Roche CoaguChek XS System User manual

User Manual for Self-Testing

0 4999045001 (10) 2022-05 USA
CoaguChek
®
XS System
User Manual for Self-Testing
Version 10.0

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 publication. However,
Roche Diagnostics reserves the right to make any changes necessary without
notice as part of ongoing product development.
Caution: Federal law restricts this device to sale by or on the order of a physician
This 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
Indianapolis, IN 46256
USA
COAGUCHEK and SOFTCLIX are trademarks of Roche. All other trademarks are
the property of their respective owners.
© 2007-2022, Roche Diagnostics.
US Order Number: 0 4999045001 (10) 2022-05 USA
Distribution in USA by: Roche Diagnostics, Indianapolis, IN
This document is available electronically at dialog.roche.com.

Manual version Revision date Changes
Version 2.0 November 2009 New document
Version 3.0 March 2011 Revised to update meter images,
add disposal information and
update product specifications
section.
Version 4.0 September 2013 Revised error 6 and error 7
verbiage.
Version 5.0 April 2016 Revised to add Rx only statement.
Version 6.0 December 2016 Revised to add pictures of
CoaguChek XS Softclix lancet
device.
Version 7.0 June 2017 Revised to add information on
display check; minor editorial
revisions.
Version 8.0 February 2021 Added procedure on how to set the
measuring unit to INR, removed
bleach as recommended cleaning
and disinfection solution, editorial
revisions. This version is only
available electronically.
Version 9.0 May 2021 Revised for software version 5.4x:
measuring units %Q and Sec
disabled and references to those
units marked as applicable only for
software versions 5.4 or lower.
Version 10.0 May 2022 Revised information on how to
obtain a blood sample; enhanced
troubleshooting section; minor
editorial revisions.

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Table of Contents
About this Manual............................................................................... 7
Symbols and Abbreviations .............................................................. 7
User Resources ..................................................................................... 8
Training DVD.......................................................................................... 8
Getting Started ...................................................................................... 8
User Manual........................................................................................... 8
Test Strip Package Inserts................................................................. 9
Lancet Device Package Inserts ....................................................... 9
The CoaguChek XS System........................................................ 10
Anticoagulation Medication ........................................................... 10
Blood-clotting Time ........................................................................... 10
How the System Works .................................................................... 11
The CoaguChek XS Meter ............................................................. 12
Operating Conditions........................................................................ 13
Getting Started..................................................................................... 15
Batteries ................................................................................................. 15
Installing (or Replacing) Batteries................................................ 16
Meter Setup.......................................................................................... 17
Setting the date format ............................................................. 18
Setting the Date and Time .............................................................. 19
Setting the measuring unit to INR ....................................... 22
Setting the beep tone ................................................................ 24
Setting the therapeutic range................................................. 25
The Meter’s Display ........................................................................... 29
Code Chip.............................................................................................. 30
Inserting a New Code Chip............................................................. 31
Integrated Quality Controls............................................................. 32

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Testing a Blood Sample................................................................ 33
Tips for a Good Fingerstick ............................................................ 33
Important Notes About Blood Testing........................................ 34
Always ............................................................................................. 34
Never ............................................................................................... 34
Infection Control.......................................................................... 35
Preparing for a Test........................................................................... 36
Performing a Test............................................................................... 38
Very Low or Very High Test Results............................................ 46
Memory ..................................................................................................... 49
Storing Test Results in Memory.................................................... 49
Reviewing Stored Test Results...................................................... 49
Erasing Stored Test Results............................................................ 51
Cleaning/Disinfecting the Meter........................................... 53
Cleaning/Disinfecting the Exterior............................................... 54
Cleaning/Disinfecting the Test Strip Guide.............................. 55
Error Messages ................................................................................... 59
Other Information .............................................................................. 75
Product Limitations............................................................................ 75
Product Specifications...................................................................... 75
Operating Conditions ............................................................... 75
Sample material........................................................................... 76
Non-Operating Storage and Transport Conditions ....... 76
Support/Services ................................................................................ 76
Questions ....................................................................................... 76
Repairs ............................................................................................ 76
Display Information and Symbols ................................................ 77
Disposal of the Meter, Test Strips, Lancets, and Batteries. 81
Warranty ................................................................................................... 83
CoaguChek XS Meter Limited (1 Year) Warranty .......... 83

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About this Manual
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
Catalog number
Consult instructions for use
Caution, consult accompanying documents.
Refer to safety-related notes in the manual
accompanying this instrument.
Manufacturer
Date of manufacture
Temperature limitation (Store at)
The system fulfills the Canadian and U.S. safety
requirements (UL LISTED, in accordance with UL
61010A-1:02 and CAN/CSA-C22.2 No. 61010-1-04)
Rx Only Caution: Federal law restricts this device to sale by
or on the order of a physician
Global Trade Item Number

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User Resources
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.

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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.

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The CoaguChek XS System
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.

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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 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.

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The CoaguChek XS Meter
ADisplay
BM (Memory) Button
CON-OFF button
DTest Strip Guide Cover
ETest Strip Guide
FBattery Compartment
Cover
GCode Chip Slot
HSET Button
IData Port
G
D
A
B
E
C
F
IH

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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.

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Getting Started
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 300 tests.
When you power 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.
When replacing the batteries you must insert the
new batteries within one minute of removing the old
ones, to keep the date and time settings. If you take
longer than this, you must re-enter the date and
time. Refer to page 19.
The meter saves battery power by automatically
powering 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.

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Installing (or Replacing) Batteries
Have ready 4 AAA alkaline 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.

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Meter Setup
When you turn the meter on, the display briefly
shows the installed software version in the upper left
corner of the display:
If you have installed the
batteries for the first time,
the meter will start up in
setup mode.

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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.
Setting the date format In case meter has lost
preset date format power
the meter on by pressing
the SET button (the
entire date display
flashes).
Press the M button
until date format 12-31-00
flashes in the display.
Press the SET button
to save this setting and
continue with the date
setting. The display
automatically moves on to
the date setting.

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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.
Note: If the date and time settings have not been set
correctly, the meter may not detect that an expired
test strip or an expired code chip is used.
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.

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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.
The date format can be
changed by pressing the
M button until the
desired format is reached.
Confirm by pressing the
SET button .
2. Set Today’s Date 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 .