Tài liệu hướng dẫn vận hành access 2 This document is not intended to replace the information in your instruments Instructions for Use, Quick Reference Guide or Help System Documentation. Information in any of the above documentation supersedes information in any other manual.
Access Immunoassay System In-Lab Training Manual _ Access In-Lab Training Manual Version 1.0 (November 2017) Page of 119 Beckman Coulter Technical Product Training Access In-Lab Training Manual Version 1.0 (November 2017) Page of 119 Beckman Coulter Technical Product Training Access Immunoassay System WARNINGS AND PRECAUTIONS Read all product manuals and consult with Beckman Coulter-trained personnel before attempting to operate the instrument Beckman Coulter, Inc urges its customers and employees to comply with all national health and safety standards such as the use of barrier protection This may include, but is not 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 instruments Instructions for Use, Quick Reference Guide or Help System Documentation Information in any of the above documentation supersedes information in any other manual REVISION STATUS Version 1.0 (October 2017) Based on: Access Immunoassay System Software version 3.5.0 Access Immunoassay System Instructions for Use C02062AA Access Immunoassay System Operators Guide C02060AB Access Immunoassay System Reference Manual C02061AA TRADEMARKS Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc in the United States and other countries All other trademarks are the property of their respective owners Access In-Lab Training Manual Version 1.0 (November 2017) Page of 119 Beckman Coulter Technical Product Training Access In-Lab Training Manual Version 1.0 (November 2017) Page of 119 Beckman Coulter Technical Product Training Access Immunoassay System In-Lab Training Manual Table of Contents Chapter Analyzer Overview 9 System Hardware 10 Access Systems with Enhanced Features 12 Communicating with the Access 13 Sample Processing Sequence 14 Assay Technology 15 Chapter Software Overview 19 Common Screen Elements 20 Main Menu Function Buttons 24 Software Navigation 25 Keyboard Function Keys 26 Filters 27 Printing 27 Using the Help System 27 Chapter Daily Start Up 29 Check System Status 30 Check Zone Temperatures 30 Check System Supplies: Wash Buffer 30 Check System Supplies: Empty the Liquid Waste 31 Substrate Handling Conditions 33 Check System Supplies: Prime Substrate 33 Check System Supplies: Load Reaction Vessels 35 Check System Supplies: Change the RV Waste Bag 37 Reagent Pack Handling Conditions 38 Reagent Inventory 38 Check System Supplies: Load Reagent Packs 39 Check System Supplies: Unload Reagent Packs 42 Confirm System Backup 42 Setup an Automatic Backup 43 Inspect the Fluidics Module 44 Access In-Lab Training Manual Version 1.0 (November 2017) Page of 119 Beckman Coulter Technical Product Training Clean the Wash Carousel Probe Exteriors 45 Daily Clean System Routine 46 Special Clean Routine 47 Calibration Test Requests 48 Quality Control Test Requests 49 Chapter Sample Management 51 Sample Racks and Containers 52 Calculating Sufficient Sample Volume 52 Processing LIS Test Requests 55 Processing Manual Test Requests 56 Additional Sample Programming Features 57 Rerunning a Test 58 Manually Add on Test(s) 58 Chapter Data Management 59 Calibrator Setup 60 Reviewing Calibration Data 61 Setting up Quality Controls 63 Reviewing Quality Control Data 65 Reviewing Patient Data 67 Test Result Reports 69 Applying a Test Results Filter 71 Chapter Weekly Maintenance 73 Clean the Instrument Exterior 74 Inspect the Liquid Waste Bottle for Wear 74 Check for Fluid in the Waste Filter Bottle 75 Insect and Clean the Primary Probe 76 Replace Aspirate Probes 77 Clean the Aspirate Probes 79 System Verification following Weekly Maintenance 82 Run the System Check Routine 83 Reviewing and Printing System Check Data 84 Chapter Troubleshooting 85 Enabling the Utility Assay 86 Run the Utility Assay 86 Resolving Sample Errors 87 Access In-Lab Training Manual Version 1.0 (November 2017) Page of 119 Beckman Coulter Technical Product Training Troubleshooting Events 88 Troubleshooting System Check Failures 89 Troubleshooting Calibration Failures 91 Troubleshooting Quality Control Failures 92 Test Result Flags 93 Chapter Resources 95 Beckman Coulter Support Personnel 95 References 96 Chapter 10 In-Lab Training Competency Exercise 99 In-Lab Training Competency Exercise Reference Key 111 Access In-Lab Training Manual Version 1.0 (November 2017) Page of 119 Beckman Coulter Technical Product Training Access In-Lab Training Manual Version 1.0 (November 2017) Page of 119 Beckman Coulter Technical Product Training Chapter Analyzer Overview Introduction The Access is an automated immunoassay system that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material, and other accessories The system is for in vitro diagnostic use only The Access performs automated analysis of serum, plasma, urine, and amniotic fluid This chapter will cover the following: System hardware components Sample processing overview Assay technology and process overview Understanding the function of hardware components in the processing of samples on the system can assist in efficient operation, as well as with performing maintenance and troubleshooting Practice Use the information presented in the following pages to identify the hardware components on the system Review the sample processing sequence overview Identify the assay technology and the processing steps NOTE: Additional learning materials can be found on the Beckman Coulter website www.beckmancoulter.com Access In-Lab Training Manual Version 1.0 (November 2017) Page of 119 Beckman Coulter Technical Product Training System Hardware Location Description Carousel Module Main Pipettor Analytical Module Fluidics Module Access In-Lab Training Manual Version 1.0 (November 2017) Page 10 of 119 Beckman Coulter Technical Product Training 13 TRUE or FALSE? RVs, RV Waste Bag, Substrate and Reagent are supplies that must be loaded through the software to update and track the onboard levels correctly 14 TRUE or FALSE? Daily or Special Clean routines must be run in a 400 series rack in 2.0 mL cups 15 A newly loaded bottle of substrate has tests available and expires after days onboard the system a 500 / 20 b 600 / 14 16 TRUE or FALSE? One Texwipe swab can be used to clean all of the probes on the wash arm 17 If you run the assay you should process a Special Clean routine at the end of the day or if the system will not process samples for hours or more a Vitamin D b Vitamin B12 18 TRUE or FALSE? The Reagent Inventory gives detailed pack information regarding pack status such as pack expiration and calibration expiration 19 How many tests are available in a new (un-punctured) pack? _ a 50 b 25 c 75 20 TRUE or FALSE? If crystalline deposits are found when inspecting the fluidics module you should contact Technical Support for assistance 21 Perform a Daily Start Up on your Access analyzer Access In-Lab Training Manual Version 1.0 (November 2017) Page 105 of 119 Beckman Coulter Technical Product Training Sample Processing and Programming 22 Match the sample container size with the correct rack series that should be used to process samples: Sample Container Size Matching Letter Rack Series Bar Code Numbers 0.5 mL cup A 1500 to 1599 16 x 100 mm tube B 400 to 499 mL insert in a 13 x 75 mm tube C 1300 to 1399 13 x 100 mm tube D 2500 to 2599 2.0 mL cup E 700 to 799 13 x 75 mm tube F 1400 to 1499 23 TRUE or FALSE? If you have samples that have bar codes and host programming in your laboratory information system, the tests will automatically be ordered when the sample bar code is read 24 Use the sample pick up volumes given for each assay to calculate the minimum sample volume required to process one level of quality control for CK-MB (55 uL), HCG5 (25 uL) and Ferritin (10 uL) using a 0.5 mL cup 25 When you select Done F1 after loading a rack you must also select _ to start sample processing a Stop b Pause c Run Access In-Lab Training Manual Version 1.0 (November 2017) Page 106 of 119 Beckman Coulter Technical Product Training Weekly Maintenance 26 Place a W in each box for all of the weekly maintenance tasks in the table below: Weekly Maintenance Tasks Clean Instrument Exterior Check Zone Temperatures Check System Supplies Inspect Liquid Waste Container Replace/Clean Aspirate Probes Check System Backup Inspect Fluidic Module Run System Check Clean Probe Exteriors Prime Substrate Check Waste Filter Bottle Run Daily Clean(Special Clean) Inspect/Clean Primary Probe Access In-Lab Training Manual Version 1.0 (November 2017) Page 107 of 119 Beckman Coulter Technical Product Training 27 TRUE or FALSE? The entire waste filter assembly must be replaced if liquid is present 28 The system power must be when replacing the aspirate probes a On b Off 29 List the three steps involved in cleaning the aspirate probes: 30 Following weekly maintenance you should run the routine to verify system performance a System Check b Carry Over 31 TRUE or FALSE? The utility assay should be enabled on your system for optimal system performance 32 Practice and review any additional tasks from the In-Lab Training Manual required of your role and responsibilities in your lab 33 You have completed the competency check Have your trainer compare the answers of your completed competency check with the Reference Key and review any questions you might have CONGRATULATIONS! Access In-Lab Training Manual Version 1.0 (November 2017) Page 108 of 119 Beckman Coulter Technical Product Training Congratulations _ has successfully completed the In-Lab Training Course on the operation of the Access Immunoassay System Beckman Coulter Representative Date Access In-Lab Training Manual Version 1.0 (November 2017) Page 109 of 119 Beckman Coulter Technical Product Training This page intentionally left blank Access In-Lab Training Manual Version 1.0 (November 2017) Page 110 of 119 Beckman Coulter Technical Product Training In-Lab Training Competency Exercise Reference Key Analyzer Overview Match each hardware component listed below with its component function: Hardware Component Carousel Module Main Pipettor Analytical Module Fluidics Module Access In-Lab Training Manual Version 1.0 (November 2017) Letter of matching Function Component Function C A Probe Washing, Wash Buffer and Liquid Waste Processing D B A B Reaction Vessel Loading, Incubation, Washing, Reading and Disposal C Process Sample Racks and Reagent Pack Storage D Sample / Reagent Pickup and Delivery to Reaction Vessels Page 111 of 119 Beckman Coulter Technical Product Training Use the following words: Wait / Run / Done / Tell / Do, to fill in the blanks on how to communicate with the Access 2: Tell the Access what you want to by selecting a function button or key Wait until the Access says it is ready, a pop-up window will indicate that the system is ready Do the task as directed Press Done to let the Access know you are finished If appropriate, press Run to initiate system action Circle T for true statements and F for false statements in the table below: T or F Statement T F The end product of the chemiluminescence reaction is heat T F Reagent Carousel is refrigerated for onboard reagent storage T F The primary probe uses ultrasonics for level sensing T F Sandwich assays have an indirectly proportional relationship between Relative Light Units and Concentration T F Substrate is the light generating reagent used on the Access T F Paramagnetic particles are coated with antibodies T F The luminometer is part of the fluidics module T F Access assays use the enzyme-mediated chemiluminescence methodology T F You can only use the mouse to navigate the system software Access In-Lab Training Manual Version 1.0 (November 2017) Page 112 of 119 Beckman Coulter Technical Product Training Software Overview Identify the name of each System Status Button and the potential colors it may turn to alert the user of a condition requiring attention: N = neutral, Y = yellow, R = red Button Name Circle the Button Colors WASH BUFFER R LIQUID WASTE R SUBSTRATE Y R REACTION VESSELS Y R RV WASTE BAG Y R QUALITY CONTROL EVENT LOG Access In-Lab Training Manual Version 1.0 (November 2017) R Y R WORK PENDING Y SUPPLIES REQUIRED Y HELP N Page 113 of 119 Beckman Coulter Technical Product Training Selecting the system command button will cancel all work in progress and put the system into the Not Ready mode d Run e Stop f Pause Which button you select to display specific information about the screen you are on or to navigate to lists of related topics? c Help d Event Log Selecting the system status button will display information about samples for which the system cannot schedule tests c Work Pending d Supplies Required The screen specific function buttons correspond to the keyboard keys d Number e Function f Letter Many screens have a button to expand or reduce the amount of information displayed c Print d Filter 10 The Help Link button can be selected to display a graphic illustration c Camera d Magnifying Glass Access In-Lab Training Manual Version 1.0 (November 2017) Page 114 of 119 Beckman Coulter Technical Product Training Daily Start Up 11 Place a D in each box for all of the daily maintenance tasks in the table below: Daily Maintenance Tasks Clean Instrument Exterior D Check Zone Temperatures D Check System Supplies D Empty Liquid Waste Container Replace/Clean Aspirate Probes D Check System Backup D Inspect Fluidic Module Run System Check D Clean Probe Exteriors D Prime Substrate Check Waste Filter Bottle D Run Daily Clean(Special Clean) Inspect/Clean Primary Probe 12 Where should you go to view the system temperatures? Circle the correct answer Supplies Diagnostics Maintenance Review Sample Manager Access In-Lab Training Manual Version 1.0 (November 2017) Page 115 of 119 Beckman Coulter Technical Product Training 13 TRUE or FALSE? RVs, RV Waste Bag, Substrate and Reagent are supplies that must be loaded through the software to update and track the onboard levels correctly 14 TRUE or FALSE? Daily or Special Clean routines must be run in a 400 series rack in 2.0 mL cups 15 A newly loaded bottle of substrate has 600 tests available and expires after 14 days onboard the system a 500 / 20 b 600 / 14 16 TRUE or FALSE? One Texwipe swab can be used to clean all of the probes on the wash arm 17 If you run the VITAMIN B 12 assay you should process a Special Clean routine at the end of the day or if the system will not process samples for hours or more a Vitamin D b Vitamin B12 18 TRUE or FALSE? The Reagent Inventory gives detailed pack information regarding pack status such as pack expiration and calibration expiration 19 How many tests are available in a new (un-punctured) pack? 50 a 50 b 25 c 75 20 TRUE or FALSE? If crystalline deposits are found when inspecting the fluidic module you should contact Technical Support for assistance 21 Perform a Daily Start Up on your Access analyzer Access In-Lab Training Manual Version 1.0 (November 2017) Page 116 of 119 Beckman Coulter Technical Product Training Sample Processing and Programming 22 Match the sample container size with the correct rack series that should be used to process samples: Sample Container Size Matching Letter Rack Series Bar Code Numbers 0.5 mL cup D A 1500 to 1599 16 x 100 mm tube A B 400 to 499 mL insert in a 13 x 75 mm tube E C 1300 to 1399 13 x 100 mm tube F D 2500 to 2599 2.0 mL cup B E 700 to 799 13 x 75 mm tube C F 1400 to 1499 23 TRUE or FALSE? If you have samples that have bar codes and host programming in your laboratory information system, the tests will automatically be ordered when the sample bar code is read 24 Use the sample pick up volumes given for each assay to calculate the minimum sample volume required to process one level of quality control for CK-MB, HCG5 and Ferritin assays using a 0.5 mL cup 170 uL 25 When you select Done F1 after loading a rack you must also select Run to start sample processing a Stop b Pause c Run Access In-Lab Training Manual Version 1.0 (November 2017) Page 117 of 119 Beckman Coulter Technical Product Training Weekly Maintenance 26 Place a W in each box for all of the weekly maintenance tasks in the table below: Weekly Maintenance Tasks W Clean Instrument Exterior Check Zone Temperatures Check System Supplies W Inspect Liquid Waste Container W Replace/Clean Aspirate Probes Check System Backup Inspect Fluidic Module W Run System Check Clean Probe Exteriors Prime Substrate Access In-Lab Training Manual Version 1.0 (November 2017) W Check Waste Filter Bottle W Run Daily Clean(Special Clean) W Inspect/Clean Primary Probe Page 118 of 119 Beckman Coulter Technical Product Training 27 TRUE or FALSE? The entire waste filter assembly must be replaced if liquid is present 28 The system power must be OFF when replacing the aspirate probes a On b Off 29 List the three steps involved in cleaning the aspirate probes: PRE-CLEANING CLEANING RINSING 30 Following weekly maintenance you should run the SYSTEM CHECK routine to verify system performance a System Check b Carry Over 31 TRUE or FALSE? The utility assay should be enabled on your system for optimal system performance 32 Practice and review any additional tasks from the In-Lab Training Manual required of your role and responsibilities in your lab 33 You have completed the competency check Have your trainer compare the answers of your completed competency check with the Reference Key and review any questions you might have Access In-Lab Training Manual Version 1.0 (November 2017) Page 119 of 119 Beckman Coulter Technical Product Training ... Technical Product Training Access In- Lab Training Manual Version 1.0 (November 20 17) Page of 119 Beckman Coulter Technical Product Training Access Immunoassay System In- Lab Training Manual Table of... concentration Access In- Lab Training Manual Version 1.0 (November 20 17) Page 17 of 119 Beckman Coulter Technical Product Training Access In- Lab Training Manual Version 1.0 (November 20 17) Page 18... 96 Chapter 10 In- Lab Training Competency Exercise 99 In- Lab Training Competency Exercise Reference Key 111 Access In- Lab Training Manual Version 1.0 (November 20 17) Page of 119