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Roche CoaguChek XS Pro Training Manual
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Roche CoaguChek XS Pro Training Manual

Professional monitoring systems
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Summary of Contents for Roche CoaguChek XS Pro

  • Page 1 CoaguChek ® Professional Monitoring Systems Training Manual...
  • Page 2 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 trademarks of Roche. Roche Diagnostics Ltd. Charles Avenue, Burgess Hill, RH15 9RY United Kingdom www.coaguchek.co.uk...
  • 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...
  • Page 7 Roche Diagnostics Contact Information UK Main Switchboard: 01444 256000 Ireland Main Switchboard: +44 (0) 1444 256000 Freephone UK Customer Services: 0808 100 9998 Freephone Ireland Customer Services: 1 800 509 586 UK Technical Support: 0808 100 1920 Ireland Technical Support: 1 800 409 564...
  • Page 11 The CoaguChek XS Plus and XS Pro meters have the ability to connect to a data management system (DMS) through the Handheld Base Unit from Roche. The meters support data exchange The CoaguChek XS Plus and XS Pro meters have the ability to connect to a data via POCT1A standard.
  • Page 12 Remove this cover to clean the test strip software or power-up errors Tab for battery compartment Infrared interface guide (if it has become soiled, e.g., with cover CoaguChek XS Pro blood). (Covered by the semi-transparent panel) Battery compartment cover Supports data communication. Covers the battery compartment (4...
  • Page 13 CoaguChek XS Pro Pictorial Guide Pictorial Guide Touchscreen Battery compartment cover Shows test results, information, icons and Covers the battery compartment (4 standard Touchscreen Battery compartment cover results recalled from memory. To select an AA alkali-manganese batteries or the Shows test results, information, icons and Covers the battery compartment (4 standard option, simply touch the button lightly.
  • Page 14 CoaguChek Test Principle Instead of detecting the clot by mechanical or optical methods, the activity Instead of detecting the clot by mechanical or optical methods, the activity of thrombin, a final stage of the clotting cascade, is Instead of detecting the clot by mechanical or optical methods, the of thrombin, a final stage of the clotting cascade, is monitored using monitored using an electrochemical detection.
  • Page 15 CoaguChek Measurement terms Prothrombin time (PT) and International Normalised Ratio (INR) are parameters used to measure the activity of oral anticoagulation therapy on the clotting ability of patient blood. Below is a short explanation of the terms most frequently used in the training session. Prothrombin Time (PT) Thromboplastin is added to blood to activate coagulation;...
  • Page 19 CoaguChek Limitations - Interferences Important Note – The test interferences below are subject to change therefore always refer to the test strip pack insert for full details and up to date information The blood drop must be a minimum of 8ml in volume. Low sample volume will cause an error message.
  • Page 20 The Hughes Syndrome Foundation are a registered UK charity aiming to provide information about Hughes Syndrome (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 monitoring of INR by patients themselves with self-testing INR machines, and we would recommend contacting them for any advice on this subject.
  • Page 21 Warfarin Interferences Important Note – The interferences below are limited, and subject to change. For a complete list of interferences refer to appropriate documentation for example the British National Formulary The action of oral anticoagulants (coumarin derivatives) can be increased or weakened when other medication is taken simultaneously (e.g.
  • Page 25 CoaguChek XS Professional Monitors Training Guide Name: Location: Date: Preparation of Equipment Storage & working temperature of meter/test strips Batteries/Mains/Charger (optional) Calibration 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 &...
  • Page 26 Sampling Correct site & method for sampling Obtaining correct amount of blood Application 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 of INR result Test Interferences...
  • Page 27 CoaguChek XS Plus Patient Testing 1) Touch 2) If prompted enter the 3) Remove test strip ‘Patient Test’ Patient ID via touch from pot and insert into screen then touch meter when prompted 4) If prompted 5) The meter finds the code 6) Lance the insert chip information and warms...
  • Page 29 CoaguChek XS Pro Patient Testing 1) Touch 2) If prompted scan the 3) Remove test strip ‘Patient Test’ Patient ID or enter via touch from pot and insert into screen then touch meter when prompted 4) If prompted 5) The meter finds the code...
  • Page 31 CoaguChek IQC and EQA Guidelines This section provides detail on the quality control systems available as an integral part of the CoaguChek systems, and quality assurance processed that are available from third party providers. It is intended as a guide to help with the management of a quality control process, and assist with meeting regulatory compliance requirements as applicable to the end user.
  • Page 32 CoaguChek XS PT Controls are used for system checks and quality control testing of prothrombin time with the CoaguChek XS Plus or CoaguChek XS Pro systems and CoaguChek XS PT Test strips. The CoaguChek XS PT Controls are intended for use by professional users.
  • Page 33 CoaguChek XS Plus Quality Control Testing 1) Remove plastic cap 2) Ensure no liquid is in 3) Replace the black cap and rubber bung the end of pipette and and swirl on desktop carefully cut end off and (do not shake), until empty all contents into all the powder has glass vial, ensuring not to...
  • Page 35 CoaguChek XS Pro Quality Control Testing 1) Remove plastic cap 2) Ensure no liquid is in 3) Replace the black cap and rubber bung the end of pipette and and swirl on desktop carefully cut end off and (do not shake), until...
  • Page 39 CoaguChek XS Professional Monitors Cleaning Guide This section is intended to be an aid to cleaning the CoaguChek XS Professional Monitors. Cleaning information from the User Manual and/or test strip pack inserts should always be followed in the first instance. •...
  • Page 40 Recommended cleaning/disinfecting solutions Use only the following solutions for cleaning/disinfecting the meter (housing and test strip guide). • 70% ethanol or isopropyl alcohol – (an internet search for these type of wipes for use on medical equipment should bring up several options) •...
  • Page 41 Cleaning/disinfecting the exterior (meter housing) Use the solutions recommended above for cleaning/disinfecting the meter exterior. Apply the solutions for a contact time of > 1 minute (refer to the corresponding product labelling). Ensure that the blue test strip guide cover remains tightly closed while cleaning the meter housing. 1.
  • Page 42 Cleaning/disinfecting the test strip guide Apply the solutions for a contact time of > 1 minute (refer to the corresponding product labelling). Using lint-free cotton swabs/buds. 1. Remove the test strip guide cover to clean it. (Use your thumbnail to open the cover of the test strip guide by pressing its front edge upward.) Move the cover safely away from the meter.
  • Page 43 On completion of cleaning: 3. With the cover off, let the test strip guide dry for at least 10 minutes before re-attaching the test strip guide cover and testing again. • Visually verify that no residual moisture is seen anywhere on the test strip guide and cover at the completion of cleaning and disinfecting.

  • Page 47: Troubleshooting

    Take the action suggested on screen to resolve the problem. If the error disappears, you may continue using the meter as desired. If the problem persists, contact Roche Technical Support. Take the action suggested on screen to resolve the problem. If the error disappears, you may continue using the meter as desired.
  • Page 48 Always consult the CoaguChek XS Plus or Pro user manual, and contact Roche Technical Always consult the CoaguChek XS Plus or Pro user manual, and contact Roche Technical Support if Support if you are unsure of how to correct an error, or if you are unsure if your CoaguChek is you are unsure of how to correct an error, or if you are unsure if your CoaguChek is working correctly.
  • Page 51 An example Protocol for an Oral Anticoagulation Clinic © UNIVERSITY 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 following who undertook peer review of this protocol. Dr Patrick Kesteven, Fiona Dobson, Dr Will Lester Updated 25/5/2014 Ellen Murray CoaguChek Professional Monitoring Systems...
  • Page 52 The service will offer equitable, standardised and clinically effective anticoagulation management for patients receiving anticoagulation therapy. Objectives • To receive, manage and ensure appropriate referral of patients who require anticoagulation therapy either registered or non registered in the practice (To include novel oral anticoagualtion thersapy where appropriate) •...
  • Page 53 Capacity All patients receiving anticoagulation therapy referred to the clinic Exceptions (primary care) • Patients under 16 years of age • Patients with complex pathologies following discussion with specialist e.g. atypical systemic emboli, anything not listed under routine indications for anticoagulation. •...
  • Page 54 Risk management Assess risk to both patient and health care professional Implement risk reduction strategies incorporated into the clinic management,e.g. 1. Patients lost to follow up 2. Inadequate or lost referrals 3. Inadequate documentation 4. Inadequate updated staff training 5. Point of care failure 6.
  • Page 55 Suggestions for manual recall periods in case of CDSS breakdown One high INR greater than or equal to 5 – recall 7-14 days One high INR greater than or equal to 6 – recall within 5 days One low INR 1 unit below target– recall 7-14 days One therapeutic INR - recall 2-4 weeks Two therapeutic INRs –...
  • Page 56 Training The clinic will be managed by trained staff - designated users. Personnel responsible for the clinic must be aware of professional accountability and undertake the clinic management only if they feel competent to do so. Accredited courses are available. Personnel managing the clinic will also be aware of continued professional development and attend regular updates on anticoagulation management.
  • Page 57 All patients will remain the responsibility of the referring centre until the patient is seen in the clinic. For patients moving to a new practice, hospital clinics will be informed if patients need to be referred back to the hospital clinic. The same referral form will be used attached to a referral letter with a copy to the patient and new GP if known.
  • Page 58 Haemorrhagic risk assessment (Beyth) Score 1 each that apply Age >65 History of stroke History of gastrointestinal bleed One or more of: • Recent MI • Diabetes Score 0 – low bleeding risk 2-3% in the first year Score 1-2 Intermediate risk of bleeding in the first year Score 3 -4 High risk of bleeding in the first year New patients •...
  • Page 59 BSH guidelines for INR greater than 5.0 3.0 < & < 6.0 (target 2.5) Reduce or stop Warfarin, restart when INR < 5.0 4.0 < & < 6.0 (target 3.5) Reduce or stop Warfarin, restart when INR < 5.0 6.0 <& < 8.0 - No bleeding or minor bleed Stop Warfarin, restart when INR <...
  • Page 60 Pre-operative management of Warfarin If major surgery - stop Warfarin 4 days before surgery, heparin introduced pre-op in hospital If minor surgery - reduce INR to approximately 2.0 on day of surgery (Liaise with hospital to discuss Warfarin dosage on discharge) Guidelines for discontinuing Warfarin To discontinue Warfarin at treatment completion, obtain written confirmation from clinician that commenced Warfarin therapy.
  • Page 61 Clinic procedure for novel anticoagulants There are currently NICE technology appraisals available for stroke prevention in atrial fibrillation for dabigatran, rivaroxaban, and apixaban Technology appraisals suggest that they should be made available for patients who require them but that the decision on choice of agent should be undertaken only following an informed discussion with the individual patient.
  • Page 62 For stroke prevention in atrial fibrillation, patients who would be considered for warfarin should be considered for rivaroxaban Dose 10 mg once daily dose – fixed Starting Rivaroxaban Initial dose should be taken 6 – 10 hours after surgery and for major hip surgery 5 weeks treatment recommended.
  • Page 63 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 Control Consultation with: CoaguChek Professional Monitoring Systems Training Manual...
  • Page 64 Appendix one Anticoagulation Clinic Referral Form Patient Name: Date of Birth: Address: Telephone number: GP Referral Consultant Referral Yes ! No ! Yes ! No ! If Yes, provide name of GP practice If Yes, provide name of consultant hospital Clinical condition requiring anticoagulant: Target and range: Concurrent medical conditions:...
  • Page 67 “I know my value” Accuracy and precision in oral anticoagulation monitoring...
  • Page 68 Fig. 1: INR values obtained using different measurement methods (CoaguChek XS and different laboratory thromboplastins) within a defined INR range of 2.0 – 3.0. Source: Roche Diagnostics GmbH, CoaguChek XS Evaluation Study Theoretically, coagulation values can be reported as either % Quick, seconds or INR units.
  • Page 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 compliance to WHO reference thromboplastin CoaguChek Professional Monitoring Systems Training Manual...
  • Page 70 Even two WHO reference thromboplastins show a certain degree of deviation, which is larger for higher INR values (Figure 2). rTF/95 (tilt tube) [INR] Fig. 2: Comparison of two reference thromboplastins (rTF/95 and CRM 149S). Source: Roche Diagnostics GmbH, CoaguChek XS Evaluation Study; n = 273...
  • Page 71 II) Errors in pre­analytics Pre-analytics includes all steps that are performed prior to measurement using a point-of- care (POC) system (e.g. CoaguChek) or in the laboratory. Several sources of error can affect measurement results at these steps. Experience has shown that when measuring with the CoaguChek system, attention must be paid to the following: ·...
  • Page 72 In general, INR differences between POC devices such as CoaguChek® systems and laboratory systems are of the same order of magnitude as those observed between various laboratory systems Experience has shown that measure- ment deviations are generally observed between different coagulation measure- ment systems, independently of whether POC or laboratory CoaguChek Professional Monitoring Systems...
  • Page 73 INR differences between CoaguChek and the laboratory are normal INR differences between CoaguChek INR differences between CoaguChek Between-laboratory measurement differences and the laboratory are normal and the laboratory are normal are of similar magnitude Between-laboratory measurement differences Between-laboratory measurement differences are of similar magnitude are of similar magnitude In general, INR differences between POC devices such as CoaguChek systems and labora-...
  • Page 74 The CoaguChek XS system ® Providing patients and their physicians with quality, reliable results Excellent performance: high correlation, high accuracy and high precision The performance of the CoaguChek XS system has been verified in a study conducted at four study centres, using venous and capillary blood samples on two CoaguChek XS PT Test Strip lots.
  • Page 75 INR of 2.0, and 0.07 INR for samples in the therapeutic range of oral anticoagulation therapy (INR 2.0 – 4.5). The equivalence of the CoaguChek XS Pro and CoaguChek XS Plus systems has also been demon- strated over the whole hematocrit range, meeting the acceptance criteria for all blood samples.
  • Page 76 J Thromb Haemost 4, 820-827. 10 Kitchen, D.P., Kitchen, S., Jennings, I., Woods, T.A., Fitzmaurice, D.A. et al. (2012). Point of Care INR testing devices: performance of the Roche 8 Amukele, T.K., Ferrell, C., & Chandler, W.L. (2010). Comparison of plasma with whole blood prothrombin time and fibrinogen on the same 8 Amukele, T.K., Ferrell, C., &...

  • Page 78: Technical Support

    0044 1 800 409 564 For further information on the CoaguChek please visit: www.coaguchek.co.uk COAGUCHEK and ‘BECAUSE IT’S MY LIFE’ are registered trademarks of the Roche Group. Roche Diagnostics Ltd, Charles Avenue, Burgess Hill, RH15 9RY Company registration number: 571546...

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Coaguchek xs plus