Roche CoaguChek XS System Installation guide

CoaguChek®X S
System
Professional
Training Manual
for Self-Testing

The contents of this manual, including all graphics and photographs, are the property of Roche Diagnostics.
No part of this document may be reproduced or transmitted in any form or by any means, electronic or
mechanical, for any purpose, without the express written permission of Roche Diagnostics.
Roche Diagnostics has made every reasonable effort to ensure that all the information contained in this manual
is correct at the time of printing. However, Roche Diagnostics reserves the right to make any changes necessary
without notice as part of ongoing product development.
This training manual was created by the Roche Diagnostics Engineering Operations department. Direct
questions or concerns regarding the contents of this document to:
Roche Diagnostics
Engineering Operations Department
9115 Hague Road
P.O. Box 50457
Indianapolis, IN 46250-0457
USA
COAGUCHEK, ACCU-CHEK and SOFTCLIX are trademarks of Roche. All other trademarks are the
property of their respective owners.
On the packaging and on the identification plate of the instrument you may encounter the following symbols,
shown here with their meaning:
Caution (consult accompanying documents). Refer to safety-related notes in the manual accompanying
this instrument.
Temperature limitation (Store at)
Use by
Manufacturer
Batch code/ Lot number
Catalog number
In vitro diagnostic medical device
Consult instructions for use
© 2007-2015, Roche Diagnostics.
US Order Number: 04999096003-0515
Distribution in USA by: Roche Diagnostics, Indianapolis, IN
This document is only available electronically at www.coaguchek-usa.com.

i
Revisions to this document are provided by Roche Diagnostics when necessary. No part of this document may be
reproduced in any form or by any means without prior written consent.
Manual version Revision date Changes
Version 1.0 November 2009 New document
Version 2.0 May 2015 Updated for meter spec changes

ii
Table of Contents
Introduction .............................................................................................................. 1
1Overview of Warfarin Therapy and the CoaguChek XS System ................... 3
2Materials for User Training ................................................................................... 5
3User Selection Guidelines ......................................................................................7
Overview .......................................................................................................................................... 7
Clinical Study .................................................................................................................................8
Performance Characteristics ....................................................................................................9
4Training Users for Self-Testing .......................................................................... 13
Preparation ...................................................................................................................................13
Supplies .........................................................................................................................................13
Training Outline ..........................................................................................................................14
Testing the Trainees ..................................................................................................................20
Certificate of Completion .........................................................................................................21
Follow-up Visits...........................................................................................................................21
5Proficiency Checks ............................................................................................... 23
6Forms ...................................................................................................................... 25

Introduction
1
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
• a description of training mat erials available from Roche Diagnostics
• a guide to selecting appropriate individuals to participate in self-testing
• a suggested outline for the training class
• Skills Checklist and Knowledge Test
• Certificate of Completion to be given to trainees
• suggestions for refresher training.
If you have questions, please contact the Roche Diagnostics Technical Service
Center 1-800-428-4674, 24 hours a day, 7 days a week, 365 days a year.
Obtaining CoaguChek XS
Meters for Users
Roche Diagnostics uses a network of certified national distributors to assist
you with acquiring a CoaguChek XS System for your patients. Contact your
Roche Account Manager or the Roche Diagnostics Technical Service Center at
1-800-428-4674, 24 hours a day, 7 days a week, 365 days a year. Potential users who
will be self-testing must have a doctor’s prescription for the CoaguChek XS meter
and complete a training program offered through an approved Roche distributor.

2

Overview of Warfarin Therapy and the CoaguChek XS System
1
3
OVERVIEW
The CoaguChek XS System from Roche Diagnostics measures blood-clotting
time for people who are taking anticoagulation medications such as warfarin
(for example Coumadin®). Warfarin is an oral anticoagulant that changes the
formation of certain blood factors produced in the liver in such a way that
the clotting time is slowed. (Refer to the latest warfarin package insert for
contraindications.) The goal is to prevent clots from forming or moving. At the
same time, however, it is important to avoid excessive anticoagulation, or blood
thinning, which carries a risk of hemorrhage.
People on warfarin therapy must be monitored closely for two reasons. First, as
indicated above, it is very important to keep blood coagulation time within an
optimal therapeutic, or target range. Second, each individual reacts differently to
warfarin, and the medication’s ability to prevent a clot is affected by a person’s
metabolism, diet, and other medications.
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. The strips are then assigned a “code,”
which standardizes the reported result via a mathematical algorithm, thus
minimizing lot-to-lot variability. No manual calibration of the system is required;
each lot of strips comes with a code chip that stores the information needed for
automatic calibration.
The CoaguChek XS System offers significant advantages in both convenience
and reliability. It is a hand-held, battery-operated system that can perform a PT/
INR blood test on a fresh whole blood sample from a fingerstick. A test strip
is inserted into the meter and a blood sample applied to the strip. The test result
is displayed in about one minute. The need for trips to the laboratory or for
venipuncture is virtually eliminated.
The CoaguChek System by Roche Diagnostics has been used successfully
since 1994 by healthcare professionals in anticoagulation clinics, physicians’
offices, and home health agencies and since 1997 for self-testing. Now, there
is the CoaguChek XS System available for self-testing. The materials that follow
are designed to help you select appropriate users and train them to use the
CoaguChek XS System properly.

4

Materials for User Training
2
5
Roche Diagnostics has developed the following materials, provided in the
product care kit, specifically for your use in training new users to self-test with
the CoaguChek XS System:
Training DVD This program, which runs approximately 15 minutes, provides step-by-step
instruction in setting up the meter, preparing for and performing a fingerstick
blood test, and cleaning the meter. It is intended to be the basis of the training
session. You may also use the DVD as a trainee selection aid; individuals who are
unsure of what self-testing involves may be shown the DVD to help them decide
if they want to go through training and try self-testing.
CoaguChek XS System
User Manual
A copy of the manual is provided with each CoaguChek XS Meter. It is intended
to be used as an ongoing reference guide by users, but should also be used in
training to familiarize trainees with the content and structure of the manual and
make them comfortable with referring to it.
Getting Started Guide A Getting Started reference guide is included in each CoaguChek XS System
Care Kit. It provides an easy reference for testing.
Package Inserts Both the test strips and lancet device have package inserts with information
about proper storage and use. It is important to call the users’ attention to the
inserts during training.

6

7
User Selection Guidelines
3
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 appropriate for self-
testing?
No, the specific diagnosis is not necessarily indicative of who should or should
not self-test. However, prior to beginning self-testing, users should be stabilized
on anticoagulation medications such as warfarin. People with chronic conditions
(for example, congestive heart failure, atrial fibrillation, prosthetic heart valve
replacement) who will need frequent monitoring over a long period of time are
certainly candidates for self-testing.
What personal
characteristics must the
potential user have?
The person must be reliable, compliance-oriented, and able to follow instructions.
What do I look for
in judging these
characteristics?
Consider the following:
• Does the person keep appointments?
• Does he or she comply with medication dosing and other elements of the
treatment regimen?
• Is he or she capable of understanding the importance of testing and the details
of the testing procedure?
• Are vision and motor skills adequate?
What else should I
consider?
Look for motivated individuals who want to take an active part in managing their
condition. Lifestyle factors may be important; people who travel, work, or find it
difficult to get to the laboratory may be especially motivated to learn self-testing.
Which individuals probably
should not self-test?
• It is up to the attending physician to determine which individuals are eligible
for self-testing.
• Refer to the test strip package insert for current limitations of procedure.
Is it appropriate to train
a third-party tester?
Caregivers for other individuals (for example, a spouse) may be trained. The
caregiver should be screened using the same criteria.

8
3 User Selection Guidelines
Once the potential user has
passed the initial screening,
what do we do next?
Explain to the person in general terms what will be involved and provide an
opportunity to ask questions. If he or she expresses interest, send a copy of
the training DVD home or show it in the office. Stress that this overview is only
intended to give a better idea of what self-testing involves and that more detailed
training and follow-up support will be provided. Each potential user will be
instructed on the fingerstick procedure and perform a fingerstick as part of the
screening. If the person wants to continue participation after seeing the DVD and
performing a fingerstick, he or she should be enrolled in a training class.
Clinical Study Information A clinical study was conducted by Roche Diagnostics consisting of four visits to
the clinical site. Informed consent and randomization occurred at Visit 1. Testing
began at Visit 2. Ninety-one individuals completed at least one visit after Visit
1. The following table outlines the demographic information for the users who
completed at least one visit after Visit 1.
Demographic Number Percent
Total number of users 91 100%
Caregivers 4 4.4%
Males 51 56%
Females 40 44%
Age range 32 – 89 100%
Mean Age 64 years N/A
Age 65 – 69 years 16 17.6%
Age 70 – 74 years 13 14.3%
Age 75 years and up 16 17.6%
Education Level-
Eighth grade or less through
advanced college degree
91 100%
Median Education Level Some college N/A
On warfarin 3 – 12 months 19 20.9%
On warfarin 1 – 2 years 22 24.2%
On warfarin 3 – 5 years 23 25.3%
On warfarin > 5 years 27 29.7%
Atrial fibrillation 38 41.8%
Valve replacement 25 27.5%
Stroke/stroke prevention 7 7.7%
DVT 5 5.5%
Other heart conditions 6 6.6%
Other clotting disorders 10 11%

9
User Selection Guidelines 3
There were 107 people enrolled. A total of 88 people completed all four visits to
the site. The reasons for drop-outs were as follows:
Reason for Drop-Out # of Subjects
Felt it was too stressful 2
Didn’t have time 3
Didn’t want to use meter on his own 1
Didn’t think he could learn to use meter 1
Was having knee surgery 1
Study terminated prior to Visit 4 1
Unknown 7
Disqualified due to target INR range outside of study protocol 3
PERFORMANCE CHARACTERISTICS
Measuring Range: The CoaguChek XS System has a PT/INR measuring range of 0.8–8.0 INR and
9.6–96.0 seconds.
Accuracy: A study was conducted comparing test results obtained by trained users
with those obtained by healthcare professionals, when both were using
the CoaguChek XS System. The correlation was very good, as indicated by
the following statistics: N=463, Slope=1.000, Intercept=0.0 and Correlation
Coefficient=0.977. This study shows that trained users are able to obtain results
that are as accurate as those obtained by healthcare professionals trained in the
use of the CoaguChek XS System.

10
3 User Selection Guidelines
109876543210
10
9
8
7
6
5
4
3
2
1
0
N = 297
PB: y = 1.154x - 0.2
Slp CI (1.111,1.198)
Int CI (-0.3, -0.2)
Correlation = 0.934
109876543210
10
9
8
7
6
5
4
3
2
1
0
N = 463
PB: y = 1.000x + 0.0
Slp CI (1.000,1.030)
Int CI (-0.05, 0)
Correlation = 0.977

11
User Selection Guidelines 3
Precision: A study was conducted and the precision of duplicates for capillary blood results
was calculated for both trained users and healthcare professionals. The following
results were obtained:
User
Results
Professional
Results
N 214 249
Mean 2.57 2.52
SD 0.13 0.13
CV 5.13 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:
Visit 1 Visit 2 Visit 3 Overall
Error 6 Test Strip
Interference
0.8% 0.9% 0.5% 0.7%
Error 5 Blood Application 31.7% 23.9% 18.9% 25.2%
Error 4 Test Strip Unusable 0.8% 0.0% 2.8% 1.1%
Error 000 Time Exceeded 1.5% 1.3% 0.0% 1.0%
Error QC Quality Control
Failure
1.1% 0.0% 0.0% 0.4%
Unknown Error 1.1% 0.0% 0.5% 0.6%

12

13
Training Users for Self-Testing
4
PREPARATION
The suggested time for each training session is two hours. If you prefer, you
may break this into two one-hour sessions. Some trainers have found that it
works well to have one educational session and one hands-on practice session.
However the training is scheduled, it is important to allow plenty of time for
trainees to practice the testing procedure and ask questions.
Training is mandatory. Users should not be permitted to take a meter home
without satisfactorily completing a training session and passing the Knowledge
Test and Skills Checklist.
Schedule training in a room free of distractions and with adequate facilities for
trainees to take notes and practice with the meters.
Limit training classes to small groups so trainees can have individual attention
during the practice session. It may be helpful to have an assistant.
Organize the presentation, gather the needed supplies, and make sure the
meters are operational.
SUPPLIES
CoaguChek XS Testing
Supplies
(one set for each trainee
plus one for demonstration)
• CoaguChek XS System Care Kit, consisting of:
• CoaguChek XS Meter
• 4 AAA batteries
• 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

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4 Training Users for Self-Testing
• CoaguChek XS PT Test Strips, consisting of:
• A container of test strips
• A test strip code chip
• The test strip package insert
Other Supplies • 70% isopropyl alcohol (rubbing alcohol)
• Or 10% bleach solution (1 part bleach to 9 parts water)
• Alcohol wipes
• Cotton balls or tissue
• Ordinary lint-free swabs/buds (available at pharmacies)
• Soft lint-free cloth
• Biohazard waste and sharps containers for disposal of supplies and lancets
used during practice
• Disposable gloves for instructor and assistants to wear when assisting trainees
in practicing fingersticks
• DVD player
• TV monitor
• Sufficient copies of the class outline, Knowledge Test, Skills Checklist, Log Book,
Certificate of Completion, and key sections of the CoaguChek XS System User
Manual, especially the Error Messages section
TRAINING OUTLINE
User Training
CoaguChek XS System
Topic Time
Introduction and Overview of Training Session 5 minutes
CoaguChek XS System Training DVD 15 minutes
Review of CoaguChek XS System and Operating Guidelines 10 minutes
Review System Set-Up 5 minutes
Testing Fingerstick Samples
(including practice and completion of Skills Checklist)
40 minutes
Documenting Results on Log Book 5 minutes
Review Built-In Quality Control 10 minutes
Cleaning the CoaguChek XS System 5 minutes
Knowledge Test 10 minutes
Local Information and Wrap-Up 10 minutes

15
Training Users for Self-Testing 4
Introduction and Overview
of Training Session
1. Explain the importance of regular PT/INR testing.
2. Review the policy for certification. Explain that each trainee will be asked to
successfully complete a Knowledge Test and Skills Checklist.
3. Review the agenda for the training session. (This outline may be copied and
distributed to attendees as a detailed reference.)
CoaguChek XS System
Training DVD
Show the 15-minute Training DVD, which gives an overview of the testing
procedure, built-in quality control testing, and maintenance.
Review of CoaguChek XS
System and Operating
Guidelines
1. Review components of the CoaguChek XS Meter
• Display panel
• M (memory) button
• ON-OFF button
• Test strip guide cover
• Test strip guide
• Battery compartment cover
• Code chip slot
• SET button
2. Review contents of the CoaguChek XS PT Test Strips
• A container of 6 test strips
• The test strip code chip
• The test strip package insert

16
4 Training Users for Self-Testing
3. Review operating conditions of the meter and proper storage conditions of test
strips
• Operate meter at room temperature, 59˚ to 90˚ F (15˚ to 32˚ C).
• Operate meter with 10% to 85% relative humidity, without condensation.
• Avoid bright sunlight.
• Operate the meter on a flat surface, free of vibrations.
• Use the provided carrying case.
• Read the information packaged with the test strips regarding up to
date product specifications and limitations.
• Read the latest warfarin package insert for contraindications.
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
compares its date with the test strip’s expiration date. If the test strip is expired,
the meter displays an error message and prevents you from running a test.)
2. Discuss the purpose of the code chip included with each test kit. The code
number on the test strip container must match the code chip number.
3. Review how to insert the code chip. Make sure the meter is off. Insert the
code chip with the code number facing up until it snaps into place.
4 Explain that the meter has set-up options that users will not be asked to change.
Appropriate settings have been programmed before they receive their meters.
Testing Fingerstick
Samples
(including practice and completion
of Skills Checklist)
Important: If a caregiver assists with the testing procedure, it is recommended
that the caregiver wash hands thoroughly and wear disposable gloves to prevent
contact with the blood sample.
1. Review supplies needed for performing a self-test:
• CoaguChek XS meter
• Container of test strips
• Test strip code chip
• ACCU-CHEK Softclix lancet device and lancet