Roche | CoaguChek XS System | User manual | Roche CoaguChek XS System User manual

®
CoaguChek XS
System
User Manual
This is a CLIA waived system.
Table of Contents
About this Manual .............................................................................................1
Symbols and Abbreviations ...........................................................................1
User Resources ...................................................................................................2
Video.......................................................................................................................2
Getting Started ...................................................................................................2
User Manual........................................................................................................2
Test Strip Package Inserts..............................................................................2
The CoaguChek XS System..........................................................................3
Anticoagulation Medication..........................................................................3
Blood-clotting Time ..........................................................................................3
How the System Works ...................................................................................4
The CoaguChek XS Meter .............................................................................5
Operating Conditions.......................................................................................6
Getting Started.....................................................................................................7
Batteries ................................................................................................................7
Installing (or Replacing) Batteries ..............................................................8
Meter Setup.........................................................................................................9
Setting the Date and Time.............................................................................9
Code Chip ..........................................................................................................12
Inserting a New Code Chip.........................................................................12
Integrated Quality Controls .........................................................................14
Testing a Blood Sample ...............................................................................15
Tips for a Good Fingerstick.........................................................................15
Important Notes about Blood Testing.....................................................16
Always ............................................................................................................16
Never...............................................................................................................16
Infection Control .........................................................................................17
Preparing for a Test........................................................................................18
Performing a Test ............................................................................................20
Out of Range Values......................................................................................24
Optional Testing Methods............................................................................25
Using Capillary Tubes...............................................................................25
Using Venous Blood..................................................................................28
About this Manual
Memory .................................................................................................................30
Storing Test Results in Memory ................................................................30
Reviewing Stored Test Results...................................................................30
Erasing Stored Test Results ........................................................................32
Cleaning the Meter ........................................................................................34
Cleaning the Exterior .....................................................................................34
Cleaning the Test Strip Guide ....................................................................35
Advanced Features .........................................................................................37
Setting Advanced Features .........................................................................38
Symbols and Abbreviations
The test strip insert, the label on the back of the meter, the User
Manual, and other packaging material may contain the following
symbols or abbreviations:
Use by/Expiration date
Lot number
The Meter’s Display .......................................................................................39
Error Messages.................................................................................................40
Error Messages You May See After You Apply Blood .....................44
For in vitro diagnostic use
Other Information............................................................................................48
Ordering Information for Health Care Professionals.........................48
Product Limitations ........................................................................................48
Product Specifications ..................................................................................49
Support/Services.............................................................................................50
Symbols...............................................................................................................51
Warranty .............................................................................................................54
This product fulfills the requirements of Directive
98/79/EC on in vitro diagnostic medical devices
Catalog number
Please read instructions for use
Caution (refer to accompanying documents).
Please refer to safety-related notes in the manual
accompanying this instrument
Manufacturer
Store at
1
User Resources
Several resources are available to help you use and maintain the
CoaguChek XS System.
Video (DVD Format)
The CoaguChek XS System Video is for new users of the
CoaguChek XS System. The video will help you get comfortable
with the CoaguChek XS Meter and the testing procedure.
Getting Started
The Getting Started guide shows you how to perform your first
coagulation test on the CoaguChek XS Meter.
User Manual
This CoaguChek XS System User Manual is a comprehensive guide
to the meter and test strips. It is designed to provide answers to
your questions about the meter’s operation and use. Read this
entire manual carefully, and refer to it as necessary.
Test Strip Package Inserts
The CoaguChek XS System
The CoaguChek XS System is intended for use by professional
healthcare providers for quantitative prothrombin time testing for
the monitoring of warfarin therapy. The CoaguChek XS System
uses fresh capillary or nonanticoagulated venous whole blood.
Anticoagulation Medication
Anticoagulation medications, also known as blood thinners, are
prescribed to avoid unwanted clots. Blood-clotting time must be
monitored to ensure that a patient’s medication dosage is correct.
Blood-clotting Time
The rate at which blood clots is measured in units called INR. It is
very important for patients to stay within their target INR range. If
the INR is too low, the risk of blood clots increases. If the INR is
too high, the risk for internal bleeding increases.
Everyone’s INR is different. The patient’s doctor determines the
best INR range for the patient, depending on why the patient is
taking anticoagulants and how the patient reacts to them. The
doctor also determines how often the patient’s blood should be
tested. The doctor needs to know the patient’s blood-clotting time
in order to successfully treat the patient.
Be sure to read the test strip package insert for important
updates and keep the insert from your current test strip package
for future reference.
2
3
How the System Works
The CoaguChek XS System includes a meter and CoaguChek XS
PT test strips. Each box of test strips has its own code chip that
you insert into the meter. The code chip contains important
information about the test strips such as their expiration date and
lot number. The meter and test strips work together to provide a
safe and reliable system for testing blood-clotting time.
The CoaguChek XS System makes measuring blood-clotting time
easy. The display on the meter guides you through the testing
process. With the code chip inserted in the meter, you simply insert
a test strip and apply a blood sample. The meter displays the result
in about a minute. The meter automatically stores the result in
memory so that you can easily recall results.
The CoaguChek XS PT test strip contains various ingredients.
When a blood drop is applied, the meter starts the test and the
blood mixes with the ingredients on the test strip. When the meter
determines that the blood has clotted, it stops the measurement
and calculates the result.
The CoaguChek XS Meter
A
B
C
D
E
DDisplay
AM (Memory) Button
ON-OFF Button
Test Strip Guide Cover
Test Strip Guide
F Battery Compartment Cover
G Code Chip Slot
H SET Button
I Data Port
A
F
B
G
C
D
E
H
I
4
5
Getting Started
Operating Conditions
To ensure that the CoaguChek XS Meter functions correctly,
follow these guidelines:
• Use the meter at room temperature, between 65°F and 90°F
(18°C and 32°C).
• Use the meter at a relative humidity of less than 85%,
without condensation.
Refer to the Getting Started guide to learn how to set up the meter
and prepare for and run your first blood-clotting-time test.
Batteries
The CoaguChek XS Meter uses 4 AAA batteries. The
recommended batteries, alkaline-manganese batteries, should
last for approximately 60 tests.
• Do not use the meter at an altitude higher than 14,000 feet
(4,300 meters).
When you turn the meter on, the display briefly
shows the battery symbol. The battery symbol is
divided into 4 segments. With new, fresh
batteries in the meter, the battery symbol shows
all 4 segments.
• Do not use the meter near a strong magnetic field, such as
a microwave oven, as this may interfere with the meter’s
proper operation.
When only 1 segment appears, replace the
batteries. When only 1 segment appears you can
still access results stored in the meter’s memory.
Note: The CoaguChek XS Meter automatically shuts off after
3 minutes if no buttons have been pushed.
If you insert new batteries within 1 minute of removing the old
batteries, the date and time settings will remain in memory. But if
you do need to reset the date and time, refer to the Meter Setup
section in this manual.
• When testing, keep the meter level.
• If you store the meter for a period of time, remove the batteries.
The meter saves battery power by automatically turning off after 3
minutes, unless you press a button or insert a test strip. Even when
the batteries are removed, the test results are saved in memory.
6
7
Installing (or Replacing) Batteries
Meter Setup
Have ready 4 AAA batteries.
1. Open Battery Compartment
With the meter turned off, turn
it over. Press the latch gently
inward and lift the cover.
Remove the old batteries,
if necessary.
The CoaguChek XS Meter is preset with the U.S. date format
(month-day-year) and U.S. time format (12-hour as opposed to
24-hour).
Before you use the meter for the first time—or if there is no battery
power for more than 1 minute—you’ll have to set the current date
and time. In addition, the meter has certain advanced features that
you can set up if you plan to use them. See the Advanced Features
section in this manual to learn more about the advanced features
and how to set them up.
Setting the Date and Time
2. Insert New Batteries
Position the batteries
according to the diagram
inside the battery
compartment. Replace
the cover. Turn the meter
back over.
The date and time settings are important. Each time you run a test,
the meter compares its date with the test strip’s expiration date. If
the test strips are expired, the meter displays an error message
and prevents you from running a test.
Whenever you put batteries in the meter, it automatically goes to
Setup mode (where you set the date and time). You can also go to
Setup mode at any time by pressing the SET button
.
To set the date and time, you’ll use these buttons:
3. Turn Off
8
Turn the meter off
.
•
to change a setting.
•
to accept a setting.
9
1. Go to Setup Mode
If the meter is not already in
Setup mode, press the SET
button
.
The time format flashes in the
upper-left corner.
3. Set Current Time
Press the SET button
.
Press the M button
to
change the hour. Press the
SET button
.
The date format flashes in the
upper-right corner.
Press the M button
to
change the minutes. Press the
SET button
.
2. Set Today’s Date
Press the SET button
.
4. Turn Off
Turn the meter off
.
Press the M button
to
change the year. Press the
SET button
.
Press the M button
to
change the month. Press the
SET button
.
Press the M button
to
change the day. Press the
SET button
.
10
11
Code Chip
2. Match Codes
Make sure that the threenumber code on the new test
strip container matches the
three-number code on the
new code chip.
3. Insert New Code Chip
Slide the new code chip into
the code chip slot until it
snaps into place.
Each box of test strips comes with its own code chip. The code
chip provides the meter with information such as the lot number
and expiration date of the test strips.
Before each test, make sure the correct code chip is in the meter.
Each time you open a new box of test strips, replace the old code
chip with the new one.
Protect the code chip from moisture and also from equipment that
produces magnetic fields, such as a microwave oven.
Inserting a New Code Chip
Have the correct code chip ready.
1. Remove Old Code Chip
12
With the meter turned off,
remove the old code chip and
throw it away.
13
Testing a Blood Sample
Integrated Quality Controls
The CoaguChek XS System has quality control functions integrated
into the meter and test strips, so you never have to run quality
control tests with liquid quality controls. The meter automatically
runs its own quality control test as part of every blood test.
When the quality control test runs, the letters QC flash on the
meter’s display. When the quality control test completes, a
checkmark (✓) appears following the letters QC. Then the meter
continues to run the blood test.
If the quality control test fails, the meter displays the following
error message. See the Error Messages section in this manual for
an explanation of this (and other) error messages and what to do
when they occur.
Tips for a Good Fingerstick
For fingerstick blood testing, increasing the blood flow in the finger
will help you get a good drop of blood. Before you prick the finger,
try the following techniques until you see that the fingertip has
good color:
• Warm the hand by having
the patient hold it under his
or her armpit, use a hand
warmer, and/or wash the
hand with warm water.
• Have the patient hold his or
her arm down to the side,
so that the hand is below
the waist.
• Massage the finger from
its base.
If needed, immediately after
pricking, gently squeeze the
finger from the base to
encourage blood to flow.
14
15
Important Notes About Blood Testing
Always
• Operate the meter at temperatures between 65°F and 90°F
(18°C and 32°C).
Infection Control
Follow appropriate infection control guidelines.
• Use gloves.
• Use a separate lancet for each person.
• Refer to the test strip package insert for proper use and
handling of test strips.
• Dispose of used lancets and test strips in a stable container with
a lid according to infection control guidelines.
• Keep the test strip guide and meter clean. You may occasionally
need to clean them. See the Cleaning the Meter section in this
manual for more information.
• Follow all other hygiene and safety procedures applicable.
Never
• Store the meter in damp or humid conditions (greater than
85% humidity).
• Remove or insert the code chip while the meter is
performing a test.
• Use a code chip from a box of test strips other than the
one in use.
Caution: There is a potential risk of infection. Medical staff and
other persons using the CoaguChek XS 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.
• Open a vial of test strips or touch a test strip with wet hands
or gloves.
• Touch or remove the test strip during a test.
• Wait more than 15 seconds after sticking the fingertip before
applying the blood.
• Add more blood after the test has begun.
• Touch any buttons while a test is in progress.
• Perform a test with a drop of blood from a previous fingerstick.
16
17
Preparing for a Test
1. Gather Items
3. Insert Code Chip
Make sure the meter is turned
off. With the code number
facing up, insert the code chip
into the code chip slot until it
snaps into place.
4. Wash Hands
Have the patient wash his or
her hands in warm, soapy
water. Or, clean the fingertip
with an alcohol wipe.
Gather the following items:
• CoaguChek XS Meter
• Container of test strips
• Test strip code chip
• CoaguChek lancet
Each box of test strips comes
with a matching code chip. Every
time you open a new box of test
strips, you must replace the
code chip.
Make sure the fingertip is
thoroughly dry.
2. Match Codes
18
Make sure the code number
on the test strip container and
the code chip match.
19
3. Match the Code
Performing a Test
1. Get Ready
Take a test strip out of the
container.
If the numbers are different,
make sure you are using the
code chip that came with the test
strips you are using.
Close the container tightly.
Do not open a vial of test strips
or touch a test strip with wet
hands or gloves. This may
damage the test strips.
An hourglass appears as the
meter warms up, which takes
about thirty seconds
You have 10 minutes to use a
test strip once you remove it
from the container.
When the meter is warmed up
a flashing test strip appears and
the meter begins a countdown.
You have 120 seconds to apply
blood to the test strip.
4. Collect the Blood
2. Insert Strip
Slide the test strip into the test
strip guide in the direction of
the arrows until it stops.
The meter turns on. The code
number of the inserted code chip
flashes on the display.
Confirm that the number
displayed matches the number
on the test strip container,
then press M
.
Twist the protective cap off the
CoaguChek lancet.
Massage the finger until you see
increased color in the fingertip.
Keeping the hand down, press
the tip of the lancet firmly
against the side of the
fingertip. Press the blue
trigger button.
Gently squeeze from the base of
the finger to develop a hanging
drop of blood.
20
21
5. Identify the Target Area
Find the target area on the
test strip.
7. Record Result
Record the result according to
your facility’s guidelines.
8. Clean Up
Place the used test strip
and lancet in an approved
container. Turn the meter
off
.
You can dose the target area by
bringing the patient’s finger to
the top of the test strip or by
bringing the meter to the
patient’s finger so that the side
of the test strip touches the
blood drop.
6. Apply the Blood
Within 15 seconds of sticking
the fingertip, apply the blood
to the target area of the test
strip—either from the top or
side of the test strip.
Hold the blood drop to the
test strip until you hear a beep.
The flashing blood drop symbol
disappears.
Do not add more blood to
the test strip. Do not touch
the test strip.
If the meter is dirty, wipe it clean
with a CoaguWipe™ Bleach
Towel or other recommended
cleaner.
The result appears in about
1 minute.
22
23
Optional Testing Methods
Out of Range Values
The CoaguChek XS PT test strips provide test results if the INR
value is between 0.8 and 8.0. If the result falls outside of this
range, the meter displays < (less than) 0.8 or > (greater than) 8.0.
If the meter indicates an out-of-range value, refer to the test strip
package insert and repeat the test.
In rare cases, Error Message 7 can occur in patients with long
coagulation times (> 8 INR). If this error message appears again
when the test is repeated, the result must be checked using
another method.
OR
Using Capillary Tubes
You may use capillary tubes to collect the blood from a fingerstick
and to dose the test strip. Use only CoaguChek Capillary
Tubes/Bulbs, Cat. No. 11621173001. Do not use glass capillary
tubes or capillary tubes that contain anticoagulants.
The following steps are optional to the fingerstick blood sample
instructions in the Preparing for a Test and Performing a Test
sections of this manual.
1. Prepare the Capillary Tube
Firmly insert the end of the
capillary tube into the capillary
bulb. Completely insert the
tube into the bulb to break the
bulb diaphragm.
Do not push the capillary tube in
so far that it extends beyond the
top of the bulb.
24
25
2. Fill the Capillary Tube
When the flashing test strip
appears on the meter’s
display, stick the fingertip.
Then touch the capillary tube
to the blood drop. Keep the
tube level, and allow it to fill
by capillary action. Fill the
tube only halfway.
Avoid getting air bubbles into the
sample. Do not touch the hole at
the top of the bulb. If blood gets
into the bulb during sample
collection, discard the bulb and
repeat the test with a new test
strip and fingerstick.
3. Dose the Test Strip
4. Record Result
Record the result according to
your facility’s guidelines.
5. Dispose of Blood
Collection Items
After testing, discard the
capillary tube along with the
used test strip and lancet
according to infection control
guidelines.
Within 15 seconds of sticking
the fingertip, apply the blood
to the test strip. Put your
finger over the hole at the end
of the capillary tube. Hold the
capillary tube directly over the
target area of the test strip.
Squeeze the bulb to dispense
one hanging drop of blood.
Do not touch the test strip, move
the meter, or add more blood
during testing.
26
27
Using Venous Blood
You may use the CoaguChek XS Meter to test venous blood. Blood
may be collected directly using a butterfly or a needle and syringe.
Do not clean the syringe tip with alcohol or water prior to dosing
the test strip. Use only a plastic syringe free of anticoagulant. Do
not use glass. The syringe needle should be 23 gauge or larger. A
21 gauge or larger needle is recommended.
2. Dose the Test Strip
Do not touch the test strip. Do
not introduce air bubbles, move
the meter, or add more blood
during testing.
Note: Refer to the Preparing for a Test and Performing a Test sections of
this manual for fingerstick blood testing instructions.
1. Collect the Venous Sample
When the flashing test strip
appears on the meter’s
display, collect the venous
blood sample.
3. Record Result
Record the result according to
your facility’s guidelines.
4. Dispose of Blood
Collection Items
After testing, discard the
needle, syringe, or butterfly,
and used test strip according
to infection control guidelines.
Do not perform venipuncture
until the flashing test strip
is displayed.
28
Discard the first 4 drops of
blood. Then immediately place
1 hanging drop of blood
directly onto the target area of
the test strip. Completely
cover the target area.
29
Memory
Storing Test Results in Memory
2. View Most Recent Result
The most recent test result
appears. The letters mem
indicate that you are viewing a
result in memory. The time
and date of the test also
appear. If there are no results
in memory, a 0 appears in the
display’s top-right corner.
3. View Earlier Results
To view earlier results, press
the M button again
.
After you have viewed all the
results in the memory,
3 dashes appear.
The CoaguChek XS Meter automatically stores up to 100 test
results and their dates and times in its memory. If the memory is
full when you perform a test, the oldest result is automatically
deleted. The most recent result is always saved.
Note: All test results, including their date and time, remain in memory
even when the meter is without batteries.
Reviewing Stored Test Results
You can review stored test results even when the meter’s battery
power is low.
To review results in memory:
1. Access the Memory
30
Press the M button
.
The meter turns on, if it is
not already on, and goes to
Memory mode.
31
Erasing Stored Test Results
2. Confirm
You can erase all of the test results that are stored in the meter’s
memory. You cannot, however, erase individual test results.
To erase all stored results:
1. Go to Erase mode.
With the meter turned off,
press and hold down the
M button
. While you are
holding down the M button,
press the ON-OFF button
and then hold down both
buttons for at least 5 seconds.
Press the M button
to
confirm that you want to erase
the entire memory.
Note: To exit Erase mode without
erasing the results, press the
ON-OFF button instead.
The hourglass symbol flashes
while the test results are
being erased. Then, the
counter is set to 0 and 3
dashes appear.
The meter displays mem
(flashing) and clr. The
number of results in memory
is shown in the top-right
corner of the display.
32
33
Cleaning the Meter
It is important to keep the meter clean. Clean the meter whenever
it looks dirty or, if you prefer a regular schedule, clean the meter
each time you open a new box of test strips.
Cleaning the Test Strip Guide
1. Open the Cover
With the meter turned off, use
your thumbnail to open the
cover of the test strip guide
by pressing its front edge
upward. Move the cover safely
away from the meter. Then
rinse the cover with water or
wipe it clean.
2. Clean the Test Strip Guide
Clean the easily accessible
areas with a cotton swab.
Use only the following products to clean the meter:
• CoaguWipe Bleach Towels or other pre-packaged bleach
towelettes
• 10% bleach solution (1 part bleach and 9 parts water)
• 70% isopropyl alcohol solution
• lint-free tissues
• cotton swabs
Caution: Do not spray any cleaning solution on the meter.
Never use a spray of any type.
Cleaning the Exterior
1. Clean the Exterior
2. Dry the Exterior
34
With the meter turned off,
wipe the meter’s exterior
clean.
With a lint-free tissue, dry
the meter.
Caution: Do not insert any
objects into the test strip
guide. Doing so could
damage the electrical
contacts behind the test
strip guide.
35
Advanced Features
3. Allow to Dry
With the cover off, allow the
test strip guide to dry for
about 10 minutes.
The CoaguChek XS Meter includes advanced features that you can
set up as necessary. They are:
• Changing the unit of measurement
• Turning off the beep (With the beep turned on, the meter beeps
when it detects a test strip, when it is ready for you to apply a
sample, when it detects a sample, when the result is displayed,
and when an error occurs—3 short beeps.)
• Setting a therapeutic range (for INR only)
4. Close the Cover
36
Close the cover, and make
sure it snaps into place.
The following table shows the setting options and the default
setting for each advanced feature:
Feature
Unit
Setting Options
%Q
Sec
INR
Default Setting
INR
Beep
On
Off
On
Therapeutic range
(for INR only)
On
Off
Off
Set range
(in INR)
Lower range (1.5 – 3.5)
Upper range (2.5 – 4.5)
1.5 INR
2.5 INR
37
The Meter’s Display
Setting Advanced Features
You can access these settings by going to Setup mode. To go to
Setup mode, press the SET button
. The date format, flashing,
will appear. Once you are in Setup mode, you’ll use these buttons:
•
•
to change a setting
to accept a setting (and move on to the next setting)
When you turn the meter on, it briefly shows all the display’s
letters, numbers, and symbols. Regularly check that all segments
of each letter, number, and symbol appear. Please compare your
meter’s display to the meter display shown here on this page.
You can display all the letters, numbers, and symbols for a longer
time to allow comparison. To do this, you will turn the meter on
and then hold down the ON-OFF button
.
The full display should appear as follows:
Note: When you go to Setup
mode, the date format, date,
time format, and time settings
appear first. Press the SET button
to move past the date and
time settings to get to the
advanced settings.
38
39
Error Messages
You may see the following error messages while using the
CoaguChek XS Meter. If you see an error message, first try to
correct the problem using the solution described below. If the
problem persists, call Roche Diagnostics Technical Service Center
at 1-800-428-4674, 24 hours a day, 7 days a week.
Error: Test Strip
A test strip was already
inserted when the meter was
turned on. If you did not
remove the test strip after the
last test, you will see this error.
This error could also occur if
the meter timed out after you
inserted the test strip.
The test strip is unusable.
Error: Meter Temperature
The meter is too cold or too
warm to measure correctly.
Solution:
Turn the meter off and allow it
to stand for about 30 minutes
at room temperature (between
65°F and 90°F).
Error: Battery
The battery level is too low.
Solution:
Replace the batteries. See
the Batteries section of
this manual.
Solution:
Remove the test strip. Then
repeat the test with a new
CoaguChek XS PT test strip.
The test strip is not a
CoaguChek XS PT test strip.
40
41
Error: Test Strip Guide Cover
The test strip guide cover is
not properly closed.
Solution:
Close the test strip guide
cover.
Error: Test Strip Expired
The test strip has expired.
Solution:
Check the meter’s date
setting. If it is not correct, set
the correct date. For more
information, see the Meter
Setup section of this manual.
If the date is correct, turn the
meter off and remove the
code chip and the test strip.
Then use the code chip and a
test strip from a new box of
test strips.
Error: Code Chip
The code chip is missing,
not properly inserted, or
damaged.
Solution:
Check to see if you have
the correct code chip
properly inserted in the meter.
For more information, see
the Code Chip section of
this manual.
If the code chip is damaged,
call Roche Diagnostics
Technical Service Center
at 1-800-428-4674.
42
Error: Test Strip Unusable
The test strip is unusable.
Solution:
Turn the meter off, remove
the test strip, and then
re-insert it. If the error
message reappears, discard
the unusable test strip and
use a new one.
43
Error Messages You May See
After You Apply Blood
Error: Time Exceeded
You did not apply blood to
the test strip within 2 minutes
after the blood drop symbol
appeared.
Error: Test Strip Interference
The test strip was touched or
removed during the test.
Solution:
Turn the meter off and
remove the test strip. Repeat
the test using the same test
strip and blood taken from a
new fingerstick from a
different finger.
Do not touch or remove
the test strip when a test is
in progress.
Error: Quality Control Failure
The test strip failed the
internal quality control check.
The test strip is unusable.
Error: Blood Application
Error applying blood to the
test strip.
Solution:
Turn the meter off and remove
the test strip.
Solution:
Turn the meter off and
remove the test strip. Repeat
the test using a new test
strip and blood taken from a
new fingerstick from a
different finger.
Solution:
Turn the meter off and
remove the test strip. Repeat
the test using a new test
strip and blood taken from a
new fingerstick from a
different finger.
Repeat the test using a new
test strip and blood taken
from a new fingerstick from a
different finger.
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Error: Measurement Error
Measurement error caused
by the blood sample.
Solution:
Do not touch or remove the test
strip when a test is in progress.
Be sure to apply the blood drop
to the test strip within 15 seconds
of sticking the fingertip.
In rare cases, Error Message 7
can occur in patients with long
coagulation times (> 8 INR). If
this error message appears again
when the test is repeated, the
result must be checked using
another method.
The CoaguChek XS PT test
strip may be used for patients
under a combination therapy
of oral anticoagulants plus
heparin injections. Under no
circumstances should heparinized
capillary tubes be used for
sample application. If capillary
tubes are used, please use only
the dedicated CoaguChek
capillary tubes.
46
Error: Internal Error
An error occurred during the
internal diagnostic test.
Solution:
Turn the meter off and
remove the batteries. Wait
at least 1 minute before
re-inserting the batteries in
the battery compartment.
Re-set the date and time as
described in the Meter Setup
section of this manual.
Caution: The date and time
must be set correctly.
Repeat the test. If you see the
same error message again,
the meter has a defect.
47
Other Information
Ordering Information for Health Care
Professionals
Please contact Roche Diagnostics Customer Service at
1-800-428-5076.
Product Specifications
Operating Conditions
Temperature
+65°F to +90°F (+18°C to +32°C)
Relative humidity
less than 85% (without condensation)
REF/Cat. Number
Maximum altitude
14,000 feet (4300 m)
CoaguChek XS System
(includes carrying case)
04837975001
Placement
Operate the meter on a level, vibration-free
surface or hold it so it is roughly
horizontal.
CoaguChek XS PT Test
2 x 24 tests
04625315160
Measuring range
Refer to test strip package insert.
Memory
100 test results with date and time
CoaguChek Lancets
Box of 200
04348150001
Interface
Infrared interface, LED/IRED Class 1
Battery operation
4 AAA batteries
Capillary Tubes/Bulbs
11621173001
Number of tests per
set of batteries
Approx. 60 tests
CoaguWipeTM Bleach Towels
04515439001
Safety class
III
Automatic power-off
After 3 minutes
Dimensions
5.43 x 3.07 x 1.10 in (138 x 78 x 28 mm)
Weight
4.48 oz. or 127 g (without batteries)
Product Limitations
Please read the information packaged with the test strips
regarding up-to-date product specifications and limitations.
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Symbols
Sample Material
Sample type
Capillary whole blood or
non-anticoagulated venous whole blood.
Sample size
At least 10 µL
Interference
Refer to the test strip package insert.
Non-Operating Storage and Transport Conditions
Temperature range
-13°F to +158°F (-25°C to +70°C)
Relative humidity
10 to 85% (without condensation)
The following table lists all of the display screen icons and
their meaning.
Symbol
Meaning
Test strip (without sample application area)
Test strip (with sample application area)
Apply sample
User must wait until the meter has
completed an action.
24-hour time format
Support/Services
Questions
Please call the Roche Diagnostics Technical Service Center at
1-800-428-4674 if you have questions regarding the handling
of your meter, the reliability of your results, or if you suspect the
meter is defective.
Repairs
Please note that repairs, new settings or other modifications to the
meter may only be performed by persons authorized by Roche
Diagnostics.
12-hour time format
Time between midnight and noon
(in 12-hour time format)
Time between noon and midnight
(in 12-hour time format)
Indicates the results are displayed as a
Quick percentage value.
Indicates the results are displayed in
Seconds.
Indicates the results are displayed in
INR units.
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51
Symbol
Meaning
Beep tone is turned on
Beep tone is turned off
Result is above the chosen therapeutic range
(only with INR as unit)
Result is below the chosen therapeutic range
(only with INR as unit)
• Results in the chosen unit
• Error numbers
Memory contains no results or no further
results
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. You can,
however, still access the meter’s memory.
The meter is in Memory Mode.
Automatic quality control completed
successfully
Reports an error (see Error messages)
Displays the time in HH:MM format
Displays the date in DD-MM-YY,
MM-DD-YY or YY-MM-DD format.
The monitor is in Setup Mode.
Room or meter temperature is outside the
acceptable range.
Communication is taking place via the
infrared interface
Measurement chamber cover is open.
Indicates the code number of the code chip
inserted in the meter.
Result in the chosen unit is above the
measuring range.
Result in the chosen unit is below the
measuring range.
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Warranty
CoaguChek XS 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 meter and parts thereof, shall be the repair and/or
replacement of the meter or parts at Roche Diagnostic’s option.
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
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® products. Meters
which show damage or misuse will be handled in accordance with
Roche Diagnostic’s non-warranty service policy.
54
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.
CoaguChek® XS System User Manual
For investigational use only. Not for use in diagnostic
procedures.
The following U.S. patents have been granted or are pending for the
CoaguChek XS System (meter and test strips): 6,662,439; 7,073,246;
2005/0103624; 6,881,378; 6,207,000; 2005/0214171; 2005/0123441; 6,645,368;
2004/0157339; 2005/0129574; 2005/0135968
COAGUCHEK and COAGUWIPE are trademarks of Roche.
DISPATCH is a registered trademark of Caltech Industries, Inc.
© 2006 Roche Diagnostics. All rights reserved.
04837991001-0806
Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46256
www.coaguchek.com
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