Roche CoaguChek XS Pro User manual

CoaguChek XS Pro
®
POINT OF CARE
TESTING
Operator’s Manual
For meters shipped before January 2013

Manual version Revision date Changes
Version 1.0 2009-09 New document
Version 2.0 2010-04 Update cleaning/disinfection, minor revisions
Version 2.1 2016-08 Revised to add Rx only statement.

US Supplement
3
US Supplement
The contents of this document, including all graphics and photographs, are the property of
Roche. 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.
Every effort has been made to ensure that the information contained in this manual is accurate at
the time of printing. Not all functionality described in this manual may be available to all users.
Roche Diagnostics reserves the right to make any further required changes to software without
prior notice. Such changes may not immediately be reflected in this document.
Any screenshots in this publication have been added exclusively for the purpose of illustration.
Configurable and variable data such as parameters, results, path names etc. visible therein must
not be used for laboratory purposes.
This document is intended for the US market only. For Prescription Use Only.
This manual was created by Roche Diagnostics GmbH (operator manual content) and Roche
Diagnostics Engineering Operations Department (US Supplement). 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 product names and trademarks are the property
of their respective owners.
© 2010-2016, Roche Diagnostics. All rights reserved.
US Order Number: 08103089001
Distribution in USA by: Roche Diagnostics, Indianapolis, IN
This document is available on the CoaguChek website at www.coaguchek-usa.com and the
Roche Diagnostics USA website at https://usdiagnostics.roche.com.

US Supplement
4
Warranty
CoaguChek XS Pro Meter Limited (1 Year) Warranty
ROCHE DIAGNOSTICS warrants, to the original purchaser only, that the meter shall be free from all
defects in material and workmanship for a period of one year from the date of purchase. Purchaser’s
sole and exclusive remedy, with respect to the CoaguChek XS Pro meter and parts thereof, shall be
the repair and/or replacement of the meter or parts at the option of Roche Diagnostics.
THE ABOVE WARRANTY IS EXCLUSIVE OF ALL OTHER WARRANTIES, AND ROCHE DIAGNOSTICS
MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE
IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO
EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE TO THE PURCHASER OR ANY OTHER PERSON
FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT, SPECIAL OR PUNITIVE DAMAGES ARISING
FROM OR IN ANY WAY CONNECTED WITH THE PURCHASE OR USE OF THE METER. NO
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, IF ANY IS
IMPLIED FROM THE SALE OF THE COAGUCHEK XS PRO METER. NO WARRANTY, EXPRESS OR
IMPLIED (IF ANY), SHALL EXTEND FOR A LONGER DURATION THAN THE DURATION OF THE
EXPRESS WARRANTY STATED ABOVE.
The foregoing warranty shall not apply to a meter which is damaged by accident or subject to
alteration, misuse, tampering, and/or abuse, including the use of Dispatch®products. Meters which
show damage or misuse will be handled in accordance with Roche Diagnostic’s non-warranty
service policy. The warranty of the repaired/replacement meter will expire on the date of the original
warranty expiration or ninety (90) days after shipment of a replacement system, whichever period is
longer.
Information about the Software License
This product incorporates software that is under license from GPL. The source code for this
software can be requested on a usual data exchange medium from the following address:
Roche Diagnostics GmbH, Sandhofer Str. 116, D-68305 Mannheim.
You may read the software license agreement on the CoaguChek XS Pro Policies and Procedures
Manual CD.

©2010-2016 Roche Diagnostics. All rights reserved 0 8103089001 (01) 2016-08 USA
Operator’s Manual
Version 2.1
For meters shipped before January 2013
CoaguChek XS Pro
®

6
©2010-2016, Roche Diagnostics
The contents of this document, including all graphics, are the property of Roche Diagnostics.
Information in this document is subject to change without notice. Roche Diagnostics shall not be
liable for technical or editorial errors or omissions contained herein. 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.
Please send questions or comments about this manual to your local Roche representative.
ACCU-CHEK, COAGUCHEK and SAFE-T-PRO 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
Global Trade Item Number
Consult instructions for use
Rx only For prescription use only
LOT
IVD

7
1 Introduction 11
Before you start......................................................................................................................................... 11
Intended use ...................................................................................................................................... 11
Important information regarding use ....................................................................................... 11
If you need help................................................................................................................................ 11
What can the system do for you? .............................................................................................. 12
Test principle ..................................................................................................................................... 12
Safety information and additional information ............................................................................. 13
Safety Information............................................................................................................................ 14
Disposal of the System................................................................................................................... 14
General Care...................................................................................................................................... 15
Laser Scanner.................................................................................................................................... 15
Electromagnetic Interference ...................................................................................................... 15
Touchscreen....................................................................................................................................... 15
Operating conditions ...................................................................................................................... 16
Quality control ................................................................................................................................... 17
2 The CoaguChek XS Pro Meter 18
Overview of the meter elements......................................................................................................... 19
Buttons and icons overview ................................................................................................................. 20
Power supply.............................................................................................................................................. 23
3 Putting the Meter into Operation 24
Inserting the batteries ............................................................................................................................ 25
Powering the meter on and off........................................................................................................... 26

8
4 Meter Setup 27
Note on presentation of screen elements in this manual................................................. 27
Settings summary ................................................................................................................................... 28
Screen setup .............................................................................................................................................. 32
Contrast................................................................................................................................................ 32
Result Units ........................................................................................................................................ 33
Language Selection......................................................................................................................... 35
Setting the date................................................................................................................................. 36
Setting the time................................................................................................................................. 38
Setting the display options for date and time ....................................................................... 40
Options setup ........................................................................................................................................... 42
Sort......................................................................................................................................................... 42
Beeper .................................................................................................................................................. 44
Auto Off................................................................................................................................................ 47
Computer............................................................................................................................................. 49
ID setup........................................................................................................................................................ 51
System Administrator (Admin.)................................................................................................... 53
Operator .............................................................................................................................................. 59
Patient................................................................................................................................................... 60
Lockouts setup.......................................................................................................................................... 63
Operator lockout............................................................................................................................... 64
QC (quality control) lockout......................................................................................................... 67
5 Testing a Capillary Blood Sample 69
Important notes......................................................................................................................................... 69
Getting a good capillary blood sample .................................................................................... 70
Getting a good result from venous whole blood.................................................................. 71
Preparing to test ....................................................................................................................................... 72
Test strip code chip ......................................................................................................................... 73
Inserting the code chip .................................................................................................................. 73
Powering on the meter................................................................................................................... 75
Performing a test...................................................................................................................................... 78
Adding comments............................................................................................................................ 87
6 Quality Control 89
Preparing to run a liquid quality control test................................................................................. 90
Performing a liquid quality control test............................................................................................ 92
7 Review Results 99
Viewing test results .............................................................................................................................. 100
Display patient result memory.................................................................................................. 102
Display QC (quality control) result memory........................................................................ 103

9
8 Extended Functionalities 105
Data handling......................................................................................................................................... 105
Computer (Setup option) ........................................................................................................... 105
Operator lists................................................................................................................................... 106
Patient lists ...................................................................................................................................... 107
Barcode scanner ........................................................................................................................... 108
Stored test results and comments.......................................................................................... 108
9 Cleaning and Disinfecting the Meter 109
Recommended cleaning/disinfecting solutions ........................................................................ 109
Cleaning/disinfecting the exterior (meter housing)................................................................. 110
Cleaning/disinfecting the test strip guide ................................................................................... 111
Cleaning the scanner window.......................................................................................................... 112
10 Troubleshooting 113
Error messages after powering on the meter ........................................................................... 114
Error messages when preparing to test ....................................................................................... 115
Error messages during or after blood application ................................................................... 116
Other error messages.......................................................................................................................... 118
11 General Product Specifications 121
Technical data........................................................................................................................................ 121
Sample material............................................................................................................................. 121
Storage and transport conditions ........................................................................................... 122
Further Information .............................................................................................................................. 122
Ordering .......................................................................................................................................... 122
Reagents and solutions .............................................................................................................. 122
Product limitations........................................................................................................................ 122
Information about software licenses .................................................................................... 123
Repairs .............................................................................................................................................. 123
Contact Roche................................................................................................................................ 123
12 Warranty 124
13 Appendix 125
Contact Roche ...................................................................................................................................... 125
Alphabetical Index 133

10
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Introduction
11
1 Introduction
Before you start
Intended use
The CoaguChek XS®Pro system (CoaguChek XS Pro meter and CoaguChek XS PT Test strips)
quantitatively determines prothrombin time (“PT”), using capillary blood or whole blood from a
vein (nonanticoagulated venous whole blood). It is indicated for use by healthcare professionals.
The system is ideally suited to monitor coagulation values in people who are taking oral antico-
agulation medication (vitamin K antagonists, VKAs).
Important information regarding use
Read this operator's manual, as well as the package inserts for all relevant consumables, before
using the system for the first time.
You must configure the CoaguChek XS Pro meter according to your needs before initial use. Refer
to chapter 4, Meter Setup. Be sure to read the Safety information and additional information sec-
tion in this chapter before operating the system.
If you need help
Information about using the system, the screen menus, and performing a test can be found in this
manual.
When error messages appear on the screen, refer to chapter 10, Troubleshooting.
For all questions about the CoaguChek XS Pro system that are not answered in this manual,
contact your Roche representative. In order to expedite troubleshooting, please have ready your
CoaguChek XS Pro meter, its serial number, this manual, and all related consumables when you
call.
Note: Before you use the meter for the first time ( after you have first inserted the batteries),
you must set the date and time correctly to allow you to perform measurements properly.
Each time you replace the batteries you need to check (and, if necessary adjust) the date
and time.

Introduction
12
What can the system do for you?
The CoaguChek XS Pro system makes coagulation testing easy. You only need to insert the code
chip, power the meter on, insert the test strip, and apply a small blood sample. The blood mixes
with the reagents on the test strip, and the meter determines when the blood clots. The meter
displays the results in about one minute. After the measurement, the meter automatically stores
the test result, together with date/time and patient ID (and operator ID, if that option is enabled)
to memory.
The CoaguChek XS Pro meter displays test results in units equivalent to laboratory plasma mea-
surements. Results may be displayed in three ways:
■International Normalized Ratio (INR)
■combination of INR/seconds, or
■combination of INR/%Quick
INR is a standardized measurement of the rate at which blood clots. A low INR can indicate an
increased risk of blood clots, while an elevated INR can indicate increased risk of bleeding.
The meter guides you through the test, step by step, using icons and instructions on the display.
Each box of test strips has its own code chip that you insert into the meter. This code chip con-
tains lot-specific information about its test strips, such as the expiration date and calibration
data. Optional liquid controls for the system are also available.
The CoaguChek XS Pro meter has the ability to connect to a data management system (DMS)
through the Handheld Base Unit from Roche (available separately). The CoaguChek XS Pro
meter supports data exchange via the POCT1A standard. Data management systems may have
the ability to expand the security features of the meter, such as enabling operator lockouts. Data
management systems may also enable data transfer to an LIS or HIS. Refer to the manuals of the
Handheld Base Unit and of your DMS for technical details.
Test principle
The CoaguChek XS PT Test contains a lyophilized reagent. The reactive components of this
reagent consist of thromboplastin and a peptide substrate. When a sample is applied, thrombo-
plastin activates coagulation, which leads to the formation of thrombin. At the same time the
meter starts to measure the time. The enzyme thrombin cleaves the peptide substrate, generating
an electrochemical signal. Depending on the time elapsed when it first appears, this signal is
then converted by means of an algorithm into customary coagulation units (INR, %Quick, sec-
onds) and the result is displayed.

Introduction
13
Safety information and additional information
This section explains how safety-related messages and information related to the proper
handling of the system are presented in the CoaguChek XS Pro Operator’s Manual. Read these
passages carefully.
The safety alert symbol by itself (without a signal word) is used to pro-
mote awareness to hazards which are generic or to direct the reader to
related safety information
WARNING
Indicates a hazardous situation which, if not avoided, could result in
death or serious injury.
CAUTION
Indicates a hazardous situation which, if not avoided, could result in
minor or moderate injury.
NOTICE Indicates a hazardous situation which, if not avoided, may result in
damage to the system.
Important information that is not safety relevant is presented against a colored background
(without a symbol). Here you will find additional information on correct use of the meter or
useful tips.
Illustrations in this manual show two different kinds of hands:
Hand without glove Hand with glove

Introduction
14
Safety Information
Disposal of the System
Operator qualification
Only trained healthcare professionals may operate the CoaguChek XS
Pro system. Operators must have received comprehensive instruction in
the operation, quality control, and care of the CoaguChek XS Pro system.
WARNING
Protection against infection
There is a potential risk of infection. Healthcare professionals using the
CoaguChek XS Pro system must be aware that any object coming into
contact with human blood is a potential source of infection. Healthcare
professionals must also be aware that any cross-contamination is a
potential source of infection for patients.
■Use gloves.
■Use a separate lancet / separate lancing device for each patient.
■Dispose of used lancets in a sturdy sharps container with lid.
■Dispose of used test strips according to your institution’s infection
control policy.
■Follow all health and safety regulations in force locally.
WARNING
Infection by a potentially biohazardous instrument
The CoaguChek XS Pro system or its components must be treated as
potentially biohazardous waste. Decontamination (i.e., a combination of
processes including cleaning, disinfection and/or sterilization) is
required before reuse, recycling, or disposal.
Dispose of the system or its components according to the appropriate
local regulations.
WARNING
Exploding batteries
Do not throw used batteries into an open fire. They may explode.
Disposal of used batteries
Do not dispose of the batteries with normal domestic waste. Dispose of
used batteries in an environmentally responsible manner and in accor-
dance with applicable local regulations and directives. Contact your local
council/local authority or the manufacturer of the used batteries for
advice on correct disposal.

Introduction
15
General Care
Laser Scanner
The built-in barcode scanner emits a laser beam when activated.
The built-in barcode scanner is a Class 1 laser, according to EN 60825-1:2007.
Electromagnetic Interference
Touchscreen
NOTICE Clean the meter only with the solutions recommended (see page 109).
Using other solutions may result in incorrect operation and possible
system failure. Do not let cleaning solution enter the instrument. Make
sure that the meter is thoroughly dried after cleaning or disinfecting.
WARNING
A barcode does not need to be present for the laser scanner to become
active. Do not stare directly into the laser beam.
Do not use the meter near strong electromagnetic fields, which could
interfere with the proper operation of the meter.
NOTICE ■Use only your finger (even when wearing gloves) or special pens
designed for use with touchscreens to touch the screen elements.
Using pointed or sharp-edged objects can damage the touchscreen.
■Avoid prolonged exposure to direct sunlight. Direct sunlight may
reduce the life expectancy and functionality of the display.

Introduction
16
Operating conditions
To ensure that the meter functions properly, please observe the following guidelines:
■Only use the meter at a room temperature between 15 °C and 32 °C (59 °F and 90 °F).
■Only use the meter at a relative humidity between 10% and 85% (no condensation).
■When operating the meter using the power supply unit, use only a voltage of 100 V to
240 V (± 10%) , 50/60 Hz.
■When testing, place the meter on a level, vibration-free surface, or hold it so it is roughly
horizontal.

Introduction
17
Quality control
The meter has a number of built-in quality-control functions:
■A check of the electronic components and functions every time the meter is powered on.
■A check of the test strip temperature while a test is in progress.
■A check of the expiration date and lot information on the test strip based on the code chip
data.
■A two-level, on-board quality control test and patient result determination within a single
test chamber.
Roche Diagnostics has available optional liquid quality controls for the CoaguChek XS Pro
system. These controls are provided to assist with meeting regulatory compliance requirements
as applicable to your facility.

The CoaguChek XS Pro Meter
18
2 The CoaguChek XS Pro Meter
A
B
C
DG
I J
F
H K L
E

The CoaguChek XS Pro Meter
19
Overview of the meter elements
ATouchscreen
Shows test results, information, icons, and
results recalled from memory. To select an
option, simply touch the button lightly.
BOn/Off button
Press and hold this button to power the
meter on or off.
CTest strip guide cover
Remove this cover to clean the test strip
guide (if it has become soiled, e.g., with
blood).
DTest strip guide
Insert the test strip here.
EBarcode scanner (Laser)
The integrated barcode scanner can read
operator and patient IDs into the meter.
FTab for battery compartment cover
GBattery compartment cover
Covers the battery compartment
(4 standard AA alkali-manganese
batteries or a rechargeable battery pack
(optional)).
HCharging terminals
Used for power supply and/or charging
the battery pack, when the meter is
docked in the (optional) Handheld Base
Unit.
ICode chip slot
Insert the code chip here.
JConnection socket for power adapter
Plug in the power adapter here.
KInfrared interface
(Covered by the semi-transparent panel)
Supports data communication.
LReset button
Use this button to reset the meter in case
of software or power-up errors.

The CoaguChek XS Pro Meter
20
Buttons and icons overview
The buttons and icons that appear during normal operation are shown here, along with their
respective meanings.
Icon Meaning
Go to Main Menu
OK; save setting
Cancel; discard setting
Return (to previous menu)
Reduce/increase the value displayed
Move screen contents
Inactive button:
Value cannot be further decreased/increased or:
End of list in this direction is reached
List of tests of a specific patient
Operator must wait until the meter has completed an action.
Insert test strip
Remove test strip
Apply sample (the time left to apply sample is counted down in the
display)
Apply liquid control (QC) sample (the time left to apply sample is
counted down in the display)
180 SEC
180 SEC