperature and Humidity

Ambient Temperature +15°C to +32°C
Ambient Relative Humidity (RH) 15% to 85% (non-condensing)
Reagent Compartment Temperature 13-22°C (32°C Ambient, <45%RH)
Reaction Module Temperature +37°C ± 0.5°C

230 (180-264) VAC RMS, Single Phase

System Description IMMAGE 800 Operations Manual A11403
Page 2-46 March 2004

Drain Requirements

Flow Rate: 3 Liters/hour minimum
Waste Container Placement: The opening should be no higher than the top of the
instrument.

Regulatory Agency Approvals

The IMMAGE 800 meets the safety requirements for the following agencies: CE, UL,
CSA, IEC and CENFLEC.

Environmental Conditions

System can operate up to 8000 ft. (2,438m) elevation.

Capacities

The following table lists various system capacities.

Table 2.9 System Capacities

Instrument Specifications

Drain Requirements

2

Item Capacity

Reagents 24 reagent cartridges can be loaded.
Reagent cartridge 40, 150, or 300 tests per cartridge.
Reaction buffers 4 bottles can be loaded.
Buffer bottle 120 mL: 350 tests.
Samples 72 samples can be loaded.
Sample diluents 4 bottles can be loaded.
Diluent bottles 120 mL: number of dilutions is workload dependent.
Sample dilution segments 4 segments of 36 wells each.
Dilution well 300 µL.
Wash solution 1 box/10 L/approximately 1,000 tests.
Waste container 5 gallons (18.9 L).

IMMAGE 800 Operations Manual A11403 System Description
March 2004 Page 2-47

Peripheral Devices Specifications

Introduction

Peripheral Devices Specifications

Introduction

Refer to the inserts which accompany the respective peripheral devices (computer,
printer, etc.) for product specifications.

System Description IMMAGE 800 Operations Manual A11403
Page 2-48 March 2004

Sample Container Information

Sample Containers Allowed

Introduction

The following categories document specifications for sample containers that can run
on the IMMAGE 800 Immunochemistry System.

Primary Tubes

16 × 100 mm (10 mL)
16 × 75 mm (7 mL)
13 × 100 mm (7 mL)
13 × 75 mm

16.5 × 92 mm

Secondary (Aliquot) Tubes

16 × 100 mm
16 × 75 mm
13 × 100 mm
12 × 75 mm

Sample Containers Allowed

Introduction

2

Microtubes

13 × 100 mm SYNCHRON® Microtube™

Sample Cups

2 mL (placed into a sample cup holder)

0.5 mL (placed into a sample cup holder)

NOTICE
Low humidity and high ambient temperature may cause evaporation when using small
volumes of sample in sample cups. To minimize evaporation:

• Program samples in positions A or B on the sample carousel.
OR

• Program samples as STATS.

IMMAGE 800 Operations Manual A11403 System Description
March 2004 Page 2-49

Bar Code Types and Options

Introduction

Bar Code Types and Options

Introduction

Four bar code types are supported by the IMMAGE 800:

•Code 39

• Code 128

• Interleaved 2 of 5

•Codabar

The bar code scanner will read any of these bar code types, provided the type is
enabled in Bar Code Setup and the options match those defined for the bar code label.
The scanner will also automatically discriminate between the symbologies, so tubes
with bar code labels of different types may be intermixed in a run.

Code 39 Options

Check Digit: If a higher degree of data integrity is required, a check digit may be
enabled and added to the bar code ID. The check digit used is a Modulus 43, which is
the sum of all the character values and is the last digit of the bar code ID. Code 39
expects the check digit to be included in the final code length.

Large Intercharacter Gap: In Code 39, the intercharacter gap has a minimum value of

one times the width of the narrow element and a maximum value of three times the
width of the narrow element, or 0.06 inches (0.152 cm), whichever is greater. This

feature should be enabled when the intercharacter gap exceeds four times the narrow
element width.

Fixed Code Length: If the sample IDs being used are all of the same length, Fixed
Code Length may be enabled to ensure that only one length of sample ID is accepted.

Define Code Length: When Fixed Code Length is enabled, the code length may be
defined as from 1 to 15 characters.

Code 128 Options

The options for Code 128 bar codes are fixed in the software and cannot be
reconfigured by the user. The IMMAGE 800 uses Code 128 formatting to read
BECKMAN COULTER bar coded cards and rack ID.

Fixed Code Length: disabled.

System Description IMMAGE 800 Operations Manual A11403
Page 2-50 March 2004

Interleaved 2 of 5 Options

Check Digit: If a higher degree of data integrity is required, a check digit may be
enabled and added to the bar code ID. The check digit used is a Modulus 10.
Interleaved 2 of 5 expects the check digit to be included in the final code length.

Code Length One: An even number from 0 to 14 must be defined as the number of
characters in the code.

Code Length Two: A second code length (an even number from 0 to 14) may be
defined. Both lengths would then be recognized.

Codabar Options

Start and Stop Codes Match: When this option is enabled, the start code and stop code
must be the same character for a valid read.

Large Intercharacter Gap: This option is used when reading Codabar labels with large
gaps between bar code characters. The normal intercharacter gap cannot exceed one
character element.

Bar Code Types and Options

Interleaved 2 of 5 Options

2

Fixed Code Length: If the sample IDs being used are all of the same length, Fixed
Code Length may be enabled to ensure that only one length of sample ID is accepted.

Define Code Length: When Fixed Code Length is enabled, the code length may be
defined as from 1 to 15 characters.

IMMAGE 800 Operations Manual A11403 System Description
March 2004 Page 2-51

Bar Code Label Specifications

Industry Standards

Bar Code Label Specifications

Industry Standards

American National Standards (ANSI X3.182.1990)
American Society for Testing Materials (ASTM E1466-92)

Symbol Size

Maximum overall length: 60 mm (2.36 inch)
(Includes bar code symbol with 5 mm (0.20 inch) quiet zone at each end.)
Minimum height: 10 mm (0.40 inch)

Symbol Content

Maximum of 15 characters.

Recommended symbol content printed on label in human-readable form. Square
bracket ([ or ]), percentage sign (%), dollar sign ($), comma (,) quotation mark ("),
ampersand (&), asterisk (*), semi-colon (;), question mark (?), back slash (\), caret (^),
tilde (~), or piping bar (|) cannot be used as a character.

Margin of Reading Accuracy

Bar code symbol (narrow) element width of 0.19 to 0.51 mm (0.0075 to 0.02 inch)

Wide-element to narrow-element ratio of 2.2:1 to 3.0:1.

Placing a Tube into a Rack

Tubes should be seated to the bottom of the rack with the bar code label facing the
same direction as the rack label.

Label Print Quality

Printed by direct thermal or thermal transfer.

Label Symbologies

Code 39
Interleaved 2 of 5
Codabar
Code 128

Check Characters

The use of check digits and fixed length codes is highly recommended where possible.
This greatly reduces the possibility of scanning errors.

System Description IMMAGE 800 Operations Manual A11403
Page 2-52 March 2004

Label Sources

All patient and control sample labels are supplied by the customer. Preprinted labels
can be used, or labels generated by a bar code printer. Beckman Coulter, Inc.
recommends the following printers:

Execuport 2400 Computer Transceiver Systems

Intermec 3000A Intermec Corporation

Zebra 130 Zebra Technologies Corp.

P.O. Box 1117
23 Carol Street
Clifton, NJ 07014-0996
Phone: [phone]

6001 36th Avenue West
Everett, WA 98203
Phone: [phone]

333 Corporate Woods Parkway
Vernon Hills, IL 60061
Phone: [phone]

Bar Code Label Specifications

Label Sources

2

Please contact any of the above vendors or industry standard associations for any
specific bar code application issues.

IMMAGE 800 Operations Manual A11403 System Description
March 2004 Page 2-53

Applying Bar Code Labels

Correct Application of Bar Codes

Applying Bar Code Labels

Correct Application of Bar Codes

Refer to the IMMAGE Sampling Template for the correct application of bar codes.

System Description IMMAGE 800 Operations Manual A11403
Page 2-54 March 2004

Sample Volume

Minimum Volumes

Refer to the IMMAGE Sampling Template for minimum volume requirements.

Primary Tube Sampling Template

Before running a primary tube on the IMMAGE 800, verify sample tube volume level
with the IMMAGE Sampling Template.

Sample Volume

Minimum Volumes

2

IMMAGE 800 Operations Manual A11403 System Description
March 2004 Page 2-55

Loading Tubes Into Racks

Guidelines

Loading Tubes Into Racks

Guidelines

• Remove stoppers from sample tubes before loading.

• Load the sample tubes onto the racks with the bar code labels facing the same
direction as the sample rack bar code label. (Refer to Figure 2.25.)

• Confirm that the tube is properly seated in the bottom of the rack.

• Be sure the entire bar code symbol, including quiet zone, is visible through the rack.

The bar code must be visible to the Sample Bar Code Reader, otherwise the sample will
not be identified or run.

Example

NOTICE

1. Rack Bar Code Label

Figure 2.25 Bar Coded Tube Orientation

System Description IMMAGE 800 Operations Manual A11403
Page 2-56 March 2004

Instrument Operation

Introduction

The following tables describe instrument functions during start-up, sample processing,
and data reduction.

Start-up

The following tables explain what happens after all reagents and samples have been
loaded and Start Run has been selected.

Table 2.10 Start Up Functions

Stage Description

1 The IMMAGE 800 will:

Instrument Operation Overview

Instrument Operation

Introduction

2

2 A fluid level sense is performed on all Buffer and Diluent bottles. The %

3 Sample and Reagent carousels are spun. Bar codes for both reagent and

4 The on-board reference cuvette is read as part of optical quality control.

Sample Processing

The following table describes typical sample processing performed by the IMMAGE

800.

Table 2.11 Sample Processing Functions

Stage Description

• home moving parts

• prime wash through the lines

• wash the probes

• perform internal diagnostic checks

volume remaining is then calculated.

samples are read.
If the reagent load procedure has been performed and the reagent cover has
not been opened, the reagent carousel is not reread.

1 Buffer is added to the reaction cuvette, followed by a 5 minute incubation

to allow temperature equilibrium.
2 Sample or diluted sample is added to the reaction cuvette with mixing.
3 Reagent is then dispensed with mixing.
4 The reaction is monitored from 90 seconds up to 5 minutes depending on

the chemistry.

(1 of 2)

IMMAGE 800 Operations Manual A11403 System Description
March 2004 Page 2-57

Instrument Operation

Data Reduction

Table 2.11 Sample Processing Functions, continued

Stage Description

Data Reduction

The following table describes the typical data reduction process performed by the
IMMAGE 800.

5 Chemistries which utilize AGXS testing have antigen dispensed and their

reaction monitored for an additional 20 seconds.

6 The instrument will automatically make the appropriate dilution for high

or low samples to obtain the final answer. Samples which exceed the
instrument range will be flagged as Out-of-Range Hi or Out-of-Range Lo.

Note: During the run, the system tracks all reagent volumes and can
switch to another bottle of the same lot number. If there are no additional
reagents of that lot number, the test will be set to Pending prior to
aspiration of sample or reagent.

(2 of 2)

Table 2.12 Data Reduction Functions

Stage Description

1 The reaction wheel operates on a 5 second cycle time. During each cycle,

the cuvettes are spun in front of the optics station and 200 data points are
taken. These 200 points per cuvette are then calculated to a single value.

2 For each spin, the calculated value, the time the data was taken, and a

calculated quality value is logged for each cuvette.

3 When the reaction incubation time has expired on each cuvette, the data

logged for that cuvette is checked for certain mathematical bounds.
4 The data is then checked for an increasing signal, indicative of a reaction.
5 Passing the checks, the data is then mathematically curve fitted to a non-

linear function. The rate of scatter intensity is calculated from the resulting

curve.
6 The rate is directly related to the concentration.
7 A concentration test result is calculated based on the calibration factor, the

rate, and any dilution factors used.
8 Results may be scaled into alternative reporting units defined by the user.

System Description IMMAGE 800 Operations Manual A11403
Page 2-58 March 2004

CHAPTER 3 Theory of Operations

Table of Contents

Theory of Operations .................................................................................................................. 3-2

Principles of Methodologies ...................................................................................................3-2

Signal Measurement and Reaction Dynamics ........................................................................ 3-3

Antigen Excess Testing ........................................................................................................... 3-8

Out-of-range Testing ............................................................................................................. 3-11

Calibration ............................................................................................................................. 3-12

3

IMMAGE 800 Operations Manual A11403 Theory of Operations
March 2004 Page 3-1

Principles of Methodologies

Principles of Rate Nephelometry

Theory of Operations

Principles of Methodologies

Principles of Rate Nephelometry

The rate nephelometer measures the increase in the intensity of light scattered by
particles suspended in a cuvette. The light source for the rate nephelometer is a 670
nm laser. The detector is placed at a 90° angle from the laser beam to measure light
scatter, as shown in Figure 3.1.

Principles of Rate Turbidimetry

The rate turbidimeter measures the decrease in the intensity of light as it passes
through a solution of light scattering particles in a cuvette. The light source for the
rate turbidimeter is an light emitting diode (LED) at a wavelength of 940 nm.
Turbidimetric measurements are made at 0° from the incident beam as shown in
Figure 3.1.

1. LED light source (turbidimetric)

2. Laser light source (nephelometric)

3. Focus lens

4. Beam splitter

5. Reaction cuvette

6. Nephelometric detector
(90° angle to incident laser beam)

7. Laser light bounces into light trap

8. Turbidimetric detector (0° angle to the
incident LED beam)

Figure 3.1 IMMAGE 800 Rate Nephelometer and Rate Turbidimeter Basic

Components

Theory of Operations IMMAGE 800 Operations Manual A11403
Page 3-2 March 2004

Signal Measurement and Reaction Dynamics

Light Scatter Signal Development

During an antigen-antibody reaction, immunoprecipitin complexes are formed.

In rate nephelometry, the light scattered at 90° increases as the complexes are formed.

In rate turbidimetry, the light intensity at 0° decreases as the complexes are formed.
This decrease is converted to an increasing scatter signal by the formula:

Signal Measurement and Reaction Dynamics

Light Scatter Signal Development

3

scatter signal = -Log

light intensity



10

initial light intensity






E011367L.EPS

Rate nephelometry and rate turbidimetry give the same signal as illustrated in
Figure 3.2.

2

Y

5

4

3

X

1. X = Increasing time

2. Y = Increasing scatter signal

3. Buffer Addition

1

4. Sample Addition

5. Antibody Addition

A011368L.EPS

Figure 3.2 Scatter Signal versus Time for Rate Nephelometry and Rate

Turbidimetry

Rate Determination

The system monitors scatter signal from the antigen antibody reaction at 5 second time
intervals. At the end of the reaction, the system mathematically calculates the rate of
change of the scatter signal.

IMMAGE 800 Operations Manual A11403 Theory of Operations
March 2004 Page 3-3

Signal Measurement and Reaction Dynamics

Dynamic Blanking

Dynamic Blanking

The IMMAGE 800 automatically performs a patented dynamic blanking algorithm for
selected analytes when testing at low serum dilutions. The results are improved by
elimination of the nonspecific light scatter produced by the polymer enhanced reaction
buffer interacting with the serum.

Dynamics of the Immunoprecipitin Reaction

The formation of light scattering complexes is dependent on the presence of antigen
and antibody molecules in optimal proportions. In general, the reagent contains a
fixed amount of antibody which binds with antigen in the sample to form light
scattering complexes. (Refer to Figure 3.3.)

1

4 5 6

2

4 5 7

3

4 5 8

1. Antibody excess

2. Optimal proportion

3. Antigen excess

4. Antigen

A011357L.EPS

5. Antibody

6. Soluble complexes

7. Insoluble complexes

8. Soluble complexes

Figure 3.3 Antigen-antibody Reaction Under Varying Concentrations Of Antigen

And Antibody

Theory of Operations IMMAGE 800 Operations Manual A11403
Page 3-4 March 2004

Protein Rate Response Curve

Figure 3.4 illustrates the rate response for several test samples with various antigen
concentrations. The antibody is maintained at a constant level. The magnitude of the
rate response increases from test sample A to test sample F. The rate response for test
sample G is less than for sample F, although the antigen concentration in sample G is
greater than sample F. Test sample H illustrates a further reduction in the rate response
due to the increase in antigen concentration in the sample.

Signal Measurement and Reaction Dynamics

F

3

Protein Rate Response Curve

3

2

Y

C

B

A

1. X = Increasing Antigen Concentration

2. Y = Peak rate of scatter

3. A-H represent peak response values at varying antigen concentrations.
The antibody is maintained at a constant level.

E

D

X

1

G

H

A011358L.EPS

Figure 3.4 Protein Rate Response Curve

IMMAGE 800 Operations Manual A11403 Theory of Operations
March 2004 Page 3-5

Signal Measurement and Reaction Dynamics

Dynamics of Inhibition of Immunoprecipitin by Hapten (Drug)

Dynamics of Inhibition of Immunoprecipitin by Hapten (Drug)

In the drug assays, the conjugate is prepared by linking several hapten (drug) residues
to a high molecular weight carrier. The conjugate competes with the free drug
(hapten) in the sample for available binding sites on the antibody. Increased drug in
the sample results in a decrease in the formation of insoluble complexes. Figure 3.5
illustrates the conjugate antibody reaction in the presence of hapten (drug).

A.

1

+

1

3

B.

2

1

3

1. Conjugate-antibody complexing

2. Inhibition of complexing by hapten

2

4

+

2

4

3

5

A011359L.EPS

4. Antibody

5. Hapten

3. Conjugate Antibody

Figure 3.5 Inhibition of Immunoprecipitin by Hapten (drug)

Theory of Operations IMMAGE 800 Operations Manual A11403
Page 3-6 March 2004

Drug Rate Response Curve

In drug assays the rate response decreases with increasing hapten (drug) concentration.
Figure 3.6 illustrates the rate response for several test samples with various hapten
concentrations. The magnitude of the rate response decreases from test sample A to
test sample E. Sample E has a very low rate response indicating a high hapten
concentration in the sample.

2

Y

Signal Measurement and Reaction Dynamics

A

3

B

C

D

E

Drug Rate Response Curve

3

X

1

1. X = Increasing free hapten (drug) concentration

2. Y = Peak rate of scatter

3. A-E represent peak rate values at varying free hapten levels.
Specific antibody and drug conjugate remain at constant levels.

Figure 3.6 Drug Rate Response Curve

A011360L.EPS

IMMAGE 800 Operations Manual A11403 Theory of Operations
March 2004 Page 3-7

Antigen Excess Testing

Overview

Antigen Excess Testing

Overview

Antigen excess (AGXS) testing is only necessary for some IMMAGE 800 protein
reagents.

Immunoglobulin G (serum IGG, urine IGU), Immunoglobulin A (IGA),
Immunoglobulin M (IGM), Kappa (KAP), Lambda (LAM), Haptoglobin (HPT), Urine
Transferrin (TRU), Alpha-1-Microglobulin (A1M), Microalbumin (MA) and Albumin
(ALB) which are identified by the system as ambiguous, are tested for antigen excess
condition if AGXS testing is enabled. (Refer to CHAPTER 5, System Setup,
Configuring Antigen Excess Testing.) A reaction is ambiguous if the rate response
could represent either an antigen excess or an antibody excess reaction.

Antibody Excess

When the reaction is to the left of the optimal antibody-antigen proportions (center
line), the reaction is in antibody excess (AbXS). (Refer to Figure 3.7.) This indicates
all the antigen in the sample is bound, forming complexes. This is the ideal condition
for the reaction to take place.

Antigen Excess

When the reaction is to the right of the optimal antigen-antibody proportions (center
line), the reaction is in antigen excess (AgXS) and the rate response will start to
decrease due to excessive levels of antigen. (Refer to Figure 3.7.)

Theory of Operations IMMAGE 800 Operations Manual A11403
Page 3-8 March 2004

Ambiguous Response

It is possible for two significantly different sample concentrations of antigen to yield
the same rate response. Either the rate response represents the correct concentration in
the area of AbXS (left side) or the same rate response represents a concentration that is
in the area of AgXS (right side) and requires further dilution. Antigen excess testing
differentiates these two situations. (Refer to Figure 3.7.)

Antigen Excess Testing

Ambiguous Response

3

3

2

Y

X

1

1. X = Increasing antigen concentration

2. Y = Rate response

Figure 3.7 Antigen Excess Detection

4

A011361L.EPS

3. Antibody excess (AbXS)

4. Antigen excess (AgXS)

IMMAGE 800 Operations Manual A11403 Theory of Operations
March 2004 Page 3-9

Antigen Excess Testing

How Antigen Excess Testing is Performed

How Antigen Excess Testing is Performed

The system performs antigen excess testing by adding additional antigen to the
completed reaction.

Table 3.1 Antigen Excess Testing

If unbound Ab is... the addition of more Ag will

result in...

present an increase in rate response, as

indicated by the solid line in
Figure 3.8

not present no increase in rate response,

as indicated by the broken line
in Figure 3.8

2

Y

and the IMMAGE 800 will...

use the initial rate response to
calculate the final result.

automatically rerun the
sample at the next higher
dilution and test for antigen
excess until a final result is
obtained.

3

4

X

1

A011362L.EPS

1. X = Reaction time (in seconds)

2. Y = Rate response

3. Response if antibody excess

4. Response if antigen excess

Figure 3.8 Rate Response versus Reaction Time

Theory of Operations IMMAGE 800 Operations Manual A11403
Page 3-10 March 2004

Out-of-range Testing

Description of Out-of-range Testing

The IMMAGE 800 reagents have been optimized so that the initial measuring range
will include the majority of the expected concentration values. Each reagent bar code
card contains information which defines the out-of-range high and out-of-range low
limits. Samples above or below the initial measuring range will automatically be
retested at the next appropriate dilution (refer to IMMAGE Immunochemistry Systems
Chemistry Information Manual Appendix B, Measuring Ranges/Dilution Fluids for
dilution scheme).

Description of Out-of-range Testing

Out-of-range Testing

3

IMMAGE 800 Operations Manual A11403 Theory of Operations
March 2004 Page 3-11

Calibration

Calibration Curve

Calibration

Calibration Curve

The calibration curve for each lot of reagent is determined by Beckman Coulter, Inc.
In general, the calibration curve is formed from eight to twelve standards of known
analyte concentrations, with approximately thirty points per standard, tested on
multiple systems. The calibration curve parameters are coded onto a lot specific
reagent bar code card. When a reagent bar code card is read, the curve parameter
information is transferred and stored by the system.

System Calibration

System calibration is accomplished by testing a single analyte concentration which is
contained in a specific calibrator. To ensure a valid calibration, the system requires
that the rate response of two replicates obtained during calibration is reproduced
within a predefined percentage. The averaged rate of the two replicates is used to
establish a calibration scale factor based on the assigned calibrator target value. The
calibration scale factor is used to adjust the measured rate response to equal the
theoretical response.

Protein Calibration Curve

When the antibody concentration is constant, the rate response will increase as antigen
concentration increases. The maximum rate response occurs when the antibody and
antigen are in optimal proportions. As antigen concentration increases further, the rate
response will then progressively decrease. The regions at lower and higher antigen
concentration are called antibody excess and antigen excess, respectively.

Drug Calibration Curve

When the concentration of conjugate and specific antibody are constant, the rate
response will decrease as drug (hapten) concentration increases. The maximum rate
response occurs when the drug is absent, and the maximum amount of antibody is
available to react with the conjugate.

Theory of Operations IMMAGE 800 Operations Manual A11403
Page 3-12 March 2004

CHAPTER 4 System Power On/Off

Table of Contents

System Power On/Off ................................................................................................................. 4-2

System Power On .................................................................................................................... 4-2

System Power Off ................................................................................................................... 4-4

Database Recovery .................................................................................................................. 4-5

Software Installation Instructions ........................................................................................... 4-6

4

IMMAGE 800 Operations Manual A11403 System Power On/Off
March 2004 Page 4-1

System Power On

Introduction

System Power On

Introduction

After the IMMAGE® 800 Immunochemistry System installation, the system can be
powered on.

Power On Sequence

Follow the steps below to power on the IMMAGE 800 system.

Step Action

1 Check that the floppy disk drive is empty.
2 Turn on the printer.

System Power On/Off

3 Turn on the monitor.
4 Turn on the CPU.
5 Verify that the UPS is on. (The UPS power switch is on and the power

indicator light is on.)
6 Turn on the instrument.
7 Close reagent and sample carousel covers.
8 When the note is displayed to check dilution segment status, select <OK>.
9 When the temperature warning note displays, select <OK>.

• The system will continue to bring the reagent chamber and reaction
cuvettes to the appropriate temperature range.

• The system will not allow a run to start until the reaction cuvettes are
within the appropriate temperature range.

10 Refer to CHAPTER 11, System Status/Instrument Commands, Checking

Dilution Segment Status and Clearing Dilution Segments, and CHAPTER
7, Sample Programming, Checking Status and Clearing/Replacing
Dilution Segments.

11 Refer to the appropriate chapters in this manual to operate the system.

System Power On/Off IMMAGE 800 Operations Manual A11403
Page 4-2 March 2004

Additional Information

• Refer to CHAPTER 1, General Information/Precautions and Hazards for a
description of switches and port connections.

• Refer to CHAPTER 2, System Description, Computer, Printer, for the location of
appropriate switches and connections.

• Refer to the instruction manual provided with the UPS for specific information on
the UPS.

System Power On

Additional Information

4

IMMAGE 800 Operations Manual A11403 System Power On/Off
March 2004 Page 4-3

System Power Off

Introduction

System Power Off

Introduction

It is recommended that the instrument remains powered on and in Standby when not in
use.

Powering off the system is recommended for the following situations:

• when parts replacement procedures specify power to be turned off

• when moving the system to a new location

• when lab power goes off (the console is protected by the UPS)

Once the procedure is complete or lab power is restored, power on the system.

Power Off Sequence

The instrument status must be in Standby in order to proceed with the steps below to
power off the IMMAGE 800 system.

Step Action

Emergency Stop

Turn the instrument main power switch off if the stop button on the screen is
unavailable and the instrument must be stopped immediately.

NOTICE
The database may become corrupted if power is turned off before the Power Off
sequence is completed.

1 Check that the floppy diskette drive is empty.
2Select Utilities from the menu bar.
3Select <Shutdown>.
4 When the message Shutdown Complete is displayed, turn off the printer,

monitor, CPU (computer), UPS, and instrument.

NOTICE
When an emergency stop or unplanned power loss occurs during a run, and power is
restored within 24 hours, the cuvettes must be washed 1 time before a run can be
started. (Refer to CHAPTER 10, Utilities, As-Indicated Maintenance, "Washing Cuvettes.")

If power is restored after 24 hours, the cuvettes must be replaced. (Refer to CHAPTER 10,
Utilities, As-Indicated Maintenance, "Replacing Cuvettes.")

System Power On/Off IMMAGE 800 Operations Manual A11403
Page 4-4 March 2004

Database Recovery

Introduction

In the event of a fatal system error or power outage, the system will attempt to recover
files and databases which may have been affected.

Fatal Errors

When a fatal error note is displayed, call Beckman Coulter for assistance.

Information Retained

The following information will be retained in the database after power is restored.

• Chemistry protocols

• Reagent and calibrator bar coded parameters

• Current calibration status for each reagent

Database Recovery

Introduction

4

• Calibration requests that were not completed

• Completed results

• Sample programming for incomplete results and samples that have not been run

• Quality control files

• All system software setup configurations

• Event logs

• All instrument hardware settings

Information Changed

The following information and/or screens will be changed after power is restored.

Table 4.1 Information Changed After Power is Restored

Dilution Segments dialog box All segments go to 0 wells available.
Sample Carousel Status monitor Screen is blank.
Reagent Status/Calibration Status screen Screen is blank. Calibration requests are

Sample Load List Samples which were In Process, become

Information/Screen Change

deleted.

Incomplete.
Instrument Status Monitor Continuously updates all parameters.
Simulated calibrations Calibration status changes to Failed.
Printing Printouts will stop. From Results Recall,

request printouts of patient and control

reports if needed. Calibration reports

cannot be recalled for printing.

IMMAGE 800 Operations Manual A11403 System Power On/Off
March 2004 Page 4-5

Software Installation Instructions

Introduction

Software Installation Instructions

Introduction

The IMMAGE 800 System Software is preloaded on the hard disk. The Installation
Diskette and System Software CD-ROM are provided in case the software is reloaded.

Preparation

The following are used during the installation:

• Installation Diskette

•CD-ROM

Storage of Software

Store the Diskette and CD-ROM in an area away from electrical and magnetic
interference to prevent damage. Avoid extreme temperature.

Installing the Software

Follow the steps below to install (reload) software.

Step Action

1 Complete backup of the database to a floppy diskette.
2 Power off the computer and the IMMAGE 800 instrument.
3 Insert the Installation Diskette into the floppy diskette drive.
4 Turn the computer power on.
5 Push the button beside the CD-ROM drive, insert the CD-ROM (label side

6 Read the introduction screen,

7 When "Installation is complete..." is displayed, remove the Diskette and

8 Power on the instrument.

up) into the CD-ROM drive and close the "drawer".

AND

Press <Enter> to continue.

CD-ROM from the drives. Turn the computer off and then on.

NOTICE

If <Esc> is selected at any time during installation, return to Step 1.

System Power On/Off IMMAGE 800 Operations Manual A11403
Page 4-6 March 2004

CHAPTER 5 System Setup

Table of Contents

System Software Configuration ..................................................................................................5-2

Overview ................................................................................................................................. 5-2

Configuring the Chemistry Menu ........................................................................................... 5-4

Panel Setup .............................................................................................................................. 5-9

Bar Code Setup ..................................................................................................................... 5-13

Reference Interval Setup .......................................................................................................5-17

Report Setup .......................................................................................................................... 5-25

Calculations Setup ................................................................................................................. 5-28

Units Setup ............................................................................................................................ 5-37

Selecting Non-Standard Dilutions as Default for Each Chemistry ....................................... 5-40

Configuring Antigen Excess Testing .................................................................................... 5-42

Date and Time Setup ............................................................................................................. 5-44

Host Communications Setup ................................................................................................. 5-50

Default Setup ......................................................................................................................... 5-57

Sample Comments Setup ...................................................................................................... 5-60

Demographics Setup .............................................................................................................5-62

Printer Setup .......................................................................................................................... 5-64

Language Setup ..................................................................................................................... 5-65

Loading the Chemistry Protocol Diskette ............................................................................. 5-66

Instrument Serial Number Setup ........................................................................................... 5-67

User-Defined Reagent Chemistry Setup ................................................................................... 5-68

UDR Chemistry Overview and Precautions ......................................................................... 5-68

Setting Up a UDR Chemistry ................................................................................................ 5-69

Defining a UDR Chemistry ................................................................................................... 5-75

Defining UDR Calibration Information ................................................................................ 5-84

Deleting UDR Chemistries ................................................................................................... 5-85

Editing UDR Definitions ...................................................................................................... 5-86

Loading UDR Reagent Cartridges ........................................................................................ 5-88

Loading/Clearing UDR Buffer and Diluent .......................................................................... 5-91

Programming Rate Mode ...................................................................................................... 5-93

Calibrating a UDR Chemistry ............................................................................................... 5-96

Approving a Calibration ...................................................................................................... 5-103

Printing UDR Reports ......................................................................................................... 5-113

Setting Up UDR Reference Intervals and Panels ................................................................ 5-115

Defining UDR Quality Control ........................................................................................... 5-116

Programming a UDR Sample ............................................................................................. 5-117

Instrument Setup ..................................................................................................................... 5-118

Overview ............................................................................................................................. 5-118

Placing Labels on a Rack .................................................................................................... 5-119

Wash Solution Box and Waste Container Placement ......................................................... 5-121

5

IMMAGE 800 Operations Manual A11403 System Setup
March 2004 Page 5-1

Overview

Introduction

Overview

Introduction

System Software Configuration

In System Setup several features of the IMMAGE® 800 Immunochemistry System
interface can be customized for the individual laboratory’s requirements. Setup
maintains the default parameters used for configuring the IMMAGE 800 interface.
These configurations can be changed when the system status is in Standby.

This chapter explains how to:

• configure the chemistry menu

• set up panels

• set up bar codes

• set up reference intervals

• set up reports

• set up special calculations

• set up units/non-standard dilutions

• configure antigen excess testing

• set up date and time

• set up host communications

• set up replicates/statistics

• set up sample comments

• set up demographics

• set up the printer

• set up the language

• read the chemistry protocol diskette

• enter the instrument serial number

• set up user-defined reagent chemistries

System Setup IMMAGE 800 Operations Manual A11403
Page 5-2 March 2004

Accessing Setup

The instrument status must be in Standby in order to proceed with the steps below to
access the Setup screen.

Step Action

Overview

Accessing Setup

1Select Setup from the menu bar.
2 Choose the desired setup option from a numbered button. (Refer to Figure

5.1.)

5

Figure 5.1 Setup Screen

E011414S.EPS

IMMAGE 800 Operations Manual A11403 System Setup
March 2004 Page 5-3

Configuring the Chemistry Menu

Introduction

Configuring the Chemistry Menu

Introduction

The chemistry menu available in the sample programming, quality control, panel
definition and other screens is defined by the individual laboratory. The menu contains
up to 72 chemistries.

Defining a Chemistry for a Position

The instrument status must be in Standby in order to proceed with the steps below to
define a chemistry.

Step Action

1 From the Setup screen, select <1> Chemistry Configuration. (Refer to

Figure 5.2.)
2 Choose the position for the chemistry.
3 Choose one:

• Type the Beckman Coulter chemistry acronym if known (e.g., IGG).

•Select Beckman Chems [F1] to display a list of all Beckman Coulter

chemistries that have a protocol on the system and select the appropriate
chemistry.

OR

E014043S.EPS

Figure 5.2 Chemistry Configuration Screen

System Setup IMMAGE 800 Operations Manual A11403
Page 5-4 March 2004

Clearing All 72 Positions

The instrument status must be in Standby in order to proceed with the steps below to
clear all positions.

Step Action

1 From the Setup screen, select <1> Chemistry Configuration.
2Select Clear All [F4].
3Select <OK> to clear all of the configured chemistries.

Select <Cancel> to return to the Chemistry Configuration screen without
clearing all of the configured chemistries.

Inserting a Blank Position for Chemistry Insertion

This function is useful for inserting a chemistry into the menu. The subsequent
chemistries will be incremented by one position. After a blank position is inserted, a
chemistry can be defined for that position using the normal procedure. (Refer to
"Defining a Chemistry for a Position" in this section.)

OR

Configuring the Chemistry Menu

Clearing All 72 Positions

5

The instrument status must be in Standby in order to proceed with the steps below to
insert a blank position.

Step Action

1 From the Setup screen, select <1> Chemistry Configuration.
2 Select a position.
3Select Insert Chem [F5] to insert a blank position and increment the

subsequent chemistries by one position.

4 Define a chemistry for the new blank position as described in "Defining a

Chemistry for a Position," in this section.

IMMAGE 800 Operations Manual A11403 System Setup
March 2004 Page 5-5

Configuring the Chemistry Menu

Deleting a Chemistry

Deleting a Chemistry

This function deletes a chemistry from the menu and decrements the subsequent
chemistries by one position. The chemistry protocol remains in the system. When the
chemistry is deleted from the chemistry menu:

• the system automatically removes the chemistry from any configured control.

• the system automatically removes the chemistry from any configured panel in which
it is defined.

• accumulated QC data for the chemistry is not deleted.

Step Action

1 From the Setup screen, select <1> Chemistry Configuration.
2 Choose a position for the chemistry to be deleted.
3Select Delete Chem [F6].
4Select <OK> to delete the chemistry.

Select <Cancel> to return to the Chemistry Configuration screen without
deleting chemistry.

OR

NOTICE
If the error message Unable to delete chemistry is displayed, one of the
following conditions exists:

• The reagent is on board the instrument.

• The chemistry is programmed for a sample.

• The chemistry is configured in a programmed control.

This condition must be corrected before the chemistry can be
deleted.

System Setup IMMAGE 800 Operations Manual A11403
Page 5-6 March 2004

Defining Print Names

This function allows definition of print names for each chemistry. A Print Name is any
defined text that will print on the patient chartable report in place of the Beckman
Coulter chemistry name.

The instrument status must be in Standby in order to proceed with the steps below to
define a Print Name.

Step Action

1 From the Setup screen, select <1> Chemistry Configuration.
2Select Define PrtName [F3]. (Refer to Figure 5.3.) The chemistry menu

3 Choose the text field beside the desired chemistry.

Configuring the Chemistry Menu

Defining Print Names

will be displayed. If there are chemistries defined for positions greater
than 20, the <Page Up> and <Page Down> buttons can be used to show
additional pages of chemistries.

5

4 Type the print name (up to 21 alphanumeric characters).
5 For additional chemistries repeat Steps 3-4.
6Select <OK> to save the changes or additions.

OR

Select <Cancel> to return to the Chemistry Configuration screen without
saving changes or making additions.

E010215S.EPS

Figure 5.3 Define Print Names Dialog Box

IMMAGE 800 Operations Manual A11403 System Setup
March 2004 Page 5-7