Beckman Coulter IMMAGE 800 User manual

A11403AE
September 2016
Operations Manual
IMMAGE 800
Immunochemistry System
For In Vitro Diagnostic Use
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821 U.S.A.

IMMAGE 800 Immunochemistry System
Operations Manual
PN A11403AE (September 2016)
© 2016 Beckman Coulter, Inc.
All rights reserved
Trademarks
Beckman Coulter, the stylized logo, and the Beckman
Coulter product and service marks mentioned herein are
trademarks or registered trademarks of Beckman Coulter,
Inc. in the United States and other countries.
All other trademarks are the property of their respective
owners.
Find us on the World Wide Web at:
www.beckmancoulter.com
Beckman Coulter Eurocenter S.A.
22, rue Juste-Olivier
Case Postale 1044
CH -1260 Nyon 1, Switzerland
Tel: [phone]
Beckman Coulter do Brasil Com e Imp de Prod de Lab Ltda
Calçada Aldebarã, 39, Centro De Apoio 2 - Alphaville,
Cep 06541-055 - Santana De Parnaíba, Sp, Brasil
CNPJ: 42.160.812/0001-44
製造販売元 : ベックマン･コールター株式会社
東京都江東区有明三丁目5番7号
TOC 有明ウエストタワー
贝克曼库尔特有限公司，
美国加利福尼亚州，Brea 市，S. Kraemer 大街 250 号，
邮编：92821 电话：[phone]
Original Instructions

IMMAGE 800 Operations Manual A11403 Revision History
September 2016 Page 1 of 2
Revision History
A11403AE, September 2016
Software version 2.0
Changes:
Copyright page
• Revised EC REP address.
Appendix A, Part Number List was deleted.
• Refer to www.beckmancoulter.com or contact your Beckman Coulter representative.
A11403AD, October 2011
Software version 2.0

Revision History IMMAGE 800 Operations Manual A11403
Page 2 of 2 September 2016

Introduction
IMMAGE 800 Operations Manual A11403 Safety Notice
September 2016 Page 1 of 2
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.
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.

Mechanical Safety
Safety Notice IMMAGE 800 Operations Manual A11403
Page 2 of 2 September 2016
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.

IMMAGE 800 Operations Manual A11403 Table of Contents
September 2016 Page 1 of 2
TABLE OF CONTENTS
REVISION HISTORY
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 Instrument Codes ............................................................................................ A-1
APPENDIX B Reports .............................................................................................................B-1
GLOSSARY
INDEX

Table of Contents IMMAGE 800 Operations Manual A11403
Page 2 of 2 September 2016

IMMAGE 800 Operations Manual A11403 General Information/Precautions and Hazards
September 2016 Page 1-1
1
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

Introduction
Intended Use
General Information/Precautions and Hazards IMMAGE 800 Operations Manual A11403
Page 1-2 September 2016
General Information/Precautions and Hazards
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.

How to Use This Manual
Scope of This Manual
IMMAGE 800 Operations Manual A11403 General Information/Precautions and Hazards
September 2016 Page 1-3
1
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.
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.
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.

How to Use This Manual
Procedure Tables
General Information/Precautions and Hazards IMMAGE 800 Operations Manual A11403
Page 1-4 September 2016
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.
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.
Step Action
1SelectRerun 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.

Warranty and Service Policy Information
Warranty Policy
IMMAGE 800 Operations Manual A11403 General Information/Precautions and Hazards
September 2016 Page 1-5
1
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].
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.

Precautions
Introduction
General Information/Precautions and Hazards IMMAGE 800 Operations Manual A11403
Page 1-6 September 2016
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.

Hazards
Introduction
IMMAGE 800 Operations Manual A11403 General Information/Precautions and Hazards
September 2016 Page 1-7
1
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.
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.

Hazards
Replacing Mechanical or Electrical Parts
General Information/Precautions and Hazards IMMAGE 800 Operations Manual A11403
Page 1-8 September 2016
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.
Handling of Hazardous Substances
If a hazardous substance such as blood is spilled onto the IMMAGE 800 System, clean
up the spill by using a 10% bleach solution, or use your laboratory decontamination
solution. Then follow your laboratory procedure for disposal of hazardous materials. If
the IMMAGE 800 System needs to be decontaminated, call your Beckman Coulter
Service Representative for assistance.
A011460L.EPS

Symbols and Labels
Introduction
IMMAGE 800 Operations Manual A11403 General Information/Precautions and Hazards
September 2016 Page 1-9
1
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
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

Symbols and Labels
Monitor Power Switch
General Information/Precautions and Hazards IMMAGE 800 Operations Manual A11403
Page 1-10 September 2016
Monitor Power Switch
This symbol is located on the monitor power button. A green light indicates the power
to the monitor is ON.
Monitor Power Switch
Printer Power Switch
This symbol is located beside the printer power button. A green light indicates the
power to the printer is ON.
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

Symbols and Labels
Connection Between Computer and Monitor
IMMAGE 800 Operations Manual A11403 General Information/Precautions and Hazards
September 2016 Page 1-11
1
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.
High Voltage - Electric Shock Risk
Read Manual
This symbol cautions that the manual should be read before using the system.
Read Manual
General Biohazard Caution
This symbol is the international symbol for biohazardous material.
Biohazard Label

Symbols and Labels
Caution Biohazard
General Information/Precautions and Hazards IMMAGE 800 Operations Manual A11403
Page 1-12 September 2016
Caution Biohazard
This cautionary label is located between the sample and reagent carousels. Operate
the system with all covers in place.
Caution Biohazard Label
Bar Code Caution Label - Sample Wheel Compartment
This label is placed inside the Sample Wheel Compartment, near the opening through
which a bar code reading beam emits. Do not stare into the laser light beam when
cover is open or removed.
Bar Code Caution Label - Sample Wheel Compartment
Bar Code Caution Label - Reagent Compartment
This label is placed inside the Reagent Compartment near the opening through which a
bar code reading beam emits. Do not stare into the laser light beam when the cover
interlock is defeated.
Bar Code Caution Label - Reagent Compartment
Reagent Compartment Cover Notice
This label is located on the reagent compartment cover. The instrument will stop if the
cover is opened.
Reagent Compartment Cover Label
A010647L.EPS