Roche CoaguChek XS Pro User manual

CoaguChek XS Pro
®
POINT OF CARE
TESTING
Operator’s Manual

Revision History
Manual version Revision date Changes
Version 1.0 2009-09 New document, international launch with
document 0 5548829001 (01) EN 2009-09.
Version 2.0 2010-04 Update cleaning/disinfection, minor revisions
Version 3.0 2010-10 Update to SW 03
Version 4.0 2013-01 Update to SW 03.01, new functions; creation of
document 0 6950540001 (01) EN-CAN/
0 6950566001 (01) FR-CAN with altered
instructions on cleaning/disinfection for
Canada
Version 5.0 2015-12 Manual update: added safety information on
battery packs, deleted appendix for addresses,
minor revisions

0 6950540001 (02) 2015-12 EN-CAN
Operator’s Manual
Version 5.0
CoaguChek XS Pro
®

4
© 2009-2015 Roche Diagnostics GmbH. All rights reserved
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
instructions for use accompanying this product.
Temperature limitation (Store at)
Use by
Manufacturer
Batch code/ Lot number
Catalog number
In vitro diagnostic medical device
This product fulfills the requirements of the European Directive 98/79/EC on in vitro
diagnostic medical devices.
Consult instructions for use
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).
LOT
IVD

5
1 Introduction 9
1.1 Before you start........................................................................................................................................... 9
Intended use ........................................................................................................................................ 9
Important information regarding use ......................................................................................... 9
If you need help................................................................................................................................ 10
General note....................................................................................................................................... 10
What can the system do for you? .............................................................................................. 10
Test principle ..................................................................................................................................... 11
1.2 Important safety instructions and additional information......................................................... 12
Safety Information............................................................................................................................ 14
Disposal of the System................................................................................................................... 15
General Care...................................................................................................................................... 17
Laser Scanner.................................................................................................................................... 18
Electromagnetic Interference ...................................................................................................... 18
Touchscreen....................................................................................................................................... 18
Local Area Network: protection from unauthorized access ............................................ 18
Wired network connection ........................................................................................................... 19
Operating conditions ...................................................................................................................... 20
Quality control ................................................................................................................................... 20
2 The CoaguChek XS Pro Meter 21
2.1 Overview of the meter elements......................................................................................................... 22
2.2 Buttons and icons overview ................................................................................................................. 23
2.3 Power supply.............................................................................................................................................. 25
3 Putting the Meter into Operation 27
3.1 Inserting the batteries ............................................................................................................................ 28
3.2 Powering the meter on and off........................................................................................................... 29
Checking the software version ................................................................................................... 30
4 Meter Setup 31
Note on presentation of screen elements in this manual................................................. 31
4.1 Settings summary ................................................................................................................................... 33
4.2 Screen setup.............................................................................................................................................. 37
Contrast ............................................................................................................................................... 37
Result Units ........................................................................................................................................ 38
Result Confirmation......................................................................................................................... 39
Language Selection......................................................................................................................... 40
Setting the date................................................................................................................................. 41
Setting the time................................................................................................................................. 43
Setting the display options for date and time ....................................................................... 44
4.3 Options setup ........................................................................................................................................... 46
Sort ........................................................................................................................................................ 46
Beeper .................................................................................................................................................. 48
Auto Off ............................................................................................................................................... 50
Connection ......................................................................................................................................... 51
Computer............................................................................................................................................. 52
Printer ................................................................................................................................................... 53

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4.4 ID setup........................................................................................................................................................ 54
System Administrator (Admin.)................................................................................................... 56
Operator ID ........................................................................................................................................ 60
Patient ID ............................................................................................................................................ 61
4.5 QC Settings setup .................................................................................................................................... 63
QC Range ............................................................................................................................................ 64
QC (quality control) Lockout........................................................................................................ 67
Operator Lockout ............................................................................................................................. 69
STAT Test Configuration................................................................................................................ 71
5 Testing a Blood Sample 73
5.1 Important notes......................................................................................................................................... 73
Getting a good capillary blood sample .................................................................................... 75
Getting a good result from venous whole blood.................................................................. 76
5.2 Preparing to test ....................................................................................................................................... 77
Test strip code chip ......................................................................................................................... 77
Inserting the code chip .................................................................................................................. 78
Powering on the meter................................................................................................................... 79
5.3 Performing a test ..................................................................................................................................... 82
Accepting or rejecting a test result........................................................................................... 91
Adding comments............................................................................................................................ 92
STAT tests ........................................................................................................................................... 94
6 Control Testing and Quality Control 95
6.1 Preparing to run a liquid quality control test................................................................................. 96
6.2 Performing a liquid quality control test............................................................................................ 98
7 Review Results 105
7.1 Viewing test results .............................................................................................................................. 106
Display patient result memory.................................................................................................. 108
Display QC (quality control) result memory........................................................................ 109
8 Extended Functionalities 111
8.1 Data handling ......................................................................................................................................... 111
Computer (Setup option)............................................................................................................ 113
Operator lists................................................................................................................................... 114
Patient lists....................................................................................................................................... 115
Patient list validation.................................................................................................................... 116
Configuring operator and patient IDs.................................................................................... 117
Barcode scanner............................................................................................................................ 117
Stored test results and comments .......................................................................................... 117

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9 Maintenance and Care 119
9.1 Conditions for storage and shipping ............................................................................................. 119
Storage.............................................................................................................................................. 119
Shipping............................................................................................................................................ 120
9.2 Cleaning and Disinfecting the Meter ............................................................................................ 121
Difference between cleaning and disinfecting.................................................................. 121
When should the meter be cleaned and disinfected....................................................... 122
Approved cleaning and disinfecting products................................................................... 123
9.3 Cleaning/disinfecting the exterior (meter housing)................................................................. 124
When to clean and disinfect the meter ................................................................................ 124
What to clean and disinfect ...................................................................................................... 124
9.4 Cleaning/disinfecting the test strip guide ................................................................................... 127
When to clean and disinfect the test strip guide.............................................................. 127
9.5 Maintenance cleaning of the interior test strip guide and battery
compartment in case of residue build-up 130
When to clean the test strip guide and battery compartment..................................... 130
Approved cleaning agents......................................................................................................... 130
How to perform maintenance cleaning of the test strip guide.................................... 130
How to perform maintenance cleaning of the battery compartment........................ 132
9.6 Cleaning the scanner window.......................................................................................................... 133
10 Troubleshooting 135
Additional information on error E-406 .................................................................................. 136
Errors and unusual behavior without error messages .................................................... 137
11 General Product Specifications 139
11.1 Technical data ....................................................................................................................................... 139
Sample material ............................................................................................................................ 139
Storage and transport conditions ........................................................................................... 140
11.2 Further Information .............................................................................................................................. 140
Ordering .......................................................................................................................................... 140
Reagents and solutions .............................................................................................................. 140
Product limitations........................................................................................................................ 140
Information about software licenses .................................................................................... 141
Repairs .............................................................................................................................................. 141
Contact Roche................................................................................................................................ 142
12 Warranty 142
A Appendix 143
A.1 Working with barcodes.........................................................................................................................143
A.2 Operator and patient ID barcode masks........................................................................................144
A.3 Example of barcode symbologies .....................................................................................................145
B Appendix 147
B.1 Supplement for Observed Test Sequence .....................................................................................147
Observed Test Sequence (OTS) ............................................................................................. 147
Using the OTS function............................................................................................................... 148
Index 151

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Introduction • 1
9
1 Introduction
1.1 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 profes-
sionals. The system is ideally suited to monitor coagula-
tion values in people who are taking oral anticoagulation
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 accord-
ing to your needs before initial use. Refer to chapter 4,
Meter Setup. Be sure to read the “Important safety
instructions and additional information” section in this
chapter before operating the system.
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 measure-
ments properly. Each time you replace the batteries you
need to check (and, if necessary adjust) the date and
time.

1• Introduction
10
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.
General note The data and information provided in this manual are
current as of issue. Any substantial changes will be incor-
porated in the next edition. If there is any conflict of infor-
mation, the package insert included with the CoaguChek
XS PT Test strips shall prevail.
What can the system do for you? The CoaguChek XS Pro system makes coagulation test-
ing 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 opera-
tor ID, if that option is enabled) to memory.
The CoaguChek XS Pro meter displays test results in
units equivalent to laboratory plasma measurements.
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.

Introduction • 1
11
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 contains lot-specific information
about its test strips, such as the expiration date and cali-
bration 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 Hand-
held 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 rea-
gent. The reactive components of this reagent consist of
thromboplastin and a peptide substrate. When a sample
is applied, thromboplastin 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 electro-
chemical 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,
seconds) and the result is displayed.

1• Introduction
12
1.2 Important safety instructions 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.
These symbols and signal words are used for specific
hazards:
The safety alert symbol alone (without a signal word)
promotes awareness to hazards which are generic or
directs the reader to related safety information.
WARNING
WARNING
Indicates a hazardous situation which, if not avoided,
could result in death or serious injury.
CAUTION
CAUTION
Indicates a hazardous situation which, if not avoided,
could result in minor or moderate injury.
NOTICE NOTICE
Indicates a hazardous situation which, if not avoided,
may result in damage to the system.
Important information that is not safety relevant is pre-
sented against a colored background (without a sym-
bol). Here you will find additional information on correct
use of the meter or useful tips.

Introduction • 1
13
Illustrations in this manual show two different kinds of
hands:
Hand without glove Hand with glove
A dashed arrow between screen illustrations indicates
that some screens have been skipped in these
illustrations.

1• Introduction
14
Safety Information
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 and blood-borne
pathogens
Healthcare professionals using the CoaguChek XS Pro
system to perform tests must be aware that any object
coming into contact with human blood is a potential
source of infection. Operators need to adhere to Standard
Precautions when handling or using the CoaguChek
XS Pro system. All parts of this system should be consid-
ered potentially infectious and are capable of transmitting
blood-borne pathogens between patients and between
patients and healthcare professionals.
■Use gloves. Wear a new pair of clean gloves for
testing each patient.
■Wash hands thoroughly with soap and water before
putting on a new pair of gloves and performing the
next patient test.
■Use an auto-disabling single-use 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.

Introduction • 1
15
Disposal of the System
WARNING
Avoidance of electrical shock, fire, and explosions
■Only use Roche Diagnostics original accessories
(cables, power supply units, battery packs, and spare
parts). Third-party cables, power supply units, and
battery packs can cause the battery pack to explode
or the meter to become damaged.
■Do not use loose power sockets or damaged power
supply units, cables, plugs, or battery packs.
■Do not short circuit the power supply unit, the hand-
held base unit contacts, or the battery pack.
■Do not drop the CoaguChek XS Pro meter, the power
supply unit, or the battery pack and protect these
against shaking and vibrations.
WARNING
Infection by a potentially biohazardous instrument
The CoaguChek XS Pro system or its components must
be treated as potentially biohazardous waste. Decontam-
ination (i.e., a combination of processes including clean-
ing, disinfection and/or sterilization) is required before
reuse, recycling, or disposal.
Dispose of the system or its components according to
the appropriate local regulations.

1• Introduction
16
WARNING
Possible hazards posed by the lithium-ion battery
pack
Damaged or swollen lithium-ion (Li-ion) battery packs
can overheat, catch fire, or leak. Immediately cease use
of CoaguChek XS Pro meters with damaged or swollen
Li-ion battery packs. Under no circumstances recharge
meters with damaged or swollen Li-ion battery packs by
placing them in the handheld base unit or connecting
them to the power adapter.
Overheating can cause the battery pack to catch fire or
explode.
■Never throw the battery pack or the meters onto a
fire. Do not dismantle, compress, or pierce the battery
pack as this could cause an internal short circuit that
leads to overheating.
■Do not place either the battery pack or the
CoaguChek XS Pro meter on or in heating appli-
ances, such as a microwave, conventional oven, or
radiator.
■Avoid prolonged exposure to direct sunlight, e.g.,
when the meter is docked in the handheld base unit.
Keep this in mind when positioning the handheld
base unit.
Battery fluid or materials leaking from damaged battery
packs can irritate your skin or cause burns due to high
temperatures.
■Avoid contact with leaking battery fluid. In the event
of accidental contact with the skin, rinse with water.
If you get battery fluid in your eye(s), you should also
seek medical attention.
Handle and dispose of battery packs with care.
Extreme temperatures reduce the charging capacity
and usage period of the meter and the battery pack.

Introduction • 1
17
General Care
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 accordance with applicable
local regulations and directives. Contact your local
council/local authority or the manufacturer of the used
batteries for advice on correct disposal.
NOTICE Clean the meter only with the solutions recommended
(see page 119). 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.

1• Introduction
18
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
Local Area Network: protection
from unauthorized access
If this product is connected to a local area network, this
network must be protected against unauthorized access.
In particular, it must not be linked directly to any other
network or the Internet. Customers are responsible for
the security of their local area network, especially in pro-
tecting it against malicious software and attacks. This
protection might include measures, such as a firewall, to
separate the device from uncontrolled networks as well
as measures that ensure that the connected network is
free of malicious code.
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 func-
tionality of the display.

Introduction • 1
19
Wired network connection If the Handheld Base Unit from Roche is used to connect
this meter to a local area network, the Handheld Base
Unit must be protected against unauthorized access by
means of a strong password management. Observe
your own facility guidelines on password management
where available, or apply the following rules:
Characteristics of strong passwords
■Passwords must not contain the user’s account
name or parts of the user’s full name that exceed
two consecutive characters.
■Passwords must be at least eight characters in
length.
■Passwords must contain characters from at least
three of the following four categories:
– English uppercase alphabetic characters
(A through Z)
– English lowercase alphabetic characters
(a through z)
–Numeric characters (0 through 9)
–Non-alphabetic characters (for example, !, $, #, %)
Examples of weak passwords
■uhxwze11 contains no upper case letter.
■UHXW13SF contains no lower case letter.
■uxxxxx7F contains the same character more than
four times.
■x12useridF contains a substring of the user ID
longer than four characters.

1• Introduction
20
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 adapter,
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.
Quality control The meter has a number of built-in quality-control func-
tions:
■A check of the electronic components and func-
tions 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, onboard 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 con-
trols are provided to assist with meeting regulatory com-
pliance requirements as applicable to your facility.