Roche CoaguChek XS Plus, Training Manual

Page 1: ...CoaguChek Professional Monitoring Systems Training Manual...

Page 2: ...version 5 0 CoaguChek XS PT Test strip pack insert 580 2010 RPD B 322 Frau Frank Copyright 2015 Roche Diagnostics Limited All rights reserved COAGUCHEK and BECAUSE IT S MY LIFE are registered tradema...

Page 3: ...CONTACT AND ORDER DETAILS Page 7 SYSTEM INTRODUCTION Page 11 INTERFERENCES Page 19 TRAINING Page 25 CLEANING Page 39 TROUBLESHOOTING Page 47 APPENDIX 1 Page 51 APPENDIX 2 Page 67...

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Page 5: ...CONTACT AND ORDER DETAILS...

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Page 7: ...Roche Diagnostics Charles Avenue Burgess Hill West Sussex RH15 9RY England CoaguChek XS Professional Monitors Consumables Cat No s for CoaguChek Consumables CoaguChek XS Test Strips x 24 04625358019...

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Page 9: ...SYSTEM INTRODUCTION...

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Page 11: ...ity features of the meter such as enabling operator lockouts Data management systems may also enable data transfer to a LIS or HIS CoaguChek XS Professional Monitors System Introduction The CoaguChek...

Page 12: ...anel Supports data communication K Reset button Use this button to reset the meter in case of software or power up errors CoaguChek XS Plus Pictorial Guide CoaguChek XS Pro A Touchscreen Shows test re...

Page 13: ...ent panel Supports data communication L Reset button Use this button to reset the meter in case of software or power up errors Pictorial Guide CoaguChek Test Principle A Touchscreen Shows test results...

Page 14: ...d for the determination of thrombin activity When a sample is applied thromboplastin activates the coagulation cascade leading to the formation of thrombin The enzyme thrombin cleaves Electrocyme TH i...

Page 15: ...against a known WHO standard preparation Every manufacturer of Thromboplastin must calibrate it against the WHO standard and the deviation from this standard is measured The value obtained is known as...

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Page 17: ...INTERFERENCES...

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Page 19: ...false and high INR measurements depend on the type and amount of APA This varies between Lupus patients Some patients do not show an influence on their INR others have a prolonged INR and again other...

Page 20: ...yndrome antiphospholipid syndrome APS Their website provides information about the charity and all aspects of Hughes Syndrome for patients doctors and supporters They have a section on treatment and m...

Page 21: ...r an increase or a decrease in prothrombin time INR Additional medication should only be taken if prescribed by a health care professional If other medication is taken it is recommended that the proth...

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Page 23: ...TRAINING...

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Page 25: ...Meter setup Meter reading range limitations Quality Assurance Internal Quality Control onboard of liquid Failed Quality Control External Quality Assurance Preparing a Test Preparation of patient Heal...

Page 26: ...cation of blood to test strip Reading recording of result Safety Correct disposal methods of Test strips Lancing devices Gloves swabs etc Cleaning of meter lancing device Interpretation Interpretation...

Page 27: ...ompted insert code chip 5 The meter finds the code chip information and warms the strip then displays a 180 second countdown 6 Lance the patients finger 7 Apply the drop of blood to the test strip usi...

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Page 29: ...f prompted insert code chip 5 The meter finds the code chip information and warms the strip then displays a 180 second countdown 6 Lance the patients finger 7 Apply the drop of blood to the test strip...

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Page 31: ...e IQC is used to ensure consistency of INR results over a period of time EQA is used to identify the degree of agreement between INR results in different centres IQC for the CoaguChek Systems The Coag...

Page 32: ...below recommended frequency of use These are only suggestions for when to use controls and are therefore not mandatory When introducing a new lot of XS PT test strips Monthly or before a large clinic...

Page 33: ...swirl on desktop do not shake until all the powder has dissolved Solution now stable for 30 minutes 4 Touch Control Test 5 Insert test strip when prompted and test strip code chip if prompted 6 Check...

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Page 35: ...swirl on desktop do not shake until all the powder has dissolved Solution now stable for 30 minutes 4 Touch Control Test 5 Insert test strip when prompted and test strip code chip if prompted 6 Check...

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Page 37: ...CLEANING...

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Page 39: ...ated Squeeze off excess solution or blot on a dry paper towel to remove any excess solution before wiping the surface of the meter CoaguChek XS Professional Monitors Cleaning Guide This section is int...

Page 40: ...tions a mixture of 1 propanol 400 mg g 2 propanol 200 mg g and glutaraldehyde 1 0 mg g Sold in some countries under the name Bacillol Plus 10 sodium hypochlorite solution 1 part bleach to 9 parts de i...

Page 41: ...areas to dry for at least 10 minutes before performing a test If you notice streaks on the housing or touchscreen or the touchscreen surface becomes slightly cloudy wipe clean immediately with a soft...

Page 42: ...t strip guide and cover at the completion of cleaning and disinfecting Ensure that the test strip guide and cover are completely dry before assembling them 2 Hold the meter upright with the test strip...

Page 43: ...dual moisture is seen anywhere on the test strip guide and cover at the completion of cleaning and disinfecting Ensure that the test strip guide and cover are completely dry before assembling them 4 R...

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Page 45: ...TROUBLESHOOTING...

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Page 47: ...ayed by the system are accompanied by a description of the error and a possible solution Take the action suggested on screen to resolve the problem If the error disappears you may continue using the m...

Page 48: ...rking correctly Roche POC Technical Support tel 0808 100 1920 UK 1 800 409 564 Ireland Roche POC Technical Support email burgesshill tsgpm roche com Power the meter off and remove the test strip Repea...

Page 49: ...APPENDIX 1...

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Page 51: ...OF BIRMINGHAM November 2009 Protocol developed by Ellen Murray David Fitzmaurice Department of Primary Care General Practice University of Birmingham Acknowledgements We would like to thank the follo...

Page 52: ...and drug interactions To advise on anticoagulant therapy regimen prior to surgery or dental care BCSH guidelines To provide optimum care in accordance with the NPSA guidelines in terms of 1 INR contr...

Page 53: ...ns and targets are taken from British Society of Haematology guidelines Baglin T Keeling D Watson H Guidelines on oral anticoagulation warfarin third edition 2005 update BJ Haem 2005 132 277 285 Other...

Page 54: ...l governance authorities where appropriate Management of clinic Allocate protected time per week for clinic andt availability for emergency services other days Inform hospital primary care clinics cur...

Page 55: ...e therapeutic INR recall 2 4 weeks Two therapeutic INRs recall 6 weeks Three therapeutic INRs recall 8 weeks Four therapeutic INRs recall 10 weeks Five therapeutic INRs recall 12 weeks Identify key pe...

Page 56: ...g the device The target INR how it relates to diagnosis action if results outside limits Management of VKA therapy based on INR results and management of other anticoagulation therapy Recording of res...

Page 57: ...strips and controls user ID Counsel patient regarding clinic process and check for Bleeding or thrombotic events Tablet compliance and change of medication Lifestyle changes e g alcohol binges Perform...

Page 58: ...condition requiring anticoagulant If not referring clinician should be consulted Educate about anticoagulant treatment target range effects of over and under anticoagulation diet lifestyle and drug i...

Page 59: ...al or if surgery was required to stop bleeding and if bleeding led to reduction of Hb of 2 g dL or more and or requiring blood transfusion 1 Thrombotic Transient Ischaemic Attack with observed neurolo...

Page 60: ...appointment Produce and send patient satisfaction questionnaire Undertake referrals to other clinics as necessary Undertake stock control as necessary Arrange protocol and clinical meetings as necess...

Page 61: ...ondary prevention of venous trhromboembolism and for prophylaxis for knee and hip replacements For stroke prevention in atrial fibrillation patients who would be considered for warfarin should be cons...

Page 62: ...WH Apixaban is another factor Xa inhibitor also taken orally and is licensed for thromboprophylaxis for knee and hip surgery and also for non valvular atrial fibrillation Dose 2 5mg taken twice a day...

Page 63: ...nal Monitoring Systems Training Manual 63 13 Declaration This protocol has been developed on behalf of the PCT by Lead Doctor Signed Date Lead Pharmacist Lead Nurse Head of Primary Care Quality Contro...

Page 64: ...mber GP Referral Yes No If Yes provide name of GP practice Consultant Referral Yes No If Yes provide name of consultant hospital Clinical condition requiring anticoagulant Target and range Concurrent...

Page 65: ...APPENDIX 2...

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Page 67: ...Accuracy and precision in oral anticoagulation monitoring I know my value...

Page 68: ...ted with a specific index called the International Sensitivity Index ISI 4 The ISI value indicates the degree of compliance to World Health Organization WHO reference thromboplastin whereby an ISI of...

Page 69: ...raining Manual 69 The use of INR allows direct comparison of measured values because reagents are calibrated by a well defined procedure and designated with an ISI value that indicates the degree of c...

Page 70: ...contained in the thromboplastin e g natural mixture or synthetically produced 7 The reagent composition e g with without stabilisers and or glycine an aqueous or dry chemical substance 6 The sample e...

Page 71: ...to coagulation activation for example if repeated pricking occurs Wrong needle size If the needle diameter is too small this can lead to activation of coagulation especially in case of rapid withdraw...

Page 72: ...such as CoaguChek systems and laboratory systems are of the same order of magnitude as those observed between various laboratory systems10 Experience has shown that measure ment deviations are genera...

Page 73: ...greater the possible deviations may be 11 INR below 2 5 possible deviation 0 1 0 3 INR INR 2 5 4 5 possible deviation 0 5 1 0 INR INR above 4 5 possible deviation 1 0 2 0 INR In cases of differences b...

Page 74: ...to a refer ence thromboplastin were found within the combined ISO acceptance limits of 0 5 INR or 30 High precision For patient samples with an INR 4 5 the CV for INR imprecision ranged from 2 0 to 3...

Page 75: ...ensure outstanding quality Integrated Quality Control system A separate chemical pathway detects deterioration of the strip chemistry due to exposure to humidity heat or light 18 As a result no liquid...

Page 76: ...SE IT S MY LIFE are trademarks of Roche 2014 Roche Roche Diagnostics International Ltd CH 6343 Rotkreuz Switzerland www coaguchek com References 1 Van Geest Daalderop J H Pequeriaux N C van den Bessel...

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Page 78: ...chnical support please call freephone 0808 100 1920 In the Republic of Ireland please call freephone 0044 1 800 409 564 For further information on the CoaguChek please visit www coaguchek co uk COAGUC...