Roche CoaguChek XS System Training Manual
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Roche CoaguChek XS System Training Manual

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CoaguChek
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Professional
Training Manual
for Self-Testing
®
XS

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Summary of Contents for Roche CoaguChek XS System

  • Page 1 ® CoaguChek System Professional Training Manual for Self-Testing...

  • Page 2: Table Of Contents

    Table of Contents Introduction....................... 1 Overview of Warfarin Therapy and the CoaguChek XS System..... 3 Materials for User Training ..................5 User Selection Guidelines..................7 Overview............................7 Clinical Study..........................8 Performance Characteristics ....................9 Training Users for Self-Testing ................13 Preparation............................13 Supplies............................13 Training Outline...........................14 Testing the Trainees........................20 Certificate of Completion......................21...

  • Page 3: Introduction

    Introduction Introduction Roche Diagnostics is pleased to present this guide to assist you in training individuals in the use of the CoaguChek ® XS System. The guide contains a variety of materials to help you plan the curriculum: • an overview of the CoaguChek XS System •...

  • Page 4: Overview Of Warfarin Therapy And The Coaguchek Xs System

    The variability of laboratory results due to reagent differences is a common problem. The CoaguChek XS System minimizes the variability that is seen with traditional PT/INR assay reagents. Each lot of test strips is compared to a reference material by Roche Diagnostics.

  • Page 5: Materials For User Training

    A Getting Started reference guide is included in each CoaguChek XS System Getting Started Guide Care Kit. It provides an easy reference for testing.

  • Page 6: User Selection Guidelines

    User Selection Guidelines OVERVIEW It is important that users be screened carefully before beginning a self-testing program. The following questions are designed to guide the physician, clinic nurse, or other healthcare professional in determining an individual’s suitability for self-testing. Are specific diagnoses more No, the specific diagnosis is not necessarily indicative of who should or should appropriate for self-testing? not self-test.

  • Page 7: Performance Characteristics

    Number Percent PERFORMANCE CHARACTERISTICS Total number of users 100% Caregivers 4.4% Measuring Range: The CoaguChek XS System has a PT/INR measuring range of 0.8–8.0 INR and Males 9.6–96.0 seconds. Females Age range 32 – 89 100% Mean Age 64 years...
  • Page 8 5.36 This study shows that trained users are able to obtain results that are as precise as those obtained by healthcare professionals trained in the use of the CoaguChek XS System. During the study, the following error rates were observed: N = 463 PB: y = 1.000x + 0.0...

  • Page 9: Training Users For Self-Testing

    • 4 AAA batteries plus one for demonstration) • CoaguChek XS System User Manual • CoaguChek XS System Getting Started Guide • CoaguChek XS System Prothrombin Time Self-Testing Log Book • ACCU-CHEK ® Softclix lancet device and lancets • CoaguChek XS System Training DVD...

  • Page 10: Training Outline

    • Test strip guide • Battery compartment cover • Sufficient copies of the class outline, Knowledge Test, Skills Checklist, Log Book, Certificate of Completion, and key sections of the CoaguChek XS System • Code chip slot User Manual, especially the Error Messages section •...
  • Page 11 Review System Set-Up 1. The CoaguChek XS System uses four AAA alkaline batteries, inserted into the battery compartment on the back of the meter. Explain the importance of entering the correct date and time. (Each time you run a test, the meter 3.
  • Page 12 • Within 15 seconds of sticking the fingertip, apply the blood drop from Review Built-In The CoaguChek XS System has built-in quality control functions in the meter and the fingertip to the target area from the side. See the user manual for Quality Control test strips.

  • Page 13: Testing The Trainees

    Remind all trainees they are required to return for two follow-up visits where they 3. Allow the test strip guide to dry, with the cover off, for about 10 will demonstrate their knowledge of self-testing with the CoaguChek XS System. minutes.

  • Page 14: Proficiency Checks

    If this test indicates a problem with the meter or test strips, repeat the test. If the result is still in question, please contact the Roche Diagnostics Technical Service Center 1-800-428-4674, 24 hours a day, 7 days a week, 365 days a year.

  • Page 15: Forms

    Follow-up for People Who Are Self-Testing Forms OVERVIEW Introduction The following forms are included as part of the CoaguChek XS System training for self-testing. These forms should be used as originals. Please feel free to copy them as needed. • Skills Checklist •...
  • Page 16 COAGUCHEK XS SYSTEM SKILLS CHECKLIST COAGUCHEK XS SYSTEM SKILLS CHECKLIST Trainer should check each activity as it is demonstrated or described. Recalls Results from Memory J Correctly recalls results stored in memory Assembles Equipment J CoaguChek XS meter Problem Solving...
  • Page 17 COAGUCHEK XS SYSTEM KNOWLEDGE TEST COAGUCHEK XS SYSTEM KNOWLEDGE TEST Mark “T” if the statement is true and “F” if the statement is false. 12. What would cause Error 3 to appear on the display? ________________________________________________________________ ________________________________________________________________ _____ 1. When coding the CoaguChek XS Meter, you must use the code chip from the same test strip container that you are using.
  • Page 18 ® CoaguChek System ANSWER KEY For CoaguChek XS System Knowledge Test 1. T 2. T 3. T Certificate of Completion presented to 4. F – The sample must be applied to the test strip within 10 minutes of removing the strip from the container.
  • Page 19 Roche Diagnostics 9115 Hague Road Indianapolis, IN 46256 www.coaguchek.com...

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