Roche CoaguChek XS System User manual

CoaguChek®XS
System
User Manual
for Self-Testing

i
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 Technical Publications department.
Direct questions or concerns regarding the contents of this document to:
Roche Diagnostics
Technical Publications Department
9115 Hague Road
P.O. Box 50457
Indianapolis, IN 46250-0457
USA
Aspects of the CoaguChek XS System (meter and test strips) and its use are covered by one
or more of the following U.S. patents: 6,662,439; 7,073,246; 7,386,937; 7,407,811; 6,881,378;
6,207,000; 7,429,865; 6,645,368; 7,049,131; 7,084,251; 5,625,036. Additional U.S. patents
pending.
COAGUCHEK, ACCU-CHEK and SOFTCLIX are trademarks of Roche. All other trademarks
are the property of their respective owners.
© 2007-2009, Roche Diagnostics.
US Order Number: 0 4999045001 (02) 2009-11 USA
Distribution in USA by: Roche Diagnostics, Indianapolis, IN
This document is available electronically at www.poc.roche.com.

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 2.0 November 2009 New document

About this Manual ..................................................................... 1
Symbols and Abbreviations ....................................................1
User Resources ........................................................................... 2
Training DVD ................................................................................2
Getting Started.............................................................................2
User Manual .................................................................................2
Test Strip Package Inserts.......................................................3
Lancet Device Package Inserts .............................................3
The CoaguChek XS System.................................................. 4
Anticoagulation Medication....................................................4
Blood-clotting Time....................................................................4
How the System Works ............................................................5
The CoaguChek XS Meter.......................................................6
Operating Conditions ................................................................7
Getting Started............................................................................. 8
Batteries..........................................................................................8
Installing (or Replacing) Batteries........................................9
Meter Setup ............................................................................... 10
Setting the Date and Time ................................................... 11
The Meter’s Display ................................................................ 14
Code Chip ................................................................................... 14
Inserting a New Code Chip.................................................. 15
Integrated Quality Controls.................................................. 16
Table of Contents

Testing a Blood Sample........................................................17
Tips for a Good Fingerstick.................................................. 17
Important Notes About Blood Testing............................. 18
Always ...................................................................................... 18
Never ........................................................................................ 18
Infection Control................................................................... 19
Preparing for a Test ................................................................ 20
Performing a Test..................................................................... 22
Very Low or Very High Test Results................................. 27
Memory..........................................................................................28
Storing Test Results in Memory......................................... 28
Reviewing Stored Test Results ........................................... 28
Erasing Stored Test Results ................................................. 30
Cleaning/Disinfecting the Meter.....................................32
Cleaning/Disinfecting the Exterior .................................... 33
Cleaning/Disinfecting the Test Strip Guide ................... 34
Error Messages..........................................................................37
Other Information.....................................................................45
Product Limitations ................................................................. 45
Product Specifications ........................................................... 45
Support/Services ...................................................................... 46
Symbols........................................................................................ 47
Warranty ........................................................................................50

1
Symbols and Abbreviations
The test strip insert, the label on the back of the meter,
the User Manual, and other packaging material may
contain the following symbols or abbreviations:
Use by
Batch code/Lot number
In vitro diagnostic medical device
This product fulfills the requirements of
the European Directive 98/79/EC for in vitro
diagnostic medical devices
Catalog number
Consult instructions for use
Caution (consult accompanying documents).
Refer to safety-related notes in the manual
accompanying this instrument.
Manufacturer
Temperature limitation (Store at)
About this Manual
0123

2
Several resources are available to help you use and
maintain the CoaguChek XS System.
Training DVD
The CoaguChek XS System DVD is for new users of
the CoaguChek XS System. This program will help you
get comfortable with the CoaguChek XS Meter and the
testing procedure.
Getting Started
The Getting Started guide shows you how to perform
your first coagulation test on the CoaguChek XS Meter.
User Manual
This CoaguChek XS System User Manual is a
comprehensive guide to the meter and test strips.
It is designed to provide answers to your questions
about the meter’s operation and use. Read this entire
manual carefully, and refer to it as necessary.
User Resources

3
Test Strip Package Inserts
Be sure to read the test strip package insert for
important updates and keep the insert from your
current test strip package for future reference.
Lancet Device Package Inserts
Be sure to read the lancet device package insert to
learn how to use the lancet device and for important
updates. Keep the insert from your current lancet
device package for future reference.

4
The CoaguChek XS System measures blood-clotting
time (Prothrombin Time) for people who are taking
anticoagulation medications such as Coumadin®or
warfarin. The CoaguChek XS System measures blood-
clotting time using blood from the fingertip.
Anticoagulation Medication
Anticoagulation medications, also known as blood
thinners, are prescribed to avoid unwanted clots. Your
blood-clotting time must be monitored to ensure that
your medication dosage is correct.
Blood-clotting Time
The rate at which blood clots is measured in units
called INR. It is very important that you stay within
your target INR range. If your INR is too low, the risk of
blood clots increases. If your INR is too high, the risk
for internal bleeding increases.
Everyone’s INR is different. Your doctor determines
the best INR range for you, depending on why you are
taking anticoagulants and how you react to them. Your
doctor also determines how often your blood should be
tested. Your doctor needs to know your blood-clotting
time in order to successfully treat you.
The CoaguChek XS System