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UniCel DxC 600i In-Lab Training Manual A24574-AD

Page 3

Professional Development Department

October 2010

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)

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Содержание DxC 600i

Страница 1: ...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 ...

Страница 2: ......

Страница 3: ...iew 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 Instr...

Страница 4: ...UniCel DxC 600i In Lab Training Manual A24574 AD Page 2 Professional Development Department October 2010 ...

Страница 5: ...ral 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 Anal...

Страница 6: ...A 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 Al...

Страница 7: ...ts 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 Pi...

Страница 8: ...nents 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 ...

Страница 9: ... 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 analysi...

Страница 10: ...he 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 ...

Страница 11: ...ing 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 R...

Страница 12: ...nk 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 e...

Страница 13: ...00i 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 ...

Страница 14: ...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 m...

Страница 15: ...i 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 backgro...

Страница 16: ...rm 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 hard...

Страница 17: ...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 ...

Страница 18: ... 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 ...

Страница 19: ...Vs 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 ...

Страница 20: ...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 a...

Страница 21: ... The CTA button is used to place the CTA off line on line The CTA must be off line for Access servicing The CTA must be placed back on line to resume normal operations 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 ...

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Страница 23: ...erform Wait for the instrument to tell you it is ready for you to perform the task Do the task Tell the instrument you are done with the task Access Maintenance Cautions Let Access maintenance routines run to completion unless there is an emergency Canceling a maintenance routine may damage the instrument and compromise the integrity of subsequent test results If a maintenance routine is cancelled...

Страница 24: ...ing Paused Yes 60 28 Red Warning No new tests scheduled must wait until Ready to load RVs Reaction Vessel Waste Ready Running Paused Yes 60 0 spaces remaining full waste bag Red Warning No new tests scheduled Do not remove RV Waste bag while an RV is ejecting Substrate Ready Yes 60 tests or 3 days left on supply screen Empty or expired on supply screen Red Warning No new tests scheduled must wait ...

Страница 25: ... No new tests scheduled Aliquot Vessel Waste Standby Running Yes None 0 spaces remaining full waste Monitor space remaining daily Red Warning No new tests scheduled Auto Gloss Standby Running Yes Pop Up warnings at 10 5 and 0 volume 0 tests available Check volume as part of weekly maintenance DxC Reagents DxC Reagent Change during Software Required Yellow Caution Red Warning Notes MC Reagent Stand...

Страница 26: ...ile another component is performing a different task This allows multi tasking to decrease start up time Some tasks may be performed at alternate times Example Access calibration may be performed during off peak hours All tasks may not be required each day Example Access assays are calibrated infrequently Refer to individual flowcharts for instructions on each task Colors are used to categorize gr...

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Страница 32: ...rom you and immediately attach it to a clean liquid waste bottle Connect the clean liquid waste bottle by reattaching the quick disconnects Remove the full liquid waste bottle from the fluids tray and replace it with the clean liquid waste bottle Is Access Running Decontaminate the contents of the liquid waste bottle according to standard laboratory practices Thoroughly rinse the liquid waste bott...

Страница 33: ...ard empty substrate bottle Unscrew the substrate supply cap from the bottle in use and immediately place the inlet tubing and cap onto the new bottle Place the new bottle back in the fluids tray Select Change Substrate F5 Select Done F1 Note Access must be in READY mode to change substrate Place a new bottle of substrate in the fluids tray to equilibrate to room temperature A prompt will appear as...

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Страница 35: ...monitor Select the pack to unload Remove the reagent pack by pressing forward as you lift the back end of the pack Open the sample carousel cover and reagent carousel door Select Supplies F3 Select Unload Reagent Pack F2 Close the reagent carousel door and sample carousel cover Select Done F1 Wait for system prompt to unload the pack Unload Access Reagent ...

Страница 36: ...correct date Select Configure F8 Select PC Admin F7 A message will display when the tape is ejected Remove the tape from the Access computer console tape drive Select Eject Tape F3 Place the alternate tape in the Access computer console tape drive Note If the backup is not successful perform an Immediate backup The procedure for the Immediate backup can be found in the Access Help System Document ...

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Страница 40: ...U or the MENU tab from the Access monitor Verify the Access System Mode is Ready Select the Substrate box Select Diagnostics F7 Select Start Priming F2 Select Prime Fluidics F2 When the priming complete window is displayed Select OK F1 Select Done F8 Document Maintenance completed in Electronic Maintenance Log Prime Substrate ...

Страница 41: ...oors Press the RVs onto the spine then remove the protective covering from the RV cartridge Close the AV Load and AV Supply doors Place the AV cartridge in the AV storage rack Press down firmly on the AV load door to release the AVs from the spine Open the AV load door and remove the spine Select the Supplies tab Select Done F1 Select AV Supply Select Load F1 Load Avs at the CTA ...

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Страница 43: ...e cap assembly to new bottle Turn new bottle upside down and place into reservoir receptacle Lot number tracking required Select Rgts Cal from the DxC 600i monitor Select the Supplies tab on the screen Procedure Complete Type the lot number into the CTA Wash Buffer field located on the CTA Supplies section of the screen Open the CTA door and slide out the metal tray to gain access to the wash buff...

Страница 44: ... the bar code on the Auto Gloss bottle when the Auto Gloss data screen appears Verify the Auto Gloss data is displayed Select Rgts Cal from the DxC 600i monitor Open the CTA door The Auto Gloss bottle is located on the bottom shelf Select the Supplies tab Select the CTA Auto Gloss Select Load F1 Place the new Auto Gloss bottle on the system and tighten the cap Select the Done F1 Change the CTA Aut...

Страница 45: ...d bottle according to laboratory procedures Open the Bulk Reagent Compartment Door of the DxC analyzer Close the Bulk Reagent Compartment Door 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 reagen...

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Страница 47: ...s 3 8 of the DxC tab Rgt Cal screen Open the Reagent Carousel door Procedure Complete 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 DxC monitor Remove the cartridge Close the reagent carousel door Additional reagents selected Yes No Select Load F1 Select the DxC ta...

Страница 48: ...ion in the correct position on the rack When the screen prompts you to load the rack place the rack in the Access sample carousel and close the sample carousel cover If you run the B12 assay perform the Special Clean in place of the Daily Clean See the Help System for information about running the Special Clean CAUTION Citranox and Contrad 70 cleaning solutions may cause eye or skin irritation See...

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Страница 55: ...imary sample tubes Caps removed 12 x 75 mm 13 x 75 mm 13 x 100 mm 16 x 75 mm 16 x 100 mm 0 5 mL sample cups P N 651412 2 0 mL sample cups P N 81902 or P N 652730 1 Blade Thick CTS closed tube sampling Primary sample tubes with caps BD Hemogard a 13 x 75 mm 13 x 100 mm 16 x 100 mm Greiner Vacuette a 13 x 75 mm 13 x 100 mm 1 Blade Narrow CTS closed tube sampling Primary sample tubes with caps Sarste...

Страница 56: ...k Designation Validated Containers Reserved 0 5 mL sample cups P N 651412 in 5 mL transfer tubes P N 979272 2 0 mL sample cups P N 81902 or P N 652730 in 5 mL transfer tubes P N 979272 13 mm 1 0 mL insert cup 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 R ...

Страница 57: ...1999 DxC only chemistries Use the following in Reserved Racks 0 5 mL cups P N 651412 in inserts P N 476406 Place rack in DxC 600i Load Area for DxC processing BD Microtainera baby bullets in pediatric tube adapter P N 472987 Place rack in DxC 600i Load Area for DxC processing SYNCHRON Microtube P N 448774 Place rack in DxC 600i Load Area for DxC processing a All trademarks are the property of thei...

Страница 58: ...es designated for their use Place validated primary sample tubes with or without caps and sample cups 0 5 mL 2 0 mL directly in non reserved racks Place cups nested in cup inserts or cups nested in primary tubes in reserved racks Use only validated sample containers in racks specified for their use Sample Preparation Prepare samples as follows prior to loading on the system Remove visible blood fr...

Страница 59: ...availability Note Additional programming features are available such as batch mode rerun off line dilution serum index manual ORDAC etc Detailed instructions for these options may be found in the UniCel DxC 600 800 Synchron Clinical Systems Instructions For Use Manual or the UniCel DxC Synchron Clinical Systems Reference Manual Independent Mode Operations The DxC 600i system is designed to allow t...

Страница 60: ...n identified above push the tube all the way down Place the bar code labeled sample container in the appropriate rack Ensure that the entire length of the bar code label is visible through the rack slot 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 Does sample have LIS program...

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Страница 63: ...able 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 module The system may disable modules automati...

Страница 64: ...elopment Department October 2010 Select Instr Cmd from the DxC 600i monitor Select 1 Home Select 1 DxC to home the DxC OR Select 2 CTA to home the CTA OR Select 3 Both to home both the DxC and CTA Home the DxC CTA The system will return to Standby in approximately 5 minutes ...

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Страница 66: ... location Recommended by a BCI specialist for troubleshooting purposes Avoid system errors by following these recommendations The CTA unit must be powered down whenever the DxC is powered down The CTA may be powered down up without rebooting the DxC analyzer if there are no racks on the CTA sample wheel or no aliquotted AVs at the AV queue Note The Access system is powered down separately at the A...

Страница 67: ...h the message Please wait for further instructions DO NOT TURN THE POWER OFF Select Shutdown when the Select Reboot or Shutdown dialogue box appears Turn OFF the power switch at the DxC instrument when the message Shutdown System may now be powered down appears Turn OFF the green power switch to the CTA located behind the CTA supply door Turn OFF the power switch to the DxC 600i computer located b...

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Страница 72: ...or additional tests from initiating at the Access instrument Any tests already in process are completed The Access cannot be paused during a maintenance routine The system may enter the Paused mode if a rack is loaded unloaded or a reagent is loaded unloaded Shutdown Use to reboot or safely shutdown the system Files are safely closed to prevent data corruption Failure to follow recommended procedu...

Страница 73: ...ize System F1 Select Yes F1 when the Initialize the System message appears Select OK F1 when the Completed Initialization box appears Set the CTA off line at the Access monitor Refer to Placing the CTA Unit Offline Online flowchart The Access will return to Ready CAUTION Do not initialize the system if a maintenance procedure is incomplete PHONE TECHNICAL SUPPORT Set the CTA online at the Access m...

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Страница 77: ... Set CTA Offline F8 Verify that the CTA button turns red and the CTA status goes to Local at the DxC 600i monitor 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 CTA CTA Placing the CTA Unit Offline Online ...

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Страница 79: ...instrument Repairs and assists in maintaining your instrument Your Field Service Engineer is ________________________ and Name can be reached at_______________________ Phone Instructions For Use The Instructions For Use Manual includes basic operating instructions and maintenance guidelines for the UniCel DxC 600i system Detailed operation maintenance and troubleshooting instructions are not inclu...

Страница 80: ... Access Clinical Systems CTA Primary Tube Sample Template Use to establish adequate sample volume Provided as a laminated sheet Access 2 Access 2 Immunoassay System Quick Reference Guide Contains basic operating and maintenance guidelines for the Access 2 analyzer Provided in a hard copy manual Access 2 Immunoassay System HELP Contains detailed operating instructions theory of operation troublesho...

Страница 81: ...Laboratory Information System LIS Includes Tables Codes to interpret instrument codes printed on patient reports Provided on a CD ROM Synchron Clinical Systems Performance Verification Manual Assists in making a smooth transition integrating your new system into your daily routine Includes guidelines for evaluating precision accuracy linearity and method comparison Provided in a hard copy manual a...

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Страница 83: ...hecklist UniCel DxC 600i Synchron Access Clinical Systemivities Purpose 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 ...

Страница 84: ...ther __________ Load supplies reagents on CTA Direct Observation Test Other __________ Load supplies reagents on DxC DxC 600i Instructions For Use IFU J Chapter 2 Pre Test Activities Direct Observation Test Other __________ Calibration Direct Observation Test Other __________ Determine calibration status for Access immunoassays Direct Observation Test Other __________ Determine calibration status ...

Страница 85: ...IFU J Chapter 4 Sample Programming and Processing Direct Observation Test Other __________ Locate completed test results DxC Instructions for Use IFU Chapter 7 Results RecallJ Recall Results by Sample ID Direct Observation Test Other __________ Quality Control Program and process QC at DxC 600i DxC 600i Instructions for Use IFU Chapter 3 System Calibration J System Calibration J Run Control Sample...

Страница 86: ...___ Perform weekly maintenance on DxC DxC Instructions for Use Chapter 9 Maintenance Direct Observation Test Other __________ Perform Twice monthly maintenance on CTA DxC 600i Instructions for Use IFU J Chapter 6 Maintenance J CTA Maintenance Direct Observation Test Other __________ Perform Monthly Maintenance on DxC DxC Instructions for Use Chapter 9 Maintenance Direct Observation Test Other ____...

Страница 87: ...r UseJChapter 3 System Setup Options Direct Observation Test Other __________ Quality Control Setup Definition at DxC 600i DxC Instructions for UseJChapter 5 Quality Control JDefine a Control Control ID Assignments Direct Observation Test Other __________ Quality Control Results Management at DxC 600i DxC Instructions for UseJChapter 5 Quality Control Direct Observation Test Other __________ Opera...

Страница 88: ... __________ Direct Observation Test Other __________ Direct Observation Test Other __________ Direct Observation Test Other __________ Direct Observation Test Other __________ Direct Observation Test Other __________ Direct Observation Test Other __________ Direct Observation Test Other __________ Direct Observation Test Other __________ Direct Observation Test Other __________ Direct Observation ...

Страница 89: ...n Coulter applications specialist Instrument Overview 1 The Closed Tube Aliquotter CTA functions as a sample processing manager by _________________ and routing samples to the Access or DxC analyzer based on programming requirements 2 The Access Main Pipettor _____________ mixes reagent mixes the reaction mixture and ______________ by ultrasonics 3 The DxC Modular Chemistry side of the analyzer is...

Страница 90: ...s or during independent mode operations 6 Label each circle on the picture below with the letter corresponding to it s description a Access Event Log b System Operating Condition c Reagent Calibration Function Selection Icon d Sample Status Icons 7 What tab would you select to view samples on the CTA sample wheel __________________________________ 8 Select the _____________ button on the _________...

Страница 91: ..._________________ ______________________ _____________________ 11 When communicating with the Access 2 you should always follow the following 4 communication steps 1___________ 2___________3___________4__________ 12 The only Access supply that requires the instrument component to be in Standby before replenishing is the ________________ Daily Start Up 13 Which reagents are stored in the Hydropneum...

Страница 92: ...tries ________________________________________________ 16 Access 2 calibrators are placed in the following container type _______________________________________________ 17 Access calibration is requested loaded at the ______________ monitor analyzer 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 ...

Страница 93: ...ssing 19 Place a check mark in the box to the right of the samples shown below that should be placed in a Reserved rack 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 _________________________________________________ ...

Страница 94: ...to your supervisor and or Beckman Coulter representative Instrument Commands 24 Draw a line between the Instrument Command you would use to perform the described function Instrument Command Function Home Use to reboot 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 LPIA Enable Module Use to recover from a motion erro...

Страница 95: ...amming requirements 2 The Access Main Pipettor level senses mixes reagent mixes the reaction mixture and cleans the probe by ultrasonics 3 The DxC Modular Chemistry side of the analyzer is composed of a glucose cup module and an ISE module where a flow cell houses electrodes for measurement of sodium potassium chloride CO2 and calcium 4 The DxC Cartridge Chemistry side of the analyzer delivers rea...

Страница 96: ...s or during independent mode operations 6 Label each circle on the picture below with the letter corresponding to it s description a Access Event Log b System Operating Condition c Reagent Calibration Function Selection Icon d Sample Status Icons 7 What tab would you select to view samples on the CTA sample wheel The CTA Sample Status Tab 3 8 Select the CTA button on the Access monitor to place th...

Страница 97: ...r when the supply is at 60 Access RVs Access RV Waste Access Substrate CTA Aliquot Vessels 11 When communicating with the Access 2 you should always follow the following 4 communication steps 1 Tell 2 Wait 3 Do 4 Done 12 The only Access supply that requires the instrument component to be in Standby before replenishing is the Substrate 13 Which reagents are stored in the Hydropneumatic compartment ...

Страница 98: ...libration load list for DxC chemistries Rgts Cal List F5 16 Access calibrators are placed in the following container type AVs Aliquot Vessels 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 ...

Страница 99: ...sing 19 Place a check mark in the box to the right of the samples shown below that should be placed in a Reserved rack 20 Tubes with caps must always be placed in a 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 ...

Страница 100: ...s to your supervisor and or Beckman Coulter representative Instrument Commands 24 Draw a line between the Instrument Command you would use to perform the described function Instrument Command Function Home Use to reboot 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 LPIA Enable Module Use to recover from a motion er...

Страница 101: ...raining Course on the operation of the UniCel DxC 600i Clinical System __________________________________________________________________________ ________________________________________ _________________ Beckman Coulter Representative Date ...

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