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INTENDED USE
The A1CNow® SELFCHECK test provides
quantitative measurement of the percent
of glycated hemoglobin (%A1C) levels in
capillary (fingerstick) blood samples. The test
is for home use to monitor glycemic control
in people with diabetes.
Before using this test, please read all
instructions carefully. If you need further
help, call 1-877-870-5610
. We invite you to
call and we will guide you through the test.
OVERVIEW AND
HELPFUL HINTS
INTRODUCTION
The percent (%) of A1C in your blood today
tells you how well you have been controlling
your blood sugar (glucose) levels over the
past 2-3 months. About 50% of the A1C
result is from the past 30 days of blood sugar
levels; about 25% is from the past 30-60
days and about 25% is from the past 60-90
days.
1
The American Diabetes Association (ADA)
recommends that your A1C levels should
be tested at least 2 times per year if you are
meeting your diabetes treatment goals and
your blood sugar is stable. If your treatment
changes or you are not meeting your
treatment goals, the ADA recommends that
you test at least every 3 months.
2
The A1CNow SELFCHECK is an easy-to-use
at home test to measure your A1C levels,
with results in 5 minutes. In addition to blood
sugar testing, you can further participate
in your diabetes care using this test. You
can have the results ready before you have
your checkups to share with your health
care professional. Contact your health care
professional if you have any concerns about
your A1C result. The A1CNow SELFCHECK
test is not a substitute for regular
assessment in a doctor’s office or laboratory
setting where a quality control program is in
effect.
KIT CONTENTS
The box contains materials for two A1C
tests. Make sure all of the following parts are
in the box. DO NOT open the pouches until
ready to use.
• A1CNow SELFCHECK Monitor (1)
• Cartridge Pouch (2)
• Shaker Pouch (2), each containing:
- Shaker (1)
- Blood Collector (1)
- Lancet, disposable (1)
• Quick Reference Guide (1)
• Overview and Helpful Hints (1)
PREPARING TO TAKE THE TEST
You may run your A1C test any time of the
day. Remember to wash your hands prior to
performing the test.
No special diet is necessary (you do not have
to be fasting when taking this test). You may
want to run this test at the same time as you
do a blood sugar test.
In order to help ensure an accurate result,
please complete the test from beginning to
end within 15 minutes. Avoid running the test
in direct sunlight, on hot or cold surfaces or
near sources of hot or cold. If the test has
recently been at high temperatures
(greater than 77° F / 25° C) or at low
temperatures (lower than 64° F / 18° C) allow
the kit parts to come to room temperature
(64° - 77° F / 18° - 25° C) for at least one
hour before you run your test. Leave the
parts in their sealed pouches while waiting.
WHAT TO DO WITH THE RESULT
The Monitor will not store your results for
more than 60 minutes, so write down the
result and the test date on the Result Log
in the Quick Reference Guide as soon as
possible to prevent loss of information.
WHAT THE TEST RESULT MEANS
For most people with diabetes, the American
Diabetes Association (ADA) recommends
that your A1C should be under 7%.
2
Your
health care professional will tell you what
target level is right for you.
HOW DOES THIS TEST COMPARE
WITH THE A1C TEST FROM THE
DOCTOR’S OFFICE OR THE
LABORATORY?
Test results will rarely match exactly. This
is true even for repeated tests done in the
same lab.
A1C results may be different due to: slight
differences between labs, normal variation
within each test method and the time
between two tests.
STORAGE
Store and use at room temperature
(64° - 77° F / 18° - 25° C) and out of direct
sunlight.
If you cannot confidently store the kit under
these recommended conditions, you have
the option of refrigerating the kit (DO NOT
freeze). However, you must bring the kit to
room temperature for at least one hour prior
to use.
DO NOT use the test after the expiration date
shown on the box.
WARNINGS AND PRECAUTIONS
• DO NOT adjust your medication unless
instructed to do so by your doctor or
health care professional.
• This test is NOT a substitute for regular
visits to your health care professional or
for monitoring your blood sugar levels.
• This test is NOT for the screening or
diagnosis of diabetes.
• DO NOT substitute this test for blood
sugar monitoring.
• The following conditions may affect the
accuracy of your A1C result: hemoglobin
variants (HbS, HbC), elevated HbF,
anemia, recent significant blood loss, a
recent blood transfusion, or high amounts
of rheumatoid factor.
• People with hemophilia (bleeding
disorder) or on anti-coagulant therapy
(blood thinning medicine) should consult
their doctor or health care professional
before using this kit.
• To ensure proper test performance,
carefully read and follow the Quick
Reference Guide.
• DO NOT use the test kit if any parts are
cracked or broken.
• DO NOT eat or drink any parts of this kit.
• For use outside of the body only (in-vitro
diagnostic use).
• Keep out of reach of children under
the age of 7 years. When children are
performing the test, be sure that testing is
done under adult supervision.
• DO NOT use any other body fluids or
food to perform this test. Use ONLY your
fingerstick blood sample.
• DO NOT reuse the Shaker, Lancet or the
Cartridge. Throw these parts away after
using them once. Refer to “Disposal of
Material” on the reverse side.
• If the solution from inside the Shaker
touches your skin or your eyes, flush with
water.
• Leave the Cartridge Pouch sealed until
ready for use.
• DO NOT add your blood directly to the
cartridge. Your blood must first be added
to the Shaker.
• DO NOT touch the white circle area of the
Cartridge.
• This test is to be used at room
temperature between 64° and 77° F
(18° and 25° C). Using the test outside
this temperature range will give you an
error code.
AT-HOME A1C SYSTEM
91076 B 3/2014
