Beckman Coulter Immage 800 User manual 1
®
IMMAGE® 800
Immunochemistry System
A11409-AA
March 2004
REPEC
Beckman Coulter Ireland, Inc.
Mervue Business Park,
Mervue Galway,
Ireland 353 91 774068
BECKMAN COULTER, INC. • 4300 N. Harbor Blvd., Fullerton, CA U.S.A. 92835
Instructions For Use
For In Vitro Diagnostic Use
© Copyright 2004 Beckman Coulter, Inc.
TABLE OF CONTENTS
CHAPTER 1 General Information ..................................................................................................... 1-1
Introduction ............................................................................................................... 1-1
Precautions And Hazards .......................................................................................... 1-3
CHAPTER 2 System Description ...................................................................................................... 2-1
System Description ................................................................................................... 2-1
System Specifications and Characteristics .................................................................. 2-4
Instrument Specifications ......................................................................................... 2-4
Sample Container Information ..................................................................................... 2-6
Sample Containers Allowed ..................................................................................... 2-6
CHAPTER 3 Theory of Operations ................................................................................................... 3-1
Principles of Methodologies ..................................................................................... 3-1
Antigen Excess Testing ............................................................................................ 3-2
CHAPTER 4 System Power On/Off .................................................................................................. 4-1
System Power On ...................................................................................................... 4-1
System Power Off ..................................................................................................... 4-2
CHAPTER 5 System Software Configuration ................................................................................... 5-1
Overview ................................................................................................................... 5-1
Selecting Non-Standard Dilutions as Default for Each Chemistry ........................... 5-6
User-Defined Reagent Chemistry Setup .................................................................... 5-10
UDR Chemistry Overview and Precautions ........................................................... 5-10
Setting Up a UDR Chemistry ................................................................................. 5-11
Defining a UDR Chemistry .................................................................................... 5-16
Defining UDR Calibration Information .................................................................. 5-25
Deleting UDR Chemistries ..................................................................................... 5-26
Editing UDR Definitions ........................................................................................ 5-27
Loading UDR Reagent Cartridges .......................................................................... 5-29
Loading/Clearing UDR Buffer and Diluent ............................................................ 5-32
Programming Rate Mode ........................................................................................ 5-34
Calibrating a UDR Chemistry ................................................................................. 5-37
Approving a Calibration ......................................................................................... 5-44
Printing UDR Reports ............................................................................................. 5-54
Setting Up UDR Reference Intervals and Panels ................................................... 5-56
Defining UDR Quality Control ............................................................................... 5-57
Programming a UDR Sample ................................................................................. 5-58
Instrument Setup ........................................................................................................ 5-59
Overview ................................................................................................................. 5-59
Placing Labels on a Rack ........................................................................................ 5-60
Wash Solution Box and Waste Container Placement ............................................. 5-61
IMMAGE 800 Instructions For Use A11409 Table of Contents
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CHAPTER 6 Reagents/Calibration .................................................................................................... 6-1
Reagents .......................................................................................................................6-1
Overview ................................................................................................................... 6-1
Calibration ................................................................................................................... 6-6
Overview ................................................................................................................... 6-6
Calibration History ................................................................................................... 6-8
CHAPTER 7 Preparing for Programming/Running .......................................................................... 7-1
Overview ................................................................................................................... 7-1
Programming a Sample ................................................................................................ 7-3
Overview ................................................................................................................... 7-3
Selecting Sample Options ......................................................................................... 7-6
Entering an Off-line Dilution Factor ........................................................................ 7-8
Programming a Batch of Samples .......................................................................... 7-12
Loading and Starting a Run ....................................................................................... 7-15
Loading Samples ..................................................................................................... 7-15
Pre-run Checklist .................................................................................................... 7-17
Starting the Run ...................................................................................................... 7-18
Pausing a Run ............................................................................................................ 7-19
Overview ................................................................................................................. 7-19
System Pause .......................................................................................................... 7-20
Pausing to Load Samples ........................................................................................ 7-21
CHAPTER 8 Results Recall .............................................................................................................. 8-1
Overview ................................................................................................................... 8-1
Displaying Recalled Results on the Screen .............................................................. 8-2
Printing Recalled Results .......................................................................................... 8-3
Sending Results to the Host ...................................................................................... 8-4
CHAPTER 9 Quality Control ............................................................................................................ 9-1
Overview ................................................................................................................... 9-1
Defining a Control .................................................................................................... 9-2
CHAPTER 10 Utilities ....................................................................................................................... 10-1
Maintenance ............................................................................................................ 10-1
Troubleshooting ...................................................................................................... 10-3
CHAPTER 11 System Status/Instrument Commands ....................................................................... 11-1
System Status/Instrument Commands .................................................................... 11-1
APPENDIX A Additional Information ............................................................................................... A-1
Pre-run Checklist ..................................................................................................... A-1
Quick References Using the IMMAGE 800 Immunochemistry System Operations
Manual ..................................................................................................................... A-2
INDEX
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Introduction
Intended Use
The Beckman Coulter IMMAGE® 800 Immunochemistry System (Refer to Figure 1.1.) 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.
Scope of 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.
CHAPTER 1 General Information
Reference Materials
Detailed information is available in the following manuals that accompany the IMMAGE 800
Immunochemistry System. Those manuals include:
• IMMAGE 800 Immunochemistry System Operations Manual. This manual contains a
detailed system description, comprehensive operating instructions, theory of operation,
system calibration and programming procedures, and quality control information for the
IMMAGE 800 analyzer.
• IMMAGE Immunochemistry Systems Chemistry Information Manual. This manual
contains specific chemistry information for the full range of analytes available on the
IMMAGE 800 analyzer.
• IMMAGE Immunochemistry Systems Host Interface Specifications.
• IMMAGE Immunochemistry Systems Sampling Template.
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1
1 2 3 4
5 6
7
8
1. Reagent Probe and Mixer
2. Sample Probe and Mixer
3. Reagent Syringe
4. Sample Syringe
5. Computer
6. Monitor
7. Printer
8. Waste Container
9. Wash Solution
Figure 1.1 IMMAGE 800 Immunochemistry System
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, It there is damage, notify the Beckman Coulter Service
Representative before his/her arrival at your facility to install your system.
®
9
Immage 800
11 12
141310
10. Reagent Compartment
11. Reaction Module
12. Cuvette Wash Station
13. Advance Button
14. Sample Carousel
15. Keyboard
16. Mouse
17. Uninterruptible Power Supply
-not shown
15
16
A011426L.EPS
If no damage is found to the shipping container, the Beckman Coulter Service Representative
will supervise the unpacking of your system. If there is damage 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 And Hazards
Precautions
• Do not store or place a diskette near electrical motors, power supplies, generators, magnets,
or magnetic fields.
• Hold a compact disk (CD) by the edges and replace it in its case after use. DO NOT place a
CD in direct sunlight or excessive heat or humidity.
• Sample containers must contain an adequate volume of test specimen to ensure accurate
aspiration.
Hazards
• Connect the three-pronged power plug from all system components of the IMMAGE 800
Immunochemistry System 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 a qualified maintenance personnel.
UNDER ANY CIRCUMSTANCES, DO NOT OPERATE THE SYSTEM UNTIL AN
ELECTRICAL GROUND IS PROVIDED AND THE POWER CORD IS PROPERLY
CONNECTED TO GROUND.
• Close reagent and sample carousel covers and keep clear of all mechanical assemblies when
booting up the system.
• Keep clear of both cranes while the instrument is running.
• Keep all covers and shields in place while the instrument is running.
• Confirm that the instrument status is 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.
• Confirm that the system is turned off before replacing any defective mechanical or electrical
part in the system.
• DO NOT tamper with or remove the housing of any bar code reader.
• Dispose all waste liquids from the IMMAGE 800 Immunochemistry System in an approved
method for handling biohazardous material.
• Observe all laboratory policies or procedures pertaining to the handling of biological
samples that may contain pathogens.
•To 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.
• 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
High Voltage-Electric Shock Risk
This symbol indicates high voltage or risk of electric shock.
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
Caution Biohazard
This cautionary label is located between the sample and reagent carousels. Operate the
system with all covers in place.
Caution Biohazard Label
Barcode Caution Label
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.
Bar Code Caution Label
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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.
Laser Caution Label
Class II Laser Caution
This cautionary label is located between the sample and reagent carousels. Do not stare into
laser light beam.
Class II Laser Caution Label
Class III B Laser Caution
This cautionary label is located at the top of the optics module. Avoid direct exposure to laser
light beam.
A010648L.EPS
Class III B Laser Caution Label
Compartment Cover Notice
This label is located on the reagent compartment cover. The instrument will stop if the cover
is opened.
A010647L.EPS
Reagent Compartment Cover Label
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System Description
Introduction
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.
CHAPTER 2 System Description
1
1. Instrument
2. Computer
3. Printer
2
Figure 2.1 The IMMAGE 800 Immunochemistry System
3
A011408P.EPS
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System Components
IMMAGE 800 Instrument
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.)
1
2
6
5
1. Reagent Compartment
2. Reagent Crane
3. Reaction Module
4. Sample Carousel
3
5. Sample Crane
6. Upper Instrument Subsystems
7. Sample Carousel Advance Button
4
A011409P.EPS
Figure 2.2 IMMAGE 800 Instrument
Computer
The computer supplies the user interface to the IMMAGE 800 Immunochemistry System and
stores data.
The user performs all software interaction in the computer portion of the system. This
software interaction is stored in the computer and is sent to the instrument at the appropriate
time.
Additionally, patient results, control results, and setup parameters are stored in the computer.
NOTICE
Only the computer supplied by Beckman Coulter is to be used with the
IMMAGE 800 Immunochemistry System.
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Changing the Date on the PC
The PC supplied with some IMMAGE 800 system 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.
Printer
The printer supplied with the IMMAGE 800 Immunochemistry System is a Hewlett Packard
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.
Program Structure
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.
CAUTION
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.
The MAIN operator screen consists of:
• Stop - Instrument stops immediately
• Home - Reagents, sample carousels, cuvettes and probes return to the home position
• Pause - Instrument stops after current samples are completed
• Run - Starts a run
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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 to 132) VAC RMS, Single Phase
Frequency 50/60 Hz nominal (47 to 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
230 (180 to 264) VAC RMS, Single Phase
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Temperature and Humidity
Ambient Temperature +15°C to +32°C
Ambient Relative Humidity
(RH)
Reagent Compartment
Temperature
Reaction Module
Temperature
Environmental Conditions
System can operate up to 8000 ft (2,438m) elevation.
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.
15% to 85% (non-condensing)
+13°C to +22°C (+32°C Ambient, <45% RH)
+37°C ± 0.5°C
Capacities
The following table lists various system capacities.
Table 2.1 System Capacities
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.
(1 of 2)
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2
Table 2.1 System Capacities, continued
Item Capacity
Wash solution 1 box/10 L/approximately 1,000 tests.
Waste container 5 gallons (18.9 L).
(2 of 2)
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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
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.
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CHAPTER 3 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 a
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
IMMAGE 800 Instructions For Use A11409 Theory of Operations
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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. 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 the reaction is in
antibody excess (AbXS). 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 the reaction is in
antigen excess (AgXS) and the rate response will start to decrease due to excessive levels of
antigen.
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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.
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
CHAPTER 4 System Power On/Off
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 the appropriate chapters in this manual to operate the system.
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System Power Off
Power Off Sequence
The instrument status must be Standby in order to proceed with the steps below to power off
the IMMAGE 800 system.
Step Action
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,
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.
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 IMMAGE 800 Immunochemistry System,
Operations Manual, Chapter 10, Utilities, As-Indicated Maintenance, "Washing
Cuvettes.")
If power is restored after 24 hours, the cuvettes must be replaced. (Refer to
IMMAGE 800 Immunochemistry System Operations Manual, Chapter 10,
Utilities, As-Indicated Maintenance, "Replacing Cuvettes.")
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Overview
Introduction
CHAPTER 5 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. The instrument must be in
Standby in order to proceed.
This chapter includes:
• 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 default
• 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
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Accessing Setup
Select Setup from the menu bar. Choose the desired setup option from a numbered button.
(Refer to Figure 5.1.) Refer to the IMMAGE 800 Immunochemistry System Operations
Manual for further details.
E011414S.EPS
Figure 5.1 Setup Screen
Configuring the Chemistry Menu
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.
From the Setup screen, select <1> Chemistry Configuration.
Panel Setup
The IMMAGE 800 holds up to 50 chemistry panels in its memory. Each panel is defined with
a name and the chemistries that it contains.
From the Setup screen, select <2> Panels.
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Bar Code Setup
The bar code symbologies recognized by the IMMAGE 800 can be selected. Additionally, the
bar code parameters can be configured to match those of the sample bar codes being read.
From the Setup screen, select <3> Bar Code. (Refer to Figure 5.2.)
E010218S.EPS
Figure 5.2 Bar Code Setup Screen
Bar Code Priority
If the bar code priority is disabled, the batch programming WILL autonumber the racks and
positions.
If the bar code priority is enabled, the batch programming will NOT autonumber the racks and
positions.
• The instrument reads bar coded samples whether or not the Bar Code Priority is enabled.
• Disabling the Bar Code Priority is recommended.
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Reference Interval Setup
When a reference interval and critical range are defined, they are printed beside the result on
the report. A result outside of the reference interval or critical range is flagged. The interval
and range are defined per chemistry or calculation with distinction made for sample type, sex,
and age group.
Chemistries must be configured and calculations must be enabled before intervals can be
defined.
The minimum entries necessary to save a reference interval are low age, low age unit, high
age, high age unit, low reference interval number and high reference interval number.
From the Setup screen, select <4> Reference Interval.
Selecting the Default
The default interval and range will be printed when an age is not specified in sample
programming or when age is specified but the reference interval has not been defined for that
age.
Only one default can be chosen for a particular interval and range definition grouped by
chemistry/calculation, sample type and sex.
Report Setup
Report formats can be selected for patient reports. A report header, including a facility name
and address, can also be defined. Automatic printing of calibration, control, and patient
reports can also be enabled.
From the Setup screen, select <5> Report Setup.
Calculations Setup
There are 12 Beckman Coulter defined calculations that can be enabled for the IMMAGE 800.
The system will automatically calculate and print the final calculation on reports when the
chemistries necessary for the calculation are run.
The system provides a maximum of 28 additional calculations that may be defined, edited,
and/or deleted by the operator. The Custom Calculations feature provides for the reporting of
operator-defined calculations using sample results when chemistries necessary for the
calculations are run. The calculations may involve results from one sample or two linked
samples.
The default for calculations is disabled.
From the Setup screen, select <6> Calculations. (Refer to Figure 5.3.)
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Units Setup
S
E014091S.EP
Figure 5.3 Calculations Summary Screen
Units can be selected for reporting with the results and displayed throughout the IMMAGE
800 system for each chemistry.
From the Setup screen, select <7> Units.
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Selecting Non-Standard Dilutions as Default for Each Chemistry
Introduction
The instrument status must be in Standby in order to select a non-standard dilution for a
chemistry. The system allows the user to select a non-standard dilution to use as the initial
dilution every time a particular assay is run.
Selecting a Non-Standard Dilution
Step Action
1 From the Setup screen, select <7> Units/Non-Standard Dilutions.
2 Select the sample type. Then select the options button < > beside the desired
chemistry. Standard and non-standard dilutions are displayed.
3 Select the number beside the desired dilution for the selected chemistry and
sample type. Note that the current default dilution is highlighted. If the chosen
dilution is a non-standard dilution, that dilution will appear on the Units/NonStandard Dilutions screen.
OR
Select <Cancel> to return to the Units/Non-Standard Dilutions screen without
changing the non-standard dilution.
OR
Select <Default> to return to the standard default dilution.
4 Repeat Steps 2-3 for additional chemistries.
When a non-standard dilution has been selected for a chemistry and sample type, whenever
this chemistry is run in this sample type, the system uses the selected non-standard default
dilution as the initial dilution. If the test is out of range at this dilution, the system will step up
or step down to a different dilution.
If the original sample was programmed to run with a standard dilution, and later you changed
the default dilution to a non-standard dilution, the sample will be rerun with the standard
dilution.
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Configuring Antigen Excess Testing
Antigen excess (AGXS) testing can be enabled or disabled for each appropriate chemistry
configured on the chemistry menu.
The default for AGXS testing is enabled for all the appropriate chemistries.
If AGXS testing is enabled, AGXS testing is always performed for the associated chemistry.
If AGXS testing is disabled, AGXS testing will not be performed for the associated chemistry.
AGXS can be enabled or disabled for an individual sample in Sample Programming.
From the Setup screen, select <8> Antigen Excess.
Date and Time Setup
At installation the system requires the date and time to be set. After this, changing the date or
time is optional. The format of the date and time for the appropriate screens and printouts
may be changed as well.
From the Setup screen, select <9> Date/Time.
Host Communications Setup
When connecting a laboratory information system (LIS) to the IMMAGE 800, several
parameters must be set. These parameters should be set by the person configuring the
connection between the IMMAGE and the LIS. Further information about all of the host
communications parameters is found in the IMMAGE Immunochemistry Systems Host
Interface Specifications.
From the Setup screen, select <10> Host Communications. (Refer to Figure 5.4.)
E010227S.EPS
Figure 5.4 Host Communications Parameters Screen
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Default Setup
Default Setup is used to:
• define the default sample type for all samples programmed. The sample type can be
changed for individual samples from the Program Sample screen.
• define the default number of replicates to be run for each sample.
• define the Post Run Summary time (none - 72 hours).
From the Setup screen, select <11> Default Setup.
Sample Comments Setup
Up to 20 sample comments may be predefined on the IMMAGE 800 Immunochemistry
System for use when programming samples on the instrument. These will be presented in a
numbered menu when programming samples.
Demographics Setup
The fields which are accessible in the demographics screen of sample programming can be
selected.
To select fields to be displayed in Sample Programming, from the Setup screen, select <13>
Demographics Setup. (Refer to Figure 5.5.)
E010230S.EPS
Figure 5.5 Demographics Setup Screen
Printer Setup
The printer type is a Hewlett Packard Deskjet® or compatible. The paper size can be selected.
From the Setup screen, select <14> Printer Setup.
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Language Setup
A language can be selected for use for system operations and printouts on the IMMAGE 800.
The keyboard should match the language.
• From the Setup screen, select <15> Languages/Keyboard.
• Select a language from the options button <▼>.
Selecting Japanese from the Language options will cause the Language/
Keyboard selection to become unavailable. Reloading of the software is
necessary to restore the Language/Keyboard Selection option.
• Perform the power off sequence and then the power on sequence. (Refer to IMMAGE 800
Immunochemistry System Instructions for Use CHAPTER 4, System Power On/Off, Power
On Sequence, Power Off Sequence.)
Loading the Chemistry Protocol Diskette
The chemistry protocol diskette is provided with each IMMAGE 800 Immunochemistry
system. It contains essential non-lot specific information about how to run each chemistry.
The chemistry protocol diskette is loaded when the IMMAGE 800 is installed. When new
chemistries become available, a new diskette is provided.
NOTICE
From the Setup screen, select <16> Chemistry Protocol Diskette.
Instrument Serial Number Setup
The serial number of the instrument is entered through the Instrument Serial Number option.
The instrument serial number will be printed on all reports.
From the Setup screen, select <17> Instrument Serial Number.
UDR Chemistry Overview and Precautions
Each laboratory can define its own user-defined reagent (UDR) chemistry protocols using the
templates from the chemistry protocol diskette. After the chemistry protocol diskette is
loaded and the UDR protocol is defined, the UDR chemistry name is available for placement
on the list of configured chemistries for selection in UDR rate mode programming, reference
intervals, UDR calibration, sample programming, control definitions and panels. Refer to the
IMMAGE 800 Immunochemistry System Operations Manual for further details.
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User-Defined Reagent Chemistry Setup
UDR Chemistry Overview and Precautions
Introduction
Each laboratory can define its own user-defined reagent (UDR) chemistry protocols using the
templates from the chemistry protocol diskette. After the chemistry protocol diskette is
loaded and the UDR protocol is defined, the UDR chemistry name is available for placement
on the list of configured chemistries for selection in UDR rate mode programming, reference
intervals, UDR calibration, sample programming, control definitions and panels.
Precautions
Since Beckman Coulter does not manufacture or otherwise control the sample and
reagents that may be used in user-defined reagent applications, Beckman Coulter
makes no warranty whatsoever with respect to such sample and reagent
performance (including sample carryover, test results, reagent and cartridge
handling), their effect on the system or required system maintenance or the
frequency thereof, or their effect on operator safety. User assumes full responsibility
for use of the proper test protocol and test result generation for the reagent(s)
selected by the user and for any errors or omissions associated therewith. BECKMAN
COULTER EXPRESSLY DISCLAIMS ALL WARRANTIES WITH RESPECT TO THIS
PRODUCT WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
CAUTION
CAUTION
Non-Beckman Coulter reagents, calibrators, and controls can contain components,
not listed on the insert, which may carry over into the system causing chemical or
optical interference. This carryover could adversely affect results on a properly
performing system. Manufacturers of user-defined reagents should be contacted for
disclosure of potentially interfering substances, such as preservatives.
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Setting Up a UDR Chemistry
Loading the Protocol Diskette
Follow the instructions under Loading the Chemistry Protocol Diskette, earlier in this chapter,
to load the user-defined reagent chemistry protocol templates.
Password Setup Procedure
Once a UDR chemistry has been defined and saved, the user must log in and perform a
password setup procedure. This password protection feature is recommended for security
purposes. The password setup is used to identify specific information, such as:
• who logged in
• which field was updated
• what screen was entered
• what field was changed
This and other information are described in the Display Events log. The password setup is
described in the following steps.
Step Action
1 Select the Password Setup box near upper right corner of the User-Defined
Chemistries screen. Refer to Figure 5.6.
2 The User Log in screen appears. Refer to Figure 5.7. Note that the Username field
defaults to ADMIN. Enter ADMIN in the Password field and select <OK>.
OR
Select <Cancel> to return to the User-Defined Chemistries screen.
3 If <OK> was selected above, the UDR User Setup/Password Protection Mode
screen appears. Refer to Figure 5.8. This screen is used to add or delete a user. Up
to 16 users are allowed. Password protection is enabled by default (i.e., the
Password Protection Mode box is checked.) If the Password Protection Mode box
is disabled (not checked), the password protection feature is not available (i.e., no
prompt after Define and Save.)
To add another user, select a new user name number. Then select <Define Edit
User> and proceed to Step 4.
4 A Define/Edit User screen appears. Refer to Figure 5.9. Enter a new user name in
the Username field. Enter your password in the Password field. Enter the same
password in the Confirm Password field.
5 To delete a user, select the username number and select <Delete User>.
OR
Select <Cancel> to return to the Password Protection Mode Screen.
6 Select <Exit> to return to the User Defined Chemistries screen.
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