Version 2.0 2010-04Update cleaning/disinfection, minor revisions
Version 2.1 2016-08Revised to add Rx only statement.
US Supplement
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.
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.
3
US Supplement
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
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.
®
products. Meters which
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.
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
LOT
Batch code/ Lot number
Catalog number
IVD
In vitro diagnostic medical device
Global Trade Item Number
Consult instructions for use
Rx onlyFor prescription use only
6
1 Introduction 11
Before you start.........................................................................................................................................
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
Quality control ................................................................................................................................... 17
2 The CoaguChek XS Pro Meter 18
Overview of the meter elements
Buttons and icons overview ................................................................................................................. 20
Power supply.............................................................................................................................................. 23
3 Putting the Meter into Operation 24
Inserting the batteries
Powering the meter on and off........................................................................................................... 26
Result Units ........................................................................................................................................ 33
Language Selection......................................................................................................................... 35
Setting the date................................................................................................................................. 36
Setting the time................................................................................................................................. 38
Setting the display options for date and time ....................................................................... 40
Auto Off................................................................................................................................................ 47
ID setup........................................................................................................................................................ 51
System Administrator (Admin.)................................................................................................... 53
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
The CoaguChek XS
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 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 according to your needs before initial use. Refer
to chapter 4, Meter Setup. Be sure to read the Safety information and additional information section in this chapter before operating the system.
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.
Pro system (CoaguChek XS Pro meter and CoaguChek XS PT Test strips)
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.
11
Introduction
What can the system do for you?
The CoaguChek XS Pro system makes coagula
tion 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 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.
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 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, 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 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, seconds) and the result is displayed.
12
Introduction
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 promote awareness to hazards which are generic or to direct the reader to
related safety information
Indicates a hazardous situation which, if not avoided, could result in
WARNING
CAUTION
death or serious injury.
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
13
Introduction
Safety Information
Operator qualification
Only trained healthcare professionals ma
Pro system. Operators must have received comprehensive instruction in
the operation, quality control, and care of the CoaguChek XS Pro system.
Protection against infection
There is a potential risk of infection. Healthcare professionals using the
WARNING
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
■Follow all health and safety regulations in force locally.
Disposal of the System
y operate the CoaguChek XS
control policy.
14
WARNING
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.
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 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.
General Care
Introduction
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.
Laser Scanner
The built-in barcode scanner emits a laser beam when activ
ated.
The built-in barcode scanner is a Class 1 laser, according to EN 60825-1:2007.
A barcode does not need to be present for the laser scanner to become
active. Do not stare directly into the laser beam.
WARNING
Electromagnetic Interference
Do not use the meter near strong electromagnetic fields, which could
interfere with the proper operation of the meter.
Touchscreen
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.
15
Introduction
Operating conditions
o ensure that the meter functions properly, please observe the following guidelines:
T
■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.
16
Introduction
Quality control
The meter has a number of built-in quality
■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
-control functions:
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.
17
The CoaguChek XS Pro Meter
2The CoaguChek XS Pro Meter
B
C
D
A
E
G
F
18
HKL
IJ
Overview of the meter elements
The CoaguChek XS Pro Meter
A Touchscreen
Shows test results, information, icons, and
results recalled from memory. To select an
option, simply touch the button lightly.
B On/Off button
Press and hold this button to pow
meter on or off.
C Test strip guide cover
Remove this cover to clean the test strip
guide (if it has become soiled, e.g., with
blood).
D Test strip guide
Inser
t the test strip here.
E Barcode scanner (Laser)
The integra
operator and patient IDs into the meter.
F Tab for battery compartment cover
ted barcode scanner can read
er the
G Battery compartment cover
vers the battery compartment
Co
(4 standard AA alkali-manganese
batteries or a rechargeable battery pack
(optional)).
H Charging terminals
Used for pow
the battery pack, when the meter is
docked in the (optional) Handheld Base
Unit.
ICode chip slot
Inser
t the code chip here.
JConnection socket for power adapter
Plug in the pow
K Infrared interface
vered by the semi-transparent panel)
(Co
Supports data communication.
L Reset button
Use this button to reset the meter in case
of software or power-up errors.
er supply and/or charging
er adapter here.
19
The CoaguChek XS Pro Meter
Buttons and icons overview
The buttons and icons that appear during normal operation are shown here, along with their
respective meanings.
IconMeaning
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
20
Remove test strip
Apply sample (the time left to apply sample is counted down in the
display)
180 SEC
Apply liquid control (QC) sample (the time left to apply sample is
counted down in the display)
180 SEC
IconMeaning
t the test strip code chip
Inser
The CoaguChek XS Pro Meter
QC
%Q
Sec
INR
QC
Insert the QC code chip
Automatic quality control completed successfully
Results are displayed as a Quick percentage value
Results are displayed in seconds
Results are displayed in INR units
Result in the chosen unit of measure is above the measuring range.
Result in the chosen unit of measure is below the measuring range.
Quality control: Result is above the specified range
Quality control: Result is below the specified range
Battery status:
• When the batteries still have their full charge, all segments are lit.
• Individual segments disappear one by one as the batteries
become weaker.
• When there is no segment remaining, you can no longer perform
a test. You can, however, still access the meter's memory.
Operation with power supply adapter
am
pm
Time between midnight and noon (in 12-hour time format)
Time between noon and midnight (in 12-hour time format)
Room or meter temperature is outside the acceptable range
The test strip guide cover is open
Communication is taking place via the infrared interface
21
The CoaguChek XS Pro Meter
Error messages and the description of the icons linked to them are pro
Troubleshooting chapter of this manual.
IconMeaning
Reports a warning message
Reports an error (see: Troubleshooting)
Reports a serious error (see: Troubleshooting)
vided in the
22
The CoaguChek XS Pro Meter
Power supply
The CoaguChek XS Pro meter can operate with either the power adapter provided, batteries, or a
special rechargeable battery pack (optional). The CoaguChek XS Pro meter uses four standard
type AA alkaline batteries. You should insert the batteries or the optional rechargeable battery
pack even when you use the power adapter. This ensures that you will not lose the date and time
settings if the power goes out.
To save power, the CoaguChek XS Pro meter has the option to automatically power itself off
based on your setup selections, unless a button has been pressed or a new test strip has been
inserted. The default setting is set to 5 minutes. When the meter powers itself off, all results
obtained up to that point remain in memory and the settings will still be there when you power
the meter back on. (Refer to Auto Off on page 47.)
Main Menu
Patient Test
Control Test
Review Results
09:15 am
During battery operation, the meter always
displays the battery power level.
When replacing the batteries you must insert
the new batteries within ten (10) minutes of
removing the old ones to keep the date and
time settings. If you take longer than this, you
must re-enter the date and time.
To make sure that you do not lose your date
and time settings, connect the power supply
unit while you change the batteries.
Setup
03/16/2010
The meter retains results in memory even when no batteries are inserted. All settings other than
date and time (deleted after 10 minutes without power) are retained as well.
Dispose of used batteries in an environmentally responsible manner and in accordance with
applicable local regulations and directives.
23
Putting the Meter into Operation
3Putting the Meter into Operation
Before using the meter for the first time, perform the following steps:
1Insert batteries and/or connect the power supply unit
2Set the current date and time
3Enter the settings of choice (language, unit of measure, user administration if applicable,
etc.)
Instead of batteries, you can use a special rechargeable battery pack. If you choose this option,
order the pack separately from Roche Diagnostics. To recharge, connect the power adapter to
the CoaguChek XS Pro meter or to the optional Handheld Base Unit (HBU) and dock the
meter.
The meter’s battery power level indicator is designed for use with either standard, nonrechargeable AA batteries or the dedicated Roche handheld battery pack. We do not recommend the use of off-the-shelf rechargeable batteries in AA format. These have lower voltages
than standard AA batteries or the special Roche handheld battery pack. This can lead to incorrect battery power level indications on the meter.
24
Inserting the batteries
Putting the Meter into Operation
1 With the meter powered off, press the
battery compartment cover release tab
and slide the cover off.
2 Insert the four batteries in the battery
compartment as indicated.
The batteries should last about 80 tests,
depending on the type of battery used.
25
Putting the Meter into Operation
Powering the meter on and off
3 Slide the battery compartment back onto
the meter and close it.
The meter powers itself on after the
batteries have been inserted.
1 Place the meter on a level, vibration-free
surface, or hold it in your hand so it is
roughly horizontal.
2 Power the meter on by pressing and
holding the button for approximately
1 second.
26
You can also power on the meter directly by
inserting a test strip or connecting the power
adapter.
3 To power the meter off after use, press the
button for approximately 2 seconds.
Meter Setup
4Meter Setup
Note on presentation of screen elements in this manual
Buttons are screen prompts that cause something to happen when touched. The names of all
buttons are either shown as bold text or as the icon used on the button (e.g., for OK ).
Other screen elements (e.g., Menu titles) are written in italics. These screen elements are not
active.
If you have not set the date and time (after powering on for the first time or because the batteries were removed from the meter for more than 10 minutes), you cannot perform a test. In
that case powering on the meter takes you immediately to the Setup mode, where you must
set the date and time (see page 36 and following).
After date and time have been set, the meter automatically moves to the Main Menu, where
you can start a test or enter more settings.
You can open any displayed function by
touching (or tapping) the button for it with
your finger (or a special pen for this purpose).
“Tap” means: Touch the button, then remove
your finger from the touchscreen. The next
screen appears once you remove your finger.
Main Menu
03/16/20
Patient Test
Control Test
Review Results
Setup
10
09:15 am
Setup Menu
03/16/20
Screen
Options
ID Setup
Lockouts
10
09:15 am
If the meter did not automatically enter the
Setup mode (e.g., after the batteries were
replaced), you can open the Setup menu from
the Main Menu.
1 Touch Setup to open the meter settings.
2 Select the group of settings of choice (see
the Settings summary following this
section.).
27
Meter Setup
Settings summary
The diagram below shows all of the setup areas that can be accessed on the meter.
Setup
Screen
LanguageUnitsContrastDate/Time
Options
Auto OffBeeperSortComputer
ID Setup
28
PatientAdmin.Operator
Lockouts
QC LockoutOperator Lockout
GroupSubgroupSettingValues *
Screen
Contrast0 – 10 (5 *)
Result UnitsINR *
INR/SEC
INR/%Q
Language SelectionDansk
Deutsch
English *
Español
Français
Italiano
Nederlands
Norsk
Português
Svenska
Date/TimeDate01/01/2005 *
Time12:00 am *
Date formatsDD.MM.YYYY (16.09.2009)
MM/DD/YYYY (09/16/2009) *
YYYY-MM-DD (2009-09-16)
Time formats24-hour time format (24h)
12-hour time format (12h), with
am/pm *
Meter Setup
* Default settings are labelled with an asterisk (*).
29
Meter Setup
GroupSubgroupSettingValues *
Options
SortDate/Time *
Beeper
Auto Off[minutes]Off
ComputerActive
BeeperOff
Key ClickOff *
Patient ID number
Low
Medium *
High
On
1 … (5*) … 10
15
20
25
30
40
50
60
Inactive *
* Default settings are labelled with an asterisk (*).
30
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