RADIOMETER FLEX ABL90 Operator Training Manual

RADIOMETER FLEX ABL90 Operator Training Manual

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ABL90 FLEX analyzer
Operator Training Guide
EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019
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Summary of Contents for RADIOMETER FLEX ABL90

  • Page 1 ABL90 FLEX analyzer Operator Training Guide EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019 1 of 36...
  • Page 2 Operator training Even a simple process or task can become erroneous and complicated without proper and relevant training. To ensure satisfaction and efficient use of this Radiometer product we offer a range of training materials. ABL90 FLEX analyzer Operator Training Guide The operator training guide is a supporting tool for the person training the operators of the device.
  • Page 3: Table Of Contents

    Index What is what Syringe samples – preanalytical errors Syringe samples – how to measure a patient sample Capillary samples – preanalytical errors 10-11 Capillary samples – how to measure a patient sample 12-14 Consumables Changing consumables 16-18 Troubleshooting General information Key Operator Training Replacements 22-23...
  • Page 4 What is what Identify the main parts of the analyzer Printer and handle Touch screen Integrated barcode reader Automatic sample mixing for safePICO syringes (mixing takes 7 seconds) Self-cleaning inlet aspirates the sample in 5 seconds Sensor cassette compartment behind the door Solution pack with waste pouch, reagents and QC.
  • Page 5: Syringe Samples – Preanalytical Errors

    • Avoid litigation and lost billing opportunities 3. Appropriate preheparinized sampler with dry electrolyte-balanced heparin • Heparin is the only anticoagulant recommended by Radiometer • Slows the clotting process • If applicable, explain about the different types of heparin: Dry/liquid/balanced/non-balanced •...
  • Page 6: Syringe Samples – Preanalytical Errors

    Syringe samples – preanalytical errors, continued Sample collection and handling 4. Correct volume of blood • Too much blood = increased risk of clotting • Too little blood = possible heparin binding effect (may cause lower Ca value) • Flush solutions used in A-lines must be removed from the sample site to avoid dilution of blood samples •...
  • Page 7: Syringe Samples – How To Measure A Patient Sample

    Syringe samples – how to measure a patient sample Training method First, demonstrate how a sample is measured in real-time speed before doing a slow step-by-step demonstration. Let the trainee try the process – both with and without trainer guidance. Emphasize how the analyzer provides feedback (sound and light indications) and provides on-screen guidance throughout the process.
  • Page 8 Syringe samples – how to measure a patient sample, continued 3. Introducing the sample Present the following steps on how to introduce the sample. Then the trainee: 1. Should repeat the steps as a practical exercise. 2. Should be informed that the analyzer will guide with on-screen video, sound and instructions during the process.
  • Page 9: Syringe Samples – How To Measure A Patient Sample

    Syringe samples – how to measure a patient sample, continued 4. Appropriate patient information If applicable, explain how to recognize a mandatory field by the pointing hand. A mandatory field needs an entry before the results can be shown. Results will be recorded but will not be visible or retrievable without advanced user access.
  • Page 10 ( safe CLINITUBES, plastic) or 100 µ L capillary tubes (CLINITUBES, glass) • Heparin is the only anticoagulant recommended by Radiometer • Slows the clotting process • If applicable, explain about the different types of heparin: Dry/balanced/non-balanced. Dry electrolyte-balanced heparin...
  • Page 11 Capillary tube samples – preanalytical errors, continued Sample collection and handling 5. Sample should be free of air bubbles • Air bubbles can affect O and CO values • Ensure the end caps match the type of capillary tube • Cap both ends of the sample to avoid contact with room air 6.
  • Page 12: Capillary Samples – How To Measure A Patient Sample

    Capillary samples – how to measure a patient sample Training method First, demonstrate how a capillary sample is measured in real-time speed before doing a slow step-by- step demonstration. Let the trainee try the process – both with and without trainer guidance. Emphasize how the analyzer provides feedback (sound and light indications) and provides on-screen guidance throughout the process.
  • Page 13 Capillary samples – how to measure a patient sample, continued 4. Introducing the sample Present the following steps on how to introduce the sample. Then the trainee should repeat the steps as a practical exercise. Inform the trainee that the analyzer will guide with on-screen video, sound and instructions during the process.
  • Page 14: Capillary Samples – How To Measure A Patient Sample

    Capillary samples – how to measure a patient sample, continued 5. Appropriate patient information If applicable, explain how to recognize a mandatory field by the pointing hand. A mandatory field needs an entry before the results can be shown. Results will be recorded but will not be visible or retrievable without advanced user access.
  • Page 15: Consumables

    Component consumables Training method To enhance the trainee's understanding of how to change consumables, point out and explain the following details on the consumables. Smart chip containing various information, no further scanning of product barcodes necessary Contains pouches with QC and calibration material, a gas mixture and closed containers to hold liquid waste Security pin for activation of the solution pack Reference sensor.
  • Page 16: Changing Consumables

    Changing consumables, continued Training method Demonstrate with participation of the trainee how to replace a consumable in a slow step-by-step guidance. Emphasize how the analyzer provides feedback (sound and light indications) and provides on-screen guidance throughout the process. Changing the thermal printer paper •...
  • Page 17 Changing consumables, continued Changing consumables – solution pack • Show how to enter Analyzer Status on the analyzer screen and find > Consumables > Replace > Replace Solutions. • Lift the inlet handle to the capillary position and wait until the solution pack is released •...
  • Page 18: Changing Consumables

    Changing consumables continued Changing consumables – sensor cassette Note: The analyzer has to condition a new sensor cassette after it is installed. This process can take up to 4 hours. • Show on the analyzer screen how to enter Analyzer Status and find >...
  • Page 19: Troubleshooting

    Troubleshooting Explain how the trainee can see when the analyzer is ready for use: The analyzer is ready for use when all three conditions are present. 1. The analyzer is in Ready mode. 2. The color of the tab of the parameters you want to get a result for is green or yellow. 3.
  • Page 20: General Information

    General information Training method Take the trainee through the following general information, demonstrating the processes when it seems necessary. Cleaning the analyzer • Remember to clean the inlet and the integrated mixing device according to local guidelines Compliance Infection control •...
  • Page 21: Key Operator Training

    • Blood Gas – Preanalytics Handbooks can be downloaded from our handbooks at www.MyRadiometer.com, from the customer portal or via www.Radiometer.com as mobile applications for smart phones and tablets. Training method To enhance the trainee's understanding and outcome of the more in-depth information, also use the latest version of the "ABL90 FLEX Instructions for use".
  • Page 22: Replacements

    Replacements Storage of consumables Sensor cassette – storage temperature 2-8 °C/35-46 °F Solution pack – storage temperature 2-25 °C/35-77 °F Always ensure stock rotation. Replacements Replacement intervals for consumables and inlet connector gasket The recommended replacement intervals shown in the table below are only meant as a guideline.
  • Page 23: Replacements

    Replacements, continued Can a sensor cassette be used again? A sensor cassette removed from one analyzer can be used on the same or on another ABL90 FLEX analyzer if the following six conditions are met: • The sensor cassette is kept right side up after its removal. This prevents damage to the sensors.
  • Page 24: Clean The Analyzer

    Note: Radiometer has not tested whether cleaning wet wipes can be used for this. Prerequisite: A lint-free cloth. Further instructions can be found in the latest version of "ABL90 FLEX Instructions for use"...
  • Page 25: Troubleshooting And Guide

    3 and 4 again. 6. If none of the actions cause the analyzer to go out of Intervention Required mode, contact your local Radiometer service representative. Please refer to the troubleshooting chapter "Possible causes", in the latest version of the "ABL90 FLEX Instructions for use".
  • Page 26: Quality Control And Calibrations

    Quality control and calibrations Overview of quality control management Quality control management is important as it evaluates the performance of the analyzer to make sure that the patient results are accurate and precise. The analyzer manages quality control automatically, but if local, federal or state regulations require additional quality control procedures, operators can do them.
  • Page 27 Quality control and calibrations, continued Here is an overview of the default schedule for system checks, QC and calibration measurements that the analyzer does to make sure that patient results are accurate, precise and reliable. Start of the system-check cycle System checks: Automatic test sequences done with each measurement and at other times to make sure that all parts of the analyzer operate within specifications.
  • Page 28: Quality Control And Calibrations

    Quality control and calibrations, continued Calibration results • A calibration result is a combination of numerous smaller calibration activities • Calibration results from the most recent activity are marked in bold • Calibration results originating from a previous activity are marked in light gray color •...
  • Page 29: Theoretical Aspects Of The Blood Gas Analyzer

    Theoretical aspects of the blood gas analyzer General measuring principles Introduction There are four different measuring principles employed in the sensors in the ABL90 FLEX analyzer. • Potentiometry: The potential of a sensor chain is recorded using a voltmeter, and related to the concentration of the sample (the Nernst equation).
  • Page 30: Theoretical Aspects Of The Blood Gas Analyzer

    Theoretical aspects of the blood gas analyzer Overview General construction Sensors The term sensor refers to an individual sensor as part of the sensing array within a sensor cassette. The electrical signal from each sensor is measured by proprietary analog electronics contained within the analyzer unit.
  • Page 31: Parameters

    Reportable range is the range of results from a testing system or method over which the analytical performance is claimed. The default reportable ranges stated in the ranges over which Radiometer has validated the analytical performance and obtained clearance with the US FDA.
  • Page 32: Limitations Of The Measuring System

    Limitations of the measuring system Limitations of the measuring system Please use the latest version of the "ABL90 FLEX Instructions for use" ("Specification" chapter). EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019 32 of 36...
  • Page 33: Analyzer Setup

    Analyzer setup Managing operators • Analyzers set up for anonymous use: Operators do not have to log on • The access profile selected for anonymous use specifies the short cut buttons and menus available for anonymous operators For further instructions on how to manage operators, please refer to the latest version of “ABL90 FLEX Instructions for use”...
  • Page 34 Notes EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019 34 of 36...
  • Page 35 Notes EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019 35 of 36...
  • Page 36 © Radiometer Medical ApS, 2700 Brønshøj, Denmark, 2014. All Rights Reserved. 939-725. 201406A. EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019 36 of 36...

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