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 A11403Table of Contents
March 2004Page 1 of 1
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
March 2004Page 1 of 2
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.
Symbols and Labels ................................................................................................................ 1-9
1
IMMAGE 800 Operations Manual A11403General Information/Precautions and Hazards
March 2004Page 1-1
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
General Information/Precautions and HazardsIMMAGE 800 Operations Manual A11403
Page 1-2March 2004
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 1.1IMMAGE 800 Conventions
ConventionDescription
Icon ButtonsIcon 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 black triangle, preceded by the phrase "options button",
all in bold.
Text fieldNames 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.
IMMAGE 800 Operations Manual A11403General Information/Precautions and Hazards
March 2004Page 1-3
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.
StepAction
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.
3Select 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.
General Information/Precautions and HazardsIMMAGE 800 Operations Manual A11403
Page 1-4March 2004
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 (800) 854-3633.
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.
IMMAGE 800 Operations Manual A11403General Information/Precautions and Hazards
March 2004Page 1-5
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.
General Information/Precautions and HazardsIMMAGE 800 Operations Manual A11403
Page 1-6March 2004
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.
IMMAGE 800 Operations Manual A11403General Information/Precautions and Hazards
March 2004Page 1-7
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.
General Information/Precautions and HazardsIMMAGE 800 Operations Manual A11403
Page 1-8March 2004
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
IMMAGE 800 Operations Manual A11403General Information/Precautions and Hazards
March 2004Page 1-9
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
General Information/Precautions and HazardsIMMAGE 800 Operations Manual A11403
Page 1-10March 2004
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
IMMAGE 800 Operations Manual A11403General Information/Precautions and Hazards
March 2004Page 1-11
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 HazardsIMMAGE 800 Operations Manual A11403
Page 1-12March 2004
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
IMMAGE 800 Operations Manual A11403General Information/Precautions and Hazards
March 2004Page 1-13
IMMAGE 800 Operations Manual A11403System Description
March 2004Page 2-1
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 2.1The IMMAGE 800 Immunochemistry System
3
A011408P.EPS
System DescriptionIMMAGE 800 Operations Manual A11403
Page 2-2March 2004
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 2.2IMMAGE 800 Instrument
5
4
A011409P.EPS
IMMAGE 800 Operations Manual A11403System Description
March 2004Page 2-3
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 2.3The 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
System DescriptionIMMAGE 800 Operations Manual A11403
Page 2-4March 2004
Component List
The following table lists each component of the reagent compartment with its
function.
Table 2.1Reagent Compartment Components
NumberComponentFunction
Reagent Compartment
Component List
2
1Reagent Compartment
Cover
Necessary to maintain temperature within
compartment.
2Reagent CarouselHolds up to 24 reagent cartridges and 4 reaction
buffer bottles.
3Reaction Buffer
Contain reaction buffers.
Bottles
4Bar 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.
5Reagent Bar Code
Reads bar codes on reagent cartridges.
Reader
6FansCirculate cool air in reagent compartment.
7Peltier Temperature
Helps control 15°C in reagent compartment.
Sensor
IMMAGE 800 Operations Manual A11403System Description
March 2004Page 2-5
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 2.4Reagent Crane
System DescriptionIMMAGE 800 Operations Manual A11403
Page 2-6March 2004
Component List
The following table lists each component of the reagent crane with its function.
Table 2.2Reagent Crane Components
NumberComponentFunction
Reagent Crane
Component List
1Reagent ProbeAspirates 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
2Reagent Syringe
Pump (500 µL)
3Reagent Crane Wash
Station
4Reagent 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.
IMMAGE 800 Operations Manual A11403System Description
March 2004Page 2-7
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 2.5Reaction Module
5. Cuvette Wash Station
6. Heat Block Temperature Sensor
7. Status Monitor Temperature Sensor
System DescriptionIMMAGE 800 Operations Manual A11403
Page 2-8March 2004
Component List
The following table lists each component of the reaction module with its function.
Table 2.3Reaction Module Components
NumberComponentFunction
Reaction Module
Component List
1OpticsMeasures light scatter in nephelometric
reactions (670 nm wavelength) and
turbidimetric reactions (940 nm wavelength).
2Reaction WheelHolds 39 reaction cuvettes and the reference
cuvette. Spins to move individual cuvettes to
correct positions for each stage of the analysis.
3CuvettesHold 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
4Reference CuvetteHas 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.
5Cuvette Wash StationWashes the cuvette after the reaction is
complete.
6Heat Block
Controls 37°C in reaction module.
Temperature Sensor
7Status Monitor
Monitors reaction module temperature.
Temperature Sensor
IMMAGE 800 Operations Manual A11403System Description
March 2004Page 2-9
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 2.6Sample Carousel
1
4
7
3
A011411P.EPS
5. Sample Bar Code Reader
6. Sample Carousel Advance Button
7. Background Bar Code Label
System DescriptionIMMAGE 800 Operations Manual A11403
Page 2-10March 2004
Component List
The following table lists each component of the sample carousel with its function.
Table 2.4Sample Carousel Components
NumberComponentFunction
Sample Carousel
Component List
2
1Sample Carousel
Reduces evaporation of sample.
Cover
2Sample Diluent
Contain sample diluents.
Bottles
3Sample RacksHold sample tubes. (Refer to Racks in this
section of the manual.)
4Dilution SegmentsThe 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.
5Sample 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
6Sample Carousel
Advance Button
Rotates the Sample Carousel to allow access for
loading sample racks, dilution segments, and
sample diluent bottles.
7Background 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.
IMMAGE 800 Operations Manual A11403System Description
March 2004Page 2-11
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 2.7Sample Crane
System DescriptionIMMAGE 800 Operations Manual A11403
Page 2-12March 2004
Component List
The following table lists each component of the sample crane with its function.
Table 2.5Sample Crane Components
NumberComponentFunction
Sample Crane
Component List
1Sample ProbeAspirates 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 MixerMixes the contents of a cuvette while diluted
sample is dispensed. Also mixes in dilution
wells.
2
2Sample Syringe Pump
(250 µL)
3Sample Crane Wash
Station
4Sample 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.
IMMAGE 800 Operations Manual A11403System Description
March 2004Page 2-13
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