Roche CoaguChek XS User Manual

PDF-X3-Druckdaten - Helmut Benz KG
# 152 / 2008 - RPD B 075 - Frau Frank
CoaguChek XS
® Before You Start Testing
If you are new to the CoaguChek XS System,
PT Test
watch the CoaguChek XS System Patient
Training DVD and read the CoaguChek XS
System Getting Started Guide before testing.
REF 0 4625374160
US
Storing the Test Strips
6 Test Strips REF 0 4499603001
and 1 Code Chip
Store the test strips in their container, with
PERSONAL USE
the cap closed. You can store the test strips
at room temperature or in the refrigerator
Purpose
(2 to 30°C or 36 to 86°F). When stored
The CoaguChek XS PT test strips are part of
properly, the test strips can be used until
the CoaguChek XS System. The CoaguChek
the expiration date printed on the test strip
XS System measures blood-clotting time strip container.
for people who are taking anticoagulation
Throw the test strips away if they are past
medications such as Coumadin ® or warfarin.
their "Use By" date.
The CoaguChek XS System uses blood from
a fingerstick. The system is intended for
properly selected and suitably trained users
Handling the Test Strips
or their caregivers on the prescription or other
order of the treating doctor. Users should be
When you are ready to test, remove 1 test
stabilized on anticoagulation medications
strip from the container. Close the container
such as Coumadin or warfarin prior to self-
tightly.
testing with the CoaguChek XS System.
You must use the test strip within 10 minutes
Caution: These test strips are for use of removing it from the container. Otherwise,
outside the body only. Do not eat the test you may get an error message and you will
strips. have to repeat the test.
pi_04899954001_04_US_594x160.ind1 1
Step 1: Getting Ready to Test
Gather supplies:
● CoaguChek XS Meter
● Container of CoaguChek XS PT Test Strips
● Test Strip Code Chip
● ACCU-CHEK
® Softclix Lancet Device and
Lancet
Step 2: Getting a Good Drop of Blood
Increasing the blood flow in your finger will
help you get a good drop of blood. Before you
lance your finger, try the following techniques
until you see that your fingertip has good color:
● Warm your hand by holding it under your
Place the meter on a flat surface (like a table arm, using a hand warmer, and/or washing
or countertop) or hold it roughly horizontal so your hand with warm water.
that it will not vibrate or move during testing.
● Hold your arm down to the side so that
Vibrations or other movement can result in an
your hand is below your waist.
error message.
● Massage your finger from its base.
If you are using test strips from a new,
● If needed, immediately after lancing,
unopened box, you will need to change the
gently squeeze your finger from its base to
test strip code chip. The 3-number code on
encourage blood flow.
the test strip container must match the 3-
number code on the code chip. To install the
Step 3: Performing the Test
code chip, follow the instructions in the Code
1. Wash your hands with warm, soapy water.
Chip section of the CoaguChek XS System
Dry completely.
User Manual for Self-Testing.
2. Take a test strip out of the container. Close 7. Use the lancet device to perform a
the container tightly. fingerstick. Set the penetration depth
to 5. See the CoaguChek XS System
3. Insert a test strip as far as you can into the
User Manual for Self-Testing for more
meter. The meter turns on.
information. After sticking your finger, you
4. Confirm that the number displayed
have 15 seconds to apply blood to the test
matches the number on the test strip
strip. If it takes longer to form a good drop
container, then press M. If the numbers
of blood, lance a different finger for the test.
are different, make sure you are using the
code chip that came with the test strips
you are using. If they still do not match, call
the Roche Diagnostics Technical Service
Center at 1-800-428-4674, 24 hours a day,
7 days a week, 365 days a year.
5. An hourglass appears as the meter warms
up, which takes about 30 seconds.
6. When the meter is warmed up, a flashing
test strip and blood drop symbol appear
and the meter begins a countdown. You
have 120 seconds to apply blood to the 8. Apply 1 drop of blood to the side of the
test strip.
test strip.
It's important to hold the blood drop to Limitations of Procedure
the test strip until you hear a beep.
Information for You and Your Physician:
9. You'll see the hourglass when the blood • The CoaguChek XS System for patient self-
test begins. Then, pull your finger away testing should not be used for patients
being treated with any direct thrombin
from the test strip.
inhibitors, including Hirudin, Lepirudin,
Bivalirudin and Argatroban.
• The CoaguChek XS PT Test for patient self-
testing uses only fresh capillary blood from
a fingerstick.
• The blood drop must be a minimum of 10 μL
in volume. Low sample volume will cause an
error message.
• Never add more blood to test strip after test
has begun or perform another test using the
same fingerstick.
• When a patient is on intravenous infusion
Remember to apply only one drop of blood— therapy, do not collect fingerstick sample
don't add more. Do not touch or remove the from arm receiving the infusion line.
test strip when a test is in progress. • Hematocrit ranges between 25-55% do not
significantly affect results.
The result appears in about 1 minute.
• Testing has confirmed that PT/INR test
10. Record the result on the CoaguChek XS
results are not affected by:
System Prothrombin Time Self-Testing Log
• Bilirubin up to 30 mg/dL
Book. Call your doctor with the test result.
• Lipemic samples containing up to 500 mg/dL
of triglycerides.
11. Properly dispose of the used lancet and
• Hemolysis up to 1000 mg/dL
test strip.
• Clopidogrel (Plavix ) up to 20 mg/dL
®
12. Turn the meter off.
• Fondaparinux (Arixtra ® ) up to 5 mg/L
If you need to redo a test, use a new lancet, a
• The results are unaffected by heparin
new test strip, and a different finger. concentrations up to 0.8 U/mL.
0 4899954001(04)
V1/R1 (black) – 2007-12
26.02.2008 11:22:24