Roche CoaguChek XS Plus User manual

CoaguChek®XS Plus
System
User Manual
For meters shipped before January 2013
This is a CLIA waived system.

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.
0 8103062001 (01) August 2016 Revised to add Rx only
statement.

The CoaguChek XS Plus System
3
The CoaguChek XS Plus System
The CoaguChek XS Plus System is used to monitor coagulation (blood-clotting) values
(prothrombin time, PT, Quick value) with CoaguChek XS PT test strips.
Please note: This manual contains the information you need to operate and care for
the CoaguChek XS Plus System. Please read this entire manual carefully before you use
the meter.
CLIA Waived
This is a CLIA Waived test system. A Certificate of CLIA Waiver (or higher) is required to
perform the test. Information on obtaining CLIA certificates can be found at
www.cms.hhs.gov/clia.
Before testing, refer to the appropriate package insert for more complete information.
Laboratories with a certificate of waiver must follow the manufacturer’s instructions for
performing the test. 42 CFR 493.15(e)(1).
Any modifications and/or failure to follow test system instructions, including those for
limitations/intended use and performance of QC testing as a failure alert mechanism, results
in use that is considered high complexity and subject to all applicable CLIA requirements.
All applicable state and local laws must be met.
Any adverse reactions experienced with the use of this product, and/or quality problems
should also be reported to the FDA’s MedWatch Adverse Event Reporting program online
(at www.fda.gov/MedWatch/report.htm), by phone (1-800-FDA-1088), or by returning the
postage-paid FDA form 3500 (which may be downloaded from
www.fda.gov/MedWatch/getforms.htm) by mail to (MedWatch, 5600 Fishers Lane, Rockville,
MD 20852-9787) or fax (1-800-FDA-1078).
If there are any problems with the CoaguChek XS Plus meter, notify CMS at
http://www.cms.hhs.gov/clia/ro-map.asp
The CoaguChek XS Plus System

CoaguChek
®XS Plus
User Manual
Version 3.1
For meters shipped before January 2013
0 8103062001 (01) 2016-08 USA

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 training manual was created by the Roche Diagnostics Engineering Operations Department.
Direct questions or concerns regarding the contents of this document to:
Roche Diagnostics
Engineering Operations Department
9115 Hague Road
P.O. Box 50457
Indianapolis, IN 46250-0457
USA
COAGUCHEK is a trademark of Roche.
All other trademarks are 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
Consult instructions for use
Global Trade Item Number
Rx Only For prescription use only
© 2007-2016, Roche Diagnostics.
US Order Number: 0 8103062001 (01) 2016-08 USA
Distribution in USA by: Roche Diagnostics, Indianapolis, IN
This document is available electronically at www.coaguchek-usa.com.

The CoaguChek XS Plus System
9
Introduction..........................................................................................................................7
The CoaguChek XS Plus System...................................................................................................7
Test principle.........................................................................................................................................8
Contents of the pack..........................................................................................................................8
Safety information...............................................................................................................................9
Operating conditions........................................................................................................................10
Quality control ....................................................................................................................................11
About this manual ........................................................................................................12
Manual format....................................................................................................................................12
The CoaguChek XS Plus meter...........................................................................14
Meter elements overview...............................................................................................................15
Power supply.......................................................................................................................................16
Operating the instrument........................................................................................17
Inserting the batteries......................................................................................................................18
Meter setup .......................................................................................................................19
Display field and symbols .............................................................................................................20
Settings summary ............................................................................................................................23
Conventions used in this manual................................................................................................27
Screen setup ......................................................................................................................................28
Contrast ...............................................................................................................................................28
Units ......................................................................................................................................................29
Language Selection ........................................................................................................................30
Setting the date ................................................................................................................................32
Setting the time ................................................................................................................................33
Setting the display options for date and time ......................................................................34
Options setup .....................................................................................................................................35
Sort ........................................................................................................................................................35
Beeper ..................................................................................................................................................36
Auto off ................................................................................................................................................38
Computer .............................................................................................................................................39
ID setup.................................................................................................................................................40
System Administrator (Admin.) ..................................................................................................41
Operator ...............................................................................................................................................45
Patient ...................................................................................................................................................46
Lockouts setup ..................................................................................................................................48
Operator lockout ..............................................................................................................................49
QC (Quality Control) lockout .......................................................................................................51
The CoaguChek XS Plus System

Testing a capillary blood sample ......................................................................53
Important notes ................................................................................................................................53
Getting a good capillary blood sample ...................................................................................54
Getting a good test with venous whole blood ......................................................................54
Preparing to test ...............................................................................................................................55
Test strip code chip .........................................................................................................................56
Inserting the code chip ..................................................................................................................56
Switching on the meter .................................................................................................................58
Performing a test ..............................................................................................................................60
Optional Quality control ...........................................................................................69
Preparing to run an optional liquid quality control test ....................................................70
Performing an optional liquid quality control test ...............................................................72
Review Results................................................................................................................79
Viewing test results .........................................................................................................................79
Display Patient Result memory ...................................................................................................81
Display QC (Quality Control) memory ......................................................................................82
Cleaning/Disinfecting....................................................................................... 83
Cleaning/Disinfecting the Exterior ............................................................................................83
Cleaning/Disinfecting the Test Strip Guide ...........................................................................84
Error messages...............................................................................................................86
Error messages overview ..............................................................................................................86
Troubleshooting error messages after turning the meter on .........................................90
Troubleshooting error messages when preparing to test ................................................91
Troubleshooting error messages during or after blood application ............................92
Troubleshooting other error messages ...................................................................................94
Further information......................................................................................................97
Ordering ...............................................................................................................................................97
Product limitations ...........................................................................................................................97
Disposing of the instrument ........................................................................................................97
Information about the software license ..................................................................................97
Product specifications............................................................................................105
Operating conditions and technical data ............................................................................105
Sample material ............................................................................................................................. 106
Storage and transport conditions ........................................................................................... 106
Support/Services ...........................................................................................................................106
Repairs ..............................................................................................................................................106
Warranty ..........................................................................................................................107

The CoaguChek XS Plus System
The CoaguChek XS Plus System measures blood-clotting time (prothrombin time) for
people who are taking anticoagulation medications, such as Coumadin®or warfarin. The
CoaguChek XS Plus System measures blood-clotting time using blood from the fingertip or
whole blood from a vein (nonanticoagulated venous whole blood).
The CoaguChek XS Plus System quantitatively measures prothrombin (blood-clotting) time
(PT/Quick value/INR). INR is a measure of the rate at which blood clots. A low INR can
increase the risk of blood clots, while a high INR can increase the risk for internal bleeding.
The patient’s physician will determine the best INR range for that patient, depending on why
the patient is taking anticoagulants and how the patient reacts to them. The doctor will also
determine how often the patient needs blood testing.
The system includes the CoaguChek XS Plus meter and CoaguChek XS PT test strips.
Optional liquid CoaguChek XS Plus PT Controls are also available. The meter guides you
through the test step by step using the symbols 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.
The CoaguChek XS Plus System makes coagulation testing easy. You only need to insert
the code chip, turn the meter on, insert the test strip, and apply a blood sample. The blood
mixes with the ingredients on the test strip, and the meter determines when the blood is
clotted. The meter displays the result in about one minute. After the measurement, the
meter automatically stores the results in memory so you can easily recall them. The patient’s
physician will use these results to successfully treat the patient’s condition.
The CoaguChek XS Plus System also includes data management with security features, such
as the QC (quality control) lockout for use with optional liquid quality controls.
If you need technical help, call Roche Diagnostics Technical Service Center
at 1-800-428-4674, 24 hours a day, 7 days a week, 365 days a year.
Introduction
Introduction
Please 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 carry out
measurements properly.
Each time you replace the batteries you need to check (and, if necessary, adjust) the
date and time.
11

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.
Contents of the pack
nCoaguChek XS Plus meter
nPower adapter
nUser manual
nTraining DVD
nGetting Started Guide
nWarranty Card
nPolicy and Procedure CD
n4 AA Batteries
n5 CoaguChek Lancets
Introduction
12

Safety Information
The CoaguChek XS Plus System
13
Protection against infection
Medical staff using the CoaguChek XS Plus System to perform tests on
patients must be aware that any contact with human blood is a potential
source of infection.
nUse gloves.
nUse a separate lancet and lancing device for each person.
nDispose of used lancets and test strips in a sturdy sharps container
with a lid.
nFollow all health and safety regulations applicable to your laboratory
or practice.
Caution: There is a potential risk of infection. Medical staff and other persons
using the CoaguChek XS Plus Meter to perform tests on more than one patient
must be aware that any object coming into contact with human blood is a
potential source of infection. (See: National Committee for Clinical Laboratory
Standards: Protection of Laboratory Workers from Instrument Biohazards and
Infectious Disease Transmitted by Blood, Body Fluids, and Tissue. Approved
Guideline, NCCLS document M29-A, 1997.) Dispose of used items according to
the disposal policy of your facility.

Operating conditions
To be sure that your CoaguChek XS Plus System functions properly, please observe the
following guidelines:
nOnly use the meter at a room temperature between 59°F and 90°F (15°C and 32°C).
nOnly use the meter at a relative humidity between 10 and 85 percent.
nWhen operating the meter using the power adapter, use only a voltage of 100 V to
240 V (± 10%), 50/60 Hz.
nA touch screen makes the meter easier to operate. To use the touch screen, simply use
your finger (even when wearing gloves) or special pens designed for use with handheld
devices to select a screen prompt. Pointed or sharp objects can damage the touch screen.
Touch lightly, holding until the prompt is selected.
nWhen testing, place the meter on a level, vibration-free surface, or hold it so it is roughly
horizontal.
Introduction
14
Electromagnetic interference
Do not use the meter near strong electromagnetic fields, which could interfere
with the proper operation of the meter.

Quality control
The CoaguChek XS Plus System has a number of built-in quality-control functions.
nA check of the electronic components and functions every time the meter is turned on.
nA check of the test strip temperature while a test is in progress.
nA check of the expiration date and lot information on the test strip carried out by the
code chip.
nA 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 Plus
System. These controls are provided to assist with regulatory compliance requirements as
applicable to your facility.
Introduction
15

Manual format
The layout of this operator’s manual has been specially designed to help you locate the most
important information quickly and easily.
All instructions that require you to actively do something, as well as very important
information, appear on a blue background.
This symbol draws attention to the possible risk of injury or of harm to your health.
Example 1:
The left column contains an illustration The right column states what you should
of the display screen. do at this point.
About this manual
About this manual
16
1Touch PATIENT TEST.

Example 2:
This column contains an illustration of the This column contains information linked to
display screen. the display screen.
The main menu of the CoaguChek XS Plus
System contains buttons for the following
functions:
nPatient Test for performing a test
nControl Test for performing an optional
liquid quality control test
nReview Results to recall results from the
memory
nSetup to edit settings
About this manual
17
Main Menu 09:15 am
09/16/2009
Control Test
Review Results
Setup
Patient Test

The CoaguChek XS Plus meter
The CoaguChek XS Plus meter
18
A
B
C
E
F
J
F
H
I
G
D

Meter elements overview
ATouch screen
Shows results, information, symbols and
results recalled from memory. To select
any of the screen prompts, touch the
prompt lightly, holding until the prompt
is selected.
BOn/Off button
Press and hold this button until the
meter turns on or off.
CTest strip guide cover
Remove this cover to clean the test strip
guide. (REF 05039657001)
DTest strip guide
Insert the test strip here.
EBattery cover
Covers the battery compartment
(four standard AA batteries or a
rechargeable battery pack).
FBattery cover tab
Press tab to slide cover off.
GCode chip slot with
code chip
Insert the code chip here.
HConnection socket for
power adapter
Plug in the power adapter here.
IContacts for optional
base unit
Charges battery pack when connected
to base unit.
JInfrared interface
Used for data communication.
The CoaguChek XS Plus meter
19

Power supply
The CoaguChek XS Plus meter can operate with either the power adapter provided, batteries,
or a special rechargeable battery pack (REF 04805640001). The CoaguChek XS Plus System
uses four AA batteries. The batteries should last for about 60 tests, depending on the type of
battery used. You should insert the batteries or 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 Plus meter has the option to automatically turn itself off
based on your setup selections, unless a screen prompt has been pressed or a new test strip
has been inserted. The default setting is set to OFF. When the meter turns 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 in the chapter entitled Options setup.)
During battery operation, the meter always
displays the battery power level.
The meter retains results in memory even when no batteries are inserted. All other settings,
other than date and time after 10 minutes, are retained as well.
The CoaguChek XS Plus meter
20
Main Menu 09:15 am
09/16/2009
Control Test
Review Results
Setup
Patient Test
When replacing the batteries, you must
insert the new batteries within 10 minutes
of removing the old ones, to keep the
date and time settings. If you take longer
than this, you may need to re-enter the
date and time. To make sure that you
do not lose your date and time settings,
connect the power adapter while you
change the batteries.