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 lotspecific 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
n CoaguChek XS Plus meter
n Power adapter
n User manual
n Training DVD
n Getting Started Guide
n Warranty Card
n Policy and Procedure CD
n 4 AA Batteries
n 5 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.
n Use gloves.
n Use a separate lancet and lancing device for each person.
n Dispose of used lancets and test strips in a sturdy sharps container
with a lid.
n Follow 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:
n Only use the meter at a room temperature between 59°F and 90°F (15°C and 32°C).
n Only use the meter at a relative humidity between 10 and 85 percent.
n When operating the meter using the power adapter, use only a voltage of 100 V to
240 V (± 10%), 50/60 Hz.
n A 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.
n When 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.
n A check of the electronic components and functions every time the meter is turned on.
n A check of the test strip temperature while a test is in progress.
n A check of the expiration date and lot information on the test strip carried out by the
code chip.
n 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 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
1 Touch 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:
n Patient Test for performing a test
n Control Test for performing an optional
liquid quality control test
n Review Results to recall results from the
memory
n Setup 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
A Touch 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.
B On/Off button
Press and hold this button until the
meter turns on or off.
C Test strip guide cover
Remove this cover to clean the test strip
guide. (REF 05039657001)
D Test strip guide
Insert the test strip here.
E Battery cover
Covers the battery compartment
(four standard AA batteries or a
rechargeable battery pack).
F Battery cover tab
Press tab to slide cover off.
G Code chip slot with
code chip
Insert the code chip here.
H Connection socket for
power adapter
Plug in the power adapter here.
I Contacts for optional
base unit
Charges battery pack when connected
to base unit.
J Infrared 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.
Before using the meter for the first time, carry out the following steps:
1 Insert batteries* and/or connect the power adapter.
2 Set the current date and time.
3 Enter 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 Plus meter.
Operating the instrument
Operating the instrument
21
Inserting the batteries
Operating the instrument
22
1 With the meter turned 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 CoaguChek XS Plus System uses
AA batteries. The batteries should last
about 60 tests, depending on the type
of battery used.)
3 Slide the battery compartment back
onto the meter and close it.
The meter turns itself on after the
batteries have been inserted.
Meter setup
You can call up any displayed function by
touching the screen prompt for it with your
finger (or a special pen for this purpose).
Touch the screen lightly, holding until the
prompt is selected.
If the meter did not automatically enter the
SETUP mode (e.g., after the batteries were
replaced), you can call up the SETUP menu
from the main menu.
The following screen prompts are used in the
Setup menus:
n SCREEN for changing the way the
display looks
n OPTIONS for setting SORT, BEEPER,
AUTO OFF, and COMPUTER options
n ID SETUP for user management and
patient management options
n LOCKOUTS for optional liquid quality
control options
Meter setup
1 Touch the SETUP screen prompt to
call up the meter settings.
2 Select the group of settings of choice.
Please note: If you have not set the date and time (after turning the meter 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, turning on the meter takes you
immediately to the Setup mode, where you must set the date and time.
Once the date and time are set, the meter automatically moves to the main menu, where
you can start a test or enter more settings. The next time you turn the meter on, the date
and time will remain and you will automatically go to the main menu.
Main Menu
09:15 am
09/16/2009
Control Test
Review Results
Setup
Patient Test
Setup Menu
09:15 am
09/16/2009
ID Setup
Lockouts
Options
Screen
23
Meter setup
24
Display field and symbols
The screen prompts that appear during normal operation are shown here, along with their
meaning. Error messages and the description of the symbols linked to them are provided in
the chapter entitled Error messages.
Symbol Meaning
OK, Save setting
Cancel, discard setting
Return (to previous menu)
Reduce/increase the value displayed
Move screen contents
List of tests of a specific patient
Scroll through the list
Operator must wait until the meter has completed an action.
Test strip
Insert test strip
Remove test strip
Meter setup
25
Symbol Meaning
180 SEC
Apply blood sample (the time left to apply sample is counted
down in the display)
180 SEC
Apply QC sample (the time left to apply sample is counted down
in the display)
Insert the code chip
QC
Automatic quality control completed successfully
%Q
Results are displayed as a Quick percentage value.
Sec
Results are displayed in seconds.
INR
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/below the specified range.
26
Meter setup
Symbol Meaning
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. However, test results are still
saved in memory.
Operation with power supply adapter
am
Time between midnight and noon (in 12-hour time format)
pm
Time between noon and midnight (in 12-hour time format)
Reports a warning message
Reports an error (see: Error messages)
Reports a serious error (see: Error messages)
Room or meter temperature is outside the acceptable range.
The cover on the test strip guide is open.
Communication is taking place via the infrared interface
Meter setup
27
Settings summary
The diagram below shows all of the SETUP areas that can be accessed on the meter.
Setup
Screen
LanguageUnitsContrast Date/Time
Options
Auto OffBeeperSort Computer
ID Setup
PatientAdmin. Operator
Lockouts
QC LockoutOperator Lockout
Meter setup
28
Group Subgroup Setting Values *
SCREEN CONTRAST 0 - 10 (5 *)
RESULT UNITS INR *
INR/SEC
INR/%Q
LANGUAGE Dansk
Deutsch
English *
Español
Français
Italiano
Nederlands
Norsk
Português
Svenska
DATE/TIME SET DATE 01/01/2005 *
SET TIME 12:00 AM *
Date formats Day.Month.Year (12.06.2006)
Month/Day/Year (06/12/2006) *
Year-Month-Day (2006-06-12)
Time formats 24-hour time format (24h)
12-hour time format (12h),
with am/pm *
* Settings that are in the meter when it leaves the factory are labeled with an asterisk (*).
Meter setup
29
Group Subgroup Setting Values *
OPTIONS SORT DATE/TIME *
PATIENT ID NUMBER
BEEPER BEEPER OFF
LOW
MEDIUM *
HIGH
KEY CLICK OFF *
ON
AUTO OFF [minutes] OFF *
1 … (5)* … 10
15
20
25
30
40
50
60
COMPUTER ACTIVE
INACTIVE *
* Settings that are in the meter when it leaves the factory are labeled with an asterisk (*).
Meter setup
30
Group Subgroup Setting Values *
ID SETUP Admin. (Administrator) Blank (off) *
OPERATOR (Operator list is optional) Blank (off) *
PATIENT NO
OPTIONAL *
MANDATORY
LOCKOUTS OPERATOR LOCKOUT (only if the Operator OFF *
option is set to Action and an operator list WEEKLY
is available) MONTHLY
EVERY 3 MONTHS
EVERY 6 MONTHS
YEARLY
QC LOCKOUT NEW CODE YES
NO *
GENERAL NO *
DAILY
WEEKLY
MONTHLY
* Settings that are in the meter when it leaves the factory are labeled with an asterisk (*).
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