Roche CoaguChek XS Plus User manual

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

0 5021464001 (05) 2012-05 USA
Operator’s Manual
CoaguChek XS Plus
®

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The contents of this manual, including all graphics and photographs, are the property of Roche
Diagnostics. No part of this document may be reproduced or transmitted in any form or by any
means, electronic or mechanical, for any purpose, without the express written permission of
Roche Diagnostics.
Roche Diagnostics has made every reasonable effort to ensure that all the information contained
in this manual is correct at the time of printing. However, Roche Diagnostics reserves the right to
make any changes necessary without notice as part of ongoing product development.
This manual was created by the Roche Diagnostics Commercial Education department. Direct
questions or concerns regarding the contents of this document to:
Roche Diagnostics
Commercial Education Department
9115 Hague Road
P.O. Box 50457
Indianapolis, IN 46250-0457
USA
ACCU-CHEK, COAGUCHEK and SAFE-T-PRO are trademarks of Roche.
All other trademarks are the property of their respective owners.
© 2007-2012 Roche Diagnostics.
US Order Number: 0 0521464001 (05) 2012-05 USA
This document is available electronically at www.poc.roche.com

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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

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Revisions to this document are provided by Roche Diagnostics when necessary. No part of this
document may be reproduced in any form or by any means without prior written consent.
Manual version Revision date Changes
05021464001 (01) June 2009 New document
05021464001 (02) November 2009 Revised for new firmware, claims changes, and
new cleaning recommendations
05021464001 (03) May 2010 Revised for CLIA waiver
05021464001 (04) August 2010 Revised for CLIA waiver re submission
05021464001 (05) May 2012 Revised for new firmware and minor revisions

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1 Introduction 11
Before you start......................................................................................................................................... 11
Intended use ...................................................................................................................................... 11
Important information regarding use ....................................................................................... 11
If you need help................................................................................................................................ 12
General note....................................................................................................................................... 12
What can the system do for you? .............................................................................................. 12
Test principle ..................................................................................................................................... 13
Important safety instructions and additional information......................................................... 14
Safety Information............................................................................................................................ 16
Disposal of the System................................................................................................................... 17
General Care...................................................................................................................................... 18
Electromagnetic Interference ...................................................................................................... 18
Touchscreen....................................................................................................................................... 18
Operating conditions ...................................................................................................................... 19
Quality control ................................................................................................................................... 19
2 The CoaguChek XS Plus Meter 20
Overview of the meter elements......................................................................................................... 21
Buttons and icons overview ................................................................................................................. 22
Power supply.............................................................................................................................................. 24
3 Putting the Meter into Operation 26
Inserting the batteries ............................................................................................................................ 27
Powering the meter on and off........................................................................................................... 28
Checking the software version ................................................................................................... 29
4 Meter Setup 31
Note on presentation of screen elements in this manual................................................. 31
Settings summary ................................................................................................................................... 32
Screen setup .............................................................................................................................................. 36
Contrast ............................................................................................................................................... 36
Result Units ........................................................................................................................................ 37
Result Confirmation......................................................................................................................... 39
Language Selection......................................................................................................................... 40
Setting the date................................................................................................................................. 41
Setting the time................................................................................................................................. 43
Setting the display options for date and time ....................................................................... 45
Options setup ........................................................................................................................................... 47
Sort ........................................................................................................................................................ 47
Beeper .................................................................................................................................................. 49
Auto Off ............................................................................................................................................... 52
Connection ......................................................................................................................................... 54

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ID setup........................................................................................................................................................ 56
System Administrator (Admin.)................................................................................................... 58
Operator ID ........................................................................................................................................ 64
Patient ID ............................................................................................................................................ 65
QC Settings setup .................................................................................................................................... 68
QC Range ............................................................................................................................................ 69
QC (quality control) Lockout........................................................................................................ 72
Operator Lockout ............................................................................................................................. 74
5 Testing a Blood Sample 77
Important notes......................................................................................................................................... 77
Getting a good capillary blood sample .................................................................................... 79
Getting a good result from venous whole blood.................................................................. 79
Preparing to test ....................................................................................................................................... 80
Test strip code chip ......................................................................................................................... 81
Inserting the code chip .................................................................................................................. 81
Powering on the meter................................................................................................................... 83
Performing a test...................................................................................................................................... 86
Accepting or rejecting a test result ........................................................................................... 94
Adding comments............................................................................................................................ 95
6 Control Testing and Quality Control 97
Preparing to run a liquid quality control test................................................................................. 98
Performing a liquid quality control test......................................................................................... 100
7 Review Results 109
Viewing test results .............................................................................................................................. 110
Display patient result memory.................................................................................................. 112
Display QC (quality control) result memory ........................................................................ 113
8 Extended Functionalities 115
Data handling ......................................................................................................................................... 115
Computer (Setup option)............................................................................................................ 115
Operator lists................................................................................................................................... 116
Patient lists....................................................................................................................................... 117
Stored test results and comments .......................................................................................... 118
9 Cleaning and Disinfecting the Meter 119
Recommended cleaning/disinfecting solutions ........................................................................ 119
Cleaning/disinfecting the exterior (meter housing)................................................................. 120
Cleaning/disinfecting the test strip guide.................................................................................... 121
10 Troubleshooting 123
Additional information on Error 406....................................................................................... 124
Errors and unusual behavior without error messages .................................................... 125

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11 General Product Specifications 127
Technical data ........................................................................................................................................ 127
Sample material............................................................................................................................. 127
Storage and transport conditions ........................................................................................... 128
Further Information .............................................................................................................................. 128
Ordering .......................................................................................................................................... 128
Reagents and solutions .............................................................................................................. 128
Product limitations........................................................................................................................ 128
Repairs .............................................................................................................................................. 128
Information about software licenses .................................................................................... 129
12 Warranty 136
13 Appendix 137
Contact Roche ....................................................................................................................................... 137
14 Supplement for Observed Test Sequence 139
Observed Test Sequence (OTS) ............................................................................................. 139
Using the OTS function............................................................................................................... 140
Index 143

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Introduction
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1 Introduction
Before you start
Intended use
The CoaguChek®XS Plus is intended for use by professional healthcare providers for quantita-
tive prothrombin time testing for the monitoring of warfarin therapy. The system uses fresh
capillary or non-anticoagulated venous whole blood.
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 Plus meter according 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 measurements properly. Each
time you replace the batteries you need to check (and, if necessary adjust) the date and
time.

Introduction
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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 Plus system that are not answered in this manual,
contact your Roche representative or Roche Diagnostics Technical Service. In order to expedite
troubleshooting, please have ready your CoaguChek XS Plus meter, its serial number, this man-
ual, 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 incorporated in the next edition. If there is any conflict of information, the pack-
age insert included with the CoaguChek XS PT Test strips shall prevail.
What can the system do for you?
The CoaguChek XS Plus 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 Plus 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
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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 Plus meter has the ability to connect to a data management system (DMS)
through the Handheld Base Unit from Roche (available separately). The CoaguChek XS Plus
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, used as directed with the CoaguChek XS Plus meter, will provide an
electrochemical measurement of prothrombin time following activation of blood coagulation with
human recombinant thromboplastin. In simple terms, blood works with the chemicals in the test
strip to make a small electric current in the test strip that measures blood-clotting time.

Introduction
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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 Plus 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 aware-
ness 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 presented against a colored background
(without a symbol). Here you will find additional information on correct use of the meter or
useful tips.

Introduction
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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.

Introduction
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Safety Information
Operator qualification
Only trained healthcare professionals may operate the CoaguChek XS
Plus system. Operators must have received comprehensive instruction in
the operation, quality control, and care of the CoaguChek XS Plus
system.
WARNING
Protection against infection
There is a potential risk of infection. Healthcare professionals using the
CoaguChek XS Plus 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 an auto-disabling single-use lancing device for each patient.
■Dispose of used lancets and needles 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
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Disposal of the System
WARNING
Any product coming in contact with blood is considered contami-
nated (potentially infectious).*
During normal testing, any meter may come in contact with blood.
Lancing devices may also be considered sharps. Disposal of
sharps is regulated by law in many jurisdictions.
The European Union has a requirement for improving waster manage-
ment practices for certain electronic equipment, but meters fall outside
the scope of the European Directive 2002/96/EC** This is not a require-
ment for the U.S.A.; however, Roche is committed to recycling and sus-
tainability. Comply with any laws or ordinances relating to the disposal of
sharps and/or contaminated products. Contact your local health depart-
ment or other appropriate authorities for proper handling and disposal of
used meters, used test strips, used lancets, and used batteries. Please
consider the following points when disposing of your used testing mate-
rials:.
Consider recycling of the meters and batteries at an appropriate facility.
Be aware the meter is potentially hazardous electronics scrap (e-scrap)
and should be disposed of accordingly. The batteries are potentially haz-
ardous also and should be disposed of accordingly.
Disinfect the meter before recycling or disposing.
*29 CFR 1910.1030 - Bloodborne pathogens
**Directive 2002/96/EC - Directive on waste electrical and electronic
equipment (WEEE)
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 accord-
ance 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
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General Care
Electromagnetic Interference
Touchscreen
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.
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
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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 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, 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 Plus
system. These controls are provided to assist with meeting regulatory compliance requirements
as applicable to your facility.

The CoaguChek XS Plus Meter
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2 The CoaguChek XS Plus Meter
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