Roche CoaguChek XS System User manual

This is a CLIA waived system.
User Manual

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.
For USA: For Prescription use only
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
P.O. Box 50457
Indianapolis, IN 46250-0457
USA
COAGUCHEK is a trademark of Roche.
All other trademarks are property of their respective owners.
© 2011-2016, Roche Diagnostics.
US Order Number: 04837991001 (07)-0816
Distribution in USA by: Roche Diagnostics, Indianapolis, IN
This document is available electronically at www.coaguchek-usa.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.
i

Manual version Revision date Changes
Version 3.0 November 2009 New document
Version 4.0 March 2011 Revised to update meter pictures,
remove patent information, add
disposal information, and update
product specifications section.
Version 5.0 September 2013 Revised ERROR 6 verbiage.
Version 6.0 February 2016 Revised for additional test strip
material number
Version 7.0 August 2016 Added GTIN information and revised
section “Out of Range Values”
ii

iii
Section Head
About this Manual .............................................................................1
Symbols and Abbreviations...........................................................................1
User Resources ..................................................................................2
Video ......................................................................................................................2
Getting Started...................................................................................................2
User Manual........................................................................................................2
Test Strip Package Inserts.............................................................................2
The CoaguChek XS System.............................................................3
Anticoagulation Medication..........................................................................3
Blood-clotting Time..........................................................................................3
How the System Works...................................................................................4
The CoaguChek XS Meter.............................................................................5
Operating Conditions.......................................................................................6
Getting Started ...................................................................................7
Batteries................................................................................................................7
Installing (or Replacing) Batteries..............................................................8
Meter Setup.........................................................................................................9
Setting the Date and Time.............................................................................9
Code Chip ......................................................................................................... 12
Inserting a New Code Chip........................................................................ 12
Integrated Quality Controls ........................................................................ 14
Testing a Blood Sample................................................................. 15
Tips for a Good Fingerstick........................................................................ 15
Important Notes about Blood Testing.................................................... 16
Always............................................................................................................ 16
Never.............................................................................................................. 16
Infection Control........................................................................................ 17
Preparing for a Test....................................................................................... 18
Performing a Test........................................................................................... 20
Out of Range Values..................................................................................... 24
Optional Testing Methods .......................................................................... 25
Using Capillary Tubes.............................................................................. 25
Using Venous Blood................................................................................. 28
Table of Contents

Memory ............................................................................................. 30
Storing Test Results in Memory ............................................................... 30
Reviewing Stored Test Results.................................................................. 30
Erasing Stored Test Results ....................................................................... 32
Cleaning the Meter......................................................................... 34
Cleaning the Exterior .................................................................................... 34
Cleaning the Test Strip Guide................................................................... 35
Advanced Features......................................................................... 37
Setting Advanced Features ........................................................................ 38
The Meter’s Display........................................................................ 39
Error Messages ............................................................................... 40
Error Messages You May See After You Apply Blood.................... 44
Other Information............................................................................ 48
Ordering Information for Health Care Professionals........................ 48
Product Limitations ....................................................................................... 48
Product Specifications ................................................................................. 49
Support/Services ............................................................................................ 50
Symbols.............................................................................................................. 51
Disposal of the Meter, Test Strips, Lancets, and Batteries............ 54
Warranty ............................................................................................................ 55
iv

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
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 For prescription use only
Global Trade Item Number
1
About this Manual

2
Several resources are available to help you use and maintain the
CoaguChek XS System.
Video (DVD Format)
The CoaguChek XS System Video is for new users of the
CoaguChek XS System. The video 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.
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.
User Resources

3
The CoaguChek XS System is intended for use by professional
healthcare providers for quantitative prothrombin time testing for
the monitoring of warfarin therapy. The CoaguChek XS System
uses fresh capillary or nonanticoagulated venous whole blood.
Anticoagulation Medication
Anticoagulation medications, also known as blood thinners, are
prescribed to avoid unwanted clots. Blood-clotting time must be
monitored to ensure that a patient’s medication dosage is correct.
Blood-clotting Time
The rate at which blood clots is measured in units called INR. It is
very important for patients to stay within their target INR range. If
the INR is too low, the risk of blood clots increases. If the INR is
too high, the risk for internal bleeding increases.
Everyone’s INR is different. The patient’s doctor determines the
best INR range for the patient, depending on why the patient is
taking anticoagulants and how the patient reacts to them. The
doctor also determines how often the patient’s blood should be
tested. The doctor needs to know the patient’s blood-clotting time
in order to successfully treat the patient.
The CoaguChek XS System

4
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 meter and test strips work together to
provide a safe and reliable system for testing blood-clotting time.
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. 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.

5
The CoaguChek XS Meter
A Display
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
AF
G
B
H
C
D
E
I

6
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.

7
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.
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 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.
Getting Started

8
Installing (or Replacing) Batteries
Have ready 4 AAA batteries.
1. Open Battery Compartment
2. Insert New Batteries
3. Power Off
With the meter powered
off, turn it over. Press the
latch gently inward and lift
the cover. Remove the old
batteries, if necessary.
Position the batteries
according to the diagram
inside the battery
compartment. Replace
the cover. Turn the meter
back over.
Power 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. In addition, the meter has certain advanced features that
you can set up if you plan to use them. See the Advanced Features
section in this manual to learn more about the advanced features
and how to set them up.
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.
• to accept a setting.
9

10
1. Go to Setup Mode
2. Set Today’s Date
If the meter is not already in
Setup mode, press the SET
button .
The date format flashes in the
upper-right corner.
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 .

11
3. Set Current Time
4. Power Off
The time format flashes in the
upper-left corner.
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 .
Power the meter off .

12
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.
Inserting a New Code Chip
Have the correct code chip ready.
1. Remove Old Code Chip With the meter powered off,
remove the old code chip and
throw it away.

13
2. Match Codes
3. Insert New Code Chip
Make sure that the three-
number code on the new test
strip container matches the
three-number code on the
new code chip.
Slide the new code chip into
the code chip slot until it
snaps into place.

14
Integrated Quality Controls
The CoaguChek XS System has quality control functions integrated
into the meter and test strips, so you never have to run quality
control tests with liquid quality controls. The meter automatically
runs its own quality control test as part of every blood test.
When the quality control test runs, the letters QC flash on the
meter’s display. When the quality control test completes, a
checkmark (P) appears following the letters QC. Then the meter
continues to run the blood test.
If the quality control test fails, the meter displays the following
error message. See the Error Messages section in this manual for
an explanation of this (and other) error messages and what to do
when they occur.