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DxC Integrated Workstation In-Lab Training Manual 

 

Page 78 of 101 

Rev. A (June 2014) 

 

Beckman Coulter Professional Development 

Reference 
Materials 

UniCel DxC Synchron Access Clinical System Integrated 
Workstations: 
 

 

UniCel DxC Synchron Access Clinical Systems Integrated 
Workstation

 

Instructions for Use Manual

 

  Provides operating instructions, maintenance instructions, and 

troubleshooting guidelines

 

  Available to view and print through Help icon at the workstation 

console

 

 Available 

at 

www.beckmancoulter.com

 and Product Manuals CD

 

 

 

UniCel DxC Synchron Access Clinical Systems Integrated 
Workstations

 UCTA

 

Primary Tube Sample Template

 

  Use to establish adequate sample volume

 

  Provided as a laminated sheet

 

 

 

UniCel DxI Access Immunoassay System: 
 

 

UniCel DxI Access Immunoassay System 

Instructions for Use

 

  Contains basic operating and maintenance guidelines for the DxI 

analyzer

 

 Available 

at 

www.beckmancoulter.com

 and CD

 

 

UniCel DxI 

Help System

 

  Contains detailed operating instructions, theory of operation, 

troubleshooting guidelines, and detailed maintenance instructions

 

  Available to view and print through the Help button at the DxI 

console

 

 

UniCel DxI 

Sample Volume Guidelines

 

  Contains information for sample container volume requirements 

when loading samples on the DxI SPU

 

  Provided as laminated sheets

 

 

Access Immunoassay Systems 

Assay Summary Tables

 and 

individual 

Assay Instructions for Use

 

  Contains specific assay information for the full range of assays 

available on the DxI analyzer

 

 Available 

at 

www.beckmancoulter.com

 

 

DxI 

Installation Implementation Guide

 

  Provides an overview of the verification process and guidelines 

for precision evaluation

 

  Provided as a hard copy manual

 

 

Содержание UniCel DxC 660i

Страница 1: ...iCel 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 Beckman Coulter Inc 250 S Kraemer Blvd Brea CA 92821 U S A ...

Страница 2: ...t limited to protective eyewear gloves suitable laboratory attire when operating or maintaining this or any other automated laboratory equipment INTENTION FOR USE This document is not intended to replace the information in your Instrument Instructions for Use Manual IFU or Help System Information in the Instructions for Use Manual or Help System supersedes information in any other manual REVISION ...

Страница 3: ... Elements 18 Workstation Console Main Screen 20 DxI Console Main Menu 22 Integrated Workstation Software Tree 25 Chapter 3 Daily Start Up 33 Introduction 33 Supply Capacities 33 Daily Start Up 36 Flowchart Information 36 Chapter 4 Sample Processing 59 Validated Sample Containers for Cap Piercing 59 Minimum Sample Volume 59 Sample Racks 59 Tips on Sample Preparation 62 Independent Mode Operations 6...

Страница 4: ...DxC Integrated Workstation In Lab Training Manual Page 4 of 101 Rev A June 2014 Beckman Coulter Professional Development ...

Страница 5: ...xC 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 DxI Analyzer UCTA DxC Analyzer Workstation Console Integrated Workstations DxC 660i DxC 600 UCTA DxI 600 DxC 680i DxC 600 UCTA DxI 800 DxC 860i DxC 800 UCTA DxI 600 DxC 880i DxC 800 UCTA DxI 800 1 1 2 2 3 3 4 4 5 5 ...

Страница 6: ...the DxI and DxC will have testing occur simultaneously on both analyzers The UCTA is self contained and houses all electronics hydropneumatics and fluid handling utilities Component Function UCTA Load Tray Sample racks are placed here UCTA RUN Button Initiate processing Racks are delivered to the UCTA shuttle Racks pass the bar code reader for sample programming information The UCTA shuttle delive...

Страница 7: ...obes pierce caps of closed sample containers Aliquot probes aspirate an aliquot of sample and dispense the aliquot into a sample vessel SV UCTA SV Shuttle Holds SVs when sample is being dispensed and transfers the SVs to the UCTA Pick and Place UCTA SV Nest Holds empty SVs for delivery to UCTA SV Shuttle for sample addition Holds SVs containing sample for delivery to UCTA Transfer Shuttle UCTA Pic...

Страница 8: ...opment UniCel 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 Picture shows DxC 800 with canopy open MC Side CC Side ...

Страница 9: ...d here for sample aspiration from both the MC and CC sample probe MC Sample Probe Aspirates and delivers sample to the MC modules Reaction Cup Modules Performs rapid analysis at each individual reaction cup module Module configuration is as follows DxC 600 GLUCm DxC 800 GLUCm BUNm PHOSm CREm ALBm and TPm Electrolyte Injection Cup EIC Sample delivered here for electrolyte analysis Ion Selective Ele...

Страница 10: ... compartment MC Reagent Compartment Reaction cup number based on instrument configuration and ISE reagents CO2 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 1 1 2 2 1 3 3 ...

Страница 11: ...he reaction carousel and the wash tower probes CC Components Function Reagent Probes 2 Aspirates and delivers reagent s to a cuvette in the reaction carousel Reagent Mixer Mixes reagents delivered to the cuvette CC Sample Probe Aspirates and delivers sample to the cuvette containing reagent s Sample Mixer Mixes sample and reagent s in the cuvette Reaction Carousel Houses cuvettes used for sample a...

Страница 12: ...Lab Training Manual Page 12 of 101 Rev A June 2014 Beckman Coulter Professional Development CC reagent carousel door open CC Component Function Reagent Carousel Refrigerated compartment with a capacity to hold 59 reagent cartridges ...

Страница 13: ...ar Code Reader Use to read bar code information on substrate bottles Liquid Waste Drawer Liquid waste containers located in this drawer Solid Waste Door Solid waste container storage Wash Buffer Drawer Wash buffer containers located in this drawer Power Switch behind door Use to power on and off the DxI analyzer DxI Pick and Place Transfers SVs between the DxI sample storage and UCTA Transfer Shut...

Страница 14: ...usel 7 UCTA Pick and Place 14 DxC Off load Area Sample Processing The DxC Integrated Workstation Sample Processing diagram identifies some of the system components used during sample processing Use the diagram as a reference For complete details on sample analysis refer to the DxC Integrated Workstation IFU A sample is placed in an appropriate sample rack and loaded on the UCTA load tray 1 The UCT...

Страница 15: ... reagent pipettor delivers reagent and sample to a reaction vessel RV The RV is incubated then washed to remove unbound material substrate is added to the RV for the chemiluminescent reaction The luminometer measures the amount of light generated from the RV the measure light is converted to assay concentration The UCTA shuttle moves the sample rack to the DxC load area If the sample needs to be t...

Страница 16: ...DxC Integrated Workstation In Lab Training Manual Page 16 of 101 Rev A June 2014 Beckman Coulter Professional Development ...

Страница 17: ...rmine the present state of the integrated workstation The DxI console is used for DxI specific functions such as calibration maintenance diagnostics and independent mode operation 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 k...

Страница 18: ...nd the DxC Integrated Workstation BLUE bar indicates that the host is sending information GREEN bar indicates that the host is receiving information Indicates the host and the workstation are not communicating 4 Instrument Status Displays the operating status for the entire Integrated Workstation The system components are listed DxI UCTA DxC MC CC 5 Printing Status Indicates you must reboot the sy...

Страница 19: ...es Perform sample programming functions for patients and quality control Results Recall and print test results Rgts Cal View print supply reagent and calibration status and perform reagent and calibration functions for UCTA and DxC QC Define and manage quality control Setup Perform system setup functions Utils Perform specific hardware functions on the DxC and UCTA Examples Maintenance Prime Align...

Страница 20: ... and status of samples DxI Samples in the DxI UCTA Samples in the UCTA sample carousel DxC Samples in the DxC sample carousel 2 Sample Status Icons Identify the status of a sample The icon is displayed in front of the sample ID The sample status icons are specific to the tab selected More information on the next page 3 Rack Sample Status Area Displays sample status for on board samples The format ...

Страница 21: ...nt of the Sample ID Sample Status Icons Status Description Not Programmed There is no programming for the sample ID Query Pending System is waiting for sample programming to be downloaded from the host In Progress Sample testing is in progress Aspirated Sample aspiration is complete DxC and DxI tabs only Incomplete The system is unable to complete at least one test Aliquoted Sample has been aliquo...

Страница 22: ... Running Paused or Not Ready 2 Status Buttons System Status buttons can be viewed at any time Select the button to view its related screen See the next page for details 3 Command Buttons Use to Stop Pause or Resume operation of the DxI 4 UCTA DxC Status Button Displays the software version and system status for the DxC and UCTA 5 Help Button The Help system includes detailed operating and referenc...

Страница 23: ...console using the Rerun Test function button A color change of this icon at the DxI console will also appear at the at the workstation console Supplies Required The Supplies Required screen displays information about needed supplies or calibrations or if an instrument condition requires attention Bulk Supplies The Bulk Supplies screen displays information about the available quantities of the bulk...

Страница 24: ...upplies and unload DxI reagent packs Used to designate a specific reagent pipettor for DxI QC testing Note All other DxI QC functions are not available on the DxI console because QC is defined and managed at the workstation console Used to define DxI calibrators view and or print DxI calibration reports Accesses a review of DxI system temperatures and review results for non routine maintenance pro...

Страница 25: ...DxC Integrated Workstation In Lab Training Manual Page 25 of 101 Rev A June 2014 Beckman Coulter Professional Development Integrated Workstation Software Tree ...

Страница 26: ...DxC Integrated Workstation In Lab Training Manual Page 26 of 101 Rev A June 2014 Beckman Coulter Professional Development ...

Страница 27: ...DxC Integrated Workstation In Lab Training Manual Page 27 of 101 Rev A June 2014 Beckman Coulter Professional Development ...

Страница 28: ...DxC Integrated Workstation In Lab Training Manual Page 28 of 101 Rev A June 2014 Beckman Coulter Professional Development ...

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Страница 30: ...DxC Integrated Workstation In Lab Training Manual Page 30 of 101 Rev A June 2014 Beckman Coulter Professional Development ...

Страница 31: ...DxC Integrated Workstation In Lab Training Manual Page 31 of 101 Rev A June 2014 Beckman Coulter Professional Development ...

Страница 32: ...DxC Integrated Workstation In Lab Training Manual Page 32 of 101 Rev A June 2014 Beckman Coulter Professional Development ...

Страница 33: ...y Start Up Introduction These procedures ensure that you complete all steps required before a patient run Supply Capacities 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 ...

Страница 34: ...able in container for collecting waste Container is Full Red Warning When the container is full it completes testing in progress but no new tests scheduled Substrate 2 x 130 mL 1200 tests A lot expires in 3 days An open bottle expires in 3 days One on board bottle is empty Only one bottle on board and it has 60 tests left One bottle is not present or not recognized by the system All lots are expir...

Страница 35: ...gent not loaded DxC Reagents DxC Reagent Capacity Yellow Caution Red Warning Notes MC Reagent 500 mL or 2000 mL containers Pop up messages at 10 5 and 0 volume remaining Days exceeded 0 tests available Reagent expired Prepare reagent according to Reagent Preparation Quick Reference or Chemistry Information Sheets CC Reagent 59 reagent positions Pop up messages at 5 and 0 tests remaining in cartrid...

Страница 36: ...brate DxI assays as needed 8 Process quality control 9 Clear manually assigned racks Note Verify the current daily start up procedures by referencing the latest version of the DxC Integrated Workstation Instructions for Use IFU Manual and the Important Notes for the IFU Flowchart Information Perform the tasks in the order listed for efficiency Some tasks may be performed on one component of the sy...

Страница 37: ...Daily Maintenance procedures Utility Assay enabled Check System Backup Shake Solid Waste Container Run DxI Clean Routine Initial and Date Electronic Maintenance Log Load UCTA supplies Load DxC reagents Calibrate DxC chemistries Process Quality Control Calibrate DxI assays UCTA supplies required DxC calibration required DxI calibration required DxC reagents required Yes Clear racks DxI supplies req...

Страница 38: ... Lab Training Manual Page 38 of 101 Rev A June 2014 Beckman Coulter Professional Development View Print Supply Reagent and Calibration Status Select Rgts Cal from the workstation console View all tabs and pages or select Print F10 ...

Страница 39: ...field Select Configure F8 Select PC Admin F7 A message will display when the tape is ejected Remove the tape from the DxI PC tape drive Select Eject Tape F3 Insert an alternate tape in the DxI PC tape drive Document completed maintenance in Electronic Maintenance Log Note If the backup is not successful perform an immediate backup or schedule a backup The instructions for the procedures can be fou...

Страница 40: ...DxC Integrated Workstation In Lab Training Manual Page 40 of 101 Rev A June 2014 Beckman Coulter Professional Development Shake the DxI Solid Waste Container ...

Страница 41: ...DxC Integrated Workstation In Lab Training Manual Page 41 of 101 Rev A June 2014 Beckman Coulter Professional Development Process Daily Clean Routine ...

Страница 42: ... Training Manual Page 42 of 101 Rev A June 2014 Beckman Coulter Professional Development Add Reaction Vessels RVs Open the vessel hopper door Open the bag of RVs and pour the contents into the vessel hopper Close the vessel hopper door ...

Страница 43: ...DxC Integrated Workstation In Lab Training Manual Page 43 of 101 Rev A June 2014 Beckman Coulter Professional Development Change a Full Liquid Waste Container ...

Страница 44: ...he container 3 4 times Press the disconnect button on the empty container to release the tubing Remove the empty container from the drawer and replace it with the new container Remove the cap draw tube assembly from the empty container and insert it into the new container Connect the tubing to the new container and close the drawer Lot number tracking requirement defined by laboratory policy No Ye...

Страница 45: ... Open the substrate load door and release the load tray Remove the empty or expired bottle and discard Remove a new bottle from the substrate equilibration area Remove the cap from the new bottle and place the bottle in the load tray with the bar code facing out Push in the load tray until it locks in place and the system closes the door Scan the bar code label Place an unequilibrated bottle in th...

Страница 46: ...rea Press the green reset button and close the door Pull down on the solid waste door handle Slide the full container out of the storage area and seal the waste bag Remove the full waste bag and insert a new bag into the container Verify the DxI is not running the Daily or Special Clean routine or initializing Caution Opening the solid waste door during any of these procedures will place the DxI i...

Страница 47: ...DxC Integrated Workstation In Lab Training Manual Page 47 of 101 Rev A June 2014 Beckman Coulter Professional Development Load DxI Reagent Pack ...

Страница 48: ...u or Menu tab from the DxI console Select pack s to unload Wait for the reagent tray in use light to turn off Open the reagent door and remove the pack s Select Reagent Supplies F2 Close the reagent load door Select Unload Reagent Packs F2 More packs to unload Select Supplies F3 Select Exit F1 No Yes To unload all packs on board select Unload All Reagent Packs F3 ...

Страница 49: ...r and tighten the cap Lot number tracking required Select Rgts Cal from the workstation console Select the Supplies tab Type the lot number into the UCTA Wash Buffer field Rear or Front located on the UCTA Supplies Status section of the screen Open the UCTA door and pull out the lower sliding tray to gain access to the wash buffer container Push in the sliding lower tray and close the UCTA door Lo...

Страница 50: ...DxC Integrated Workstation In Lab Training Manual Page 50 of 101 Rev A June 2014 Beckman Coulter Professional Development Change the UCTA Auto Gloss ...

Страница 51: ... the tray and reconnect fitting s to the straw s Notes Take care not to contaminate the draw tube Discard the old bottle according to laboratory procedures Open the MC reagent compartment door of the DxC analyzer Close the MC reagent compartment door Use the bar code reader to scan the reagent bar code label on the new reagent bottle Verify the new reagent information is displayed Place the new bo...

Страница 52: ...DxC Integrated Workstation In Lab Training Manual Page 52 of 101 Rev A June 2014 Beckman Coulter Professional Development Load CC Reagents ...

Страница 53: ...e unloaded from the CC carousel 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 of the bar code reader beam Verify the reagent information is removed from the screen Remove the cartridge Close the reagent carousel door Additional reagents selected Yes No Select Load F1 Procedure complete Select posit...

Страница 54: ... button on the UCTA Locate the racks to be used for calibration Pour the calibrator s into sample cups and place the sample cups in either the assigned bar code labeled tube s or the assigned calibrator rack number and position Place the rack s in the UCTA load tray Select Cal F4 Select List F5 When Calibration is complete view calibration status on Rgts Cal screen Calibration successful Consult r...

Страница 55: ...DxC Integrated Workstation In Lab Training Manual Page 55 of 101 Rev A June 2014 Beckman Coulter Professional Development Calibrate DxI Assays ...

Страница 56: ...DxC Integrated Workstation In Lab Training Manual Page 56 of 101 Rev A June 2014 Beckman Coulter Professional Development Process Quality Control using Auto Generation of Control ...

Страница 57: ...DxC Integrated Workstation In Lab Training Manual Page 57 of 101 Rev A June 2014 Beckman Coulter Professional Development Manually Program and Process Quality Control ...

Страница 58: ...velopment Clear Racks Select Samples from the workstation console Select Clear F7 Select OK F1 Type the range of rack numbers to be cleared in the Rack s field Note Enter 1 999 to clear all racks Select OK F1 to confirm Calibrator rack assignments and racks in progress are not cleared with this step Select Enter ...

Страница 59: ...Volume All sample containers sample cups and insert cups must contain a minimum sample volume to run tests The UCTA Primary Tube Sample Template identifies the volume of sample required to avoid sample and aliquot probe errors QNS probe motion errors probes aspirating gel or blood clot For primary tubes use the template to verify that the container has the required volume of sample for the tests o...

Страница 60: ... Primary tube 92 x 15 mm 0 5 mL Sample Cup PN 651412 Dead volume 160 µL 2 0 mL Sample Cup PN 652730 or 81902 Dead volume 420 µL 1 0 mL Insert Cup PN 81915 in a 13 x 75 mm tube Dead volume 310 µL 1 0 mL Insert Cup PN 81915 in a 13 x 100 mm tube Dead volume 310 µL 2 0 mL Insert Cup PN 81917 in 16 x 100 mm tube Dead volume 210 µL Dead volumes identified for Shared racks include DxI and DxC dead volum...

Страница 61: ...de DxI and DxC dead volumes DxC Only Racks Racks defined as DxC Only are validated to be used only when DxC tests are ordered These racks are loaded through the UCTA or placed directly on the DxC during independent mode operations The UCTA will not sample from the container for DxI testing since only DxC tests are ordered DxC Rack Labels Use for SYNCHRON Microtube PN 448774 Dead volume 60 µL 0 5 m...

Страница 62: ...priate rack Use only validated sample containers in racks specified for their use Use the UCTA Primary Tube Sample Template PN A50304 to verify samples meet minimum and maximum volume requirements Do not overfill insert cups Sample Processing Samples may be processed using various programming methods on the DxC Integrated Workstation Samples may be programmed at the LIS HOST at the Beckman Coulter...

Страница 63: ... cotton tipped applicator stick moistened with DI water No Place sample in the rack and position identified above Adequate Sample Volume Yes Use Low Volume Sample Processing flowchart Adequate sample volume determined by UCTA Primary Tube Sample Template 1 Select Samples from the workstation monitor 2 Enter Rack Pos if bar code is not available 3 Enter Sample ID 4 Select Chemistries 5 If needed se...

Страница 64: ... DxI tests ordered Use a validated DxI Only low volume sample container and rack Load directly on DxI SPU No Yes Procedure complete Place sample in a Shared or DxC UCTA rack for low volume sample containers insert cups or 0 5 mL sample cup Manually Assign 1 Select Samples from the workstation monitor 2 Select Racks F8 3 Enter Rack number 4 Enter SAMPLE ID in appropriate position field 5 Select OK ...

Страница 65: ...ure may result in data corruption Enable Disable Modules Use to enable disable an individual MC cup module the MC ISE the entire MC side the CC Photometer the LPIA module the CC lower reagent carousel or the entire CC side of the system All programming for disabled modules is aborted When a module is disabled the system will not run prime perform diagnostics or maintenance procedures using that mo...

Страница 66: ...d the Home command operates on the side that is Stopped Select Instr Cmd from the workstation console Homing is complete when the status displays Standby for the selected system s Select one of the options 1 DxC 2 UCTA OR 3 Both IMPORTANT If the STOP button is pressed immediately after selecting Home wait at least 10 seconds and press the STOP button again to ensure that the system correctly reach...

Страница 67: ... Both MC and CC 4 UCTA 5 MC CC and UCTA Select Instr Cmd from the workstation console The status of the selected system s will change to Pausing and return to Standby when in progress tests are completed IMPORTANT When Pausing the system cuvette washing stops as soon the last result is available Cuvettes may be left dirty Do not request a Pause and leave the DxC sitting for a long period of time w...

Страница 68: ...y a BCI specialist for troubleshooting purposes Avoid system errors by following these recommendations When one instrument component must be shut down all three components DxI UCTA DxC of the DxC Integrated Workstation must be shut down Components should not be powered down independently Reboot is not recommended The DxI and DxC can be shut down and restarted simultaneously at their respective con...

Страница 69: ...ress and hold the DxI console power switch for at least 20 seconds or until the green LED is off Note If the software does not respond to shutting down the PC press Ctrl Alt Delete on the keyboard to shut down the PC before turning off the computer power Shut Down the UCTA 1 Press the UCTA power switch off 0 position Shut Down the DxC 1 Verify the DxC system status is Standby Stopped or Instrument...

Страница 70: ... Ready mode and no message is displayed in the system mode area Note that this may take several minutes Restart the DxC 1 Turn on the power to the workstation console computer 2 Turn on the power switch behind the far right door of the DxC instrument 3 The DxC system status displays Startup during the boot up routine followed by Homing of all mechanisms Restart the UCTA 1 Verify the DxI is in the ...

Страница 71: ...t Enable Disable Modules Select 7 Enable Disable Modules Select Instr Cmd from the workstation console Enable or Disable Module Select the desired module button s to disable Select the desired module button s to enable Select OK to enable the module s Select OK to disable the module s Select OK to confirm Enable Disable ...

Страница 72: ...pment Unload All Racks Select 8 Unload All Racks All racks in the selected sample carousel s will be removed to the DxC off load area Note The status displays Loading for the selected system s during the Unload All command Select Instr Cmd from the workstation console Select one of the options 1 DxC 2 UCTA OR 3 Both ...

Страница 73: ...ted 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 mode Pause Prevents new or additional tests from initiating at the DxI instrument Any tests already in process are completed The DxI cannot be paused during a maintenance routine The system may enter the Paused mode if an error condition is detecte...

Страница 74: ...wing cleanout options are selected for a standard initialization Sample Wheel Expired Only Analytical Module In Progress Only Note See the DxI Help system for more details on when to select the other initialization options Verify the DxI is in the Not Ready or Ready mode at the DxI console Select Initialize System F1 Select OK F1 to begin initialization Note The progress is displayed in the Initia...

Страница 75: ...ing Manual Page 75 of 101 Rev A June 2014 Beckman Coulter Professional Development Pause the DxI Select Yes F1 to the Pause the system message Select Resume to restart the system Select Pause at the DxI console The DxI mode changes to Paused ...

Страница 76: ...DxC Integrated Workstation In Lab Training Manual Page 76 of 101 Rev A June 2014 Beckman Coulter Professional Development ...

Страница 77: ...he instrument Repairs and assists in maintaining your instrument Your Field Service Engineer is ________________________ and Name can be reached at _______________________ Phone Instructions For Use and DxI Help System The Instructions for Use IFU Manual includes basic operating instructions and maintenance guidelines for the UniCel DxC Integrated Workstation system Detailed operation maintenance ...

Страница 78: ...UniCel DxI Access Immunoassay System Instructions for Use Contains basic operating and maintenance guidelines for the DxI analyzer Available at www beckmancoulter com and CD UniCel DxI Help System Contains detailed operating instructions theory of operation troubleshooting guidelines and detailed maintenance instructions Available to view and print through the Help button at the DxI console UniCel...

Страница 79: ...x Available at www beckmancoulter com UniCel DxC Synchron Clinical Systems Host Interface Specifications Provides necessary information to interface the DxC Integrated Workstation to a Laboratory Information System LIS Includes Tables Codes to interpret instrument codes printed on patient reports Available at www beckmancoulter com and Product Manuals CD Performance Verification Manual Assists in ...

Страница 80: ...DxC Integrated Workstation In Lab Training Manual Page 80 of 101 Rev A June 2014 Beckman Coulter Professional Development ...

Страница 81: ... Chapter 7 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 ...

Страница 82: ...DxC Integrated Workstation In Lab Training Manual Page 82 of 101 Rev A June 2014 Beckman Coulter Professional Development ...

Страница 83: ...ystem Description Direct Observation Test Other __________ Identify DxC Modular Chemistry MC Components Direct Observation Test Other __________ Identify DxC Cartridge Chemistry CC Components Direct Observation Test Other __________ Software Overview Workstation Console DxC Integrated Workstation Instructions For Use IFU Manual Chapter 2 Software Description Direct Observation Test Other _________...

Страница 84: ...servation Test Other __________ Calibration Determine calibration status for DxI immunoassays DxC Integrated Workstation Instructions For Use IFU Manual Chapter 3 Daily Start Up Direct Observation Test Other __________ Determine calibration status for DxC chemistries Direct Observation Test Other __________ Program and process calibration for DxI immunoassays Direct Observation Test Other ________...

Страница 85: ... Integrated Workstation Instructions For Use IFU Manual Chapter 5 Quality Control Direct Observation Test Other __________ Define Quality Control Direct Observation Test Other __________ QC Results Management Direct Observation Test Other __________ Maintenance Perform Daily maintenance on DxI DxC Integrated Workstation Instructions For Use IFU Manual Chapter 3 Daily Start Up Direct Observation Te...

Страница 86: ...ct Observation Test Other __________ Perform Yearly Maintenance on UCTA Direct Observation Test Other __________ Perform 5 000 Test Interval Maintenance on DxI Direct Observation Test Other __________ Perform 10 000 Test Interval Maintenance on DxI Direct Observation Test Other __________ Miscellaneous Instrument Setup at the workstation console DxC Integrated Workstation Instructions For Use IFU ...

Страница 87: ...UCTA and DxC DxC Integrated Workstation Instructions For Use IFU Manual Chapter 8 System Status Instrument Commands and Utilities Direct Observation Test Other __________ Initialize DxI DxI Online Help Main Menu Help Topics Contents Tab Reference Information Diagnostics Initialize System Direct Observation Test Other __________ Home UCTA and DxC DxC Integrated Workstation Instructions For Use IFU ...

Страница 88: ...DxC Integrated Workstation In Lab Training Manual Page 88 of 101 Rev A June 2014 Beckman Coulter Professional Development ...

Страница 89: ...cise Instructions The competency exercise should be completed at the end of the in lab training session All materials supplied with the instrument or used during the training may be used to complete this exercise Save all reports generated during the exercise Submit all printed reports and this exercise to your supervisor and or your Beckman Coulter Applications Specialist ...

Страница 90: ...DxC Integrated Workstation In Lab Training Manual Page 90 of 101 Rev A June 2014 Beckman Coulter Professional Development ...

Страница 91: ...___ 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 On the MC side of the DxC analyzer sample is delivered to the ____________________ for analysis of electrolytes sodium potassium chloride CO2 and calcium 4 The CC side of the DxC analyzer delivers reagent from ...

Страница 92: ...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 Status c Reagent Calibration Menu Bar Icon d Sample Status Icons 8 What tab would you select to view samples on the UCTA sample carousel ___________________________ 9 On the workstation console the icon with the drawing of the wrench takes the user ...

Страница 93: ... order they should be performed as part of a Daily Start Up _____ Process Quality Control _____ Print View Reagent Calibration and Supply Status _____ Perform Daily Maintenance _____ Calibrate required tests _____ Load Reagents and Supplies 12 The Daily Clean is requested at the ____________ console using the ________________ F1 menu 13 If your lab processes the ________ assay you should run a Spe...

Страница 94: ..._______ 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 Sample Processing 18 If you are processing a validated capped sample you should remove __________ __________ using a cotton tipped swab moistened with DI water 19 What do you use to determine adequate...

Страница 95: ...reports to your supervisor and or Beckman Coulter representative Instrument Commands 23 Draw a line between the Instrument Command you would use to perform the described function Instrument Command Function Home Use to power off the DxC Pause Use to remove racks from the Main Menu screen that are not present on the sample carousel Shutdown Use to turn on the Glucose module Enable Module Use to rec...

Страница 96: ...DxC Integrated Workstation In Lab Training Manual Page 96 of 101 Rev A June 2014 Beckman Coulter Professional Development ...

Страница 97: ...o the DxC for further processing 2 The DxC is composed of two sides Which side performs rapid analysis for specific chemistries Modular Chemistry MC side 3 On the MC side of the DxC analyzer sample is delivered to the electrolyte injection cup EIC for analysis of electrolytes sodium potassium chloride CO2 and calcium 4 The CC side of the DxC analyzer delivers reagent from cartridges stored in a re...

Страница 98: ...nd 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 Status c Reagent Calibration Menu Bar Icon d Sample Status Icons 8 What tab would you select to view samples on the UCTA sample carousel UCTA Tab 9 On the workstation console the icon with the drawing of the wrench takes the user to the Utilities...

Страница 99: ...g the recommended order they should be performed as part of a Daily Start Up 5 Process Quality Control 1 Print View Reagent Calibration and Supply Status 2 Perform Daily Maintenance 4 Calibrate required tests 3 Load Reagents and Supplies 12 The Daily Clean is requested at the DxI console using the Sample Manager F1 menu 13 If your lab processes the Vitamin B12 assay you should run a Special Clean ...

Страница 100: ...U 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 Sample Processing 18 If you are processing a validated capped sample you should remove visible blood using a cotton tipped swab moistened with DI water 19 What do you use to determine adequate sample volume UCT...

Страница 101: ...r Beckman Coulter representative Instrument Commands 23 Draw a line between the Instrument Command you would use to perform the described function Instrument Command Function Home Use to power off the DxC Pause Use to remove racks from the Main Menu screen that are not present on the sample carousel Shutdown Use to turn on the Glucose module Enable Module Use to recover from a motion error Unload ...

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