Beckman Coulter DxC 600i Training Manual
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Beckman Coulter DxC 600i Training Manual

Beckman Coulter DxC 600i Training Manual

Unicel synchron access clinical system for in vitro diagnostic use
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A24574-AD
October 2010
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821
In-Lab Training Manual
®
UniCel
DxC 600i
®
Synchron
Access
Clinical System
For In Vitro Diagnostic Use
®

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  • Page 1 In-Lab Training Manual ® UniCel DxC 600i ® ® Synchron Access Clinical System For In Vitro Diagnostic Use A24574-AD October 2010 Beckman Coulter, Inc. 250 S. Kraemer Blvd. Brea, CA 92821...

  • Page 3: Table Of Contents

    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 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 1 Professional Development Department October 2010...

  • Page 4: Professional Development Department October

    UniCel DxC 600i In-Lab Training Manual A24574-AD Page 2 Professional Development Department October 2010...

  • Page 5: Chapter 1-Instrument Overview

    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.

  • Page 6: Closed Tube Aliquotter

    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 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 4 Professional Development Department October 2010...

  • Page 7: Access 2 Immunoassay Analyzer

    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. UniCel DxC 600i In-Lab Training Manual A24574-AD Page 5 Professional Development Department October 2010...
  • Page 8 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. UniCel DxC 600i In-Lab Training Manual A24574-AD Page 6 Professional Development Department October 2010...

  • Page 9: Unicel Dxc 600 General Chemistry Analyzer

    (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. UniCel DxC 600i In-Lab Training Manual A24574-AD Page 7 Professional Development Department October 2010...
  • Page 10 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.

  • Page 11: 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.
  • Page 12 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. UniCel DxC 600i In-Lab Training Manual A24574-AD Page 10 Professional Development Department October 2010...

  • Page 13: Chapter 2-Software Overview

    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.

  • Page 14: Dxc 600I Main Menu

    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...
  • Page 15 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 System Operating Condition Identifies the operating condition of the entire DxC 600i system...
  • Page 16 Function icons provide access to each of the major functional areas of Function the DxC 600i system. The background color of the function icons may Selection change to yellow or red to alert the operator when attention is Icons required.
  • Page 17 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.

  • Page 18: Access Main Menu

    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.
  • Page 19 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. UniCel DxC 600i In-Lab Training Manual A24574-AD Page 17 Professional Development Department October 2010...
  • Page 20 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.
  • Page 21 The <CTA> button is red when the CTA is off-line. The <CTA> button is yellow during normal operations (when the CTA is in control of the Access 2). UniCel DxC 600i In-Lab Training Manual A24574-AD Page 19 Professional Development Department...
  • Page 22 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 20 Professional Development Department October 2010...

  • Page 23: Chapter 3-Daily Start Up

    Chapter 3-Daily Start Up Daily Start Up General The following information will assist you in successfully Information performing the DxC 600i Daily Start Up. Access Follow these steps when interacting with the software to Communication successfully communicate with Access: ⎯...

  • Page 24: Access Supplies

    <3 days yellow to alert Reagent expired (on left (on operator when Running Packs supply Paused supply reagent is not screen) screen) on-board, expired or not calibrated UniCel DxC 600i In-Lab Training Manual A24574-AD Page 22 Professional Development Department October 2010...

  • Page 25: Cta Supplies

    10%, available, Reagent 5% and Expired 0% volume Pop-Up warning at 0 tests Standby 5 test and available, Reagent Running 0 tests Expired remaining in cartridge UniCel DxC 600i In-Lab Training Manual A24574-AD Page 23 Professional Development Department October 2010...
  • Page 26 The Daily Start Up flowchart lists all tasks necessary to bring the Information UniCel DxC 600i to operating condition for the start of a run. The tasks are listed in the most efficient order. Some tasks may be performed on one component of the system while another component is performing a different task.
  • Page 27 DxC 600i Daily Start Up UniCel DxC 600i In-Lab Training Manual A24574-AD Page 25 Professional Development Department October 2010...
  • Page 28 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 26 Professional Development Department October 2010...
  • Page 29 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 27 Professional Development Department October 2010...
  • Page 30 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 28 Professional Development Department October 2010...
  • Page 31 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 29 Professional Development Department October 2010...
  • Page 32 Thoroughly rinse the liquid waste bottle to remove any traces of decontaminant. Store the liquid waste bottle for future use UniCel DxC 600i In-Lab Training Manual A24574-AD Page 30 Professional Development Department October 2010...
  • Page 33 Select Yes [F1] Discard empty substrate bottle Place a new bottle of substrate in the fluids tray to equilibrate to room temperature UniCel DxC 600i In-Lab Training Manual A24574-AD Page 31 Professional Development Department October 2010...
  • Page 34 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 32 Professional Development Department October 2010...
  • Page 35 Remove the reagent pack by pressing forward as you lift the back end of the pack Close the reagent carousel door and sample carousel cover Select Done [F1] UniCel DxC 600i In-Lab Training Manual A24574-AD Page 33 Professional Development Department October 2010...
  • Page 36 Remove the tape from the Access computer console tape drive Place the alternate tape in the Access computer console tape drive Document Maintenance completed in Electronic Maintenance Log UniCel DxC 600i In-Lab Training Manual A24574-AD Page 34 Professional Development Department October 2010...
  • Page 37 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 35 Professional Development Department October 2010...
  • Page 38 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 36 Professional Development Department October 2010...
  • Page 39 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 37 Professional Development Department October 2010...
  • Page 40 Select the Substrate box Select Start Priming [F2] When the priming complete window is displayed, Select OK [F1] Select Done [F8] Document Maintenance completed in Electronic Maintenance Log UniCel DxC 600i In-Lab Training Manual A24574-AD Page 38 Professional Development Department October 2010...
  • Page 41 Load Avs at the CTA Select Rgts/Cal from the DxC 600i monitor Select the Supplies tab Select AV Supply Select Load [F1] Press the RVs onto the spine, then remove the protective covering from the RV cartridge Open the AV Supply and AV Load doors Place the AV cartridge in the AV storage rack.
  • Page 42 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 40 Professional Development Department October 2010...
  • Page 43 Select the Supplies tab on the screen Type the lot number into the CTA Wash Procedure Buffer field located on the CTA Supplies Complete section of the screen UniCel DxC 600i In-Lab Training Manual A24574-AD Page 41 Professional Development Department October 2010...
  • Page 44 Open the CTA door. The Auto-Gloss bottle is located on the bottom shelf Unfasten the cap and remove the old Auto-Gloss bottle Select Rgts/Cal from the DxC 600i monitor Select the Supplies tab Select the CTA Auto-Gloss Select Load [F1]...
  • Page 45 Use the hand-held bar code reader to scan the bar code label on the new reagent bottle/box. The system will “beep” to indicate successful bar code read. Verify the new reagent information is displayed on the DxC 600i monitor Place the new bottle into the reagent storage area Select Done [F10]...
  • Page 46 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 44 Professional Development Department October 2010...
  • Page 47 Unload DxC CC Reagent Select Rgts/Cal from the DxC 600i monitor Select the DxC tab Page down to locate the position(s) of the reagent(s) to be unloaded on the CC carousel. Note: CC reagents are displayed on pages 3-8 of the...
  • Page 48 When the screen prompts you to load the rack, place the rack in the Access sample carousel and close the sample carousel cover Select Done [F1] Select <RUN> UniCel DxC 600i In-Lab Training Manual A24574-AD Page 46 Professional Development Department October 2010...
  • Page 49 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 47 Professional Development Department October 2010...
  • Page 50 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 48 Professional Development Department October 2010...
  • Page 51 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 49 Professional Development Department October 2010...
  • Page 52 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 50 Professional Development Department October 2010...
  • Page 53 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 51 Professional Development Department October 2010...
  • Page 54 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 52 Professional Development Department October 2010...

  • Page 55: Chapter 4-Sample Processing

    Primary sample tubes with caps: Sarstedt S-Monovette 15 x 92 mm 15 x 75 mm (requires rack A18642) All trademarks are the property of their respective owners. UniCel DxC 600i In-Lab Training Manual A24574-AD Page 53 Professional Development Department October 2010...
  • Page 56 (P/N 81916) for 12 x 75 mm or 13 x 75 mm tubes • 16 mm (2.0 mL) insert cup (P/N 81917) for 16 x 75 mm tubes UniCel DxC 600i In-Lab Training Manual A24574-AD Page 54 Professional Development Department October 2010...
  • Page 57 Load Area for DxC processing • SYNCHRON Microtube (P/N 448774). Place rack in DxC 600i Load Area for DxC processing All trademarks are the property of their respective owners. UniCel DxC 600i In-Lab Training Manual A24574-AD Page 55 Professional Development Department October 2010...

  • Page 58: Sample Racks

    Sample Racks Samples are placed in Synchron sample racks for processing on the DxC 600i system. The following rack sizes are available: • 13 x 75 mm • 16 x 75 mm • 13 x 100 mm • 16 x 100 mm Racks come in various colors.

  • Page 59: Processing Samples

    Samples may be processed using various programming methods on the DxC 600i system. Samples may be programmed at the LIS/HOST, at the DL2000, or at the DxC 600i. Samples may be processed with or without bar codes. Use the instructions on the...
  • Page 60 Push the tube all the way down. 1. Open the CTA cover and place the rack in the DxC 600i load area with the bar code facing to the right 2. Press the <RUN> button on the CTA...
  • Page 61 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 59 Professional Development Department October 2010...
  • Page 62 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 60 Professional Development Department October 2010...

  • Page 63: Chapter 5-Dxc 600I Instrument Commands

    Chapter 5-DxC 600i Instrument Commands DxC 600i Instrument Commands The DxC 600i instrument commands can be used to control functions of DxC and CTA instrument components. Instrument commands include: Home: • Moves mechanical assemblies to their “home” positions and primes the system •...
  • Page 64 Home the DxC/CTA Select Instr Cmd from the DxC 600i monitor Select <1> Home Select <1> DxC to home the DxC Select <2> CTA to home the CTA Select <3> Both to home both the DxC and CTA The system will return to Standby...
  • Page 65 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 63 Professional Development Department October 2010...

  • Page 66: Shutdown The Dxc 600I System

    Shutdown the DxC 600i System The DxC 600i system may require power down when: • Parts replacement procedures specify power to be turned off • The lab power goes off • The system is moved to a new location •...
  • Page 67 Turn OFF the power switch at the DxC instrument when the message “Shutdown: System may now be powered down” appears Turn OFF the power switch to the DxC 600i computer located below the Access analyzer Turn OFF the green power switch to the CTA located...
  • Page 68 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 66 Professional Development Department October 2010...
  • Page 69 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 67 Professional Development Department October 2010...
  • Page 70 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 68 Professional Development Department October 2010...
  • Page 71 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 69 Professional Development Department October 2010...

  • Page 72: Access Commands

    Removes the Access analyzer from control of the CTA • Use before conducting diagnostic or troubleshooting activities on the Access analyzer • Use before homing Access components UniCel DxC 600i In-Lab Training Manual A24574-AD Page 70 Professional Development Department October 2010...
  • Page 73 Select OK [F1] when the “Completed Initialization” box appears The Access will return to Ready Set the CTA online at the Access monitor Refer to “Placing the CTA Offline/Online” flowchart UniCel DxC 600i In-Lab Training Manual A24574-AD Page 71 Professional Development Department October 2010...
  • Page 74 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 72 Professional Development Department October 2010...
  • Page 75 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 73 Professional Development Department October 2010...
  • Page 76 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 74 Professional Development Department October 2010...
  • Page 77 Select the <CTA> button when diagnostic/troubleshooting activities are completed Select CTA Online [F8] Verify that the <CTA> button turns neutral and the CTA status goes to Standby at the DxC 600i monitor UniCel DxC 600i In-Lab Training Manual A24574-AD Page 75 Professional Development Department...
  • Page 78 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 76 Professional Development Department October 2010...

  • Page 79: Resources

    DxC 600i and DxC 600/800 Instructions For Use manuals are available through the Online Help of the DxC 600i system. Detailed instructions are contained in the Reference materials listed on the next page.
  • Page 80 Provides additional information about the system and the chemistries used on the system − Provided as laminated sheets • UniCel DxC 600i Synchron Access Clinical Systems CTA Primary Tube Sample Template − Use to establish adequate sample volume − Provided as a laminated sheet Access 2: •...
  • Page 81 • UniCel DxC Synchron Clinical Systems Host Interface Specifications − Provides necessary information to interface the DxC 600i system to a Laboratory Information System (LIS) − Includes Tables/Codes to interpret instrument codes printed on patient reports − Provided on a CD-ROM •...
  • Page 82 UniCel DxC 600i In-Lab Training Manual A24574-AD Page 80 Professional Development Department October 2010...

  • Page 83: In-Lab Competency Checklist

    The following In-Lab Competency Checklist can be used to document the In-Lab training of laboratory staff members on the operation of the DxC 600i system. As each operator is trained, both the trainer and the trainee initial and date the documentation form.
  • Page 84 • Determine supply / reagent Direct Observation Test status for CTA Other __________ • Determine supply / reagent Direct Observation DxC 600i Instructions For Use Test status for DxC (IFU) Chapter 2: Pre-Test Other __________ • Load supplies/reagents on Activities...
  • Page 85 Access Assay Manual or Direct Observation Synchron Chemistry Information Test Other __________ Manual • Determine correct sample rack/ DxC 600i In Lab Training Manual Direct Observation Chapter 4: Sample Processing Test container for sample processing Other __________ at DxC 600i •...
  • Page 86 • Perform weekly maintenance DxC Instructions for Use: Chapter Direct Observation 9: Maintenance Test on DxC Other __________ • Perform Twice-monthly DxC 600i Instructions for Use Direct Observation (IFU) Chapter 6: Maintenance Test maintenance on CTA Other __________ CTA Maintenance •...
  • Page 87 Other __________ • Perform Yearly Maintenance on Direct Observation Test Other __________ • Perform As-Needed Maintenance on CTA Flush CTA Aliquot Probe DxC 600i Instructions for Use − Direct Observation (IFU) Chapter 6: Maintenance Test CTA Maintenance Other __________ Replacing the CTA Pick and Direct Observation −...
  • Page 88 Access Clinical System Achieved? Trainee Trainer Task Resource How Measured? Date Initial Initial Home CTA and DxC DxC 600i Instructions for Use Direct Observation (IFU) Chapter 5 Post Test Test Other __________ Activities Direct Observation Test Other __________ Direct Observation...
  • Page 89 CO2, and calcium. 4) The DxC Cartridge Chemistry side of the analyzer delivers reagent from cartridges stored in a refrigerated compartment that houses _____ reagent cartridges. UniCel DxC 600i In-Lab Training Manual A24574-AC Page 87 Professional Development Department December 2008...
  • Page 90 7) What tab would you select to view samples on the CTA sample wheel? __________________________________ 8) Select the _____________ button on the ___________monitor to place the CTA offline. UniCel DxC 600i In-Lab Training Manual A24574-AD Page 88 Professional Development Department October 2010...
  • Page 91 Standby before replenishing is the ________________. 13) Which reagents are stored in the Hydropneumatic compartment? ____________, ___________, _______________ 14) Where is the Alkaline Buffer stored? _________________________________________________ UniCel DxC 600i In-Lab Training Manual A24574-AD Page 89 Professional Development Department October 2010...
  • Page 92 Daily Start 15) Using the DxC 600i monitor, where would you go to get a calibration load list for DxC chemistries? (Continued) ________________________________________________ 16) Access 2 calibrators are placed in the following container type: _______________________________________________ 17) Access calibration is requested/loaded at the ______________ monitor/analyzer.
  • Page 93 20) Tubes with caps must always be placed in a _____________ rack. 21) How do you determine adequate sample volume before placing a sample on the system? _________________________________________________ UniCel DxC 600i In-Lab Training Manual A24574-AD Page 91 Professional Development Department October 2010...
  • Page 94 Timed Urine Routine GLUCm Volume: 1340 mL Note: You may use any material you have available for the samples. 23) Show the reports to your supervisor and/or Beckman Coulter representative. Instrument 24) Draw a line between the Instrument Command you would use...
  • Page 95 CO2, and calcium. 4) The DxC Cartridge Chemistry side of the analyzer delivers reagent from cartridges stored in a refrigerated compartment that houses reagent cartridges. UniCel DxC 600i In-Lab Training Manual A24574-AD Page 93 Professional Development Department October 2010...
  • Page 96 7) What tab would you select to view samples on the CTA sample wheel? The CTA Sample Status Tab (3) 8) Select the button on the Access monitor to place the CTA offline. UniCel DxC 600i In-Lab Training Manual A24574-AD Page 94 Professional Development Department October 2010...
  • Page 97 13) Which reagents are stored in the Hydropneumatic compartment? Wash Concentrate, No Foam, Auto Gloss 14) Where is the Alkaline Buffer stored? In the ISE Module Assembly UniCel DxC 600i In-Lab Training Manual A24574-AD Page 95 Professional Development Department October 2010...
  • Page 98 17) Access calibration is requested/loaded at the Access monitor/carousel. 18) Perform a Daily Start Up on your DxC 600i system. Keep all reports and show them to your supervisor and/or Beckman Coulter representative when the Daily Start Up is completed.
  • Page 99 Non-Reserved rack. 21) How do you determine adequate sample volume before placing a sample on the system? Compare the tubes to the Primary Sample Template (PTS) UniCel DxC 600i In-Lab Training Manual A24574-AD Page 97 Professional Development Department October 2010...
  • Page 100 GLUCm Volume: 1340 mL Note: You may use any material you have available for the samples. 23) Show the reports to your supervisor and/or Beckman Coulter representative. 24)Draw a line between the Instrument Command you would use to Instrument Commands...
  • Page 101 __________________________________________________________________________ Has satisfactory completed the In-Lab Training Course on the operation of the UniCel DxC 600i Clinical System ________________________________________ _________________ Beckman Coulter Representative Date...

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