Beckman Coulter DxC 600i Installation guide

A24574-AD
October 2010
In-Lab Training Manual
UniCel®DxC 600i
Synchron®Access®
Clinical System
For In Vitro Diagnostic Use
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821

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UniCel®DxC 600i
In-Lab Training Manual
Table of Contents
Chapter 1-Instrument Overview ............................................................................3
General Introduction..........................................................................................3
System Components .........................................................................................3
Closed Tube Aliquotter......................................................................................4
Access 2 Immunoassay Analyzer......................................................................5
UniCel DxC 600 General Chemistry Analyzer...................................................7
Sample Processing Summary ...........................................................................9
Chapter 2-Software Overview.............................................................................11
General Introduction........................................................................................11
DxC 600i Main Menu.......................................................................................12
Access Main Menu ..........................................................................................16
Chapter 3-Daily Start Up.....................................................................................21
General Information.........................................................................................21
Access Communication...................................................................................21
Access Maintenance Cautions ........................................................................21
Access Supplies ..............................................................................................22
CTA Supplies ..................................................................................................23
DxC Reagents .................................................................................................23
Flowchart Information......................................................................................24
Chapter 4-Sample Processing ............................................................................53
DxC 600i Sample Containers ..........................................................................53
Sample Racks .................................................................................................56
Sample Preparation.........................................................................................56
Processing Samples........................................................................................57
Chapter 5-DxC 600i Instrument Commands .......................................................61
DxC 600i Instrument Commands ....................................................................61
Shutdown the DxC 600i System......................................................................64
Access Commands .........................................................................................70
Resources...........................................................................................................77
In-Lab Competency Checklist .............................................................................81
DxC 600i Competency Exercise Test Activities ..................................................87

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Chapter 1-Instrument Overview
Instrument Overview
General Introduction
The UniCel®DxC 600i Synchron® Access®Clinical System is an
automated, computer-driven, general chemistry and immunoassay
system. The DxC 600i combines the UniCel DxC 600 general
chemistry analyzer and the Access 2 immunoassay analyzer into a
single instrument presentation. Samples are loaded from a single
point of entry, through a Closed Tube Aliquotter (CTA) unit.
System Components
The UniCel DxC 600i consists of three major components:
1) Closed Tube Aliquotter (CTA)
2) Access 2 Immunoassay Analyzer (Access)
3) UniCel DxC 600 General Chemistry Analyzer (DxC)
3
1
2

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Closed Tube Aliquotter
The CTA functions as a sample processing manager by aliquotting
and routing samples to the Access 2 and/or UniCel DxC 600 analyzer
according to programming requirements.
The CTA can be divided into the following areas:
Sample Loading Area
The Sample Loading area is used to:
•Load samples onto the system
•Identify sample programming by bar code ID
•Identify sample routing requirements
•Present samples to the Sample Aliquotting Area
•Load samples onto the DxC
Sample Aliquotting Area
The Sample Aliquotting area is used to:
•Pierce primary tube caps for entry of the aliquot probe
•Aliquot samples for Access testing
•Hold aliquots for transfer to the Access
•Transfer aliquots to the Access

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Access 2 Immunoassay Analyzer
The Access 2 Immunoassay Analyzer is a random access
immunoassay instrument. The Access 2 Analyzer is intended for the
in vitro determination of a variety of analytes such as cardiac markers,
thyroid hormones, cancer markers, fertility hormones, and anemia
markers in biological fluids such as serum, plasma, and urine (sample
type is assay dependent).
The Access consists of the following modules:
Carousel Module
The Carousel Module identifies samples and presents samples and
reagents to the main pipettor. The reagents are stored in a
refrigerated reagent compartment that holds 24 reagent packs.
Automation racks on the sample carousel receive aliquots from the
CTA. Racks may be manually loaded for maintenance, calibration, low
volume sample processing, and independent mode operation.
Main Pipettor Module
The Main Pipettor Module pipettes sample and reagent into a Reaction
Vessel in the Analytical Module. The Main Pipettor level senses,
mixes reagent, mixes the reaction mixture, and cleans the probe by
ultrasonics.
Fluidics Module
The Fluidics Module provides wash buffer delivery, liquid waste
removal and substrate delivery.
Analytical Module
The testing process occurs at the Analytical Module. Reaction
Vessels (RVs) which are used for the testing process are stored here.
During the testing process, vessels are transported, incubated,
washed, and have readings taken.

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Electronics Module
The Electronics Module provides the electronic components necessary
for powering the system; computer drives to support mechanical
functions, and component drivers for the various components of the
analyzer.
Peripherals Module
The Access Peripherals Module consists of an external hand-held bar
code reader, a touch screen monitor, a keyboard, a mouse, and a
computer. These components allow the operator to interface with the
instrument.

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UniCel DxC 600 General Chemistry Analyzer
The UniCel DxC 600 Synchron Clinical System is an automated
clinical chemistry analyzer designed for the in vitro determination of a
variety of general chemistries, therapeutic drugs, and other
chemistries. Analysis can be performed on a variety of biological fluids
such as serum, plasma, urine, and cerebrospinal fluid (CSF). Sample
type is chemistry dependent.
The DxC can be divided into the following:
Sample Handling System
The DxC Sample Handling System is used to deliver samples to the
Modular Chemistry and Cartridge Chemistry systems. The sample
handling system receives the samples from the CTA, positions the
samples for pipetting and analysis, and removes the samples when
they are no longer needed by the system.
Modular Chemistry (MC) System
The Modular Chemistry System is used to provide rapid analysis of
sodium, potassium, chloride, carbon dioxide, total calcium, and
glucose. Glucose analysis is performed in a cup module. The
remaining chemistries are performed by an Ion Selective Electrode
(ISE) module consisting of an Electrolyte Injection Cup (EIC), a flow
cell, and electrodes specific for each analyte. Bulk reagents are
stored in the reagent storage area.

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Cartridge Chemistry (CC) System
The Cartridge Chemistry System provides random access analysis of
analytes chosen by the user. Reagents are delivered from reagent
cartridges stored in a refrigerated compartment that houses up to 59
cartridges. The reactions occur in permanent glass cuvettes that are
housed in a reaction carousel. Reagents are delivered to the reaction
carousel by reagent probes working in conjunction with a reagent
syringe. Sample is added by a CC sample probe and syringe. Mixers
are responsible for mixing the reagent and sample. Reactions are
read by a photometer assembly. A cuvette wash station cleans the
cuvettes for reuse.
Hydropneumatic System
The Hydropneumatic System is responsible for providing vacuum,
compressed air, diluted wash solution, and deionized water.
Operation and Control Components
Basic operating functions are controlled and reviewed by utilizing the
DxC 600i monitor, mouse, touch screen, keyboard, and push-button
controls. These provide the interface between the operator and the
DxC.
Additional detailed information about CTA components, DxC 600
components, and Access components can be found in the following
References:
CTA: UniCel DxC 600i Synchron Access Clinical Systems
(Online) Instructions For Use Manual
DxC 600: UniCel DxC Synchron Clinical Systems (Online)
Instructions For Use Manual
Access: Access Online HELP System

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Sample Processing Summary
CTA Processing Summary
Programming functions are performed, and then the sample is loaded
onto the DxC 600i load area. The operator presses the green RUN
button to begin the test process. Once the RUN button is pressed, the
CTA identifies sample programming and loads the sample on the CTA
sample wheel.
If Access testing is required:
The sample cap is pierced (when a cap is present on the
sample) and the aliquot probe aspirates the sample and
delivers it to an aliquot vessel (AV). The cap piercing probe and
aliquot probe are cleaned with wash buffer.
The Pick and Place transfers each AV containing an aliquot to
an automation rack on the Access sample carousel.
The sample rack containing the sample is then transferred to
the DxC analyzer.
If no Access testing is required:
The CTA sends the sample rack directly to the DxC analyzer.
Access Processing Summary
Sample and reagent are transferred by the main pipettor from their
respective carousels to an RV in the analytical module and mixed
The RV containing the sample and reagent is transferred to the
incubator belt and incubated. The RV is transferred to the wash/read
carousel when incubation is complete.
The RV is washed three times to remove all unbound material.
Substrate is added, and the RV is incubated while being moved to the
luminometer. The luminometer reads the amount of light generated by
the chemiluminescent reaction, and the light generated is converted to
concentration.
The used RV is transferred back to the incubator belt and into the RV
waste bag.

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DxC Processing Summary
The sample rack is loaded onto the DxC load area by the CTA. The
CTS (closed tube sampling) will pierce the cap (if present) in
preparation for the MC and CC sample probes. The rack is then
loaded onto the DxC Sample Carousel by the DxC sample handling
system.
If CC testing is required, the CC reagent probes aspirate reagent from
the CC reagent carousel into a cuvette. The reagent is mixed and
warmed to reaction temperature, during which time reagent blank
readings are taken. The blank readings may or may not be used in
calculating the concentration of analyte.
The MC System begins MC testing (if required) by delivering reagent
to the glucose cup and the ISE module. Sample is added by the MC
sample probe. The glucose sensor determines the glucose
concentration in the cup, and the ion selective electrodes in the flow
cell determine the concentration of each of the electrolytes.
When the CC reagent has been warmed to the reaction temperature,
the CC sample probe delivers sample to the cuvette containing the
pre-warmed reagent. Measurements are taken by the photometer.
The reaction readings are converted to concentration.
The sample rack is off-loaded when it is no longer needed by the
system.
MC and CC processes occur simultaneously.

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Chapter 2-Software Overview
Software Overview
General Introduction
DxC 600i operating functions and programming functions are
initiated from the main operator screen at the DxC analyzer. The
screen provides status information to determine the present state
of the entire DxC 600i system.
The Access analyzer screen is used for Access specific functions
such as calibration, maintenance, reagent/supply load, diagnostics,
or during independent mode operations.

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DxC 600i Main Menu
Navigation The DxC 600i system* provides three software navigation methods
that you can use to select an item on a screen or in a window:
Touchscreen:
Touch a part of the screen using the tip of your finger or a touch
device
Mouse:
Use the mouse to point the cursor and click the left mouse button
to select an item
Keyboard:
Press a keyboard equivalent such as a function key or the tab key
to select an item
*Both the DxC600i and Access monitors use the three software
navigational methods.

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Status
Indicators
The status of the system can be determined from any screen on the DxC
600i monitor using the following indicators:
1 CTS Indicator
•Indicates when the Closed Tube Sampling is enabled
•A red circle with a slash through it indicates the CTS is not
enabled
2 Host Communication Bar
•Shows communication status between host/DxC 600i
•Blue/Green bar indicates information transfer
•A red circle with a slash through it indicates the host and DxC 600i
are not communicating
3 System Operating Condition
•Identifies the operating condition of the entire DxC 600i system
•The operating condition is arranged in the following order:
Access |CTA |DxC
Note: the DxC status may be divided into MC/CC
4 Access Event Log Symbol
•Neutral color background indicates the Access is operating
normally
•Yellow color background indicates a caution condition exists at the
Access analyzer
•Red color background indicates a warning condition requiring
immediate attention exists at the Access analyzer
1 2
4
3

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Function
Selection
Icons
Function icons provide access to each of the major functional areas of
the DxC 600i system. The background color of the function icons may
change to yellow or red to alert the operator when attention is
required.
Main View status information and perform main
operating functions.
Samples Perform sample programming functions including
patients and quality control.
Results Retrieve results.
Rgts/Cal View reagent and calibration status and perform
reagent and calibration functions.
QC Define and manage Quality Control functions.
Setup Perform Set Up functions.
Utils Perform priming, maintenance, and diagnostic
functions on the DxC and CTA.
Status View hardware status information.
Instr Cmd Initiate specific instrument commands (example:
Home, Pause, Shutdown, etc).
Help View the DxC 600i and/or the DxC 600/800
Instructions for Use (IFU) Manuals

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The Main Menu Screen at the DxC 600i monitor is used to
determine the sample status for each sample.
Sample Status Icons are available from each tab to view the
sample status. The icon is displayed in front of the Sample ID on
the Main Menu screen.
Tabs are available to view the sample status at the following four
areas:
•Access analyzer
•AV area
•CTA unit
•DxC analyzer

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Access Main Menu
The Access monitor is used during Access calibration,
maintenance, reagent /supply load, diagnostics, or when
operating the Access analyzer during independent mode.
The following can be monitored from any screen at the Access
monitor:
System Mode
•Indicates the status of the Access analyzer
•May be Ready (blue), Running (green), Paused (yellow), or
Not Ready (red)
The Access System Mode corresponds to the Access status at
the System Operating Condition field from the DxC 600i monitor.
Note: A Menu and Back tab appear at the right side of all
screens on the Access monitor except for the Main Menu. The
Menu tab gives the operator access to the Main Menu Functions.
The Back tab returns the operator to the previously viewed
screen.

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Status Buttons
•Includes the following: Wash Buffer, Liquid Waste, Substrate,
Reaction Vessels (RVs), RV Waste Bag, Quality Control, Event
Log, Work Pending, Supplies Required, CTA, and Help
•Buttons change color to reflect conditions:
- Neutral
♦Normal operating condition
- Yellow
♦Caution condition/event
- Red
♦Warning condition/event
•System Command Buttons
- Used to initiate the following commands:
♦Run, Pause, Stop (Emergency)
Note: When the CTA is loading patient or QC samples the
CTA will initiate the Access Run.

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Function
Buttons
The following Access menu functions can be selected from the Main
Menu or from any screen at the Access monitor using the MENU tab:
Program maintenance and calibration requests at the Access analyzer,
and program/process patients during independent mode operation.
Monitor samples in progress at the Access analyzer and recall results
at the Access analyzer during independent mode operation
Load supplies and load/unload reagents at the Access analyzer
Not used with a DxC 600i system
Configure calibrator lot specific parameters into the Access analyzer
and review calibration information from the Access analyzer
Check/print the temperatures of thermal zones and substrate,
Run/Enable/Disable the Utility assay, and display the System Check
results screen
Initialize, prime and access Device Diagnostics at the Access analyzer.
(Diagnostic functions at the Access analyzer can only be performed
when the CTA is off line.)
Set the system default values and formats, and configure tests
Note: When the Access is operating as part of the DxC 600i system, certain
operating functions are grey (not active) at the Access analyzer. Certain
Diagnostic features are not available when the CTA is online, including Device
Diagnostics, Initialize System, and Volume Check.