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

5
How the System Works
The CoaguChek XS System includes a meter and
CoaguChek XS PT test strips. Each box of test strips has
its own code chip that you insert into the meter. The
code chip contains important information about the test
strips such as their expiration date and lot number.
The CoaguChek XS System makes measuring blood-
clotting time easy. The display on the meter guides
you through the testing process. With the code chip
inserted in the meter, you simply insert a test strip and
apply a blood sample when the meter is ready. The
meter displays the result in about a minute. The meter
automatically stores the result in memory so that you
can easily recall results.
The CoaguChek XS PT test strip contains various
ingredients. When a blood drop is applied, the meter
starts the test and the blood mixes with the ingredients
on the test strip. When the meter determines that
the blood has clotted, it stops the measurement and
calculates the result.

The CoaguChek XS Meter
6
AF
G
B
H
C
D
E
I
ADisplay
B M (Memory) Button
C ON-OFF Button
D Test Strip Guide Cover
E Test Strip Guide
F Battery Compartment
Cover
G Code Chip Slot
H SET Button
I Data Port

7
Operating Conditions
To ensure that the CoaguChek XS Meter functions
correctly, follow these guidelines:
• Use the meter at room temperature, between 59°F
and 90°F (15°C and 32°C).
• Use the meter at a relative humidity of less than
85%, without condensation.
• When testing, keep the meter level.
• If you store the meter for a period of time, remove
the batteries.
• Do not use the meter at an altitude higher than
14,000 feet (4,300 meters).
• Do not use the meter near a strong magnetic field,
such as a microwave oven, as this may interfere with
the meter’s proper operation.
Note: The CoaguChek XS Meter automatically shuts off after
3 minutes if no buttons have been pushed.

Refer to the Getting Started guide to learn how to set
up the meter and prepare for and run your first blood-
clotting time test.
Batteries
The CoaguChek XS Meter uses 4 AAA batteries. The
recommended batteries, alkaline-manganese batteries,
should last for approximately 60 tests.
When you turn the meter on, the display
briefly shows the battery symbol. The
battery symbol is divided into 4 segments.
With new, fresh batteries in the meter, the
battery symbol shows all 4 segments.
When only 1 segment appears, replace the
batteries. When only 1 segment appears
you can still access results stored in the
meter’s memory.
If you insert new batteries within 1 minute of removing
the old batteries, the date and time settings will remain
in memory. But if you do need to reset the date and
time, refer to the Meter Setup section in this manual.
The meter saves battery power by automatically turning
off after 3 minutes, unless you press a button or insert a
test strip. Even when the batteries are removed, the test
results are saved in memory.
Getting Started
8

9
Installing (or Replacing) Batteries
Have ready 4 AAA batteries.
1. Open Battery
Compartment
With the meter turned
off, turn it over. Press the
latch gently inward and
lift the cover. Remove
the old batteries, if
necessary.
2. Insert New Batteries Position the batteries
according to the diagram
inside the battery
compartment. Replace
the cover. Turn the meter
back over.
Whenever you put
batteries in the meter,
it automatically goes to
Setup mode.

10
3. Turn Off Turn the meter off .
Meter Setup
The CoaguChek XS Meter is preset with the U.S. date
format (month-day-year) and U.S. time format (12-hour
as opposed to 24-hour).
Before you use the meter for the first time—or if there is
no battery power for more than 1 minute—you’ll have to
set the current date and time.

11
Setting the Date and Time
The date and time settings are important. Each time you
run a test, the meter compares its date with the test
strip’s expiration date. If the test strips are expired, the
meter displays an error message and prevents you from
running a test.
Whenever you put batteries in the meter, it
automatically goes to Setup mode (where you set the
date and time). You can also go to Setup mode at any
time by pressing the SET button ( ).
To set the date and time, you’ll use these buttons:
• to change a setting.
• (SET) to accept a setting.

12
1. Go to Setup Mode If the meter is not already
in Setup mode, press the
SET button .
The date format flashes
in the upper-right corner.
2. Set Today’s Date Press the SET button .
Press the M button
to change the year.
Press the SET button .
Press the M button to
change the month.
Press the SET button .
Press the M button to
change the day.
Press the SET button .

13
3. Set Current Time Press the SET button .
Press the M button
to change the hour.
Press the SET button .
Press the M button
to change the minutes.
Press the SET button .
4. Turn Off Turn the meter off .
If, in the future, you need
to change the date and
time, press the SET button
to re-enter Setup
mode. After you change
the date and time, just
turn the meter off .
Other set-up choices in
the meter must be set or
changed by your doctor.

14
The Meter’s Display
When you turn the meter on, it briefly shows all the
display’s letters, numbers, and symbols. Regularly check
that all segments of each letter, number, and symbol
appear. Please compare your meter’s display to the
meter display shown here on this page.
You can display all
the letters, numbers, and
symbols for a longer time
to allow comparison. To do
this, turn the meter on
and then hold down the
ON-OFF button .
The full display should
appear as shown at left.
Code Chip
Each box of test strips comes with its own code chip.
The code chip provides the meter with information such
as the lot number and expiration date of the test strips.
Before each test, make sure the correct code chip is in
the meter. Each time you open a new box of test strips,
replace the old code chip with the new one.
Protect the code chip from moisture and also from
equipment that produces magnetic fields, such as
a microwave oven.