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Beckman Couler UniCel DxC 660i Training Manual

Clinical system integrated workstations
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A47765AC
October 2010
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821
In-Lab Training Manual
®
UniCel
DxC Synchron
®
Access
Clinical System
Integrated Workstations
For In Vitro Diagnostic Use
This manual is intended for
®
UniCel
DxC 660i
®
UniCel
DxC 680i
®
UniCel
DxC 860i
®
UniCel
DxC 880i
®

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  • Page 1 In-Lab Training Manual ® ® UniCel DxC Synchron ® Access Clinical System Integrated Workstations For In Vitro Diagnostic Use This manual is intended for ® UniCel DxC 660i ® UniCel DxC 680i ® UniCel DxC 860i ® UniCel DxC 880i A47765AC October 2010 Beckman Coulter, Inc.

  • Page 3: Table Of Contents

    Table of Contents Table of Contents Chapter 1: Instrument Overview ................3 Introduction .......................3 ® UniCel Closed Tube Aliquotter (UCTA) ............4 ® UniCel DxC Analyzer ..................6 ® ® UniCel Analyzer..................11 Integrated Workstation Sample Processing Overview........12 Chapter 2: Software Overview ................15 Introduction .....................15 Main Screen Elements ..................19 DxI Main Menu ....................21 Integrated Workstation Software Tree.............23...

  • Page 4: Professional Development Department October

    DxC Integrated Workstation In-Lab Training Manual A47765-AC Page 2 Professional Development Department October 2010...

  • Page 5: Chapter 1: Instrument Overview

    C hapter 1: Instrument Overview Instrument Overview I ntroduction The UniCel DxC Integrated Workstation* combines a UniCel DxC analyzer, a UniCel DxI analyzer, and a UniCel Closed Tube Aliquotter (UCTA) into a single integrated system. DxI Console DxC Analyzer DxI Analyzer Workstation Console UCTA *Integrated Workstations:...

  • Page 6: Unicel ® Closed Tube Aliquotter (Ucta)

    ® U niCel Closed Tube Aliquotter (UCTA) The UCTA functions as a sample processing manager. It serves as a single point of entry for the integrated workstation. The UCTA utilizes piercing probes that eliminate the need to uncap and recap sample containers. When a sample has DxI testing requirements, the UCTA will create an aliquot which is transferred to the DxI for processing.
  • Page 7 The following table identifies some components used during sample processing. Diagram of an overhead view of the inside of the UCTA and the back of the DxI Component Function UCTA Bar Code Reader Sample requirements identified. UCTA Sample Carousel Sample racks are delivered here for processing. •...

  • Page 8: Unicel ® Dxc Analyzer

    ® U niCel DxC Analyzer The DxC analyzer performs in vitro determination of a variety of general chemistries, therapeutic drugs, proteins, and drugs of abuse. The DxC can be divided into two sides: the Modular Chemistry (MC) side and the Cartridge Chemistry (CC) side.
  • Page 9 Modular Chemistry (MC) The modular chemistry system is used to provide rapid analysis for chemistries identified in the table below. The reactions occur in individual reaction cup modules or in an ion selective electrode (ISE) module. Picture showing MC side of a DxC 800 MC Components Function Sample racks delivered here for sample aspiration...
  • Page 10 DxC 800 MC reagent compartment MC Reagent Compartment Reaction cup (number based on instrument configuration) and ISE reagents. Alkaline Buffer reagent located within the ISE module. MC reagent bar code reader (also used for UCTA reagents) DxC hydropneumatics compartment (behind door) contains DxC wash concentrate, DxC Auto-Gloss and No Foam reagent.
  • Page 11 Cartridge Chemistry (CC) The Cartridge Chemistry System provides random access analysis using cartridge reagents. The analysis is performed in glass cuvettes located in the reaction carousel where absorbance readings are taken by a multi-wavelength photometer. Covers removed from the reaction carousel and the wash tower probes.
  • Page 12 Door open to CC reagent carousel CC Component Function Refrigerated compartment with a capacity to hold 59 Reagent Carousel reagent cartridges. DxC Integrated Workstation In-Lab Training Manual A47765-AC Page 10 Professional Development Department October 2010...

  • Page 13: Unicel ® Dxi ® Analyzer

    ® ® U niCel Analyzer 1 0 B The DxI Analyzer is an automated, random access immunoassay system used for the in vitro determination of a wide variety of immunoassays. The system utilizes chemiluminescent technology. DxI 800 pictured Component Function Sample Presentation Unit Sample racks are loaded here for maintenance, (SPU)

  • Page 14: Integrated Workstation Sample Processing Overview

    I ntegrated Workstation Sample Processing Overview 1 1 B UCTA UCTA Load Tray UCTA Transfer Shuttle UCTA RUN button DxI Pick and Place UCTA Sample Carousel DxI Sample Storage UCTA SV Shuttle DxC Load Area UCTA Pick and Place DxC Sample Carousel DxC Off-load Area Sample Processing* The diagram above identifies the system components used for sample...
  • Page 15 • DxI analysis begins − The SV will be used as the sample for immunoassay testing − Reagent and sample will be delivered to a reaction vessel (RV) − The RV will be incubated, washed to remove unbound material, and substrate added for the chemiluminescent reaction −...
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  • Page 17: Chapter 2: Software Overview

    C hapter 2: Software Overview Software Overview I ntroduction 1 2 B The DxC Integrated Workstation operating and programming functions are initiated from the workstation console. The screen provides status information which allows the operator to determine the present state of the integrated workstation.
  • Page 18 Navigation The DxC Integrated Workstation provides three software navigation methods* that you can use to select an item on a screen or in a window. Use the touch screen. Use the mouse and click on a selected item. Press a keyboard equivalent function or tab key to select an item. *Both the workstation console and the DxI console use the three software navigation methods.
  • Page 19 Integrated Workstation Main Menu Status Indicators Status Description • Appears when the 1-Blade Thick CTS (Closed Tube Sampling) or 1-Blade Narrow CTS Cap Piercer Assembly is enabled. • ppears over CTS when the feature is not enabled. • Reagent Appears in the middle of the communication line during the Load Status waiting period before a reagent can be loaded on the DxC.
  • Page 20 Menu Bar icons background colors: • Neutral indicates normal conditions • Yellow indicates a caution condition • indicates a warning condition Operators should investigate all icon color changes. Menu Bar Icons Function View sample status information and perform main operating Main functions.

  • Page 21: Main Screen Elements

    M ain Screen Elements 1 3 B The Main screen displays the status information for all samples loaded onto the system. Status information is sorted by instrument and the information for each area is displayed on separate tabs. Select a tab to identify the location and status of samples. The tab selected will move to the front.
  • Page 22 Sample Status Icons are available from each tab to view the sample status. The icon is displayed in front of the Sample ID. Sample Status Icon Status Description Not Programmed There is no programming for the sample ID. Query Pending Waiting for programming to be downloaded from the Host.

  • Page 23: Dxi Main Menu

    D xI Main Menu 1 4 B The DxI monitor is used for DxI calibration, maintenance, diagnostics and during independent mode operation. Screen Element Description • Indicates the status of the DxI analyzer. System Mode • Modes include: Ready, Running, Paused or Not Ready. •...
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  • Page 25: Integrated Workstation Software Tree

    I ntegrated Workstation Software Tree 1 5 B DxC Integrated Workstation In-Lab Training Manual A47765-AC Page 23 Professional Development Department October 2010...
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  • Page 33: Chapter 3: Daily Start Up

    C hapter 3: Daily Start Up Daily Start Up I ntroduction 1 6 B These procedures ensure that you complete all steps required before a patient run. S upply Capacities 1 7 B The following tables identify the supply capacities for each instrument component. All supplies required can be viewed using the appropriate supply tabs available within the Rgts/Cal icon at the workstation console.
  • Page 34 DxI Supplies Capacity Yellow Caution Red Warning Notes Supply • Red Warning: Wash Both Containers Completes testing in Buffer 2 x 10 L 1 Container Empty Empty progress, but no new tests scheduled • Red Warning: Completes testing in DxI 800: Liquid 2 x 9.5 L progress, but no new...
  • Page 35 UCTA Supplies UCTA Supply Capacity Yellow Caution Red Warning Notes • 1 Container • Both • Red Warning: Empty Containers Wash Buffer 2 x 10 L No new tests Empty scheduled • Pop-up • 0 tests • UCTA will off- load racks messages at available...

  • Page 36: Daily Start Up

    D aily Start Up 1 8 B The following procedures are required for a daily start up of the DxC Integrated Workstation. The order listed below is the most efficient way to complete the procedures. 1. Determine integrated workstation supply and calibration status. 2.
  • Page 37 DxC Integrated Workstation Daily Start Up Print/View Integrated Workstation supply, reagent, and calibration status Perform the following Daily Maintenance procedures (Utility Assay enabled): ~ Check System Backup ~ Shake Solid Waste Container ~ Run DxI Clean Routine ~ Initial and Date Electronic Maintenance Log *Note: DxI supplies can be loaded...
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  • Page 41 Process Daily Clean Routine Select Main Menu or the Menu tab from the DxI console Select Sample Manager F1 Select New Request F3 Select Maintenance F3 At the Request Maintenance Screen *If you run the B12 assay, perform the Special Clean in place of Select Daily Clean System* the Daily Clean.
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  • Page 43 Change a Full Liquid Waste Container Use supply status to determine which bulk liquid waste container(s) needs to be changed Pull out the liquid waste drawer Press the disconnect button on the full container to release the tubing Remove the full container and replace it with an empty container Connect the tubing to the...
  • Page 44 Change an Empty DxI Wash Buffer Container Use supply status to determine which container(s) of wash buffer needs to be replaced Pull out the wash buffer supply drawer Remove the perforated cardboard panels of the new container and gently invert the container 3-4 times.
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  • Page 47 Load a DxI Reagent Pack Check the status of the reagent tray in-use light Wait until the green Is the light on? light turns off Gently mix the packs and open the reagent load door Place pack(s) in the tray positions Close the reagent load door More reagent pack(s) to load?
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  • Page 53 Unload CC Reagent Select Rgts/Cal from the workstation console Select the DxC tab Page down (pages 3-8) to locate the position(s) of the reagent(s) to be unloaded from the CC carousel. Select position(s) to unload reagent cartridges Select Load F1 Open the reagent carousel door when prompted Grasp the cartridge in the load position (located at the blinking bar code reader) and move it in front...
  • Page 54 Calibrate DxC Chemistries Select Rgts/Cal from the workstation console Select the DxC tab Select each chemistry for calibration. Page down to view additional chemistries Select Cal F4 Select List F5 Review the calibrator load list. Verify the calibrator lot number in use matches the load list Note: For some calibrators, the lot number is N/A Locate the racks to be used for calibration.
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  • Page 56 Process Quality Control using Auto Generation of Control Locate the rack containing the bar code labeled tube(s) for the control sample(s) Pour the control material into a sample cup Nest the sample cup in the appropriate bar code labeled tube(s) Load the rack(s) on the UCTA load tray Press the RUN button on the UCTA *Quality Control...
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  • Page 59: Chapter 4: Sample Processing

    C hapter 4: Sample Processing Sample Processing Validated Sample Containers for Cap Piercing Only validated closed sample tubes can be processed on the UCTA or the CTS (Closed Tube Sampling) on the DxC. 1 -Blade Thick CTS • Becton Dickinson VACUTAINER with HEMOGARD 13 x 75 mm 13 x 100 mm...
  • Page 60 Shared Racks Shared racks accommodate one container type per rack. Shared racks may be processed through the UCTA, placed directly on the DxC load area or on the DxI SPU. Shared racks should be the most commonly used racks. Note: Sample containers with caps must have the caps removed before being loaded directly onto the DxI.
  • Page 61 DxC/UCTA Racks Racks defined as DxC/UCTA can be processed through the UCTA or placed directly on the DxC during independent mode operations. These racks can not be loaded directly on the DxI SPU. DxC/UCTA Rack Labels Sample Container 0.5 mL Sample Cup in 5 mL Transfer Tube (PN 979272) 5 mL DxC/UCTA dead volume=160* µL...

  • Page 62: Sample Preparation

    DxI Only Racks Racks defined as DxI Only will be loaded on the DxI SPU. DxI Rack Label Sample Container/Sample Rack • Sample rack type: Low Volume Sample Rack PN 386167 • Low Volume Sample Vessel (DxI RV) • Maximum allowable volume= 500 µL •...
  • Page 63 Sample Processing Remove visible blood from the top of capped tubes using a cotton tipped applicator stick moistened with DI water *Adequate sample volume Use “Low Volume *Adequate Sample Processing” determined by Sample Volume? flowchart UCTA Primary Tube Sample Template 1 Select Samples from the Is sample workstation console...
  • Page 64 Low Volume Sample Processing Start Here *For samples with only DxC tests Place sample in a Shared or ordered: DxC/UCTA rack for Use a validated DxC Only low low volume sample containers volume sample container and (insert cups or 0.5 mL sample cup)* rack.

  • Page 65: Chapter 5: Instrument Commands

    Chapter 5: Instrument Commands Instrument Commands Instrument commands can be used to control functions of DxC and UCTA instrument components. Instrument commands include: Home: • Moves mechanical assemblies to their “home” positions and primes the system • Recovers from a motion error •...
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  • Page 68 Shutdown the DxC Integrated Workstation The DxC Integrated Workstation may require power down when: • Part replacement procedures specify power to be turned off • The lab power goes off • The system is moved to a new location, or •...
  • Page 69 Shut Down the DxC Integrated Workstation Shut Down the DxI Instrument and PC 1. Verify the instrument is in the Ready or Not Ready mode 2. Select Configure F8 from the DxI console 3. Select PC Admin F7, then System Admin F8, then Shut Down Instrument F2 4.
  • Page 70 Restarting the DxC Integrated Workstation Restarting the DxI PC and Instrument 1. Verify that the upper main covers of the DxI instrument are closed. 2. Turn on the DxI instrument power switch. 3. Press and hold the DxI console power switch for at least 10 seconds to turn on the PC 4.
  • Page 71 Enable/Disable Modules Verify the system is in Standby or Stopped Select Instr Cmd from the workstation console Select 7 Enable/Disable Modules Select the desired module button to Disable a module Select the desired module button with the blue indicator bar to Enable a module Select OK to Enable/Disable the desired modules DxC Integrated Workstation In-Lab Training Manual A47765-AC Page 69...
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  • Page 73 DxI Commands The DxI system has commands that can be used to Initialize (home), Pause and Resume the DxI analyzer. These commands are initiated at the DxI console. Initialize: • Use to move mechanical assemblies to their “home” position • Use to return the system to Ready from the Not Ready/Stopped state Pause:...
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  • Page 75 Pause DxI Select Pause at the DxI console A message may display “Waiting for Automation Sampling to Complete” if the UCTA is preparing to transfer a sample. Select OK F1 A message will display “Pause the System?” when the UCTA has completed transfer of the sample. Select Yes F1 Select Resume to restart the system DxC Integrated Workstation In-Lab Training Manual A47765-AC...
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  • Page 77: Chapter 6: Resources

    C hapter 6: Resources Resources Support Technical Support (Hotline): • Personnel Provides 24 hour phone support • Contact at 1-800-854-3633 Applications Specialist: • Provides installation support • Your Application Specialist is ________________________ (Name) and may be reached at_______________________ (Phone) Field Service Engineer: •...
  • Page 78 Reference UniCel DxC Synchron Access Clinical System Integrated Materials Workstation: • UniCel DxC Synchron Access Clinical Systems Integrated Workstation In-Lab Training Manual − May be used to train laboratory personnel about basic operations of the DxC Integrated Workstation − Provided as a hard copy manual and on the Product Manuals CD Rom •...
  • Page 79 Reference UniCel DxC Synchron Clinical Systems: • Materials UniCel DxC Synchron Clinical Systems Reference Manual − Contains detailed system description, operating (Continued) instructions, theory of operation, system calibration, programming procedures, and quality control information. − Provided on a CD ROM •...
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  • Page 81: Chapter 7: In-Lab Competency Checklist

    C hapter In-Lab Competency Checklist In-Lab Training Competency Checklist Purpose The following In-Lab Training Competency Checklist may be used to document the in-lab training of laboratory staff on the operation of the DxC Integrated Workstation. As each operator is trained, both the trainer and the trainee initial and date the documentation form DxC Integrated Workstation In-Lab Training Manual A47765-AC Page 79...
  • Page 82 Competency Checklist ® ® ® UniCel DxC Synchron Access Clinical System Integrated Workstation Achieved? Trainee Trainer Task Resource How Measured? Date Initial Initial System Overview DxI Online Help (Main Menu) Direct Observation Help System Overview Test • Identify DxI Hardware Other __________ Instrument Overview Show me...
  • Page 83 Competency Checklist ® ® ® UniCel DxC Synchron Access Clinical System Integrated Workstation Achieved? Trainee Trainer Task Resource How Measured? Date Initial Initial Other __________ Direct Observation • Load supplies/reagents on DxI Test Other __________ • Load supplies/reagents on Direct Observation Test UCTA Other __________...
  • Page 84 Competency Checklist ® ® ® UniCel DxC Synchron Access Clinical System Integrated Workstation Achieved? Trainee Trainer Task Resource How Measured? Date Initial Initial at workstation console • Program and process routine Direct Observation Test and STAT patient samples at Other __________ DxC Integrated Workstation workstation console Instructions For Use (IFU)
  • Page 85 Competency Checklist ® ® ® UniCel DxC Synchron Access Clinical System Integrated Workstation Achieved? Trainee Trainer Task Resource How Measured? Date Initial Initial maintenance on UCTA Test Other __________ • Perform Monthly Maintenance Direct Observation Test on DxC Other __________ •...
  • Page 86 Competency Checklist ® ® ® UniCel DxC Synchron Access Clinical System Integrated Workstation Achieved? Trainee Trainer Task Resource How Measured? Date Initial Initial Direct Observation • Quality Control Results DxC Integrated Workstation Test Management at workstation Instructions For Use (IFU) Manual Other __________ Chapter 5: Quality Control console...

  • Page 87: Chapter 8: Competency Exercise

    C hapter 8: Competency Exercise DxC Integrated Workstation Competency Exercise How to The competency exercise should be completed at the end of the Complete in-lab training session. All materials supplied with the instrument this Exercise or used during the training may be used to complete this exercise.
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  • Page 89 Name:_____________________________________________________ Instrument 1. As a sample processing manager, the UniCel Closed Tube Overview Aliquotter (UCTA) will create an ____________ for processing on the DxI and __________ the sample container to the DxC for further processing. 2. The DxC is composed of two sides. Which side performs rapid analysis for specific chemistries? ___________ __________ (__ __) side 3.
  • Page 90 Software 6. The DxI console is used for DxI ____________, Overview ______________________, diagnostics and in independent mode operations. 7. Label each circle on the picture below with the letter corresponding to its description: a DxI Console Status b System Operating Status c Reagent/Calibration Icon d Sample Status Icons 8.
  • Page 91 Daily Start 10. Which icon would you use at the workstation console to print a supply status for the entire system?______________ 11. Place a number before each task below indicating the order they should be performed as part of a Daily Start Up: _____ Process Quality Control _____ Print/View Rgt/Cal/Supply Status _____ Perform Daily Maintenance...
  • Page 92 Daily Start 15. When calibrating DxC chemistries, what function key do you use to view the calibrator load list? _________________ (Continued) 16. DxI calibration is requested at the _________console and loaded on the DxI _______ ________ ________ (SPU). 17. Perform a Daily Start Up on your DxC Integrated Workstation. Keep all reports and show them to your supervisor and/or Beckman Coulter representative when the Daily Start Up is completed.
  • Page 93 Sample 18. If you are processing a validated capped sample, you should Processing remove__________ __________ using a cotton tipped swab moistened with DI water. 19. What do you use to determine adequate sample volume? ______________________________ 20. DxC/UCTA sample racks can be loaded on the UCTA load tray and used to create sample vessels (SVs) for DxI testing.
  • Page 94 Instrument 23. Draw a line between the Instrument Command you would use Commands to perform the described function: Instrument Function Command Home Use to power off the system Pause Use to remove racks from the Menu screen that are not present on the sample carousel Shutdown Use to turn on the Glucose...
  • Page 95 Answer Key Instrument 1. As a sample processing manager, the UniCel Closed Tube Overview Aliquotter (UCTA) will create an a liquot for processing on the DxI and t ransfer the sample container to the DxC for further processing. 2. The DxC is composed of two sides. Which side performs rapid analysis for specific chemistries? M odular Chemistry (MC) side...
  • Page 96 Software 6. The DxI analyzer screen is used for DxI c alibration m aintenance Overview diagnostics and in independent mode operations. 7. Label each circle on the picture below with the letter corresponding to its description: a. DxI Console Status b.
  • Page 97 Daily Start- 10. Which icon would you use at the workstation console to print a supply status for the entire system? R gts/Cal icon 11. Place a number before each task below indicating the order they should be performed as part of a Daily Start-Up: Process Quality Control Print/View Rgts/Cal/Supply Status Perform Daily Maintenance...
  • Page 98 Daily Start- 15. When calibrating DxC chemistries, what function key do you use to view the calibrator load list? L ist F5 (Continued) 16. DxI calibration is requested at the D xI console and loaded on the DxI S ample P resentation U nit (SPU).
  • Page 99 Sample 21. Manually program and process the samples using the following Processing information: Sample Other Sample ID Priority Tests Type Information Test 1 Serum Routine Na, K, Cl, Patient CO2, Name: Test GLUCm Sample Patient Age: 3 yrs Test 2 STAT GLUCm Test 3...
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This manual is also suitable for:

Unicel dxc 680iUnicel dxc 860iUnicel dxc 880i

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